2026 年至 2032 年医药契约製造和合约研究市场（按服务类型、最终用户和地区划分）

2026-2032 年医药契约製造与合约研究市场评估

将生产和研究业务委託给专业公司的製药公司本质上采用的是契约製造和合约研究。合约研究组织 (CRO) 提供各种服务，例如临床试验管理、数据分析和监管咨询；而受託製造厂商(CMO)监督药品生产，确保其符合品质和监管标准。受这些因素影响，预计到 2024 年，市场规模将超过 1,765 亿美元，到 2032 年将达到约 3,243 亿美元。

疾病研究数量的不断增长刺激了对学名药的需求，从而鼓励生物製药行业拓展药品契约製造和合约研究市场。此外，临床试验的全球化、对更广泛和多样化测试的需求以及严格的监管标准，使得外包成为寻求降低风险和控製成本的製药公司的一个有吸引力的选择。药品契约製造和合约研究需求的不断增长，推动该市场在2026年至2032年间以7.9%的复合年增长率成长。

医药契约製造与研究市场：定义/概述

契约製造和合约研究涉及委託给专业公司。药品製造由受託製造厂商(CMO) 负责，该组织还确保药品符合品质和监管标准。委外研发机构(CRO) 提供数据分析和临床试验管理等服务，使製药公司能够专注于其核心竞争力，同时降低成本并加快药物开发速度。

合约研究涉及委託一系列研究活动，包括数据分析、监管咨询和临床试验管理。契约製造涉及将药品生产委託给专业机构，以确保品质和合规性。这些服务有助于製药公司满足日益复杂和国际化的市场需求，降低成本，加快药物开发速度，并专注于核心竞争力。

其未来取决于受託製造和研发在加速药物研发、提高生产效率和确保合规性方面发挥的重要作用。在日益复杂且竞争激烈的製药行业中，这些服务可帮助製药公司利用外部知识、获得专业设施并优化流程——所有这些最终都有助于加快产品进入市场、优化成本并改善患者治疗效果。

医药全球化将如何推动医药受託製造市场？

全球化是推动医药受託製造需求成长的主要因素之一。医药市场不断超越传统边界，为寻求在不同国家开展业务的公司创造了机会。这一趋势在开发中国家医疗成本的上涨、人口的成长以及法规环境的改善，使它们成为对製药公司更具吸引力的投资目的地。

在製药业，全球化催生了复杂的供应链。此外，由于成品、中间体和原材料的采购来自世界各地，因此对高效生产和分销的需求也日益增长。为了解决这个问题，製药契约製造使企业能够利用位于关键地区的策略性製造地网路。因此，那些需要缩短前置作业时间、简化供应链并快速响应消费者需求变化的营运商在市场上占据了有利地位。

製药业正朝着全球化发展，这鼓励知识共用和资源的有效利用，因此製药企业和製造外包的合作日益增加。为了适应全球市场情势，製药公司可以与全球製造外包合作，在国际市场上进行谈判，缩短产品上市时间，并确保更有效率、更具成本效益的方法。

不同的地区监管要求是否会阻碍医药受託製造市场的发展？

在製药业，忽视监管要求会对公司及其品牌造成不利影响已是众所周知的事实。因此，遵守法规至关重要，因为违规可能会造成严重后果。製药公司利用受託製造厂商(CDMO) 来开发药物成分和製剂，而 CDMO 是这项流程中不可或缺的一部分。由于这些药品通常以合约公司的品牌销售，因此在整个生产过程中保持高品质标准至关重要，从而影响市场成长。

预计未来几年，监管合规的困难将阻碍医药CDMO市场的扩张。为了有效管理监管数据和提交，CDMO需要投资强大的系统和流程。这需要改进培训计划，以确保员工掌握最新的最佳实践和监管义务，并采用现代技术解决方案进行资料管理和监管报告。

法规合规性在製药业至关重要，尤其对于合约受託製造厂商(CDO) 而言。如果不同学科的监管数据和提交处理不一致，监管文件很容易出错。投资尖端技术解决方案、改进培训以及与行业相关人员和监管机构密切合作可能充满挑战。儘管面临这些挑战，但积极采取措施确保法规合规性有助于降低风险，并促进製药 CDMO 的长期发展和繁荣。

