United States Biopharmaceuticals Contract Manufacturing Market By Source (Mammalian, Non-mammalian), By Service (Process Development, Fill & Finish Operations, Analytical & QC studies, Packaging & Labelling, Others), By Product (Biologics, Biosimilars), By Therapeutic Area (Oncology, Autoimmune Diseases, Infectious Diseases, Cardiovascular Diseases, Metabolic Diseases, Neurology, Others), By Region, Competition, Forecast & Opportunities, 2020-2030F

Market Overview

The United States Biopharmaceuticals Contract Manufacturing Market was valued at USD 10.58 Billion in 2024 and is expected to reach USD 19.52 Billion by 2030 with a CAGR of 10.72%. This growth is driven by the increasing demand for biologics and biosimilars, which address complex diseases with innovative therapies. Advancements in manufacturing technologies, such as single-use systems and continuous processing, enhance production efficiency and scalability. These factors enable contract manufacturers to meet the rising need for cost-effective and high-quality biopharmaceuticals, driving market growth and fostering innovation in the industry.

Technological advancements are transforming the biopharmaceutical contract manufacturing landscape. The integration of digital technologies, including automation, artificial intelligence (AI), and machine learning, is optimizing production efficiency and product quality. Automation in bioreactors and downstream processing reduces human error and enhances repeatability, while AI and data analytics provide insights for optimizing manufacturing parameters. Additionally, the growing shift toward personalized medicine is driving demand for flexible and specialized manufacturing capabilities. Contract manufacturers are adapting by offering services that cater to small-batch production, personalized biologics, and cell and gene therapies.

Despite the positive outlook, the market faces challenges, including regulatory complexity and supply chain constraints. Biopharmaceutical production is subject to stringent guidelines set by agencies such as the FDA, requiring adherence to Good Manufacturing Practices (GMP) and rigorous quality control standards. Contract manufacturers must invest substantial resources to ensure compliance, which can be costly and time-consuming. Additionally, managing supply chain disruptions and scalability issues poses significant challenges. Securing a reliable supply of raw materials, such as high-quality biological ingredients, can be difficult due to global supply chain uncertainties. Scaling up production to meet growing demand often requires significant investments in new technologies, facilities, and workforce training.

Key Market Drivers

Rising Demand for Biologics and Biosimilars

The escalating demand for biologics and biosimilars is a significant catalyst propelling the growth of the United States Biopharmaceuticals Contract Manufacturing Market. Biologics, encompassing monoclonal antibodies, recombinant proteins, vaccines, and cell and gene therapies, have become integral in treating chronic and complex diseases such as cancer, autoimmune disorders, and rare genetic conditions. These therapies offer high specificity and efficacy, making them valuable tools in personalized medicine.

According to the U.S. Food and Drug Administration (FDA), as of April 1, 2025, there are 69 FDA-licensed biosimilars, with 49 products launched for 17 reference molecules. This expansion reflects the growing acceptance and utilization of biosimilars in the healthcare system. Moreover, the FDA's Center for Biologics Evaluation and Research (CBER) reported significant milestones in 2024, including the approval of 17 biologics license applications and 26 biologics license application supplements. These approvals indicate a robust pipeline and a supportive regulatory environment for biologics and biosimilars.

Manufacturing biologics and biosimilars is inherently complex, requiring specialized facilities, stringent quality controls, and regulatory compliance. Many biopharmaceutical companies opt to outsource these manufacturing processes to contract manufacturing organizations (CMOs) that possess the necessary technical expertise and infrastructure. CMOs offering scalable solutions, single-use bioreactor technology, and advanced purification systems are in high demand. As more biologics progress from clinical trials to commercialization, the need for efficient and compliant production intensifies. The rise in biosimilars also drives volume manufacturing as companies seek to capture market share with competitive pricing. The expanding patient base, technological advancements, and favorable regulatory environment further support this rising demand for biologic and biosimilar manufacturing services.

