According to the report, the global biopharmaceutical CMO And CRO market size was estimated at USD 37.19 billion in 2023 and is projected to hit around USD 65.36 billion by 2033, growing at a CAGR of 5.8% during the forecast period from 2024 to 2033. North America dominated the biopharmaceutical CMO And CRO market with the largest revenue share of 34.11% in 2023.
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The biopharmaceutical industry has witnessed a steady increase in the demand for outsourced services, with Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) playing crucial roles. CROs provide comprehensive research and development services throughout clinical trials, while CMOs specialize in manufacturing drugs on a larger scale, encompassing primary synthesis of drug substances and secondary formulation into final products across various dosage forms.
This trend towards outsourcing has led to a heightened focus on talent acquisition within CROs and CMOs, fostering specialized expertise and operational efficiency. By leveraging these external partnerships, pharmaceutical companies effectively manage internal resources and costs, transforming the CRO/CMO relationship into a strategic alliance. This collaborative approach not only supports industry growth but also enhances flexibility and innovation in biopharmaceutical development and manufacturing.
Market Overview
The biopharmaceutical CMO and CRO market is rapidly expanding as pharmaceutical and biotechnology companies increasingly rely on outsourced services for research, development, and manufacturing. Contract Research Organizations (CROs) provide essential support throughout clinical trial phases, offering expertise in clinical research, regulatory affairs, and trial logistics. Meanwhile, Contract Manufacturing Organizations (CMOs) facilitate efficient production of drug substances, ensuring compliance with rigorous quality standards and regulatory requirements. This outsourcing trend not only enhances cost-effectiveness through access to advanced facilities and skilled personnel but also accelerates drug development timelines, positioning CMOs and CROs as pivotal partners in the industry’s growth and innovation efforts.
• In April 2024, Parexel and Palantir expanded their collaboration to accelerate clinical data delivery and improve clinical outcomes for patients.
Biopharmaceutical CMO And CRO Market Key Takeaways
- North America held a largest revenue share of 34.11% in 2023.
- Asia Pacific biopharmaceuticals CMO & CRO Market is growing at a significant rate and the region is expected to emerge as the fastest-growing market
- The mammalian segment held the highest market share of more than 57.11% in 2023
- Non-mammalian segment is projected to witness a rapid growth of 7.7% during the forecast period.
- Contract Manufacturing segment held a dominant share of over 58.98% in 2023.
- Contract Research segment is anticipated to witness the fastest growth rate of 6.4% in biopharmaceutical CMO and CRO market over a forecast period.
- Biologics segment dominated a market with largest revenue share of over 80.11% in 2023.
- Biosimilars segment is anticipated to witness a fastest growth rate of 8.7% in biopharmaceutical CMO and CRO market over a forecast period.
U.S. Biopharmaceutical CMO And CRO Market Size and Growth 2024 to 2033
The U.S. biopharmaceutical CMO And CRO market size was valued at USD 10.82 billion in 2023 and is anticipated to reach around USD 19.75 billion by 2033, growing at a CAGR of 6.2% from 2024 to 2033.
North America held a largest revenue share of 34.11% in 2023, maintaining its largest share throughout the forecast period. The U.S. pharmaceutical industry leads in developing innovative drugs, albeit often expensive, contributing significantly to healthcare costs for both private sectors and federal agencies. In Canada, the focus of Contract Research Organizations (CROs) on histopathology and genomics services underscores growing capabilities in advanced medical research.
CellCarta in Canada offers diverse biomarker platforms and services including antigen presentation, bioanalytical solutions, and immune profiling, enhancing capabilities in biologics characterization and data mining. Mexico’s evolving healthcare sector, with recent reforms in procurement and distribution systems, positions it as a crucial market for diverse healthcare products and services. These regional dynamics highlight North America’s pivotal role in pharmaceutical innovation and healthcare advancements.
Asia Pacific emerges as a highly promising market during the forecast period, driven by shifting dynamics in pharmaceutical outsourcing and strategic location decisions. Beyond being a manufacturing hub, Asia is increasingly recognized as pivotal in global drug discoveries. Pharmaceutical companies are expanding their presence in Asia to capitalize on its growing significance as both a consumer market and a hub for manufacturing and human capital. India, in particular, is gaining traction as a preferred destination for biotechnology outsourcing, attracting global biopharmaceutical firms seeking cost efficiencies in development and manufacturing. This trend reflects a strategic move by “Big Pharma” to optimize operational costs while leveraging Asia’s expanding capabilities in biopharmaceutical innovation and production.
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Report Highlights
By Service Insights
Contract Manufacturing segment held a dominant share of over 58.98% in 2023, driven by its ability to help pharmaceutical companies enhance productivity and efficiency while ensuring quality products. Partnering with contract manufacturing organizations (CMOs) allows pharmaceutical firms to achieve significant cost savings and gain access to specialized services that optimize manufacturing processes. This strategic collaboration not only boosts productivity but also improves overall quality control, making CMOs preferred partners in the pharmaceutical industry. The key benefits include operational efficiencies, cost-effectiveness, and enhanced capabilities in delivering high-quality pharmaceutical products to meet market demands.
Contract Research segment is anticipated to witness the fastest growth rate of 6.4% in biopharmaceutical CMO and CRO market over a forecast period .as contract research organizations (CROs) play a critical role in providing specialized research services to biotechnology, pharmaceutical, and medical device industries, along with academic institutions. Whether offering comprehensive full-service capabilities or specialized services, CROs are pivotal partners for pharmaceutical companies in advancing research and development initiatives. Their contributions are instrumental in shaping advancements in life sciences and healthcare, facilitating innovation and efficiency across the sector. This growing reliance on CROs underscores their significance in driving research excellence and supporting pharmaceutical companies in achieving their scientific and commercial objectives.
By Source Insights
The mammalian segment held the highest market share of more than 57.11% in 2023, to the burgeoning potential of biopharmaceuticals. This segment focuses on producing medicinal products through mammalian cell cultures, encompassing a wide array of therapeutic substances such as hormones, enzymes, cytokines, clotting factors, antibodies, and fusion protein therapeutics. The utilization of mammalian cell cultures offers significant commercial opportunities for drug developers by enabling the production of complex biologics that meet diverse medical needs. This growth underscores the pivotal role of mammalian sources in advancing biopharmaceutical research and expanding therapeutic options in the healthcare sector.
Non-mammalian segment is projected to witness a rapid growth of 7.7% during the forecast period, driven by efforts to overcome historical challenges in producing biologically active whole antibodies through systems like yeast or bacteria cultures. Previous limitations related to achieving proper folding and glycosylation have posed hurdles. Advancements in biotechnology and genetic engineering are enhancing the potential of non-mammalian sources to produce complex biologics more effectively. These developments are poised to expand the scope of non-mammalian cell culture systems in biopharmaceutical production, offering new opportunities for innovation and commercialization in the healthcare industry.
By Product Type Insights
Biologics segment dominated a market with largest revenue share of over 80.11% in 2023, commanding the largest share. Biologics, also known as biological drugs, are manufactured using living organisms such as microorganisms, plant cells, or animal cells. They have long been integral to medical treatments, particularly in oncology where they are used to combat cancer by slowing tumor growth and aiding recovery from other anti-cancer therapies. The growth of biologics underscores their therapeutic importance and increasing adoption in diverse disease treatments, driven by advancements in biotechnology and the demand for targeted and personalized medicine solutions. This trend highlights biologics as pivotal drivers of innovation and growth in the pharmaceutical and healthcare sectors.
The biosimilars segment is poised for growth in the forecast period as these biologic products are designed to replicate FDA-approved reference biologics with high similarity in safety, purity, and potency. Biosimilars undergo rigorous testing and trials by manufacturers to demonstrate their equivalence to the reference product, ensuring they meet stringent regulatory standards. This segment offers significant opportunities by providing cost-effective alternatives to expensive biologics, thereby enhancing patient access to essential treatments. As healthcare systems worldwide seek to contain costs while maintaining treatment efficacy, biosimilars play a crucial role in expanding therapeutic options and fostering competition in the biopharmaceutical market. The anticipated growth of biosimilars underscores their potential to drive innovation and affordability in biologic therapies, benefiting both patients and healthcare providers.
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Market Dynamics
Driver
The Role of CROs and CMOs in Biopharmaceutical Development
The demand for cost-effective development and manufacturing of biopharmaceutical products is escalating, amidst global healthcare systems’ efforts to enhance efficiency and curb costs. In response, industries are reassessing and optimizing their internal processes. Outsourcing to Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) has emerged as a pivotal trend, facilitating streamlined operations and expanding market opportunities. This strategic shift not only supports industry adaptability but also fosters growth in the biopharmaceutical CMO and CRO market, driven by the need for specialized expertise and enhanced operational efficiency.
Restraints Risk Management Challenges
Pharmaceutical companies engaged in outsourcing agreements must prioritize risk management, especially given the critical nature of supply chain strategies. The sector faces significant risks associated with logistics outsourcing, influenced by both internal and external factors. To effectively navigate these challenges, organizations require a systematic and disciplined approach to identify and mitigate risks. Factors such as market dynamics, competitive pressures, technological advancements, evolving client demands, reduced response times, and strategic global outsourcing pose continuous risks that can hinder the growth of the biopharmaceutical CMO and CRO market. Addressing these complexities is essential to sustain operational resilience and foster growth in an increasingly dynamic industry environment.
Opportunities
The Evolution of Biopharmaceutical Outsourcing in CMOs and CROs
Outsourcing has become indispensable in the biopharmaceutical industry, with contract manufacturing organizations (CMOs) playing a critical role in meeting high-volume production demands for vaccines and therapies. Beyond capacity, outsourcing offers pharmaceutical companies essential benefits such as cost control, resource optimization, and expedited market entry. CMOs are poised to significantly expand outsourcing across analytical and toxicity testing, as well as fill/finish operations, driven by increasing demands and the need for advanced services.
Simultaneously, pharmaceutical firms are outsourcing research activities to maintain competitiveness amidst rapid technological advancements and economic uncertainties. This strategic shift toward outsourcing creates substantial growth opportunities for both biopharmaceutical CMOs and contract research organizations (CROs), fostering innovation and flexibility in a dynamic industry landscape.
- In January 2023, Agilent and Akoya Biosciences announced a partnership to advance multiplex tissue assay development for biopharma applications.
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Biopharmaceutical CMO And CRO Market Top Key Companies:
- Boehringer Ingelheim GmbH
- Lonza Group AG
- Inno Biologics Sdn Bhd
- Rentschler Biopharma SE
- JRS Pharma
- Biomeva GmbH
- ProBioGen AG
- Fujifilm Diosynth Biotechnologies U.S.A., Inc.
- Toyobo Co., Ltd.
- Samsung Biologics
- Thermo Fisher Scientific Inc (Patheon & PPD)
- CMC Biologics
- WuXi Biologics
- AbbVie Inc.
- Binex Co., Ltd.
- Charles River Laboratories International, Inc.
- ICON Plc
- Parexel International Corporation
- Laboratory Corporation of America Holdings
Biopharmaceutical CMO And CRO Market Recent Developments
- In June 2023, Lonza, a contract manufacturing services (CMO) in the biotechnology and pharmaceutical industries,acquired Synaffix B.V. (Synaffix), a biotechnology company dedicated to advancing its clinical-stage technology platform for Antibody-Drug Conjugate development. The acquisition is set to enhance Lonza’s bioconjugates portfolio by incorporating Synaffix’s proprietary technology platform and research and development capabilities.
- In October 2023, Samsung Biologics and Kurma Partners entered in to strategic collaboration for the development and manufacturing of biologics intended for Kurma’s portfolio companies.The multi-year collaboration is anticipated to foster the sustainable growth of the biopharmaceutical industry, enabling Samsung Biologics to extend its presence into the European market.
Biopharmaceutical CMO And CRO 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 Biopharmaceutical CMO And CRO market.
By Source
- Mammalian
- Non-mammalian
By Service Type
- Contract Manufacturing
- Process Development
- Downstream
- Upstream
- Fill & Finish Operations
- Analytical & QC Studies
- Packaging
- Process Development
- Contract Research
- Oncology
- Inflammation & Immunology
- Cardiology
- Neuroscience
- Others
By Product
- Biologics
- Monoclonal antibodies (MAbs)
- Recombinant Proteins
- Vaccines
- Antisense, RNAi, & Molecular Therapy
- Others
- Biosimilars
By Region
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa (MEA)
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Reasons to Purchase this Report
- Qualitative and quantitative analysis of the market based on segmentation involving both economic as well as non-economic factors
- Provision of market value (USD Billion) data for each segment and sub-segment
- Indicates the region and segment that is expected to witness the fastest growth as well as to dominate the market
- Analysis by geography highlighting the consumption of the product/service in the region as well as indicating the factors that are affecting the market within each region
- Competitive landscape which incorporates the market ranking of the major players, along with new service/product launches, partnerships, business expansions, and acquisitions in the past five years of companies profiled
- Extensive company profiles comprising of company overview, company insights, product benchmarking, and SWOT analysis for the major market players
- The current as well as the future market outlook of the industry with respect to recent developments which involve growth opportunities and drivers as well as challenges and restraints of both emerging as well as developed regions
- Includes in-depth analysis of the market from various perspectives through Porter’s five forces analysis
- Provides insight into the market through Value Chain
- Market dynamics scenario, along with growth opportunities of the market in the years to com
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