Pharmaceutical CDMO Market Size, Share, Growth, and Industry Analysis, By Type (API CDMO, FDF CDMO, Packaging CDMO & Clinical CDMO), By Application (Pharmaceutical Company, Biotechnology Company & Other), and Regional Insights and Forecast to 2035

  
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PHARMACEUTICAL CDMO MARKET OVERVIEW

The global Pharmaceutical CDMO Market size is valued at USD 163.61 billion in 2025 and is expected to reach USD 172.61 billion in 2026, progressing steadily to USD 281.82 billion by 2035, exhibiting a CAGR of 5.5% over the forecast period 2025-2035.

CDMO, commonly known as Contract Development and Manufacturing Organisation, is a third-party service provider who will be responsible for the development and manufacturing of pharmaceutical or biotechnology products. The services offered by CDMOs include drug discovery and development services, formulation development and analytical development, clinical trial services, manufacturers and packaging and distribution services, etc. Outsourcing these services through CDMO enables the pharmaceutical and biotech firm to concentrate on research, development, and invention of new products and/or services differentiation while relying on the efficiency and large-scale production of the CDMO to upgrade on its product development and reduce its cost.

KEY FINDINGS

COVID-19 IMPACT

Pharmaceutical CDMO Industry Had a Positive Effect due to Increased Need for Vaccines

The global COVID-19 pandemic has been unprecedented and staggering, with the market experiencing higher-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden market growth reflected by the rise in CAGR is attributable to the market’s growth and demand returning to pre-pandemic levels.

The COVID-19 had a few beneficial effects on this market. Increased need for vaccines and other therapeutical products raised demand for CDMO services; to fill this demand, much money was invested and many agreements were made. The pandemic also showed the important function of CDMOs in the management of complex diseases, thereby strengthening their standing as valuable collaborators for pharmaceutical and biotechnology businesses. Moreover, the crisis also forced growth in the pace of technology adoptions and digitisation across the sector, which enhanced effectiveness and performances.

LATEST TRENDS

Cell and Gene Therapies to Propel the Market Growth

There are several important trends occurring in this market. One of the ascending patterns is the constant rise of client interest in the diversification of attending services, namely cell and gene therapies, innovative biologics, and precision medicines. CDMOs are, therefore, diversifying to embrace the growing needs of clients. The other emerging trend is the issue of digitalisation and solving of production and logistical issues through automation of processes, control of data flow, and supply chain visibility. Externally, there is continuity of emphasis on sustainability and environmentalism, with CDMOs embracing the environment by practicing and minimising negative impacts towards the environment.

• According to the U.S. Food and Drug Administration (FDA), over 75% of new investigational drug applications in 2023 were related to biologics and advanced therapies, driving CDMO demand for specialized production capabilities.

• As per the International Society for Pharmaceutical Engineering (ISPE) 2023 report, 63% of pharmaceutical manufacturers are integrating continuous manufacturing methods in CDMO partnerships to improve efficiency and product consistency.

  
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PHARMACEUTICAL CDMO MARKET SEGMENTATION

By Type

Based on Type, the global market can be categorized into API CDMO, FDF CDMO, Packaging CDMO & Clinical CDMO

• API CDMOs: These CDMOs are involved in the synthesis and production of active pharmaceutical ingredients or the basic modules of medication.

• FDF CDMOs: Some are focused on formulation and development of final therapeutic products, or FDFs, which include tableting, encapsulation, and injectable products.

• Packaging CDMOs: These CDMOs provide services that relate to packaging and labelling together with the distribution of various drugs.

• Clinical CDMOs: Some of these CDMOs are services of clinical trials, including trial design, patient enrolment, trial administration, and compliance with regulatory bodies.

By Application

Based on application, the global market can be categorized into Pharmaceutical Company, Biotechnology Company & Other

• Pharmaceutical Companies: Pharmaceutical companies use CDMO services to outsource different processes that cover various steps in drug development, such as the synthesis of API and formulation to the last packaging of the product.

• Biotechnology Companies: These firms employ the services of CDMOs in the backing of development as well as manufacturing of complex biologic products, including monoclonal antibodies, recombinant proteins, and cell and gene therapies.

MARKET DYNAMICS

Market dynamics include driving and restraining factors, opportunities and challenges stating the market conditions.

Driving Factors

Increasing Demand for Outsourcing to Expand the Market

A factor in the Pharmaceutical CDMO market growth is the Increasing demand for outsourcing. For the strategic operations, an overwhelming majority of the pharmacy and biotechnology businesses’ responses said that core activities are being subcontracted to CDMOs to keep the actual business dynamics. Possible reasons for this are lower costs of the platform, faster time to market, and specific skill availability.

• According to the U.S. Department of Health and Human Services (HHS), over 70% of mid-to-large pharmaceutical companies outsource at least one stage of drug manufacturing to CDMOs to optimize operational efficiency.

• As per Pharmaceutical Research and Manufacturers of America (PhRMA), 52% of newly approved drugs in 2023 were specialty medicines, creating a surge in CDMO services for complex formulations.

Technological and Innovation in the Enhancement of Market

Today, thanks to higher advancements in technology, both in biotechnology and in pharmaceutical sciences, many of the drugs themselves and the treatment process too have evolved. CDMOs are therefore practicing newer technologies and innovation in order to address these requirements.

Restraining Factor

Regulatory Challenges to Pose Potential Impediments on this Market

It is important to make a note that the pharmaceutical industry is highly regulated with a special focus on numerous guidelines and quality standards. One of the major difficulties in managing relations in the Pharmaceutical CDMO Market share is the fact that regulatory standards can be highly intricate both for traditional and innovative treatments and new markets.

• According to the U.S. FDA, 48% of small CDMOs reported delays in production due to complex compliance requirements for biologics and sterile products.

• As per ISPE 2023 survey, 42% of emerging CDMOs face challenges in implementing advanced manufacturing technologies due to high capital and technical expertise requirements.

Emergence of Biosimilars and Biologics to Create Opportunity in this Market

Opportunity

This factor offers a good business opportunity to CDMOs in view of increasing demand for biosimilars and biologic drugs. These are large molecular structures that need unique fabrication techniques to be handled based on the knowledge of a CDMO. To that extent, as the popularity of these therapies grows, so does the requirement for CDMO services.

• According to FDA statistics, the number of biopharmaceutical clinical trials increased by 59% from 2020 to 2023, presenting growth opportunities for CDMOs.

• As per the World Health Organization (WHO) 2023 report, over 63% of global pharmaceutical production growth is expected to come from Asia-Pacific regions, encouraging CDMO expansions.

Rivalry Among CDMO Suppliers to Pose Potential Challenge for this Market

Challenge

One of the biggest struggles in this market is great rivalry among CDMO suppliers. As the population of players entering the market increases, it becomes critical for CDMOs to leverage their services and technology that is unique to their specialisation and backed up by tremendous regulatory knowledge. Sustaining product quality reputations, strict delivery deadlines, and correcting intricate supply chains can be difficult even in the fast-paced industry.

• According to the U.S. Department of Commerce 2023 report, 46% of pharmaceutical manufacturers experienced delays in raw material supply, affecting CDMO production timelines.

• As per the U.S. Bureau of Labor Statistics, over 40% of pharmaceutical production facilities reported shortages of specialized personnel for biologics and sterile manufacturing processes.

  
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PHARMACEUTICAL CDMO MARKET REGIONAL INSIGHTS

• North America

More generally speaking, North America is one of the world’s leading regions in pharmaceutical research and industry. It holds a large number of pharmaceutical companies and biotechnology firms that are forcing the adoption of CDMO solutions. Because of the stringent regulatory environment and focus on standards of quality across the region, the best CDMOs have been established therein. The United States Pharmaceutical CDMO Market has the utmost influence in the global pharma CDMO market as well. The US, as one of the leading players in pharmaceuticals and biotechnology, has a large number of inhabitants—pharmaceutical and biotech majors and startups that require CDMO services.

• Europe

This market is also dominated by Europe and is expected to witness healthy growth in years to come. Germany, Switzerland, and the United Kingdom are among the leaders in terms of pharmaceutical industries, and their presence varies from multinational ones to local ones. Stakeholders’ emphasis on patient-centred healthcare delivery and the region’s R&D agenda have burgeoned the CDMO market.

• Asia 

Currently, Asia, especially China and India, among other countries, are steadily rising to become part of the international pharma market. These countries have cheap labour, support from their government, and a continuously increasing talent base. Chinese CDMOs are becoming increasingly versatile at a rather fast pace, and Indian CDMOs are using the generic medicine production competence to push into the world market. 

KEY INDUSTRY PLAYERS

Key Industry Players Shaping the Market through Product Innovations

Essential stakeholders in this global market have a vast contribution to its growth strategy and market trends. Influential through strategic partnerships, investments, or technological updates of innovative new products or processes, these players span across the sectors of pharma giants, biotech, and CDMO. Through partnerships with organisations in the CDMO industry, they advance ideas and facilitate faster-moving processes for product development within the CDMO services market. Moreover, thanks to their investment in hi-tech solutions and facilities, CDMOs can effectively address the growth of the sector’s requirements. Key players have responsibilities in the development of the market as they act as benchmarks in the industry as well as drive the formulation of policies within this market.

• Lonza: According to Lonza official resources, the company supports over 200 biotech clients globally in biologics development and manufacturing.

• Catalent: As per Catalent reports, the firm has handled over 3,500 product development projects for pharmaceutical and biologic drugs.

List of Top Pharmaceutical CDMO Companies

• Lonza (Switzerland)
• Catalent (U.S.)
• Thermo Fisher Scientific (U.S.)
• Samsung Biologics (South Korea)
• Fareva (Luxemburg)

KEY INDUSTRY DEVELOPMENTS

2023: Catalent, the world’s largest supplier of advanced delivery technologies and development services for drugs, biologics, and consumer health products, recently said that it was stepping up the capacity of the production of biologics. This expansion encompasses new capacities and tools to address higher capacity for intricate biologics and cell and gene therapies.

REPORT COVERAGE

The study encompasses a comprehensive SWOT analysis and provides insights into future developments within the market. It examines various factors that contribute to the growth of the market, exploring a wide range of market categories and potential applications that may impact its trajectory in the coming years. The analysis takes into account both current trends and historical turning points, providing a holistic understanding of the market's components and identifying potential areas for growth.

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