The biosimilar pipeline analysis market involves products such as monoclonal antibodies, insulin, granulocyte colony-stimulating factor, interferons, erythropoietin, and others. Biosimilar versions offer significant cost savings compared to their reference biologics, expanding patient access to lifesaving biologic treatments. Biosimilars also represent an opportunity for biopharmaceutical companies to participate in established therapeutic areas and earn revenues from mature products.

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., Biocon, Pfizer Inc., F.Hoffmann- La Roche Ltd, Amgen Inc, Kyowa Pharmaceutical Industry Co. Ltd, Boehringer GmbH, AstraZeneca, Novartis AG. Key players are focusing on expansion of their product portfolio through collaborations to increase their market share.

There are significant opportunities for development of biosimilars for monoclonal antibodies and other non-interchangeable biologics. As patents of many blockbuster biologics expire, biosimilar developers will focus their efforts on developing biosimilars for high revenue products.

Global expansion remains a key focus for leading biosimilar developers to gain wider market access and maximize revenues. Europe has emerged as the most lucrative and advanced market for biosimilars while markets in Asia Pacific and Latin America offer high growth potential.

Market drivers
One of the key drivers for the biosimilar pipeline analysis market is the increasing number of patent expiry of blockbuster biologics. Between 2020 to 2026, patents of biologics with annual sales of over $72 billion will expire in the US alone, opening several opportunities for biosimilar developers. This will significantly drive the demand for biosimilars worldwide and support the growth of the overall biosimilar pipeline analysis market over the forecast period.

PEST Analysis
Political: Regulation in biosimilars approval and testing requirements across countries have significantly impacted the biosimilar pipeline. Differences in approval pathways can affect the market potential.

Economic: Cost-savings achieved through biosimilars are expected to strengthen healthcare systems. Increased accessibility to affordable treatment options is likely to reduce disease and economic burden.

Social: Awareness and acceptance of biosimilars among patients and physicians influences market uptake. Utilization is dependent on demonstrated equivalence to reference products for efficacy, safety and immunogenicity.

Technological: Advances in analytical techniques facilitate stringent quality comparison of biosimilars against references. Continuous development of manufacturing capabilities allows for consistency in quality, safety and efficacy to match innovator biologics.

In terms of value, North America is the largest market for biosimilar pipeline owing to favorable regulatory policies and healthcare reforms focusing on reducing treatment costs in the United States. Europe contributes significantly driven by uptake in major markets such as Germany, United Kingdom, France and Italy. Strategic partnerships between European and Asian players are also expanding penetration in the region.

The Asia Pacific region is expected to witness highest growth through 2030 with increasing focus on enhancing accessibility to affordable treatment options. Countries like China, India, South Korea and Japan with progressive regulatory framework and improved production facilities present immense opportunities. In addition, collaborations between local players and global pharma companies are facilitating faster development and approval of biosimilars.