| Study Period | 2019 - 2030 |
| Market Size (2025) | USD 25.62 Billion |
| Market Size (2030) | USD 44.51 Billion |
| CAGR (2025 - 2030) | 11.68 % |
| Fastest Growing Market | North America |
| Largest Market | Asia Pacific |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Large Molecule Contract Development And Manufacturing Organization Market Analysis
The Large Molecule Contract Development And Manufacturing Organization Market size is estimated at USD 25.62 billion in 2025, and is expected to reach USD 44.51 billion by 2030, at a CAGR of 11.68% during the forecast period (2025-2030).
The large molecules contract development and manufacturing organization (CDMO) market is experiencing substantial growth, driven by the increasing demand for biologics and biosimilars. Large molecules, also known as biologics, are complex compounds derived from living organisms, including monoclonal antibodies, recombinant proteins, and vaccines. Their proven therapeutic efficacy in managing chronic diseases has accelerated their adoption. CDMOs play a critical role in scaling production, ensuring regulatory compliance, and offering end-to-end solutions. This growing reliance on CDMOs underscores their importance in the market's expansion.
Biologics are becoming essential in treating a wide range of diseases, such as cancer, autoimmune disorders, and rare genetic conditions. As regulatory approvals for large molecule therapies increase, the need for specialized manufacturing services provided by CDMOs is expected to rise. For example, the FDA approved 17 biologics in 2023 and 13 in 2022. Additionally, as of July 15, 2024, the FDA approved 22 new molecular entities (NMEs) and therapeutic biologics, marking significant progress in addressing diseases like melanoma. This trend highlights the growing demand for CDMO services, which is anticipated to drive market growth during the forecast period.
Pharmaceutical companies are intensifying their research and development (R&D) efforts in biologics, fueled by advancements in biotechnology and a deeper understanding of disease mechanisms. Emerging modalities, such as antibody-drug conjugates (ADCs), gene therapies, and mRNA vaccines, have expanded the scope of large molecules. As of November 2024, ClinicalTrials.gov reported approximately 3,219 biologic drugs in development globally. This surge in R&D activities is expected to create significant opportunities for CDMOs, further strengthening their position in the market.
The rising prevalence of chronic conditions, including cancer, diabetes, and autoimmune diseases, has driven the demand for biologics. These therapies offer targeted and personalized treatment options with fewer side effects compared to small molecules. For instance, the American Cancer Society's 2024 update estimates approximately 2 million new cancer cases in the United States, equating to around 5,480 new cases daily. CDMOs are instrumental in meeting the high production demands for these therapies, enabling pharmaceutical companies to address the growing disease burden effectively. This trend is likely to sustain the market's growth trajectory.
Furthermore, strategic initiatives by market players, such as expanding service portfolios, mergers, collaborations, and partnerships, are expected to enhance the demand for CDMO services. For example, in March 2024, Alcami Corporation formed a strategic alliance with Tanvex CDMO, a biologics developer offering services from pre-clinical stages to commercial production. This collaboration enables both companies to provide comprehensive solutions, from bulk drug substance production to final drug product manufacturing. Such partnerships are anticipated to strengthen the market's competitive landscape and drive growth.
In conclusion, the increasing approval of large molecules, the growing prevalence of chronic diseases, and strategic activities by market players are expected to propel the large molecule CDMO market during the forecast period. However, challenges such as stringent government regulations and compliance issues with outsourcing may act as potential restraints to market growth.
Large Molecule Contract Development And Manufacturing Organization Market Trends
The Cell Line Development Segment is Expected to Witness a Significant Growth Over the Forecast Period
In the biopharmaceutical industry, cell line development serves as a critical component, particularly for the production of biologics such as monoclonal antibodies, recombinant proteins, and vaccines. Acting as biological production systems, cell lines enable large-scale manufacturing of therapeutic proteins with superior yield and quality. This segment has experienced substantial growth, driven by the increasing demand for biologics, advancements in genetic engineering, and the rising prevalence of chronic diseases. CDMOs specializing in cell line development play a crucial role by providing expertise in developing stable and high-performing cell lines.
Biopharmaceutical companies are increasingly outsourcing cell line development to CDMOs to reduce operational complexities and focus on core activities such as research and development (R&D) and commercialization. This outsourcing trend has encouraged CDMOs to expand their service offerings, providing end-to-end solutions from cell line development to biomanufacturing. For example, in November 2024, Scorpius Holdings, Inc. partnered with Celltheon Corporation to utilize Celltheon's proprietary GOLDILOCKS transposase platform for cell line development services. Additionally, Celltheon offers services such as antibody discovery, variant screening, and comparability studies to Scorpius's clients. Notably, the first client under this collaboration is set to advance to GMP manufacturing with Scorpius.
The growing demand for biologic drugs, driven by the increasing burden of chronic diseases and rising approvals for biologics, is expected to fuel the need for cell line development services, thereby driving segment growth. For instance, the Canadian Cancer Statistics 2023 report highlighted an increase in new cancer cases in Canada, from 233.9 thousand in 2022 to 239.2 thousand in 2023. This rising cancer burden is anticipated to further boost the demand for cell line development services. CDMOs with advanced cell line development platforms enable companies to meet these objectives, accelerating market entry.
Stable and efficient cell lines are essential for the large-scale production of biologics, and companies rely on CDMOs to develop cell lines that meet high productivity and regulatory compliance standards. For instance, Chinese hamster ovary (CHO) cell lines are extensively used in the production of monoclonal antibodies.
Collaborative efforts among companies are expected to further accelerate market growth during the forecast period. For example, in April 2023, Lotte Biologics and Excellence signed a memorandum of understanding to collaborate in the biopharmaceutical contract development organization (CDO) sector. This partnership aims to deliver comprehensive CDMO services, ranging from pharmaceutical cell line development to large-scale contract manufacturing. Similarly, in May 2023, Aronora Inc., a clinical-stage biotechnology company focused on next-generation therapeutics for blood clotting disorders, partnered with Samsung Biologics to enhance its cell line development capabilities.
In conclusion, the increasing complexity of cell line development processes, the operational benefits provided by CDMO services, and strategic collaborations among market players are expected to drive the growth of the cell line development segment. The rising demand for biologics and the need for efficient, regulatory-compliant cell lines further underscore the critical role of CDMOs in meeting industry demands.
Understand The Key Trends Shaping This Market
Download PDF
North America is Expected to Hold a Significant Market Share Over the Forecast Period
The large molecule CDMO market in North America is experiencing significant growth, driven by the increasing demand for biologics and the rising prevalence of chronic diseases. Strategic collaborations between CDMOs and biopharmaceutical companies are enhancing drug development and manufacturing processes, positioning the region as a leader in the global market. This growth is further supported by the presence of established pharmaceutical companies, advanced manufacturing infrastructure, and favorable regulatory frameworks, which collectively strengthen the market's competitive edge.
The expiration of patents for major biologics has created a surge in biosimilar development, presenting substantial opportunities for CDMO services in large molecule production. For example, Stelara, a key drug by Johnson & Johnson, achieved USD 9.7 billion in sales in 2022. With its patent set to expire in 2025, the market is preparing for the introduction of cost-effective biosimilars. North American CDMOs are capitalizing on this trend by offering customized solutions to meet regulatory and market requirements, thereby solidifying their role in the biosimilar development segment and driving market expansion. This development is expected to significantly boost the demand for CDMO services in the region, as biosimilar production requires specialized expertise and infrastructure, areas where CDMOs excel.
Market players are actively broadening their service offerings to address the growing demand for large molecule CDMO services, which is expected to fuel market growth. For instance, in October 2023, Eurofins CDMO Alphora Inc. launched its Biologics initiative, reflecting its strategic focus on diversification and growth within the North American contract development and manufacturing sector. Such initiatives are critical in meeting the evolving needs of the market and ensuring sustained growth in the region. This development highlights the increasing focus of CDMOs on biologics, which is anticipated to drive further investments and innovations in the market, strengthening their role in supporting biopharmaceutical companies.
Strategic partnerships and service expansions are further shaping the competitive dynamics of the market. A notable example is the October 2023 collaboration between Vectron Biosolutions and Cytovance Biologics, aimed at advancing biologics development. This partnership introduces more efficient solutions for E. coli-expressed products, addressing key demands across various drug development indications and contributing to the overall growth of the market. Such collaborations not only enhance the capabilities of CDMOs but also enable them to meet the increasing demand for innovative and cost-effective biologics, thereby driving the market forward in the region.
In summary, the rising prevalence of chronic diseases, coupled with strategic initiatives by market players, is expected to drive significant growth in the North American large molecule CDMO market during the forecast period. These factors collectively position the region as a critical player in the global market landscape.
Get Analysis on Important Geographic Markets
Download PDF
Large Molecule Contract Development And Manufacturing Organization Industry Overview
The large molecule contract development and manufacturing organization market is semi-consolidated in nature, with the presence of many market players. The players operating in the market are adopting various strategies to stay afloat in the market. Product launches, innovations, mergers and acquisitions, and intensive R&D are some of the growth strategies adopted by the players. The key players in the large molecule CDMO market are Thermo Fisher Scientific Inc., Eurofins Scientific, Wuxi Biologics, Samsung Biologics, Catalent, Inc., and others.
