医薬品受託製造・受託研究市場：サービスタイプ別、エンドユーザー別、地域別、2026年～2032年

医薬品受託製造・受託研究市場の評価、2026年～2032年

製造や研究業務を専門企業に委託する製薬企業は、基本的に医薬品受託製造や医薬品受託研究を利用しています。調査受託機関（CRO）が臨床試験管理、データ分析、薬事コンサルティングなどさまざまなサービスを提供するのに対し、製造受託機関（CMO）は医薬品の製造を監督し、品質基準や規制基準を満たしていることを確認します。これらの要因により、市場規模は2024年に1,765億米ドルを突破し、2032年には約3,243億米ドルに達する見込みです。

疾病の調査件数の増加はジェネリック医薬品の需要を急増させ、それによってバイオ医薬品業界が医薬品受託製造・受託研究市場を開拓することを後押ししています。さらに、臨床試験の世界化、より広範で多様な試験の必要性、厳格な規制基準により、アウトソーシングはリスクを軽減し費用を管理しようとする製薬企業にとって魅力的な選択肢となっています。医薬品受託製造・受託研究に対する需要の高まりにより、市場は2026年から2032年にかけてCAGR 7.9％で成長しています。

医薬品受託製造・受託研究市場：定義/概要

医薬品受託製造・受託研究は、医薬品の製造や研究を専門企業に委託するものです。医薬品製造は医薬品製造受託機関（CMO）が担当し、CMOは品質や規制基準が満たされていることも確認します。データ分析や臨床試験管理などのサービスを提供することで、医薬品開発業務受託機関（CRO）は、製薬企業が自社のコアコンピタンスに集中できるようにするとともに、経費を削減し、医薬品開発を迅速化します。

研究受託には、データ解析、規制当局への助言、臨床試験管理など、さまざまな研究活動の委託が含まれます。医薬品受託製造は、医薬品の製造を専門機関に委託することで、品質と規制遵守を保証するものです。これらのサービスは、製薬企業がより複雑で国際的な市場のニーズに対応し、経費を削減し、医薬品開発を迅速化し、中核能力に集中できるよう支援するものです。

創薬の迅速化、生産効率の向上、規制遵守の確保において、医薬品製造受託・調査が果たす重要な役割は、その将来を左右します。ますます複雑化し競合が激化する製薬業界において、これらのサービスは製薬会社が外部の知識を活用し、専門施設にアクセスし、プロセスを最適化するのに役立ち、最終的にはこれらすべてが、より迅速な市場参入、コストの最適化、患者転帰の改善に貢献します。

製薬業界の世界化は医薬品製造受託市場をどのように牽引するか？

世界化は、医薬品製造受託の需要増加の主な要因の1つです。従来の国境を越えた医薬品市場の開拓は、さまざまな国で存在感を示そうとする企業にチャンスをもたらしています。この傾向は特に発展途上国で顕著であり、ヘルスケアコストの拡大、人口の増加、規制環境の改善が、製薬企業にとって投資対象としての魅力を高めています。

医薬品分野では、世界化の結果、複雑なサプライチェーンが出現しています。また、完成品、中間品、原材料を世界各地から調達するため、効率的な製造・流通の必要性が高まっています。この問題に対処するため、医薬品受託製造は、企業が重要な地域に戦略的に配置された製造拠点のネットワークを利用できるようにします。したがって、リードタイムを短縮し、サプライチェーンを合理化し、消費者需要のシフトに迅速に対応する必要がある事業者は、市場にとって好都合です。

医薬品業界は世界化の傾向にあり、知識の共有や資源の有効活用が促進されるため、医薬品事業者と製造委託先が協力することが多くなっています。製薬企業は、世界化する市場情勢に対応するため、製造委託先と世界に協業することで、国際市場の交渉、市場投入までの時間の短縮、より効率的で費用対効果の高い方法を確保することができます。

地域別異なる規制要件は、医薬品製造受託市場の妨げになるか？

製薬業界では、規制要件を無視すると、企業やそのブランドに悪影響を及ぼすことが知られています。従って、コンプライアンス違反は深刻な結果をもたらす可能性があるため、規制の遵守は不可欠です。製薬企業は医薬品成分や製剤の開発に開発製造受託機関（CDMO）を利用しており、CDMOはこのプロセスに不可欠な存在です。これらの医薬品の販売には契約企業のブランドが使用されることが多いため、製造プロセスを通じて高い品質基準を維持することが極めて重要であり、市場の成長に影響を与えています。

今後数年間は、規制遵守に関する困難が医薬品CDMO市場の拡大を妨げると予想されます。規制データと提出書類を効率的に管理するため、CDMOは強力なシステムとプロセスに投資する必要があります。そのためには、従業員がベストプラクティスと規制上の義務について熟知していることを保証するための研修プログラムの改善や、データ管理と規制当局への報告のための最新技術ソリューションの導入が必要となります。

製薬部門では、特に医薬品製造受託機関（CDO）にとって、法規制の遵守は極めて重要です。薬事データと提出書類が異なる領域で一貫して扱われない場合、薬事ファイルのエラーが発生しやすくなります。最先端の技術的ソリューションへの投資、トレーニングの改善、業界関係者や規制当局との緊密な連携は困難な状況にあります。このような困難にもかかわらず、規制遵守を保証するための積極的な措置を講じることで、リスクを軽減し、医薬品CDMOの長期的な発展と繁栄を促進することができます。

目次

第1章 イントロダクション

• 市場の定義
• 市場セグメンテーション
• 調査手法

第2章 エグゼクティブサマリー

• 主な調査結果
• 市場概要
• 市場ハイライト

第3章 市場概要

• 市場規模と成長の可能性
• 市場動向
• 市場促進要因
• 市場抑制要因
• 市場機会
• ポーターのファイブフォース分析

第4章 医薬品受託製造・受託研究市場：サービスタイプ別

• 受託製造機関（CMO）
• 受託研究機関（CRO）

第5章 医薬品受託製造・受託研究市場：開発段階別

• 前臨床サービス
• 臨床サービス

第6章 医薬品受託製造・受託研究市場：エンドユーザー別

• 製薬・バイオ関連企業
• 医療機器企業
• 学術・研究機関

第7章 地域分析

• 北米
• 米国
• カナダ
• メキシコ
• 欧州
• 英国
• ドイツ
• フランス
• イタリア
• アジア太平洋
• 中国
• 日本
• インド
• オーストラリア
• ラテンアメリカ
• ブラジル
• アルゼンチン
• チリ
• 中東・アフリカ
• 南アフリカ
• サウジアラビア
• アラブ首長国連邦

第8章 市場力学

• 市場促進要因
• 市場抑制要因
• 市場機会
• COVID-19の市場への影響

第9章 競合情勢

• 主要企業
• 市場シェア分析

第10章 企業プロファイル

• 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11章 市場の展望と機会

• 新興技術
• 今後の市場動向
• 投資機会

第12章 付録

• 略語リスト
• 出典と参考文献

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