表紙：薬事アウトソーシングの市場規模、シェア、成長分析、サービス別、サイズ別、カテゴリー別、適応症別、ステージ別、エンドユーザー別、地域別 - 産業予測 2025～2032年

市場調査レポート

商品コード

1724781

薬事アウトソーシングの市場規模、シェア、成長分析、サービス別、サイズ別、カテゴリー別、適応症別、ステージ別、エンドユーザー別、地域別 - 産業予測 2025～2032年

Regulatory Affairs Outsourcing Market Size, Share, and Growth Analysis, By Service (Regulatory Consulting, Legal Representation), By Size (Small, Medium), By Category, By Indication, By Stage, By End-User, By Region - Industry Forecast 2025-2032

出版日: 2025年05月09日
発行: SkyQuest
ページ情報: 英文 157 Pages
納期: 3～5営業日

価格

PDF & Excel (Single User License)

USD 5,300 765,108円

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PDF & Excel (Multiple User License)

USD 6,200 895,032円

レポートPDF・Excel2-5名様までがご利用頂けるライセンスです。PDF・Excel内のテキスト等のコピーは可能です。PDF・Excelの印刷は可能ですが、印刷したもののご利用はPDF・Excelのご利用範囲に準拠します。

PDF & Excel (Enterprise License)

USD 7,100 1,024,956円

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価格表記: USDを日本円(税抜)に換算

本日の銀行送金レート: 1USD=144.36円

全表示
概要
目次

概要

サンプル依頼リストに入れる

薬事アウトソーシングの世界市場規模は2023年に59億米ドルと評価され、2024年の63億8,000万米ドルから2032年には118億9,000万米ドルに成長し、予測期間（2025-2032年）のCAGRは8.1％で成長する見通しです。

薬事アウトソーシング市場は、ヘルスケア企業が世界の規制当局からのタイムリーな臨床承認に対する圧力の高まりに直面していることから、大きな成長が見込まれています。Genpactの調査によると、ライフサイエンス企業の経営幹部の72%がコンプライアンスを重要な課題として認識しており、新製品の承認に対する要求が高まる中、効率的な法務情報サービスが必要とされています。複雑な規制環境を乗り切るため、企業は法務サービスのアウトソーシング戦略を採用することが増えており、より迅速な承認と幅広い市場参入を目指しています。ヘルスケア費用の自己負担の増加や薬価引き下げに向けた政府の取り組みなどの経済的要因が、薬事機能のアウトソーシングの必要性をさらに高めています。さらに、開発初期段階における戦略的な医薬品固有のコンプライアンス対策は、進化するライフサイエンス情勢において迅速な承認を達成し、競争力を維持するために不可欠です。

北米
- 米国
- カナダ
欧州
- ドイツ
- スペイン
- フランス
- 英国
- イタリア
- その他欧州地域
アジア太平洋地域
- 中国
- インド
- 日本
- 韓国
- その他アジア太平洋地域
ラテンアメリカ
- ブラジル
- その他ラテンアメリカ地域
中東・アフリカ
- GCC諸国
- 南アフリカ
- その他中東・アフリカ

競合情報

上位5社の比較
主要企業の市場ポジショニング（2024年）
主な市場企業が採用した戦略
最近の市場動向
企業の市場シェア分析（2024年）
主要企業の企業プロファイル
- 企業の詳細
- 製品ポートフォリオ分析
- 企業のセグメント別シェア分析
- 収益の前年比比較（2022-2024年）

主要企業プロファイル

Genpact（India）
Freyr（India）
IQVIA（United States）
Parexel International（United States）
Charles River Laboratories（United States）
WuXi AppTec（China）
ICON plc（Ireland）
Labcorp Drug Development（United States）
PharmaLex GmbH（Germany）
NDA Group AB（Sweden）
Pharmexon（Denmark）
Qvigilance（United Kingdom）
BlueReg（France）
Cambridge Regulatory Services（United Kingdom）
APCER Life Sciences（India）
Real Regulatory Ltd（United Kingdom）
Voisin Consulting Life Sciences（VCLS）（France）

結論と提言

Product Code: SQMIG35D2051

Global Regulatory Affairs Outsourcing Market size was valued at USD 5.9 billion in 2023 and is poised to grow from USD 6.38 billion in 2024 to USD 11.89 billion by 2032, growing at a CAGR of 8.1% during the forecast period (2025-2032).

The regulatory affairs outsourcing market is poised for significant growth as healthcare companies face mounting pressure for timely clinical approvals from global regulators. A Genpact survey reveals that 72% of life sciences executives identify compliance as a critical challenge, necessitating efficient legal information services amid increasing demands for new product approvals. To navigate complex regulatory environments, companies are increasingly adopting outsourcing strategies for legal services, aiming for faster approvals and broader market access. Economic factors, including rising out-of-pocket healthcare costs and government efforts to reduce drug prices, further intensify the need for regulatory function outsourcing. Additionally, strategic drug-specific compliance measures during early development stages are essential for achieving swift approvals and maintaining competitive viability in the evolving life sciences landscape.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Regulatory Affairs Outsourcing market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Regulatory Affairs Outsourcing Market Segments Analysis

Global Regulatory Affairs Outsourcing Market is segmented by Service, Size, Category, Indication, Stage, End-User and region. Based on Service, the market is segmented into Regulatory Consulting, Legal Representation, Regulatory Writing and Publishing, Product Registration, Clinical Trial Applications and Other Services. Based on Size, the market is segmented into Small, Medium and Large. Based on Category, the market is segmented into Drugs, Generics, Innovators, Biologics, Biotech, ATMPs, Medical Devices, Therapeutic and Diagnostic. Based on Indication, the market is segmented into Oncology, Neurology, Cardiology, Immunology and Others. Based on Stage, the market is segmented into Preclinical, Clinical and Post Market Authorization (PMA). Based on End-User, the market is segmented into Medical Device Companies, Pharmaceutical Companies and Biotechnology Companies. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Regulatory Affairs Outsourcing Market

The Global Regulatory Affairs Outsourcing market is being propelled by the increasingly intricate regulatory framework across various sectors, especially in the pharmaceutical, biotechnology, and medical device industries. Regulatory bodies such as the FDA in the United States and the EMA in Europe consistently revise their regulations, guidelines, and compliance standards, making it challenging for companies to adapt. Outsourcing regulatory affairs allows organizations to tap into the expertise of specialized firms that possess in-depth knowledge of both local and global regulatory requirements, ensuring compliance and facilitating navigation through these dynamic landscapes. This demand for specialized knowledge and adaptability is a key driver of growth in the market.

Restraints in the Global Regulatory Affairs Outsourcing Market

A significant challenge facing the global regulatory affairs outsourcing market is the apprehension surrounding data security and privacy. Outsourcing essential regulatory functions often necessitates sharing sensitive information, including clinical trial results, proprietary business methods, and intellectual property, which raises the risk of potential data breaches and complicates compliance with regulations like the GDPR. Many companies hesitate to depend fully on external service providers due to these privacy concerns, especially in heavily regulated sectors such as pharmaceuticals and biotechnology, where safeguarding data is crucial. Such apprehensions could hinder the adoption of outsourcing solutions and impede the growth of the market.

Market Trends of the Global Regulatory Affairs Outsourcing Market

The Global Regulatory Affairs Outsourcing market is witnessing a robust trend towards the integration of digital solutions, significantly transforming how regulatory processes are managed. Companies are increasingly adopting Regulatory Technology (RegTech) solutions that streamline compliance and automate workflows, including shipments and regulatory approvals. Legal outsourcing firms are leveraging advanced cloud-based platforms, artificial intelligence, and automation technologies to enhance productivity and minimize human error, while ensuring real-time updates on regulatory changes. This shift not only fosters transparency and scalability in outsourced regulatory functions but also offers cost-effective, quick, and accurate solutions, thereby setting a new benchmark for efficiency in the regulatory landscape.

