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薬事アウトソーシングの世界市場：産業分析、市場規模・シェア・成長・動向・予測 (2025年～2035年)

Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2025-2035

出版日
ページ情報
英文 221 Pages
納期
2～10営業日
カスタマイズ可能
価格
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=148.47円
薬事アウトソーシングの世界市場：産業分析、市場規模・シェア・成長・動向・予測 (2025年～2035年)
出版日: 2025年05月30日
発行: Transparency Market Research
ページ情報: 英文 221 Pages
納期: 2～10営業日
GIIご利用のメリット
  • 全表示
  • 概要
  • 図表
  • 目次
概要

薬事アウトソーシング市場 - 分析範囲

TMRの調査レポート「世界の薬事アウトソーシング市場」は、2025年から2035年までの予測期間における市場の指標に関する貴重な洞察を得るために、過去だけでなく現在の成長動向と機会についても調査しています。当レポートでは、2025年を基準年、2035年を予測年として、2019年から2035年までの世界の薬事アウトソーシング市場の収益と予測を提供します。また、2025年から2035年までの世界の薬事アウトソーシング市場の複合年間成長率（CAGR、%）も掲載しています。

当レポートは広範な調査を経て作成されています。一次調査では、アナリストが主要オピニオンリーダー、業界リーダー、オピニオンメーカーへのインタビューを実施しました。二次調査では、主要企業の製品資料、アニュアルレポート、プレスリリース、関連資料などを参照し、薬事アウトソーシング市場を推察しました。

市場概況
市場規模（2024年） 74億米ドル
市場規模（2035年） 223億米ドル
CAGR 10.6%

当レポートでは、世界の薬事アウトソーシング市場の競合情勢について分析しています。世界の薬事アウトソーシング市場で事業を展開する主要企業が特定され、各企業がさまざまな属性でプロファイルされています。企業概要・財務状況・最新動向・SWOTが、当レポートで紹介されている世界の薬事アウトソーシング市場における各企業の属性です。

目次

第1章 序論

第2章 前提条件と分析手法

第3章 エグゼクティブサマリー：世界市場

第4章 市場概要

  • イントロダクション
  • 概要
  • 市場力学
  • 世界の薬事アウトソーシング市場分析と予測（2020～2035年）

第5章 主要洞察

  • 現在の動向の概要
  • ポーターのファイブフォース分析
  • PESTEL分析
  • 主要地域/国における規制シナリオ
  • 主要企業/規制当局によるサービス開始/承認
  • 企業合併・買収 (M&A) のシナリオ：薬事アウトソーシング市場
  • 競合が提供するサービスのベンチマーク
  • 薬事アウトソーシングサービスへの投資動向
  • 新規市場参入者のための市場開拓戦略

第6章 世界市場の分析と予測：サービスの種類別

  • イントロダクション・定義
  • 主な分析結果/進展
  • 市場予測（金額ベース）：サービスの種類別（2020～2035年）
    • 規制コンサルティング・法的代理
    • 製品登録・臨床試験申請
    • 規制文書の執筆・刊行
    • 規制当局への提出
    • 規制業務
    • その他
  • 市場の魅力：サービスの種類別

第7章 世界市場の分析と予測：製品の開発段階別

  • イントロダクション・定義
  • 主な分析結果/進展
  • 市場予測（金額ベース）：製品の開発段階別（2020～2035年）
    • 前臨床
    • 臨床
    • PMA（市販後承認）
  • 市場の魅力：製品の開発段階別

第8章 世界の市場分析と予測：企業規模別

  • イントロダクション・定義
  • 主な分析結果/進展
  • 市場予測（金額ベース）：企業規模別（2020～2035年）
    • 中小企業
    • 大企業
  • 市場の魅力：企業規模別

