Large Molecule Drug Substance CDMO Market

Market Overview

The global Large Molecule Drug Substance CDMO Market was valued at approximately USD 10.7 billion in 2024 and is projected to reach USD 23.9 billion by 2033, growing at a CAGR of 9.4% during the forecast period (2025–2033).

Large molecule drug substance Contract Development Manufacturing Organizations (CDMO) are companies that provide specialized services for the development and manufacturing of biologics. The definition of biologic is broad but includes monoclonal antibodies, recombinant proteins, cell and gene therapies and vaccines. They help biopharmaceutical companies with cell line development, upstream and downstream development, and commercial manufacturing at GMP scale.                                       The growth of the market is based on the growth of the biologics pipeline, outsourcing trends for biopharma companies, and the complexity and cost of producing biologics in-house. The market is further bolstered by the demand for personalized medicine, ongoing advancements in bioprocessing technology, and regulatory support for expedited use of biologics. Ultimately, they are enabling emerging biotech catered companies and large, traditional pharmaceutical companies to bring complex biologics to market with increased speed and efficiencies.

Market Dynamics

Market Drivers

Rising Demand for Biologics and Monoclonal Antibodies 

The increasing worldwide demand of biologics, especially monoclonal antibodies, is the leading driver of the large molecule drug substance contract development and manufacturing organization (CDMO) market. Biologics currently account for greater than 30% of global pharmaceutical spending, and also have a leadership position in modern treatments for cancer, autoimmune diseases, and infectious diseases.

Due to complexity and costs of manufacturing biologics, most pharmaceutical and biotech companies do not have internal capabilities to develop and manufacture biologics; therefore, they are increasingly outsourcing to CDMOs to access all the necessary biological development capabilities the pharmaceutical businesses need for success, which include technical experience and knowledge, regulatory knowledge and compliance, and scalability for the biological development and manufacturing processes.

For example, in April 2024, Pfizer signed a contract worth $1.9 billion with Samsung Biologics to manufacture biosimilars, which indicates the growing reliance of large pharmaceutical companies on external partners for biosurfactants. CDMOs are also critical when enabling smaller biotechs to take biologic candidates through the clinical trial process, and market without needing to actually invest in expensive manufacturing facilities.

Growth of the client base for CDMO – biopharmaceutical companies and increasing expansion of the biopharmaceutical pipeline – including expanded biologics that include immunotherapy candidates, and next-generation monoclonal antibodies require ongoing access to flexible, high-capacity CDMO services, which reflects a strategic application in the pharmaceutical manufacturing ecosystem.

Expansion of Cell and Gene Therapy (CGT) Pipelines

Just as the large molecule CDMO market is rapidly growing, so too is the growth of cell and gene therapy (CGT) pipelines. CGT therapies are capitalizing on the need to treat rare, genetic, or previous untreatable diseases. From the commercialization standpoint, CGTs rely on an ecosystem, which inherits an extraordinarily customized technical complexity in their manufacturing processes.

Given that CGT therapies often require the handling of living cells, viral vectors, and gene modifications, CGT requires a specialized infrastructure and complicated workflow. This means pharmaceutical companies are increasingly turning to large molecule contract development and manufacturing organizations (CDMOs) for end-to-end support for CGTs.

For example, in February 2024, Lonza expanded its cell and gene therapy manufacturing facility in Houston and increased the capability to produce viral vectors to meet the rapidly growing clinical and commercial demand. Furthermore, as of 2024, there were over 2,400 ongoing global regenerative medicine trials, including more than 200 in late-stage development, showcasing a significant shift in market opportunity.

To adapt to the complexities of CGT development, CDMOs are investing in modular and flexible manufacturing suites to accommodate the range of projects from autologous cell processing to large-scale allogeneic therapies. As the regulation landscape around CGTs continues to mature, CDMOs are positioning themselves to be valued institutions in making discoveries a reality in the market.

Market Restraints

High Capital Investment and Complex Manufacturing Infrastructure

The large molecule drug substance CDMO market is primarily limited by high capital investments and the complexity of manufacturing biologics. While small molecule manufacturing typically has a single, predictable process, large molecule exposure involves more complex processes (such as cell culture, fermentation, protein purification, cold-chain logistics).

There are currently no standardized steps that are universally predictable across large molecules, only general parameters that are best applicable to specific manufacturing processes. Manufacturing biologics requires adhering to GMP, working with sophisticated bioprocessing equipment, and hiring skilled personnel. Building or expanding a large molecule manufacturing facility can take up to several hundreds of millions of dollars and upwards of several years to construct, test, and gain regulatory approval.

For example, the investment for a commercial scale mammalian cell based biologics manufacturing facility usually exceeds USD 300 million. This number does not include maintenance, quality assurance considerations, or compliance with regulatory guidelines. These are all significant barriers to entry for new CDMO’s and limit the opportunity to scale for small or mid-sized CDMO’s.

Additionally, there are several barriers to final product release that add various personnel stages and expertise in operation of each facility. There is a limited bioprocessing expertise and experienced workers, limiting the operational readiness of new xxM plant that could supply large molecule drugs, if we made some assumptions about the capacity at the very beginning of any project like this.

Segmental Analysis

The Large Molecule Drug Substance CDMO Market is segmented by source and end-user. Each segment plays a vital role in supporting the growing demand for biologics and enhancing biopharmaceutical development and manufacturing efficiency.

By Source

In 2024, the mammalian segment accounted for the largest market share, with 64.8%, largely due to the segment’s ability to offer complex biologics such as monoclonal antibodies, fusion proteins, and therapeutic enzymes. Given its ability to mediate human-like post-translational modifications to proteins, mammalian cell-lines, including Chinese Hamster Ovary (CHO) cells, have been established globally as the preferred expression platform to evaluate high-efficacy biologics.

The overall and extensive reliance on mammalian systems for commercial manufacturability of biologics, and the continued investment in scalable bioreactor systems, will only continue to advance this segment of the biologics market. The microbial segment will experience some growth, including for the production of simpler proteins, insulin, growth hormones, and other enzymes.

Furthermore, E. coli and yeast-based expression systems have lower cost of production and faster expression systems making them suitable for certain biologics. However, this segment is the most relevant for new biotech companies that will develop biosimilars in an economical manner and also early-stage commercial research and development products.

We are also observing the growth of “others,” which incorporates plant-based, insect, and transgenic systems (this provides details about non-mammalian systems). This segment has garnered attention as it may deliver disruptive innovation in certain niche areas of the biotechnology market. Although the segment is relatively small today, as alternative expression platforms more efficiently develop and commercially deliver to the end-user, it is possible for this segment to grow modestly.

By End-User

Biopharmaceutical companies dominate the large molecule CDMO market, accounting for 71.5% of the market share in 2024. These companies rely heavily on CDMOs for development, scale-up, and commercial manufacturing due to the high cost and complexity of building in-house capabilities. CDMOs enable rapid time-to-market, regulatory compliance, and scalability—critical for biologics developers managing multiple pipeline candidates across various therapeutic areas.

Academic and research institutes represent a growing segment, as translational research and early discovery efforts increasingly lead to biologic candidates requiring process development and small-batch GMP manufacturing. Universities and public-private research consortia frequently collaborate with CDMOs to bridge the gap between lab research and clinical testing.

The “others” segment, which includes government health agencies, military research divisions, and nonprofit organizations involved in vaccine or orphan drug development, contributes modestly to market demand. This segment has gained prominence during public health emergencies such as the COVID-19 pandemic, where government-backed programs required rapid biologics production using CDMO infrastructure.

Regional Analysis

North America

North America holds the largest market share of 41.2% in 2024, driven by the region’s well-established biopharmaceutical industry, high R&D spending, and early adoption of advanced biologics. The United States plays a dominant role due to the presence of leading CDMOs such as Lonza (U.S. sites), Catalent, Thermo Fisher Scientific, and Patheon, as well as a strong pipeline of biologics and gene therapies in clinical development.

The U.S. Food and Drug Administration’s supportive regulatory pathways for biologics, biosimilars, and advanced therapies have accelerated drug approvals, fueling demand for commercial-scale CDMO partnerships. Additionally, strong venture capital funding and public-private collaborations in biotechnology contribute significantly to market growth.

Europe

Europe is a significant market, supported by robust healthcare systems and a high concentration of biopharma hubs in countries like Germany, Switzerland, the Netherlands, France, and the UK. The region benefits from a strong academic research base, government incentives for innovation, and the presence of global CDMOs like Recipharm and Boehringer Ingelheim BioXcellence.

According to the European Medicines Agency (EMA), the number of centrally approved biologic drugs continues to rise annually. Germany, in particular, leads in biomanufacturing capabilities, with increased investments in state-of-the-art GMP facilities. Europe is expected to experience consistent growth due to the increasing demand for biosimilars and advanced therapies, coupled with a rising aging population and chronic disease burden.

Asia-Pacific

The Asia-Pacific region is expected to grow at the fastest rate, with a projected CAGR of 10.6% during the forecast period, driven by rapidly expanding pharmaceutical industries in China, India, South Korea, and Japan. These countries are investing heavily in biologics R&D and manufacturing infrastructure to become global biologics hubs.

China’s push for biopharma self-sufficiency and India’s emergence as a global supplier of biosimilars and vaccines have led to the growth of local CDMOs like WuXi Biologics, Samsung Biologics, and Syngene. Favorable government policies, cost advantages, a skilled workforce, and increasing clinical trial activity are further accelerating regional market expansion. Additionally, Asia-Pacific is attracting global biotech companies looking to outsource manufacturing to reduce costs and access regional markets.

Latin America and Middle East & Africa

Latin America and the Middle East & Africa (MEA) generally present moderate growth, largely as a result of an improvement in healthcare infrastructure and pharmaceutical investments. Brazil, Mexico, South Africa, and Saudi Arabia are enhancing their capabilities in the biologics sector by capitalizing on public-private partnerships and modernizing regulatory frameworks.

As a region, they face challenges such as economic disparity, developing economies with little access to high-end biomanufacturing technologies, and the complexities of regulatory frameworks, but as long as the region progresses, they can expect to benefit from growing demand for vaccines, biosimilars products, and the treatment of chronic disease. The growing demand may offer new prospects for contract development and manufacturing organizations (CDMOS) to developed localized production facilities to service developing markets more economically.

Recent Development

1. February 2025 – Samsung Biologics launched its dedicated ADC facility and initiated ADC service offerings, addressing growing demand for antibody–drug conjugates. The facility began processing multiple ADC programs for clients such as LigaChem Biosciences.
2. April 2025 – Plant 5 at Samsung’s Bio Campus II became operational, adding 180,000 L of commercial cell culture capacity. The plant is equipped with advanced digital systems and sustainable automation, ramping up Samsung’s total biomanufacturing capacity to 784,000.
3. January 2025 – Samsung Biologics revealed plans to build a sixth manufacturing plant (pending board approval), which would further increase capacity to approximately 964,000 L to meet rising biologics demand.