Biosimilar Monoclonal Antibodies Market Size, Share, Report 2023 To 2032

According to Vision Research Reports, the global biosimilar monoclonal antibodies market size was estimated at USD 8.75 billion in 2022 and it is projected to hit around USD 65.29 billion by 2032, growing at a CAGR of 22.26% from 2023 to 2032.

In the biopharmaceuticals, biosimilar monoclonal antibodies (mAbs) have emerged as a pivotal class of drugs, promising innovative therapeutic approaches and substantial cost savings. These biosimilars are akin to their reference monoclonal antibodies, possessing comparable efficacy, safety, and quality. The biosimilar monoclonal antibodies market represents a significant stride in the evolution of biotechnology and healthcare.

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The growth of the global biosimilar monoclonal antibodies (mAbs) market can be attributed to various factors which include increasing patent expiries of monoclonal antibodies, advancements in mAbs innovation, increasing demand for cost-efficient products, the rising prevalence of chronic and autoimmune diseases like rheumatoid arthritis and cancer, as well as the aging population. Moreover, the rising investments in research and development for biological drugs are expected to drive the adoption during the forecast period. Increased R&D activities lead to the development of innovative drug products, improved developmental procedures, and enhanced healthcare facilities, all such factors contribute to market growth.

The expiration of patents for prominent monoclonal antibodies (mAbs) has increased significant interest among pharmaceutical companies to develop biosimilars. Moreover, the introduction of biosimilars following the patent expiries of key monoclonal antibodies, such as Remicade from Johnson & Johnson, Herceptin from Roche, and Humira from Abbott, is a major driving factor for the market.

Furthermore, strategic collaborations and initiatives among key players in space are boosting industry growth. For instance, in July 2021, Abzena (UK), a global research organization specializing in biologics and bioconjugates, collaborated with BioXpress Therapeutics (Switzerland) to support biosimilar development for third-party customers. This collaboration created an integrated solution between two leading service providers in biosimilar development and GMP manufacturing. Similarly, in February 2020, Mylan (US) launched Ogivri, a biosimilar of trastuzumab. Trastuzumab is a mAb used to treat HER2-positive breast cancer and was previously marketed by Genentech as Herceptin.

However, stringent regulations related to product approvals and the cost structure associated with the manufacturing process may hinder space growth during the forecast period. Additionally, the lack of clarity regarding regulations for the development of biosimilar mAbs in emerging markets could act as a restraint on market growth.

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The biosimilar monoclonal antibodies market segmentation is based on product, application, and region. The product segment is based on Infliximab, Rituximab, Abciximab, Trastuzumab, Adalimumab, Bevacizumab, and others. The application segment is based on oncology, chronic and autoimmune diseases, and others. The Asia Pacific region is expected to experience significant growth in the market from 2023 to 2032. Factors contributing to this growth include the increasing burden of chronic diseases, the growing need for cost-effective treatments, and rising government funding for improving healthcare facilities. For instance, in Asia Pacific countries such as China, since the launch of the first biosimilar of Rituximab injection by Henlius in 2019, there have been 142 biosimilar mAbs researched and developed, targeting 16 different treatments. Out of these, 10 products have been launched, including Herceptin (trastuzumab) x 1, Avastin (bevacizumab) x 3, MabThera (rituximab) x 2, and Humira (adalimumab) x 4. China has more than 60 pharmaceutical companies actively involved in the development of products.

Trends of Biosimilar Monoclonal Antibodies Market?

  • Market Growth: The biosimilar mAbs market has been experiencing significant growth, driven by the expiration of patents for several originator biologics. This has created opportunities for biosimilar manufacturers to enter the market with more affordable alternatives.
  • Regulatory Approvals: Regulatory agencies, including the U.S. FDA and the European Medicines Agency (EMA), have been actively working on establishing clear regulatory pathways for the approval of biosimilar mAbs. The approval processes have become more defined, providing a more predictable environment for manufacturers.
  • Increasing Competition: The increasing number of players entering the biosimilar mAbs market has intensified competition. This competition is beneficial for healthcare systems and patients, as it often leads to reduced prices and increased accessibility to biologic therapies.
  • Focus on Oncology: A significant portion of biosimilar mAbs is used in the treatment of cancer. The focus on developing biosimilars for oncology indications, where monoclonal antibodies play a crucial role, has been notable.
  • Collaborations and Partnerships: Companies in the biosimilar mAbs space have been engaging in collaborations and partnerships to enhance their development capabilities, share expertise, and navigate the complexities of the biologics market more effectively.
  • Biosimilar Interchangeability: The concept of biosimilar interchangeability has been gaining attention. Establishing interchangeability with the reference product allows biosimilars to be substituted for the originator product without the intervention of the prescribing healthcare provider.
  • Patient and Physician Education: Given the complexity of biologics and biosimilars, there has been a focus on educating both healthcare professionals and patients about these products. Understanding the similarities and differences between biosimilars and reference products is crucial for acceptance and adoption.
  • Global Market Expansion: The biosimilar mAbs market has been expanding globally, with increased efforts to make these therapies accessible in emerging markets. This expansion is supported by regulatory developments and a growing awareness of the benefits of biosimilars.

Market Dynamics:

Drivers

  • Increasing Prevalence of Chronic Diseases: Rising incidence of chronic diseases such as cancer, autoimmune disorders, and diabetes fuels the demand for targeted therapies, driving the adoption of biosimilar monoclonal antibodies.
  • Expanding Applications and Therapeutic Areas: Ongoing research expands the applications of biosimilar monoclonal antibodies to treat a wider array of diseases, broadening their market presence and adoption.

Restraints

  • Complex Research and Development Process: The development of biosimilar monoclonal antibodies demands extensive research, often involving complex analytical and clinical studies. This intricate process leads to substantial time and financial investments, acting as a deterrent for many companies, particularly smaller ones.
  • Biosimilar Naming and Branding Issues: Differentiation between biosimilars and their reference products is essential for safety monitoring. However, naming conventions and branding strategies are not standardized globally, leading to confusion among healthcare professionals and patients.

Opportunities

  • Rising Demand for Biologics: The increasing prevalence of chronic diseases and the growing aging population create a substantial demand for biologic therapies, including biosimilar monoclonal antibodies, presenting a vast market opportunity for pharmaceutical companies.
  • Biosimilars in Emerging Markets: Emerging markets, with their improving healthcare infrastructure and rising awareness about biosimilars, offer significant growth opportunities. These regions present untapped markets where biosimilar monoclonal antibodies can address unmet medical needs.

Companies Mentioned in Report:

Pfizer

Novartis AG

AbbVie, Inc.

Coherus BioSciences

Biocon

Related Reports

Report Segmentation:

By Product

  • Infliximab
  • Rituximab
  • Abciximab
  • Trastuzumab
  • Adalimumab
  • Bevacizumab
  • Others

By Application

  • Oncology
  • Chronic & Autoimmune Diseases
  • Others

By Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

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