U.S. Biopharmaceutical CMO & CRO Market Size to Surpass USD 19.89 Bn by 2032
The U.S. biopharmaceutical CMO & CRO market size was estimated at USD 10.9 billion in 2022 and is expected to surpass around USD 19.89 billion by 2032 and poised to grow at a compound annual growth rate (CAGR) of 6.2% during the forecast period 2023 to 2032.
Key Takeaways:
U.S. Biopharmaceutical CMO & CRO Market Report Scope
| Report Coverage | Details |
| Market Size in 2023 | USD 19.89 Billion |
| Market Size by 2032 | USD 11.58 Billion |
| Growth Rate From 2023 to 2032 | CAGR of 6.2% |
| Base Year | 2022 |
| Forecast Period | 2023 to 2032 |
| 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 |
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.
Source Insights
In 2022, the mammalian segment of the biopharmaceutical manufacturing market held the highest market share at 68.19%. 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 6.11%, 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 82.11% in 2022. 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 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the U.S. Biopharmaceutical CMO & CRO market.
By Source
By Service Type
By Product
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