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Triple-Negative Breast Cancer Market Gearing Up for Impressive Growth at a CAGR of 4.7% During the Forecast Period (2025-2034)
Triple-Negative Breast Cancer Market Gearing Up for Impressive Growth at a CAGR of 4.7% During the Forecast Period (2025-2034)

Malaysian Reserve

time6 hours ago

  • Business
  • Malaysian Reserve

Triple-Negative Breast Cancer Market Gearing Up for Impressive Growth at a CAGR of 4.7% During the Forecast Period (2025-2034)

The triple-negative breast cancer market is expected to grow due to rising incidence rates, increasing awareness, advancements in targeted therapies, ongoing clinical trials, improved diagnostics, and greater investment in research and development. Along with these, the launch of emerging therapies such as DATROWAY, PADCEV, BNT327/ PM8002, and others will fuel the TNBC market growth. LAS VEGAS, July 29, 2025 /PRNewswire/ — DelveInsight's Triple-Negative Breast Cancer Market Insights report includes a comprehensive understanding of current treatment practices, triple-negative breast cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Triple-Negative Breast Cancer Market Report According to DelveInsight's analysis, the market size for triple-negative breast cancer was found to be USD 4.5 billion in the 7MM in 2024. The United States accounted for the highest market size of TNBC, approximately 69% of the total market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan. As per the estimates, among the current treatment options, KEYTRUDA (pembrolizumab) and chemotherapy held the largest TNBC treatment market share, generating approximately USD 2 billion in revenue in 2024 across the 7MM. In 2024, 7MM recorded approximately 104K new TNBC cases. With a projected CAGR of 0.7%, the number of cases is expected to gradually rise, leading to a higher disease burden by 2034. Leading triple-negative breast cancer companies developing emerging therapies, such as AstraZeneca, Daiichi Sankyo, Astellas Pharma, Pfizer, Galera Therapeutics, BioNTech, and others, are developing new TNBC treatment drugs that can be available in the triple-negative breast cancer market in the coming years. The promising triple-negative breast cancer therapies in the pipeline include DATROWAY (Datopotamab Deruxtecan), PADCEV (Enfortumab vedotin), Tilarginine, BNT327/PM8002, IMFINZI (Durvalumab), and others. Discover the TNBC new treatment @ New Treatments for TNBC Triple-Negative Breast Cancer Market Dynamics The triple-negative breast cancer market dynamics are expected to change in the coming years. Combining chemotherapy, immunotherapy, and targeted therapies, such as TALZENNA and TRODELVY, offers enhanced disease control and expands treatment options for advanced-stage TNBC patients, while innovations in immune checkpoint inhibitors, therapeutic vaccines, and ongoing research into personalized approaches are transforming long-term management by boosting immune response, improving survival rates, and addressing the need for more effective, tailored solutions beyond first-line therapy As potential therapies are being investigated for the treatment of triple-negative breast cancer, it is safe to predict that the treatment space will significantly impact the triple-negative breast cancer market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the triple-negative breast cancer market in the 7MM. However, several factors may impede the growth of the triple-negative breast cancer market. TNBC is the most difficult breast cancer subtype to manage due to its aggressive nature, lack of targeted treatment options, and high rates of chemotherapy resistance, which contribute to frequent relapse, reduced treatment efficacy, and limited long-term remission, even when diagnosed early; this underscores the urgent need for innovative, effective therapies that not only improve outcomes and prevent disease progression but also minimize the significant side effects of current aggressive treatments like chemotherapy and immunotherapy, which severely impact patient quality of life. Moreover, triple-negative breast cancer treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the triple-negative breast cancer market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the triple-negative breast cancer market growth. Triple-Negative Breast Cancer Treatment Market Triple-negative breast cancer lacks expression of hormone receptors and HER2, rendering it unresponsive to endocrine and HER2-targeted therapies. Consequently, systemic chemotherapy has long been the mainstay of treatment, especially in metastatic settings. Management typically starts with neoadjuvant or adjuvant chemotherapy, progressing to first-line treatments in advanced stages. If the disease advances or shows inadequate response, additional lines of therapy are introduced. Immunotherapies, particularly PD-1/PD-L1 inhibitors, are increasingly being utilized in metastatic TNBC to boost the body's immune defense against cancer cells. In early-stage TNBC, the PD-1 inhibitor KEYTRUDA (pembrolizumab) has become a standard part of treatment. It is administered with neoadjuvant chemotherapy and then continued as adjuvant monotherapy. In PD-L1-positive patients (CPS ≥10), it is also used alongside chemotherapy for locally recurrent or metastatic disease. Targeted therapies are making headway as well, particularly for patients with BRCA mutations. In such cases, PARP inhibitors like LYNPARZA (olaparib) and TALZENNA (talazoparib) target defective DNA repair pathways. TRODELVY (sacituzumab govitecan), an antibody-drug conjugate (ADC) targeting TROP-2, is approved for relapsed or treatment-resistant metastatic TNBC. Although TECENTRIQ (atezolizumab) was withdrawn from the U.S. market after failing confirmatory trials, it is still available in Europe and Japan. Taxane-based chemotherapy continues to be a cornerstone of TNBC treatment and is often combined with immune checkpoint inhibitors in PD-L1-positive cases. Platinum-based chemotherapy, though occasionally used, has shown mixed results due to concerns over toxicity and limited benefit. Despite therapeutic progress, TNBC remains a particularly aggressive subtype, underscoring the urgent need for continued innovation. Overall, current treatments frequently fall short of achieving lasting disease control, highlighting the pressing demand for novel therapies that can improve long-term outcomes and survival for TNBC patients. To know more about FDA-approved drugs for TNBC, visit @ Approved TNBC Treatment Triple-Negative Breast Cancer Pipeline Therapies and Key Companies Some of the drugs in the pipeline include DATROWAY [(Datopotamab Deruxtecan), AstraZeneca and Daiichi Sankyo], IMFINZI [(Durvalumab), AstraZeneca], PADCEV [(Enfortumab vedotin), Astellas Pharma and Pfizer], Tilarginine [(L-NMMA), Galera Therapeutics], and others. Datopotamab deruxtecan (Dato-DXd), also known as DATROWAY, is an experimental antibody-drug conjugate (ADC) being evaluated for the treatment of triple-negative breast cancer, both as a standalone therapy and in combination with IMFINZI (durvalumab). The therapy is aimed at high-risk TNBC patients, including those who are PD-L1-positive. Results from pivotal Phase III trials are expected in 2025, with more comprehensive findings anticipated by 2026, potentially influencing future treatment approaches for TNBC. Currently in Phase III development for TNBC, Dato-DXd is part of a global collaboration between AstraZeneca and Daiichi Sankyo, initiated in July 2020. Under this partnership, Daiichi Sankyo retains exclusive rights in Japan and oversees manufacturing and supply, while both companies are co-developing the drug across several cancer types globally. Tilarginine (L-NMMA), a broad nitric oxide synthase (NOS) inhibitor, is under Phase II investigation for metaplastic breast cancer (MpBC) in combination with alpelisib and nab-paclitaxel in HER2-negative metastatic or locally advanced settings. It is also being explored with a taxane in Phase II trials for patients with metastatic or locally advanced TNBC. In December 2024, Galera Therapeutics acquired Nova Pharmaceuticals. IMFINZI (durvalumab), an FDA-approved PD-L1 inhibitor developed by AstraZeneca for other cancers, works by blocking PD-L1 to enhance immune system recognition and destruction of tumor cells. It is currently undergoing Phase I/II studies in combination with paclitaxel and other novel therapies as a first-line option for metastatic TNBC (mTNBC), with key data expected by late 2025. Notably, the BEGONIA trial (October 2023) reported durable and significant tumor responses from the combination of datopotamab deruxtecan and IMFINZI when used as a first-line treatment for patients with mTNBC, along with a favorable safety profile. The anticipated launch of these emerging therapies are poised to transform the triple-negative breast cancer market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the triple-negative breast cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. Discover more about triple-negative breast cancer drugs in development @ Triple-Negative Breast Cancer Clinical Trials Recent