第9章 世界市場の分析と予測：治療領域別

  • イントロダクション・定義
  • 主な分析結果/進展
  • 市場予測（金額ベース）：治療領域別（2020～2035年）
    • 腫瘍学
    • 神経学
    • 心臓病学
    • 免疫学
    • 皮膚科
    • その他
  • 市場の魅力：治療領域別

第10章 世界市場の分析と予測：エンドユーザー別

  • イントロダクション・定義
  • 主な分析結果/進展
  • 市場予測（金額ベース）：エンドユーザー別（2020～2035年）
    • 医療機器企業
    • バイオ医薬品・製薬会社
    • その他
  • 市場の魅力：エンドユーザー別

第11章 世界市場の分析と予測：地域別

  • 主な分析結果
  • 市場予測（金額ベース）：地域別
    • 北米
    • 欧州
    • アジア太平洋
    • ラテンアメリカ
    • 中東・アフリカ
  • 市場の魅力：地域別

第12章 北米市場の分析と予測

  • 米国
  • カナダ

第13章 欧州市場の分析と予測

  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • スイス
  • オランダ
  • その他欧州地域

第14章 アジア太平洋市場の分析と予測

  • 中国
  • 日本
  • インド
  • オーストラリアとニュージーランド
  • 韓国
  • その他アジア太平洋

第15章 ラテンアメリカ市場の分析と予測

  • ブラジル
  • メキシコ
  • アルゼンチン
  • その他ラテンアメリカ地域

第16章 中東・アフリカ市場の分析と予測

  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ

第17章 競合情勢

  • 市場企業・競合マトリックス（企業の階層別・規模別）
  • 市場シェア分析：企業別（2024年）
  • 企業プロファイル
    • Accell Clinical Research, LLC
    • Genpact
    • CRITERIUM, INC
    • Promedica International
    • WuXi AppTec
    • Medpace
    • Charles River Laboratories
    • ICON plc
    • Parexel International Corporation
    • Freyr
    • PHARMALEX GMBH
    • Labcorp Drug Development
    • Other Prominent Players
図表

List of Tables

  • Table 01: Global Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Service Type, 2020 to 2035
  • Table 02: Global Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Product Development Stage, 2020 to 2035
  • Table 03: Global Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Enterprise Size, 2020 to 2035
  • Table 04: Global Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Therapeutic Area, 2020 to 2035
  • Table 05: Global Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By End-user, 2020 to 2035
  • Table 06: Global Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Region, 2020 to 2035
  • Table 07: North America Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, by Country, 2020 to 2035
  • Table 08: North America Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, by Service Type, 2020 to 2035
  • Table 09: North America Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Product Development Stage, 2020 to 2035
  • Table 10: North America Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Enterprise Size, 2020 to 2035
  • Table 11: North America Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Therapeutic Area, 2020 to 2035
  • Table 12: North America Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By End-user, 2020 to 2035
  • Table 13: Europe Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, by Country/Sub-region, 2020 to 2035
  • Table 14: Europe Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, by Service Type, 2020 to 2035
  • Table 15: Europe Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Product Development Stage, 2020 to 2035
  • Table 16: Europe Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Enterprise Size, 2020 to 2035
  • Table 17: Europe Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Therapeutic Area, 2020 to 2035
  • Table 18: Europe Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By End-user, 2020 to 2035
  • Table 19: Asia Pacific Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, by Country/Sub-region, 2020 to 2035
  • Table 20: Asia Pacific Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, by Service Type, 2020 to 2035
  • Table 21: Asia Pacific Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Product Development Stage, 2020 to 2035
  • Table 22: Asia Pacific Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Enterprise Size, 2020 to 2035
  • Table 23: Asia Pacific Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Therapeutic Area, 2020 to 2035
  • Table 24: Asia Pacific Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By End-user, 2020 to 2035
  • Table 25: Latin America Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, by Country/Sub-region, 2020 to 2035
  • Table 26: Latin America Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, by Service Type, 2020 to 2035
  • Table 27: Latin America Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Product Development Stage, 2020 to 2035
  • Table 28: Latin America Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Enterprise Size, 2020 to 2035
  • Table 29: Latin America Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Therapeutic Area, 2020 to 2035
  • Table 30: Latin America Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By End-user, 2020 to 2035
  • Table 31: Middle East & Africa Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, by Country/Sub-region, 2020 to 2035
  • Table 32: Middle East & Africa Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, by Service Type, 2020 to 2035
  • Table 33: Middle East & Africa Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Product Development Stage, 2020 to 2035
  • Table 34: Middle East & Africa Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Enterprise Size, 2020 to 2035
  • Table 35: Middle East & Africa Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By Therapeutic Area, 2020 to 2035
  • Table 36: Middle East & Africa Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, By End-user, 2020 to 2035

