The growth of the global Bruton’s tyrosine kinase (BTK) inhibitors market is driven by the rising number of mantle cell lymphoma cases, which was close to 559 million in 2022. The market value of mantle cell lymphoma is likely to grow at a CAGR of 8.2% in the forecast period of 2023-2031 and is likely to reach 20 billion by 2031.
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A Bruton tyrosine kinase inhibitor targets B cell receptors to regulate B cell signalling, proliferation, growth, and differentiation. BTK inhibitors are non-receptor tyrosine kinase inhibitors.
Haematologic malignancies, B-cell leukaemia, lymphoma, and graft-versus-host disease (GVHD) are some of the main diseases that are treated with Bruton tyrosine kinase (BTK) inhibitors. The BTK inhibitor Imbruvica (ibrutinib) is approved for the treatment of non-Hodgkin's lymphoma, haematologic malignancies, and GVHD. It has been more than twenty years since Bruton's tyrosine kinase (BTK) inhibitors became available in the market.
The demand for Bruton tyrosine kinase (BTK) inhibitors is predicted to grow further in the coming years due to current improvements in medical and therapeutic demand.
Bruton tyrosine kinase (BTK) inhibitors have a large consumer base and is likely to continue to grow with the rapid developments in the market.
According to the global Bruton’s tyrosine kinase (BTK) inhibitor market research report, the market can be categorised into the following segments:
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Market Breakup by Type
Market Breakup by Drug Type
Market Breakup by Application
Market Breakup by Distribution Channel
Market Breakup by Region
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The growth of the global market is driven by the rising prevalence of mantle cell lymphoma. The market demand is predicted to grow significantly due to the increase in investment in healthcare infrastructure and the number of research and development activities.
The growing healthcare expenditure, supported by improved infrastructure, is also among the primary factors affecting the Bruton’s tyrosine kinase (BTK) inhibitors market growth rate.
Rising initiatives for spreading awareness about the treatment will further aid the growth of the market, along with the rising disposable income of the people and their lifestyle changes.
In addition, the growth of global Bruton’s tyrosine kinase (BTK) inhibitor market will be driven by an ageing population and favourable reimbursement policies. Rising investments in the development of advanced technology and the growth of emerging markets will also provide lucrative growth opportunities to the Bruton tyrosine kinase (BTK) inhibitor market.
The market growth can also be attributed to the increasing number of research and development operations. Lucrative opportunity exists for the growth of the market for Bruton tyrosine kinase inhibitors. The market's growth rate will be boosted by increased approvals and launches of pharmaceutical products.
Geographically, North America is the leading region for Bruton tyrosine kinase (BTK) inhibitors due to improved healthcare, higher prices, and increased chronic diseases, followed by Europe, which is the world's second largest region for the inhibitors. Biotechnology research and therapeutic development in the Asia Pacific region has also grown at a rapid pace and the market for BTK inhibitors is likely to witness significant growth in the coming years.
The growth of the market is hampered by the obstructed approvals and off-target effects of first-generation Bruton tyrosine kinase (BTK) inhibitors. It is expected that the market in developing countries will face further challenges due to the shortage of qualified professionals and poor medical infrastructure.
Moreover, mantle cell lymphoma and adverse events associated with Bruton tyrosine kinase inhibitors will restrain the market growth and hinder its growth during the forecast period.
Mantle cell lymphoma is treated with the drug Bruton tyrosine kinase. As of right now, the United States Food and Drug Administration has approved only a few drugs.
Tozanubrutinib (Brukinsa) was recently approved by the FDA for the treatment of patients with MCL who have received at least one prior treatment. It was reported in a phase II trial that 83.5% of patients achieved an objective response (ORR) while 58.1% of patients achieved a complete response (CR).
Calabrutinib (Calquence) approved by the FDA in October 2017 with an ORR of 81% and CR of 40%. The FDA approved Ibrutinib (Imbruvica) in November 2013, but the drug continues to demonstrate efficacy in either single or combination therapy settings. Ibrutinib and venetoclax (Venclexta) are currently being studied as therapeutic agents for MCL patients.
FDA-approved BTK inhibitors, such as Ibrutinib and Acalabrutinib, are used to treat B-cell malignancies. Clinical trials have shown that both drugs are superior to chemoimmunotherapy in the treatment of chronic lymphocytic leukaemia. Both ibrutinib and acalabrutinib are versatile and have been shown to directly affect immune cells other than B cells and other cell subsets.
The small molecule inhibitor zanubrutinib (BGB-3111) is currently being evaluated in large-scale clinical trial programs, including in China, as a potential monotherapy and other therapies for a variety of B-cell tumors worldwide.
It has been approved for the treatment of mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenstrom's macroglobulinemia.
BeiGene announced that in May 2021, the U.S. The Food and Drug Administration (FDA) has approved a supplemental drug application (sNDA) with one or more antipathogenic effects for the treatment of BRUKINSA (zanubrutinib) in adults with marginal zone lymphoma (MZL).
Rilzabrutinib: Principia Biopharma
Principia Biopharma is evaluating the first-generation BTK inhibitor rilzabrutinib (formerly PRN1008) in three disease indications. Phase III clinical trials for pemphigus and immune thrombocytopenia (ITP) and phase II clinical trials for autoimmune diseases such as IgG4-related diseases are currently ongoing.
Rilzabrutinib has received rare pemphigus designation for the treatment of pemphigus vulgaris by the Food and Drug Administration and the European Commission.
The report gives an in-depth analysis of the top players involved in the Bruton’s tyrosine kinase (BTK) inhibitors market, sponsors manufacturing the drugs, and putting them through trials to get FDA approvals. The companies included in the market are as follows:
|Scope of the Report||
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
|Breakup by Type||
|Breakup by Drug||
|Breakup by Application||
|Breakup by Distribution Channel||
|Breakup by Region||
*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
2 Research Methodology
3 Executive Summary
4 Bruton’s Tyrosine Kinase (BTK) Inhibitors Overview
4.1 Drug Overview
4.1.3 Adverse Events
5 Patient Profile
5.1 Patient Profile Overview
5.2 Patient Psychology and Emotional Impact Factors
5.3 Risk Assessment and Treatment Success Rate
6 Current Scenario Evaluation and Regulatory Framework
6.1 Emerging Therapies and Clinical Trials Synopsis
6.2 Patent Landscape
6.2.1 Patent Overview
18.104.22.168 Patent Status and Expiry
22.214.171.124 Timelines from Drug Development to Commercial Launch
126.96.36.199 New Drug Application
188.8.131.52.1 Documentation and Approval Process
6.3 Cost of Treatment
6.4 Investment Scenarios
6.5 Regulatory Framework
6.5.1 Regulatory Overview
184.108.40.206 US FDA
220.127.116.11 EU EMA
18.104.22.168 INDIA CDSCO
22.214.171.124 JAPAN PMDA
7 Challenges and Unmet Need
7.1 Treatment Pathway Challenges
7.2 Compliance and Drop-Out Rate
7.3 Awareness and Prevention Gaps
8 Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market
8.1 Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market Overview
8.2 Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market Analysis
8.2.1 Market Overview
126.96.36.199 Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market Historical Value (2016-2022)
188.8.131.52 Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market Forecast Value (2023-2031)
8.3 Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market by Type
8.3.1 Market Overview
184.108.40.206 First Generation
220.127.116.11 Second Generation
8.4 Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market by Drug
8.4.1 Market Overview
8.5 Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market by Application
8.5.1 Market Overview
18.104.22.168 Chronic lymphocytic leukemia (CLL)
22.214.171.124 Mantle cell lymphoma (MCL)
126.96.36.199 Waldenström’s Macroglobulinemia
188.8.131.52 Small Lymphocytic Lymphoma
184.108.40.206 Marginal Zone Lymphoma
8.6 Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market by Distribution Channel
8.6.1 Market Overview
220.127.116.11 Hospital Based Pharmacies
18.104.22.168 Online Pharmacies
22.214.171.124 Retail Pharmacies
8.7 Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market by Region
8.7.1 Market Overview
126.96.36.199 North America
188.8.131.52 Asia Pacific
184.108.40.206 Latin America
220.127.116.11 Middle East and Africa
9 North America Bruton’s Tyrosine Kinase (BTK) Inhibitors Market
9.1 Market Share by Country
9.2 United States of America
9.2.1 Historical Trend (2016-2022)
9.2.2 Forecast Trend (2023-2031)
9.3.1 Historical Trend (2016-2022)
9.3.2 Forecast Trend (2023-2031)
10 Europe Bruton’s Tyrosine Kinase (BTK) Inhibitors Market
10.1 Market Share by Country
10.2 United Kingdom
10.2.1 Historical Trend (2016-2022)
10.2.2 Forecast Trend (2023-2031)
10.3.1 Historical Trend (2016-2022)
10.3.2 Forecast Trend (2023-2031)
10.4.1 Historical Trend (2016-2022)
10.4.2 Forecast Trend (2023-2031)
10.5.1 Historical Trend (2016-2022)
10.5.2 Forecast Trend (2023-2031)
11 Asia Pacific Bruton’s Tyrosine Kinase (BTK) Inhibitors Market
11.1 Market Share by Country
11.2.1 Historical Trend (2016-2022)
11.2.2 Forecast Trend (2023-2031)
11.3.1 Historical Trend (2016-2022)
11.3.2 Forecast Trend (2023-2031)
11.4.1 Historical Trend (2016-2022)
11.4.2 Forecast Trend (2023-2031)
11.5.1 Historical Trend (2016-2022)
11.5.2 Forecast Trend (2023-2031)
11.6.1 Historical Trend (2016-2022)
11.6.2 Forecast Trend (2023-2031)
12 Latin America Bruton’s Tyrosine Kinase (BTK) Inhibitors Market
12.1 Market Share by Country
12.2.1 Historical Trend (2016-2022)
12.2.2 Forecast Trend (2023-2031)
12.3.1 Historical Trend (2016-2022)
12.3.2 Forecast Trend (2023-2031)
12.4.1 Historical Trend (2016-2022)
12.4.2 Forecast Trend (2023-2031)
13 Middle East and Africa Bruton’s Tyrosine Kinase (BTK) Inhibitors Market
13.1 Market Share by Country
13.2 Saudi Arabia
13.2.1 Historical Trend (2016-2022)
13.2.2 Forecast Trend (2023-2031)
13.3 United Arab Emirates
13.3.1 Historical Trend (2016-2022)
13.3.2 Forecast Trend (2023-2031)
13.4.1 Historical Trend (2016-2022)
13.4.2 Forecast Trend (2023-2031)
13.5 South Africa
13.5.1 Historical Trend (2016-2022)
13.5.2 Forecast Trend (2023-2031)
14 Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market Dynamics
14.1 Market Drivers and Constraints
14.2 SWOT Analysis
14.3 Drug Adoption Parameters
14.4 Porter’s Five Forces Model
14.5 Key Demand Indicators
14.6 Key Price Indicators
14.7 Value Chain Analysis
15 Supplier Landscape
15.1 BeiGene, Ltd.
15.1.1 Company Overview
15.1.2 Product Portfolio
15.1.3 Demographic Reach and Achievement
15.1.4 Merger and Acquisitions
15.2 Merck KGaA
15.2.1 Company Overview
15.2.2 Product Portfolio
15.2.3 Demographic Reach and Achievement
15.2.4 Merger and Acquisitions
15.3 Principia Biopharma Inc.
15.3.1 Company Overview
15.3.2 Product Portfolio
15.3.3 Demographic Reach and Achievement
15.3.4 Merger and Acquisitions
15.4 ACEA Biosciences, Inc.
15.4.1 Company Overview
15.4.2 Product Portfolio
15.4.3 Demographic Reach and Achievement
15.4.4 Merger and Acquisitions
15.5 Bristol- Myers Squibb Company
15.5.1 Company Overview
15.5.2 Product Portfolio
15.5.3 Demographic Reach and Achievement
15.5.4 Merger and Acquisitions
15.6 Adolph Kiefer & Associates, Llc
15.6.1 Company Overview
15.6.2 Product Portfolio
15.6.3 Demographic Reach and Achievement
15.6.4 Merger and Acquisitions
15.7 Johnson & Johnson Services, Inc
15.7.1 Company Overview
15.7.2 Product Portfolio
15.7.3 Demographic Reach and Achievement
15.7.4 Merger and Acquisitions
15.8 ACEA Biosciences Inc.
15.8.1 Company Overview
15.8.2 Product Portfolio
15.8.3 Demographic Reach and Achievement
15.8.4 Merger and Acquisitions
15.9 Aptose Biosciences Inc. (APTO)
15.9.1 Company Overview
15.9.2 Product Portfolio
15.9.3 Demographic Reach and Achievement
15.9.4 Merger and Acquisitions
15.10 Eternity Bioscience Inc.
15.10.1 Company Overview
15.10.2 Product Portfolio
15.10.3 Demographic Reach and Achievement
15.10.4 Merger and Acquisitions
15.11 Takeda Pharmaceuticals Industries Ltd.
15.11.1 Company Overview
15.11.2 Product Portfolio
15.11.3 Demographic Reach and Achievement
15.11.4 Merger and Acquisitions
15.12 Gilead Sciences Inc.
15.12.1 Company Overview
15.12.2 Product Portfolio
15.12.3 Demographic Reach and Achievement
15.12.4 Merger and Acquisitions
15.13 AbbVie Inc.
15.13.1 Company Overview
15.13.2 Product Portfolio
15.13.3 Demographic Reach and Achievement
15.13.4 Merger and Acquisitions
16 Pricing Models and Strategies (Additional Insight)
16.1 Cost Model
16.1.1 Manufacturing Cost Analysis
16.1.2 Procurement Cost Analysis
16.2 Pricing Strategies
16.2.1 Competitor Pricing Analysis
16.2.2 Key Assessment of Product Attributes
16.2.3 Pricing Benchmark
17 Global Bruton’s Tyrosine Kinase (BTK) Inhibitor Market- Distribution Model (Additional Insight)
17.2 Potential Distributors
17.3 Key Parameters for Distribution Partner Assessment
*Additional insights provided are customisable as per client requirements.
In 2022, 547 million people were affected from mantle cell lymphoma.
The market value of the global bruton tyrosine kinase inhibitors market is likely to grow at a CAGR of 8.2% during the forecast period of 2023-2031.
The factors stimulating the development of the market are increased government initiatives and a rise in R&D expenditure in biopharmaceutical companies.
Fewer drug approvals, stringent government regulations, and lack of awareness are the suspected reasons for hindering the growth of this market.
The major regional markets include North America, Europe, Asia Pacific, Latin America, Middle East and Africa. North America has been dominating the global Bruton’s tyrosine kinase (BTK) inhibitor market and is likely to continue doing so.
Bruton’s tyrosine kinase (BTK) inhibitors find wide applications in the treatment of mantle cell lymphoma and leukaemia.
The key players in the market include BeiGene, Ltd., Merck KGaA, Principia Biopharma Inc., ACEA Biosciences, Inc., Bristol- Myers Squibb Company, Adolph Kiefer & Associates, Llc, Johnson & Johnson Services, Inc, ACEA Biosciences Inc., Aptose Biosciences Inc., and Eternity Bioscience Inc., Gilead Sciences Inc., and AbbVie Inc., among others.
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