Latest news with #DelveInsight
Business Upturn
an hour 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
Globe and Mail
19 hours ago
- Business
- Globe and Mail
Cutaneous T-Cell Lymphoma Pipeline Outlook Report 2025: Key 25+ Companies and Breakthrough Therapies Shaping the Future Landscape
DelveInsight's ' Cutaneous T-cell lymphoma Pipeline Insight 2025 ' report provides comprehensive insights about 25+ companies and 30+ pipeline drugs in the Cutaneous T-cell lymphoma pipeline landscape. It covers the Cutaneous T-Cell Lymphoma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Cutaneous T-Cell Lymphoma pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Cutaneous T-Cell Lymphoma Treatment Landscape. Click here to read more @ Cutaneous T-Cell Lymphoma Pipeline Outlook Key Takeaways from the Cutaneous T-Cell Lymphoma Pipeline Report In July 2025, Prescient Therapeutics Ltd. announced a phase 2 study to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmadynamics (PD), of PTX-100 monotherapy at 500 or 1000 mg/m2 in patients with relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL). In July 2025, Dren Bio conducted a Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas. In July 2025, Soligenix announced a Phase 3 study is to evaluate the ability of an 18-week course of HyBryte and visible light to induce a Treatment Response in patients with patch/plaque phase CTCL compared to patients receiving placebo and visible study will evaluate the efficacy and safety of HyBryte (0.25% hypericin) gel or placebo gel applied twice weekly for 18 weeks. Treated lesions will be covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light. DelveInsight's Cutaneous T-Cell Lymphoma pipeline report depicts a robust space with 25+ active players working to develop 30+ pipeline therapies for Cutaneous T-Cell Lymphoma treatment. The leading Cutaneous T-Cell Lymphoma Companies such as HyBryte, Resminostat, Mundipharma International, Shanghai Pharmaceuticals Holding, Moleculin Biotech, Inc., BeiGene, Mundipharma Research Limited, Jiangsu Simcere Biologics Co., Ltd, Teva Pharmaceuticals USA, Pfizer, Galderma R&D, Merck Sharp & Dohme LLC, Bio-Path Holdings, Inc., Kymera Therapeutics, Inc., Karyopharm Therapeutics Inc and others. Promising Cutaneous T-Cell Lymphoma Pipeline Therapies such as E7777, CD11301 0.03%, Panobinostat, ONTAK (denileukin difitox, DAB389IL-2), Quisinostat, 12 mg, APO866, Enzastaurin, SGX301 (synthetic hypericin), Mogamulizumab, Romidepsin (depsipeptide, FK228), and others. Stay informed about the cutting-edge advancements in Cutaneous T-Cell Lymphoma Treatments. Download for updates and be a part of the revolution in oncology care @ Cutaneous T-Cell Lymphoma Clinical Trials Assessment Cutaneous T-cell lymphoma Emerging Drugs HyBryte™ (synthetic hypericin or SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. Synthetic hypericin sodium, the active ingredient in HyBryte™, has Orphan Drug designation in the United States for the treatment of T-cell lymphoma and CTCL and in Europe for CTCL. HyBryte™ has received Fast Track designation for the treatment of cutaneous t-cell lymphoma in the United States. AFM13: Affimed GmbH AFM-13 is under development for the treatment of refractory and relapsed Hodgkin lymphoma, CD30+ lymphoma such as transformed mycosis fungoides, peripheral and cutaneous T-cell lymphoma, large B-cell lymphoma, B-cell non-Hodgkin lymphoma, Hodgkin lymphoma combination with check point inhibitors and Hodgkin lymphoma combination with lenalidomide. The drug candidate is administered intravenously. AFM-13 is a bi-specific, tetravalent human antibody, it acts by targeting CD30/CD16A. The drug is currently in Phase II stage of its development for the treatment of Cutaneous T Cell Lymphoma. ASTX660: Otsuka Pharmaceutical Co., Ltd ASTX660 (Tolinapant) is a novel, orally administered, non-peptidomimetic antagonist of the cellular and X-linked inhibitors of apoptosis proteins (cIAP1/2 and XIAP). Inhibitors of apoptosis proteins (IAPs) are frequently overexpressed in tumor cells and contribute to tumor cell survival and