U.S. Pharmaceutical Contract Manufacturing And Research Services Market Size, Share & Trends Analysis Report By Service (Manufacturing, Drug Delivery Formulations, Finished Dose Formulations, Research)) - Industry Analysis, Size, Share, Growth, Trends, and Forecast 2024-2033

U.S. Pharmaceutical Contract Manufacturing And Research Services Market Size and Trends

The U.S. pharmaceutical contract manufacturing and research services market size was valued at USD 60.19 billion in 2023 and is projected to surpass around USD 105.77 billion by 2033, registering a CAGR of 5.8% over the forecast period of 2024 to 2033. 

U.S. Pharmaceutical Contract Manufacturing And Research Services Market Key Takeaways

• Manufacturing dominated the market and held the largest revenue share of over 66.85% in 2023.
• Research is anticipated to witness the fastest CAGR during the forecast period.

U.S. Pharmaceutical Contract Manufacturing And Research Services Market Growth Factors

This growth is being driven by the cost and time savings associated with outsourcing. Companies are continually investing in facilities, staff, and technology in order to increase their portion of outsourcing revenue. The presence of comprehensive service providers, who provide additional services as part of a unified or risk-sharing business model, is expected to drive market expansion. However, the initial impact of the COVID-19 pandemic interrupted the supply chain, which could impede market expansion.

In 2023, the United States accounted for more than 24.5% of the global pharmaceutical contract manufacturing and research services market. Contract Manufacturing Organizations (CMOs) are expected to develop because to their extensive product offerings, which position them as a handy "one-stop-shop". Larger CMOs are turning their focus to specialized areas of pharmaceutical research and building regulatory paths for the production of medicines using transgenic technologies. Companies, on the other hand, tend to prefer in-house production for complicated and considerable components due to specific requirements, thus providing a challenge to the outsourcing industry.

Companies involved in R&D and production of healthcare products, including those that supply hardware and services, are boosting their investments in response to increased demand for rapid development, testing, and deployment of COVID-19 vaccine. Despite small setbacks, pharmaceutical contract manufacturers have continued to operate, and long-term capital-intensive mergers and acquisitions have increased. In addition, governments are collaborating with pharmaceutical companies to develop COVID-19 vaccines through projects such as Operation Warp Speed, which is funded by the US federal government.

COVID-19 has caused a surge in demand for treatments and vaccines as a result of the virus's broad transmission. As a result, many pharmaceutical companies have partnered with Contract Manufacturing Organizations (CMOs) to speed drug production. For example, in December 2020, Recipharm, a Contract Development and Manufacturing Organization (CDMO), formed a cooperation with Moderna, a pharmaceutical business. Under this deal, Recipharm assisted the fill-finish process for Moderna's COVID-19 vaccine, which is intended for distribution outside of the United States. Furthermore, several public entities have provided funds to support research of COVID-19 vaccines.

U.S. Pharmaceutical Contract Manufacturing And Research Services Market Report Scope

U.S. Pharmaceutical Contract Manufacturing And Research Services Market Trends

• Outsourcing Growth: Pharmaceutical companies are increasingly outsourcing manufacturing and research services to contract organizations due to cost-saving initiatives, flexibility in capacity, and access to specialized expertise. This trend is driven by the need for efficiency and focus on core competencies.
• Increasing Complexity: The pharmaceutical landscape is becoming more complex with the development of biologics, personalized medicines, and specialty drugs. This complexity requires specialized manufacturing capabilities and research expertise, leading to a growing demand for contract services.
• Rise in Biologics: Biologic drugs, including monoclonal antibodies and cell therapies, are gaining prominence in the pharmaceutical market. Contract manufacturing organizations (CMOs) are investing in bioprocessing capabilities to meet the demand for manufacturing these complex therapeutics.
• Regulatory Compliance: Stringent regulatory requirements in the pharmaceutical industry necessitate adherence to quality standards and compliance with Good Manufacturing Practices (GMP). Contract manufacturing and research organizations must maintain regulatory compliance to ensure the safety and efficacy of products.
• Technology Advancements: Advancements in technology, such as automation, analytics, and digitalization, are transforming the pharmaceutical manufacturing and research landscape. Contract organizations are adopting these technologies to improve efficiency, quality, and speed to market.
• Partnerships and Collaborations: Collaboration between pharmaceutical companies and contract organizations is increasing, with partnerships often extending beyond traditional outsourcing models. Companies are forming strategic alliances to leverage each other's strengths in drug development and manufacturing.
• Shift towards Flexible Manufacturing: Flexibility in manufacturing is becoming crucial to accommodate changing demand, shorter product life cycles, and personalized medicine. Contract manufacturing organizations are investing in flexible manufacturing platforms to adapt to evolving market needs.
• Focus on Supply Chain Resilience: The COVID-19 pandemic highlighted vulnerabilities in the global pharmaceutical supply chain. Pharmaceutical companies are reevaluating their supply chain strategies, including reliance on contract manufacturing partners, to enhance resilience and mitigate risks.
• Increased Competition: The contract manufacturing and research services market is becoming more competitive with the entry of new players and expansion of existing ones. Differentiation through specialized capabilities, quality, and customer service is key to maintaining a competitive edge.
• Growing Importance of Outsourced Research Services: In addition to manufacturing, there is a growing demand for outsourced research services, including drug discovery, preclinical development, and clinical research. Contract research organizations (CROs) are playing a vital role in accelerating the drug development process.

U.S. Pharmaceutical Contract Manufacturing And Research Services Market By Service Insights

Manufacturing dominated the market and held the largest revenue share of over 66.85% in 2023, owing to a rising trend of companies choosing to outsource the production of drug substances, APIs, and completed drug products or clinical trial materials. Contract manufacturers offer a range of services to the pharmaceutical industry, such as safety evaluation, development of dosage and formulation, regulatory support, development of analytical assays, and conducting release and stability tests. These contract manufacturers are frequently selected as a temporary fix for limitations in production capacity.This sector is further divided into several sub-sectors, including manufacturing of API/bulk drugs, the creation of advanced drug delivery formulations, packaging, and production of finished dose formulations. Companies are actively involved in establishing large-scale manufacturing facilities, both at the pilot and commercial levels.

Research is anticipated to witness the fastest CAGR during the forecast period. The growth in this segment is driven by the presence of numerous multinational and established contract service providers, such as Charles River Laboratories, Pharmaceutical Product Development Inc. (PPD), Covance, and Quintiles. These market players are poised to gain from the increasing trend of outsourcing. The Contract Research Organization (CRO) sector has seen a surge in mergers and acquisitions, leading to heightened competition among CROs. This has spurred the CROs to enhance their capabilities to cater to the needs of drug developers. Services provided by CROs span from the inception of drug development to the final marketing approval. The segment is further divided into oncology, vaccines, inflammation & immunology, cardiology, neuroscience, and others.

U.S. Pharmaceutical Contract Manufacturing And Research Services Market Recent Developments

• In January 2023, Pfizer, a leading pharmaceutical company, entered into an agreement to acquire Abzena's manufacturing site located in Sanford, North Carolina. Once finishing the construction, the cutting-edge facility will be equipped with comprehensive features to produce biologics drug substance. This will enhance Pfizer’s manufacturing capacity, thereby speeding up its innovative pipeline.
• In April 2022, Catalent, Inc. acquired a facility from Vaccine Manufacturing and Innovation Centre UK Limited. The intention of this acquisition was to expand its manufacturing capabilities in producing biologics in the UK.
• In March 2022, Albany Molecular Research, Inc. (CURIA) entered into a cooperative Agreement with biomedical Advanced Research and Development Authority (BARDA) to add a high-speed line to expand its sterile fill-finish capabilities.
• In July 2021, Catalent, Inc. launched GPEx Lightning Cell Line Expression Technology to reduce the time for Drug Substance Development. This technology leverages company’s GPEx expression platform in the knock-out Chinese Hamster Ovary (CHO) cell line system, and Glutamine Synthase (GS). This technology includes novel gene insertion technology which shortens the drug development by up to three months.

U.S. Pharmaceutical Contract Manufacturing And Research Services Market Top Key Companies:

• Catalent
• Pfizer (CentreOne)
• Charles River Laboratories International, Inc.
• Albany Molecular Research, Inc.
• Laboratory Corporation of America Holdings (LabCorp)
• IQVIA
• Baxter BioPharma Solutions
• Lingand Pharmaceuticals
• Thermo Fisher Scientific, Inc.
• AbbVie, Inc.
• West Pharmaceutical Services

U.S. Pharmaceutical Contract Manufacturing And Research Services Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Pharmaceutical Contract Manufacturing And Research Services market.

By Service 

• Manufacturing
  • API/Bulk Drugs
  • Advanced Drug Delivery Formulations Packaging
  • Packaging
  • Finished Dose Formulations
    • Solid Formulations
    • Liquid Formulations
    • Semi-solid Formulations
• Research
  • Oncology
  • Vaccines
  • Inflammation & Immunology
  • Cardiology
  • Neuroscience
  • Others