Biosimilar Contract Manufacturing Market Is Estimated To Witness High Growth Owing To Increasing Demand For Cost-Effective Biologics

The Biosimilar Contract Manufacturing Market is estimated to be valued at US$ 10.70 Bn in 2024 and is expected to exhibit a CAGR of 15.9% over the forecast period 2024- 2031, as highlighted in a new report published by Coherent Market Insights.

The growth of the biosimilar contract manufacturing market is attributed to the increasing prevalence of chronic diseases and rising demand for affordable biologics. Biologics offer targeted treatment options and have significantly improved patient outcomes. However, the high costs associated with their development restrict widespread access and adoption. This has propelled the biosimilar market which provides near-replicates of original biologics at a fraction of the cost. Contract manufacturing aids in mitigating investments required for facility setup and maintenance, resulting in cheaper biosimilars. Furthermore, the shift towards outsourcing of manufacturing operations allows companies to focus on core competencies like R&D. This has boosted the outsourcing of biologics manufacturing to specialized contract development and manufacturing organizations (CDMOs).

Key Market Trends:

Development of Biosimilar Contract Manufacturing Capabilities: Key players in the market are expanding their manufacturing capabilities for biosimilars to cater to the growing demand and tap business opportunities. For instance, in June 2021, Lonza expanded its formulation and fill/finish capabilities for large volume parenterals (LVPs) at its facility in Visp, Switzerland to support biosimilar drug development and commercial manufacturing programs.

Advent of Single-Use Technologies: Single-use bioprocessing technologies help minimize downtime costs, reduce cleaning and validation requirements, and provide improved flexibility. The increasing adoption of these flexible and disposable systems streamline manufacturing operations and enable contract manufacturers to rapidly respond to changing production demands. More coverage can be found in the sample copy.

Biosimilar Contract Manufacturing Market Opportunities

With growing demand for affordable biologic drugs, biosimilar drug development is expected to provide sizable opportunities for contract manufacturing organizations (CMOs). Manufacturing biosimilars requires specialized expertise and facilities that are available with CMOs. This removes significant investment barriers for pharmaceutical companies looking to enter the biosimilars market. By 2024, over 100 biosimilar drugs are expected to lose their patents providing major opportunities for development of affordable biosimilar versions through contract manufacturing routes.

Cell and gene therapies are leading-edge areas that hold immense promise for treatment of complex diseases. However, their manufacturing is highly specialized involving cutting-edge technologies like viral vectors, cell culture, purification etc. Most pharmaceutical companies lack required infrastructure for these advanced therapies. CMOs having capabilities across multiple modalities like plasmid DNA, viral vectors, cell cultures etc. can fill this gap by providing specialized services on a contract basis. Their expertise in handling highly regulated advanced therapy processes will be key to tapping the large market potential expected in cell and gene therapies over the next decade.

The monoclonal antibodies segment dominated the market in 2019 and is expected to maintain its lead, growing at over 16% CAGR during the forecast period. Increasing pipeline and launches of affordable biosimilar monoclonal antibodies are driving the segment’s growth.

Oncology is expected to remain the highest revenue generating segment. Anticipated approval of several biosimilar drugs for cancer treatment is supporting the segment’s growth. The autoimmune segment is expected to witness highest CAGR during the forecast period.

North America dominated the global market in 2019 with over 40% revenue share. Presence of major CMOs and approval of several biosimilar drugs drove the region’s lead. Europe followed North America with a sizable share. Asia Pacific market is anticipated to witness highest CAGR during the forecast period supported by investments in biosimilars manufacturing in countries like India, China and South Korea.

Market Key Takeaways

The biosimilar contract manufacturing market is anticipated to witness a CAGR of 15.9% during the forecast period 2024-2031, owing to growing demand for affordable biologic therapies as patents of major brands expire. On the basis of product type, monoclonal antibodies segment is expected to hold a dominant position, owing to robust pipeline and launches. On the basis of region, North America is expected to hold a dominant position over the forecast period, due to presence of major CMOs and biosimilar approvals in the region.

Competitor Insights:

Biocon
Lonza
Fujifilm Diosynth Biotechnologies
Samsung Biologics

Recent Developments in Biosimilar Contract Manufacturing Market

In July 2023, Samsung Biologics of South Korea revealed plans to construct a new manufacturing campus, adding over 400,000 liters of capacity dedicated to monoclonal antibody and viral vector production. The first phase costing $2.5 billion is scheduled for completion in 2024. These expansions underline the long-term bullishness of major CMOs on biosimilar demand drivers.

In August 2023, Celltrion and Samsung Biologics extended their existing manufacturing collaboration to include viral vector and mRNA vaccine production beyond monoclonal antibodies. These agreements position partners to serve future growth jointly instead of independently.Full coverage of the report available here.