List of Figures

  • Figure 01: Global Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, 2020 to 2035
  • Figure 02: Global Regulatory Affairs Outsourcing Market Value Share Analysis, By Service Type, 2024 and 2035
  • Figure 03: Global Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Service Type, 2025 to 2035
  • Figure 04: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Regulatory Consulting and Legal Representation, 2020 to 2035
  • Figure 05: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Product Registration and Clinical Trial Product Development Stages, 2020 to 2035
  • Figure 06: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Regulatory Writing and Publishing, 2020 to 2035
  • Figure 07: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Regulatory Submission, 2020 to 2035
  • Figure 08: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Regulatory Operations, 2020 to 2035
  • Figure 09: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Others, 2020 to 2035
  • Figure 10: Global Regulatory Affairs Outsourcing Market Value Share Analysis, By Product Development Stage, 2024 and 2035
  • Figure 11: Global Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Product Development Stage, 2025 to 2035
  • Figure 12: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Preclinical, 2020 to 2035
  • Figure 13: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Clinical, 2020 to 2035
  • Figure 14: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by PMA (Post Market Authorization), 2020 to 2035
  • Figure 15: Global Regulatory Affairs Outsourcing Market Value Share Analysis, By Enterprise Size, 2024 and 2035
  • Figure 16: Global Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Enterprise Size, 2025 to 2035
  • Figure 17: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Small/Medium Enterprises, 2020 to 2035
  • Figure 18: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Large Enterprises, 2020 to 2035
  • Figure 19: Global Regulatory Affairs Outsourcing Market Value Share Analysis, By Therapeutic Area, 2024 and 2035
  • Figure 20: Global Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Therapeutic Area, 2025 to 2035
  • Figure 21: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Oncology, 2020 to 2035
  • Figure 22: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Neurology, 2020 to 2035
  • Figure 23: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Cardiology, 2020 to 2035
  • Figure 24: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Immunology, 2020 to 2035
  • Figure 25: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Dermatology, 2020 to 2035
  • Figure 26: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Others, 2020 to 2035
  • Figure 27: Global Regulatory Affairs Outsourcing Market Value Share Analysis, By End-user, 2024 and 2035
  • Figure 28: Global Regulatory Affairs Outsourcing Market Attractiveness Analysis, By End-user, 2025 to 2035
  • Figure 29: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Medical Device Companies, 2020 to 2035
  • Figure 30: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Biopharma & Pharmaceutical Companies, 2020 to 2035
  • Figure 31: Global Regulatory Affairs Outsourcing Market Revenue (US$ Bn), by Others, 2020 to 2035
  • Figure 32: Global Regulatory Affairs Outsourcing Market Value Share Analysis, By Region, 2024 and 2035
  • Figure 33: Global Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Region, 2025 to 2035
  • Figure 34: North America Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, 2020 to 2035
  • Figure 35: North America Regulatory Affairs Outsourcing Market Value Share Analysis, by Country, 2024 and 2035
