Biosimilar Contract Manufacturing Market Size, Share & Trends Analysis Report By Production Technology (Mammalian, Non-mammalian), By Application (Oncology, Blood Disorders, Chronic & Autoimmune Disorders), By Product, By Region, And Segment Forecasts, 2024 - 2030

Market Size & Trends

The global biosimilar contract manufacturing market size was valued at USD 8.59 billion in 2023 and is expected to grow at a CAGR of 15.9% from 2024 to 2030. The rising prevalence of chronic diseases such as cancer, autoimmune disorders, and diabetes has fueled the demand for biologic therapies, including biosimilars. These medications offer comparable effectiveness to their reference biologics and are cheaper, making them more accessible to patients worldwide. As governments and healthcare systems seek to manage escalating healthcare expenditures, biosimilars present a cost-effective alternative to expensive biologics, driving their adoption.

Another critical factor contributing to the demand for biosimilar contract manufacturing is the advancement in biotechnological capabilities. Innovations in manufacturing processes, such as cell line development, purification technologies, and analytical methods, have enhanced the scalability and quality of biosimilar production. Contract manufacturing organizations (CMOs) with advanced facilities and expertise can meet stringent regulatory requirements for biosimilars, ensuring consistent product quality and compliance with global standards.

Furthermore, partnerships between biopharmaceutical companies and CMOs have become increasingly common, driven by the need for specialized manufacturing capabilities and operational flexibility. These collaborations allow companies to focus on core competencies such as research and commercialization while outsourcing manufacturing to specialized CMOs. Such arrangements enable manufacturers to optimize resource allocation, mitigate risks, and accelerate market entry for biosimilars, meeting the growing demand from healthcare providers and patients worldwide.

Product Insights

The recombinant non-glycosylated proteins segment held the largest market revenue share of 54.5% in 2023. The increasing demand is attributed to their simplicity in production and broad therapeutic applications. These proteins, such as insulin and interferon, do not require complex post-translational modifications like glycosylation, making them easier and more cost-effective to produce. This efficiency is useful to biosimilar manufacturers aiming to reduce production costs while ensuring high-quality output. Additionally, the growing prevalence of chronic diseases and the need for affordable therapeutic options drive the demand for biosimilars, further boosting the segment for non-glycosylated proteins.

The recombinant glycosylated proteins segment is projected to grow at the fastest CAGR over the forecast period. The rising need for complex biologics that mimic the structure and function of natural proteins drives segment growth. Glycosylation, a critical post-translational modification, significantly influences these proteins' stability, efficacy, and immunogenicity. Manufacturers are turning to contract manufacturing organizations (CMOs) with specialized expertise in this area as more biologics, especially monoclonal antibodies and hormones, require precise glycosylation patterns to function effectively. Additionally, the growing prevalence of chronic diseases and the push for cost-effective treatments drive the demand for biosimilars, further boosting the need for recombinant glycosylated proteins in this segment.

Production Technology Insights

The mammalian segment held the largest market revenue share in 2023. The demand is increasing due to its ability to produce complex biologics, such as monoclonal antibodies, closely mimicking human proteins. Mammalian cell lines, such as Chinese hamster ovary (CHO) cells, are preferred for biosimilar production because they offer higher compatibility with human systems, leading to better therapeutic outcomes. Additionally, advancements in mammalian cell culture technologies have improved yields and reduced production costs, making this method more attractive for biosimilar manufacturers.

The non-mammalian segment is projected to grow significantly in the coming years. The increasing demand is attributed to its cost-effectiveness and efficiency. Non-mammalian systems, such as yeast and bacteria, offer faster production times and reduced costs than mammalian systems, which are more complex and expensive to maintain. Additionally, non-mammalian systems can produce high-quality biosimilars and are easier to scale up, making them beneficial for contract manufacturers aiming to meet the growing demand for biosimilars globally. The increasing regulatory approval of biosimilars produced in non-mammalian systems further boosts this demand as companies seek to balance quality with affordability in the competitive biosimilar market.

Application Insights

The chronic and autoimmune disorders segment held the largest market revenue share in 2023.  The rising prevalence of chronic and autoimmune disorders globally drives segment growth. Chronic and autoimmune disorders, such as rheumatoid arthritis, psoriasis, and Crohn's disease, require long-term treatment, often involving biologics, which can be costly. Biosimilars offer a more affordable alternative to branded biologics while maintaining efficacy and safety, making them a preferred choice for healthcare providers and patients. Additionally, the growing regulatory approvals for biosimilars and increasing pressure to reduce healthcare costs further drive the demand for contract manufacturing services to meet the rising production needs of biosimilars in this segment.

The oncology segment is expected to grow at the fastest CAGR over the forecast period. The demand is increasing primarily due to the rising incidence of cancer globally and the growing need for cost-effective treatment options. Biosimilars, highly similar to biologic drugs but offered at a lower cost, provide a suitable alternative for treating cancer, particularly as the patents for several blockbuster oncology biologics expire. Additionally, the increasing focus on reducing healthcare costs and expanding access to cancer therapies has led to higher adoption of biosimilars in oncology.

Regional Insights

North America biosimilar contract manufacturing market is projected to grow significantly in the coming years. The rising adoption of biosimilars due to their cost-effectiveness compared to branded biologics makes them a preferred option for healthcare providers and patients. Additionally, the U.S. has seen many biosimilars receiving FDA approval, leading to increased production requirements. Pharmaceutical companies outsource manufacturing to specialized contract manufacturers to meet these demands efficiently while focusing on their core competencies. The aging population and the rising prevalence of chronic diseases in North America also contribute to the demand for affordable biosimilar treatments, further fueling the need for contract manufacturing services.

