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U.S. Biopharmaceutical CMO & CRO Market Size, Share & Growth Report, 2033

April 15, 2024 | 
11 min read

The U.S. biopharmaceutical CMO & CRO market size was estimated at USD 10.82 billion in 2023 and is projected to hit around USD 19.75 billion by 2033, growing at a CAGR of 6.2% during the forecast period from 2024 to 2033.

The U.S. biopharmaceutical CMO & CRO market size was estimated at USD 10.82 billion in 2023 and is projected to hit around USD 19.75 billion by 2033, growing at a CAGR of 6.2% during the forecast period from 2024 to 2033.

The contract manufacturing organization (CMO) and contract research organization (CRO) industries have seen significant growth in recent years, particularly in the U.S. This growth is driven by a variety of factors, including the increasing demand for biologics and other complex therapies, the need for more flexible and scalable manufacturing capabilities, and the desire to reduce supply chain risks and costs.

Another factor driving the expansion of CMO and CRO manufacturing facilities in the U.S. is the need for more flexible and scalable manufacturing capabilities. The biopharmaceutical industry is characterized by rapid technological change and changing demands, which can create challenges for companies that have invested heavily in fixed manufacturing assets. By outsourcing to CMOs and CROs, pharmaceutical companies can access manufacturing and research capacity on an as-needed basis, without incurring the fixed costs associated with building and maintaining their own facilities. This approach allows companies to more quickly and efficiently respond to changes in market demand.

The increased demand for biopharmaceutical research and manufacturing has resulted in CMOs and CROs acquiring existing biopharmaceutical manufacturing and research facilities or building new facilities in their existing plants. This is because the expansion of these facilities increases the capacity to meet the growing demand for biologics and other biopharmaceutical products.

With the U.S. being a major market for biopharmaceuticals, expansion of facilities in this region is crucial for companies to cater to the needs of their customers and stay competitive in the market. For instance, FUJIFILM Diosynth Biotechnologies announced plans to expand their Taxes plant by adding 138,000 sq feet by 2024. This expansion will lead to the construction of a new cGMP production facility that is expected to become operational in 2024. This expansion is expected to double the advanced therapy and vaccine manufacturing capacity of the company in the U.S.

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Key Takeaways:

  • In 2023, the mammalian segment of the biopharmaceutical manufacturing market held the highest market share at 69.14%. and is expected to grow at a CAGR of 6.3% during the forecast period.
  • The contract research service types segment is expected to register the fastest CAGR of 6.9% over the forecast period
  • The biologics segment is expected to dominate the market with the largest revenue share of 83.4% in 2023.
  • This can be attributed to the local presence of several contract research service providers in the country. The U.S. has a higher concentration and number of biopharmaceutical CMOs and CROs in comparison with other countries

CROs vs CMOs, and CDMOs: What’s the difference between the three?

Developing and manufacturing a new drug is an intense undertaking with many moving parts. From discovery and development to preclinical research, clinical research, review and approval, and commercialization, the list of to-dos is seemingly endless. What’s more, biotechnology and pharmaceutical companies must abide by current good manufacturing practice (cGMP) regulations enforced by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other international counterparts, which outline minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.1

To navigate industry complexities and bridge resource gaps, biotechnology and pharmaceutical companies often look to third-party vendors for development and manufacturing support — most often to CROs, CMOs, or CDMOs, specifically. But what’s the difference between the three? Contract research organizations (CROs), contract manufacturing organizations (CMOs), and contract development and manufacturing organizations (CDMOs) all provide specialized capabilities and operational infrastructure when it comes to drug development and manufacturing. Although their services and solutions often overlap, there are some key differences to keep in mind. Read on to discover the key differences between CROs, CMOs, and CDMOs, and explore which one’s right for you.

U.S. Biopharmaceutical CMO & CRO Market Top Trends

  • Outsourcing Expansion: Biopharmaceutical companies continue to outsource more of their manufacturing and research activities to CMOs and CROs to streamline operations, reduce costs, and access specialized expertise.
  • Increasing Demand for Biologics: The rising demand for biologic drugs, including monoclonal antibodies and cell therapies, is driving the need for CMOs with advanced bioprocessing capabilities to manufacture these complex molecules.
  • Technological Advancements: Adoption of advanced technologies such as single-use systems, continuous manufacturing, and process automation is enhancing efficiency, reducing production costs, and improving product quality in biopharmaceutical manufacturing.
  • Bioprocessing Innovation: CMOs are investing in innovative bioprocessing technologies and techniques to optimize manufacturing processes, increase product yields, and shorten time-to-market for biopharmaceutical products.
  • Regulatory Compliance and Quality Assurance: With stringent regulatory requirements for biopharmaceutical manufacturing, CMOs are focusing on maintaining compliance with current Good Manufacturing Practices (cGMP) and ensuring high standards of quality assurance to meet regulatory expectations.
  • Integration of Data Analytics and AI: CROs are leveraging data analytics and artificial intelligence (AI) to improve clinical trial design, patient recruitment, data management, and analysis, thereby enhancing the efficiency and success rates of clinical research studies.
  • Expansion of Outsourced Clinical Trials: Biopharmaceutical companies are increasingly outsourcing clinical trial activities to CROs to leverage their expertise, resources, and global networks for faster patient recruitment, efficient trial management, and access to diverse patient populations.
  • Emergence of Virtual Trials: The COVID-19 pandemic has accelerated the adoption of decentralized and virtual clinical trial models, prompting CROs to develop innovative remote monitoring technologies and digital platforms to conduct trials remotely while ensuring data integrity and patient safety.

These trends underscore the evolving landscape of biopharmaceutical outsourcing in the U.S., characterized by a growing emphasis on innovation, efficiency, and collaboration between biopharma companies and CMOs/CROs to drive drug development and commercialization success.

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Source Insights

In 2023, the mammalian segment of the biopharmaceutical manufacturing market held the highest market share at 69.14%. This is primarily due to the lack of internal expertise in the biopharmaceutical industry to add human-like post-translational modifications to complex protein therapeutics. Mammalian cells are capable of performing such modifications, making them an attractive option for the production of biologics.

Moreover, advancements in technology have greatly benefited the mammalian cell line segment. The introduction of novel and robust enhanced expression systems, improved process monitoring solutions, cell line engineering tools, automated screening methods, and disposable devices have all contributed to a more efficient and productive manufacturing process of biologics using mammalian cells.

While mammalian cells dominate the biopharmaceutical manufacturing market, non-mammalian cell lines such as microbial cells are also gaining recognition as potent factories for biologics. Innovative strategies are being implemented to identify and explore the potential of various microbes, which is expected to contribute to the growth of the non-mammalian biopharmaceutical manufacturing segment. With the ongoing development of new technologies and approaches, the biopharmaceutical manufacturing market is expected to witness significant growth in the coming years, providing new opportunities for both mammalian and non-mammalian cell lines.

Service Type Insights

Over the forecast period, the contract research segment is expected to exhibit a higher CAGR of 6.9%, primarily due to the increasing trend of outsourcing research activities by biopharmaceutical companies. Furthermore, CROs are striving to capitalize on the potential avenues in the biopharmaceutical industry.

New market entrants and small participants that are focused on developing biopharmaceuticals are anticipated to opt for contract research services for their discovery programs of new candidates, which is expected to boost the revenue growth of CROs. As more biopharma companies and research firms seek to reduce costs and increase efficiency, outsourcing is likely to remain a key trend in the industry, providing ample opportunities for the contract research segment to expand its market share.

Many CMOs and opportunistic CMOs present in the market are engaged in providing biopharma entities with end-to-end coverage, from cell cultivation to fill/finish services. Moreover, clients are investing heavily in outsourcing the manufacturing aspect of their product development program, which has resulted in the largest share of this segment. With the presence of many CMOs and CROs providing a wide range of services, this segment is expected to continue to gain momentum in the coming years.

Product Insight

The biologics segment is expected to dominate the market with the largest revenue share of 83.4% in 2023. This growth is attributed to the high specificity of biologics, complex manufacturing steps, and higher success rates compared to other drug molecules, resulting in the dominance of this segment.

The use of innovative technologies such as single-use bioreactors, continuous purification processing, disposable plastic containers, and real-time quality analysis has enabled CMOs to meet the increasing demand for biologics production effectively. Additionally, several companies are investing in biosimilar development to outperform the safety, efficacy, disposition, or cost of earlier in-class innovator drugs. This has increased the level of competition among innovator manufacturers, which in turn, is likely to benefit the CMOs.

As the biologics market continues to grow and biosimilar development gains traction, CMOs are expected to play a critical role in the manufacturing process. The use of advanced technologies and techniques is likely to further enhance their ability to provide high-quality, efficient, and cost-effective manufacturing services. This, in turn, will drive the growth of the biologics segment and the overall CMO & CRO market.

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Key Companies & Market Share Insights

To gain a competitive advantage over other players in the CMO & CRO market, companies are undertaking various strategic initiatives. Key parameters affecting the competitive nature of the market include acquisitions, geographic expansions, mergers and acquisitions, and product launches. For instance, in February 2023, Lonza announced the opening of a new laboratory in Cambridge, Massachusetts, as part of the Swiss CDMO’s plan to expand its early development services (EDS) division in North America.

The expanded services by Lonza are focused on helping customers identify and address potential problems with drug candidates during the early stages of development and before clinical trials to help reduce the risks of failure. The new facility will serve preclinical-stage small and mid-sized biotechs looking to develop biologic drugs. This expansion is expected to enhance Lonza’s market presence in North America and strengthen its position in the CMO & CRO market. Such strategic initiatives by players in the market are likely to drive growth, promote innovation, and enhance their overall market competitiveness. Some prominent players in the U.S. biopharmaceutical CMO and CRO market include:

  • Catalent
  • Boehringer Ingelheim GmbH
  • Thermo Fisher Scientific Inc
  • Lonza
  • Rentschler Biopharma SE
  • FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
  • Samsung Biologics
  • AGC Biologics
  • WuXi Biologics
  • Abzena

Segments Covered in the Report

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. Biopharmaceutical CMO & CRO market.

By Source

  • Mammalian
  • Non-mammalian

By Service Type

  • Contract Manufacturing
    • Process Development
      • Downstream
      • Upstream
    • Fill & Finish Operations
    • Analytical & QC studies
    • Packaging
  • Contract Research
    • Oncology
    • Inflammation & Immunology
    • Cardiology
    • Neuroscience
    • Others

By Product

  • Biologics
    • Monoclonal antibodies (MAbs)
    • Recombinant Proteins
    • Vaccines
    • Antisense, RNAi, & Molecular Therapy
    • Others
  • Biosimilars

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