by Biosimilars are biologic medical products that are introduced once the patents of originator biologics expire. Biosimilars provide an opportunity for patients to access high quality biologic medicines at a reduced cost compared to originator biologics. Although the development of biosimilars is complex and requires extensive comparability testing, once proven to be highly similar to the reference product, they are as safe and effective as their reference biologics. Some key advantages of biosimilars include reduced costs for healthcare systems and improved access for patients suffering from chronic diseases like cancer, autoimmune diseases etc.
The global Biosimilars Market is estimated to be valued at US$ 29.4 Bn in 2023 and is expected to exhibit a CAGR of 5.9% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.
Market key trends:
The expiry of major biologics patents is poised to boost the biosimilars market in the coming years. For instance, the patent of blockbuster biological drugs such as Humira, Herceptin, and Avastin are expected to expire during 2022–2023. This presents lucrative opportunities for biosimilars manufacturers to launch affordable biosimilar versions of these drugs. In addition, favourable regulatory guidelines and acceptance of biosimilars across regions is also stimulating market growth. For example, in the U.S. FDA has approved over 30 biosimilars since 2015 and continues to approve biosimilars at an accelerated rate. Similarly, the European regulatory framework also promotes biosimilars with the objective to increase accessibility and affordability of quality biologics.
Porter’s Analysis
Threat of new entrants: The biosimilars market requires huge R&D investments and regulatory approvals which increase the entry barriers.
Bargaining power of buyers: Large pharmaceutical companies and generic drug makers have significant bargaining power over smaller biosimilar manufacturers.
Bargaining power of suppliers: Few contract manufacturing organizations with specialized manufacturing capabilities for biosimilars hold strong bargaining power.
Threat of new substitutes: New biologics that provide distinct therapeutic benefits over existing ones pose a threat of substitution.
Competitive rivalry: The market is highly competitive with many global players fighting for market share and patents of top selling biologics expiring.
Key Takeaways
The Global Biosimilars Market Size is expected to witness high growth. Supported by patent expiries of major biologics, expiry of existing biologics patents provides greater opportunity for biosimilar manufacturers.
Regional analysis:
Europe dominates currently due to an established regulatory framework and favorable reimbursement policies. The Asia Pacific region is expected to grow at the fastest pace due to rising healthcare expenditure, increasing penetration of health insurance, patent expiry of blockbuster biologics and growing demand for affordable treatment options.
Key players operating in the biosimilars market are U.S. Environmental Protection Agency (EPA), European Chemicals Agency (ECHA), Food and Drug Administration (FDA). Key players operating in the biosimilars market are Sandoz International, Biocon, Pfizer, Celltrion Healthcare, Samsung Bioepis, Amgen, AbbVie. These players are focusing on expanding their product portfolios through partnerships and collaborations with other market players.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
