North American Pharmaceutical Contract Manufacturing Market 2025-2035

North America Pharmaceutical Contract Manufacturing Market Size, Share & Trends Analysis Report By Category (Human-Based Drugs, and Animals Based Drugs), By Type (Sterile Manufacturing, and Non-Sterile Manufacturing), By Product (Over-The-Counter (OTC) Drugs, Active Pharmaceutical Ingredients (API), Finished Dosage Formulation, and Others) and By Services (Manufacturing Services, Non-Clinical Services, and Research and Development), Forecast Period (2025-2035)

Industry Overview

North America pharmaceutical contract manufacturing was valued at $96.5 billion in 2024 and is projected to reach $270.0 billion by 2035, growing at a CAGR of 9.9% during the forecast period (2025–2035). The market growth is driven by increasing demand for outsourced production services and advancements in drug development. All pharmaceutical companies operate as outsourcing companies, dealing with the development and manufacturing of drugs, which leads to business scalability and revenue, which allows for the development of new drugs. The growing need for state-of-the-art processes and production technologies, which have proven highly effective in meeting regulatory requirements, is the most important factor driving the growth of CMOs in the pharmaceutical industry.

The increasing number of cell therapy candidates, combined with their steady growth through the various stages of clinical development and their complicated manufacturing process, drives up demand for manufacturing services for these therapies. Therefore, this factor creates an opportunity for market growth. However, the dynamic changes seen in this sector, combined with extreme margin pressure, are expected to restrict growth significantly.

Market Dynamics

Rising Demand for Biologics and Complex Therapies

The increasing prevalence of chronic diseases such as cancer, diabetes, and cardiovascular conditions is driving the demand for biologics and complex therapies. These treatments require specialized manufacturing processes, including sterile manufacturing and high-potency API production. Contract manufacturers are well-positioned to meet these needs, offering expertise and facilities that pharmaceutical companies may lack in-house

Cost Efficiency and Operational Flexibility

Outsourcing manufacturing operations allows pharmaceutical companies to reduce capital expenditures and operational costs. By partnering with contract manufacturers, companies can access state-of-the-art facilities and specialized expertise without the need for significant investment in infrastructure. This flexibility is particularly beneficial for small and mid-sized enterprises aiming to bring products to market efficiently

Regulatory Support and Domestic Manufacturing Initiatives

Government initiatives aimed at strengthening domestic manufacturing capabilities are bolstering the pharmaceutical contract manufacturing market. For instance, companies like Eli Lilly are investing in new manufacturing facilities within the United States to produce active pharmaceutical ingredients and other critical components. Such investments not only support local economies but also ensure a stable supply chain for essential medications.

Market Segmentation

• Based on the category, the market is segmented into human-based drugs and animal-based drugs.
• Based on the type, the market is segmented into sterile manufacturing and non-sterile manufacturing.
• Based on the product, the market is segmented into over-the-counter (OTC) drugs, active pharmaceutical ingredients (API), finished dosage formulation, and others (nutritional products and packaging)
• Based on the services, the market is segmented into manufacturing services, non-clinical services, and research and development.

Active Pharmaceutical Ingredients (API) to Lead the Market with the Largest Share

APIs are the core components responsible for the therapeutic effects of medications, making their production a critical aspect of pharmaceutical manufacturing. The increasing demand for both generic and branded drugs, coupled with the complexity of modern therapeutics, has propelled the need for specialized API manufacturing services. Contract Development and Manufacturing Organizations (CDMOs) are increasingly sought after to handle the production of APIs, especially those that are high-potency or biologically derived, due to their advanced capabilities and compliance with stringent regulatory standards.

Human-Based Drugs: A Key Segment in Market Growth

Among the various segments in the North American pharmaceutical contract manufacturing market, the human-based drugs category holds the fastest-growing share and is projected to continue its dominance through 2035. This segment encompasses a wide array of therapeutic areas, including oncology, immunology, neurology, and endocrinology, with a significant focus on biologics and biosimilars. The increasing prevalence of chronic diseases, coupled with advancements in biotechnology, has led to a surge in demand for human-based therapeutics. Biologics, in particular, require specialized manufacturing processes, such as mammalian cell culture systems and aseptic fill-finish capabilities, which are more prevalent in human drug production. The human-based drugs segment benefits from a well-established infrastructure, a skilled workforce, and a robust regulatory framework in North America, making it the preferred choice for pharmaceutical companies seeking contract manufacturing services. Additionally, the growing emphasis on personalized medicine and the development of complex biologic therapies further bolster the prominence of this segment in the contract manufacturing landscape.

Regional Outlook

US Dominates the Market with a Major Share

Geographically, US is forecast to have a large market share in the pharmaceutical contract manufacturing market across the world. This growth is being driven by a rise in the number of firms outsourcing projects in the developing economies of this region. Moreover, the increase in the incidence of chronic diseases like diabetes and cancer has augmented the need for injectable drug delivery in the US, driving the growth of the pharmaceutical contract manufacturing industry. According to the American Cancer Society, in 2025, the US is expected to experience around 2,041,910 new cases of cancer and 618,120 deaths due to cancer. While the overall cancer death rate has fallen, it has been prevented in nearly 4.5 million deaths since 1991 through improved prevention, early detection, and treatment. Cancer incidence in men has fallen but risen in women, particularly those under the age of 50, where rates are currently 82% higher than men's.

Market Players Outlook

The major companies operating in the North America pharmaceutical contract manufacturing market include Baxter Biopharma Solutions (Baxter International Inc., Catalent Inc., Charles River Laboratories, Pfizer CentreOne (Pfizer Inc.), Thermo Fisher Scientific Inc., and others. The companies are pursuing partnerships, collaborations, mergers, and acquisitions to drive innovation, expand product portfolios, enhance sustainability, and strengthen market presence. These strategies enable players to respond to growing demand for energy-efficient, high-performance insulation solutions across residential, commercial, and industrial applications while maintaining a competitive edge.

Recent Developments

• In September 2025, Kashiv BioSciences and JAMP Pharma launched biosimilars Pexegra and Filra in Canada, with support from JAMP's commercialization efforts. These biosimilars, used to treat neutropenia, low neutrophils, commonly experienced by chemotherapy patients, will be marketed in Canada through an exclusive agreement.

The Report Covers

• Market value data analysis of 2024 and forecast to 2035.
• Annualized market revenues ($ million) for each market segment.
• Country-wise analysis of major geographical regions.
• Key companies operating in the North America pharmaceutical contract manufacturing market. Based on the availability of data, information related to new products and relevant news is also available in the report.
• Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.
• Analysis of market-entry and market expansion strategies.
• Competitive strategies by identifying ‘who-stands-where’ in the market.

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