Large Molecule Contract Development And Manufacturing Organization Market Leaders
-
Thermo Fisher Scientific Inc
-
Eurofins Scientific
-
Wuxi Biologics
-
Samsung Biologics
-
Catalent, Inc
- *Disclaimer: Major Players sorted in no particular order
Need More Details on Market Players and Competiters?
Download PDF
Large Molecule Contract Development And Manufacturing Organization Market News
- October 2024: Lonza has extended its collaboration with a leading global biopharmaceutical partner, focusing on the commercial-scale manufacture of ADCs. Furthermore, Lonza is set to offer commercial-scale manufacturing services for monoclonal antibodies (mAbs) tied to a new ADC therapy.
- May 2024: ExcellGene SA, a prominent Swiss biotech with over two decades of expertise in mammalian cell line development, has forged a strategic alliance with Cytovance Biologics, a leading Contract Development and Manufacturing Organization (CDMO) in the United States. This collaboration underscores a pivotal advancement in biopharmaceutical development, leveraging ExcellGene’s innovative transposon technologies for the benefit of Cytovance’s biopharma clientele. Given that CHO (Chinese Hamster Ovary) and HEK (Human Embryonic Kidney) cells are optimal for recombinant protein production and biological research, this partnership is poised to make significant strides in the industry.
Large Molecule Contract Development And Manufacturing Organization Industry Segmentation
As per the scope of the report, a contract development and manufacturing organization (CDMO) is a company that provides a comprehensive range of services from drug development to manufacturing. CDMOs provide critical services by incorporating third-party projects and offering their knowledge, development, and manufacturing capabilities. This report focuses only on the outsourcing of development and manufacturing activities related to large molecules.
The large molecule contract development and manufacturing organization market is segmented by service, sources, end user, and geography. By services, the market is segmented into contract development and contract manufacturing. By contract development the market is further segmented as cell line development and process development. By contract manufacturing, the market is further segmented into clinical and commercial. By source, the market is segmented into mammalian, microbial, and other sources. By end user, the market is segmented into pharmaceutical and biotechnology companies and research institutes, and academics. By geography , the market is segmented into North America, Europe, Asia-Pacific, Middle East and Africa, and South America. The report offers values in USD for the abovementioned segments. The report also covers the estimated market sizes and trends for 17 countries across major regions globally.
| By Service | Contract Development | Cell Line Development | |
| Process Development | |||
| Contract Manufacturing | Clinical | ||
| Commercial | |||
| By Sources | Mammalian | ||
| Microbial | |||
| Other Sources | |||
| By End User | Pharmaceutical and Biotechnology Companies | ||
| Research Institutes and Academics | |||
| By-Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| Europe | United Kingdom | ||
| Germany | |||
| France | |||
| Spain | |||
| Italy | |||
| Rest of Europe | |||
| Asia-Pacific | India | ||
| Japan | |||
| China | |||
| Australia | |||
| South Korea | |||
| Rest of Asia-Pacific | |||
| Middle East and Africa | GCC | ||
| South Africa | |||
| Rest of the Middle East and Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
Need A Different Region or Segment?
Customize Now
Large Molecule Contract Development And Manufacturing Organization Market Research FAQs
How big is the Large Molecule Contract Development And Manufacturing Organization Market?
The Large Molecule Contract Development And Manufacturing Organization Market size is expected to reach USD 25.62 billion in 2025 and grow at a CAGR of 11.68% to reach USD 44.51 billion by 2030.
What is the current Large Molecule Contract Development And Manufacturing Organization Market size?
In 2025, the Large Molecule Contract Development And Manufacturing Organization Market size is expected to reach USD 25.62 billion.
Who are the key players in Large Molecule Contract Development And Manufacturing Organization Market?
Thermo Fisher Scientific Inc, Eurofins Scientific, Wuxi Biologics, Samsung Biologics and Catalent, Inc are the major companies operating in the Large Molecule Contract Development And Manufacturing Organization Market.
Which is the fastest growing region in Large Molecule Contract Development And Manufacturing Organization Market?
North America is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Large Molecule Contract Development And Manufacturing Organization Market?
In 2025, the Asia Pacific accounts for the largest market share in Large Molecule Contract Development And Manufacturing Organization Market.
What years does this Large Molecule Contract Development And Manufacturing Organization Market cover, and what was the market size in 2024?
In 2024, the Large Molecule Contract Development And Manufacturing Organization Market size was estimated at USD 22.63 billion. The report covers the Large Molecule Contract Development And Manufacturing Organization Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Large Molecule Contract Development And Manufacturing Organization Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
Large Molecule Contract Development And Manufacturing Organization Industry Report
Statistics for the 2025 Large Molecule Contract Development And Manufacturing Organization market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Large Molecule Contract Development And Manufacturing Organization analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
