U.S. Biopharmaceutical CMO & CRO Market Share Analysis Report, 2024-2033
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.
Key Takeaways:
U.S. Biopharmaceutical CMO & CRO Market Growth
Increasing adoption and investment in advanced research and manufacturing technologies by Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) based in the U.S. is propelling the growth of the biopharmaceutical CMO & CRO market in the country. In addition, quality services offered by service providers are driving the biopharma and CMO partnerships in the country. In addition, the expansion of foreign CMOs and CROs into the country is expected to propel the growth.
Given the growing demand for high-quality biopharmaceutical products and services, many global companies are expanding their operations in the U.S. biopharmaceutical CMO and CRO market to tap into this lucrative market opportunity. This will likely further drive market growth and create new job opportunities in the U.S. biopharmaceutical industry.
For instance, in 2022, the CEO of Samsung Biologics announced that the company is considering the states of California, North Carolina, Washington, and Texas for its first overseas production facility. The South Korean contract manufacturing organization is exploring these locations as potential strong candidates for the new facility.
The pharmaceutical and biopharmaceutical industry has experienced significant supply chain disruptions due to the COVID-19 pandemic. However, the biopharmaceutical CMOs and CROs have been able to respond effectively to the crisis. These organizations have emerged as beneficiaries of the supply chain disruptions caused by the pandemic.
Not only are CMOs and CROs meeting the increasing demand for more flexible and scalable manufacturing capabilities, but they are also taking steps to reduce supply chain risks and costs by expanding their manufacturing facilities in the U.S. The pandemic has exposed the vulnerability of global supply chains, as critical raw materials and finished products experienced severe disruptions. By locating their manufacturing facilities in the U.S., CMOs, and CROs can mitigate the risks associated with geopolitical events, transportation delays, and other factors that could impact the supply chain.
In addition to reducing supply chain risks, locating manufacturing and research facilities in the U.S. can also enhance the efficiency of product delivery by minimizing shipping costs and lead times. This can enable organizations to deliver their products more quickly and efficiently, thereby enhancing their competitiveness in the market. As such, CMOs and CROs are proactively taking steps to adapt to the challenges posed by the pandemic and emerge as stronger players in the biopharmaceutical industry.
U.S. Biopharmaceutical CMO & CRO Market Report Scope
| Report Attribute | Details |
| Market Size in 2024 | USD 11.49 Billion |
| Market Size by 2033 | USD 19.75 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 6.2% |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| Segments Covered | Source, service, product |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Key Companies Profiled | Catalent; Lonza Group AG; Boehringer Ingelheim GmbH; Rentschler Biopharma SE; Thermo Fisher Scientific, Inc; AGC Biologics; Fujifilm Diosynth Biotechnologies U.S.A., Inc.; Samsung Biologics; WuXi Biologics; AbbVie Inc.; Charles River Laboratories International, Inc.; ICON Plc; Parexel International Corporation; Labcorp, Abzena |
Segments Insights:
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.
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:
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
By Service Type
By Product
Chapter 1 Research Methodology
1.1 Market Segmentation & Scope
1.2 Market Definition
1.3 Information Procurement
1.3.1 Purchased database
1.3.2 Nova one advisor’s internal database
1.3.3 Secondary sources & third party perspectives
1.3.4 Primary research
1.4 Information Analysis
1.4.1 Data analysis models
1.5 Market Formulation & Data Visualization
1.6 Data Validation & Publishing
Chapter 2 Executive Summary
2.1 Biopharmaceutical CMO & CRO Market Outlook, 2020 - 2032
Chapter 3 Industry Outlook: Market Variables, Trends, & Scope
3.1 Penetration &Growth Prospect Mapping For Contract Manufacturing Service, 2020
3.2 Trend Analysis
3.2.1 Source trend
3.2.2 Service trend
3.2.3 Product trend
3.2.4 Regional trend
3.3 Biopharmaceutical CMO & CRO Market: Market Dynamics
3.3.1 Market driver analysis
3.3.1.1 Rising investment by CMOs for capacity expansion
3.3.1.2 Commercial success of biopharmaceuticals and consequent increased demand for the biopharmaceuticals
3.3.1.3 Robust biopharmaceuticals pipeline
3.3.1.4 Cost and time-saving benefits offered by contract services
3.3.2 Market restraint analysis
3.3.2.1 Limited outsourcing among well-established biopharmaceutical manufacturers
3.4 Key Opportunity Analysis
3.4.1 Rising funds in the biopharmaceutical industry
3.4.2 Mergers & acquisition for facility expansion
3.4.3 Growing demand for protein therapeutics
3.5 Industry Analysis - Porter’s
3.5.1 Supplier Power: Substantial number of suppliers for bioprocessing equipment contributes to the low supplier power
3.5.2 Buyer Power: Fragmented nature of the biopharmaceutical industry has led to the moderate bargaining power of buyers
3.5.3 Substitution Threat: High due to the presence of several big pharma companies
3.5.4 New Entrants Threat: Presence of established players coupled with the need for adequate capacity results in a moderate threat of new entrants
3.5.5 Competitive Rivalry: High due to the fragmented nature of the market
3.6 Biopharmaceuticals CMO & CRO-SWOT Analysis, By PEST
3.6.1 Political landscape
3.6.2 Economic landscape
3.6.3 Social landscape
3.6.4 Technology landscape
3.7 COVID-19 Impact and Reformation Analysis
Chapter 4 U.S. Biopharmaceuticals CMO & CRO Market: Source Estimates & Trend Analysis
4.1 U.S. Biopharmaceuticals CMO & CRO Market: Source Movement Analysis
4.2 Mammalian Source
4.2.1 U.S. mammalian source market, 2020 - 2032
4.3 Non-mammalian Source
4.3.1 U.S. mammalian source market, 2020 - 2032
Chapter 5 U.S. Biopharmaceuticals CMO & CRO Market: Service Type Estimates & Trend Analysis
5.1 U.S. Biopharmaceuticals CMO & CRO Market: Service Type Movement Analysis
5.2 Contract Manufacturing, by service
5.2.1 U.S. contract manufacturing market, 2020 - 2032
5.2.2 Process development
5.2.2.1 U.S. process development market, 2020 - 2032
5.2.2.2 Downstream processing
5.2.2.2.1 U.S. downstream processing market, 2020 - 2032
5.2.2.3 Upstream processing
5.2.2.3.1 U.S. upstream processing market, 2020 - 2032
5.2.3 Fill & finish operations
5.2.3.1 U.S. fill & finish operations market, 2020 - 2032
5.2.4 Analytical & QC testing
5.2.4.1 U.S. analytical & QC testing market, 2020 - 2032
5.2.5 Packaging
5.2.5.1 U.S. contract packaging market, 2020 - 2032
5.3 Contract Research
5.3.1 U.S. contract research market, 2020 - 2032
5.3.2 Oncology
5.3.2.1 U.S. oncology market, 2020 - 2032
5.3.3 Inflammation & immunology
5.3.3.1 U.S. inflammation & immunology market, 2020 - 2032
5.3.4 Cardiology
5.3.4.1 U.S. cardiology market, 2020 - 2032
5.3.5 Neuroscience
5.3.5.1 U.S. neuroscience market, 2020 - 2032
5.3.6 Others
5.3.6.1 U.S. other CRO services market, 2020 - 2032
Chapter 6 U.S. Biopharmaceuticals CMO & CRO Market: Product Estimates & Trend Analysis
6.1 U.S. Biopharmaceuticals CMO & CRO Market: Product Movement Analysis
6.2 Biologics
6.2.1 U.S. biologics market, 2020 - 2032
6.2.2 Monoclonal Antibodies
6.2.2.1 U.S. monoclonal antibodies market, 2020 - 2032
6.2.3 Recombinant proteins
6.2.3.1 U.S. recombinant proteins market, 2020 - 2032
6.2.4 Vaccines
6.2.4.1 U.S. vaccines market, 2020 - 2032
6.2.5 Antisense, RNAi, & molecular therapy
6.2.5.1 U.S. antisense, RNAi, &molecular therapy market, 2020 - 2032
6.2.6 Others
6.2.6.1 U.S. other product market, 2020 - 2032
6.3 Biosimilars
6.3.1 U.S. biosimilars market, 2020 - 2032
Chapter 7 Competitive Landscape
7.1 Company Profiles
7.1.1 Boehringer Ingelheim GmbH
7.1.1.1 Company overview
7.1.1.2 Financial performance
7.1.1.3 Product benchmarking
7.1.1.4 Strategic initiatives
7.1.2 LONZA
7.1.2.1 Company overview
7.1.2.2 Financial performance
7.1.2.3 Product benchmarking
7.1.2.4 Strategic initiatives
7.1.3 Catalent
7.1.3.1 Company overview
7.1.3.2 Financial performance
7.1.3.3 Product benchmarking
7.1.3.4 Strategic initiatives
7.1.4 Rentschler Biotechnologie GmbH
7.1.4.1 Company overview
7.1.4.2 Financial performance
7.1.4.3 Product benchmarking
7.1.4.4 Strategic initiatives
7.1.5 Thermo Fisher Scientific Inc
7.1.5.1 Company overview
7.1.5.2 Financial performance
7.1.5.3 Product benchmarking
7.1.5.4 Strategic initiatives
7.1.6 AGC Biologics
7.1.6.1 Company overview
7.1.6.2 Financial performance
7.1.6.3 Product benchmarking
7.1.6.4 Strategic initiatives
7.1.7 Fujifilm Diosynth Biotechnologies
7.1.7.1 Company overview
7.1.7.2 Financial performance
7.1.7.3 Product benchmarking
7.1.7.4 Strategic initiatives
7.1.8 Abzena
7.1.8.1 Company overview
7.1.8.2 Financial performance
7.1.8.3 Product benchmarking
7.1.8.4 Strategic initiatives
7.1.9 Samsung Biologics
7.1.9.1 Company overview
7.1.9.2 Financial performance
7.1.9.3 Product benchmarking
7.1.9.4 Strategic initiatives
7.1.10 WuXi Biologics
7.1.10.1 Company overview
7.1.10.2 Financial performance
7.1.10.3 Product benchmarking
7.1.10.4 Strategic initiatives
7.1.11 AbbVie Inc.
7.1.11.1 Company overview
7.1.11.1.1 DPx
7.1.11.2 Financial performance
7.1.11.3 Product benchmarking
7.1.11.4 Strategic initiatives
7.1.12 Charles River Laboratories International, Inc.
7.1.12.1 Company overview
7.1.12.2 Financial performance
7.1.12.3 Product benchmarking
7.1.12.4 Strategic initiatives
7.1.13 ICON Plc
7.1.13.1 Company overview
7.1.13.2 Financial performance
7.1.13.3 Product benchmarking
7.1.13.4 Strategic initiatives
7.1.14 Parexel International Corporation
7.1.14.1 Company overview
7.1.14.2 Financial performance
7.1.14.3 Product benchmarking
7.1.14.4 Strategic initiatives
7.1.15 Labcorp.
7.1.15.1 Company overview
7.1.15.2 Financial performance
7.1.15.3 Product benchmarking
7.1.15.4 Strategic initiatives
Cross-segment Market Size and Analysis for
Mentioned Segments
Additional Company Profiles (Upto 5 With No Cost)
Additional Countries (Apart From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers