Biosimilars are biopharmaceutical drugs developed to have highly similar clinical efficacy and safety to that of an already approved biological drug (also known as reference product or originator biologic). Biosimilars provide clinically meaningful advantages over existing biological treatments by offering more affordable alternatives to costly biologics. The patent on most primary biologic drugs will expire between 2020 and 2025, opening the market for biosimilars.
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: 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).
Growing demand: The growing prevalence of chronic diseases globally has increased the demand for effective and affordable treatments. Biosimilars provide clinically effective alternatives to expensive biologics at a much lower cost, helping patients access life-saving therapies. This has boosted the demand for biosimilars across major markets.
Global expansion: Leading biosimilar manufacturers are expanding their global footprint through partnerships, acquisitions, and entry into emerging markets. While the U.S. and Europe currently dominate the market, Asian countries like India and China are expected to offer high growth opportunities leading players to expand in these regions.
Market key trends
Emerging therapeutic areas: Biosimilars were initially approved only for a few disease indications, but are now approved or in development across multiple treatment areas like oncology, immunology and endocrinology. This therapeutic area expansion will fuel future Biosimilars Market Growth. Moreover, research into complex biologics is extending the range of biologics that can be biosimilarized.
Increasing acceptance: Regulatory approvals and guidance from agencies like the FDA and EMA along with favourable healthcare policies are increasing acceptance and adoption of biosimilars among patients and physicians worldwide. Growing clinical evidence comparing the efficacy and safety of biosimilars against reference products is also driving higher acceptance rates.
Porter’s Analysis
Threat of new entrants: Biosimilars require significant investments and time for R&D as well as clinical trials. Established companies have considerable resources and expertise making entry difficult.
Bargaining power of buyers: Due to availability of few substitutes and medical importance of biosimilars, bargaining power of buyers is relatively low.
Bargaining power of suppliers: Major suppliers for biosimilars manufacturing are CMOs and academic research organisations. Dependence of established companies on such suppliers increases their bargaining power.
Threat of new substitutes: Development of novel biologics poses a threat but high investments lower the threat in the short term.
Competitive rivalry: Presence of many global and regional players results in intense competition. Price wars and new product launches are common to gain market share.
Geographical Regions
North America dominated the global biosimilars market in terms of value in 2020. This is attributed to approvals and launches of various biosimilars as well as established regulatory guidelines in the region. The U.S. represented a major share due to early adoption.
Asia Pacific is expected to witness the highest growth during the forecast period. This can be attributed to increasing healthcare infrastructure, rising biologics consumption, and supportive regulatory approvals in major countries including China, India, and South Korea. Growing geriatric population and increasing generics market also aid market growth in the region.