Introduction

Objectives of the Study
Scope of the Report
Definitions

Research Methodology

Information Procurement
Secondary & Primary Data Methods
Market Size Estimation
Market Assumptions & Limitations

Executive Summary

Global Market Outlook
Supply & Demand Trend Analysis
Segmental Opportunity Analysis

Market Dynamics & Outlook

Market Overview
Market Size
Market Dynamics
- Drivers & Opportunities
- Restraints & Challenges
Porters Analysis
- Competitive rivalry
- Threat of substitute
- Bargaining power of buyers
- Threat of new entrants
- Bargaining power of suppliers

Key Market Insights

Key Success Factors
Degree of Competition
Top Investment Pockets
Market Ecosystem
Market Attractiveness Index, 2024
PESTEL Analysis
Macro-Economic Indicators
Value Chain Analysis
Pricing Analysis
Regulatory Landscape
Case Studies
Technology Analysis

Global Regulatory Affairs Outsourcing Market Size by Service & CAGR (2025-2032)

Market Overview
Regulatory Consulting
Legal Representation
Regulatory Writing and Publishing
Product Registration
Clinical Trial Applications
Other Services

Global Regulatory Affairs Outsourcing Market Size by Size & CAGR (2025-2032)

Market Overview
Small
Medium
Large

Global Regulatory Affairs Outsourcing Market Size by Category & CAGR (2025-2032)

Market Overview
Drugs
Generics
Innovators
Biologics
Biotech
ATMPs
Medical Devices
Therapeutic
Diagnostic

Global Regulatory Affairs Outsourcing Market Size by Indication & CAGR (2025-2032)

Market Overview
Oncology
Neurology
Cardiology
Immunology
Others

Global Regulatory Affairs Outsourcing Market Size by Stage & CAGR (2025-2032)

Market Overview
Preclinical
Clinical
Post Market Authorization (PMA)

Global Regulatory Affairs Outsourcing Market Size by End-User & CAGR (2025-2032)

Market Overview
Medical Device Companies
Pharmaceutical Companies
Biotechnology Companies

Global Regulatory Affairs Outsourcing Market Size & CAGR (2025-2032)

North America (Service, Size, Category, Indication, Stage, End-User)
- US
- Canada
Europe (Service, Size, Category, Indication, Stage, End-User)
- Germany
- Spain
- France
- UK
- Italy
- Rest of Europe
Asia Pacific (Service, Size, Category, Indication, Stage, End-User)
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
Latin America (Service, Size, Category, Indication, Stage, End-User)
- Brazil
- Rest of Latin America
Middle East & Africa (Service, Size, Category, Indication, Stage, End-User)
- GCC Countries
- South Africa
- Rest of Middle East & Africa

Competitive Intelligence

Top 5 Player Comparison
Market Positioning of Key Players, 2024
Strategies Adopted by Key Market Players
Recent Developments in the Market
Company Market Share Analysis, 2024
Company Profiles of All Key Players
- Company Details
- Product Portfolio Analysis
- Company's Segmental Share Analysis
- Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

Genpact (India)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Freyr (India)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
IQVIA (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Parexel International (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Charles River Laboratories (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
WuXi AppTec (China)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
ICON plc (Ireland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Labcorp Drug Development (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
PharmaLex GmbH (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
NDA Group AB (Sweden)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Pharmexon (Denmark)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Qvigilance (United Kingdom)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
BlueReg (France)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Cambridge Regulatory Services (United Kingdom)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
APCER Life Sciences (India)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Real Regulatory Ltd (United Kingdom)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Voisin Consulting Life Sciences (VCLS) (France)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments

薬事アウトソーシングの市場規模、シェア、成長分析、サービス別、サイズ別、カテゴリー別、適応症別、ステージ別、エンドユーザー別、地域別 - 産業予測 2025～2032年

Regulatory Affairs Outsourcing Market Size, Share, and Growth Analysis, By Service (Regulatory Consulting, Legal Representation), By Size (Small, Medium), By Category, By Indication, By Stage, By End-User, By Region - Industry Forecast 2025-2032

目次

イントロダクション

調査手法

エグゼクティブサマリー

市場力学と見通し

主な市場の考察

薬事アウトソーシング市場規模：サービス別& CAGR（2025-2032）

薬事アウトソーシング市場規模：サイズ別& CAGR（2025-2032）

薬事アウトソーシング市場規模：カテゴリー別& CAGR（2025-2032）

薬事アウトソーシング市場規模：適応症別& CAGR（2025-2032）

薬事アウトソーシング市場規模：ステージ別& CAGR（2025-2032）

薬事アウトソーシング市場規模：エンドユーザー別& CAGR（2025-2032）

薬事アウトソーシング市場規模：地域別& CAGR（2025-2032）