美国生物制药CMO和CRO市场规模、份额和增长报告，2033年-动脉网

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

BioSpace 等信源发布 2024-04-15 12:28

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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.

2023年，美国生物制药CMO和CRO市场规模估计为108.2亿美元，预计到2033年将达到约197.5亿美元，在2024年至2033年的预测期间，复合年增长率为6.2%。

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..

近年来，合同制造组织（CMO）和合同研究组织（CRO）行业取得了显着增长，尤其是在美国。这种增长是由多种因素驱动的，包括对生物制剂和其他复杂疗法的需求不断增加，对更灵活和可扩展的制造能力的需求，以及降低供应链风险和成本的愿望。。

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.

推动美国CMO和CRO制造工厂扩张的另一个因素是需要更灵活和可扩展的制造能力。生物制药行业的特点是技术变革迅速，需求不断变化，这可能会给在固定制造资产上进行大量投资的公司带来挑战。

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..

通过外包给CMO和CRO，制药公司可以根据需要获得制造和研究能力，而无需承担建造和维护自己设施的固定成本。这种方法使公司能够更快速有效地应对市场需求的变化。。

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..

对生物制药研究和制造的需求增加，导致CMO和CRO收购现有的生物制药制造和研究设施，或在现有工厂建设新设施。这是因为这些设施的扩建提高了满足生物制剂和其他生物制药产品日益增长的需求的能力。。

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.

由于美国是生物制药的主要市场，该地区设施的扩建对于公司满足客户需求并保持市场竞争力至关重要。例如，富士薄膜Diosynch Biotechnologies宣布计划在2024年前扩建其税务工厂，增加138000平方英尺。

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..

此次扩建将导致新建cGMP生产设施，预计将于2024年投入运营。预计这一扩张将使该公司在美国的先进治疗和疫苗生产能力翻一番。。

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Key Takeaways:

关键要点：

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.

2023年，生物制药制造市场的哺乳动物市场份额最高，为69.14%。预计在预测期内，复合年增长率将达到6.3%。

The contract research service types segment is expected to register the fastest CAGR of 6.9% over the forecast period

在预测期内，合同研究服务类型部门预计将实现6.9%的最快复合年增长率

The biologics segment is expected to dominate the market with the largest revenue share of 83.4% in 2023.

预计2023年生物制品部门将以83.4%的最大收入份额主导市场。

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

这可以归因于该国几家合同研究服务提供商在当地的存在。与其他国家相比，美国的生物制药CMO和CRO的浓度和数量更高

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

CROs vs CMOs和CDMOs：三者之间的区别是什么？

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.

开发和制造新药是一项涉及许多活动部件的艰巨任务。从发现和开发到临床前研究、临床研究、审查和批准以及商业化，待办事项似乎无穷无尽。此外，生物技术和制药公司必须遵守美国现行的良好生产规范（cGMP）规定。

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.

食品和药物管理局（FDA），欧洲药品管理局（EMA）和其他国际同行，概述了药品制造，加工和包装中使用的方法，设施和控制的最低要求。

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.

为了应对行业复杂性和弥合资源缺口，生物技术和制药公司通常会寻求第三方供应商的开发和制造支持，尤其是CRO，CMO或CDMOs。但是这三者之间有什么区别呢？合同研究组织（CRO），合同制造组织（CMO）和合同开发和制造组织（CDMO）在药物开发和制造方面都提供专业能力和运营基础设施。

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..

尽管他们的服务和解决方案经常重叠，但仍有一些关键差异需要牢记。继续阅读以发现CRO、CMO和CDMOs之间的关键区别，并探索哪一个适合您。。

U.S. Biopharmaceutical CMO & CRO Market Top Trends

U、美国生物制药CMO和CRO市场最高趋势

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.

外包扩张：生物制药公司继续将更多的制造和研究活动外包给CMO和CRO，以简化运营，降低成本并获得专业知识。

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.

对生物制剂的需求不断增加：对生物药物（包括单克隆抗体和细胞疗法）的需求不断增长，推动了对具有先进生物加工能力的CMOs的需求，以制造这些复杂分子。

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.

技术进步：采用一次性系统，连续制造和过程自动化等先进技术正在提高生物制药制造的效率，降低生产成本，提高产品质量。

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.

生物加工创新：CMOs正在投资创新的生物加工技术和技术，以优化制造工艺，提高产品产量，缩短生物制药产品的上市时间。

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.

法规遵从性和质量保证：随着对生物制药制造的严格监管要求，CMOs专注于保持符合当前良好制造规范（cGMP）的要求，并确保高标准的质量保证以满足监管期望。

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.

数据分析和人工智能的集成：CRO正在利用数据分析和人工智能（AI）来改进临床试验设计，患者招募，数据管理和分析，从而提高临床研究的效率和成功率。

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.

扩大外包临床试验：生物制药公司越来越多地将临床试验活动外包给CRO，以利用其专业知识，资源和全球网络，更快地招募患者，有效地进行试验管理，并接触不同的患者群体。

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.

虚拟试验的出现：新型冠状病毒肺炎加速了分散和虚拟临床试验模型的采用，促使首席风险官开发创新的远程监测技术和数字平台，以远程进行试验，同时确保数据完整性和患者安全。

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.

这些趋势突显了美国生物制药外包的发展前景，其特点是越来越重视生物制药公司与CMOs/CRO之间的创新，效率和合作，以推动药物开发和商业化成功。

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Source Insights

源洞察

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..

2023年，生物制药制造市场的哺乳动物市场份额最高，为69.14%。这主要是由于生物制药行业缺乏内部专业知识，无法将类似人类的翻译后修饰添加到复杂的蛋白质疗法中。哺乳动物细胞能够进行这种修饰，使其成为生产生物制剂的有吸引力的选择。。

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..

此外，技术的进步极大地使哺乳动物细胞系片段受益。新型和强大的增强表达系统的引入，改进的过程监测解决方案，细胞系工程工具，自动筛选方法和一次性设备都有助于使用哺乳动物细胞进行更高效和生产性的生物制剂制造过程。。

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.

虽然哺乳动物细胞主导着生物制药制造市场，但微生物细胞等非哺乳动物细胞系也被公认为生物制剂的有效工厂。正在实施创新战略，以识别和探索各种微生物的潜力，预计这将有助于非哺乳动物生物制药制造部门的增长。

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..

随着新技术和方法的不断发展，预计未来几年生物制药制造市场将出现显着增长，为哺乳动物和非哺乳动物细胞系提供新的机会。。

Service Type Insights

服务类型洞察

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..

在预测期内，预计合同研究部门的复合年增长率将达到6.9%，这主要是由于生物制药公司外包研究活动的增加趋势。此外，首席风险官正在努力利用生物制药行业的潜在途径。。

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..

专注于开发生物制药的新市场进入者和小型参与者预计会选择合同研究服务来发现新候选人，这有望促进CRO的收入增长。随着越来越多的生物制药公司和研究公司寻求降低成本和提高效率，外包可能仍然是该行业的一个关键趋势，为合同研究部门扩大其市场份额提供了充足的机会。。

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.

市场上的许多CMO和机会主义CMO都致力于为生物制药实体提供端到端的覆盖范围，从细胞培养到填充/完成服务。此外，客户正在大量投资于将其产品开发计划的制造方面外包，这导致了该细分市场的最大份额。

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..

随着许多CMO和CRO的出现提供了广泛的服务，预计未来几年这一细分市场将继续保持增长势头。。

Product Insight

产品洞察力

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..

预计2023年生物制品部门将以83.4%的最大收入份额主导市场。这种增长归因于生物制剂的高度特异性，复杂的制造步骤以及与其他药物分子相比更高的成功率，从而导致了这一部分的主导地位。。

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.

一次性生物反应器、连续净化处理、一次性塑料容器和实时质量分析等创新技术的使用，使CMOs能够有效满足日益增长的生物制品生产需求。此外，一些公司正在投资生物仿制药开发，以超越早期同类创新药物的安全性，有效性，处置或成本。

This has increased the level of competition among innovator manufacturers, which in turn, is likely to benefit the CMOs..

这增加了创新者制造商之间的竞争水平，这反过来可能会使CMOs受益。。

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.

随着生物制品市场的持续增长和生物仿制药的发展，预计CMOs将在制造过程中发挥关键作用。先进技术和技术的使用可能会进一步增强他们提供高质量，高效和经济高效的制造服务的能力。

This, in turn, will drive the growth of the biologics segment and the overall CMO & CRO market..

反过来，这将推动生物制品部门和整个CMO&CRO市场的增长。。

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Key Companies & Market Share Insights

关键公司和市场份额洞察

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..

为了在CMO和CRO市场上获得优于其他参与者的竞争优势，公司正在采取各种战略举措。影响市场竞争性质的关键参数包括收购、地理扩张、并购和产品发布。例如，2023年2月，Lonza宣布在马萨诸塞州剑桥开设一个新实验室，作为瑞士CDMO计划在北美扩展早期开发服务（EDS）部门的一部分。。

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.

Lonza的扩展服务专注于帮助客户在开发的早期阶段和临床试验之前识别和解决候选药物的潜在问题，以帮助降低失败的风险。新设施将服务于临床前阶段寻求开发生物药物的中小型生物技术公司。

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.

预计此次扩张将增强Lonza在北美的市场占有率，并巩固其在CMO和CRO市场的地位。市场参与者的此类战略举措可能会推动增长，促进创新，并增强其整体市场竞争力。美国的一些著名球员。

biopharmaceutical CMO and CRO market include:.

生物制药CMO和CRO市场包括：。

Catalent

卡特伦

Boehringer Ingelheim GmbH

勃林格殷格翰股份有限公司

Thermo Fisher Scientific Inc

赛默飞世尔科技公司

Lonza

隆萨

Rentschler Biopharma SE

FUJIFILM Diosynth Biotechnologies U.S.A., Inc.

FUJIFILM Diosynch Biotechnologies U.S.A.，Inc。

Samsung Biologics

三星生物制品

AGC Biologics

AGC生物制品

WuXi Biologics

无锡生物制品

Abzena

阿布泽纳

Segments Covered in the Report

报告涵盖的部分

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.

本报告预测了国家层面的收入增长，并对2021年至2033年各细分市场的最新行业趋势进行了分析。在这项研究中，Nova one advisor，Inc.对美国生物制药CMO和CRO市场进行了细分。

By Source

按来源

Mammalian

哺乳动物

Non-mammalian

非哺乳动物

By Service Type

按服务类型

Contract Manufacturing

合同制造

Process Development