Advancements in Manufacturing Technologies

Advancements in manufacturing technologies are significantly driving the growth of the United States Biopharmaceuticals Contract Manufacturing Market. The biopharmaceutical industry requires precise, high-quality, and scalable production processes due to the complexity of biologic products such as monoclonal antibodies, recombinant proteins, vaccines, and cell and gene therapies. As the demand for these therapies increases, contract manufacturing organizations (CMOs) are adopting advanced technologies to improve production efficiency, enhance product quality, and reduce time to market. Continuous bioprocessing, for example, is replacing traditional batch manufacturing by enabling non-stop production with greater consistency and reduced costs. This approach minimizes downtime, increases yields, and ensures a more stable supply chain.

Single-use technologies are gaining widespread adoption due to their ability to streamline operations, lower contamination risk, and reduce the need for intensive cleaning and validation processes. These disposable systems are particularly useful in multi-product facilities, allowing faster changeovers and flexibility in accommodating smaller batch sizes or personalized therapies. Automation and digitalization are also transforming the manufacturing landscape. Integration of advanced analytics, real-time monitoring, and artificial intelligence supports predictive maintenance, process optimization, and better-quality control. These tools enable CMOs to respond quickly to market changes and regulatory demands while ensuring compliance with current Good Manufacturing Practices (cGMP).

The U.S. Food and Drug Administration (FDA) has supported the implementation of modern manufacturing platforms through its Emerging Technology Program (ETP), encouraging early adoption of innovative technologies that enhance drug quality and supply reliability. In 2024, the FDA's Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) released a draft Strategy Document outlining specific activities to facilitate the use of innovative manufacturing technologies. These activities include enhancing the CBER Advanced Technologies Team (CATT) and CDER Emerging Technology Program (ETP), implementing the Advanced Manufacturing Technologies Designation Program (AMTDP), and supporting training in advanced manufacturing for FDA assessment staff.

With growing pressure to increase production speed and scalability without compromising on safety or efficacy, CMOs investing in state-of-the-art infrastructure and smart manufacturing systems are better positioned to meet client expectations. These technological improvements not only reduce production costs but also support the rapid development and commercialization of complex biologics, making technological advancement a key enabler in the continued expansion of the biopharmaceutical contract manufacturing sector in the United States.

Growth in Cell and Gene Therapies

The expansion of cell and gene therapies is a significant driver for the United States Biopharmaceuticals Contract Manufacturing Market. These advanced therapies offer transformative potential for treating a range of diseases, including genetic disorders, cancers, and rare conditions. The complexity and specialized nature of manufacturing these therapies necessitate expertise, advanced facilities, and stringent quality controls, leading many biopharmaceutical companies to partner with contract manufacturing organizations (CMOs) to meet production demands.

In 2023, the U.S. Food and Drug Administration (FDA) approved seven cell and gene therapies, including two cell therapies, three gene therapies, and two gene-modified cell therapies, marking a record year for such approvals. Notable approvals include Casgevy (Exagamglogene autotemcel), the first FDA-approved treatment utilizing CRISPR/Cas9 gene editing technology for sickle cell disease and beta-thalassemia, and Lyfgenia (Lovotibeglogene autotemcel), both approved in December 2023. In February 2024, the FDA granted accelerated approval to Lifileucel (Amtagvi), the first tumor-derived T cell immunotherapy for unresectable or metastatic melanoma. Additionally, in April 2024, the FDA approved Fidanacogene elaparvovec (Beqvez), a one-time gene therapy for adults with hemophilia B.

The increasing number of approvals reflects a robust pipeline and a supportive regulatory environment. The FDA's Center for Biologics Evaluation and Research (CBER) has reported a significant rise in investigational new drug (IND) applications for cell and gene therapies, more than doubling since 2017. This surge underscores the growing interest and investment in these therapies.

Manufacturing cell and gene therapies involves complex processes, including viral vector production, cell expansion, and stringent quality control measures. CMOs equipped with specialized facilities and expertise are essential to meet these demands. The reliance on CMOs is expected to grow as more therapies progress from clinical trials to commercialization, driving the expansion of the biopharmaceutical contract manufacturing market in the United States.

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Key Market Challenges

High Capital Investment and Operational Costs

High capital investment and operational costs represent a significant challenge for the United States Biopharmaceuticals Contract Manufacturing Market. Establishing and maintaining a compliant biopharmaceutical manufacturing facility involves substantial financial commitments. Building advanced production infrastructure requires state-of-the-art equipment, specialized cleanroom environments, and robust quality control systems, all of which contribute to high initial capital expenditures. Beyond the setup costs, ongoing operational expenses such as energy-intensive production processes, facility maintenance, skilled labor, and regular validation and calibration activities add to the financial burden. The cost of adhering to current Good Manufacturing Practices (cGMP) and other regulatory standards also places continuous pressure on contract manufacturing organizations (CMOs), as failure to meet these requirements can result in fines, product recalls, or facility shutdowns.

The complexity of biologic drug manufacturing intensifies these challenges. Biopharmaceuticals, including monoclonal antibodies, vaccines, and cell and gene therapies, require highly controlled environments and intricate processing steps that demand both technical expertise and extensive monitoring. Scaling up production from clinical to commercial volumes often involves redesigning processes and reinvesting in infrastructure, leading to further cost escalation. Smaller CMOs or new market entrants may find it difficult to compete due to these high barriers to entry, limiting innovation and reducing market competitiveness. Even established CMOs must continuously reinvest in technology upgrades and workforce development to stay aligned with client expectations and evolving industry standards.

Fluctuations in project volumes also contribute to financial unpredictability. Contract manufacturers depend heavily on client demand, and project delays, cancellations, or variability in batch sizes can disrupt financial planning and operational efficiency. Maintaining underutilized capacity or excess inventory during periods of reduced activity impacts profitability. These financial risks require CMOs to adopt strategic planning, flexible production models, and prudent resource management, all of which add to operational complexity. High investment and running costs thus remain a persistent hurdle to sustainable growth in the biopharmaceuticals contract manufacturing space.

Complexity of Biologics Manufacturing Processes

The complexity of biologics manufacturing processes presents a major challenge for the United States Biopharmaceuticals Contract Manufacturing Market. Biologics are derived from living cells, making their production inherently more intricate and sensitive compared to traditional small-molecule drugs. The upstream and downstream processes involved in biologics manufacturing require precise control of various parameters such as temperature, pH, oxygen levels, and nutrient supply to maintain optimal cell culture conditions. Even slight variations can significantly affect the quality, yield, and safety of the final product. This complexity increases the need for advanced bioprocessing equipment, skilled personnel, and rigorous quality control systems.

Contract manufacturing organizations (CMOs) must invest heavily in infrastructure and adopt cutting-edge technologies such as single-use bioreactors, high-performance chromatography systems, and real-time monitoring tools to meet client expectations and comply with stringent regulatory standards. Establishing and maintaining current Good Manufacturing Practice (cGMP) compliance adds another layer of operational and financial burden. Regulatory authorities like the U.S. Food and Drug Administration (FDA) require comprehensive documentation, validation of processes, and detailed audits to ensure product consistency and patient safety, creating significant compliance pressure for manufacturers.

Tech transfer from biopharmaceutical companies to CMOs is another challenge due to the complexity and customization of biologics processes. Each biologic has unique characteristics that require tailored production methods, and ensuring consistent results during scale-up can be difficult. Limited standardization across platforms, variability in raw materials, and sensitivity to contamination further complicate the production lifecycle. Any deviations can lead to batch failures, costly delays, or loss of product. These challenges not only increase the time and cost of production but also limit the scalability and flexibility of contract manufacturing operations. As demand for biologics continues to rise, addressing these manufacturing complexities will be critical for CMOs to deliver reliable and efficient production services to their clients.

Key Market Trends

Adoption of Single-Use Technologies

​The adoption of single-use technologies (SUTs) has become a pivotal trend in the United States biopharmaceutical contract manufacturing sector, driven by the need for enhanced flexibility, cost-efficiency, and rapid scalability in biologics production. Single-use systems, including disposable bioreactors, filtration assemblies, and chromatography devices, are transforming manufacturing operations by reducing the risk of cross-contamination and eliminating the need for extensive cleaning and sterilization processes. This is especially advantageous for contract manufacturing organizations (CMOs) that manage multiple client products and must frequently switch between batches without compromising product integrity or timelines.

Increased use of SUTs has allowed CMOs to streamline production, reduce downtime, and accelerate time-to-market. These benefits are particularly critical in the production of biologics such as monoclonal antibodies, vaccines, and gene therapies, where speed and compliance are paramount. According to data from BioPlan Associates, over 85% of biomanufacturing facilities in the U.S. have integrated single-use components into their operations. CMOs show higher levels of adoption compared to traditional biopharma companies due to the operational agility and lower upfront capital investment that SUTs offer.

Advances in design and material science have also led to the development of more robust and scalable single-use systems. Innovations in bioreactor engineering, fluid management, and disposable sensor technologies have significantly improved the reliability and efficiency of these systems. The trend toward modular, pre-assembled, and pre-validated SUTs is further reducing the setup time and complexity in manufacturing environments. Regulatory bodies have also acknowledged the safety and reliability of SUTs, contributing to broader acceptance in commercial manufacturing.

As biopharmaceutical pipelines expand and the demand for faster, more flexible production grows, the strategic implementation of single-use technologies is expected to deepen. CMOs leveraging these systems are better positioned to meet the evolving demands of their clients and regulatory agencies while maintaining high standards of product quality and compliance.

Emphasis on Sustainability and Green Manufacturing

​The U.S. biopharmaceutical contract manufacturing market is increasingly focusing on sustainability and green manufacturing practices to address environmental concerns and meet regulatory expectations. The pharmaceutical industry is a significant contributor to environmental pollution, accounting for approximately 12% of acid rain and 10% of greenhouse gas emissions in the United States. This has prompted stakeholders to adopt eco-friendly practices throughout the product lifecycle.

Contract manufacturing organizations (CMOs) are implementing various strategies to reduce their environmental footprint. These include optimizing energy and water usage, minimizing waste generation, and adopting renewable energy sources. For instance, companies are transitioning to renewable energy sources such as biomethane and adopting electric vehicle fleets to reduce carbon emissions. The integration of process analytical technologies (PAT), artificial intelligence (AI), and machine learning (ML) into manufacturing processes enables real-time monitoring and control, leading to more efficient resource utilization and waste reduction.

Regulatory bodies like the U.S. Food and Drug Administration (FDA) are encouraging the adoption of sustainable practices by providing guidelines and support for continuous manufacturing and green chemistry initiatives. These efforts aim to modernize pharmaceutical production, improve drug quality, safety, and supply chain resilience. The FDA's Emerging Technology Program and the European Medicines Agency's Quality by Design (QbD) framework are examples of regulatory initiatives that facilitate the implementation of sustainable manufacturing practices.

The emphasis on sustainability is not only driven by regulatory requirements but also by consumer demand for environmentally responsible products. As environmental concerns become more prominent, stakeholders in the biopharmaceutical industry are increasingly prioritizing sustainability to align with global efforts toward environmental conservation and to meet the expectations of environmentally conscious consumers.

Segmental Insights

Source Insights

Based on the Source, Mammalian emerged as the dominant segment in the United States Biopharmaceuticals Contract Manufacturing Market in 2024. This is driven by its critical role in the production of complex biologics such as monoclonal antibodies, therapeutic proteins, and vaccines. Mammalian cell culture systems, particularly Chinese Hamster Ovary (CHO) cells, are widely preferred due to their ability to perform human-like post-translational modifications, which are essential for the safety, efficacy, and functionality of many biopharmaceutical products. The rising demand for biologics to treat chronic diseases, cancer, and autoimmune disorders has significantly increased reliance on mammalian expression systems. Contract manufacturing organizations (CMOs) have responded to this demand by heavily investing in expanding their mammalian cell-based production capabilities, including large-scale bioreactor systems and single-use technologies.

Service Insights

Based on the Service, Process Development emerged as the dominant segment in the United States Biopharmaceuticals Contract Manufacturing Market in 2024, reflecting the critical role it plays in ensuring efficient, scalable, and cost-effective biopharmaceutical production. Process development involves optimizing the various stages of biologic drug manufacturing from cell line development and upstream processing to downstream purification and formulation. This phase is essential for establishing robust manufacturing protocols that maintain product quality and consistency while minimizing production costs. The increasing complexity of biologics, including monoclonal antibodies, recombinant proteins, and advanced therapies such as gene and cell therapies, has driven demand for specialized process development services. Pharmaceutical companies are increasingly outsourcing these activities to contract manufacturing organizations (CMOs) with expertise and advanced technologies that can accelerate timelines and reduce risks associated with scale-up and regulatory approval.

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Regional Insights

The Mid-West region emerged as the dominant region in the United States Biopharmaceuticals Contract Manufacturing Market in 2024. This is driven by its strong industrial infrastructure and concentration of leading biopharmaceutical companies. The region’s well-established manufacturing facilities, coupled with access to a skilled workforce specializing in bioprocess engineering and quality assurance, have made it an attractive destination for contract manufacturing organizations (CMOs). The presence of several top-tier pharmaceutical and biotechnology firms in states like Illinois, Ohio, and Indiana fosters collaboration and innovation, supporting the growth of biopharmaceutical contract manufacturing activities. Additionally, the Mid-West benefits from robust logistical networks and proximity to major raw material suppliers, enabling efficient supply chain management and timely delivery of biologics. State and local governments in the region also offer favorable policies, incentives, and investments aimed at promoting life sciences and advanced manufacturing sectors, further encouraging the expansion of CMO operations.

Recent Developments

• In July 2024, KBI Biopharma, Inc., a JSR Life Sciences company, announced the extension and expansion of its manufacturing contract with a major global pharmaceutical firm. The agreement, originally signed in 2020, now runs through 2029 and includes a USD 250 million purchase commitment for two therapeutic products. Separately, KBI successfully completed a U.S. FDA inspection of its mammalian manufacturing facility in Durham, North Carolina, enabling commercial supply of drug substances to a key strategic partner and reinforcing its position as a trusted large-scale CDMO.
• In February 2024, Samsung Biologics, a global leader in contract development and manufacturing (CDMO) services, has announced the signing of a strategic partnership agreement with LegoChem Biosciences, a cutting-edge biotech firm specializing in the development of antibody-drug conjugate (ADC) therapies. This collaboration aims to leverage Samsung Biologics’ extensive manufacturing capabilities to support LegoChem’s innovative ADC programs, advancing the development and production of novel oncology treatments.
• In January 2024, Pune-based CDMO Enzene Biosciences, a subsidiary of Alkem Labs, announced the launch of its first U.S. manufacturing facility at the Princeton West Innovation Campus in New Jersey. The site, expected to be operational by June 2024, aims to position Enzene as a CDMO partner for U.S. biotech firms focused on advancing novel therapeutics to market.
• In May 2023, Baxter International Inc. announced a definitive agreement to sell its BioPharma Solutions (BPS) business to Advent International and Warburg Pincus for USD 4.25 billion in cash. The deal is projected to yield approximately USD 3.4 billion in net after-tax proceeds. Baxter plans to use the funds to reduce debt.

Key Market Players

• Lonza Group Ltd.
• WuXi Biologics Co., Ltd.
• Boehringer Ingelheim International GmbH
• Thermo Fisher Scientific Inc.
• Rentschler Biopharma SE
• JRS PHARMA GmbH & Co. KG
• AGC Biologics
• ProBioGen AG
• Samsung Biologics
• FUJIFILM Diosynth Biotechnologies

Report Scope:

In this report, the United States Biopharmaceuticals Contract Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• United States Biopharmaceuticals Contract Manufacturing Market, By Source:

o   Mammalian

o   Non-mammalian

• United States Biopharmaceuticals Contract Manufacturing Market, By Service:

o   Process Development

o   Fill & Finish Operations

o   Analytical & QC studies

o   Packaging & Labelling

o   Others

• United States Biopharmaceuticals Contract Manufacturing Market, By Product:

o   Biologics

o   Biosimilars

• United States Biopharmaceuticals Contract Manufacturing Market, By Therapeutic Area:

o   Oncology

o   Autoimmune Diseases

o   Infectious Diseases

o   Cardiovascular Diseases

o   Metabolic Diseases

o   Neurology

o   Others

• United States Biopharmaceuticals Contract Manufacturing Market, By Region:

o   North-East

o   Mid-West

o   West

o   South

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the United States Biopharmaceuticals Contract Manufacturing Market.

Available Customizations:

United States Biopharmaceuticals Contract Manufacturing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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