Global Bruton’s Tyrosine Kinase (BTK) Inhibitors Market Report and Forecast 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.

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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:  

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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

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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