The biosimilar pipeline analysis market comprises of biologic drugs that are approved through an abbreviated regulatory pathway for drugs that have already been approved, also known as reference products (originator biologics).Biosimilars offer a cost-effective alternative to originator biologics for treatments of various chronic diseases. The market is currently dominated by drugs in oncology and autoimmune disease segments with a wide number of pipeline molecules in chronic disorders like diabetes and cardiovascular disease. With patents of blockbuster biologics set to expire in coming years, biosimilars are expected to significantly reduce healthcare costs without compromising on 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 are Pfizer Inc., Biocon, Pfizer Inc., F.Hoffmann- La Roche Ltd, Amgen Inc, Kyowa Pharmaceutical Industry Co. Ltd, Boehringer GmbH, AstraZeneca, Novartis AG. These players are focusing on expanding their product portfolio through acquisitions and partnerships. For instance, in 2022 Pfizer acquired biosimilar developer Global Blood Therapeutics for $5.4 billion to strengthen its pipeline of haematology drugs.
The biosimilar pipeline presents huge growth opportunities, especially in complex disease segments like oncology and immunology. Drugs coming off patent provide a multi-billion dollar market potential. For example, the expiry of Humira’s (arthritis drug) patents by 2023 is estimated to open a $20 billion biosimilar market.
Major players are eyeing international expansion into high-growth pharmaceutical markets like China, India, Brazil and Mexico. This is through local manufacturing partnerships to ensure affordable access and gain early-mover advantage. For instance, Biocon has commercialized several biosimilars in developed markets of US, EU and Australia through partner Mylan.
Market Drivers
1) Strong Demand for Affordable Biologic Drugs- With the rising prevalence of chronic diseases globally, the demand for affordable treatment options is increasing. Biosimilars provide significant cost-savings of up to 30% compared to reference biologics which is driving their adoption.
Market Restrains
1) Complex Manufacturing and Regulatory Approvals- Biosimilars are complex to manufacture due to their large molecular size and require stringent quality testing. This increases development costs. Additionally, country-specific regulations can delay market entry of biosimilars.
Segment Analysis
The biosimilar monoclonal antibodies sub segment dominates the market currently due to high demand for affordable cancer therapies. Biosimilar monoclonal antibodies are direct copies of original antibodies and have high potential to treat cancer and autoimmune diseases in a cost effective way. Biosimilar interferons sub segment is another major segment growing at a fast pace due to increasing use of interferons for treatment of hepatitis, multiple sclerosis and cancer.
Global Analysis
North America region holds the largest share in biosimilar pipeline analysis market owing to established healthcare infrastructure and presence of major pharmaceutical players in the US and Canada. Asia Pacific region shows fastest growth rate during the forecast period due to improving access to affordable biologics due to rising healthcare expenditure and increasing generic competition in countries like China and India. Development of novel drug delivery technologies also supports market growth in Asia Pacific region. Europe is another major regional market growing at a steady rate due to supportive regulatory environment aimed at increasing patient access to lower cost biosimilars.
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