The global biologics contract development and manufacturing organization market size was estimated at USD 19.22 billion in 2024 and is projected to reach USD 42.32 billion by 2033, growing at a CAGR of 9.21% from 2025 to 2033. This steady expansion is primarily attributed to the rising prevalence of chronic and rare diseases worldwide, which has significantly increased the demand for advanced therapeutic solutions. Additionally, the rapidly aging global population is contributing to higher healthcare needs, particularly for complex treatments that biologics are well-suited to address. The growing preference for highly targeted therapies, including monoclonal antibodies, cell and gene therapies, and personalized medicines, is further accelerating the adoption of biologics, thereby strengthening the demand for specialized development and manufacturing support services.

Moreover, as the need for biologics continues to expand, the pharmaceutical and biopharmaceutical industry is witnessing a notable increase in the number of companies choosing CDMO services to streamline operations and reduce infrastructure costs. Outsourcing development and manufacturing activities enables companies to focus on core competencies such as research, innovation, and commercialization while leveraging the technical expertise and scalable production capabilities offered by CDMOs. At the same time, growing investments in biologics are fostering increased venture capital activity, strategic collaborations, mergers, and acquisitions, all of which are contributing to growth across the entire value chain.

Many pharmaceutical and biopharmaceutical companies are increasingly forming partnerships with CDMO service providers to expand manufacturing capacity, accelerate time-to-market, and gain access to specialized technologies such as advanced biologics processing, high-efficiency bioreactors, and integrated development platforms. In parallel, private equity firms and institutional investors are channeling substantial funds into platform companies that demonstrate innovative operational models and strong scalability potential. Large pharmaceutical companies are also actively pursuing acquisitions to strengthen their biologics pipelines, diversify therapeutic portfolios, and secure access to advanced manufacturing capabilities that support next-generation therapies.

Collectively, these capital investments, technological advancements, and strategic initiatives are accelerating the commercialization of biologic products while reshaping the competitive landscape of the industry. As collaboration, innovation, and investment activity continue to intensify, these factors are expected to play a crucial role in driving sustained market growth in the coming years.

Key Market Trends & Insights:

• The North America biologics contract development and manufacturing organization (CDMO) market held the largest share of 43.41% of the global market in 2024, reflecting the region’s strong biopharmaceutical ecosystem and advanced healthcare infrastructure. This dominant position can be attributed to the presence of leading biotechnology and pharmaceutical companies, well-established research and development capabilities, and a highly supportive regulatory environment that encourages innovation and commercialization of biologics. In addition, substantial investments in biologics research, increasing clinical trial activities, and the availability of advanced manufacturing technologies have strengthened the region’s leadership in outsourced development and production services. The growing adoption of complex biologic therapies and continuous expansion of manufacturing facilities further support North America’s significant contribution to overall market revenue.

• The biologics contract development and manufacturing organization (CDMO) sector in the U.S. is expected to grow significantly over the forecast period, driven by increasing demand for biologics, biosimilars, and next-generation therapies such as cell and gene therapies. The country benefits from strong collaborations between pharmaceutical companies, biotechnology startups, academic institutions, and contract service providers, which collectively accelerate drug development timelines. Furthermore, rising outsourcing trends among pharmaceutical companies seeking cost efficiency, operational flexibility, and access to specialized expertise are expected to boost the growth of CDMO services in the U.S. Continuous investments in advanced bioprocessing technologies and expansion of large-scale manufacturing capabilities are also contributing to sustained growth prospects.

• Based on product, the monoclonal antibodies (mAbs) segment held the largest market share in 2024, primarily due to their widespread application in treating chronic diseases such as cancer, autoimmune disorders, and inflammatory conditions. Monoclonal antibodies offer high specificity and targeted therapeutic action, which improves treatment outcomes while minimizing side effects. The increasing number of approved antibody-based therapies, along with a strong pipeline of biologics under development, has significantly increased the demand for specialized development and manufacturing services tailored to mAbs production. Continuous technological advancements in antibody engineering and large-scale biomanufacturing processes are further supporting the dominance of this segment.

