Biopharmaceutical CMO & CRO Market

Market Overview

The global Biopharmaceutical CMO & CRO Market was valued at approximately USD 38.6 billion in 2024 and is projected to reach USD 70.5 billion by 2033, growing at a CAGR of 6.8% during the forecast period (2025–2033).

Biopharmaceutical CMO (Contract Manufacturing Organization) and CRO (Contract Research Organization) services assist pharmaceutical companies with the outsourcing specifics of drug development, starting from pre-clinical stage, through clinical trials, and eventually full production biologics. Biopharmaceutical CMO and CRO services have become crucial in reducing costs, increasing time to market, and accessing capabilities. Market demand is increasing for biologics and biosimilars, combined with rising R&D spend rates, large biologics losing patent protection, and the complexities of biologic drug development. Most larger biopharma are outsourcing nowadays but for biopharma who don’t have the capacity this can create a strategic need for their business. CMO and CRO services support biopharma coping with their growing commercial activities. In addition, advances in biomanufacturing technologies and increasing FDA approvals for biologics continue to spur market growth.

Market Dynamics

Market Dynamics

Growing Demand for Biologics and Biosimilars

The considerable increase in demand for biologics and biosimilars is one of the primary factors driving the overall growth of the biopharmaceutical CMO and CRO market. Biologics, which consists of monoclonal antibodies, vaccines, cell and gene therapy products, has become necessary in the treatment of chronic and complex diseases such as cancer, autoimmune disease, and rare genetic diseases.

The IQVIA Institute reported that biologics accounted for almost 40% of global pharmaceutical spending in 2023, with monoclonal antibodies alone accounting for over $180 billion in annual sales. The expiration of patents for blockbuster biologics such as Humira (adalimumab) and Avastin (bevacizumab) has created a tremendous surge in the development of biosimilars (lower cost versions of branded biologics that are highly similar).

Amgen and Pfizer both began expanding biosimilars production in 2024. Samsung Biologics also began commercial manufacturing for biosimilars clients in multiple European and North American markets. As the pipeline of biologics continues to expand and with more biosimilars receiving regulatory approval, pharmaceutical companies have made the decision to continue outsourcing their manufacturing and clinical trial services to CMOs and CROs in order to manage capacity, mitigate time to market, and comply with increasingly stringent regulatory requirements. This is especially the case for small-to-mid-sized biotechnologies without a manufacturing facility set up internally.

Increasing Outsourcing of Clinical Trials and Manufacturing

Pharmaceutical and biotechnology companies are increasingly delegating research and manufacturing to CMOs and CROs, allowing these companies to act more efficiently and focus on their more primary competencies, such as drug discovery and commercialization. The impetus is driven by high costs of undertaking these clinical trials, the growing complexities arising from differences in regulatory regimes around the world, and the growing need for capabilities that require specialized skills.

For example, in May 2024, Lonza increased its biologics development services in the U.S. and Switzerland by adding capacity for clinical-stage manufacturing and early-phase development. WuXi AppTec also opened a new facility in China for integrated drug discovery and clinical support services. Each of these represents investment in either developing a new capability or expanding an existing capability, but both demonstrate increased reliance on external partners who can improve the timelines of development and manage the service from the end-to-end processes.

Finally, because of the growing need for personalized medicine, orphan drugs, and products for patients with rare diseases, production capabilities that are much more flexible and scalable are required, which is something CMOs and CROs have the capacity to provide. According to a report by GlobalData, more than half of clinical trials across the globe are outsourced in 2024 (most notably either oncology or immunology).

Market Restraints

Stringent Regulatory Compliance and Quality Control Challenges

The biopharmaceutical CMO & CRO market faces significant restraints due to the complex and evolving regulatory landscape across different regions. Biologic drugs, in particular, require highly stringent manufacturing standards to ensure safety, efficacy, and consistency. CMOs and CROs must comply with various national and international regulations such as the U.S. FDA’s cGMP guidelines, EMA regulations, ICH standards, and WHO quality benchmarks.

Failure to meet these standards can result in production delays, product recalls, or facility shutdowns. For example, in 2023, a leading CMO faced a warning letter from the FDA over data integrity issues and inadequate sterility assurance in a fill-finish facility, leading to contract terminations and reputational damage.

Additionally, CROs managing global clinical trials often deal with inconsistent requirements in ethics approvals, patient data privacy laws (like GDPR), and documentation formats, which can cause delays in regulatory submissions. This environment makes it increasingly difficult for smaller CMOs/CROs to maintain competitiveness, as they may lack the infrastructure or resources to keep up with evolving standards—ultimately hampering their growth and scalability in global markets.

Segmental Analysis

Here is a Segmental Analysis for the Biopharmaceutical CMO & CRO Market, modeled on your angiography catheters reference:

By Source

The Mammalian segment will continue to dominate the market, accounting for the most revenue in 2024. Mammalian cell lines, including CHO (Chinese hamster ovary) cells, represent a common cell line used to produce complex biologics, including monoclonal antibodies because they provide the ability to perform post translational modifications. In fact, mammalian cell lines are the preferred process for producing clinical and commercial biologics, particularly therapeutic proteins and vaccines. 

Non-mammalian systems such as microbial (e.g., E. coli) and yeast-based production, are also starting to show positive trends. Non-mammalian systems allow for lower manufacturing costs with development timelines, and are being used more frequently, especially using non-mammalian systems to produce simple proteins (or for development of biosimilars). The use of non-mammalian systems continues to be quite low when exploring the development of complex molecules.

By Service Type

Contract Manufacturing services had the largest market share in 2024, due to increasing market demand for biologics, biosimilars, and personalized therapies. Per the use of GMP compliant large-scale production using CMOs are leading pharma companies to outsource manufacturing with specialized contract development manufacturing organizations (CDMO) with subsequent capabilities in both upstream, downstream, and fill-finish.

Contract Research services are developing equally fast, with early-phase research, toxicology, and clinical trial management experiencing the most rapid growth. The outsourcing trend is not expected to plateau, as the research and development (R&D) of drugs becomes increasingly complicated and expensive. This is clearly understandable in the distinction of oncology, neurology, and rare disease CRA clinical trials described above, where clinical research organizations (CRO’s) provided a full-service solution.

By Product

Biologics dominate the market given the intense demand for monoclonal antibodies, therapeutic proteins, and vaccines. This is not just due to the rise of biologics R&D and approvals, which we have witnessed recently, especially in oncology and autoimmune diseases, but is the principal driver of growth in the market. By 2024, over 60% of the CMO pipeline will be biologics based.

Biosimilars will continue a rapid rise, especially with the recent patent expirations on blockbuster biologics like Humira and Enbrel. Growing European regulatory guidance, as well as increased FDA approvals in the U.S. are greatly impacting biosimilar manufacturing and clinical trials, especially in the cost-conscious regions of Asia-Pacific and Latin America.

By End-User

Biopharmaceutical companies are the main end-users, in particular small to mid-sized firms with no in-house infrastructure that rely heavily on outsourcing, for both R&D and manufacturing. Such companies provide the largest demand for integrated CMO/CRO services.

Pharmaceutical companies also have a major share of the market demand, especially for biologics diversification or to globalize manufacturing capabilities. Large pharma companies increasingly rely on CMO’s and CRO’s to manufacture biopharmaceuticals in emerging markets or to run late-stage clinical trials.

Regional Analysis

North America

North America commands the largest market share – about 40.2% in 2024 – mainly due to the presence of large and established biopharmaceutical companies, strong R&D infrastructure, and a well-established infrastructure of CMOs and CROs. The United States within the region shows the largest opportunity with high levels of biologics production, FDA (EMA) approved biosimilar pipelines, and robust outsourcing services investment.

Large players such as Catalent, Thermo Fisher Scientific, and Lonza (U.S. operations) are expanding facilities to accommodate increased demand for both clinical and commercial manufacturing. Also, the regional growth is fueled by improved advanced bioprocessing technologies and the rapid adoption of cell and gene therapies.

Europe

Europe has strong markets for biopharmaceutical CMO & CRO services, chiefly due to a strong regulatory environment and density of biotech firms. Germany, Switzerland, the UK, France, and Ireland are key markets. Germany has a strong biomanufacturing base and is home to the key CDMOs like Boehringer Ingelheim and Rentschler Biopharma.

The European Medicines Agency (EMA) approved over 50 biologics in 2023, with many of them supported by outsourced development services. The region also has strong public & private funding for life sciences and increased trial activity across oncology and rare diseases.

Asia-Pacific

Asia-Pacific is the most dynamic and rapidly expanding region, projected to experience a CAGR of 8.5% over the period 2025–2033. Growth in the region is driven by increasing pharmaceutical R&D investments, low-cost manufacturing, and widespread skilled labor. The region’s largest countries: China, India, South Korea and Japan are leading innovation and investment.

China is positioning itself as a global biologics manufacturing hub, with CDMOs such as WuXi Biologics undertaking substantial expansions in clinical and commercial capacity. India is becoming increasingly important in biosimilar research as well as early-phase clinical studies, primarily due to the government implementing regulatory reforms and significantly lower operational costs. Coupled with an increasingly evident demand for healthcare innovation and supportive government policies in South Korea and Singapore, the region is experiencing expansion.

Latin America and Middle East & Africa

The Latin America, Middle East and Africa regions are experiencing moderate growth with acceleration touted as increased investment is made in biopharma infrastructure, along with demand for biosimilars. Latin America’s leader is Brazil, and next is Mexico, as both countries are benefitting from government-led initiatives to develop biomanufacturing domestically and increase participation in clinical trials.

In the Middle East and Africa, countries such as South Africa, UAE and Saudi Arabia are supporting the expansion of their biopharmaceutical sector through public-private partnerships. While low-skilled labor, varying regulatory requirements, and unequivocal access to sophisticated technologies hinder more rapid development in this region

Recent Development

1. March 2025: Lonza opened a new mammalian biologics facility in Switzerland to boost commercial production capacity.
2. January 2025: WuXi Biologics launched a microbial CDMO plant in Chengdu, China, for large-scale biosimilar manufacturing.
3. December 2024: Samsung Biologics expanded its Songdo facility to include cell and gene therapy manufacturing suites.