Biosimilars Market

Biosimilars Market to Witness High Growth Supported by Increasing Biosimilar Drug Approvals


The biosimilars market has seen significant growth in the past few years owing to the increasing number of biologic drugs going off-patent. Biosimilars offer advantages such as cost-savings compared to their reference biologic drugs. Due to the complex nature of biologics, the development and regulatory approval process of biosimilars is more involved compared to generic drugs. However, growing biosimilar drug approvals have helped increase competition and lower drug costs.

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

The key opportunities in the Biosimilars Market Demand include strong biosimilar drug pipelines, increasing educational campaigns about biosimilars, and rising demand for affordable biologics in developing nations. Further, growing uptake of biosimilars in Europe and expansion in emerging Asian markets will help drive future market growth.

Market drivers

The increasing number of blockbuster biologics going off-patent each year such as Humira, Herceptin, Avastin, etc. provides major market opportunities for biosimilar drug developers. Further, strict healthcare cost containment measures and favorable regulatory policies across regions are encouraging the adoption of biosimilars. Growing disease prevalence worldwide has also increased the demand for affordable biologics treatment, thereby fuelling biosimilars market growth.

PEST Analysis

Political: The biosimilars market is regulated by various government agencies across different countries and regions. Their regulations determine the approval pathways for manufacturing and commercialization of biosimilars. Any changes in regulations can impact the development and use of biosimilars.

Economic: Biosimilars provide more affordable treatment options compared to reference biologics, expanding access to patients. Their adoption depends on reimbursement policies of healthcare systems and incentive programs by governments to increase use of lower-cost biosimilars.

Social: With growing prevalence of chronic diseases, biosimilars help meet the increasing healthcare needs of aging populations. Their adoption requires education of physicians and patients regarding their safety, efficacy and interchangeability with reference products.

Technological: Advancements in analytics and manufacturing technologies help accelerate biosimilar development and lower costs. Increased understanding of complex large molecule drugs enables developers to more closely match reference products. Continued innovations will expand the pipeline of biosimilar candidates.

Regions of concentration

The biosimilars market in terms of value is highly concentrated in regions with developed healthcare infrastructure and supportive regulatory pathways. Europe, especially Germany, UK and France collectively account for around 60% of global biosimilars market owing to early approval and adoption of these products. The U.S. market is also growing significantly with recent approvals of high demand biosimilar candidates.

Fastest growing region

Asia Pacific region is poised to be the fastest growing market for biosimilars over the forecast period. This is driven by high disease burden, growing geriatric population, expanding biologics market and developing regulatory frameworks in major countries like China and India. Governments are promoting local biosimilar manufacturing through incentives and trade agreements, improving regional self-sufficiency. Emerging biosimilars hubs in Asia will be crucial to meeting the global demand.

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