chemo-resistance. By inhibiting IAPs, tolinapant promotes cell death. Tolinapant also acts via a newly described immunomodulatory mechanism, which works to enhance an anti-tumor immune response in T-cell lymphomas. The drug is in Phase I/II for the treatment of CTCL. WUCART007: Wugen WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T-cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T-cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. Currently, the drug is in Phase I stage of its clinical trial for the treatment of CTCL. The Cutaneous T-Cell Lymphoma pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Cutaneous T-Cell Lymphoma with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Cutaneous T-Cell Lymphoma Treatment. Cutaneous T-Cell Lymphoma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Cutaneous T-Cell Lymphoma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Cutaneous T-Cell Lymphoma market. Get a detailed analysis of the latest innovations in the Cutaneous T-Cell Lymphoma pipeline. Explore DelveInsight's expert-driven report today! @ Cutaneous T-Cell Lymphoma Unmet Needs Cutaneous T-Cell Lymphoma Companies HyBryte, Resminostat, Mundipharma International, Shanghai Pharmaceuticals Holding, Moleculin Biotech, Inc., BeiGene, Mundipharma Research Limited, Jiangsu Simcere Biologics Co., Ltd, Teva Pharmaceuticals USA, Pfizer, Galderma R&D, Merck Sharp & Dohme LLC, Bio-Path Holdings, Inc., Kymera Therapeutics, Inc., Karyopharm Therapeutics Inc and others. Cutaneous T-cell lymphoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Cutaneous T-Cell Lymphoma Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Discover the latest advancements in Cutaneous T-Cell Lymphoma Treatment by visiting our website. Stay informed about how we're transforming the future of oncology @ Cutaneous T-Cell Lymphoma Market Drivers and Barriers, and Future Perspectives Scope of the Cutaneous T-Cell Lymphoma Pipeline Report Coverage- Global Cutaneous T-Cell Lymphoma Companies- HyBryte, Resminostat, Mundipharma International, Shanghai Pharmaceuticals Holding, Moleculin Biotech, Inc., BeiGene, Mundipharma Research Limited, Jiangsu Simcere Biologics Co., Ltd, Teva Pharmaceuticals USA, Pfizer, Galderma R&D, Merck Sharp & Dohme LLC, Bio-Path Holdings, Inc., Kymera Therapeutics, Inc., Karyopharm Therapeutics Inc and others. Cutaneous T-Cell Lymphoma Pipeline Therapies- E7777, CD11301 0.03%, Panobinostat, ONTAK (denileukin difitox, DAB389IL-2), Quisinostat, 12 mg, APO866, Enzastaurin, SGX301 (synthetic hypericin), Mogamulizumab, Romidepsin (depsipeptide, FK228), and others. Cutaneous T-Cell Lymphoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Cutaneous T-Cell Lymphoma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III For a detailed overview of our latest research findings and future plans, read the full details of Cutaneous T-Cell Lymphoma Pipeline on our website @ Cutaneous T-Cell Lymphoma Emerging Drugs and Companies Table of Content Introduction Executive Summary Cutaneous T-cell lymphoma: Overview Pipeline Therapeutics Therapeutic Assessment Cutaneous T-cell lymphoma– DelveInsight's Analytical Perspective Late Stage Products (Phase III) Drug Name: Company Name Mid Stage Products (Phase II) AFM13: Affimed GmbH Early Stage Products (Phase I) WUCART007: Wugen Preclinical Stage Products Drug Name: Company Name Inactive Products Cutaneous T-cell lymphoma Key Companies Cutaneous T-cell lymphoma Key Products Cutaneous T-cell lymphoma- Unmet Needs Cutaneous T-cell lymphoma- Market Drivers and Barriers Cutaneous T-cell lymphoma- Future Perspectives and Conclusion Cutaneous T-cell lymphoma Analyst Views Cutaneous T-cell lymphoma Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
Business Upturn
a day ago
- Business
- Business Upturn
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
Yahoo
3 days ago
- Business
- Yahoo
Melanoma Market Anticipates a Dynamic Shift During the Forecast Period (2025–2034) Owing to the Strong Pipeline Activity
