Biosimilars are biologic medical products that are developed to be similar to an already approved biologic drug, which is known as the reference product. Biosimilars work in a similar way compared to the reference product in the body (human body) and provide similar clinical benefits. Biosimilars are used for treating conditions such as cancer, inflammatory diseases, and others. Biosimilars offer cost-effective alternatives to expensive biologic drugs treating chronic diseases when patents expire.

The global biosimilars market is estimated to be valued at US$ 33.87 Mn in 2024 and is expected to exhibit a CAGR of 5.9% over the forecast period 2024 to 2031.

Key Takeaways

Key players operating in the biosimilars market are U.S. Environmental Protection Agency (EPA), European Chemicals Agency (ECHA), Food and Drug Administration (FDA), Ministry of Environment, Forest and Climate Change (India), National Health Commission (China), Canadian Food Inspection Agency (CFIA), National Institute for Health and Welfare (THL) (Finland), Federal Institute for Risk Assessment (BfR) (Germany), National Institute of Food and Drug Safety Evaluation (KFDA) (South Korea), Ministry of Ecology and Environment (China), Environment Agency (United Kingdom), Ministry of Health, Labour and Welfare (Japan), Australian Government Department of Agriculture, Water and the Environment, Health Canada, Ministry of Health (Brazil). Key players are focusing on expanding their product portfolios and geographical presence by collaborating with regional players.

The Biosimilars Market Growth offers immense opportunities such as increasing demand for affordable treatment options and drug development of biosimilar antibodies. Key players are expanding their presence across global regions such as Asia Pacific, Europe, North America, Middle East & Africa and Latin America. Growth opportunities in emerging economies are boosting global expansion of players in the biosimilars market.

Market Drivers

Growing incidence of chronic diseases as well as rising healthcare expenditure is positively impacting the biosimilars market growth. According to WHO, cancer is the second leading cause of death globally with 10 million deaths in 2020 alone. Biosimilars provide a cost-effective treatment option.

Biosimilar approval pathways established by regulatory bodies ensure biosimilarity and quality of products, thus increasing adoption. Patent expiry of biologics creates opportunities for biosimilars. For instance, patent expiry of blockbuster biologics such as Humira, Avastin, and others worth billions create substantial opportunities.

Market Restrains

High costs associated with development and manufacturing of biosimilars restrains market potential. Biosimilar development requires advanced techniques, expertise and capital investment. Maintaining biosimilarity adds to costs.

Perceived risks regarding interchangeability of biosimilars with reference products limits widespread adoption. Lack of differentiated strategies for interchangeable products challenges. Stringent regulations also add to costs and complexity.

Segment Analysis

The biosimilars market is dominated by monoclonal antibodies segment owing to the rising demand for affordable treatment options for diseases like cancer and autoimmune disorders. Monoclonal antibodies make around 70% share of the overall market as of 2024 with their applications in dealing with range of conditions from arthritis to psoriasis to cancer. They offer similar clinical results as their reference biologic drugs with reduced costs, thereby gaining higher preference over costly biologics.

Global Analysis

Regionally, Europe accounts for the largest share in the biosimilars market and is expected to maintain its dominance during the forecast years. This can be attributed to the early adoption of biosimilars in the region backed by supportive regulatory guidelines and increasing biosimilar approvals. Countries like Germany, UK, France, Spain, and Italy are the major revenue generators. The Asia Pacific region is anticipated to witness the fastest growth during the forecast period owing to the improving healthcare infrastructure, rising healthcare expenditure, and increasing incidence of chronic diseases. Additionally, growing awareness regarding biosimilars and their cost-effectiveness is further augmenting the market growth in Asia Pacific region.

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