PUBLISHER: Orion Market Research | PRODUCT CODE: 1749623
PUBLISHER: Orion Market Research | PRODUCT CODE: 1749623
Global Pharmaceutical Contract Manufacturing Market Size, Share & Trends Analysis 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 & Development) Forecast Period (2025-2035)
Industry Overview
Pharmaceutical contract manufacturing market was valued at $201 billion in 2024 and is projected to reach $549 billion by 2035, growing at a CAGR of 9.6% from 2025 to 2035. 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
The Growing Adoption of Biologics and Biosimilars
The growing consumption of biologics and biosimilars is highly impacting the pharmaceutical contract manufacturing business. Biologics, including monoclonal antibodies, vaccines, and gene therapies, are highly complex molecules produced from living organisms, so their manufacture is specialized and capital-intensive. Drug makers focus on R&D and drug development, the majority of them are having their manufacturing outsourced to contract manufacturing organizations (CMOs) that have the capability, infrastructure, and regulatory expertise needed for bulk biologics production. In addition, biosimilars, lower-cost, near-identical copies of biologic drugs, are growing in popularity as patents expire on top-selling biologics. Health systems and governments worldwide are encouraging biosimilar use as a means to control healthcare costs and increase access for patients to innovative therapies.
Growth in Biopharmaceuticals & Advanced Therapies
The fast growth of biopharmaceuticals and advanced therapies is one of the key factors for the expansion of the pharmaceutical contract manufacturing industry. Biopharmaceuticals such as monoclonal antibodies, recombinant proteins, and vaccines have witnessed a growth in demand as they are highly effective in treating chronic diseases like cancer, autoimmune diseases, and genetic disorders. Additionally, the development of cell and gene therapies (CGTs) and targeted medicines has created a massive need for specialty manufacturing capacity. Many pharma firms, especially small and medium-sized biotech companies, lack the experience, facilities, and regulatory compliance infrastructures to manufacture biopharmaceuticals. As a result, increased outsourcing to Contract Development and Manufacturing Organizations (CDMOs) with advanced biologics manufacturing facilities has taken place.
Market Segmentation
Active Pharmaceutical Ingredients (API) to Lead the Market with the Largest Share
The Active Pharmaceutical Ingredients (API) segment will dominate the market for pharmaceutical contract manufacturing worldwide and have the highest share in the market. The reason for this segment's growth is primarily the increased demand for good-quality, low-cost drug ingredients, an increasing number of chronic diseases, and pharma companies' rising trend of outsourcing. With greater complexity in drug product formulations, most firms are turning to specialized contract manufacturers with better API synthesis, scale-up, and conformity to strict worldwide regulations (such as FDA, EMA, and ICH standards). For instance, in February of 2025, Eli Lilly intended to spend $27 billion to build four new plants for manufacturing in the US, with a target to improve local production against the looming import tariffs on drugs under the Trump administration. Three of the facilities will manufacture Active Pharmaceutical Ingredients (APIs), while the fourth will manufacture sterile injectable pharmaceuticals, like the blockbuster weight-loss drug Mounjaro. The growth is expected to create 3,000 high-skilled jobs and 10,000 construction jobs and aligns with the drive to restore pharma manufacturing and reduce reliance on foreign sources, particularly from China and India.
Source: OMR Analysis
Human-Based Drugs: A Key Segment in Market Growth
The human-derived drugs category is becoming the key growth driver of the pharma contract manufacturing sector globally, driven by the rapidly growing need for biopharmaceuticals, personalized medicine, and emerging medicines like monoclonal antibodies, gene therapy, and mRNA vaccines. The rising prevalence of long-term conditions, rare genetic disorders, and cancer has further driven the demand for highly advanced and scalable manufacturing of medicines. For example, in December 2024, the US FDA granted GSK's request to review Nucala (mepolizumab) for add-on treatment in patients with a COPD eosinophilic phenotype, following positive results from the MATINEE trial. The trial demonstrated that the addition of Nucala to conventional inhaled therapy significantly decreased moderate to severe COPD exacerbations.
The global pharmaceutical contract manufacturing market is further divided by geography, including North America (the US and Canada), Asia-Pacific (India, China, Japan, South Korea, Australia and New Zealand, ASEAN Countries, and the Rest of Asia-Pacific), Europe (the UK, Germany, France, Italy, Spain, Russia, and the Rest of Europe), and the Rest of the World (the Middle East & Africa, and Latin America).
Increasing Production Facility for CMOs in Europe
As demand for complex and high-potency drugs rises, especially in oncology and biologics, contract manufacturing organizations (CMOs) are expanding and upgrading their facilities across Europe to meet stringent quality standards and growing client needs. These investments enhance capacity, enable the production of specialized drugs like HPAPIs and antibody-drug conjugates (ADCs), and reduce time-to-market for pharmaceutical companies. The creation of such infrastructure places Europe at the forefront of high-quality, large-scale pharma production, which also adds to the attractiveness of outsourcing on the continent. In June 2022, for instance, Merck inaugurated a new €59 million, 70,000-square-meter CDMO facility in Verona, Wisconsin, and doubled its capacity for producing high-potent active pharmaceutical ingredients (HPAPIs). These blocks are important in cancer treatments like antibody drug conjugates (ADCs) due to their high activity at low doses, reducing side effects. With over 30 years of experience in handling complicated and highly active molecules, Merck is today one of the largest HPAPI manufacturers globally with extremely low occupational exposure levels. The facility enables faster development and production of life-saving therapies, underpinned by Merck's technology strengths and extensive testing services.
North America Region Dominates the Market with Major Share
Geographically, North America 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 such as diabetes and cancer has augmented the need for injectable drug delivery in the US driving the growth of the pharmaceutical contract manufacturing industry. Based on the American Cancer Society, in 2025, the US is expected to experience around 2 million new cases of cancer and 618,120 mortalities due to cancer. While the overall cancer death rate has fallen-preventing nearly 4.5 million 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. In April 2024, Ferring Pharmaceuticals and SK Pharmteco agreed to scale up commercial manufacturing capacity for the drug substance of Ferring's intravesical gene therapy Adstiladrin to ensure long-term future supply. Following technology transfer, SK Pharmteco, a contract development manufacturing organization (CDMO), qualified as another source for manufacturing, testing, and release of the medicine, subject to regulatory approval by the U.S. FDA.
The major companies operating in the global pharmaceutical contract manufacturing market include Thermo Fisher Scientific, Inc., Pfizer CentreOne (Pfizer, Inc.), and Catalent, Inc. among others. Market players are leveraging partnerships, collaborations, mergers and acquisition strategies for business expansion and innovative product development to maintain their market positioning.
Recent Development