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 due to it's frequently used to treat long-term autoimmune conditions like Crohn's disease and rheumatoid arthritis.
• Autoimmune diseases hold the largest share in the biosimilar industry.
• In-house manufacturing remains a dominant segment in the market because it permits more control over the quality of production and lessens dependency on outside manufacturers, guaranteeing adherence to stringent regulatory requirements.
• The growing investment from pharmaceutical companies in biosimilar research and development (R&D), as they seek to diversify their portfolios and tap into the rising demand for cost-effective biologic alternatives, is bolstering the market demand.
• Besides this, the increasing awareness and acceptance among healthcare professionals and patients, driven by educational initiatives and clinical evidence demonstrating the safety and efficacy of biosimilars compared to reference biologics, is impelling the market growth.

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Industry Trends and Drivers:

• Patent Expiration of Biologic Drugs:

As patents on several high-revenue biologics have expired or are nearing expiry, the market has opened up opportunities for the development and commercialization of biosimilars. This expiration reduces the monopoly held by original biologic manufacturers, allowing biosimilar producers to enter the market with similar therapeutic agents at a lower cost.

For instance, blockbuster biologics used in treating chronic diseases such as cancer, diabetes, and autoimmune disorders are losing their exclusivity, driving biosimilar developers to capitalize on the growing demand for affordable alternatives. The global healthcare system's shift towards cost-effective treatment options, as they can be priced lower than their reference biologics, is aiding the market growth.

• Increasing Prevalence of Chronic Diseases:

Diseases such as cancer, diabetes, rheumatoid arthritis, and cardiovascular (CVD) conditions are becoming more prevalent worldwide, creating a growing demand for biologic treatments. Biologic drugs, while effective, are often expensive, limiting their accessibility. Biosimilars provide a more affordable option for patients, thus playing a critical role in addressing the healthcare needs of an expanding patient pool.

The aging population, particularly in regions like North America and Europe, has a higher incidence of chronic diseases, and biosimilars offer a solution to reduce the financial burden on healthcare systems while maintaining treatment efficacy. As governments and health agencies prioritize cost-effective solutions for managing chronic diseases, strengthening the market growth.

• Favorable Regulatory Frameworks and Government Initiatives Promoting Biosimilars:

Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established clear guidelines for biosimilar approval, ensuring they meet the same safety, efficacy, and quality standards as the original biologics. These well-defined pathways have simplified the approval process, encouraging more companies to invest in biosimilar development.

Additionally, government initiatives aimed at reducing healthcare costs are promoting biosimilar adoption. In many countries, policies supporting the use of biosimilars, such as reimbursement strategies and incentive programs for healthcare providers, are contributing to the market expansion.

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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 due to its widespread use in treating chronic autoimmune diseases such as rheumatoid arthritis and Crohn's disease.

Breakup By Indication:

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

Autoimmune diseases dominate the market as biologics, and biosimilars are highly effective in managing conditions like rheumatoid arthritis, psoriasis, and inflammatory bowel disease.

Breakup By Manufacturing Type:

• In-house Manufacturing
• Contract Manufacturing

In-house manufacturing represents the majority of shares because it enables better control over production quality and reduces reliance on third-party manufacturers, ensuring compliance with strict regulatory standards.

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 its well-established regulatory pathways for biosimilars and strong government support for biosimilar adoption.

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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