Latest news with #BTKInhibitor
Emirates 24/7
08-07-2025
- Health
- Emirates 24/7
Emirates Drug Establishment approves world's first oral therapy for immune thrombocytopenia
The Emirates Drug Establishment (EDE) has granted official approval for Rilzabrutinib, the first oral Bruton's tyrosine kinase (BTK) inhibitor to be authorised in the country for the treatment of Immune Thrombocytopenia (ITP), a rare autoimmune disorder that affects approximately 2 to 5 individuals per 100,000 people worldwide. With this landmark approval, the UAE becomes the first country in the world to authorise this innovative medication, reflecting the nation's global leadership in accelerating access to advanced treatments and addressing critical medical needs. The approval of Rilzabrutinib in the UAE represents a major step forward, offering patients with ITP early access to a pioneering therapeutic solution that contributes to a faster treatment journey and a tangible improvement in quality of life. The decision aligns with the UAE's strategic commitment to ensuring the availability of high-efficacy, globally benchmarked treatments in line with the highest international standards and protocols. Developed by global pharmaceutical and healthcare company Sanofi, Rilzabrutinib represents a breakthrough in restoring immune system balance by targeting the underlying cause of ITP. By increasing platelet counts, the treatment addresses both the symptoms and root causes of the condition. Clinical studies have demonstrated promising outcomes, with patients reporting substantial improvement in health indicators. Dr. Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, stated, 'The UAE is committed to providing access to the world's latest therapeutic innovations and further promoting its position as a regional hub for pharmaceutical excellence. With Rilzabrutinib getting approved, we take another step further in achieving our strategy aimed at enhancing national pharmaceutical security, implementing advanced treatment protocols, and streamlining regulatory frameworks in collaboration with international partners.' Dr. Al Kaabi emphasised that the milestone demonstrates the effectiveness of the UAE's proactive healthcare policies and flexible regulatory systems in fostering innovation and facilitating patient access to advanced medications. 'The Emirates Drug Establishment will spare no effort to accelerate regulatory procedures, and strengthen global partnerships,' she said. 'This further solidifies the UAE's role as a regional centre for pharmaceutical innovation.' She added, 'Granting approval for Rilzabrutinib reaffirms the Establishment's commitment to fast-tracking access to transformative therapies that create significant impact, particularly in the treatment of rare and chronic diseases. EDE will continue to adopt a proactive, innovation-driven approach, fuelled by international collaboration, to ensure that safe, effective therapeutic options are available across the country in accordance with the highest global standards. Our goal is to enhance the UAE's health system preparedness in an era of rapid scientific progress.' For her part, Preeti Futnani, MCO Lead and General Manager, Specialty Care for KSA & Gulf Countries at Sanofi, said, 'We are honoured to collaborate with the Emirates Drug Establishment to bring this groundbreaking treatment to patients in the UAE living with Immune Thrombocytopenia. The approval of Rilzabrutinib demonstrates our shared commitment to placing patients at the centre of our mission and delivering cutting-edge solutions that address some of the most pressing unmet medical needs.' Follow Emirates 24|7 on Google News.
Yahoo
09-06-2025
- Business
- Yahoo
Everest Medicines Presents Positive Results in Preliminary Analysis of Phase 1b/2a Clinical Trial of Novel BTK Inhibitor EVER001 at the 62nd Congress of the European Renal Association
EVER001 is a covalent reversible BTK inhibitor with potentially best-in-class characteristics for the treatment of primary membranous nephropathy (pMN) and other autoimmune renal diseases, including IgA nephropathy (IgAN), minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and lupus nephritis (LN), offering treatment options for over 10 million patients worldwide. No drug has been approved globally for the treatment of pMN currently. There are approximately 2 million patients with pMN in China, and nearly 220,000 patients in the United States, Europe and Japan. As of December 17th, 2024, the ongoing Phase 1b/2a clinical trial of EVER001 includes longer-term data collected from some patients: 10 patients in the low-dose cohort completed 52 weeks of follow-up, and 10 patients in the high-dose cohort completed 24 weeks of treatment. Preliminary results showed that EVER001 was well-tolerated and effective in patients with pMN. These results support the potential of EVER001 as a treatment for proteinuric autoimmune glomerular diseases.- Compared to baseline, the least squares (LS) geometric mean levels of anti-PLA2R autoantibodies decreased by 62.1% in the low-dose cohort and 87.3% in the high-dose cohort at week 12. The reductions in both cohorts reached approximately 93% at week 24.- In the low-dose cohort, a 78.0% of reduction in proteinuria was observed by the end of 36 weeks of treatment. This reduction was sustained through week 52. In the high-dose cohort, a 70.1% of reduction in proteinuria at week 24 was shown.- EVER001 was generally safe and well tolerated. No clinically significant adverse events commonly associated with covalent irreversible BTK inhibitors were observed. SHANGHAI, June 9, 2025 /PRNewswire/ -- Everest Medicines (HKEX "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that positive results in the ongoing Phase 1b/2a clinical trial for the treatment of primary membranous nephropathy (pMN) with EVER001 (previously known as XNW1011), a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor will be presented in a focused oral session at the 62nd Congress of the European Renal Association (ERA 2025). Preliminary results showed that EVER001 was well-tolerated and effective in patients with pMN. These results support the potential of EVER001 as a treatment for proteinuric autoimmune glomerular diseases. This initial unveiling of the preliminary data at an international congress focuses on pMN, which is the second most common cause of primary glomerulonephritis. EVER001 is a covalent reversible BTK inhibitor with potentially best-in-class characteristics for the treatment of autoimmune renal diseases. Compared to covalent irreversible BTK inhibitors, EVER001 offers improved selectivity while maintaining high potency, thereby potentially avoiding many of the side effects associated with earlier-generation BTK inhibitors. Everest Medicines holds global rights to EVER001 for the treatment of renal diseases. This oral presentation highlights an ongoing Phase 1b/2a clinical trial of EVER001 for the treatment of pMN, which is being conducted in China. The study is designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of EVER001 in Chinese patients with glomerular diseases characterized by proteinuria. A total of 31 patients with biopsy-proven pMN who tested positive for anti-PLA2R autoantibodies were enrolled into two cohorts. The total treatment duration was 36 weeks. The presentation includes longer-term data collected from some patients (10 patients in the low-dose cohort completed 52 weeks of follow-up, and 10 patients in the high-dose cohort completed 24 weeks of treatment). Preliminary results showed that EVER001 was well-tolerated and effective in patients with pMN. These results support the potential of EVER001 as a treatment for proteinuric autoimmune glomerular diseases. The trial results, based on data analysis as of December 17th, 2024, demonstrated that EVER001 was generally safe and well tolerated, with the most common TRAEs being Grade 1-2. No clinically significant adverse events commonly associated with covalent irreversible BTK inhibitors, such as bleeding, arrhythmia, severe infections, or severe liver function impairment were observed. Compared to baseline, the least squares (LS) geometric mean levels of anti-PLA2R autoantibodies decreased by 62.1% in the low-dose cohort and 87.3% in the high-dose cohort at week 12. The reductions in both cohorts reached approximately 93% at week 24. 76.9% of patients in the low-dose cohort and 81.8% in the high-dose cohort achieved immunological complete remission at week 24. For 24-hour proteinuria, the LS geometric mean decreased by 78.0% from baseline in the low-dose cohort at week 36 and the reduction was maintained for 16 weeks after the end of treatment. At week 36, 69.2% of patients in the low-dose group achieved clinical remission. In the high-dose cohort, proteinuria had already decreased by 70.1% at week 24, with 80.0% of patients achieving clinical remission. Patients in both cohorts maintained stable renal function during the treatment period. "As a next-generation BTK inhibitor, EVER001 offers key advantages, including covalent reversibility, high selectivity, strong target-binding affinity, and reduced off-target toxicity. These attributes highlight its substantial potential in the treatment of pMN." Professor Minghui Zhao, leading principal investigator of EVER001 and an influential nephrologist at Peking University First Hospital, said: "Preliminary results from the Phase 1b/2a clinical trial of EVER001, presented at the 62nd ERA Congress, demonstrate that EVER001 induced rapid reductions in anti-PLA2R autoantibodies and proteinuria observed across both low- dose and high-dose cohorts. The treatment exhibits a favorable safety and tolerability profile. Currently, no drug has been approved globally for the treatment of pMN. Traditional immunosuppressive therapies carry a high risk of relapse following discontinuation, and many are associated with adverse effects. We therefore hope that new treatment options will become available to offer patients safer and more effective therapies." "To date, no drug has been approved globally for the treatment of pMN. As a potential best-in-class therapy, EVER001 holds promise to offer more treatment options for over 10 million patients worldwide affected by pMN, IgA nephropathy (IgAN), minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and lupus nephritis (LN)." Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, said: "We are very pleased to see that the positive results in the preliminary analysis of our Phase 1b/2a clinical proof-of-concept trial of EVER001 were presented for the first time at an international academic conference. These preliminary results, disclosed at the 62nd ERA Congress, demonstrated that this next-generation covalent reversible BTK inhibitor was well-tolerated and effective in patients with pMN. Moving forward, we will continue to drive the global clinical development of EVER001, to meet patients' urgent clinical needs." pMN is a common pathological type of nephrotic syndrome in adults, and its prevalence in China has been increasing, ranking second only to IgA nephropathy[1]. There are approximately 2 million patients with pMN in China, and nearly 220,000 patients in the United States, Europe and Japan. There are no approved drugs for this indication worldwide. The current treatment goal is to improve remission rates, reduce high relapse rates, and minimize the risk of chronic toxicity caused by currently available treatments. More than one-third of pMN patients still progress to end-stage renal disease under current standards of care. This Phase 1b/2a clinical trial was approved by the Center for Drug Evaluation of the National Medical Products Administration in September 2022 to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of EVER001 in Chinese patients with glomerular diseases characterized by proteinuria. About EVER001 EVER001 (previously known as XNW1011) is a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor in development globally for the treatment of renal diseases. BTK is an essential component of the B-cell receptor signaling pathways that regulate the survival, activation, proliferation, and differentiation of B lymphocytes. Targeting BTK with small molecule inhibitors has been demonstrated to be an effective treatment option for B-cell lymphomas and autoimmune diseases. Under an exclusive licensing agreement with Sinovent Pharmaceuticals and SinoMab BioScience, Everest owns global rights to develop, produce and commercialize EVER001 for the treatment of renal diseases. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at Forward-Looking Statements: This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. References: 1. Expert consensus on the application of rituximab in the treatment of membranous nephropathy, Chin J Intern Med, March 2022, Vol. 61, No. 3. View original content: SOURCE Everest Medicines 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
Yahoo
30-05-2025
- Business
- Yahoo
Roche's fenebrutinib maintains near-complete suppression of disease activity and disability progression for up to two years in people with relapsing multiple sclerosis
Patients on fenebrutinib had low relapse rates with data showing no active brain lesions or disability progression after nearly two years of treatment Phase III studies for fenebrutinib in relapsing and primary progressive multiple sclerosis are expected to start reading out at year end Basel, 30 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new, 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no disability progression and low levels of disease activity for up to two years. The latest results for this investigational Bruton's tyrosine kinase (BTK) inhibitor from the Phase II FENopta open-label extension (OLE) study were presented at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting in Phoenix, Arizona. 'These data show that patients treated with fenebrutinib experienced an annualised relapse rate equal to one relapse every 17 years and no observed disability progression up to two years,'' said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. 'Fenebrutinib is potent, highly selective and the only reversible BTK inhibitor currently in Phase III trials for multiple sclerosis, and we look forward to seeing the first of those results later this year.' Ninety-nine patients entered the OLE and 93 remained in the OLE after 96 weeks. During the OLE period, patients treated with fenebrutinib for up to 96 weeks had a low annualised relapse rate (ARR) of 0.06, and during this time there was no disability progression, as measured by the Expanded Disability Status Scale (EDSS). MRI scans showed that fenebrutinib treatment suppressed disease activity in the brain. At 96 weeks zero new T1 gadolinium-enhancing (T1-Gd+) lesions, which are markers of active inflammation, were detected. In the treatment group that switched from placebo to fenebrutinib in the OLE, the annualised rate of new or enlarging T2 lesions, which represent chronic disease burden, decreased from 6.72 at the end of the 12 week double-blind period to 0.34 by 96 weeks. The safety profile of fenebrutinib in the OLE was consistent with previously reported data, with no new safety concerns identified at 96 weeks. The most common adverse events (AEs) in ≥5% of patients were COVID-19 (10%), urinary tract infection (10%), pharyngitis (6%) and respiratory tract infection (5%). Serious AEs occurred in two patients (2%). During the OLE, one patient experienced asymptomatic alanine aminotransferase elevation at OLE week 4, after 16 weeks on treatment, which resolved with treatment discontinuation. Three Phase III clinical trials are ongoing, including the FENhance 1 and 2 trials in RMS and the FENtrepid trial in primary progressive multiple sclerosis (PPMS). The first data from these studies, which will characterise the effects of fenebrutinib on disease progression across the multiple sclerosis spectrum, are expected at the end of 2025. About fenebrutinibFenebrutinib is an investigational oral, reversible and non-covalent Bruton's tyrosine kinase (BTK) inhibitor that blocks the function of BTK. BTK, also known as tyrosine-protein kinase BTK, is an enzyme that regulates B-cell development and activation and is also involved in the activation of innate immune system myeloid lineage cells, such as macrophages and microglia. Preclinical data have shown fenebrutinib to be potent and highly selective, and it is the only reversible BTK inhibitor currently in Phase III trials for multiple sclerosis. Fenebrutinib has been shown to be 130 times more selective for BTK vs. other kinases. Fenebrutinib is a dual inhibitor of both B-cell and microglia activation. This dual inhibition may be able to reduce both multiple sclerosis disease activity and disability progression, thereby potentially addressing the key unmet medical need of disability progression in people living with multiple sclerosis. The fenebrutinib Phase III programme includes two identical trials in relapsing multiple sclerosis (RMS) (FENhance 1 & 2) with active comparator teriflunomide and the only trial in primary progressive multiple sclerosis (PPMS) (FENtrepid) in which a BTK inhibitor is being evaluated against OCREVUS. To date, more than 2,700 patients and healthy volunteers have been treated with fenebrutinib in Phase I, II and III clinical programmes across multiple diseases, including multiple sclerosis and other autoimmune disorders. About the FENopta studyThe FENopta study was a global Phase II, randomised, double-blind, placebo-controlled 12-week study to investigate the efficacy, safety and pharmacokinetics of fenebrutinib in 109 adults aged 18-55 years with relapsing multiple sclerosis (RMS). The primary endpoint was the total number of new T1 gadolinium-enhancing (T1-Gd+) lesions as measured by MRI scans of the brain at 4, 8 and 12 weeks. Secondary endpoints included the number of new or enlarging T2-weighted lesions as measured by MRI scans of the brain at 4, 8 and 12 weeks, and the proportion of patients free from any new T1-Gd+ lesions and new or enlarging T2-weighted lesions as measured by MRI scans of the brain at 4, 8 and 12 weeks. The goal of the FENopta study was to characterise the effect of fenebrutinib on MRI and soluble biomarkers of disease activity and progression, and it included an optional substudy to measure cerebrospinal fluid fenebrutinib levels and biomarkers of neuronal injury. Data from the 12-week study showed that fenebrutinib is central nervous system (CNS) penetrant (crosses the blood-brain barrier) and has the potential to impact mechanisms underlying chronic progressive disease biology in multiple sclerosis patients. Fenebrutinib significantly reduced new T1-Gd+ lesions and new/enlarging T2 lesions compared to placebo. The safety profile of fenebrutinib was consistent with previous and ongoing fenebrutinib clinical trials and there were no new safety concerns identified. Patients who completed the FENopta study were given the option to take part in an open-label extension (OLE) study, in which all patients receive fenebrutinib up to 192 weeks. About multiple sclerosisMultiple sclerosis is a chronic disease that affects more than 2.9 million people worldwide. Multiple sclerosis occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the central nervous system (brain, spinal cord and optic nerves), causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with multiple sclerosis experience their first symptom between 20 and 40 years of age, making the disease the leading cause of non-traumatic disability in younger adults. People with all forms of multiple sclerosis experience disease progression from the beginning of their disease. Therefore, delays in diagnosis and treatment can negatively impact people with multiple sclerosis, in terms of their physical and mental health, and contribute to the negative financial impact on the individual and society. An important goal of treating multiple sclerosis is to slow, stop and ideally prevent progression as early as possible. Approximately 85% of people with multiple sclerosis have a relapsing form of the disease (RMS) characterised by relapses and also worsening disability over time. Primary progressive multiple sclerosis (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease. Until the FDA approval of OCREVUS, there had been no FDA-approved treatments for PPMS and OCREVUS is still the only approved treatment for PPMS. About Roche in NeuroscienceNeuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases. Roche is investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer's disease, Huntington's disease, Parkinson's disease and Duchenne muscular dystrophy. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by law. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 68-75284e-mail: Dr Sabine BorngräberPhone: +41 61 68-88027e-mail: Dr Birgit MasjostPhone: +41 61 68-84814e-mail: Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: Attachment 30052025_96-week data for fenebrutinib_enError while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
09-04-2025
- Business
- Yahoo
BTK Inhibitor Research Report 2025: Market Opportunities, Drivers, Trends, and Forecasts to 2034 - Rising Prevalence of Leukemia, Lymphoma, and Autoimmune Disorders Fueling Growth
Bruton's tyrosine kinase (BTK) inhibitors play a crucial role in targeted therapies, effectively disrupting key signaling pathways involved in these diseases. The increasing focus on precision medicine, coupled with advancements in drug formulations, is further fueling market expansion. BTK Inhibitor Market Dublin, April 09, 2025 (GLOBE NEWSWIRE) -- The "BTK Inhibitor Market Opportunity, Growth Drivers, Industry Trend Analysis, and Forecast 2025-2034" report has been added to BTK Inhibitor Market was valued at USD 9.4 billion in 2024, and is projected to reach USD 28.9 billion by 2034, rising at a CAGR of 12%, driven by the rising prevalence of leukemia, lymphoma, and autoimmune disorders. A surge in clinical trials, growing awareness about hematologic malignancies, and an expanding patient pool are key factors accelerating the adoption of BTK inhibitors. Pharmaceutical companies are heavily investing in research and development, aiming to introduce next-generation inhibitors with enhanced efficacy and safety profiles. Regulatory approvals, particularly from the U.S. Food and Drug Administration (FDA), continue to set high standards, ensuring the development of drugs with superior therapeutic benefits. Additionally, the growing shift toward oral therapies over traditional chemotherapy is contributing to the widespread acceptance of BTK inhibitors among healthcare professionals and patients alike. The market is also benefiting from an increase in strategic collaborations and partnerships between biotech firms and major pharmaceutical companies, fostering innovation and expanding product BTK inhibitor market is categorized into first-generation and second-generation inhibitors. In 2024, the first-generation segment accounted for USD 5.9 billion and is expected to grow at a CAGR of 11.9% over the forecast period. These inhibitors have demonstrated substantial clinical benefits in treating chronic lymphocytic leukemia and mantle cell lymphoma, significantly improving patient survival rates and slowing disease progression. The rising success of these treatments is expected to sustain high demand, particularly as newer indications continue to segmentation of the market includes drug types such as selective BTK inhibitors, non-selective BTK inhibitors, and dual BTK inhibitors. Among these, the selective BTK inhibitors segment holds the largest market share, representing 52.5% with a valuation of USD 4.9 billion in 2024. These inhibitors provide targeted therapy with minimal off-target effects, reducing adverse reactions like atrial fibrillation and gastrointestinal complications. This specificity enhances their appeal among clinicians and patients, further driving their North American BTK Inhibitor Market was valued at USD 3.8 billion in 2024 and is forecasted to reach USD 11.5 billion by 2034. The growing prevalence of cancer in the United States is a major factor propelling demand for these inhibitors, especially as targeted therapies gain prominence in oncology. The stringent regulatory landscape set by the FDA is pushing pharmaceutical companies to develop safer and more effective BTK inhibitors, ensuring continuous innovation in the sector. Leading industry players are actively focusing on developing next-generation BTK inhibitors with improved drug stability, enhanced bioavailability, and reduced side effects, further strengthening market growth in the Market Analysis and Forecast Industry trends, key growth drivers, challenges, future opportunities, and regulatory landscape Competitive landscape with Porter's Five Forces and PESTEL analysis Market size, segmentation, and regional forecasts In-depth company profiles, business strategies, financial insights, and SWOT analysis Amgen AstraZeneca Agilent Technologies BristolMyers Squibb Celgene Biogen Eli Lilly and Company F. Hoffmann-La Roche Ltd Gilead Sciences Johnson and Johnson Incyte Merck and Co Novartis Sanofi Takeda Pharmaceutical Key Attributes: Report Attribute Details No. of Pages 132 Forecast Period 2024 - 2034 Estimated Market Value (USD) in 2024 $9.4 Billion Forecasted Market Value (USD) by 2034 $28.9 Billion Compound Annual Growth Rate 12.0% Regions Covered Global Key Topics Covered: Chapter 1 Methodology and Scope1.1 Market scope and definitions1.2 Research design1.2.1 Research approach1.2.2 Data collection methods1.3 Base estimates and calculations1.3.1 Base year calculation1.3.2 Key trends for market estimation1.4 Forecast model1.5 Primary research and validation1.5.1 Primary sources1.5.2 Data mining sourcesChapter 2 Executive Summary2.1 Industry 360 synopsisChapter 3 Industry Insights3.1 Industry ecosystem analysis3.2 Industry impact forces3.2.1 Growth drivers3.2.1.1 Rising prevalence of cancers and autoimmune diseases3.2.1.2 Advancements in targeted therapies3.2.1.3 Ongoing research and development3.2.1.4 Increasing focus on personalized medicine3.2.2 Industry pitfalls and challenges3.2.2.1 High cost of BTK inhibitors3.2.2.2 Adverse side effects3.3 Growth potential analysis3.4 Regulatory landscape3.5 Technological landscape3.6 Future market trends3.7 Porter's analysis3.8 PESTEL analysisChapter 4 Competitive Landscape, 20244.1 Introduction4.2 Company market share analysis4.3 Company matrix analysis4.4 Competitive analysis of major market players4.5 Competitive positioning matrix4.6 Strategy dashboardChapter 5 Market Estimates and Forecast, by Type, 2021-2034 ($ Mn)5.1 Key trends5.2 First generation5.3 Second generationChapter 6 Market Estimates and Forecast, by Drug Type, 2021-2034 ($ Mn)6.1 Key trends6.2 Selective BTK inhibitors6.3 Non-selective BTK inhibitors6.4 Dual BTK inhibitorsChapter 7 Market Estimates and Forecast, by Application, 2021-2034 ($ Mn)7.1 Key trends7.2 Cancer7.2.1 Chronic lymphocytic leukemia (CLL)7.2.2 Follicular lymphoma7.2.3 Mantle cell lymphoma7.2.4 Marginal zone lymphoma7.2.5 Small lymphocytic lymphoma (SLL)7.2.6 Waldenstrom macroglobulinemia7.2.7 Other selective B cell malignancies7.3 Autoimmune diseases7.3.1 Systemic lupus erythematosus (SLE)7.3.2 Rheumatoid arthritis (RA)7.3.3 Multiple sclerosis (MS)7.3.4 Immune thrombocytopenia (ITP)7.3.5 Inflammatory disorders7.4 Inflammatory bowel disease (IBD)7.4.1 Asthma and allergic diseases7.4.2 IgG4-Related diseases7.4.3 Vasculitis7.5 Other applicationsChapter 8 Market Estimates and Forecast, by Route of Administration, 2021-2034 ($ Mn)8.1 Key trends8.2 Oral administration8.3 Intravenous administration8.4 Subcutaneous administrationChapter 9 Market Estimates and Forecast, by Distribution Channel, 2021-2034 ($ Mn)9.1 Key trends9.2 Hospital pharmacy9.3 Retail pharmacy9.4 Online pharmacyChapter 10 Market Estimates and Forecast, by Region, 2021-2034 ($ Mn)10.1 Key trends10.2 North America10.2.1 U.S.10.2.2 Canada10.3 Europe10.3.1 Germany10.3.2 UK10.3.3 France10.3.4 Spain10.3.5 Italy10.3.6 Netherlands10.4 Asia-Pacific10.4.1 China10.4.2 Japan10.4.3 India10.4.4 Australia10.4.5 South Korea10.5 Latin America10.5.1 Brazil10.5.2 Mexico10.5.3 Argentina10.6 Middle East and Africa10.6.1 South Africa10.6.2 Saudi Arabia10.6.3 UAEChapter 11 Company ProfilesFor more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment BTK Inhibitor Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Sign in to access your portfolio