Developments in the Triple-Negative Breast Cancer Market In May 2025, Gilead Sciences, Inc. reported that TRODELVY (sacituzumab govitecan-hziy) combined with KEYTRUDA (pembrolizumab) lowered the risk of disease progression or death by 35% (hazard ratio: 0.65) compared to the standard treatment of Keytruda plus chemotherapy as a first-line therapy for patients with PD-L1–positive (CPS ≥10) metastatic triple-negative breast cancer (TNBC). In May 2025, Gilead Sciences, Inc. reported positive topline results from the Phase 3 ASCENT-03 trial evaluating TRODELVY (sacituzumab govitecan-hziy). The study achieved its primary goal by showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not eligible for PD-1/PD-L1 inhibitors, either due to being PD-L1 negative or otherwise unsuitable for immunotherapy. In December 2024, Galera Therapeutics completed the acquisition of Nova Pharmaceuticals. Triple-Negative Breast Cancer Overview Triple-negative breast cancer is a particularly aggressive and diverse form of breast cancer that lacks expression of estrogen receptors (ER), progesterone receptors (PR), and HER2. It accounts for a substantial share of breast cancer cases and is associated with fast disease progression, high chances of recurrence, and unfavorable outcomes. TNBC tends to occur more frequently in younger women, individuals of African American descent, and those with BRCA1 gene mutations. The risk factors for TNBC are divided into two categories: non-modifiable factors, such as age, gender, genetic mutations, family history, and breast density, and modifiable ones, which include obesity, exposure to certain chemicals, and specific drug use. Due to its aggressive behavior and absence of hormone receptors, TNBC is particularly difficult to treat, highlighting the need for continuous research to enhance therapeutic approaches and patient survival. Diagnosis typically involves imaging tools like mammography, ultrasound, and MRI, followed by tissue sampling techniques including core needle biopsy, fine needle aspiration, or surgical biopsy. TNBC tumors are often high-grade and poorly differentiated, and the disease is staged using the TNM system, which evaluates tumor size, lymph node involvement, and the extent of metastasis. Triple-Negative Breast Cancer Epidemiology Segmentation The triple-negative breast cancer epidemiology section provides insights into the historical and current triple-negative breast cancer patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The triple-negative breast cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Incident Cases of Breast Cancer Total Incident Cases of TNBC Gene Mutation-specific Incident Cases of TNBC Stage-specific Incident Cases of TNBC Age-specific Incident Cases of TNBC Line-wise Treated Incident Cases of TNBC Triple-Negative Breast Cancer Market Report Metrics Details Study Period 2020–2034 Coverage 7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Triple-Negative Breast Cancer Market CAGR 4.7 % Triple-Negative Breast Cancer Market Size in 2024 USD 4.5 Billion Key Triple-Negative Breast Cancer Companies AstraZeneca, Daiichi Sankyo, Astellas Pharma, Pfizer, Galera Therapeutics, BioNTech, Merck, Gilead Sciences, Roche, Genentech, and others Key Triple-Negative Breast Cancer Therapies DATROWAY (Datopotamab Deruxtecan), PADCEV (Enfortumab vedotin), Tilarginine, BNT327/PM8002, IMFINZI (Durvalumab), KEYTRUDA, TRODELVY, TALZENNA, LYNPARZA, TECENTRIQ, and others Scope of the Triple-Negative Breast Cancer Market Report Therapeutic Assessment: Triple-Negative Breast Cancer current marketed and emerging therapies Triple-Negative Breast Cancer Market Dynamics: Key Market Forecast Assumptions of Emerging Triple-Negative Breast Cancer Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Triple-Negative Breast Cancer Market Access and Reimbursement Download the report to understand which factors are driving triple-negative breast cancer market trends @ Triple-Negative Breast Cancer Market Forecast Table of Contents 1 Key Insights 2 Report Introduction 3 TNBC Market Overview at a Glance 3.1 Market Share (%) Distribution of TNBC by Therapies in the 7MM in 2020 3.2 Market Share (%) Distribution of TNBC by Therapies in the 7MM in 2034 4 Executive Summary 5 Key Events 6 Disease Background and Overview 6.1 Introduction 6.2 Various Subtypes of Breast Cancer Based on Immunohistochemical Expression 6.3 TNBC Overview 6.3.1 Intrinsic Molecular Subtypes in TNBC 6.3.2 Characteristics of Tumor Microenvironment in TNBC 6.3.3 Potential Risk Factors 6.3.4 Clinical Presentation 6.3.5 Characterization of HER2-low Breast Cancers 6.4 Diagnosis 6.4.1 Staging 6.4.2 Grading 6.4.3 Clinical Prognostic Stage 6.4.4 Pathological Prognostic Stage 6.4.5 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer 6.4.6 Recommendations for HER2 Testing in Breast Cancer: American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Clinical Practice Guideline Update 6.4.7 Diagnostic Algorithm 6.5 Treatment and Management 6.5.1 NCCN Clinical Practice Guidelines in Oncology for Breast Cancer 6.5.2 ESMO Clinical Practice Guidelines for Diagnosis, Treatment, and Follow-up of Early Breast Cancer 6.5.3 ESMO Clinical Practice Guideline for the Diagnosis, Staging, and Treatment of Patients with Metastatic Breast Cancer 6.5.4 Japanese Breast Cancer Society (JBCS) Clinical Practice Guidelines for Breast Cancer – 2022 Update 6.5.5 Treatment Algorithm 7 Epidemiology and Market Forecast Methodology 8 Epidemiology and Patient Population 8.1 Key Findings 8.2 Assumptions and Rationale: 7MM 8.2.1 Incident Cases of Breast Cancer 8.2.2 Incident Cases of TNBC 8.2.3 Gene Mutation-specific Incident Cases of TNBC 8.2.4 Stage-specific Incident Cases of TNBC 8.2.5 Age-specific Incident Cases of TNBC 8.3 Total Incident Cases of Breast Cancer in the 7MM 8.4 Total Incident Cases of TNBC in the 7MM 8.5 The United States 8.6 EU4 and the UK 8.7 Japan 9 Patient Journey 10 Marketed Therapies 10.1 Key Cross Competition 10.2 KEYTRUDA (pembrolizumab): Merck 10.2.1 Product Description 10.2.2 Regulatory Milestone 10.2.3 Other Developmental Activities 10.2.4 Clinical Trials Information 10.2.5 Safety and Efficacy 10.3 TRODELVY (sacitzumab govitecan-hziy): Gilead Sciences 10.4 TALZENNA (talazoparib): Pfizer 10.5 LYNPARZA (olaparib): AstraZeneca/Merck 10.6 TECENTRIQ (atezolizumab): Roche/Genentech To be continued in the report… 11 Emerging Drug Profiles 11.1 Key Cross Competition of Emerging Drugs 11.2 DATROWAY (Datopotamab Deruxtecan): AstraZeneca/Daiichi Sankyo 11.2.1 Drug Description 11.2.2 Other Developmental Activities 11.2.3 Clinical Trials Information 11.2.4 Safety and Efficacy 11.2.5 Analysts' View 11.3 PADCEV (Enfortumab vedotin): Astellas Pharma/Pfizer 11.4 Tilarginine: Galera Therapeutics 11.5 BNT327/PM8002: BioNTech 11.6 IMFINZI (Durvalumab): AstraZeneca To be continued in the report… 12 TNBC: Market Analysis 12.1 Key Findings 12.2 Market Outlook 12.3 Attribute Analysis 12.4 Key Market Forecast Assumptions 12.4.1 Cost Assumptions and Rebates 12.4.2 Pricing Trends 12.4.3 Analogue Assessment 12.4.4 Launch Year and Therapy Uptake 12.5 Total Market Size of TNBC in the 7MM 12.6 Market Size of TNBC by Therapies in the 7MM 12.7 Market Size of TNBC in the United States 12.8 Market Size of TNBC in EU4 and the UK 12.9 Market Size of TNBC in Japan 13 Key Opinion Leaders' Views 14 Unmet Needs 15 SWOT Analysis 16 Market Access and Reimbursement 16.1 The United States 16.2 In EU4 and the UK 16.3 Japan 17 Acronyms and Abbreviations 18 Bibliography 19 Report Methodology Related Reports PD-L1 Inhibitors Market PD-L1 Inhibitors Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PD-L1 inhibitors companies including EQRX, CSTONE PHARMACEUTICALS, PFIZER, NOVARTIS, ARCUS BIOSCIENCES, AGENUS, TRACON PHARMACEUTICALS, SHANGHAI HENLIUS BIOTECH, INCYTE CORPORATION, among others. PARP Inhibitors Market PARP Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PARP inhibitors companies including AstraZeneca, Merck, Janssen, Pfizer, Astellas, Pharma& Schweiz, AtlasMedx, AbbVie, GlaxoSmithKline, Pfizer, BeiGene, Allarity Therapeutics, among others. Triple-Negative Breast Cancer Pipeline Triple-Negative Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key TNBC companies, including G1 Therapeutics, Inc., Gilead Sciences, Biotheus Inc., GlaxoSmithKline, AstraZeneca, Shanghai Jiaolian Drug Research and Development Co., Ltd, Coherent Biopharma, Daiichi Sankyo Company, Merck, SynDevRx, Inc., Treadwell Therapeutics, AstraZeneca, Novartis Pharmaceuticals, NEC Corporation, Cardiff Oncology, Ocellaris Pharma, Inc., Nuvation Bio Inc., Phoenix Molecular Designs, Pure Biologics S.A., Pure Biologics S.A., Mersana Therapeutics, Zumutor Biologics Inc., Tubulis GmbH, Hinova Pharmaceuticals, Primevax, ARCE Therapeutics, HC Biopharma, Casinvent, among others. Breast Cancer Market Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key breast cancer companies including Veru, Sanofi, Roche, AstraZeneca, Eli Lilly, EQRx, Gilead, Sermonix Pharmaceuticals, Evgen Pharma, Tyme, Genentech, Daiichi Sankyo, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakur [email protected] + Logo: View original content:

