The biosimilar pipeline analysis market comprises products and services that provide insights into the current status of biosimilar development pipelines. Biosimilars offer cost savings compared to reference biologics and help expand patient access to important biologic medicines for conditions like cancer, diabetes, and immune disorders. The demand for biosimilars is growing as many innovative biologics are expected to lose patent protection in the coming years. With the patent cliff looming large, developers are exploring biosimilars as an alternate revenue stream and to capitalize on lucrative product opportunities.

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). Pfizer has made several strategic acquisitions and has a robust pipeline of nearly 20 molecules including biosimilars for Lucentis and Humira.

The biosimilar industry is witnessing numerous business opportunities with the expiry of biologic patents. Companies are investing in late-stage pipeline candidates as well as acquiring early-stage assets. Partnerships between originators and generic developers are also gaining traction.

To maintain their stronghold in global markets, leading biosimilar developers are focusing on expanding their geographic presence. Several companies are seeking regulatory approvals and commercialization partnerships in new regions including Asia, Africa, and Latin America. This will help minimize dependence on saturated markets.

Market Drivers
Expanding patient pool - The growing incidence of chronic diseases worldwide is spurring the demand for affordable biologics. Biosimilars present an cost-effective option to treat a wider patient population.
Patent expiries of blockbuster biologics - Major biologic drugs losing exclusivity in the coming years such as Humira, Rituximab, Trastuzumab provides opportunity for biosimilar makers.

Market Restrains
Complex development and regulatory pathway - Biosimilars require extensive comparability studies to prove similarity to the reference product posing high investment barriers. Stringent regulations also delay market entry.
Physician reluctance - Many physicians remain apprehensive regarding efficacy, safety and interchangeability of biosimilars impacting their prescriber base. Extensive real-world evidence is required to address this challenge.


Segment Analysis

The biosimilar pipeline market is dominanted by Oncology Segment which accounts for around 35% share. Oncology biosimilars are dominating due to huge patient pool of cancer patients worldwide requiring cost effective treatment options. Within oncology, monoclonal antibody biosimilars for cancer treatment have highest demand and sales.

Global Analysis
North America region currently leads the biosimilar pipeline market with around 40% share due to favorable regulations and reimbursement policies promoting biosimilars adoption in the region. However, Asia Pacific region is fastest growing market at CAGR of 20% driven by increasing healthcare infrastructure,rising incidences of chronic diseases and focus of global players on emerging Asian markets. Countries like China, India and Japan are witnessing high demand of biosimilars in Asia Pacific region. Europe is also a substantial and well established market for biosimilars having second largest regional share globally.

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