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Bruton’s Tyrosine Kinase (BTK) Inhibitors Market

Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market Share, Size, Analysis, Growth: By Type: First Generation, Second Generation; By Drug: Imbruvica, Calquence, Brukinsa; By Application: Chronic lymphocytic leukemia (CLL), Mantle cell lymphoma (MCL), Others; By Distribution Channel; Regional Analysis; Supplier Landscape; 2024-2032

Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market Outlook

The Bruton’s tyrosine kinase (BTK) inhibitors market size attained a value of USD 10.48 billion in 2023. The market is further expected to grow at a CAGR of 8.0% during the forecast period of 2024-2032 to attain a value of USD 20.94 billion by 2032, driven by the rising prevalence of mantle cell lymphoma. These inhibitors are widely used in the treatment of mantle cell lymphoma.

 

brutons tyrosine kinase btk inhibitors market

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Bruton’s Tyrosine Kinase (BTK) Inhibitors Market: Introduction and Insights

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:  

 

brutons tyrosine kinase btk inhibitors market by segments

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Market Breakup by Type

  • First Generation
  • Second Generation

 

Market Breakup by Drug Type

  • Imbruvica
  • Calquence
  • Brukinsa

 

Market Breakup by Application

  • Chronic Lymphocytic Leukemia (CLL)
  • Mantle Cell Lymphoma (MCL)
  • Waldenström’s Macroglobulinemia
  • Small Lymphocytic Lymphoma
  • Marginal Zone Lymphoma
  • Others

 

Market Breakup by Distribution Channel

  • Hospital Based Pharmacies
  • Online Pharmacies
  • Retail Pharmacies

 

Market Breakup by Region

  • North America
    • United States of America
    • Canada
  • Europe
    • United Kingdom
    • Germany
    • France
    • Italy
    • Others
  • Asia Pacific
    • China
    • Japan
    • India
    • ASEAN
    • Australia
    • Others
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • United Arab Emirates
    • Nigeria
    • South Africa
    • Others

 

brutons tyrosine kinase btk inhibitors market by region

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Rising Prevalence of Mantle Cell Lymphoma to Drive the Growth of the Global Bruton’s Tyrosine Kinase (BTK) Inhibitor Market

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.

 

Factors Restricting the Growth of the Global Bruton’s Tyrosine Kinase (BTK) Inhibitor Market

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.

 

North America and Europe to Continue Dominating the Therapeutic Landscape

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.

 

Clinical Trials

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.

 

Brutons Tyrosine Kinase (BTK) Inhibitors Emerging Drugs

Zanubrutinib: BeiGene

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.

 

Competitive Landscape 

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:

 

  • 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. (APTO)
  • Eternity Bioscience Inc.
  • Takeda Pharmaceuticals Industries Ltd.
  • Gilead Sciences Inc.
  • AbbVie Inc.

 

Key Highlights of the Report

REPORT FEATURES DETAILS
Base Year 2023
Historical Period 2017-2023
Forecast Period 2024-2032
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Type
  • Drug
  • Application
  • Distribution Channel
  • Region
Breakup by Type
  • First Generation
  • Second Generation
Breakup by Drug
  • Imbruvica
  • Calquence
  • Brukinsa
Breakup by Application
  • Chronic lymphocytic leukemia (CLL)
  • Mantle cell lymphoma (MCL)
  • Waldenström’s Macroglobulinemia
  • Small Lymphocytic Lymphoma
  • Marginal Zone Lymphoma
  • Others
Breakup by Distribution Channel
  • Hospital Based Pharmacies
  • Online Pharmacies
  • Retail Pharmacies
Breakup by Region
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa
Market Dynamics
  • Market Drivers and Constraints
  • SWOT Analysis
  • Drug Adoption Parameters
  • Porter's Five Forces
  • Key Indicators for Demand
  • Key Indicators for Price
  • Value Chain Analysis
Supplier Landscape
  • Market Structure
  • Company Profiles
    • Company Overview
    • Product Portfolio
    • Demographic Reach and Achievements
    • Merger and Acquisitions
    • Certifications
Companies Covered
  • 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. (APTO)
  • Eternity Bioscience Inc.
  • Takeda Pharmaceuticals Industries Ltd.
  • Gilead Sciences Inc.
  • AbbVie Inc.

 

*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    Preface
    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
        4.1.1    Pharmacodynamics
        4.1.2    Pharmacokinetics
        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
            6.2.1.1    Patent Status and Expiry
            6.2.1.2    Timelines from Drug Development to Commercial Launch
            6.2.1.3    New Drug Application
                6.2.1.3.1    Documentation and Approval Process
    6.3    Cost of Treatment
    6.4    Investment Scenarios
    6.5    Regulatory Framework
        6.5.1    Regulatory Overview
            6.5.1.1    US FDA
            6.5.1.2    EU EMA
            6.5.1.3    INDIA CDSCO
            6.5.1.4    JAPAN PMDA
            6.5.1.5    Others
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
            8.2.1.1    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market Historical Value (2017-2023) 
            8.2.1.2    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market Forecast Value (2024-2032)
    8.3    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market by Type
        8.3.1    Market Overview
            8.3.1.1    First Generation
            8.3.1.2    Second Generation
    8.4    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market by Drug 
        8.4.1    Market Overview
            8.4.1.1    Imbruvica
            8.4.1.2    Calquence
            8.4.1.3    Brukinsa
    8.5    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market by Application
        8.5.1    Market Overview
            8.5.1.1    Chronic lymphocytic leukemia (CLL)
            8.5.1.2    Mantle cell lymphoma (MCL) 
            8.5.1.3    Waldenström’s Macroglobulinemia 
            8.5.1.4    Small Lymphocytic Lymphoma
            8.5.1.5    Marginal Zone Lymphoma
            8.5.1.6    Others
    8.6    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market by Distribution Channel
        8.6.1      Market Overview
            8.6.1.1    Hospital Based Pharmacies
            8.6.1.2    Online Pharmacies
            8.6.1.3    Retail Pharmacies
    8.7    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market by Region
        8.7.1     Market Overview
            8.7.1.1    North America
            8.7.1.2    Europe 
            8.7.1.3    Asia Pacific
            8.7.1.4    Latin America
            8.7.1.5    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 (2017-2023)
        9.2.2    Forecast Trend (2024-2032)
    9.3    Canada
        9.3.1    Historical Trend (2017-2023)
        9.3.2    Forecast Trend (2024-2032)
10    Europe Bruton’s Tyrosine Kinase (BTK) Inhibitors Market
    10.1    Market Share by Country
    10.2    United Kingdom
        10.2.1    Historical Trend (2017-2023)
        10.2.2    Forecast Trend (2024-2032)
    10.3    Germany
        10.3.1    Historical Trend (2017-2023)
        10.3.2    Forecast Trend (2024-2032)
    10.4    France
        10.4.1    Historical Trend (2017-2023)
        10.4.2    Forecast Trend (2024-2032)
    10.5    Italy
        10.5.1    Historical Trend (2017-2023)
        10.5.2    Forecast Trend (2024-2032)
    10.6    Others
11    Asia Pacific Bruton’s Tyrosine Kinase (BTK) Inhibitors Market
    11.1    Market Share by Country
    11.2    China
        11.2.1    Historical Trend (2017-2023)
        11.2.2    Forecast Trend (2024-2032)
    11.3    Japan
        11.3.1    Historical Trend (2017-2023)
        11.3.2    Forecast Trend (2024-2032)
    11.4    India
        11.4.1    Historical Trend (2017-2023)
        11.4.2    Forecast Trend (2024-2032)
    11.5    ASEAN
        11.5.1    Historical Trend (2017-2023)
        11.5.2    Forecast Trend (2024-2032)
    11.6    Australia
        11.6.1    Historical Trend (2017-2023)
        11.6.2    Forecast Trend (2024-2032)
    11.7    Others
12    Latin America Bruton’s Tyrosine Kinase (BTK) Inhibitors Market
    12.1    Market Share by Country
    12.2    Brazil
        12.2.1    Historical Trend (2017-2023)
        12.2.2    Forecast Trend (2024-2032)
    12.3    Argentina
        12.3.1    Historical Trend (2017-2023)
        12.3.2    Forecast Trend (2024-2032)
    12.4    Mexico
        12.4.1    Historical Trend (2017-2023)
        12.4.2    Forecast Trend (2024-2032)
    12.5    Others
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 (2017-2023)
        13.2.2    Forecast Trend (2024-2032)
    13.3    United Arab Emirates
        13.3.1    Historical Trend (2017-2023)
        13.3.2    Forecast Trend (2024-2032)
    13.4    Nigeria
        13.4.1    Historical Trend (2017-2023)
        13.4.2    Forecast Trend (2024-2032)
    13.5    South Africa
        13.5.1    Historical Trend (2017-2023)
        13.5.2    Forecast Trend (2024-2032)
    13.6    Others
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
        15.1.5    Certifications 
    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
        15.2.5    Certifications 
    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
        15.3.5    Certifications
    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
        15.4.5    Certifications 
    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
        15.5.5    Certifications  
    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
        15.6.5    Certifications 
    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
        15.7.5    Certifications 
    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
        15.8.5    Certifications 
    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
        15.9.5    Certifications 
    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
        15.10.5    Certifications 
    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
        15.11.5    Certifications 
    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
        15.12.5    Certifications 
    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
        15.13.5    Certifications 
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)
    17.1    Overview
    17.2    Potential Distributors
    17.3    Key Parameters for Distribution Partner Assessment

 

*Additional insights provided are customisable as per client requirements.

Key Questions Answered in the Report

The Bruton’s tyrosine kinase (BTK) inhibitors market size attained a value of USD 10.48 billion in 2023.

The market is further expected to grow at a CAGR of 8% during the forecast period of 2024-2032 to attain a value of USD 20.94 billion by 2032.

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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Why Expert Market Research?

Right People

We are technically excellent, strategic, practical, experienced and efficient; our analysts are hand-picked based on having the right attributes to work successfully and execute projects based on your expectations.

Right Methodology

We leverage our cutting-edge technology, our access to trusted databases, and our knowledge of the current models used in the market to deliver you research solutions that are tailored to your needs and put you ahead of the curve.

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We deliver in-depth and superior quality research in prices that are reasonable, unmatchable, and shows our understanding of your resource structure. We, additionally, offer attractive discounts on our upcoming reports.

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Our team of expert analysts are at your beck and call to deliver you optimum results that are customised to meet your precise needs within the specified timeframe and help you form a better understanding of the industry.

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