Triple-Negative Breast Cancer Market Gearing Up for Impressive Growth at a CAGR of 4.7% During the Forecast Period (2025-2034)
Triple-Negative Breast Cancer Market Gearing Up for Impressive Growth at a CAGR of 4.7% During the Forecast Period (2025-2034)

Yahoo

time6 hours ago

  • Business
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Triple-Negative Breast Cancer Market Gearing Up for Impressive Growth at a CAGR of 4.7% During the Forecast Period (2025-2034)

The triple-negative breast cancer market is expected to grow due to rising incidence rates, increasing awareness, advancements in targeted therapies, ongoing clinical trials, improved diagnostics, and greater investment in research and development. Along with these, the launch of emerging therapies such as DATROWAY, PADCEV, BNT327/ PM8002, and others will fuel the TNBC market growth. LAS VEGAS, July 29, 2025 /PRNewswire/ -- DelveInsight's Triple-Negative Breast Cancer Market Insights report includes a comprehensive understanding of current treatment practices, triple-negative breast cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Triple-Negative Breast Cancer Market Report According to DelveInsight's analysis, the market size for triple-negative breast cancer was found to be USD 4.5 billion in the 7MM in 2024. The United States accounted for the highest market size of TNBC, approximately 69% of the total market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan. As per the estimates, among the current treatment options, KEYTRUDA (pembrolizumab) and chemotherapy held the largest TNBC treatment market share, generating approximately USD 2 billion in revenue in 2024 across the 7MM. In 2024, 7MM recorded approximately 104K new TNBC cases. With a projected CAGR of 0.7%, the number of cases is expected to gradually rise, leading to a higher disease burden by 2034. Leading triple-negative breast cancer companies developing emerging therapies, such as AstraZeneca, Daiichi Sankyo, Astellas Pharma, Pfizer, Galera Therapeutics, BioNTech, and others, are developing new TNBC treatment drugs that can be available in the triple-negative breast cancer market in the coming years. The promising triple-negative breast cancer therapies in the pipeline include DATROWAY (Datopotamab Deruxtecan), PADCEV (Enfortumab vedotin), Tilarginine, BNT327/PM8002, IMFINZI (Durvalumab), and others. Discover the TNBC new treatment @ New Treatments for TNBC Triple-Negative Breast Cancer Market Dynamics The triple-negative breast cancer market dynamics are expected to change in the coming years. Combining chemotherapy, immunotherapy, and targeted therapies, such as TALZENNA and TRODELVY, offers enhanced disease control and expands treatment options for advanced-stage TNBC patients, while innovations in immune checkpoint inhibitors, therapeutic vaccines, and ongoing research into personalized approaches are transforming long-term management by boosting immune response, improving survival rates, and addressing the need for more effective, tailored solutions beyond first-line therapy As potential therapies are being investigated for the treatment of triple-negative breast cancer, it is safe to predict that the treatment space will significantly impact the triple-negative breast cancer market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the triple-negative breast cancer market in the 7MM. However, several factors may impede the growth of the triple-negative breast cancer market. TNBC is the most difficult breast cancer subtype to manage due to its aggressive nature, lack of targeted treatment options, and high rates of chemotherapy resistance, which contribute to frequent relapse, reduced treatment efficacy, and limited long-term remission, even when diagnosed early; this underscores the urgent need for innovative, effective therapies that not only improve outcomes and prevent disease progression but also minimize the significant side effects of current aggressive treatments like chemotherapy and immunotherapy, which severely impact patient quality of life. Moreover, triple-negative breast cancer treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the triple-negative breast cancer market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the triple-negative breast cancer market growth. Triple-Negative Breast Cancer Treatment Market Triple-negative breast cancer lacks expression of hormone receptors and HER2, rendering it unresponsive to endocrine and HER2-targeted therapies. Consequently, systemic chemotherapy has long been the mainstay of treatment, especially in metastatic settings. Management typically starts with neoadjuvant or adjuvant chemotherapy, progressing to first-line treatments in advanced stages. If the disease advances or shows inadequate response, additional lines of therapy are introduced. Immunotherapies, particularly PD-1/PD-L1 inhibitors, are increasingly being utilized in metastatic TNBC to boost the body's immune defense against cancer cells. In early-stage TNBC, the PD-1 inhibitor KEYTRUDA (pembrolizumab) has become a standard part of treatment. It is administered with neoadjuvant chemotherapy and then continued as adjuvant monotherapy. In PD-L1-positive patients (CPS ≥10), it is also used alongside chemotherapy for locally recurrent or metastatic disease. Targeted therapies are making headway as well, particularly for patients with BRCA mutations. In such cases, PARP inhibitors like LYNPARZA (olaparib) and TALZENNA (talazoparib) target defective DNA repair pathways. TRODELVY (sacituzumab govitecan), an antibody-drug conjugate (ADC) targeting TROP-2, is approved for relapsed or treatment-resistant metastatic TNBC. Although TECENTRIQ (atezolizumab) was withdrawn from the U.S. market after failing confirmatory trials, it is still available in Europe and Japan. Taxane-based chemotherapy continues to be a cornerstone of TNBC treatment and is often combined with immune checkpoint inhibitors in PD-L1-positive cases. Platinum-based chemotherapy, though occasionally used, has shown mixed results due to concerns over toxicity and limited benefit. Despite therapeutic progress, TNBC remains a particularly aggressive subtype, underscoring the urgent need for continued innovation. Overall, current treatments frequently fall short of achieving lasting disease control, highlighting the pressing demand for novel therapies that can improve long-term outcomes and survival for TNBC patients. To know more about FDA-approved drugs for TNBC, visit @ Approved TNBC Treatment Triple-Negative Breast Cancer Pipeline Therapies and Key Companies Some of the drugs in the pipeline include DATROWAY [(Datopotamab Deruxtecan), AstraZeneca and Daiichi Sankyo], IMFINZI [(Durvalumab), AstraZeneca], PADCEV [(Enfortumab vedotin), Astellas Pharma and Pfizer], Tilarginine [(L-NMMA), Galera Therapeutics], and others. Datopotamab deruxtecan (Dato-DXd), also known as DATROWAY, is an experimental antibody-drug conjugate (ADC) being evaluated for the treatment of triple-negative breast cancer, both as a standalone therapy and in combination with IMFINZI (durvalumab). The therapy is aimed at high-risk TNBC patients, including those who are PD-L1-positive. Results from pivotal Phase III trials are expected in 2025, with more comprehensive findings anticipated by 2026, potentially influencing future treatment approaches for TNBC. Currently in Phase III development for TNBC, Dato-DXd is part of a global collaboration between AstraZeneca and Daiichi Sankyo, initiated in July 2020. Under this partnership, Daiichi Sankyo retains exclusive rights in Japan and oversees manufacturing and supply, while both companies are co-developing the drug across several cancer types globally. Tilarginine (L-NMMA), a broad nitric oxide synthase (NOS) inhibitor, is under Phase II investigation for metaplastic breast cancer (MpBC) in combination with alpelisib and nab-paclitaxel in HER2-negative metastatic or locally advanced settings. It is also being explored with a taxane in Phase II trials for patients with metastatic or locally advanced TNBC. In December 2024, Galera Therapeutics acquired Nova Pharmaceuticals. IMFINZI (durvalumab), an FDA-approved PD-L1 inhibitor developed by AstraZeneca for other cancers, works by blocking PD-L1 to enhance immune system recognition and destruction of tumor cells. It is currently undergoing Phase I/II studies in combination with paclitaxel and other novel therapies as a first-line option for metastatic TNBC (mTNBC), with key data expected by late 2025. Notably, the BEGONIA trial (October 2023) reported durable and significant tumor responses from the combination of datopotamab deruxtecan and IMFINZI when used as a first-line treatment for patients with mTNBC, along with a favorable safety profile. The anticipated launch of these emerging therapies are poised to transform the triple-negative breast cancer market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the triple-negative breast cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. Discover more about triple-negative breast cancer drugs in development @ Triple-Negative Breast Cancer Clinical Trials Recent Developments in the Triple-Negative Breast Cancer Market In May 2025, Gilead Sciences, Inc. reported that TRODELVY (sacituzumab govitecan-hziy) combined with