Biopharmaceutical Contract Manufacturing Market

Market Overview

The global Biopharmaceutical Contract Manufacturing Market was valued at approximately USD 18.2 billion in 2024 and is projected to reach USD 36.5 billion by 2033, growing at a CAGR of 8.1% during the forecast period (2025–2033).

Biopharmaceutical contract manufacturing organizations (CMOs) offer outsourced service providers to produce biologic products, from monoclonal antibodies, recombinant proteins, vaccines, and biosimilars, to process development, upstream/downstream production, fill-finish operations and quality control.  Biopharmaceutical CMOs are critical partners for drug developers, providing fast time to market opportunities, cost-effective solutions, and access to  cutting-edge manufacturing facilities without the burden of investing in expensive capital. The market is forecasted to continue expanding, in part due to increased complexity of biologics, pent-up demand for biosimilars, and the increased propensity of large pharmaceutical manufacturers and emerging biotechs to outsource commercial production activities.

The increasing complexity of biopharmaceuticals, advances in bioprocessing technologies, expansion of biologics pipelines, and global demand from emerging markets will continue to power the market. The proliferation of GMP-compliant manufacturing facilities and increasing globalization across borders will create opportunities for interesting and effective partnerships for biopharmaceutical CMOs.

Market Dynamics

Market Drivers

Growing Biologics Pipeline and Demand for Monoclonal Antibodies (mAbs)

The growth and approval of biologic drugs, especially monoclonal antibodies (mAbs), are major contributors to growth in the biopharmaceutical contract manufacturing market. Biologics are now the standard of care for a variety of chronic diseases including cancer, autoimmune disorders, and infectious diseases.

In the PhRMA 2023 report, there are over 1,000 biologics being developed (and most often approved) in the U.S. (carry a letter of authorization) many of which are monoclonal antibodies targeting specific disease pathways. The complexities and special capabilities to manufacture biologics has caused pharmaceutical companies to contract out the production to manufacturers with biologic experience and GMP-certified facilities.

A recent example in the contract biologics manufacturing request is Amgen’s Imdelltra (tarlatamab) a novel bispecific monoclonal antibody approved by the U.S. FDA for small cell lung cancer in April 2024, which is in part being manufactured by a third-party contract manufacturer to expedite commercial manufacturing scalability. This is reflective of the overall trend of using external manufacturing as a means to expedite launch timelines and perform cost management.

Furthermore, the costs of monoclonal antibody manufacture, the sensitive nature and complexity of scale-up have created the need for CMOs that can provide services from cell line development, process optimization to commercial batch manufacture. The demand for these services are likely to continue to grow, as many biotech companies without the resources to build in-house manufacturing capabilities bring innovative biologics to the market.

Increased Outsourcing by Small and Mid-Sized Biotech Firms Amid Funding Growth

The rise of venture capital funding and public investment in biotechnology innovation has given an abundance of small to mid-sized biotechnology companies the opportunity to produce novel biologic drugs. Many of those companies do not have the ability or resources to build their own biomanufacturing facility and consequently have become dependent on contract manufacturing organizations (CMOs).

As stated by Biocom California, biotech venture capital investment was over $33 billion in 2023 worldwide, with a large percentage of it going to biologics and early stage companies. For example, in January 2024, U.S. based TScan Therapeutics, a biotech startup, partnered with Lonza, one of the largest global CMOs, to help the biomanufacturing of its TCR-engineered cell therapy candidates for oncology clinical trials.

This partnership allows students to fill the need of building a capital-intensive facility, yet they can assure GMP compliance and scale-up for manufacturing. As the regulatory timeframe for fast tracking approval processes (e.g. FDA Fast Track, EMA’s PRIME) increases, these biotech firms will need to move from clinical scale manufacturing to commercial-scale manufacturing quickly.

As important partners in this pathway are CMOs that have agile capacity and have experience and success with commercial manufacturing under regulatory scrutiny. The importance of CMOs to the biopharmaceutical supply chain is becoming more valuable.

Market Restraints

High Cost and Complexity of Biologics Manufacturing Infrastructure

A significant factor impeding the growth of the biopharmaceutical contract manufacturing market is the high cost and technical complexity of the infrastructure to produce biologics. As opposed to small molecule drugs, biologics require highly specialized facilities that are sterile, GMP compliant and have facilities with bioreactors, cell culture systems, and more advanced purification technologies.

Establishing and maintaining a biologics production facility requires considerable capital, lengthy validation programs and strict regulatory oversight. Even for CMOs, the up-front cost for expanding biologics capacity or updating an existing biologics facility to be able to produce a new modality (e.g., gene therapies or mRNA vaccines) can be prohibitive.

According to BioPlan Associates, the cost of developing a mid-sized biomanufacturing facility can run anywhere from $250 million to $500 million, depending on automation and specific regulatory requirements. In addition, biomanufacturing is labor-intensive and significant development time is needed for a biologics process, which adds both to operational costs and risks.

If demand declines or failed clinical trials, there is a risk that the high value assets are underutilized which can negatively impact profitability. Additionally, smaller CMOs may be typically slow to adopt new technologies, such as continuous bioprocessing or single-use systems which limits their ability to obtain contracts with biopharma innovators for contract manufacturing.

Segmental Analysis

The Biopharmaceutical Contract Manufacturing Market is segmented by product type by service and end-user. Each segment contributes uniquely to the scalability, innovation, and commercialization of biologic therapies.

By Product Type

Monoclonal Antibodies (mAbs) are the leader in the market comprising the largest share with a momentum of approx. 41.2% by 2024. Growth for mAbs represents increased utilization for cancer, autoimmune disorders, and infectious diseases, resulting in consistent demand. With multiple blockbuster biologics and biosimilars currently in production, contract manufacturers are continuing to invest in specialized capacity for mAbs.

Recombinant proteins are the second largest segment, led by therapeutic proteins for insulin, erythropoietin, and coagulation factors. Recombinant protein consumption across chronic, genetic conditions underlines its continuing importance for sustained growth. Vaccines have strong growth potential, particularly post-COVID-19 with the resurgence of global immunization programs, expansion of immunization programs, and new vaccine platforms like mRNA and vaccinations represented an even larger market.

Contract manufacturers will play an influential part in accomplishing the necessary scale-up and fill-finish. Biosimilars are growing rapidly under continued patent expirations of the blockbuster biologics and robust regulatory support. As healthcare systems around the world target costs, the demand for biosimilars in service is steadily increasing.

By End-User

Biopharmaceutical Companies are estimated to be the major customer base within the contract manufacturing market, with a ruling share of over 62.5% in 2024. In this era of innovation and speed-to-market, it is a natural choice for companies to outsource their manufacturing and reduce capital investment, while still relying on CMOs with specialized expertise and GMP-compliant facilities.

Contract Research Organizations (CROs) are also growing in partnering with CMOs to provide integrated drug development options for small biotech porivders lacking in-house capabilities. CRO-CMO partnerships can offer drug development timeliness and regulatory progress ease.

Academic & Research Institutes are a minor but growing segment of the contract manufacturing industry that demonstrate promise, especially in the early-stage development and technology transfer. As academic institutions turn more toward translational reactions, is not uncommon for them to rely on CMOs for non-commercial pilot manufacture and generate materials for clinical trials.

By Service

Commercial manufacturing accounts for the greatest share of the service sector, with estimates of over 49.7% of the market in 2024. As regulation timeframes for the approval to market of biologics comes down, biopharma companies are counting on CMOs for large-scale production to support commercial demands.

Capital investments that enable companies to scale to commercial quantities, as well as the regulatory complexity of producing biologics demonstrate that an outsourcing approach to be reasonably efficient. Process development, and especially upstream services such as cell line development and media optimization, is seeing huge interest from emerging biotech firms that require rapid and scalable solutions.

Downstream process development, including purification and formulation, is also receiving attention as companies have an interest in maximizing product yield and purity. Standard fill & finish services are seeing steady demand growth as these services have become a staple in the preparation of final products, and are dependent on maintaining sterility and regulatory compliance in packaging within the requirements for products that are injectable biologics, such as mAbs and vaccines.

Analytical and quality control services are emergent and experiencing growth as regulatory controls become more stringent and additional testing and supporting documentation for a drug product emerges, Contract manufacturers are developing in-house QC labs with full-service capabilities to support client needs throughout the clinical and commercial lifecycle of a drug.

Regional Analysis

North America

North America has the largest share of 39.5% market share in the year 2024, serving by its well-defined and established biotechnology industry, as well as the presence of major biopharmaceutical firms and cluster of contract manufacturing organizations. In North America’s case, the regional entity responsible is the United States due to its advanced biomanufacturing infrastructure, well-defined Intellectual Property laws, and an emphasis on biologics in government-sponsored research and development with significant investment.

According to the Biotechnology Innovation Organization (BIO), the U.S. had almost 60% of all the biologic drug approvals worldwide from 2018 to 2023. Furthermore, the use of outsourcing strategies by both large pharma and up-and-coming biotech firms has aligned competitive and commercial advantages that increased the demand for CMO services. 

Europe

Europe is the other major market and is characterized by strong support from countries such as Germany, Switzerland, Ireland, the Netherlands, and the UK where biologics production and pharmaceutical innovation was well-established. Germany is also regarded as the EU biopharmaceutical manufacturing hub because the presence of accomplished research institutions and favorable regulations.

The region has also exhibited active governmental support for life sciences and growth of biosimilar manufacturers. The presence of EU-wide regulations has allowed CMOs to take efficiencies from being able to work over borders which allows them to be scalable and accessible across the surrounding region.

Asia-Pacific

The Asia-Pacific region is forecasted to be the fastest-growing, with a CAGR of 9.3% over the forecast period. Countries such as China, India, South Korea, and Japan are quickly ramping up biopharmaceutical manufacturing through public-private investment and partnerships with global companies. India and China have also matured into cost-effective manufacturing options due to their larger GMP-compliant facility base and skilled labor force.

In addition, China is increasingly stilling biologics for domestic consumption, providing its City and County health facilities with increased national reimbursement for biologics sold. South Korea’s “K-Bio” initiative, and sectors in the country such as the reliable expansion of Samsung Biologics act to constantly reaffirm the generation and impact on global contract manufacturing in this expanding sector.

Latin America and Middle East & Africa

The Latin America and the Middle East & Africa regions are showing moderate growth, as the pharmaceutical market is growing, healthcare awareness is increasing and foreign investment is being made into healthcare infrastructure. Countries like Brazil, Mexico, South Africa and Saudi Arabia are investing in biopharmaceutical development and creating local manufacturing capabilities through incentives and partnerships.

Growth is somewhat constrained due to limited access to, and knowledge of, advanced biomanufacturing technologies, complex regulatory processes, and varying levels of access to healthcare. A rapid increase in environmental, social and governance (ESG) sourcing activities is leading to regional players partnering with global CMOs to facilitate localized product demand and enhancing reliability within their supply chain network.

Recent Development

1. March 2025: Syngene International acquired its first U.S. biologics facility to expand large-molecule manufacturing capacity.
2. April 2025: Samsung Biologics announced two new biologics plants, including a dedicated ADC facility and a 180,000 L Plant 5.
3. July 2025: Thermo Fisher Scientific to acquire Sanofi’s sterile biologics plant in New Jersey, boosting fill-finish capacity.