• Based on service, the contract manufacturing segment held the largest market share in 2024, as pharmaceutical and biopharmaceutical companies increasingly outsource large-scale production to specialized CDMOs. Contract manufacturing provides cost advantages, scalability, regulatory compliance support, and access to advanced manufacturing infrastructure without requiring significant capital investment from drug developers. As biologics production involves complex processes and stringent quality standards, companies rely on experienced CDMOs to ensure efficient manufacturing, consistent product quality, and faster commercialization timelines, thereby driving the segment’s strong market position.

• Based on source, the microbial segment held the largest market share in 2024, supported by its efficiency, scalability, and cost-effectiveness in biologics production. Microbial expression systems, such as bacteria and yeast, are widely used for producing recombinant proteins and certain biologic products due to their rapid growth rates and relatively simpler manufacturing requirements compared to mammalian systems. These systems enable high-yield production and shorter development cycles, making them a preferred choice for many biologics developers. Ongoing improvements in microbial engineering and fermentation technologies continue to enhance productivity and process optimization, reinforcing the segment’s leading share in the market.

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Market Size & Forecast:

• 2024 Market Size: USD 19.22 Billion

• 2033 Projected Market Size: USD 42.32 Billion

• CAGR (2025-2033): 9.21%

• North America: Largest market in 2024

• Asia Pacific: Fastest growing market

Key Companies & Market Share Insights:

The key players operating across the market are increasingly adopting a wide range of strategic initiatives, including service launches, mergers and acquisitions, partnerships and agreements, as well as geographic and operational expansions, to strengthen their competitive positioning and enhance long-term growth opportunities. These strategies enable companies to broaden their service portfolios, improve technological capabilities, and respond more effectively to the evolving needs of biopharmaceutical clients. By expanding their offerings and forming strategic collaborations, market participants are able to accelerate innovation, optimize manufacturing efficiency, and provide end-to-end solutions that support biologics development from early-stage research through commercial-scale production. Such initiatives also help organizations expand their global footprint, access new customer segments, and reinforce supply chain resilience in an increasingly competitive and innovation-driven environment.

For instance, in April 2025, AGC Biologics introduced a new division dedicated specifically to cell and gene therapies, reflecting the growing industry focus on advanced therapeutic modalities. The newly established cell and gene technologies division is designed to strengthen the company’s existing development and manufacturing capabilities while addressing the rising demand for specialized services in this rapidly advancing field. Through this initiative, the company aims to provide therapy developers with expanded production capacity, advanced scientific and technical expertise, and access to highly qualified CDMO services tailored for complex cell and gene therapy manufacturing processes.

This strategic expansion not only enhances operational flexibility but also supports innovators seeking reliable partners capable of managing sophisticated biologics workflows, regulatory requirements, and scalable production needs. By investing in advanced therapy platforms and specialized infrastructure, companies are positioning themselves to meet future demand while accelerating the commercialization of next-generation treatments. Overall, such strategic innovations and capability enhancements are expected to play a crucial role in strengthening competitive differentiation and driving sustained growth across the market in the coming years.

Key Players

• Lonza Group

• Catalent Pharma Solutions

• Samsung Biologics

• WuXi Biologics / WuXi AppTec

• Thermo Fisher Scientific

• Fujifilm Diosynth Biotechnologies

• Boehringer Ingelheim (Biopharma CDMO)

• Rentschler Biopharma SE

• AGC Biologics

• Charles River Laboratories

• Siegfried Holding

• Sandoz

• GenScript Biologics

• Vetter Pharma

• IDT Biologika

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Conclusion:

The biologics contract development and manufacturing organization (CDMO) industry is experiencing strong momentum driven by the increasing demand for biologics, rising adoption of outsourcing strategies by pharmaceutical and biopharmaceutical companies, and continuous advancements in bioprocessing technologies. Growing innovation in targeted therapies, expanding biologics pipelines, and the need for specialized manufacturing capabilities are strengthening the role of CDMOs as essential partners across the drug development lifecycle. Additionally, strategic collaborations, service expansion, and regional growth initiatives are reshaping the competitive landscape, positioning CDMOs to support faster commercialization and improved operational efficiency in the evolving biologics ecosystem.