The melanoma market is predicted to surge during the forecast period (2025–2034) owing to factors, as the increasing incidence of melanoma, the launch of emerging therapies such as Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), and others, heightened UV exposure, advancements in diagnostic techniques, and lifestyle changes. New York, USA, July 22, 2025 (GLOBE NEWSWIRE) -- Melanoma Market Anticipates a Dynamic Shift During the Forecast Period (2025–2034) Owing to the Strong Pipeline Activity | DelveInsight The melanoma market is predicted to surge during the forecast period (2025–2034) owing to factors, as the increasing incidence of melanoma, the launch of emerging therapies such as Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), and others, heightened UV exposure, advancements in diagnostic techniques, and lifestyle changes. DelveInsight's Melanoma Market Insights report includes a comprehensive understanding of current treatment practices, emerging melanoma drugs, market share of individual therapies, and current and forecasted Melanoma 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 Melanoma Market Report According to DelveInsight's analysis, the total melanoma market size is expected to grow positively by 2034. The United States accounts for the largest market size of melanoma, in comparison to EU4 (Germany, Italy, France, and Spain) and the UK, and Japan. In 2024, the total number of incident cases of melanoma was approximately 105K in the US. The trend indicates that melanoma occurs more frequently in males than in females, and around 20% of cases eventually progress to advanced stages (stage III/IV), involving unresectable or distant metastatic disease. Prominent companies, including Istari Oncology, Philogen, Georgiamune, Diakonos Oncology, Immatics Biotechnologies, Replimune, BMS, Ascentage Pharma, Erasca, Krystal Biotech, IDEAYA Biosciences, Novartis, HUYA Bioscience, Regeneron Pharmaceuticals, and others, are actively working on innovative melanoma drugs. Some of the key melanoma therapies in the pipeline include Lerapolturev, Nidlegy, GIM-531, DOC-1021, IMA203, RP1 (vusolimogene oderparepvec) plus nivolumab, APG-115, Naporafenib (ERAS-254), KB707, Darovasertib (IDE196), HBI-8000, Fianlimab, and others. These novel melanoma therapies are anticipated to enter the melanoma market in the forecast period and are expected to change the market. In May 2025, Immatics announced the presentation of expanded data from the ongoing Phase Ib clinical trial evaluating IMA203 in heavily pretreated patients with metastatic melanoma In April 2025, IDEAYA Biosciences announced a successful FDA Type D meeting on the Phase III registrational trial design that would assess the safety and efficacy of darovasertib for potential regulatory approval as neoadjuvant therapy for primary uveal melanoma. Discover which melanoma medications are expected to grab the market share @ Melanoma Market Report Melanoma Overview Melanoma is a type of skin cancer that originates in melanocytes, the pigment-producing cells responsible for giving skin its color. While it is less common than other skin cancers, melanoma is significantly more aggressive and has a higher risk of spreading to other parts of the body if not detected early. It can occur anywhere on the body but is most frequently found on areas exposed to the sun, such as the back, legs, arms, and face. The primary cause of melanoma is ultraviolet radiation from sunlight or artificial sources like tanning beds, which can damage the DNA in skin cells. Individuals with fair skin, a history of sunburns, a large number of moles, or a family history of melanoma are at higher risk. Genetic mutations, such as in the BRAF gene, also play a significant role in the development of melanoma in certain cases. Symptoms of melanoma often begin with changes in the appearance of a mole or pigmented area. Warning signs include asymmetry, irregular borders, color variation, a diameter larger than 6 mm, and evolving shape or size, summarized by the ABCDE rule. Itching, bleeding, or the appearance of a new mole can also be concerning signs. Diagnosis typically involves a thorough skin examination followed by a biopsy of