The Biosimilars Market is estimated to be valued at US$ 29.4 Bn in 2023 and is expected to exhibit a CAGR of 17% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.
Market Overview:
Biosimilars are biologic drugs that are highly similar to an approved biologic drug (reference product) in quality, safety, and efficacy. Biosimilars offer large cost savings compared to their reference biologics and expand access to important biologics by increasing competition. Biosimilars are produced after the patent expiry of original biologic drugs and hence provide affordable treatment options.
Market Dynamics:
The increasing demand for affordable medicines across developing economies is a key driver boosting the biosimilars market growth. Due to patent expiry of several biologic drugs and introduction of biosimilar versions at substantially lower prices, healthcare systems are able to expand access and offer treatments to larger patient population. For instance, in August 2020, Mylan launched its biosimilar pegfilgrastim (Fulphila) in Australia at a 30% discount to the brand product Neulasta.
Another important driver augmenting the market is strong government support and initiatives to promote the uptake of biosimilars. Regulators and governments are educating prescribers and patients about biosimilars through awareness campaigns to encourage biosimilar adoption and substitution. For example, the EU has mandated automatic substitution of biosimilars for biologics to enhance the former's utilization.
Segment Analysis
The global biosimilars market is dominated by oncology segment, which is expected to account for over 35% of the market share by 2030. Oncology biosimilars are the most mature therapeutic segment with established regulations and guidelines for approval of oncology biosimilars. Several blockbuster biosimilars such as Rituximab, Bevacizumab, and Trastuzumab have lost their patents and their biosimilars are being approved rapidly across regions, contributing to the dominance of oncology segment.
PEST Analysis
Political: Regulations promoting approval and adoption of biosimilars in major markets such as US, EU, Japan are expected to boost the market growth. The BPCIA regulations simplified the approval process in the US.
Economic: Reduced development and production costs of biosimilars compared to biologics allow biosimilar drugs to be priced 15-30% lower than the reference product, improving access to biologic treatment especially in developing countries.
Social: Increasing prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders is leading to rising demand for affordable treatment options such as biosimilars.
Technological: Advancements in analytical techniques have enabled characterization of complex molecules and ensured biosimilarity, facilitating regulatory approvals of a growing number of biosimilars.
Key Takeaways
The Global Biosimilars Market Demand is expected to witness high growth, exhibiting CAGR of 17% over the forecast period, due to increasing demand for affordable biologic drugs. The market size is projected to reach US$ 129.1 Bn by 2030 from US$ 29.4 Bn in 2023.
Europe currently dominates the global biosimilars market, accounting for over 40% market share in 2023. Presence of streamlined regulatory approvals and incentive programs for biosimilars adoption have aided early commercialization of biosimilars in major European markets.
The Asia Pacific region is expected to be the fastest growing market, expanding at a CAGR of around 20% owing to rising healthcare expenditure, large patient population, and increasing focus of global players on markets like China, India and South Korea.
Key players operating in the biosimilars market are Eli Lilly and Company, Merck & Co. Inc., Teva Pharmaceutical Industries Limited, Kashiv Bio Sciences, Intas Pharmaceutical Ltd, Dr. Reddy’s Laboratories, Biocon Ltd, Pfizer Inc., Amgen Inc. Major players are focusing on expanding their product portfolios and gaining initial approvals in key markets to gain market share.
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