July 14, 2024

Biosimilars Market Is Estimated To Witness High Growth Owing To Growing Acceptance Of Biosimilars

Market Overview:

Biosimilars are biopharmaceutical drugs that are developed to be similar to an existing FDA-approved biologic, which is named reference product. Biosimilars provide viable treatment alternatives to existing biologics with similar efficacy and safety at lower costs. They are marketed after gaining approval from drug regulatory authorities following patent expiration of reference biologics. Key therapeutic areas where biosimilars are available include oncology, autoimmune diseases, growth hormone deficiencies and blood disorders.

Market Dynamics:

Growing acceptance of biosimilars by patients and physicians is a major factor driving growth of the market. Biosimilars are adopted as they provide cost-saving alternatives to treat diseases. In addition, regulatory bodies across major markets are promoting biosimilars which is also supporting the market growth. For instance, FDA has approved over 60 biosimilars and EMA also encourages development and adoption of biosimilars. Furthermore, the expiry of patents of major biologics is prompting manufacturers to develop biosimilars for such biologics. However, complex nature of development and reluctance of physicians to switch patients from reference to biosimilars poses challenges to the market. Nonetheless, investments in R&D of biosimilars for complex disease areas including cancer is expected to create lucrative opportunities for players over the forecast period.

SWOT Analysis

Strength: Biosimilars are considered to be more cost-effective alternatives to expensive brand biologic drugs as they provide substantial cost savings up to 30-40% as compared to their branded counterparts. Biosimilars have a fairly straightforward regulatory pathway for approval as compared to innovative biologics. Biosimilars allow increased patient access to life-saving treatments especially for conditions like cancer.

Weakness: Most manufacturers still lack experience and expertise in biosimilar development and manufacturing which is a complex multi-step process. Biosimilars face challenges related to interchangeability and automatic substitution that could hamper uptake.

Opportunity: Rising healthcare costs and patent expiries of major biologic drugs provide major opportunities for biosimilars to gain market share especially in therapeutics areas like oncology. Emerging markets like Asia Pacific and Latin America offer vast growth prospects due to rising incomes and demand for affordable biologics.

Threats: Uncertainties still persist regarding long term safety, immunogenicity and interchangeability of biosimilars that impede their uptake. Strategic collaborations and litigations by innovator companies delay market entry of biosimilars in some countries.

Key Takeaways

The Global Biosimilars Market Demand is expected to witness high growth, exhibiting CAGR of 17% over the forecast period, due to increasing uptake of affordable treatment options for chronic diseases. The market size is projected to reach US$ 29.4 Bn by 2023 from US$ 19.2 Bn in 2018.

Regional analysis: North America currently dominates the biosimilars market owing to favourable regulations and reimbursement schemes driving adoption rates. Europe is another major regional market supported by cost-containment strategies and biosimilar-friendly incentives in countries like Germany and UK. However, Asia Pacific region is poised to showcase fastest growth fueled by bursting patient population, increasing healthcare expenditures and focus of leading players in this region.

Key players: Key players operating in the biosimilars market are Eli Lilly and Company, Merck & Co. Inc., Teva Pharmaceutical Industries Limited, Kashiv Bio Sciences, Intas Pharmaceutical Ltd, Dr. Reddy’s Laboratories, Biocon Ltd, Pfizer Inc., Amgen Inc. These companies have gained early-mover advantages through extensive research efforts and partnerships to build robust pipelines of biosimilar drug candidates targeting cancer and autoimmune conditions.


  1. Source: Coherent Market Insights, Public sources, Desk research
  2. We have leveraged AI tools to mine information and compile it