Summary:

  • The global biosimilar market size reached USD 21.2 billion in 2023.
  • The market is expected to reach USD 164.5 Billion by 2032, exhibiting a growth rate (CAGR) of 25.1% during 2024-2032.
  • Europe leads the market, accounting for the largest biosimilar market share.
  • Infliximab accounts for the majority of the market share in the molecule segment as it is a highly sought-after biosimilar because it is frequently used to treat a variety of autoimmune diseases.
  • Autoimmune diseases hold the largest share in the biosimilar industry.
  • In-house manufacturing remains a dominant segment in the market because it gives businesses more control over quality control, cost control, and production procedures when developing biosimilars.
  • The increasing regulatory support for biosimilars, with streamlined approval processes making it easier for manufacturers to bring these drugs to market, is aiding the market growth.
  • Besides this, the growing awareness and acceptance of biosimilars among healthcare professionals and patients which is boosting their adoption as safe and effective alternatives to biologics.

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Industry Trends and Drivers:

  • The Rising Prevalence of Chronic Diseases:

Chronic conditions such as cancer, diabetes, and autoimmune disorders are on the rise globally due to factors like aging populations, sedentary lifestyles, and unhealthy dietary habits. Biologic drugs have become crucial in treating these conditions because of their efficacy in targeting specific disease mechanisms. However, biologics are often expensive and can be cost-prohibitive for patients in need of long-term treatment.

Biosimilars offer a more affordable alternative to biologics without compromising on safety and effectiveness, making them an attractive option for both patients and healthcare providers. As the demand for affordable therapies increases in response to the growing burden of chronic diseases, the market for biosimilars continues to expand.

  • Patent Expirations of Biologic Drugs:

The expiration of patents on biological drugs is a crucial factor driving the growth of the biosimilar market. Many blockbuster biological drugs that have been instrumental in treating chronic diseases are reaching the end of their patent protection periods. Once the patent for a biologic expires, it opens the door for biosimilar manufacturers to enter the market with similar, lower-cost versions of these drugs. This creates a competitive landscape that drives down prices, benefiting patients and healthcare systems alike.

The expiration of patents for high-profile biologics such as Humira (adalimumab), Enbrel (etanercept), and Herceptin (trastuzumab) has spurred the development of biosimilars, with many pharmaceutical companies investing in the production of these alternatives. This influx of biosimilars increases market competition, which is strengthening the market growth.

  • Increasing Cost Pressures on Healthcare Systems:

Increasing cost pressures on healthcare systems are driving the adoption of biosimilars. Healthcare expenditures are rising globally due to aging populations and the growing prevalence of chronic diseases, placing significant strain on healthcare budgets. Governments and healthcare providers are under pressure to contain costs while maintaining access to effective treatments. Biosimilars present a viable solution to this challenge, as they are typically 15-30% less expensive than their biological counterparts.

This cost differential allows healthcare systems to provide biologic-like treatments to a larger population without the financial burden associated with expensive biologics. As a result, many countries have implemented policies and incentives to encourage the use of biosimilars, further bolstering their market growth.

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Biosimilar Market Report Segmentation:

Breakup By Molecule:

  • Infliximab
  • Insulin Glargine
  • Epoetin Alfa
  • Etanercept
  • Filgrastim
  • Somatropin
  • Rituximab
  • Follitropin Alfa
  • Adalimumab
  • Pegfilgrastim
  • Trastuzumab
  • Bevacizumab
  • Others

Infliximab accounts for the majority of shares as it is widely used to treat multiple autoimmune diseases, making it a high-demand biosimilar in the market.

Breakup By Indication:

  • Auto-Immune Diseases
  • Blood Disorder
  • Diabetes
  • Oncology
  • Growth Deficiency
  • Female Infertility
  • Others

Autoimmune diseases dominate the market as it require long-term biologic treatments, creating a high demand for cost-effective biosimilars.

Breakup By Manufacturing Type:

  • In-house Manufacturing
  • Contract Manufacturing

In-house manufacturing holds the majority of shares because it allows companies greater control over production processes, quality assurance, and cost management in biosimilar development.

Breakup By Region:

  • Europe
    • Germany
    • France
    • Italy
    • Spain
    • United Kingdom
    • Rest of Europe
  • United States
  • Japan
  • India
  • South Korea
  • Others

Europe holds the leading position due to early regulatory approvals and strong healthcare support for cost-effective alternatives to biologics.

Top Biosimilar Market Leaders: The biosimilar market research report outlines a detailed analysis of the competitive landscape, offering in-depth profiles of major companies.

Some of the key players in the market are:

  • Sandoz International GmbH
  • Pfizer Inc.
  • Teva Pharmaceutical Industries Limited
  • Celltrion Inc.
  • Biocon Limited
  • Samsung Biologics
  • Amgen, Inc.
  • Dr. Reddy's Laboratories Limited
  • Stada Arzneimittel Ag.

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