薬事申請の市場規模、シェア、成長分析：サービス別、カテゴリー別、適応症別、製品ステージ別、タイプ別、企業規模別、地域別 - 産業予測、2025年～2032年

薬事申請の世界市場規模は2023年に152億米ドルと評価され、2024年の165億7,000万米ドルから2032年には330億1,000万米ドルに成長し、予測期間（2025-2032年）のCAGRは9.0%で成長する見通しです。

薬事申請市場は、希少疾病用医薬品、個別化医薬品、免疫療法、併用療法などの新興分野の進歩によって大きな成長を遂げています。この急成長は、規制要件の進化や、効果的なワクチンや治療を必要とする新規疾患の増加によって後押しされており、厳格な安全性と有効性のガイドラインの重要性が浮き彫りになっています。さらに、業界各社による合併、提携、買収の増加が市場拡大をさらに促進すると予想されます。バイオ医薬品・医療機器企業が世界に、特にアジア太平洋、ラテンアメリカ、中東・アフリカの新興市場に進出するにつれて、コスト効率の高い開発と製造の魅力的な機会に遭遇し、薬事サービスの需要が高まっています。このような市場情勢は、ヘルスケア部門が革新的な治療法と複雑な規制経路を重視していることを浮き彫りにしており、市場の力強い成長軌道を反映しています。

目次

イントロダクション

• 調査の目的
• 調査範囲
• 定義

調査手法

• 情報調達
• 二次データと一次データの方法
• 市場規模予測
• 市場の前提条件と制限

エグゼクティブサマリー

• 世界市場の見通し
• 供給と需要の動向分析
• セグメント別機会分析

市場力学と見通し

• 市場概要
• 市場規模
• 市場力学
  • 促進要因と機会
  • 抑制要因と課題
• ポーターの分析

主な市場の考察

• 重要成功要因
• 競合の程度
• 主な投資機会
• 市場エコシステム
• 市場の魅力指数（2024年）
• PESTEL分析
• マクロ経済指標
• バリューチェーン分析
• 価格分析
• 規制情勢
• ケーススタディ
• 技術の進歩

薬事申請市場規模：サービス別& CAGR（2025-2032）

• 市場概要
• 規制コンサルティング
• 法的代理
• 規制文書の執筆と出版
  • 書き込み
  • 出版
• 製品登録と臨床試験申請
• その他

薬事申請市場規模：カテゴリ別& CAGR（2025-2032）

• 市場概要
• 薬物
  • 先発品
  • ジェネリック
• 生物学的製剤
  • バイオテクノロジー
  • ATMP
  • バイオシミラー
• 医療機器
  • 診断
  • 治療薬

薬事申請市場規模：適応症別& CAGR（2025-2032）

• 市場概要
• 腫瘍学
• 神経学
• 心臓病学
• 免疫学
• その他

薬事申請市場規模：製品ステージ別& CAGR（2025-2032）

• 市場概要
• 前臨床
• 臨床
• 市販前承認（PMA）

薬事申請市場規模：タイプ別& CAGR（2025-2032）

• 市場概要
• 社内
• アウトソーシング

薬事申請市場規模：企業規模別& CAGR（2025-2032）

• 市場概要
• 小規模
• 中規模
• 大規模

薬事申請市場規模：エンドユーザー別& CAGR（2025-2032）

• 市場概要
• 医療機器企業
• 製薬会社
• バイオテクノロジー企業
• その他

薬事申請市場規模：地域別& CAGR（2025-2032）

• 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
• 市場の最近の動向
• 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
  • 会社概要
  • 製品ポートフォリオ分析
  • セグメント別シェア分析
  • 収益の前年比比較（2022-2024）

主要企業プロファイル

• IQVIA Holdings Inc.（USA）
• ICON plc（Ireland）
• Charles River Laboratories International, Inc.（USA）
• Labcorp Drug Development（USA）
• WuXi AppTec（China）
• Syneos Health（USA）
• Medpace, Inc.（USA）
• Parexel International Corporation（USA）
• Amicus GMP（USA）
• Pace Life Sciences（USA）
• CTI Clinical Trial & Consulting（USA）
• Accell Clinical Research LLC（USA）
• Consumer Product Testing Co（USA）
• Promedica International（USA）
• Clinilabs Inc.（USA）
• CliniExperts Pvt Ltd.（India）

結論と推奨事項

Global Regulatory Affairs Market size was valued at USD 15.2 billion in 2023 and is poised to grow from USD 16.57 billion in 2024 to USD 33.01 billion by 2032, growing at a CAGR of 9.0% during the forecast period (2025-2032).

