Reports

Amid Ukraine-Russia crisis, our analysts and industry experts are closely monitoring the markets and working hard to identify, gather and timely deliver analysis of the impact of the situation and the impact that it has on various markets. All our reports are updated with the latest impact on the market before being sent out to our customers.

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; 2023-2031

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

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. 

 

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:  

 

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

 

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 2022
Historical Period 2016-2022
Forecast Period 2023-2031
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
  • SWOT
  • Porter's Five Forces
  • Key Indicators for Demand
  • Key Indicators for Price
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
        1.1.1    Research Objectives
        1.1.2    Key Findings of the Report
    1.2    Limitations of the Study and Scope for Future Research
2    Research Methodology
3    Executive Summary
4    Global 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    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market
    6.1    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market Overview
    6.2    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market Analysis 
        6.2.1    Market Overview
            6.2.1.1    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market Historical Value (2016-2022) 
            6.2.1.2    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market Forecast Value (2023-2031)
    6.3    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market by Type
        6.3.1    Market Overview
            6.3.1.1    First Generation
            6.3.1.2    Second Generation
    6.4    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market by Drug 
        6.4.1    Market Overview
            6.4.1.1    Imbruvica
            6.4.1.2    Calquence
            6.4.1.3    Brukinsa
    6.5    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market by Application
        6.5.1    Market Overview
            6.5.1.1    Chronic lymphocytic leukemia (CLL)
            6.5.1.2    Mantle cell lymphoma (MCL) 
            6.5.1.3    Waldenström’s Macroglobulinemia 
            6.5.1.4    Small Lymphocytic Lymphoma
            6.5.1.5    Marginal Zone Lymphoma
            6.5.1.6    Others
    6.6    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market by Distribution Channel
        6.6.1      Market Overview
            6.6.1.1    Hospital Based Pharmacies
            6.6.1.2    Online Pharmacies
            6.6.1.3    Retail Pharmacies
    6.7    Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market by Region
        6.7.1     Market Overview
            6.7.1.1    North America 
                6.7.1.1.1    Historical Trend (2016-2022)
                6.7.1.1.2    Forecast Trend (2023-2031)
            6.7.1.2    Europe
                6.7.1.2.1    Historical Trend (2016-2022)
                6.7.1.2.2    Forecast Trend (2023-2031)
            6.7.1.3    Asia Pacific
                6.7.1.3.1    Historical Trend (2016-2022)
                6.7.1.3.2    Forecast Trend (2023-2031)
            6.7.1.4    Latin America
                6.7.1.4.1    Historical Trend (2016-2022)
                6.7.1.4.2    Forecast Trend (2023-2031)
            6.7.1.5    Middle East and Africa
                6.7.1.5.1     Historical Trend (2016-2022)
                6.7.1.5.2    Forecast Trend (2023-2031)
7    North America Bruton’s Tyrosine Kinase (BTK) Inhibitors Market
    7.1    United States of America
        7.1.1    Historical Trend (2016-2022)
        7.1.2    Forecast Trend (2023-2031)
    7.2    Canada 
        7.2.1    Historical Trend (2016-2022)
        7.2.2    Forecast Trend (2023-2031)
8    Europe Bruton’s Tyrosine Kinase (BTK) Inhibitors Market
    8.1    United Kingdom
        8.1.1    Historical Trend (2016-2022)
        8.1.2    Forecast Trend (2023-2031)
    8.2    Germany
        8.2.1    Historical Trend (2016-2022)
        8.2.2    Forecast Trend (2023-2031)
    8.3    France
        8.3.1    Historical Trend (2016-2022)
        8.3.2    Forecast Trend (2023-2031)
    8.4    Italy
        8.4.1    Historical Trend (2016-2022)
        8.4.2    Forecast Trend (2023-2031)
9    Asia Pacific Bruton’s Tyrosine Kinase (BTK) Inhibitors Market
    9.1    China
        9.1.1    Historical Trend (2016-2022)
        9.1.2    Forecast Trend (2023-2031)
    9.2    Japan
        9.2.1    Historical Trend (2016-2022)
        9.2.2    Forecast Trend (2023-2031)
    9.3    India
        9.3.1    Historical Trend (2016-2022)
        9.3.2    Forecast Trend (2023-2031)
    9.4    ASEAN
        9.4.1    Historical Trend (2016-2022)
        9.4.2    Forecast Trend (2023-2031)
    9.5    Australia
        9.5.1    Historical Trend (2016-2022)
        9.5.2    Forecast Trend (2023-2031)
10    Latin America Bruton’s Tyrosine Kinase (BTK) Inhibitors Market
    10.1    Brazil
        10.1.1    Historical Trend (2016-2022)
        10.1.2    Forecast Trend (2023-2031)
    10.2    Argentina
        10.2.1    Historical Trend (2016-2022)
        10.2.2    Forecast Trend (2023-2031)
    10.3    Mexico
        10.3.1    Historical Trend (2016-2022)
        10.3.2    Forecast Trend (2023-2031)
11    Middle East and Africa Bruton’s Tyrosine Kinase (BTK) Inhibitors Market
    11.1    Saudi Arabia
        11.1.1    Historical Trend (2016-2022)
        11.1.2    Forecast Trend (2023-2031)
    11.2    United Arab Emirates
        11.2.1    Historical Trend (2016-2022)
        11.2.2    Forecast Trend (2023-2031)
    11.3    Nigeria
        11.3.1    Historical Trend (2016-2022)
        11.3.2    Forecast Trend (2023-2031)
    11.4    South Africa
        11.4.1    Historical Trend (2016-2022)
        11.4.2    Forecast Trend (2023-2031)
12    Current Scenario Evaluation and Regulatory Framework
    12.1    Emerging Therapies and Clinical Trials Synopsis
    12.2    Patent Landscape
        12.2.1    Patent Overview
            12.2.1.1    Patent Status and Expiry
            12.2.1.2    Timelines from Drug Development to Commercial Launch
            12.2.1.3    New Drug Application
                12.2.1.3.1    Documentation and Approval Process
    12.3    Cost of Treatment
    12.4    Investment Scenarios
    12.5    Regulatory Framework
        12.5.1    Regulatory Overview
            12.5.1.1    US FDA
            12.5.1.2    EU EMA
            12.5.1.3    INDIA CDSCO
            12.5.1.4    JAPAN PMDA
            12.5.1.5    Others
13    Challenges and Unmet Need
    13.1    Treatment Pathway Challenges
    13.2    Compliance and Drop-Out Rate
    13.3    Awareness and Prevention Gaps
14    Global Exosome Drug 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    Recommendations and Discussion
17    Pricing Models and Strategies (Additional Insight)

    17.1    Cost Model
        17.1.1    Manufacturing Cost Analysis
        17.1.2    Procurement Cost Analysis
    17.2    Pricing Strategies
        17.2.1    Competitor Pricing Analysis
        17.2.2    Key Assessment of Product Attributes
        17.2.3    Pricing Benchmark
18    Global Bruton’s Tyrosine Kinase (BTK) Inhibitor Distribution Model (Additional Insight)
    18.1    Overview
    18.2    Potential Distributors
    18.3    Key Parameters for Distribution Partner Assessment

 

*Additional insights provided are customisable as per client requirements.

Key Questions Answered in the Report

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.

Purchase Full Report

Mini Report

$2499
  • Selected Sections, One User
  • Printing Not Allowed
  • Email Delivery in PDF
  • Free Limited Customisation
  • Post Sales Analyst Support
  • 50% Discount on Next Update

Single User License

$4999
  • All Sections, One User
  • One Print Allowed
  • Email Delivery in PDF
  • Free Limited Customisation
  • Post Sales Analyst Support
  • 50% Discount on Next Update

Five User License

$6499
  • All Sections, Five Users
  • Five Prints Allowed
  • Email Delivery in PDF
  • Free Limited Customisation
  • Post Sales Analyst Support
  • 50% Discount on Next Update

Corporate License

$7999
  • All Sections, Unlimited Users
  • Unlimited Prints Allowed
  • Email Delivery in PDF + Excel
  • Free Limited Customisation
  • Post Sales Analyst Support
  • 50% Discount on Next Update

Any Question? Speak With An Analyst

Contact Analyst

View A Sample

Request Sample

Did You Miss Anything, Ask Now

Request Customisation
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.

Right Price

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.

Right Support

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.

NEWSLETTER