  • Figure 36: North America Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Country, 2025 to 2035
  • Figure 37: North America Regulatory Affairs Outsourcing Market Value Share Analysis, By Service Type, 2024 and 2035
  • Figure 38: North America Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Service Type, 2025 to 2035
  • Figure 39: North America Regulatory Affairs Outsourcing Market Value Share Analysis, By Product Development Stage, 2024 and 2035
  • Figure 40: North America Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Product Development Stage, 2025 to 2035
  • Figure 41: North America Regulatory Affairs Outsourcing Market Value Share Analysis, By Enterprise Size, 2024 and 2035
  • Figure 42: North America Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Enterprise Size, 2025 to 2035
  • Figure 43: North America Regulatory Affairs Outsourcing Market Value Share Analysis, By Therapeutic Area, 2024 and 2035
  • Figure 44: North America Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Therapeutic Area, 2025 to 2035
  • Figure 45: North America Regulatory Affairs Outsourcing Market Value Share Analysis, By End-user, 2024 and 2035
  • Figure 46: North America Regulatory Affairs Outsourcing Market Attractiveness Analysis, By End-user, 2025 to 2035
  • Figure 47: Europe Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, 2020 to 2035
  • Figure 48: Europe Regulatory Affairs Outsourcing Market Value Share Analysis, by Country/Sub-region, 2024 and 2035
  • Figure 49: Europe Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Country/Sub-region, 2025 to 2035
  • Figure 50: Europe Regulatory Affairs Outsourcing Market Value Share Analysis, By Service Type, 2024 and 2035
  • Figure 51: Europe Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Service Type, 2025 to 2035
  • Figure 52: Europe Regulatory Affairs Outsourcing Market Value Share Analysis, By Product Development Stage, 2024 and 2035
  • Figure 53: Europe Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Product Development Stage, 2025 to 2035
  • Figure 54: Europe Regulatory Affairs Outsourcing Market Value Share Analysis, By Enterprise Size, 2024 and 2035
  • Figure 55: Europe Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Enterprise Size, 2025 to 2035
  • Figure 56: Europe Regulatory Affairs Outsourcing Market Value Share Analysis, By Therapeutic Area, 2024 and 2035
  • Figure 57: Europe Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Therapeutic Area, 2025 to 2035
  • Figure 58: Europe Regulatory Affairs Outsourcing Market Value Share Analysis, By End-user, 2024 and 2035
  • Figure 59: Europe Regulatory Affairs Outsourcing Market Attractiveness Analysis, By End-user, 2025 to 2035
  • Figure 60: Asia Pacific Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, 2020 to 2035
  • Figure 61: Asia Pacific Regulatory Affairs Outsourcing Market Value Share Analysis, by Country/Sub-region, 2024 and 2035
  • Figure 62: Asia Pacific Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Country/Sub-region, 2025 to 2035
  • Figure 63: Asia Pacific Regulatory Affairs Outsourcing Market Value Share Analysis, By Service Type, 2024 and 2035
  • Figure 64: Asia Pacific Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Service Type, 2025 to 2035
  • Figure 65: Asia Pacific Regulatory Affairs Outsourcing Market Value Share Analysis, By Product Development Stage, 2024 and 2035
  • Figure 66: Asia Pacific Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Product Development Stage, 2025 to 2035
  • Figure 67: Asia Pacific Regulatory Affairs Outsourcing Market Value Share Analysis, By Enterprise Size, 2024 and 2035
  • Figure 68: Asia Pacific Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Enterprise Size, 2025 to 2035
  • Figure 69: Asia Pacific Regulatory Affairs Outsourcing Market Value Share Analysis, By Therapeutic Area, 2024 and 2035
  • Figure 70: Asia Pacific Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Therapeutic Area, 2025 to 2035
  • Figure 71: Asia Pacific Regulatory Affairs Outsourcing Market Value Share Analysis, By End-user, 2024 and 2035
  • Figure 72: Asia Pacific Regulatory Affairs Outsourcing Market Attractiveness Analysis, By End-user, 2025 to 2035
  • Figure 73: Latin America Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, 2020 to 2035
  • Figure 74: Latin America Regulatory Affairs Outsourcing Market Value Share Analysis, by Country/Sub-region, 2024 and 2035
  • Figure 75: Latin America Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Country/Sub-region, 2025 to 2035
  • Figure 76: Latin America Regulatory Affairs Outsourcing Market Value Share Analysis, By Service Type, 2024 and 2035
  • Figure 77: Latin America Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Service Type, 2025 to 2035
  • Figure 78: Latin America Regulatory Affairs Outsourcing Market Value Share Analysis, By Product Development Stage, 2024 and 2035
  • Figure 79: Latin America Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Product Development Stage, 2025 to 2035
  • Figure 80: Latin America Regulatory Affairs Outsourcing Market Value Share Analysis, By Enterprise Size, 2024 and 2035
  • Figure 81: Latin America Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Enterprise Size, 2025 to 2035
  • Figure 82: Latin America Regulatory Affairs Outsourcing Market Value Share Analysis, By Therapeutic Area, 2024 and 2035
  • Figure 83: Latin America Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Therapeutic Area, 2025 to 2035
  • Figure 84: Latin America Regulatory Affairs Outsourcing Market Value Share Analysis, By End-user, 2024 and 2035
  • Figure 85: Latin America Regulatory Affairs Outsourcing Market Attractiveness Analysis, By End-user, 2025 to 2035
  • Figure 86: Middle East & Africa Regulatory Affairs Outsourcing Market Value (US$ Bn) Forecast, 2020 to 2035
  • Figure 87: Middle East & Africa Regulatory Affairs Outsourcing Market Value Share Analysis, by Country/Sub-region, 2024 and 2035
  • Figure 88: Middle East & Africa Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Country/Sub-region, 2025 to 2035
  • Figure 89: Middle East & Africa Regulatory Affairs Outsourcing Market Value Share Analysis, By Service Type, 2024 and 2035
  • Figure 90: Middle East & Africa Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Service Type, 2025 to 2035
  • Figure 91: Middle East & Africa Regulatory Affairs Outsourcing Market Value Share Analysis, By Product Development Stage, 2024 and 2035
  • Figure 92: Middle East & Africa Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Product Development Stage, 2025 to 2035
  • Figure 93: Middle East & Africa Regulatory Affairs Outsourcing Market Value Share Analysis, By Enterprise Size, 2024 and 2035
  • Figure 94: Middle East & Africa Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Enterprise Size, 2025 to 2035
  • Figure 95: Middle East & Africa Regulatory Affairs Outsourcing Market Value Share Analysis, By Therapeutic Area, 2024 and 2035
  • Figure 96: Middle East & Africa Regulatory Affairs Outsourcing Market Attractiveness Analysis, By Therapeutic Area, 2025 to 2035
  • Figure 97: Middle East & Africa Regulatory Affairs Outsourcing Market Value Share Analysis, By End-user, 2024 and 2035
  • Figure 98: Middle East & Africa Regulatory Affairs Outsourcing Market Attractiveness Analysis, By End-user, 2025 to 2035
目次
Product Code: TMRGL3528

