by Biosimilars are bio therapeutic products developed to be similar to already approved biologic drugs known as reference biologics. Biosimilars contain similar but not identical active substances to the reference biologic, and are generally 25-30% cheaper than the original biologics. Biosimilars are used in treatment of range of diseases including cancer, diabetes, autoimmune diseases. Some prominent biosimilars include lipegfilgrastim, bevacizumab, rituximab, trastuzumab which are used as alternatives to filgrastim, avastin, rituxan and herceptin respectively.
The global biosimilars market is estimated to be valued at US$ 33.87 million in 2024 and is expected to exhibit a CAGR of 5.9% over the forecast period 2024 to 2031, as highlighted in a new report published by Coherent Market Insights.
Market Dynamics:
Growing demand for Cost-effective Biologics (referred from heading): With biologics being highly expensive, biosimilars provide a cost-effective alternative for both patients and healthcare systems. For example in Europe, biosimilars entry led to a savings of €620 million in 2017 alone for national healthcare budgets. As more biosimilars gain approval and enter the market, they are expected to significantly reduce treatment costs. This growing demand for affordable treatments will drive growth of the biosimilars market over the forecast period.
Stringent regulations: Regulatory bodies like EMA, FDA have established scientific and regulatory guidelines to bring more transparency and clarity in biosimilars development and approval pathway. This involves comprehensive similarity exercise between biosimilar and reference product to ensure similar quality, safety and efficacy. Stringent evaluation and approval process ensures biosimilars maintain same standard of care as reference products, gaining more confidence among patients and physicians.
Segment Analysis
The biosimilars market is segmented into monoclonal antibodies, recombinant hormones/proteins, vaccines and others. The monoclonal antibodies segment dominates the market and held around 46% market share in 2024 owing to high demand for monoclonal antibody biosimilars such as adalimumab and infliximab for treating autoimmune and inflammatory diseases.
PEST Analysis
Political: Governments across the globe are supporting the growth of biosimilars through enacting favorable regulations and policies to reduce healthcare expenditure. For example, FDA provides guidelines for approval of biosimilars.
Economic: Lower pricing of biosimilars compared to biologics is driving their adoption. The cost savings achieved through biosimilars are being invested in research and development of novel therapeutics.
Social: Rising prevalence of chronic diseases and growing geriatric population who require long-term therapies are fueling the demand for affordable treatment options like biosimilars.
Technological: Advancements in analytical techniques allow thorough characterization of the biosimilarity and quality of biosimilars, improving their confidence level among patients and physicians.
Key Takeaways
The Global Biosimilars Market Size is expected to witness high growth over the forecast period. The global biosimilars market is estimated to be valued at US$ 33.87 million in 2024 and is expected to exhibit a CAGR of 5.9% over the forecast period 2024 to 2031.
Regional analysis shows that North America leads with the largest market share currently due to established regulatory guidelines and rapid uptake of biosimilars. Europe is anticipated to showcase fastest growth during the forecast period with biosimilars penetration rising rapidly across major countries.
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 like FDA, EMA are actively involved in developing favorable regulations to facilitate biosimilars approval.