any suspicious lesion. If melanoma is confirmed, further tests such as sentinel lymph node biopsy, imaging scans (CT, MRI, or PET), and blood work may be conducted to determine the stage and whether the cancer has spread. Early diagnosis is critical, as it significantly improves the prognosis and expands treatment Epidemiology Segmentation The melanoma epidemiology section provides insights into the historical and current melanoma 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 melanoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Incident Cases of Melanoma Stage-specific Incident Cases of Melanoma Mutation-specific Incident Cases of Melanoma Line-wise Treated Cases of Melanoma Download the report to understand which factors are driving melanoma epidemiology trends @ Melanoma Treatment Algorithm Melanoma Treatment Market There remains a substantial unmet need for effective treatment options in melanoma patients who are resistant to, unsuitable for, or unresponsive to standard therapies like checkpoint inhibitors or BRAF/MEK-targeted treatments. The FDA has approved several therapies for melanoma, including AMTAGVI (lifileucel, Iovance Biotherapeutics), OPDUALAG (nivolumab + relatlimab, Bristol Myers Squibb), KEYTRUDA (pembrolizumab, Merck), OPDIVO (nivolumab, BMS), KIMMTRAK (tebentafusp-tebn, Immunocore), YERVOY (ipilimumab, BMS), TECENTRIQ (atezolizumab, Roche), among others. AMTAGVI, from Iovance Biotherapeutics, became the first FDA-approved, personalized, one-time T cell therapy in February 2024. It is intended for adults with unresectable or metastatic melanoma who have previously been treated with PD-1 inhibitors, and for those with BRAF V600 mutations, after BRAF inhibitor ± MEK inhibitor therapy. That same year, Iovance submitted a Marketing Authorization Application (MAA) for lifileucel to the EMA in June (validated in August) and to the UK's MHRA in October. In June 2025, Iovance announced that the final results from the Phase II C-144-01 trial of AMTAGVI in advanced melanoma patients were published in the Journal of Clinical Oncology and presented at the 2025 ASCO Annual Meeting. Bristol Myers Squibb's OPDUALAG combines nivolumab, a PD-1 inhibitor, with relatlimab, a LAG-3 inhibitor, and is indicated for the treatment of unresectable or metastatic melanoma. The FDA approved it in March 2022 for adults and children aged 12 and above. However, in February 2025, BMS reported that the Phase III RELATIVITY-098 trial did not achieve its primary endpoint of recurrence-free survival (RFS) in the adjuvant setting for completely resected stage III–IV melanoma, although the safety profile remained consistent with existing data on the combination. KEYTRUDA and OPDIVO both demonstrate strong efficacy in treating melanoma, though OPDIVO has gained greater commercial traction through effective combination regimens and broader clinical use. Despite metastatic melanoma often being incurable, the emergence of advanced treatments such as immune checkpoint inhibitors and targeted therapies has markedly improved survival and quality of life, signaling a significant evolution in the standard of care. Learn more about the melanoma treatment options @ Melanoma Treatment Guidelines Melanoma Emerging Drugs and Companies Some of the products in the pipeline include Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), RP1 (vusolimogene oderparepvec) plus nivolumab (Replimune and BMS), APG-115 (Ascentage Pharma), Naporafenib (ERAS-254) (Erasca), KB707 (Krystal Biotech), Darovasertib (IDE196) (IDEAYA Biosciences and Novartis), HBI-8000 (HUYA Bioscience and BMS), Fianlimab (Regeneron Pharmaceuticals), and others. IMA203 is a TCR T-cell therapy that targets the Preferentially Expressed Antigen in Melanoma (PRAME). It's designed to identify an intracellular PRAME-derived peptide displayed on the surface of cells by HLA-A*02:01, triggering a strong and specific anti-tumor immune response. Encouraging Phase Ib results, along with PRAME's high expression rate in melanoma (~90–95%), support IMA203's therapeutic promise. The therapy is currently under investigation in the SUPRAME Phase III trial (NCT06743126) for previously treated advanced or metastatic cutaneous melanoma, and its Phase Ib expansion now includes uveal melanoma. According to the company's 2024 Annual Report, interim analysis for IMA203 is expected in Q1 2026, with final Phase III results in Q4 2026. A Biologics License Application (BLA) submission is planned for Q1 2027, aiming for a market launch in Q3 2027. RP1 is a herpes simplex virus-based therapy modified with a fusogenic protein (GALV-GP R) and GM-CSF to enhance tumor cell destruction, increase immunogenic cell death, and promote a systemic anti-tumor immune response. The FDA has awarded Breakthrough Therapy Designation (BTD) for RP1 in combination with nivolumab for adults with advanced melanoma that has progressed after anti-PD1 treatment. In June 2025, Replimune shared updated results from the IGNYTE study (RP1 + nivolumab in anti-PD1-refractory melanoma) at the 2025 ASCO Annual Meeting. Darovasertib (IDE196) is a potent, selective PKC inhibitor in clinical development. PKC lies downstream of the GNAQ and GNA11 pathways. Darovasertib is currently in a Phase III trial for primary non-metastatic uveal melanoma, a Phase II/III (DAR-UM-2) study for HLA-A2-negative metastatic uveal melanoma (MUM), and other Phase II trials in ocular melanoma. The company expects results from the pivotal DAR-UM-2 trial in first-line HLA-A2-negative MUM by late 2025. In March 2025, the FDA granted BTD to darovasertib for neoadjuvant treatment of primary uveal melanoma patients recommended for enucleation. The anticipated launch of these emerging melanoma therapies are poised to transform the Melanoma market landscape in the coming years. As these cutting-edge melanoma therapies continue to mature and gain regulatory approval, they are expected to reshape the melanoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about new treatment for melanoma, visit @ Melanoma Management Melanoma Market Dynamics The melanoma market dynamics are anticipated to change in the coming years. Drugs like OPDIVO and KEYTRUDA, particularly in combination with ipilimumab, have significantly improved overall survival and achieved durable response rates (~30–40%) in metastatic melanoma; however, the limited long-term efficacy in many patients highlights the urgent need for effective second-line therapies and continued innovation. With nearly 50% of melanoma patients harboring BRAF mutations, targeted therapy has become a viable option, while molecular profiling enables patient stratification even in refractory settings for clinical trials and off-label interventions. Moreover, targeting underrepresented melanoma subtypes such as uveal, mucosal, and acral presents opportunities for market expansion and accelerated regulatory pathways, given the high unmet need and paucity of existing therapies. Furthermore, many potential therapies are being investigated for the treatment of melanoma, and it is safe to predict that the treatment space will significantly impact the melanoma 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 melanoma market in the 7MM. However, several factors may impede the growth of the melanoma market. Moreover, melanoma treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the melanoma 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 melanoma market growth. Melanoma Report Metrics Details Study Period 2020–2034 Melanoma Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Melanoma Companies Istari Oncology, Philogen, Georgiamune, Diakonos Oncology, Immatics Biotechnologies, Replimune, BMS, Ascentage Pharma, Erasca, Krystal Biotech, IDEAYA Biosciences, Novartis, HUYA Bioscience, Regeneron Pharmaceuticals, and others Key Melanoma Therapies Lerapolturev, Nidlegy, GIM-531, DOC-1021, IMA203, RP1 (vusolimogene oderparepvec) plus nivolumab, APG-115, Naporafenib (ERAS-254), KB707, Darovasertib (IDE196), HBI-8000, Fianlimab, and others Scope of the Melanoma Market Report Melanoma Therapeutic Assessment: Melanoma current marketed and emerging therapies Melanoma Market Dynamics: Conjoint Analysis of Emerging Melanoma Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Melanoma Market Access and Reimbursement Discover more about melanoma drugs in development @ Melanoma Clinical Trials Table of Contents 1. Melanoma Market Key Insights 2. Melanoma Market Report Introduction 3. Melanoma Market Overview at a Glance 4. Melanoma Market Executive Summary 5. Disease Background and Overview 6. Melanoma Treatment and Management 7. Melanoma Epidemiology and Patient Population 8. Patient Journey 9. Melanoma Marketed Drugs 10. Melanoma Emerging Drugs 11. Seven Major Melanoma Market Analysis 12. Melanoma Market Outlook 13. Potential of Current and Emerging Therapies 14. KOL Views 15. Unmet Needs 16. SWOT Analysis Related Reports Melanoma Pipeline Melanoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key melanoma companies, including IO Biotech, Moderna Inc., Merck Sharp & Dohme LLC, BioNTech SE, TILT Biotherapeutics LLC, Nykode Therapeutics, Achilles Therapeutics UK Limited, Evaxion Biotech, InxMed, AiVita Biomedical, Cytovation AS, Ono Pharmaceuticals, Neon Therapeutics, Iovance Biotherapeutics, among others. Ocular Melanoma Market Ocular Melanoma 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 ocular melanoma companies, including Bristol Myers Squibb, Merck & Co., Inc., Novartis AG, Roche Holding AG, Pfizer Inc., AstraZeneca PLC, Eli Lilly and Company, Bayer AG, GlaxoSmithKline PLC, Amgen Inc., among others. Uveal Melanoma Market Uveal Melanoma 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 uveal melanoma companies, including Novartis Pharmaceuticals, Foghorn Therapeutics, TriSalus Life Sciences, Inc., Bristol Myers Squibb, Array BioPharma, Ono Pharmaceutical, AstraZeneca, Roche, IDEAYA Biosciences, Merck & Co, GlaxoSmithKline, Janssen, among others. Metastatic Melanoma Market Metastatic Melanoma 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 metastatic melanoma companies, including Cancer Insight LLC, Elios Therapeutics LLC, Evaxion Biotech A/S, Merck Sharp & Dohme LLC, Novartis Pharmaceuticals, InxMed (Shanghai) Co. Ltd., Aivita Biomedical Inc., Hoffmann-La Roche, Idera Pharmaceuticals, Iovance Biotherapeutics Inc., Eisai Inc., Biocad, Myrexis Inc., Pain Therapeutics, Altor BioScience, among others. Refractory Metastatic Melanoma Market Refractory Metastatic Melanoma 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 refractory metastatic melanoma companies, including BioNTech SE, Y-mAbs Therapeutics, Seagen Inc., 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 CONTACT: Contact Us Shruti Thakur info@ +14699457679 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
Globe and Mail
4 days ago
- Business
- Globe and Mail
CAR T-Cell Therapy for Multiple Myeloma Pipeline Experiences Rapid Expansion as Over 5+ Leading Companies Advance Novel Therapies
DelveInsight's, 'CAR T-Cell Therapy for Multiple Myeloma Pipeline Insight, 2025,' report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in CAR T-Cell Therapy for Multiple Myeloma pipeline landscape. It covers the CAR T-Cell Therapy for Multiple Myeloma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the CAR T-Cell Therapy for Multiple Myeloma pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Discover the latest drugs and treatment options in the CAR T-Cell Therapy for Multiple Myeloma Pipeline. Dive into DelveInsight's comprehensive report today! @ CAR T-Cell Therapy for Multiple Myeloma Pipeline Outlook Key Takeaways from the CAR T-Cell Therapy for Multiple Myeloma Pipeline Report In July 2025, Janssen Research & Development LLC announced a study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS). DelveInsight's CAR T-Cell Therapy for Multiple Myeloma pipeline report depicts a robust space with 5+ active players working to develop 5+ pipeline therapies for CAR T-Cell Therapy for Multiple Myeloma treatment. The leading CAR T-Cell Therapy for Multiple Myeloma Companies such as Novartis, Janssen Biotech, Yake Biotech, Celgene Corporation and others. Promising CART-Cell Therapy for Multiple Myeloma Pipeline Therapies such as Cevostamab, Talquetamab, Bortezomib, Dexamethasone, Lenalidomide, Nivolumab and others. Stay ahead with the most recent pipeline outlook for CAR T-Cell Therapy for Multiple Myeloma. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ CAR T-Cell Therapy for Multiple Myeloma Treatment Drugs CAR T-Cell Therapy for Multiple Myeloma Emerging Drugs Profile Novartis drug candidate, PHE 885, is in its phase I trials. The study is to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous T cells genetically engineered with a novel B-cell Maturation Antigen (BCMA)-specific chimeric antigen receptor (CAR). The drug is in the development for the multiple myeloma treatment. JNJ-68284528: Janssen Biotech Janssen's drug JNJ-68284528 is currently being evaluated for the treatment of CAR T-Cell Therapy for Multiple Myeloma. The drug is in pre-registration and from the class CAR-T cell therapies. The drug has been designated with orphan drug status. The CAR T-Cell Therapy for Multiple Myeloma Pipeline Report Provides Insights into The report provides detailed insights about companies that are developing therapies for the treatment of CAR T-Cell Therapy for Multiple Myeloma with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for CAR T-Cell Therapy for Multiple Myeloma Treatment. CAR T-Cell Therapy for Multiple Myeloma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. CAR T-Cell Therapy for Multiple Myeloma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the CAR T-Cell Therapy for Multiple Myeloma market Explore groundbreaking therapies and clinical trials in the CAR T-Cell Therapy for Multiple Myeloma Pipeline. Access DelveInsight's detailed report now! @ New CAR T-Cell Therapy for Multiple Myeloma Drugs CAR T-Cell Therapy for Multiple Myeloma Companies Novartis, Janssen Biotech, Yake Biotech, Celgene Corporation and others. CAR T-Cell Therapy for Multiple Myeloma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Subcutaneous Intravenous Oral Intramuscular Molecule Type CAR T-Cell Therapy for Multiple Myeloma Products have been categorized under various Molecule types such as Small molecules Natural metabolites Monoclonal antibodies Product Type Unveil the future of CAR T-Cell Therapy for Multiple Myeloma Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ CAR T-Cell Therapy for Multiple Myeloma Market Drivers and Barriers Scope of the CAR T-Cell Therapy for Multiple Myeloma Pipeline Report Coverage- Global CAR T-Cell Therapy for Multiple Myeloma Companies- Novartis, Janssen Biotech, Yake Biotech, Celgene Corporation and others. CART-Cell Therapy for Multiple Myeloma Pipeline Therapies- Cevostamab, Talquetamab, Bortezomib, Dexamethasone, Lenalidomide, Nivolumab and others. CAR T-Cell Therapy for Multiple Myeloma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination CAR T-Cell Therapy for Multiple Myeloma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Get the latest on CAR T-Cell Therapy for Multiple Myeloma Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ CAR T-Cell Therapy for Multiple Myeloma Companies, Key Products and Unmet Needs Table of Contents Introduction Executive Summary CAR T-Cell Therapy for Multiple Myeloma: Overview Pipeline Therapeutics Therapeutic Assessment CAR T-Cell Therapy for Multiple Myeloma – DelveInsight's Analytical Perspective In-depth Commercial Assessment CAR T-Cell Therapy for Multiple Myeloma Collaboration Deals Early Stage Products (Phase I) PHE 885: Novartis Drug profiles in the detailed report….. Pre-clinical Stage JNJ-68284528: Janssen Biotech Drug profiles in the detailed report….. Pre-clinical and Discovery Stage Products Drug profiles in the detailed report….. Inactive Products CAR T-Cell Therapy for Multiple Myeloma Key Companies CAR T-Cell Therapy for Multiple Myeloma Key Products CAR T-Cell Therapy for Multiple Myeloma- Unmet Needs CAR T-Cell Therapy for Multiple Myeloma- Market Drivers and Barriers CAR T-Cell Therapy for Multiple Myeloma- Future Perspectives and Conclusion CAR T-Cell Therapy for Multiple Myeloma Analyst Views CAR T-Cell Therapy for Multiple Myeloma Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
