The biosimilar pipeline analysis market consists of pharmaceutical drugs that have been approved as substitutes for biologic drugs. Biosimilars provide more affordable treatment options compared to reference biologics as they have lower development costs and therefore lower prices. The demand for biosimilars is driven by the need for more cost-effective substitutes of biologics drugs, whose patents have expired. Biosimilars are developed through extensive characterization and comparison studies against reference biologics to demonstrate similarity.

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 are Pfizer Inc. (AC. Hospira), Celltrion Inc, Teva Pharmaceutical, 3SBio, Amgen, Novartis, Dr Reddy's Laboratories, SamsungBioepis.

The key opportunities in the biosimilar pipeline analysis market include developing biosimilar versions of blockbuster biologics whose patents have expired. The patent expiry of major biologics will open up lucrative development opportunities.

Globally, companies are focusing on expanding their biosimilar pipeline by filing applications in key markets like the US, Europe, and Asia Pacific. Regional and global partnerships are also being formed to commercialize biosimilars in international markets.

Market drivers
High development and commercialization of biosimilar drugs and a robust biosimilars pipeline portfolio driving the market growth. Patent expiry of blockbuster biologics and lower prices of biosimilars compared to reference biologics boosting biosimilars adoption.

Market restraints
Complex development and stringent regulatory pathways for biosimilars approval pose challenges. Limited automatic substitution policies and interchangeability uncertainties inhibit biosimilars uptake in some regions.

Segment Analysis
The biosimilar pipeline analysis market is segmented based on product, disease area, and end user. By product, monoclonal antibodies dominate the market as they account for over 70% of biosimilar clinical trial activity. Monoclonal antibodies biosimilars have gained traction among patients and healthcare providers as they have comparable clinical efficacy to reference products but at a lower price. By disease area, oncology dominates as many blockbuster oncology drugs are expected to lose patent protection in the coming years opening opportunities for biosimilars. By end user, hospital pharmacies hold the largest share due to their capability to store and dispense large volumes of biological medicine.

Global Analysis
On the regional front, Europe dominates the global biosimilar pipeline analysis market and accounts for over 50% share. Presence of favorable regulations and significant healthcare cost-cutting has boosted biosimilar adoption in Europe. Government initiatives to promote biosimilars as an affordable treatment alternative are driving growth. North America is the fastest growing regional market and is expected to witness a CAGR of over 20% during the forecast period. Increase in patent expiration of biologic drugs and new product approvals will support market growth in the region. Regulatory agencies like the FDA has shown commitment towards approval and uptake of biosimilars which is encouraging their development and commercialization in the US. Asia Pacific also demonstrates high potential for growth and emerging biosimilar markets like China, India, and South Korea will witness increased investments from global biosimilar manufacturers.