by Biosimilars are biologic medical products that are developed to be similar to an already approved biologic medicine known as reference product. Biosimilars work in a similar way and have no meaningful clinical differences from the original reference product in terms of safety, purity, and potency. Biosimilars offer cost savings in comparison to their reference biologic products as their pricing is significantly lower owing to lower R&D costs. Biosimilars are used to treat various chronic diseases including cancer, auto-immune diseases, and other diseases.
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 Dynamics:
High cost savings from biosimilars is one key driver that is expected to flourish the biosimilars market over the forecast period. Biosimilars are priced significantly lower than their reference biologic products majorly due to lower R&D and manufacturing costs involved in developing a biosimilar. Biosimilars typically enter the market at 25% lower price than the reference product which in turn provides substantial cost savings to the healthcare systems and patients. For instance, biosimilar versions of Adalimumab, Infliximab, and Trastuzumab offer over 30% cost savings as compared to their reference biologics. This aids in making expensive biologics affordable and increasing adoption of biosimilars globally. Further, supporting regulatory framework and patent expiration of biologics also aids the growth of biosimilars market over the forecast period.
Segment Analysis
The biosimilars market is segmented based on molecule type, application, and geography. Based on molecule type, the market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins and others. Recombinant non-glycosylated proteins dominate the market and accounts for over 60% share. This is because these molecules are relatively easier to develop and obtain biosimilar approval as compared to recombinant glycosylated proteins which requires complex manufacturing process.
PEST Analysis
Political: Government bodies like FDA, EMA are promoting use of biosimilars to reduce healthcare costs. FDA has well defined pathways and guidelines for biosimilar approval which is supporting market growth.
Economic: High cost of biologics makes biosimilars an attractive and cost effective alternative. Patent expiration of blockbuster biologics is opening large market potential for biosimilars.
Social: Increasing burden of chronic diseases and aging population is driving demand for affordable treatment options like biosimilars.
Technological: Advancements in analytical techniques and manufacturing capabilities have enhanced biosimilar development and approval process. Continuous cell culture and perfusion platforms allows for consistent yield and quality.
Key Takeaways
The Global Biosimilars Market Growth is expected to witness high over the forecast period of 2023 to 2030. 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.
Regional analysis
The Asia Pacific region is witnessing increased acceptance of biosimilars owing to rising healthcare expenditure, growing number of biosimilar approvals and ongoing clinical trials of various pipeline molecules. China, India and South Korea are expected to be the major revenue generators in the region.
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), Sandoz, Pfizer, Celltrion, Teva Pharmaceutical, Samsung Bioepis and Mylan. Sandoz and Pfizer lead the biosimilars market with wide portfolio and global commercialization network. Celltrion and Samsung Bioepis are emerging as strong players from South Korea with their successful monoclonal antibody biosimilars.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
