Biologics Contract Development and Manufacturing Organization Market - Forecast(2024 - 2030)

Overview

The Global Biologics Contract Development and Manufacturing Organization (CDMO) market size is forecast to reach USD 33.5 billion by 2028, after growing at a CAGR of 12.89% during 2024-2028. The Global Biologics Contract Development and Manufacturing Organization (CDMO) market is integral to the biopharmaceutical industry, providing essential services that support the development and manufacturing of biologic drugs. These organizations offer expertise in areas such as cell line development, process optimization, and large-scale manufacturing, which are critical for bringing biologic therapies from conception to market. Biologics CDMOs enable pharmaceutical companies to reduce costs, accelerate time-to-market, and navigate complex regulatory landscapes. 
Lonza, a leading CDMO, partnered with Moderna to manufacture the mRNA COVID-19 vaccine. This collaboration significantly scaled up the production of the vaccine, demonstrating Lonza's capability to handle large-scale, rapid production of complex biologics. Samsung Biologics announced a substantial investment to build its fourth and largest biomanufacturing plant in South Korea. The new facility is expected to significantly increase Samsung Biologics' manufacturing capacity, making it one of the largest CDMO facilities globally. WuXi Biologics acquired a drug substance manufacturing facility from Bayer in Germany. The facility enhances WuXi Biologics' global manufacturing network, allowing it to offer end-to-end solutions to its clients.

Report Coverage
The report “Global Biologics Contract Development and Manufacturing Organization (CDMO) Market– Forecast (2024-2028)”, by IndustryARC, covers an in-depth analysis of the following segments of the Global Biologics Contract Development and Manufacturing Organization (CDMO) market.
By Type: Mammalian, Microbial
By Product Type: Biologics, Biosimilars
By Geography:  North America, South America, Europe, Asia-Pacific

Key Takeaways

• AGC Biologics expanded its capabilities in cell and gene therapy by partnering with Novartis to manufacture the CAR-T cell therapy Kymriah. The growing focus on cell and gene therapy highlights the segment’s importance within the biologics CDMO market, driven by breakthroughs in personalized medicine and targeted treatments.
• WuXi Biologics has been rapidly expanding its manufacturing facilities across China, including the opening of a large-scale biologics production facility in Shanghai. China’s aggressive expansion in the biologics CDMO sector exemplifies how the country is becoming a major hub for biologics manufacturing, driven by favorable government policies, investment incentives, and a growing domestic biopharmaceutical industry.
• Fujifilm Diosynth Biotechnologies announced a significant investment to expand its biologics manufacturing capabilities in Denmark, including the construction of a new state-of-the-art facility. Europe’s continued investment in cutting-edge biologics manufacturing infrastructure highlights the region’s strategic importance in the global biologics CDMO market, supported by a strong regulatory framework and skilled workforce

By Type - Segment Analysis
Mammalian dominated the Global Biologics Contract Development and Manufacturing Organization (CDMO) market in 2023. The mammalian biologics CDMO market is experiencing significant growth driven by the rising demand for complex biologic drugs, such as monoclonal antibodies, vaccines, and cell therapies. Mammalian cell cultures are preferred for their ability to produce proteins with human-like post-translational modifications, essential for the efficacy and safety of these biologics. Lonza has entered a long-term partnership with AstraZeneca to manufacture its monoclonal antibody products. This collaboration helps AstraZeneca meet the growing demand for its mAb therapies, particularly for oncology and autoimmune diseases. The increasing prevalence of chronic diseases and the effectiveness of mAbs in treatment are driving this demand, pushing CDMOs to expand their mammalian cell culture capabilities. 
Sartorius Stedim Biotech has expanded its single-use bioreactor production facilities to meet the rising demand for disposable bioprocessing technologies. Single-use technologies offer flexibility, reduce cross-contamination risks, and lower operational costs, making them ideal for the production of various biologics. The adoption of single-use systems in mammalian cell culture is growing, driven by the need for more efficient and scalable manufacturing solutions. Catalent has acquired a biologics manufacturing facility from Bristol-Myers Squibb in Massachusetts. This acquisition expanded Catalent’s capabilities in mammalian cell culture and increased its production capacity for biologics. CDMOs are increasingly engaging in mergers, acquisitions, and strategic collaborations to enhance their mammalian cell culture capabilities and expand their market presence.

By Product Type - Segment Analysis
Biologics dominated the Global Biologics Contract Development and Manufacturing Organization (CDMO) market in 2023 The mammalian biologics CDMO market is experiencing substantial growth, driven by increasing demand for complex biologic drugs, advancements in bioprocessing technologies, and strategic investments in manufacturing capabilities. Mammalian cell cultures are favored for their ability to produce proteins with human-like post-translational modifications, essential for the efficacy and safety of biologics. Bluebird Bio partnered with Brammer Bio (a part of Thermo Fisher Scientific) to enhance the production of its gene and cell therapies. This partnership bolstered Bluebird Bio's capacity to produce therapies for rare genetic diseases, reflecting the expanding market for gene and cell therapies. The rise of personalized medicine and advanced therapies is driving the growth of the mammalian biologics segment, with CDMOs investing in specialized capabilities to meet these demands.
Abzena implemented continuous bioprocessing technologies in its facilities to enhance production efficiency. This innovation allowed Abzena to improve product consistency, reduce costs, and increase scalability. Continuous bioprocessing is becoming a key trend in the mammalian biologics CDMO market, offering significant advantages over traditional batch processing methods. Fujifilm Diosynth Biotechnologies announced the expansion of its facilities in Texas, USA, to include additional mammalian cell culture production capabilities. This expansion strengthens Fujifilm's position in North America, meeting the growing demand for biologics in the region. Regional expansions, particularly in North America and Europe, are critical for CDMOs to leverage local expertise, regulatory environments, and market access.

By Geography - Segment Analysis
North America dominated the dominated the Global Biologics Contract Development and Manufacturing Organization (CDMO) market in 2023. Aging population, increased prevalence of chronic diseases, and focus on personalized medicine are driving the need for more complex and targeted treatments, often in the form of biologics (e.g., antibodies, vaccines). Amgen, a major North American biopharmaceutical company, recently announced a significant expansion of its biologics manufacturing capacity to meet growing demand for its oncology drugs. Biologics are often more effective for complex diseases and offer longer-lasting effects compared to traditional small molecule drugs. Merck, another major North American pharmaceutical company, has been actively acquiring smaller biotech companies specializing in biologics development, demonstrating their strategic shift. Pharmaceutical companies are increasingly outsourcing development and manufacturing to CDMOs to reduce costs, leverage expertise, and focus on core competencies. Eli Lilly, a large American pharmaceutical company, recently signed a multi-year deal with a North American CDMO (Lonza) for the development and manufacturing of a new antibody drug

Drivers – Global Biologics Contract Development and Manufacturing Organization (CDMO) Market

•    Surge in Biopharmaceutical Pipeline and Venture Capital Funding
Rising investments in biopharmaceutical research and development (R&D) are leading to a robust pipeline of new biologics. Venture capital firms are also actively funding promising biotech startups developing novel drugs, creating a demand for CDMO expertise. A recent industry report highlights a record high of over $100 billion invested globally in biopharmaceutical R&D in 2023, with a significant portion flowing to North America and Europe. Additionally, a major biotech startup in the US just secured a $200 million Series C funding round to advance its gene therapy candidate, requiring a CDMO partner for future manufacturing

•    Geopolitical Tensions and Supply Chain Concerns  
Recent global events have exposed vulnerabilities in pharmaceutical supply chains, particularly with reliance on specific regions for certain raw materials or manufacturing capabilities. Companies are looking to diversify their CDMO partnerships and potentially bring some production closer to home (North America or Europe) for better control and security. A major pharmaceutical company recently announced plans to build a new biologics manufacturing facility in North America, citing the need for greater supply chain resilience in the wake of global disruptions. Additionally, several North American CDMOs are expanding their capacity to meet the anticipated demand for domestic biologics production.

Challenges – Global Biologics Contract Development and Manufacturing Organization (CDMO) Market
 

•    Workforce Shortages and Talent Acquisition
The rapid growth of the biologics market has created a significant demand for skilled professionals like scientists, engineers, and regulatory specialists. Filling these positions is proving difficult due to limited talent pool and specialized skillsets required. A recent industry survey revealed that over 70% of North American CDMOs are facing challenges in hiring qualified personnel for their biologics manufacturing facilities. This can lead to delays in project timelines and impact overall capacity.

•    Meeting Stringent Regulatory Requirements
Biologics are complex molecules, and their development and manufacturing are subject to strict regulatory oversight by agencies like the FDA. Navigating complex regulations and ensuring compliance can be time-consuming and expensive. A recent FDA inspection at a major CDMO facility resulted in a warning letter due to deviations from good manufacturing practices (GMP). This highlights the challenges CDMOs face in maintaining compliance with ever-evolving regulations.

Market Landscape
Technology launches, acquisitions, and R&D activities are key strategies adopted by players in the Global Biologics Contract Development and Manufacturing Organization (CDMO) market. In 2023, the Global Biologics Contract Development and Manufacturing Organization (CDMO) market share has been consolidated by the major players accounting for 88.71% of the share. Major players in the Global Biologics Contract Development and Manufacturing Organization (CDMO) market are Lonza Group Ltd., WuXi Biologics Cayman Inc., Samsung Biologics, Catalent Inc., FUJIFILM Corp., Siegfried, Thermo Fisher Scientific, Boehringer Ingelheim International GmbH, MilliporeSigma, Recipharm, Evonik Industries AG, and Grifols SA among others.

Developments:

• April 20, 2022, As a fully owned subsidiary, Samsung Bioepis has now been completely bought by Samsung Biologics. The first payment was funded by capital that was paid in advance. Future R&D for innovative therapies and biosimilars is anticipated to grow at a rapid pace.
• April 27, 2023, German R&D facility worth $386 million has been inaugurated by Boehringer Ingelheim. The BDC will produce materials for research studies as well as medicinal proteins and antibodies.
• March 28, 2024, Samsung Biologics declared that it and LegoChem have forged a cooperation and as per the agreement, Samsung Biologics will supply drug ingredient manufacturing and antibody development services to support LegoChem Biosciences' ADC program.

For more Lifesciences and Healthcare Market reports, please click here