The regulatory affairs market is experiencing significant growth, driven by advancements in emerging sectors like orphan drugs, personalized medicines, immunotherapies, and combination therapies. This surge is bolstered by evolving regulatory requirements and an increase in novel diseases necessitating effective vaccines and treatments, highlighting the importance of stringent safety and efficacy guidelines. Additionally, the rise of mergers, partnerships, and acquisitions among industry players is expected to further propel market expansion. As biopharmaceutical and medical device companies expand globally, particularly into emerging markets in Asia Pacific, Latin America, and the Middle East & Africa, they encounter attractive opportunities for cost-efficient development and manufacturing, enhancing the demand for regulatory services. This landscape underscores the healthcare sector's emphasis on innovative therapies and complex regulatory pathways, reflecting a robust growth trajectory in the market.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Regulatory Affairs 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 Market Segmental Analysis

Global Regulatory Affairs Market is segmented by Services, Category, Indication, Product Stage, Type, Company Size, End User and region. Based on Services, the market is segmented into Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications and Others. Based on Category, the market is segmented into Drugs, Biologics and Medical Devices. Based on Indication, the market is segmented into Oncology, Neurology, Cardiology, Immunology and Others. Based on Product Stage, the market is segmented into Preclinical, Clinical and Pre-Market Approval (PMA). Based on Type, the market is segmented into In-house and Outsourced. Based on Company Size, the market is segmented into Small, Medium and Large. Based on End User, the market is segmented into Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies and Others. 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 Market

One of the key drivers of the Global Regulatory Affairs market is the globalization of biopharmaceuticals. As biopharmaceutical companies increasingly venture into emerging markets-particularly in regions such as Asia Pacific, Latin America, and the Middle East-there is a pressing need for robust regulatory strategies. These strategies must navigate the complexities and variations in regional regulations, ensuring compliance with local requirements while facilitating market entry and product availability. This expansion not only enhances the reach of biopharmaceutical products but also underscores the importance of adept regulatory affairs to align with the diverse regulatory landscapes found in these burgeoning markets.

Restraints in the Global Regulatory Affairs Market

The Global Regulatory Affairs market faces significant restraints primarily due to its resource and cost-intensive nature. Ensuring regulatory compliance demands considerable investment in both skilled personnel and financial resources, which can stretch the budgets of organizations. This burden often proves to be a challenge, particularly for smaller companies, ultimately impeding their growth and ability to compete in the market. As these companies navigate complex regulatory landscapes, the requirement for extensive resources can limit their capacity to innovate and expand, creating a challenging environment that disproportionately affects less established players in the industry.

Market Trends of the Global Regulatory Affairs Market

The Global Regulatory Affairs market is witnessing a significant trend towards accelerated approval programs, driven by an urgent need to address unmet medical demands, especially for orphan drugs and breakthrough therapies. Regulatory authorities are increasingly adopting expedited pathways that allow for faster market entry of critical medications, facilitating quicker patient access to innovative treatments. This shift is influencing the operational strategies of pharmaceutical companies, as they must navigate these evolving regulatory landscapes while ensuring compliance and risk management. Consequently, the emphasis on agile regulatory strategies is shaping a dynamic environment, fostering collaboration between stakeholders and enhancing the overall efficiency of drug development processes.

Table of Contents

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
• Technological Advancement

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

• Market Overview
• Regulatory Consulting
• Legal Representation
• Regulatory Writing & Publishing
  • Writing
  • Publishing
• Product Registration & Clinical Trial Applications
• Others

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

• Market Overview
• Drugs
  • Innovator
  • Generics
• Biologics
  • Biotech
  • ATMP
  • Biosimilars
• Medical Devices
  • Diagnostics
  • Therapeutics

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

• Market Overview
• Oncology
• Neurology
• Cardiology
• Immunology
• Others

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

• Market Overview
• Preclinical
• Clinical
• Pre-Market Approval (PMA)

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

• Market Overview
• In-house
• Outsourced

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

• Market Overview
• Small
• Medium
• Large

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

• Market Overview
• Medical Device Companies
• Pharmaceutical Companies
• Biotechnology Companies
• Others

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

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

• IQVIA Holdings Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• ICON plc (Ireland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Charles River Laboratories International, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Labcorp Drug Development (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WuXi AppTec (China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Syneos Health (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Medpace, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Parexel International Corporation (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Amicus GMP (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pace Life Sciences (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• CTI Clinical Trial & Consulting (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Accell Clinical Research LLC (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Consumer Product Testing Co (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Promedica International (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Clinilabs Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• CliniExperts Pvt Ltd. (India)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations