Biosimilar drugs are biopharmaceutical drugs that are highly similar to already approved original branded biologics in terms of safety, purity, and potency. Biosimilar drugs offer significant cost savings compared to their reference biologic drugs and expanding access to expensive biologic therapies. Various biologic drugs facing patent expiry in the coming years offer lucrative opportunities for biosimilar drugs. For instance, Abbvie’s blockbuster antibody Humira, used for the treatment of autoimmune diseases like rheumatoid arthritis and inflammatory bowel disease, faces U.S patent expiry in 2023. Significant cost savings presented by biosimilars of Humira and other blockbuster biologics are expected to drive the demand for these biosimilar drugs.
The global Biosimilar Pipeline Analysis Market is estimated to be valued at US$ 8.3 billion in 2023 and is expected to exhibit a CAGR of 17. % over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.
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Market key trends:
One of the key trends in the biosimilar pipeline analysis market is the increasing number of biosimilar approval applications. Various pharmaceutical companies are developing biosimilar versions of blockbuster biologics and submitting regulatory approval applications to commercialize these biosimilars. For instance, in 2022, the United States Food and Drug Administration approved five biosimilar applications including Semglee, a biosimilar of Lantus for treatment of diabetes. Similarly, in 2021, the European Medicines Agency approved 18 original biosimilar marketing authorization applications. Such rising biosimilar approval applications are expected to positively impact the market growth over the forecast period.
Porter’s Analysis
Threat of new entrants: The threat is moderate as R&D and manufacturing costs for biosimilars is high requiring significant investments. Regulations also require extensive clinical trial data.
Bargaining power of buyers: The bargaining power is high given the presence of many established biologics manufacturers. Biosimilar approval process also reduces switching costs for buyers.
Bargaining power of suppliers: The power is moderate as key materials and manufacturing services have few potential substitutes and biosimilar developers depend on them.
Threat of new substitutes: The threat is low as developing novel biologics takes significant time and cost compared to biosimilars targeting existing biologic drugs.
Competitive rivalry: Competition is intense among leading players to commercialize biosimilars and capture market share.
Key Takeaways
The global biosimilar pipeline analysis is expected to witness high growth.
Regional analysis: North America dominates currently due to established regulatory guidelines and pharmaceutical infrastructure for biosimilar development and manufacturing. Europe is also a major market driven by initiatives to increase biosimilar adoption. Asia Pacific is poised to be the fastest growing market attributed to rising healthcare infrastructure and increasing patient pool.
Key players operating in the biosimilar pipeline analysis are Sandoz International, Celltrion, Pfizer, Samsung Bioepis, Amgen, and Biogen among others. Sandoz and Celltrion have leading pipelines and several approved products. Companies are focused on expanding their product portfolios and markets through partnerships.
*Note:
- Source: Coherent Market Insights, Public sources, Desk research
- We have leveraged AI tools to mine information and compile it