U.S. Biologics CDMO Market Size & Share Analysis - Trends, Drivers, Competitive Landscape, and Forecasts (2025 – 2032)

U.S. Biologics CDMO Market Size

U.S. Biologics CDMO Market Trends and Growth Drivers

Shift in Preference toward CDMOs Is Biggest Market Trend

Big pharmaceutical companies are striving to de-risk R&D efforts and increasing the speed to market of their life-changing drugs, while simultaneously reducing their development and manufacturing costs. The rising number of specialty and biotech firms are turning to service providers to avoid the high-fixed costs of in-house development, manufacturing, and expertise required to get their molecules through clinical development. The growing complexity of new molecular entities (NMEs) development has created a demand for niche capabilities and competencies that pharmaceutical companies prefer to access externally rather than incorporate in-house.

In addition, high internal fixed cost bases associated with internal capabilities limit their ability to scale up and down based on the size and nature of their pipeline and ever-changing requirements. CDMOs provide this agility and flexibility to the pharmaceutical companies to spend a large portion of their capital and profits on R&D to create better drugs at lower costs, so the strategic use of external CDMO partners grants companies a significant competitive advantage. Companies that engage CDMOs early in the R&D process are involved in the development of intellectual property (IP), the filing of patents for customers, and the assistance of customers in protecting their IP.

Moreover, pharmaceutical companies are consolidating their supplier base and prefer to work with CDMOs that provide services such as drug substance and drug product development as well as manufacturing. To meet this market demand, CDMOs are expanding their capabilities across all stages of development and commercialization in order to eliminate the need for technology transfer and serve customers end-to-end. Thus, the shift in preference toward CDMOs is another major market trend.

Rising Geriatric Population Is Driving Market Growth

The increasing life expectancy and falling death rates are the major contributors to the growth of the geriatric population. According to a report by the World Health Organization (WHO), people are living longer as the average life expectancy of the population has increased. This has led to a huge growth in the world’s aged population. According to the American Geriatrics Society (AGS), by 2030, over 20% of the Americans are expected to be more than 65 years of age.

Elderly people require extensive care as they are highly prone to illnesses owing to their low immunity level and longer recovery time. Besides, the elderly fall sick more often, which raises the requirement for various types of medication. Therefore, the consumption of therapies is increasing in order to treat different types of diseases in the elderly people. Furthermore, geriatric care is complex and requires better management through cutting-edge technologies and treatments. Owing to the intensive care required by the geriatric population, healthcare settings are increasingly adopting technologically advanced and effective therapies, which, in turn, is boosting the growth of the market globally.

Drug Price Control Policies Can Hamper Market Growth

Several national governments are laying emphasis on adopting price control policies with respect to drugs. For instance, in September 2020, the U.S. government released four Executive Orders (EO) to curb drug prices in the country. Under these EOs, the U.S. would pay no more than the lowest price prevailing in 14 countries, including Canada, England, Greece, Italy, and Japan. These countries are focused on using some form of price control and rationing to ensure drug prices stay down for consumers.

Moreover, government policies and public insurance programs in the U.S. have a few unintended consequences, which negate healthy price competition and induce artificially high prices. And, lowering the cost of prescription medications hinders innovation and slows the development of new drugs, which ultimately leads to fewer options available for patients. Thus, the unfavorable drug price control policies impede drug production, which further hampers the industry.

U.S. Biologics CDMO Market Analysis

Product Type Insights

• The drug substance category holds larger share in the market in 2024, of around 55%, and it is expected to retain its position in the upcoming years, based on the type of product type.
• This is attributed to the increasing rate of approvals from the FDA to new biologic substances and the lower chances of their failure than drug products.
• Another key driver for this category is the increasing launch of biosimilars following the patent expiration of branded biopharmaceuticals.
• The drug product category has the higher CAGR primarily because of the increasing demand for effective biopharmaceuticals.
• In the context of the U.S., this is credited to the rise in the geriatric population, surge in the prevalence of chronic diseases, advances in drug delivery systems, shift toward personalized medicine, strong focus on antiviral vaccines and strong patient preference for oral (capsule, pill and tablet) forms.

These product types are covered in the report:

• Drug Substance (Larger Category)
• Drug Product (Faster-Growing Category)

Cell Line Insights

• The mammalian category dominates the market, with a revenue share of around 55%, primarily attributed to the creation of complex biopharmaceuticals from mammalian cell cultures, such as tri- and bi-specific antibodies and antibody–drug conjugates.
• Additionally, Chinese hamster ovary cells and many other mammalian cell culture systems can produce complex proteins, which mimic those naturally found in humans.
• This enables the production of an array of biopharmaceuticals, such as vaccines, enzymes and monoclonal antibodies. The FDA’s guidelines and process for mammalian-cell biologics are also clear and standardized.
• The viral vector & other modalities category has the highest CAGR in the market.
• This is credited to the increasing demand for gene therapies, for which viral cell lines are crucial.
• Further, with viral vectors, therapeutic genes and other kinds of biologics can be better delivered to the target area.
• Therefore, adenoviruses, adeno-associated viruses and lentiviruses are increasingly being used to create biopharmaceuticals against cancer, rare diseases, and genetic conditions.

We studied the following cell lines:

• Mammalian (Largest Category)
• Microbial
• Viral Vector & Other Modalities (Fastest-Growing Category)

Service Type Insights

• The commercial category holds the larger revenue share, of around 70%, in 2024.
• This is due to the increasing approvals and launch of cell and gene therapies against a rising number of diseases.
• Other reasons for this category’s dominance are the rising outsourcing of mAb production to CDMOs by major biopharmaceutical companies and the fact that they are the most-widely used kind of biologic.
• The clinical bifurcation is expected to grow faster during the forecast period.
• This is attributed to the increasing preference of biologic companies to outsource the drug development phase to CDMOs, to control risk and cost.
• Moreover, this outsourcing enables CDMOs to gain supply contracts in the early stages of the product R&D cycle, allowing them to edge out their competitors.
• Moreover, since the COVID-19 pandemic, biologics companies have significantly increased their investment in advancing their preclinical and clinical pipelines.

These service types were analyzed:

• Commercial (Larger Category)
• Clinical (Faster-Growing Category)

Regional Analysis

• Northeast U.S. dominates the market in 2024 with 35% share.
• This is attributed to the high density of both biopharmaceutical companies, biologics CDMOs and academic and research institutions in the states of Massachusetts, New Jersey and New York.
• Massachusetts, in particular, has been a hotbed in the country to R&D on mAbs, cell therapies and gene therapies.
• The western region is witnessing the fastest growth during the forecast period.
• This is credited to the favorable infrastructure and policies for biologics R&D and production in California, especially San Diego and San Francisco.
• Moreover, the presence of the Silicon Valley encourages the usage of digital technologies, including AI, ML and big data analytics, in the biologics R&D process.

The geographical breakdown of the market is as follows:

• Northeast (Largest Regional Market)
• Midwest (Fastest-Growing Regional Market)
• West
• South

U.S. Biologics CDMO Market Share

Owing to the technically demanding nature of biologics production and R&D, the market in the U.S. is consolidated. The major companies are entering into partnerships with customers of all sizes, from start-ups to large biotech and major pharmaceutical companies and investing in large-scale multi-purpose facilities, alongside dedicated suites. They are also dedicatedly working to ensure that it can offer services across the value chain and the lifecycle of a molecule. Further, as their pipelines become more complicated, they are complementing their platform with other molecular tools for the stable expression of large DNA cargos and the discovery and design of bispecific antibodies.

Players are also expanding their presence in contract R&D services for cell line development, to offer technical support for manufacturing, production, and R&D services for cell line and process development.

Companies are further expanding their footprint with the construction of additional commercial gene therapy suites across the U.S. for both small- and large-scale plasmid DNA production. Certain players also offer biologics analytical development and testing services for large molecules, such as bioassay, biophysical characterization, and cGMP release and stability testing.

U.S. Biologics CDMO Market News

• In December 2024, Novo Holdings completed all the regulatory proceeding to acquire Catalent Inc.
• In July 2024, Rentschler Biopharma SE operationalized its new production line at the Rentschler Biopharma Manufacturing Center, in Milford, Massachusetts.
• In May 2023, Novartis AG and Sandoz announced their partnership with Just - Evotec Biologics, a subsidiary of Evotec SE. Under this agreement, they develop and manufacture multiple biosimilar medicines with an option for expansion and strengthening the Sandoz foundation as a stand-alone off-patent medicines company.
• In April 2023, Samsung Biologics announced an investment of $1.46 billion (KRW 1.9 trillion) in a new biomanufacturing facility in South Korea, which will be the first plant of the company’s second Bio Campus and its fifth biomanufacturing plant overall.