The biosimilar pipeline analysis market comprises biosimilars that are developed to be similar to biological drugs called reference drugs. Biosimilars are biologic medical products manufactured using living cells and offer similar clinical results as the reference biologic medicine. Biosimilars are considered cost-effective alternatives to their reference biologics as they offer significant cost savings for patients as well as for healthcare systems.

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 leading players are focusing on advancing their pipeline molecules and launching high quality biosimilars to capture major market share.

The biosimilar pipeline analysis market is witnessing high growth owing to increasing demand for affordable healthcare. The cost of biologic reference drugs is rising continuously putting financial burden on patients as well as governments. Biosimilars offer significant cost savings of upto 30% as compared to reference biologics making healthcare affordable.

Technological advancements in analytical techniques and manufacturing processes have enabled development of highly similar biosimilars. State-of-the-art technologies help in comprehensive physicochemical and functional characterization of biosimilars establishing biosimilarity with reference products. This is expected to increase biosimilar approvals and commercialization.

Market Trends

Consolidation of players: Leading players are pursuing strategic collaborations and acquisitions to consolidate their position and strengthen biosimilar pipeline. For instance, Pfizer acquired Hospira to enhance biosimilar presence.

High demand in oncology: Majority of biosimilars in pipeline are developed for oncology treatment where demand is rapidly growing. Biosimilars save huge costs for cancer treatment making therapy accessible to more patients.

Market Opportunities

Emerging markets: Developing nations offer significant untapped potential owing to growing patient population andrising healthcare expenditures. Players can leverage emerging markets through collaborations.

Patent expiries: Biosimilars of blockbuster biologics whose patents expire offer first mover advantage to players launching biosimilars first with enhanced market share potential. For example, biosimilar of blockbuster biologic Humira.

Impact of COVID-19 on biosimilar pipeline analysis market growth

The COVID-19 pandemic has significantly impacted the biosimilar pipeline analysis market. During the initial months of the pandemic, there was disruption in the supply chain and production facilities due to nationwide lockdowns across various countries. This led to delays in clinical trials and drug approvals. However, the demand for affordable biosimilar drugs increased as they provide cost-effective treatment alternatives. Many healthcare systems are focusing on increasing the uptake of biosimilars to reduce healthcare expenditure in a financially challenging environment.

Post pandemic, the approval process for biosimilars is expected to accelerate as regulatory agencies fast track approvals. Manufacturers are ramping up production capacities of leading products to meet the growing demand. Governments are likely to provide incentives to local biosimilar manufacturers to reduce import dependence. Increased R&D investments in cell line development and analytics can help biosimilar manufacturers expand their product portfolios. Thus, the biosimilar pipeline analysis market is anticipated to grow significantly in the coming years driven by cost benefits, fast approvals and worldwide demand for biologics.

The United States and Europe account for the majority of the biosimilar pipeline analysis market value currently owing to their large biologic drug markets and progressive biosimilar regulations. However, Asia Pacific region especially China, India and South Korea are emerging as the fastest growing markets due to their immense population base, rising healthcare expenditures and government policies supporting domestic biosimilar industries. Nations with significant genetic diversity present lucrative opportunities for clinical trials of biosimilars as well.