Biosimilar Pipeline Analysis Market is Estimated to Witness High Growth Owing to Patent Expiry of Biologics
The biosimilar pipeline analysis market comprises products such as monoclonal antibodies, insulin, recombinant human growth hormones, granulocyte colony-stimulating factor, and interferon. Biosimilars are biopharmaceutical drugs that are alternatives to already-approved innovative biological drugs that are manufactured by a living organism. Biosimilars provide vast cost savings over the reference biologics while maintaining high efficacy and safety.
The global biosimilar pipeline analysis market is estimated to be valued at US$ 29.4 Bn in 2024 and is expected to exhibit a CAGR of 17% over the forecast period 2023 to 2030.
Key Takeaways
Key players operating in the biosimilar pipeline analysis market are Pfizer Inc. (AC. Hospira), Celltrion Inc., Teva Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories Ltd., Biocon Ltd., Amgen Inc., Samsung Biologics, Intas Pharmaceuticals Ltd., STADA Arzneimittel AG, and Sandoz International GmbH.
The key opportunities in the market include the patent expiry of major biologics such as Herceptin, Remicade, Humira, Avastin, Rituxan and others. This expiry opens up significant opportunities for biosimilar products in these therapeutic areas. Moreover, the low healthcare access and rising healthcare expenditures make emerging markets like Asia Pacific an attractive region for global players in this market.
Globally, Europe is expected to dominate the biosimilar pipeline analysis market owing to favorable regulatory policies. However, Asia Pacific is expected to exhibit the highest growth rate over the forecast period due to the presence of emerging biosimilars markets like China, India, Japan and South Korea coupled with rising healthcare expenditures.
Market drivers
The major market driver is the patent expiry of major blockbuster biologics. Biologics worth over $150 billion in annual sales are expected to lose their patents by 2024 which opens up new opportunities for biosimilars. Other key drivers include the cost savings associated with biosimilars which is nearly 30% lower than the reference biologic. This reduces the cost of treatment especially in developing markets with constrained healthcare budgets.
PEST Analysis
Political: Rules and regulations regarding the approval of biosimilars are still evolving in many countries. However, favorable government policies are encouraging generics manufacturers to invest in this field.
Economic: Cost savings achieved from biosimilars are driving their increased adoption. As patents on major biologics expire, biosimilars are expected to capture a larger share of the market and reduce spending on healthcare.
Social: Greater awareness and acceptance of biosimilars among physicians and patients is positively impacting the market. Confidence in the equivalence of biosimilars to reference products is growing.
Technological: Continuous innovation in analytical techniques allows for more robust characterization and comparison of biosimilars against their reference products. Advanced cell line and process engineering enables higher product consistency required for biosimilars.
The geographical regions where the market is currently concentrated in terms of value are North America and Europe. North America accounts for the largest share due to favorable regulatory guidelines and a higher adoption rate of biosimilars in the US. Europe is also a significant market driven by increasing uptake in countries like Germany, UK, France and Italy.
The Asia Pacific region is poised to be the fastest growing market for biosimilar pipeline globally during the forecast period. This can be attributed to rising healthcare expenditure, expanding patient pool affected by chronic diseases, and evolving regulatory framework encouraging local biosimilar development in several APAC countries including China, India, South Korea and others.
