Biosimilars Market Analysis and Forecast 2031: Opportunities in a Vital Pharmaceuticals Sector

According to the report, the global biosimilars industry was estimated at $15.9 billion in 2021, and is anticipated to hit $143.6 billion by 2031, registering a CAGR of 24.7% from 2022 to 2031.

Increase in incidences of diabetes and autoimmune diseases drives the growth of the global biosimilars market. Moreover, favorable government policies and new product launches in the biosimilars industry have supplemented the growth yet more. Moreover, several growth prospects in the developed as well as developing economies have been beneficial for the key players in the industry.

Key Takeaways:

• The oncology diseases segment to dominate by 2031
• The monoclonal antibodies segment to maintain the lion’s share
• Europe region to maintain its dominance by 2031

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Major Factors Driving the Growth of Biosimilars Market:

Patent Expiry of Biological Products: The expiration of patents on many blockbuster biological drugs is creating a surge in the development and commercialization of biosimilars. These patent expirations open up opportunities for biosimilar manufacturers to enter the market with more affordable alternatives to the original biologics.

Cost-Effectiveness of Biosimilars: Biosimilars are significantly more cost-effective than their original biologic counterparts, offering healthcare providers and payers substantial cost savings. This cost-effectiveness is driving the adoption of biosimilars, especially in countries with limited healthcare budgets.

Increasing Regulatory Approval and Adoption: Regulatory bodies worldwide are increasingly approving biosimilars, recognizing their efficacy and safety. This regulatory approval is fostering greater acceptance and adoption of biosimilars among healthcare providers and patients.

Expanding Therapeutic Applications: The scope of biosimilars is expanding beyond traditional areas like oncology to encompass a wider range of therapeutic applications, including autoimmune diseases, inflammatory disorders, and chronic diseases. This expansion is opening up new opportunities for biosimilar manufacturers and driving market growth.

Growing Government Support: Governments worldwide are recognizing the potential of biosimilars to improve patient access to affordable biologics and are providing support for their development and adoption. This support is creating a favorable environment for the growth of the biosimilars market.

Market Segmentation:

By Application

• Blood disorders
• Oncology diseases
• Chronic and autoimmune diseases
• Others

By Type

• Human growth hormone
• Erythropoietin
• Monoclonal antibodies
• Insulin
• Granulocyte-Colony
• Stimulating Factor
• Others

By Region:

• North America (U.S., Canada, Mexico)
• Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
• Asia-Pacific (Japan, China, Australia, India, South Korea, Rest of Asia-Pacific)
• LAMEA (Brazil, Saudi Arabia, South Africa, Rest of LAMEA)

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Key Players and Strategies:

Kashiv Bio Sciences, Amgen Inc., reliance life sciences, Dr. Reddy’s Laboratories, Merck & Co. Inc., Intas Pharmaceutical Ltd, Pfizer Inc., Biocon Ltd, Teva Pharmaceutical Industries Limited, Eli Lilly and Company.

Recent Developments:

• In September 2023, Biogen Inc, received U.S. Food and Drug Administration (FDA) approval for its TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA.
• In August 2023, Sandoz received U.S. Food and Drug Administration (FDA) approval for its biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics
• In May 2023, Celltrion Healthcare received U.S. Food and Drug Administration (FDA) approval for its adalimumab-aaty (Yuflyma; Celltrion USA), a high concentration and citrate-free formulation of adalimumab (Humira; Abbvie) biosimilar.

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Key Questions Answered in the Intelligent Study

What is the market size and growth rate of the global and regional market by various segments?
What is the market size and growth rate of the market for selective countries?
Which region or sub-segment is expected to drive the market in the forecast period?
What Factors are estimated to drive and restrain the market growth?
What are the key technological and market trends shaping the market?
What are the key opportunities in the market?
What are the key companies operating in the market?
Which company accounted for the highest market share?

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