U.S. Biosimilar Contract Manufacturing Market Trends

The U.S. biosimilar contract manufacturing market is expected to grow significantly in coming years. The U.S. government's push for reducing healthcare costs, including introducing policies that encourage the use of biosimilars, has spurred demand. The U.S. market's growing acceptance of biosimilars, alongside the significant number of biologic patents expiring, has led pharmaceutical companies to outsource production to contract manufacturers. This approach allows companies to scale production efficiently and focus on core competencies such as research and development.

Europe Biosimilar Contract Manufacturing Market Trends

Europe biosimilar contract manufacturing market held the largest revenue share of 46.3% in 2023. The region's supportive regulatory environment, growing acceptance of biosimilars among healthcare providers, and the need to reduce healthcare costs drive the market. European countries, facing rising healthcare expenditures, are increasingly turning to biosimilars as a cost-effective alternative to expensive biologics. Additionally, the European Medicines Agency (EMA) has established clear guidelines for biosimilar approval, encouraging pharmaceutical companies to invest in biosimilar production.

Germany biosimilar contract manufacturing market was witnessed as lucrative in this market. The country's robust healthcare system supports the adoption of cost-effective alternatives such as biosimilars. Germany has one of Europe's highest per capita healthcare expenditures, and the government is keen on reducing healthcare costs without compromising quality. Furthermore, Germany's strong biopharmaceutical industry infrastructure and favorable regulatory pathways encourage local and international companies to partner with contract manufacturers to meet the growing demand for biosimilars.

Asia Pacific Biosimilar Contract Manufacturing Market Trends

The Asia Pacific biosimilar contract manufacturing market is expected to grow at the fastest CAGR over the forecast period. The increasing prevalence of chronic diseases such as cancer and diabetes, which boosts the need for affordable biologic treatments, drives the demand. Additionally, governments in countries such as India, China, and South Korea promote biosimilars through favorable regulatory frameworks and incentives, making it easier for local companies to enter the market. The region also benefits from a cost advantage, with lower production and labor costs than Western markets, drawing global pharmaceutical companies to outsource their biosimilar production to Asia-Pacific contract manufacturers.

India biosimilar contract manufacturing market is anticipated to grow significantly over the forecast period. India is a significant global pharmaceutical industry player driven by its cost-effective manufacturing capabilities, skilled workforce, and regulatory advancements. The country offers substantial cost savings compared to Western countries, which highly benefits global pharmaceutical companies looking to outsource biosimilar production. Additionally, India's increasing focus on biopharmaceutical innovation and well-established manufacturing infrastructure make it a favorable location for contract manufacturing.

Key Biosimilar Contract Manufacturing Company Insights

Some key companies in the biosimilar contract manufacturing markets are Samsung Biologics; Biocon; Amgen; Pfizer; Almac Group; Almac Group; and Wuxi Biologics; and others.

• Boehringer Ingelheim Biopharmaceuticals GmbH offers comprehensive contract manufacturing services for biosimilars through its BioXcellence unit. They provide end-to-end solutions, including developing and manufacturing biologics such as monoclonal antibodies and recombinant proteins. Boehringer Ingelheim supports the production of biosimilars from DNA to fill and finish, leveraging advanced technologies and a global network of manufacturing facilities. Their expertise spans mammalian cell cultures and microbial & yeast fermentations, ensuring high-quality and efficient production processes

• Biocon Biologics offers comprehensive contract manufacturing services for biosimilars, leveraging advanced technologies and state-of-the-art facilities in Bengaluru, India, and Johor, Malaysia. Their capabilities include large-scale microbial fermentation, mammalian cell culture, and aseptic formulation, ensuring compliance with global regulatory standards. With specialized facilities for monoclonal antibodies and insulins, Biocon’s infrastructure supports a diverse portfolio addressing therapeutic areas like diabetes, oncology, and immunology.

Recent Developments

• In May 2024, Boehringer Ingelheim Biopharmaceuticals GmbH announced an agreement with Quallent Pharmaceuticals. This collaboration is expected to enhance the availability of Boehringer Ingelheim's biosimilar products through Qallent's network and expertise. The agreement is part of Boehringer Ingelheim's broader strategy to improve healthcare affordability and increase patient access to high-quality biosimilars.

• In June 2023, Samsung Biologics announced a long-term partnership with Pfizer to manufacture Pfizer's biosimilar portfolio. This partnership aims to expand Pfizer's global reach in the biosimilars market by leveraging Samsung Biologics' manufacturing capabilities. The deal highlights both companies' commitment to increasing access to affordable biological medicines worldwide.

Biosimilar Contract Manufacturing Market Report Scope

Global COVID-19 Vaccine Packaging And Delivery Devices Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global biosimilar contract manufacturing market report based on product, production technology, application, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Recombinant Non-glycosylated Proteins

  • Recombinant Glycosylated Proteins

• Production Technology Outlook (Revenue, USD Million, 2018 - 2030)

  • Mammalian

  • Non-mammalian

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncology

  • Blood Disorders

  • Growth Hormonal Deficiency

  • Chronic & Autoimmune Disorders

  • Rheumatoid Arthritis

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America 

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait