Biosimilar Contract Manufacturing Market By Product Type (Recombinant Non-Glycosylated Proteins, Recombinant Glycosylated Proteins); By Production Technology (Mammalian Cell Expression Systems, Non-Mammalian [Microbial] Expression Systems); By Application (Oncology, Blood Disorders, Growth Hormonal Deficiency, Chronic and Autoimmune Disorders, Rheumatoid Arthritis, Others); By Service Type (Process Development, Upstream Processing, Downstream Processing, Analytical and Bioassay Testing, Fill and Finish Operations); By End User (Biopharmaceutical Companies, Contract Manufacturing Organizations [CMOs], Others); By Geography, Segment Revenue Estimation, Forecast, 2024–2032.

Biosimilar Contract Manufacturing Market: Unveiling Growth Potential and Size

The biosimilar contract manufacturing market was valued at approximately $6.6 billion in 2023 and is expected to grow at a CAGR of 8.5% from 2024-2030, reaching an estimated size of $11.7 billion by 2030. The growth is fueled by increasing biosimilar approvals, expanding healthcare access in emerging markets, and pharmaceutical companies outsourcing complex manufacturing processes to CMOs with advanced bioproduction technologies.

 

The biosimilar contract manufacturing market focuses on outsourcing the production of biosimilars, biological products highly similar to existing reference biologics. Biosimilars offer cost-effective alternatives to expensive biologics, and their demand has surged globally, driving the need for contract manufacturing organizations (CMOs).

 

Biosimilar Contract Manufacturing Market Dynamics: The Forces Shaping the Industry

Biosimilar Contract Manufacturing Market Drivers: Fueling the Biosimilar Boom

Increasing Demand for Cost-Effective Biologics: Rising healthcare costs and the need for affordable alternatives to biologic drugs drive demand for biosimilars, boosting contract manufacturing opportunities. According to the Association for Accessible Medicines, biosimilars are expected to save the U.S. healthcare system approximately $133 billion by 2025. Launching biosimilar adalimumab (Humira) has significantly reduced treatment costs for autoimmune diseases, increasing biosimilar adoption.

 

Patent Expirations of Blockbuster Biologics: The expiration of patents for major biologic drugs creates a substantial opportunity for biosimilar development and manufacturing. Patents for biologics worth over $70 billion are expected to expire by 2030, paving the way for biosimilar competition. The expiration of Herceptin’s (trastuzumab) patent has led to a surge in biosimilar manufacturing agreements.

 

Biosimilar Contract Manufacturing Market Opportunities: Unlocking Emerging Possibilities

Expansion in Emerging Markets: Growing healthcare infrastructure and government support for biosimilars in Asia-Pacific and Latin America present lucrative opportunities. The Asia-Pacific biosimilars market is expected to grow at a CAGR of over 10%, driven by low-cost manufacturing capabilities.

 

Adoption of Single-Use Bioprocessing Technologies: Innovations such as single-use bioreactors and disposable systems enhance flexibility, reduce costs, and shorten production cycles. Sartorius AG and Thermo Fisher Scientific are advancing single-use bioprocessing solutions widely adopted by CMOs to meet growing demand.

 

Biosimilar Contract Manufacturing Market Challenges: Navigating Complexities in Biologics

Complexity of Biosimilar Manufacturing: Biosimilar manufacturing is more complex than that of small-molecule drugs, requiring significant investment in infrastructure, technology, and expertise. Unlike generics, biosimilars require extensive clinical trials and process development, which increases manufacturing timelines and costs.

 

Regulatory Challenges and Variability: Stringent regulatory requirements and differences in biosimilar approval pathways across regions can hinder market growth. Regulatory compliance can account for up to 40% of the total cost of biosimilar development. The varying approval pathways between the FDA (U.S.) and EMA (Europe) complicate global market entry for biosimilar manufacturers.

 

 

Biosimilar Contract Manufacturing Market Segmentation: Mapping the Key Component

By Product Type

• Recombinant Non-Glycosylated Proteins

• Recombinant Glycosylated Proteins

 

By Production Technology

• Mammalian Cell Expression Systems

• Non-Mammalian (Microbial) Expression Systems

 

By Application

• Oncology

• Blood Disorders

• Growth Hormonal Deficiency

• Chronic and Autoimmune Disorders

• Rheumatoid Arthritis

• Others

 

By Service Type

• Process Development

• Upstream Processing

• Downstream Processing

• Analytical and Bioassay Testing

• Fill and Finish Operations

 

By End User

• Biopharmaceutical Companies

• Contract Manufacturing Organizations (CMOs)

• Others

 

By Region

• North America

• Europe

• Asia-Pacific

• Latin America

• Middle East and Africa

 

Biosimilar Contract Manufacturing Market Segment Analysis: Spotlight on Leading Segments

Leading Segment: By Product Type

Recombinant non-glycosylated proteins, such as insulin and growth hormones, dominate the market with 51% market share due to their simpler structure and manufacturing processes. This helps in easier replication and production which makes them a preferred choice for biosimilar development. Biosimilar versions of insulin, like Basaglar have gained significant market share by offering cost-effective alternatives for diabetes management.

 

Leading Segment: By Production Technology

Mammalian cell expression systems are preferred for producing complex glycosylated proteins, such as monoclonal antibodies, due to their ability to perform post-translational modifications.This technology ensures the biosimilars closely mimic the reference biologics in structure and function. Samsung Biologics uses mammalian cell lines in their contract manufacturing services for producing biosimilars like trastuzumab, which ensures high fidelity to the original biologic.

 

Leading Segment: By Application

The oncology segment leads the market, driven by the high prevalence of cancer. Biosimilars in oncology provide more affordable treatment options along with increasing patient accessibility & reducing healthcare expenditures. Biosimilars of Rituximab & Bevacizumab have been developed to treat various cancers, offering cost savings and expanding patient access to essential therapies.

 

Leading Regions:

North America is expected to hold a significant share of the biosimilar contract manufacturing market. The presence of a well-established pharmaceutical industry and supportive regulatory frameworks contribute to the region's leading position in the market. The U.S. FDA's approval of multiple biosimilars has facilitated their integration into the healthcare system which promotes market growth.

 

Biosimilar Contract Manufacturing Market Key Players: Leaders Driving Innovation in Biosimilars

• Samsung Biologics

• Lonza Group

• Boehringer Ingelheim

• WuXi Biologics

• Fujifilm Diosynth Biotechnologies

• Catalent, Inc.

• Thermo Fisher Scientific

• AbbVie Contract Manufacturing

• Baxter BioPharma Solutions

• Amgen Contract Manufacturing

 

Biosimilar Contract Manufacturing Market Report Coverage

Report Attribute	Details
Forecast Period	2023 – 2030
Market Size Value in 2023	USD 6.6 Billion
Revenue Forecast in 2030	USD 11.7 Billion
Overall Growth Rate	CAGR of 8.5%
Base Year for Estimation	2022
Historical Data	2017 – 2021
Unit	USD Million, CAGR (2023 – 2030)
Segmentation	By Product Type, By Production Technology, By Application, By Service Type, By End User, By Region
By Product Type	Recombinant Non-Glycosylated Proteins, Recombinant Glycosylated Proteins
By Production Technology	Mammalian Cell Expression Systems, Non-Mammalian (Microbial) Expression Systems
By Application	Oncology, Blood Disorders, Growth Hormonal Deficiency, Chronic and Autoimmune Disorders, Rheumatoid Arthritis, Others
By Service Type	Process Development, Upstream Processing, Downstream Processing, Analytical and Bioassay Testing, Fill and Finish Operations
By End User	Biopharmaceutical Companies, Contract Manufacturing Organizations (CMOs), Others
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	US, Canada, UK, Germany, France, China, Japan, India, etc.
Pricing and Purchase Options	Customized options available

 

Future Outlook

The biosimilar contract manufacturing market is poised for substantial growth due to the increasing adoption of biosimilars, rising patent expirations, and the expanding focus on cost-effective healthcare solutions. Emerging markets in APAC & Latin America are expected to witness fastest growth driven by increasing healthcare investments, cost advantages, and supportive government policies. The market is expected to thrive through strategic partnerships, technological innovation, and global expansion. The growing pipeline of biosimilars and the need for specialized manufacturing expertise ensure a promising future for this market.