目录

第一章 引言

• 市场定义
• 市场区隔
• 调查方法

第二章执行摘要

• 主要发现
• 市场概览
• 市集亮点

第三章市场概述

• 市场规模和成长潜力
• 市场趋势
• 市场驱动因素
• 市场限制
• 市场机会
• 波特五力分析

第四章。医药契约製造和研究市场（按服务类型）

• 契约製造组织（CMO）
• 受託研究机构（CRO）

第五章医药契约製造与研究市场依发展阶段划分

• 临床前服务
• 临床服务

第六章 医药契约製造和研究市场（按最终用户）

• 製药和生物相关企业
• 医疗设备公司
• 学术和研究机构

第七章区域分析

• 北美洲
• 美国
• 加拿大
• 墨西哥
• 欧洲
• 英国
• 德国
• 法国
• 义大利
• 亚太地区
• 中国
• 日本
• 印度
• 澳洲
• 拉丁美洲
• 巴西
• 阿根廷
• 智利
• 中东和非洲
• 南非
• 沙乌地阿拉伯
• 阿拉伯聯合大公国

第八章市场动态

• 市场驱动因素
• 市场限制
• 市场机会
• COVID-19 市场影响

第九章 竞争态势

• 主要企业
• 市场占有率分析

第十章 公司简介

• Lonza Group（Switzerland）
• Catalent, Inc.（US）
• Thermo Fisher Scientific（US）（acquired Patheon）
• Recipharm AB（Sweden）
• Boehringer Ingelheim（Germany）
• WuXi AppTec（China）
• Samsung Biologics（South Korea）
• Dr. Reddy's Laboratories（India）
• Jubilant Life Sciences（India）
• Almac Group（Northern Ireland）

第十一章 市场展望与机会

• 新兴技术
• 未来市场趋势
• 投资机会

第十二章 附录

• 简称列表
• 来源和参考文献

Pharmaceutical Contract Manufacturing Contract Research Market Valuation - 2026-2032

Pharmaceutical enterprises that outsource their manufacturing and research operations to specialist companies are basically using the pharmaceutical contract manufacturing and contract research. While Contract Research Organizations (CROs) offer a variety of services like clinical trial administration, data analysis, and regulatory consultation, Contract Manufacturing Organizations (CMOs) supervise the production of medications and make sure they fulfil quality standards and regulatory criteria. These factors are likely to enable the market size surpass USD 176.5 Billion valued in 2024 to reach a valuation of around USD 324.3 Billion by 2032.

Rising incidences of diseases is surging demand for generic drugs, thereby encouraging enabling biopharmaceutical industry explore the pharmaceutical contract manufacturing and contract research market. Additionally, the globalization of clinical trials, the need for more extensive and varied testing, and stringent regulatory standards have made outsourcing an attractive option for pharmaceutical companies looking to mitigate risks and manage expenses. The rising demand for pharmaceutical contract manufacturing contract research is enabling the market grow at a CAGR of 7.9% from 2026 to 2032.

Pharmaceutical Contract Manufacturing Contract Research Market: Definition/ Overview

Pharmaceutical contract manufacturing and contract research entail contracting out the creation of pharmaceuticals and research to specialized companies. Drug manufacture is handled by Contract manufacture Organizations (CMOs), who also make sure that quality and regulatory standards are met. By offering services like data analysis and clinical trial management, contract research organizations (CROs) free up pharmaceutical corporations to concentrate on their core competencies while reducing expenses and expediting medication development.

Contract research include contracting out a range of research activities, including data analysis, regulatory advice, and clinical trial management. Pharmaceutical contract manufacturing involves contracting out the production of medications to specialist organizations, guaranteeing quality and compliance with regulations. These services help pharmaceutical businesses in meeting the needs of a more complicated and international market, reducing expenses, speeding up drug development, and concentrating on their core capabilities.

The key role that pharmaceutical contract manufacturing and research will play in expediting drug discovery, improving production efficiencies, and ensuring regulatory compliance will determine their future. In an increasingly complicated and competitive pharmaceutical industry, these services help pharmaceutical companies to take use of outside knowledge, gain access to specialized facilities, and optimize processes, all of which eventually contribute to more rapid market entrance, cost optimization, and improved patient outcomes.

How will the Globalization of the Pharmaceutical Industry Drive the Pharmaceutical Contract Manufacturing Contract Research Market?

Globalization is one of the main factors contributing to the rise in demand for pharmaceutical contract manufacturing. Growth of pharmaceutical markets outside of conventional borders are creating opportunities for businesses trying to develop a presence in a variety of countries. This tendency has been especially noticeable in developing nations, where expanding healthcare costs, expanding populations, and bettering regulatory environments are making it more attractive for pharmaceutical companies to invest.

In the pharmaceutical sector, complicated supply chains are emerging as a result of globalization. Also, the necessity for effective manufacturing and distribution procedures is growing as businesses acquire their finished pharmaceuticals, intermediate goods, and raw materials from many parts of the world. To address this issue, pharmaceutical contract manufacturing gives businesses access to a network of strategically placed manufacturing sites in important areas. Thus, the need shorten lead times, streamline their supply chains, and react quickly to shifts in consumer demand by the business is a boon to the market.

Pharmaceutical businesses and contract manufacturers collaborate more often as a result of the industry's tendency toward globalization, facilitating the sharing of knowledge and effective use of resources. Pharmaceutical businesses may negotiate international markets, shorten time-to-market, and assure a more efficient and cost-effective way to meet the increasing demands of a globalized pharmaceutical landscape by collaborating with contract manufacturers globally.

Will the Varying Regulatory Requirements Across Regions Hamper the Pharmaceutical Contract Manufacturing Contract Research Market?

In the pharmaceutical industry, neglecting regulatory requirements is known to have negative impacts on companies and their brands. Thus, compliance with regulations is essential since noncompliance can have severe consequences. Pharmaceutical businesses rely on Contract Development and Manufacturing Organizations (CDMOs) to develop medicinal ingredients and formulations, and CDMOs are essential to this process. Since the contractor's brand is frequently used to sell these medications, it is crucial to maintain high standards of quality throughout the manufacturing process, impacting the growth of the market.

In the upcoming years, it is expected that the difficulties related to regulatory compliance will impede the pharmaceutical CDMO market's expansion. To efficiently manage regulatory data and submissions, CDMOs will need to invest in strong systems and processes as the business grows more worldwide and regulatory requirements become more intricate. Thereby, entailing in improving training programs to guarantee that employees are knowledgeable about best practices and regulatory obligations, as well as putting modern technological solutions for data management and regulatory reporting into place.

In the pharmaceutical sector, regulatory compliance is critical, especially for contract drug manufacturing organizations (CDOs). Errors in regulatory files are more likely when regulatory data and submissions are handled inconsistently across different areas. Investments in cutting-edge technological solutions, improved training initiatives, and tighter coordination with industry players and regulatory bodies are proving difficult. Despite these difficulties, proactive steps taken to guarantee regulatory compliance can reduce risks and promote the long-term development and prosperity of pharmaceutical CDMOs.

Category-Wise Acumens

Will Increase in Drug Development Process Drive the Contract Manufacturing Organization Segment?

Rising focus on drug discovery by the pharmaceutical manufacturers is expected to propel the Contract Manufacturing Organization (CMO) segment's expansion. This tendency is influenced by a number of reasons, such as the growing need for novel treatments, the growth of biopharmaceuticals, and the difficulty of contemporary drug development.

The need for new therapies to fill unmet medical needs is surging, according to the pharmaceutical industry. Globally, the incidence of chronic illnesses is increasing, making it more and more necessary to create innovative therapies that provide better patient outcomes, safety, and efficacy. Pharmaceutical companies have been investing extensively in research and development (R&D) as a result of this increased focus on innovation, which has increased the number of medication candidates entering the development pipeline.

The need for production flexibility and scalability offered by CMOs among the pharma firms with strategically placed facilities in key global locations. This allows the companies to tap into local markets and react promptly to fluctuations in demand. The pharmaceutical firms are streamlining their supply chains, reducing logistical obstacles, and guarantying regulatory compliance across many countries by working with global CMOs.

Increasing focus of pharmaceutical industries on drug discovery is creating growth opportunities for the Contract Manufacturing Organization (CMO) segment. Thus, pharmaceutical companies are becoming more dependent on outside partners for manufacturing support due to factors like the growing need for novel therapies, the growth of biopharmaceuticals, the complexity of drug development, and the globalization of the pharmaceutical industry.

Will Rise in Adoption of Clinical Trial Development Drive the Pharmaceutical Contract Manufacturing and Contract Research Market?

The pharmaceutical contract manufacturing and contract research market is anticipated to be driven by the high emergence of clinical trial development. In addition to this, pharmaceutical companies are expanding their investments in clinical research to bring novel pharmaceuticals to market, in response to the growing need for novel treatments and therapies. The need for specialized services provided by Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs), such as trial design, patient recruiting, data management, and the production of investigational pharmaceuticals, is fueled by the increase in clinical trial activities. In order to support the growing clinical trial landscape, the market for pharmaceutical contract manufacturing and contract research is growing significantly.

Trial design entails carefully organizing the procedure of the trial, including participant eligibility requirements, treatment schedules, and outcome evaluations. Finding and recruiting eligible individuals while abiding by ethical standards is the task of patient recruitment. Accurate and secure trial data collection, archiving, and analysis are guaranteed via data management.

Pharmaceutical companies are turning to CROs for specialized expertise due to the growing complexity of clinical trial protocols. Clinical trials nowadays are getting more complicated, combining new technologies, creative research designs, and sophisticated data analytics methods. Adaptive trial designs, for example, provide real-time protocol modifications by researchers in response to interim data analysis, thereby optimizing patient recruitment, treatment allocation, and trial efficiency.

Country/Region-wise Acumens

Will the increasing Research Funding for drug development drive the North America region?

North America boasts high concentration of pharmaceutical companies especially in areas like the US and Canada. These businesses, which range in size from big multinational conglomerates to smaller biotech startups, all support a healthy pharmaceutical environment. Large pharmaceutical businesses provide an ideal environment for contracting out research and manufacture to specialized CMOs and CROs. These businesses support the drug development process by utilizing their infrastructure, experience, and regulatory compliance, which propels the expansion of the CMO/CRO industry in the area.

The CMO segment's growth is being driven by the rising demand for generic medications in North America. Because they are more affordable than name-brand drugs, generics are becoming more and more appealing to payers, healthcare providers, and patients. As a result, in order to fulfil market demand, pharmaceutical companies are increasing the production of generic medications, which is increasing the demand for contract manufacturing services. CMOs are essential to the creation of generic medications because they provide scalable and effective production solutions that help pharmaceutical companies launch generic goods into the market at a reasonable price.

The prevalence of numerous pharmaceutical companies, the rising demand for generics, and increased funding for research and development for contract manufacturing and development are some of the factors contributing to North America's market dominance in pharmaceutical contract manufacturing and contract research

Will Increase in Demand of Generic Drugs Drive the Asia Pacific Region?

The Asia-Pacific region Driven by a number of critical variables that position the region for quick expansion and importance in the industry, the Asia-Pacific area is emerging as a major player in the pharmaceutical contract manufacturing market. Pharmaceutical businesses looking to minimize production costs while upholding quality standards find Asia-Pacific's cost-effective manufacturing capabilities to be very appealing. The area gains from reduced labor expenses, advantageous tax laws, and infrastructure improvements that facilitate effective and simplified production procedures.

The Asia-Pacific pharmaceutical contract manufacturing industry is expanding due to rising demand for biopharmaceuticals and generic medications. Worldwide demand for generic drugs is significant because they provide affordable substitutes for branded pharmaceuticals, especially in developing nations where access to affordable healthcare is a top concern.

In light of its cost-effective manufacturing capabilities, trained workforce, regulatory compliance, and important positioning in the global pharmaceutical supply chain, Asia-Pacific is expected to experience substantial expansion in the pharmaceutical contract manufacturing market. It is anticipated that the region's reputation as a center for contract manufacturing services will only get stronger as pharmaceutical companies looking for scalable and effective production solutions continue to draw to the area, driving more expansion and innovation in the sector.

Competitive Landscape

The pharmaceutical contract manufacturing contract research market is a dynamic and competitive space, characterized by a diverse range of players vying for market share. These players are on the run for solidifying their presence through the adoption of strategic plans such as collaborations, mergers, acquisitions, and political support. The organizations are focusing on innovating their product line to serve the vast population in diverse regions.

Some of the prominent players operating in the pharmaceutical contract manufacturing contract research market include:

• Lonza Group
• Catalent, Inc.
• Thermo Fisher Scientific (acquired Patheon)
• Recipharm AB
• Boehringer Ingelheim
• WuXi AppTec
• Samsung Biologics
• Reddy's Laboratories
• Jubilant Life Sciences
• Almac Group
• Patheon (Now part of Thermo Fisher Scientific)
• Fareva
• Vetter Pharma
• Evonik Industries
• Pfizer Centre One
• AbbVie Contract Manufacturing

Latest Developments

• In February 2022 Lonza Group and Touch light, a biotechnology startup, partnered to improve Lonza Group's full mRNA synthesis capabilities by adding another supply of DNA.
• In February 2022, Moderna, Inc. and Thermo Fisher Scientific partnered in February 2022 to enable Moderna's COVID-19 vaccine, Spikevax, and other experimental mRNA medicines under development to be produced on a large scale.
• In January 2023, Catalent was instrumental in facilitating the production process of delandistrogene moxeparvovec (SRP-9001), an advanced gene therapy candidate developed by Sarepta to treat Duchenne muscular dystrophy.

Pharmaceutical Contract Manufacturing Contract Research Market, By Category

• Service Type:
• Contract Research Organization (CROs)
• Contract Manufacturing Organization (CMOs)
• Phase of Development:
• Preclinical Services
• Clinical Services
• End-User:
• Large Pharmaceutical Companies
• Small & Medium-Sized Pharmaceutical Companies
• Generic Pharmaceutical Companies
• Region:
• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

TABLE OF CONTENTS

1. Introduction

• Market Definition
• Market Segmentation
• Research Methodology

2. Executive Summary

• Key Findings
• Market Overview
• Market Highlights

3. Market Overview

• Market Size and Growth Potential
• Market Trends
• Market Drivers
• Market Restraints
• Market Opportunities
• Porter's Five Forces Analysis

4. Pharmaceutical Contract Manufacturing Contract Research Market, By ServiceType

• Contract Manufacturing Organizations (CMOs)
• Contract Research Organizations (CROs)

5. Pharmaceutical Contract Manufacturing Contract Research Market, By Phase of Development

• Preclinical Services
• Clinical Services

6. Pharmaceutical Contract Manufacturing Contract Research Market, By End-User

• Businesses in the pharmaceutical and biotechnology industries
• Medical Device Companies
• Academic and Research Institutions

7. Regional Analysis

• North America
• United States
• Canada
• Mexico
• Europe
• United Kingdom
• Germany
• France
• Italy
• Asia-Pacific
• China
• Japan
• India
• Australia
• Latin America
• Brazil
• Argentina
• Chile
• Middle East and Africa
• South Africa
• Saudi Arabia
• UAE

8. Market Dynamics

• Market Drivers
• Market Restraints
• Market Opportunities
• Impact of COVID-19 on the Market

9. Competitive Landscape

• Key Players
• Market Share Analysis

10. Company Profiles

• Lonza Group (Switzerland)
• Catalent, Inc. (US)
• Thermo Fisher Scientific (US) (acquired Patheon)
• Recipharm AB (Sweden)
• Boehringer Ingelheim (Germany)
• WuXi AppTec (China)
• Samsung Biologics (South Korea)
• Dr. Reddy's Laboratories (India)
• Jubilant Life Sciences (India)
• Almac Group (Northern Ireland)

11. Market Outlook and Opportunities

• Emerging Technologies
• Future Market Trends
• Investment Opportunities

12. Appendix

• List of Abbreviations
• Sources and References