KEYTRUDA (pembrolizumab) lowered the risk of disease progression or death by 35% (hazard ratio: 0.65) compared to the standard treatment of Keytruda plus chemotherapy as a first-line therapy for patients with PD-L1–positive (CPS ≥10) metastatic triple-negative breast cancer (TNBC). In May 2025, Gilead Sciences, Inc. reported positive topline results from the Phase 3 ASCENT-03 trial evaluating TRODELVY (sacituzumab govitecan-hziy). The study achieved its primary goal by showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not eligible for PD-1/PD-L1 inhibitors, either due to being PD-L1 negative or otherwise unsuitable for immunotherapy. In December 2024, Galera Therapeutics completed the acquisition of Nova Pharmaceuticals. Triple-Negative Breast Cancer Overview Triple-negative breast cancer is a particularly aggressive and diverse form of breast cancer that lacks expression of estrogen receptors (ER), progesterone receptors (PR), and HER2. It accounts for a substantial share of breast cancer cases and is associated with fast disease progression, high chances of recurrence, and unfavorable outcomes. TNBC tends to occur more frequently in younger women, individuals of African American descent, and those with BRCA1 gene mutations. The risk factors for TNBC are divided into two categories: non-modifiable factors, such as age, gender, genetic mutations, family history, and breast density, and modifiable ones, which include obesity, exposure to certain chemicals, and specific drug use. Due to its aggressive behavior and absence of hormone receptors, TNBC is particularly difficult to treat, highlighting the need for continuous research to enhance therapeutic approaches and patient survival. Diagnosis typically involves imaging tools like mammography, ultrasound, and MRI, followed by tissue sampling techniques including core needle biopsy, fine needle aspiration, or surgical biopsy. TNBC tumors are often high-grade and poorly differentiated, and the disease is staged using the TNM system, which evaluates tumor size, lymph node involvement, and the extent of metastasis. Triple-Negative Breast Cancer Epidemiology Segmentation The triple-negative breast cancer epidemiology section provides insights into the historical and current triple-negative breast cancer patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The triple-negative breast cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Incident Cases of Breast Cancer Total Incident Cases of TNBC Gene Mutation-specific Incident Cases of TNBC Stage-specific Incident Cases of TNBC Age-specific Incident Cases of TNBC Line-wise Treated Incident Cases of TNBC Triple-Negative Breast Cancer Market Report Metrics Details Study Period 2020–2034 Coverage 7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Triple-Negative Breast Cancer Market CAGR 4.7 % Triple-Negative Breast Cancer Market Size in 2024 USD 4.5 Billion Key Triple-Negative Breast Cancer Companies AstraZeneca, Daiichi Sankyo, Astellas Pharma, Pfizer, Galera Therapeutics, BioNTech, Merck, Gilead Sciences, Roche, Genentech, and others Key Triple-Negative Breast Cancer Therapies DATROWAY (Datopotamab Deruxtecan), PADCEV (Enfortumab vedotin), Tilarginine, BNT327/PM8002, IMFINZI (Durvalumab), KEYTRUDA, TRODELVY, TALZENNA, LYNPARZA, TECENTRIQ, and others Scope of the Triple-Negative Breast Cancer Market Report Therapeutic Assessment: Triple-Negative Breast Cancer current marketed and emerging therapies Triple-Negative Breast Cancer Market Dynamics: Key Market Forecast Assumptions of Emerging Triple-Negative Breast Cancer Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Triple-Negative Breast Cancer Market Access and Reimbursement Download the report to understand which factors are driving triple-negative breast cancer market trends @ Triple-Negative Breast Cancer Market Forecast Table of Contents 1 Key Insights 2 Report Introduction 3 TNBC Market Overview at a Glance 3.1 Market Share (%) Distribution of TNBC by Therapies in the 7MM in 2020 3.2 Market Share (%) Distribution of TNBC by Therapies in the 7MM in 2034 4 Executive Summary 5 Key Events 6 Disease Background and Overview 6.1 Introduction 6.2 Various Subtypes of Breast Cancer Based on Immunohistochemical Expression 6.3 TNBC Overview 6.3.1 Intrinsic Molecular Subtypes in TNBC 6.3.2 Characteristics of Tumor Microenvironment in TNBC 6.3.3 Potential Risk Factors 6.3.4 Clinical Presentation 6.3.5 Characterization of HER2-low Breast Cancers 6.4 Diagnosis 6.4.1 Staging 6.4.2 Grading 6.4.3 Clinical Prognostic Stage 6.4.4 Pathological Prognostic Stage 6.4.5 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer 6.4.6 Recommendations for HER2 Testing in Breast Cancer: American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Clinical Practice Guideline Update 6.4.7 Diagnostic Algorithm 6.5 Treatment and Management 6.5.1 NCCN Clinical Practice Guidelines in Oncology for Breast Cancer 6.5.2 ESMO Clinical Practice Guidelines for Diagnosis, Treatment, and Follow-up of Early Breast Cancer 6.5.3 ESMO Clinical Practice Guideline for the Diagnosis, Staging, and Treatment of Patients with Metastatic Breast Cancer 6.5.4 Japanese Breast Cancer Society (JBCS) Clinical Practice Guidelines for Breast Cancer – 2022 Update 6.5.5 Treatment Algorithm 7 Epidemiology and Market Forecast Methodology 8 Epidemiology and Patient Population 8.1 Key Findings 8.2 Assumptions and Rationale: 7MM 8.2.1 Incident Cases of Breast Cancer 8.2.2 Incident Cases of TNBC 8.2.3 Gene Mutation-specific Incident Cases of TNBC 8.2.4 Stage-specific Incident Cases of TNBC 8.2.5 Age-specific Incident Cases of TNBC 8.3 Total Incident Cases of Breast Cancer in the 7MM 8.4 Total Incident Cases of TNBC in the 7MM 8.5 The United States 8.6 EU4 and the UK 8.7 Japan 9 Patient Journey 10 Marketed Therapies 10.1 Key Cross Competition 10.2 KEYTRUDA (pembrolizumab): Merck 10.2.1 Product Description 10.2.2 Regulatory Milestone 10.2.3 Other Developmental Activities 10.2.4 Clinical Trials Information 10.2.5 Safety and Efficacy 10.3 TRODELVY (sacitzumab govitecan-hziy): Gilead Sciences 10.4 TALZENNA (talazoparib): Pfizer 10.5 LYNPARZA (olaparib): AstraZeneca/Merck 10.6 TECENTRIQ (atezolizumab): Roche/Genentech To be continued in the report… 11 Emerging Drug Profiles 11.1 Key Cross Competition of Emerging Drugs 11.2 DATROWAY (Datopotamab Deruxtecan): AstraZeneca/Daiichi Sankyo 11.2.1 Drug Description 11.2.2 Other Developmental Activities 11.2.3 Clinical Trials Information 11.2.4 Safety and Efficacy 11.2.5 Analysts' View 11.3 PADCEV (Enfortumab vedotin): Astellas Pharma/Pfizer 11.4 Tilarginine: Galera Therapeutics 11.5 BNT327/PM8002: BioNTech 11.6 IMFINZI (Durvalumab): AstraZeneca To be continued in the report… 12 TNBC: Market Analysis 12.1 Key Findings 12.2 Market Outlook 12.3 Attribute Analysis 12.4 Key Market Forecast Assumptions 12.4.1 Cost Assumptions and Rebates 12.4.2 Pricing Trends 12.4.3 Analogue Assessment 12.4.4 Launch Year and Therapy Uptake 12.5 Total Market Size of TNBC in the 7MM 12.6 Market Size of TNBC by Therapies in the 7MM 12.7 Market Size of TNBC in the United States 12.8 Market Size of TNBC in EU4 and the UK 12.9 Market Size of TNBC in Japan 13 Key Opinion Leaders' Views 14 Unmet Needs 15 SWOT Analysis 16 Market Access and Reimbursement 16.1 The United States 16.2 In EU4 and the UK 16.3 Japan 17 Acronyms and Abbreviations 18 Bibliography 19 Report Methodology Related Reports PD-L1 Inhibitors Market PD-L1 Inhibitors Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PD-L1 inhibitors companies including EQRX, CSTONE PHARMACEUTICALS, PFIZER, NOVARTIS, ARCUS BIOSCIENCES, AGENUS, TRACON PHARMACEUTICALS, SHANGHAI HENLIUS BIOTECH, INCYTE CORPORATION, among others. PARP Inhibitors Market PARP Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PARP inhibitors companies including AstraZeneca, Merck, Janssen, Pfizer, Astellas, Pharma& Schweiz, AtlasMedx, AbbVie, GlaxoSmithKline, Pfizer, BeiGene, Allarity Therapeutics, among others. Triple-Negative Breast Cancer Pipeline Triple-Negative Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key TNBC companies, including G1 Therapeutics, Inc., Gilead Sciences, Biotheus Inc., GlaxoSmithKline, AstraZeneca, Shanghai Jiaolian Drug Research and Development Co., Ltd, Coherent Biopharma, Daiichi Sankyo Company, Merck, SynDevRx, Inc., Treadwell Therapeutics, AstraZeneca, Novartis Pharmaceuticals, NEC Corporation, Cardiff Oncology, Ocellaris Pharma, Inc., Nuvation Bio Inc., Phoenix Molecular Designs, Pure Biologics S.A., Pure Biologics S.A., Mersana Therapeutics, Zumutor Biologics Inc., Tubulis GmbH, Hinova Pharmaceuticals, Primevax, ARCE Therapeutics, HC Biopharma, Casinvent, among others. Breast Cancer Market Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key breast cancer companies including Veru, Sanofi, Roche, AstraZeneca, Eli Lilly, EQRx, Gilead, Sermonix Pharmaceuticals, Evgen Pharma, Tyme, Genentech, Daiichi Sankyo, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakur info@ + Logo: View original content: SOURCE DelveInsight Business Research, LLP Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Adrenocortical Carcinoma Market Forecast upto 2034—Insights into Emerging Therapies and Market Trends
Adrenocortical Carcinoma Market Forecast upto 2034—Insights into Emerging Therapies and Market Trends

Business Upturn

time10 hours ago

  • Business
  • Business Upturn

Adrenocortical Carcinoma Market Forecast upto 2034—Insights into Emerging Therapies and Market Trends

New York, USA, July 29, 2025 (GLOBE NEWSWIRE) — Adrenocortical Carcinoma Market Forecast upto 2034—Insights into Emerging Therapies and Market Trends | DelveInsight The adrenocortical carcinoma market in the 7MM is anticipated to boost during the forecast period (2025–2034), due to the launch of emerging therapies such as CY‑101 from Cytovation and OR‑449 from Orphagen Pharmaceuticals, and others, and the increasing cases of ACC. DelveInsight's Adrenocortical Carcinoma Market Insights report includes a comprehensive understanding of current treatment practices, emerging adrenocortical carcinoma drugs, market share of individual therapies, and current and forecasted adrenocortical carcinoma market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Adrenocortical Carcinoma Market Report According to DelveInsight's analysis, the total adrenocortical carcinoma market size is expected to grow from USD 30 million in the 7MM in 2024. in the 7MM in 2024. The United States accounts for the largest market size of adrenocortical carcinoma, in comparison to EU4 (Germany, Italy, France, and Spain) and the UK, and Japan. Based on DelveInsight's assessment in 2024, the 7MM had 1,250 incident cases of ACC, and it is projected that these cases will experience an increasing growth trend with a significant CAGR during the forecast period (2025−2034). incident cases of ACC, and it is projected that these cases will experience an increasing growth trend with a significant CAGR during the forecast period (2025−2034). Prominent companies, including GlaxoSmithKline, Bristol Myers Squibb, Merck, Cytovation, Enterome, Orphagen Pharmaceuticals, and others, are actively working on innovative adrenocortical carcinoma drugs. and others, are actively working on innovative adrenocortical carcinoma drugs. Some of the key adrenocortical carcinoma therapies in the pipeline include CY-101, OR-449, dostarlimab, nivolumab + ipilimumab, and pembrolizumab, EO2401 + Nivolumab, and others. These novel adrenocortical carcinoma therapies are anticipated to enter the adrenocortical carcinoma market in the forecast period and are expected to change the market. Discover which adrenocortical carcinoma medications are expected to grab the market share @ Adrenocortical Carcinoma Market Report Adrenocortical Carcinoma Market Dynamics The adrenocortical carcinoma market dynamics are anticipated to change in the coming years. The availability of surgical options such as adrenalectomy provides a practical approach for removing the diseased adrenal gland, thereby improving access to treatment. Mitotane remains the mainstay treatment for ACC, with its exclusive status as an 'Off-Patent, Off-Exclusivity Drug without an Approved Generic' in the Orange Book reinforcing its dominant position. There is significant potential for collaboration among medical professionals, researchers, and patient advocacy organizations to raise disease awareness and broaden access to care. The limited therapeutic landscape for ACC presents a strategic opportunity for new players to enter and expand within the market. Furthermore, many potential therapies are being investigated for the treatment of adrenocortical carcinoma, and it is safe to predict that the treatment space will significantly impact the adrenocortical carcinoma market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate is expected to drive the growth of the adrenocortical carcinoma market in the 7MM. However, several factors may impede the growth of the adrenocortical carcinoma market. The reliance on surgery as the main treatment for ACC, due to the limited availability of systemic therapies, highlights a weakness stemming from a lack of diverse treatment options. ACC's rarity and the small number of affected patients make it difficult to conduct large-scale clinical trials, complicating the development of evidence-based treatment protocols and assessment of new therapies. Resistance to current treatments like mitotane monotherapy, or their limited effectiveness, often leads to poor patient outcomes and represents a major challenge. Additionally, the ultra-rare nature of ACC limits access to funding and resources for research and development, posing a significant barrier to progress. Moreover, adrenocortical carcinoma treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the adrenocortical carcinoma market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the adrenocortical carcinoma market growth. Adrenocortical Carcinoma Treatment Market Surgical removal is the primary treatment option for localized adrenocortical carcinoma. However, many patients are diagnosed at advanced stages, where surgery alone is unlikely to be curative. Chemotherapy, particularly mitotane, is the only FDA-approved drug for ACC, though its effectiveness varies, and it often causes substantial side effects. Complete surgical excision remains the only potentially curative option. For localized cases, adjuvant therapies are used to reduce the risk of recurrence. In cases where the tumor is unresectable or has metastasized, treatment shifts to palliative care. First-line treatment strategies for ACC are personalized, taking into account the patient's prognostic profile. For those with good performance status and aggressive disease, a combination regimen like EDP-M (etoposide, doxorubicin, cisplatin, and mitotane) is often employed. Patients with less aggressive disease may be treated with mitotane alone, sometimes alongside locoregional interventions. Despite some efficacy, EDP-M is not curative, and the overall prognosis remains poor. Second-line options such as streptozocin with mitotane (S+M) and gemcitabine with capecitabine (G+C) show limited effectiveness, with response rates around 10%. G+C is generally well tolerated but lacks strong molecular predictors of response. Temozolomide, used as a third-line option, shows anti-cancer activity in laboratory settings. While some patients experience disease stabilization, its clinical benefit is modest, and research is ongoing to determine which patient subgroups may respond best. Looking ahead, future treatment advances may include new chemotherapies, angiogenesis inhibitors, and targeted small-molecule drugs. These innovations, driven by deeper molecular insights into ACC biology, offer potential for improved therapeutic outcomes. Learn more about the adrenocortical carcinoma treatment options @ Adrenocortical Carcinoma Drugs Market Adrenocortical Carcinoma Emerging Drugs and Companies Research and development efforts in adrenocortical carcinoma remain limited due to its classification as an ultra-rare disease, resulting in a sparse pipeline with only a few therapies currently in Phase II, Phase I/II, or preclinical stages. Among the investigational treatments being evaluated in clinical trials are Dostarlimab (GlaxoSmithKline), the combination of Nivolumab and Ipilimumab (Bristol Myers Squibb), Pembrolizumab (Merck), CY-101 (Cytovation), EO2401 combined with Nivolumab (Enterome/Bristol Myers Squibb), OR-449 (Orphagen Pharmaceuticals), and others. CY-101 is designed to selectively attack and destabilize cancer cell membranes, which leads to the release of tumor-specific neoantigens and enables the immune system to launch a targeted, systemic response against the cancer. In addition, CY-101 blocks the β-catenin signaling pathway, thereby impeding tumor progression and further activating immune defenses. Currently being developed by Cytovation, CY-101 is slated to enter a multi-national Phase II clinical trial for adrenocortical carcinoma in late 2025, with initial data expected in 2026. This study is being conducted in collaboration with Cancer Research UK and the Norwegian Cancer Society, as announced in January 2025. OR-449 is a first-in-class, orally available inhibitor of the orphan nuclear receptor steroidogenic factor-1 (SF-1, NR5A1), a validated target in ACC—a rare and difficult-to-treat adrenal gland cancer. The U.S. FDA has granted OR-449 Rare Pediatric Disease Designation (RPDD) to support its expedited development for pediatric ACC. Additionally, Orphagen has secured a $10.2 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to fund its IND application and a Phase I trial in adults with ACC. The grant spans three years and requires Orphagen to raise matching funds. Pembrolizumab, a widely approved PD-1 checkpoint inhibitor, is under evaluation in a Phase II trial for patients with advanced ACC. The trial, sponsored by Memorial Sloan Kettering Cancer Center, is currently in the 'active, not recruiting' phase. EO2401, a novel microbiome-based therapeutic vaccine developed by Enterome, was aimed at treating solid tumors such as glioblastoma and ACC. However, in November 2024, its Phase I/II SPENCER trial was terminated due to strategic considerations. This development marks a setback in the search for innovative treatments targeting ACC. The anticipated launch of these emerging adrenocortical carcinoma therapies are poised to transform the adrenocortical carcinoma market landscape in the coming years. As these cutting-edge adrenocortical carcinoma therapies continue to mature and gain regulatory approval, they are expected to reshape the adrenocortical carcinoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about new treatment for adrenocortical carcinoma, visit @ Adrenocortical Carcinoma Management Recent Developments in the Adrenocortical Carcinoma Market In April 2025, Cytovation announced that it had raised NOK62 million (USD 6 million) largely from existing investors, led by Sandwater. These funds will be used to advance CY-101 into a multi-national Phase II clinical trial in patients with ACC. announced that it had raised NOK62 million (USD 6 million) largely from existing investors, led by Sandwater. These funds will be used to advance CY-101 into a multi-national Phase II clinical trial in patients with ACC. In November 2024, the status of the Phase I/II SPENCER study was updated to 'terminated,' with the reason cited as a strategic decision. This termination represents a setback in the emerging prospects for developing therapies for ACC. Adrenocortical Carcinoma Overview Adrenocortical carcinoma (ACC) is a rare and aggressive cancer that originates in the cortex of the adrenal glands, which are located above the kidneys and are responsible for producing essential hormones such as cortisol, aldosterone, and androgens. ACC can occur at any age but is most commonly diagnosed in children under 5 and adults in their 40s and 50s. The exact causes of ACC are not well understood, but it has been associated with certain genetic syndromes, including Li-Fraumeni syndrome, Beckwith-Wiedemann syndrome, and multiple endocrine neoplasia type 1 (MEN1), which suggests a hereditary component in some cases. Symptoms of ACC can vary depending on whether the tumor is functioning (hormone-producing) or non-functioning. Functioning tumors may cause signs of hormone excess, such as Cushing's syndrome (weight gain, high blood pressure, muscle weakness, and skin changes), virilization in women (facial hair, deepened voice), or feminization in men. Non-functioning tumors may present later and often manifest as abdominal pain, a palpable mass, or symptoms related to tumor spread, such as weight loss or back pain. Diagnosis of ACC typically involves a combination of imaging studies and laboratory tests. Imaging techniques such as CT scans or MRI help identify the size, location, and potential spread of the tumor. Hormonal blood and urine tests assess whether the tumor is producing excess hormones. A definitive diagnosis is usually confirmed through histological examination of tissue obtained via biopsy or after surgical removal of the tumor. Early detection is crucial, as ACC often presents at an advanced stage and has a poor prognosis if not treated promptly. Adrenocortical Carcinoma Epidemiology Segmentation The adrenocortical carcinoma epidemiology section provides insights into the historical and current adrenocortical carcinoma patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The adrenocortical carcinoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Incident Cases of ACC Stage-specific Incident Cases of ACC Gender-specific Incident Cases of ACC Age-specific Incident Cases of ACC Download the report to understand which factors are driving adrenocortical carcinoma epidemiology trends @ Adrenocortical Carcinoma Treatment Algorithm Adrenocortical Carcinoma Report Metrics Details Study Period 2020–2034 Adrenocortical Carcinoma Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Adrenocortical Carcinoma Market Size in 2024 USD 30 Million Key Adrenocortical Carcinoma Companies GlaxoSmithKline, Bristol Myers Squibb, Merck, Cytovation, Enterome, Orphagen Pharmaceuticals, and others Key Adrenocortical Carcinoma Therapies CY-101, OR-449, dostarlimab, nivolumab + ipilimumab, and pembrolizumab, EO2401 + Nivolumab, and others Scope of the Adrenocortical Carcinoma Market Report Adrenocortical Carcinoma Therapeutic Assessment: Adrenocortical Carcinoma current marketed and emerging therapies Adrenocortical Carcinoma current marketed and emerging therapies Adrenocortical Carcinoma Market Dynamics: Conjoint Analysis of Emerging Adrenocortical Carcinoma Drugs Conjoint Analysis of Emerging Adrenocortical Carcinoma Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Adrenocortical Carcinoma Market Access and Reimbursement Discover more about adrenocortical carcinoma drugs in development @ Adrenocortical Carcinoma Clinical Trials Table of Contents 1. Adrenocortical Carcinoma Market Key Insights 2. Adrenocortical Carcinoma Market Report Introduction 3. Adrenocortical Carcinoma Market Overview at a Glance 4. Adrenocortical Carcinoma Market Executive Summary 5. Disease Background and Overview 6. Adrenocortical Carcinoma Treatment and Management 7. Adrenocortical Carcinoma Epidemiology and Patient Population 8. Patient Journey 9. Adrenocortical Carcinoma Marketed Drugs 10. Adrenocortical Carcinoma Emerging Drugs 11. Seven Major Adrenocortical Carcinoma Market Analysis 12. Adrenocortical Carcinoma Market Outlook 13. Potential of Current and Emerging Therapies 14. KOL Views 15. Unmet Needs 16. SWOT Analysis Related Reports Adrenocortical Carcinoma Pipeline Adrenocortical Carcinoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key adrenocortical carcinoma companies, including Corcept Therapeutics, Bristol-Myers Squibb, Enterome, Exelixis, Ipsen, Genentech, among others. Congenital Adrenal Hyperplasia Market Congenital Adrenal Hyperplasia Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key congenital adrenal hyperplasia companies, including Crinetics Pharmaceuticals Inc., Diurnal Limited, Adrenas Therapeutics Inc, Neurocrine Biosciences, Spruce Biosciences, among others. Congenital Adrenal Hyperplasia Pipeline Congenital Adrenal Hyperplasia Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key congenital adrenal hyperplasia companies, including Neurocrine Biosciences, Spruce Biosciences, Adrenas Therapeutics Inc., Crinetics Pharmaceuticals, Diurnal, among others. Cushing's Syndrome Market Cushing's Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Cushing's syndrome companies including Corcept Therapeutics, Crinetics Pharmaceuticals, Cyclacel Pharmaceuticals, Sparrow Pharmaceuticals, Stero Therapeutics, among others. DelveInsight's Pharma Competitive Intelligence Service: Through its CI solutions, DelveInsight provides its clients with real-time and actionable intelligence on their competitors and markets of interest to keep them stay ahead of the competition by providing insights into the latest therapeutic area-specific/indication-specific market trends, in emerging drugs, and competitive strategies. These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion. Other Business Pharmaceutical Consulting Services Healthcare Conference Coverage Pipeline Assessment Healthcare Licensing Services Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Connect with us on LinkedIn|Facebook|Twitter Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash

Juvenile Idiopathic Arthritis Therapeutic Landscape Shifts as Biologics and JAK Inhibitors Drive Significant Growth
Juvenile Idiopathic Arthritis Therapeutic Landscape Shifts as Biologics and JAK Inhibitors Drive Significant Growth

Globe and Mail

timea day ago

  • Health
  • Globe and Mail

Juvenile Idiopathic Arthritis Therapeutic Landscape Shifts as Biologics and JAK Inhibitors Drive Significant Growth

The Juvenile Idiopathic Arthritis market is entering a period of robust expansion, underpinned by increasing awareness, advances in diagnostics, and a wave of novel therapeutics from leading pharmaceutical and biotech companies, such as Novartis, Roche (Chugai Pharmaceutical), AbbVie, AstraZeneca, Pfizer, Eli Lilly, and Incyte Corporation. DelveInsight's report, ' Juvenile Idiopathic Arthritis Market Insight, Epidemiology and Market Forecast – 2032,' reveals that the Juvenile Idiopathic Arthritis therapeutic landscape across the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom and Japan is growing noticeably, underpinned by advancements in targeted therapies (such as biologics and JAK inhibitors), increased investment in research and development, and the introduction of innovative diagnostic tools. The United States holds the largest market share in terms of both revenue and patient pool across 7MM, primarily due to better diagnosis, the highest pharmaceutical spending per capita globally, and significant drug development efforts with the presence of major Juvenile Idiopathic Arthritis drug companies in the country. Download the Juvenile Idiopathic Arthritis Market report to understand market dynamics and treatment landscape trends. DelveInsight's epidemiological modelling underscores that Juvenile Idiopathic Arthritis, the most common chronic rheumatic disease of childhood, continues to present significant clinical and economic challenges across the 7MM. Studies show that females are generally more affected than males by Juvenile Idiopathic Arthritis, although this trend varies depending on the specific subtype, with enthesitis-related JIA notably showing a male predominance. Furthermore, the DelveInsight report details country-specific diagnosed Juvenile Idiopathic Arthritis patient pools from 2019 to 2032 and highlights a steady upward trend driven by heightened diagnostic vigilance and improved registry coverage. Notably, the United States captures the largest share of identified Juvenile Idiopathic Arthritis cases, whereas Germany leads within the European countries, reflecting regional variations in paediatric rheumatology infrastructure and reporting mechanisms. Discover evolving trends in the Juvenile Idiopathic Arthritis patient pool forecasts @ Juvenile Idiopathic Arthritis Epidemiology Analysis. The Juvenile Idiopathic Arthritis treatment landscape has evolved considerably, transitioning from conventional non-steroidal anti-inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs (DMARDs) to sophisticated biologic and targeted synthetic agents that inhibit key inflammatory pathways. Although methotrexate retains a central role as an anchor DMARD, an expanding class of tumour necrosis factor (TNF) inhibitors, interleukin (IL) blockers and Janus kinase (JAK) inhibitors has reshaped the Juvenile Idiopathic Arthritis therapeutic paradigm, offering clinicians greater flexibility for refractory disease. According to the DelveInsight report, the Juvenile Idiopathic Arthritis therapies pipeline shows promising development activity. New developments in Juvenile Idiopathic Arthritis therapies are focused on targeted approaches, particularly JAK inhibitors. Tofacitinib and baricitinib are two JAK inhibitors that have been approved for use in specific Juvenile Idiopathic Arthritis subtypes, primarily in cases where patients haven't responded well to other treatments like TNF inhibitors. Baricitinib, for instance, has shown efficacy in patients with polyarticular Juvenile Idiopathic Arthritis, extended oligoarticular Juvenile Idiopathic Arthritis, enthesitis-related arthritis, and psoriatic Juvenile Idiopathic Arthritis aged 2 to 18 years. Tofacitinib has also been shown to be effective in patients with polyarticular course Juvenile Idiopathic Arthritis. Furthermore, the competitive intelligence section of the report highlights novel agents targeting cytokine signalling beyond TNF and IL-6, as well as next-generation oral molecules designed to optimise patient adherence. Robust evaluation of launch timelines, annual cost of therapy, and forecast clinical differentiation suggests a wave of innovative entrants that could meaningfully expand the Juvenile Idiopathic Arthritis drugs in the coming decade. Dive Deeper into the evolving treatment landscape @ Juvenile Idiopathic Arthritis Emerging Therapies. Key opinion leader insights collected through primary research validate these trends and pinpoint persistent gaps such as limited treatment options for systemic Juvenile Idiopathic Arthritis flares, glucocorticoid sparing strategies, and long-term safety surveillance in growing children. KOLs also emphasise the need for biomarkers that can guide personalised therapeutic sequencing and predict disease trajectory, a frontier that remains largely unaddressed despite significant scientific advances. Addressing these challenges offers significant opportunities for innovative biotech and pharma entities to carve out competitive advantages in an increasingly crowded market landscape. Looking ahead, the Juvenile Idiopathic Arthritis market is poised to benefit from deeper understanding of disease pathogenesis, breakthrough device-assisted drug-delivery platforms and collaborative research networks that accelerate paediatric trial recruitment. While significant strides have been made, continued innovation in immune-modulation, tolerability optimisation and health-equity initiatives will be essential to fully meet the unmet needs of this vulnerable patient population. Stakeholders who leverage DelveInsight's granular insights stand to capitalise on the forthcoming wave of therapeutic progress and capture value in a market primed for transformative growth through 2032. Table of Contents 1. Key Insights 2. Executive Summary of Juvenile Idiopathic Arthritis 3. Competitive Intelligence Analysis for Juvenile Idiopathic Arthritis 4. Juvenile Idiopathic Arthritis Market Overview at a Glance 5. Juvenile Idiopathic Arthritis: Disease Background and Overview 6. Juvenile Idiopathic Arthritis Patient Journey 7. Juvenile Idiopathic Arthritis Epidemiology and Patient Population 8. Treatment Algorithm, Current Treatment, and Medical Practices 9. Juvenile Idiopathic Arthritis Unmet Needs 10. Key Endpoints of Juvenile Idiopathic Arthritis Treatment 11. Juvenile Idiopathic Arthritis Marketed Products 12. Juvenile Idiopathic Arthritis Emerging Therapies 13. Juvenile Idiopathic Arthritis: Seven Major Market Analysis 14. Attribute analysis 15. 7MM: Market Outlook 16. Access and Reimbursement Overview of Juvenile Idiopathic Arthritis 17. KOL Views 18. Juvenile Idiopathic Arthritis Market Drivers 19. Juvenile Idiopathic Arthritis Market Barriers 20. Appendix 21. DelveInsight Capabilities 22. Disclaimer 23. About DelveInsight Related Reports Juvenile Idiopathic Arthritis Pipeline Insight Juvenile Idiopathic Arthritis pipeline insight provides comprehensive insights about the Juvenile Idiopathic Arthritis pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the Juvenile Idiopathic Arthritis companies, including Novartis, Roche, AbbVie, AstraZeneca, Pfizer, Eli Lilly, and Incyte Corporation, among others. About DelveInsight DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Arpit Anand Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website:

Duchenne Muscular Dystrophy Market to Witness Significant Expansion During the Forecast Period (2025–2034) Amidst Advances in Gene Therapy and Novel Drug Approvals
Duchenne Muscular Dystrophy Market to Witness Significant Expansion During the Forecast Period (2025–2034) Amidst Advances in Gene Therapy and Novel Drug Approvals

Business Upturn

timea day ago

  • Business
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Duchenne Muscular Dystrophy Market to Witness Significant Expansion During the Forecast Period (2025–2034) Amidst Advances in Gene Therapy and Novel Drug Approvals

New York, USA, July 28, 2025 (GLOBE NEWSWIRE) — Duchenne Muscular Dystrophy Market to Witness Significant Expansion During the Forecast Period (2025–2034) Amidst Advances in Gene Therapy and Novel Drug Approvals | DelveInsight The Duchenne muscular dystrophy market is witnessing steady growth driven by advancements in gene therapies, exon-skipping drugs, and corticosteroid alternatives. Increasing diagnosis rates, rising awareness, and supportive regulatory pathways have accelerated therapy approvals. Additionally, key players continue to expand their pipelines, with several novel therapies in late-stage clinical trials. DelveInsight's Duchenne Muscular Dystrophy Market Insights report includes a comprehensive understanding of current treatment practices, emerging Duchenne muscular dystrophy drugs, market share of individual therapies, and current and forecasted Duchenne muscular dystrophy market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Duchenne Muscular Dystrophy Market Report According to DelveInsight's analysis, the total Duchenne muscular dystrophy market size is expected to grow positively by 2034. The United States accounts for the largest market size of Duchenne Muscular Dystrophy, in comparison to EU4 (Germany, Italy, France, and Spain) and the UK, and Japan. In 2024, the United States had the highest prevalence of DMD among the 7MM countries, with approximately 17,000 cases. This number is expected to grow at a steady CAGR. cases. This number is expected to grow at a steady CAGR. Prominent companies, including FibroGen, Santhera Pharmaceutical, Italfarmaco, ReveraGen BioPharma, Cumberland Pharmaceuticals, Sarepta Therapeutics, Antisense Therapeutics, Capricor Therapeutics, and others, are actively working on innovative Duchenne muscular dystrophy drugs. and others, are actively working on innovative Duchenne muscular dystrophy drugs. Some of the key Duchenne muscular dystrophy therapies in the pipeline include NS-089/NCNP-02 (brogidirsen), TAS-205 (pizuglanstat), RGX-202, and others. These novel Duchenne muscular dystrophy therapies are anticipated to enter the Duchenne muscular dystrophy market in the forecast period and are expected to change the market. Discover which Duchenne muscular dystrophy medications are expected to grab the market share @ Duchenne Muscular Dystrophy Market Report Duchenne Muscular Dystrophy Market Dynamics The Duchenne muscular dystrophy market dynamics are anticipated to change in the coming years. Glucocorticosteroids remain the mainstay treatment option for Duchenne muscular dystrophy, despite their associated adverse side effects, while newer corticosteroids like EMFLAZA face cost-effectiveness challenges in the United States; moreover, there is currently no cure or disease-reversing therapy available for non-ambulant DMD patients. However, ongoing research in gene therapy and genetic technologies offers promising opportunities for developing targeted and personalized treatments, alongside a wider commercial potential for therapies such as Capricor's CAP-1002 and Antisense's ATL1102, which are specifically aimed at improving upper limb function in DMD patients and addressing a broader patient population. Furthermore, many potential therapies are being investigated for the treatment of Duchenne muscular dystrophy, and it is safe to predict that the treatment space will significantly impact the Duchenne muscular dystrophy market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate is expected to drive the growth of the Duchenne muscular dystrophy market in the 7MM. However, several factors may impede the growth of the Duchenne muscular dystrophy market. The diagnosis of Duchenne muscular dystrophy is often complicated due to inadequate patient history, the use of inappropriate medical tests, and the presence of multiple comorbidities, frequently leading to delayed or incorrect diagnosis; additionally, the high cost of current and emerging therapies may limit patient access globally, while the rarity of DMD and its occurrence in the paediatric population contribute to a low availability of participants for clinical trials, posing further challenges to therapeutic development. Moreover, Duchenne muscular dystrophy treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the Duchenne muscular dystrophy market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the Duchenne muscular dystrophy market growth. Duchenne Muscular Dystrophy Treatment Market The primary treatment approaches for Duchenne muscular dystrophy focus on restoring dystrophin production through gene replacement or mutation-targeted genetic therapies, stabilizing muscle membranes, enhancing compensatory protein expression, reducing inflammation, and promoting muscle regeneration. In the United States, several therapies have received approval for DMD management, including AGAMREE (vamorolone), VYONDYS 53 (golodirsen), EXONDYS 51 (eteplirsen), AMONDYS 45 (casimersen), VILTEPSO (viltolarsen), and ELEVIDYS (delandistrogene moxeparvovec), among others. DUVYZAT (givinostat), a histone deacetylase (HDAC) inhibitor, has been authorized for use in DMD patients aged six and older. Notably, it is the first FDA-approved non-steroidal drug applicable to all genetic forms of DMD. Givinostat works by inhibiting HDAC enzymes, which regulate gene expression and contribute to muscle inflammation and damage. By blocking these enzymes, givinostat seeks to reduce inflammation, support muscle repair, and slow muscle degeneration in DMD patients. AMONDYS 45, or casimersen, developed by Sarepta Therapeutics, is an antisense oligonucleotide designed for patients with a specific DMD gene mutation suitable for exon 45 skipping. Casimersen employs exon-skipping technology, targeting the dystrophin gene pre-mRNA to exclude exon 45 during processing. This allows the creation of a shortened but functional dystrophin protein, which helps maintain muscle fiber structure and function, aiming to restore the disrupted reading frame and partially compensate for the dystrophin deficiency. AGAMREE is a prescription therapy for children aged two and older with DMD. It is a novel anti-inflammatory drug that selectively binds the glucocorticoid receptor but modulates downstream effects, bypassing the 11β-HSD enzyme pathway associated with steroid-induced toxicity. This distinct mechanism potentially provides the anti-inflammatory benefits of corticosteroids while minimizing their harmful side effects, making AGAMREE a safer treatment option for pediatric and adolescent patients. AGAMREE was granted Orphan Drug designation in August 2014. Learn more about the Duchenne muscular dystrophy treatment options @ Duchenne Muscular Dystrophy Treatment Guidelines Duchenne Muscular Dystrophy Emerging Drugs and Companies The Expected launch of potential therapies may increase the market size in the coming years, assisted by an increase in the diagnosed prevalent population of DMD. Owing to the positive outcomes of several products during the developmental stage by key players such as NS Pharma/Nippon Shinyaku (NS-089/NCNP-02), Taiho Pharma (TAS-205), REGENXBIO (RGX-202), and others. NS-089/NCNP-02 is an antisense oligonucleotide jointly developed by Nippon Shinyaku and the National Center of Neurology and Psychiatry (NCNP). It is being explored as a treatment option for Duchenne muscular dystrophy (DMD) patients whose dystrophin gene mutations can be addressed through exon 44 skipping. In January 2025, NS Pharma announced that NCNP published the outcomes of a first-in-human, investigator-led study of NS-089/NCNP-02 (brogidirsen) in Cell Reports Medicine. This therapy is currently being investigated in a global Phase II clinical trial (NCT05996003) for DMD. TAS-205 (pizuglanstat), discovered by Taiho Pharmaceutical, is a selective inhibitor of hematopoietic prostaglandin D synthase (HPGDS). It is under development for DMD treatment and works independently of the type of dystrophin gene mutation. By inhibiting HPGDS, which contributes to inflammation in muscle tissue, TAS-205 aims to slow the progression of motor decline in DMD patients. This drug is currently undergoing Phase III trials. RGX-202 is a gene therapy designed to deliver a transgene encoding a novel microdystrophin that retains critical functional components of the C-terminal domain present in natural dystrophin. RGX-202 is in a Phase II/III pivotal trial. The therapy has been granted Orphan Drug Designation, Rare Pediatric Disease Designation, and Fast Track Designation by the FDA. In November 2024, REGENXBIO announced that the AFFINITY DUCHENNE trial of RGX-202 has progressed to its pivotal stage, with the first patient receiving the treatment. The company shared positive safety and efficacy results from its earlier Phase I/II study, which included functional outcomes. REGENXBIO has also reached an agreement with the FDA on the pivotal study design and the potential for accelerated approval, with a Biologics License Application (BLA) filing targeted for 2026. The pivotal trial is currently enrolling ambulatory patients aged 1 year and older. The anticipated launch of these emerging Duchenne muscular dystrophy therapies are poised to transform the Duchenne muscular dystrophy market landscape in the coming years. As these cutting-edge Duchenne muscular dystrophy therapies continue to mature and gain regulatory approval, they are expected to reshape the Duchenne muscular dystrophy market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about new treatment for Duchenne muscular dystrophy, visit @ Duchenne Muscular Dystrophy Management Recent Developments in the Duchenne Muscular Dystrophy Market In May 2025, Capricor Therapeutics completed a mid-cycle review meeting with the FDA for its Biologics License Application (BLA) for deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD) cardiomyopathy. The FDA confirmed no significant deficiencies in the review and affirmed that the application is on track for a Prescription Drug User Fee Act (PDUFA) action date of August 31, 2025. An advisory committee meeting is also planned, but no date has been set yet. completed a mid-cycle review meeting with the FDA for its Biologics License Application (BLA) for deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD) cardiomyopathy. The FDA confirmed no significant deficiencies in the review and affirmed that the application is on track for a Prescription Drug User Fee Act (PDUFA) action date of August 31, 2025. An advisory committee meeting is also planned, but no date has been set yet. In March 2025, the FDA accepted Capricor Therapeutics' application for approval of deramiocel, a cell therapy developed to treat heart muscle disease in individuals with Duchenne muscular dystrophy (DMD), and granted it priority review to accelerate the agency's decision. the FDA accepted Capricor Therapeutics' application for approval of deramiocel, a cell therapy developed to treat heart muscle disease in individuals with Duchenne muscular dystrophy (DMD), and granted it priority review to accelerate the agency's decision. In January 2025, Capricor Therapeutics announced the submission of its Biologics License Application (BLA) to the FDA for full approval of deramiocel, an investigational cell therapy for treating Duchenne muscular dystrophy cardiomyopathy. announced the submission of its Biologics License Application (BLA) to the FDA for full approval of deramiocel, an investigational cell therapy for treating Duchenne muscular dystrophy cardiomyopathy. In November 2024, Regenxbio is advancing its gene therapy RGX-202 for Duchenne muscular dystrophy (DMD) into pivotal development, with plans for a BLA submission by 2026. The company has secured FDA alignment on an accelerated approval pathway, proposing RGX-202 as a one-time treatment, potentially challenging Sarepta's Elevidys in the DMD market. is advancing its gene therapy RGX-202 for Duchenne muscular dystrophy (DMD) into pivotal development, with plans for a BLA submission by 2026. The company has secured FDA alignment on an accelerated approval pathway, proposing RGX-202 as a one-time treatment, potentially challenging Sarepta's Elevidys in the DMD market. In November 2024, Cumberland Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation and Rare Pediatric Disease Designation to Ifetroban for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). Duchenne Muscular Dystrophy Overview Duchenne muscular dystrophy (DMD) is a severe, progressive genetic disorder characterized by muscle degeneration and weakness. It primarily affects boys, with symptoms typically becoming evident between the ages of 2 and 5. DMD is caused by mutations in the DMD gene located on the X chromosome, which encodes for dystrophin, a crucial protein that helps stabilize and protect muscle fibers during contraction. The absence or dysfunction of dystrophin leads to muscle damage, inflammation, and eventual replacement of muscle tissue with fat and fibrotic tissue. Clinically, children with Duchenne Muscular Dystrophy often present with delayed motor milestones, difficulty running or climbing stairs, frequent falls, and a characteristic waddling gait. As the disease progresses, they may develop calf muscle pseudohypertrophy, scoliosis, and cardiac or respiratory complications due to the involvement of the heart and diaphragm muscles. Cognitive difficulties and learning disabilities are also reported in some cases. The diagnosis of DMD typically involves a combination of clinical evaluation and laboratory tests. Elevated levels of creatine kinase (CK) in the blood are indicative of muscle damage and often prompt further investigation. Genetic testing is the gold standard for confirming mutations in the DMD gene. Muscle biopsy, though less commonly performed today, can reveal dystrophin deficiency. Additional assessments, such as electromyography (EMG) and cardiac evaluations, help monitor disease progression and guide management. Early diagnosis enables timely intervention with corticosteroids, physical therapy, and supportive care aimed at improving quality of life and prolonging mobility. Duchenne Muscular Dystrophy Epidemiology Segmentation The Duchenne muscular dystrophy epidemiology section provides insights into the historical and current Duchenne muscular dystrophy patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The Duchenne muscular dystrophy market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Duchenne Muscular Dystrophy Age-specific Cases of Duchenne Muscular Dystrophy Ambulatory and Non-ambulatory Cases of Duchenne Muscular Dystrophy Mutation-specific Cases of Duchenne Muscular Dystrophy Associated Comorbidities in Duchenne Muscular Dystrophy Download the report to understand which factors are driving Duchenne muscular dystrophy epidemiology trends @ Duchenne Muscular Dystrophy Treatment Algorithm Duchenne Muscular Dystrophy Report Metrics Details Study Period 2020–2034 Duchenne Muscular Dystrophy Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Duchenne Muscular Dystrophy Companies FibroGen, Santhera Pharmaceutical, Italfarmaco, ReveraGen BioPharma, Cumberland Pharmaceuticals, Sarepta Therapeutics, Antisense Therapeutics, Capricor Therapeutics, and others Key Duchenne Muscular Dystrophy Therapies NS-089/NCNP-02 (brogidirsen), TAS-205 (pizuglanstat), RGX-202, VYONDYS 53, EXONDYS 51, AGAMREE, VILTEPSO, VILTEPSO, and others Scope of the Duchenne Muscular Dystrophy Market Report Duchenne Muscular Dystrophy Therapeutic Assessment: Duchenne Muscular Dystrophy current marketed and emerging therapies Duchenne Muscular Dystrophy current marketed and emerging therapies Duchenne Muscular Dystrophy Market Dynamics: Conjoint Analysis of Emerging Duchenne Muscular Dystrophy Drugs Conjoint Analysis of Emerging Duchenne Muscular Dystrophy Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Duchenne Muscular Dystrophy Market Access and Reimbursement Discover more about Duchenne muscular dystrophy drugs in development @ Duchenne Muscular Dystrophy Clinical Trials Table of Contents 1. Duchenne Muscular Dystrophy Market Key Insights 2. Duchenne Muscular Dystrophy Market Report Introduction 3. Duchenne Muscular Dystrophy Market Overview at a Glance 4. Duchenne Muscular Dystrophy Market Executive Summary 5. Disease Background and Overview 6. Duchenne Muscular Dystrophy Treatment and Management 7. Duchenne Muscular Dystrophy Epidemiology and Patient Population 8. Patient Journey 9. Duchenne Muscular Dystrophy Marketed Drugs 10. Duchenne Muscular Dystrophy Emerging Drugs 11. Seven Major Duchenne Muscular Dystrophy Market Analysis 12. Duchenne Muscular Dystrophy Market Outlook 13. Potential of Current and Emerging Therapies 14. KOL Views 15. Unmet Needs 16. SWOT Analysis Related Reports Duchenne Muscular Dystrophy Pipeline Duchenne Muscular Dystrophy Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key DMD companies, including Santhera Pharmaceuticals, Sarepta Therapeutics, Italfarmaco, Wave Life Sciences Ltd, FibroGen, EDG 5506 Edgewise Therapeutics, Fordadistrogene movaparvovec, Daiichi Sankyo, Sarepta Therapeutics, Inc., ENCell, Taiho Pharmaceutical, Solid Biosciences, Capricor, Nippon Shinyaku, Hansa Biopharma, among others. Duchenne Muscular Dystrophy Epidemiology Forecast Duchenne Muscular Dystrophy Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted Duchenne muscular dystrophy epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Facioscapulohumeral Muscular Dystrophy Market Facioscapulohumeral Muscular Dystrophy Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key FSHD companies, including Fulcrum Therapeutics, Dyne Therapeutics, Hoffmann-La Roche, aTyr Pharma, Inc., Avidity Biosciences, Inc., among others. Spinal Muscular Atrophy Market Spinal Muscular Atrophy Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SMA companies, including Scholar Rock, Biogen, Astellas Pharma, Alcyone Therapeutics, AndroScience Corporation, Hanugen Therapeutics, Voyager Therapeutics, Hoffmann-La Roche, Catalyst Pharmaceuticals, NMD Pharma, Biohaven Pharmaceuticals, CANbridge Pharmaceuticals Inc., Aurimed Pharma, Exicure, Amylon Therapeutics, Amniotics, among others. Becker Muscular Dystrophy Market Becker Muscular Dystrophy Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Becker muscular dystrophy companies, including Italfarmaco, Immunoforge Co., Ltd., Edgewise Therapeutics, Epirium Bio, Ultragenyx, Strykagen, among others. DelveInsight's Pharma Competitive Intelligence Service: Through its CI solutions, DelveInsight provides its clients with real-time and actionable intelligence on their competitors and markets of interest to keep them stay ahead of the competition by providing insights into the latest therapeutic area-specific/indication-specific market trends, in emerging drugs, and competitive strategies. These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion. Other Business Pharmaceutical Consulting Services Healthcare Conference Coverage Pipeline Assessment Healthcare Licensing Services Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Connect with us on LinkedIn|Facebook|Twitter Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash

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