Regulatory Affairs Outsourcing Market - Scope of Report

TMR's report on the global regulatory affairs outsourcing market studies the past as well as the current growth trends and opportunities to gain valuable insights of the indicators of the market during the forecast period from 2025 to 2035. The report provides revenue of the global regulatory affairs outsourcing market for the period 2019-2035, considering 2025 as the base year and 2035 as the forecast year. The report also provides the compound annual growth rate (CAGR %) of the global regulatory affairs outsourcing market from 2025 to 2035.

The report has been prepared after an extensive research. Primary research involved bulk of the research efforts, wherein analysts carried out interviews with key opinion leaders, industry leaders, and opinion makers. Secondary research involved referring to key players' product literature, annual reports, press releases, and relevant documents to understand the regulatory affairs outsourcing market.

Market Snapshot
Market Value in 2024US$ 7.4 Bn
Market Value in 2035US$ 22.3 Bn
CAGR10.6%

Secondary research also included Internet sources, statistical data from government agencies, websites, and trade associations. Analysts employed a combination of top-down and bottom-up approaches to study various attributes of the global regulatory affairs outsourcing market.

The report includes an elaborate executive summary, along with a snapshot of the growth behavior of various segments included in the scope of the study. Moreover, the report throws light on the changing competitive dynamics in the global regulatory affairs outsourcing market. These serve as valuable tools for existing market players as well as for entities interested in participating in the global regulatory affairs outsourcing market.

The report delves into the competitive landscape of the global regulatory affairs outsourcing market. Key players operating in the global regulatory affairs outsourcing market have been identified and each one of these has been profiled in terms of various attributes. Company overview, financial standings, recent developments, and SWOT are the attributes of players in the global regulatory affairs outsourcing market profiled in this report.

Key Questions Answered in Global regulatory affairs outsourcing Market Report:

  • What is the sales/revenue generated by regulatory affairs outsourcing across all regions during the forecast period?
  • What are the opportunities in the global regulatory affairs outsourcing market?
  • What are the major drivers, restraints, opportunities, and threats in the market?
  • Which regional market is set to expand at the fastest CAGR during the forecast period?
  • Which segment is expected to generate the highest revenue globally in 2035?
  • Which segment is projected to expand at the highest CAGR during the forecast period?
  • What are the market positions of different companies operating in the global market?

Regulatory Affairs Outsourcing Market - Research Objectives and Research Approach

The comprehensive report on the global regulatory affairs outsourcing market begins with an overview, followed by the scope and objectives of the study. The report provides detailed explanation of the objectives behind this study and key vendors and distributors operating in the market and regulatory scenario for approval of products.

For reading comprehensibility, the report has been compiled in a chapter-wise layout, with each section divided into smaller ones. The report comprises an exhaustive collection of graphs and tables that are appropriately interspersed. Pictorial representation of actual and projected values of key segments is visually appealing to readers. This also allows comparison of the market shares of key segments in the past and at the end of the forecast period.

The report analyzes the global regulatory affairs outsourcing market in terms of product, end-user, and region. Key segments under each criterion have been studied at length, and the market share for each of these at the end of 2035 has been provided. Such valuable insights enable market stakeholders in making informed business decisions for investment in the global regulatory affairs outsourcing market.

Table of Contents

1. Preface

  • 1.1. Market Definition and Scope
  • 1.2. Market Segmentation
  • 1.3. Key Research Objectives
  • 1.4. Research Highlights

2. Assumptions and Research Methodology

3. Executive Summary : Global Regulatory Affairs Outsourcing Market

4. Market Overview

  • 4.1. Introduction
    • 4.1.1. Segment Definition
  • 4.2. Overview
  • 4.3. Market Dynamics
    • 4.3.1. Drivers
    • 4.3.2. Restraints
    • 4.3.3. Opportunities
  • 4.4. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, 2020 to 2035
    • 4.4.1. Market Revenue Projections (US$ Mn)

5. Key Insights

  • 5.1. Overview on Current Trends
  • 5.2. PORTER's Five Forces Analysis
  • 5.3. PESTEL Analysis
  • 5.4. Regulatory Scenario across Key Regions/Country
  • 5.5. Service Launches/Approvals by the Major Players/Regulatory Authority
  • 5.6. Mergers and Acquisition Scenario for Regulatory Affairs Outsourcing Market
  • 5.7. Benchmarking of the Services Offered by the Competitors
  • 5.8. Investment Trends in Regulatory Affairs Outsourcing Services
  • 5.9. Go-to-Market Strategy for New Market Entrants

6. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By Service Type

  • 6.1. Introduction & Definition
  • 6.2. Key Findings / Developments
  • 6.3. Market Value Forecast By Service Type, 2020 to 2035
    • 6.3.1. Regulatory Consulting and Legal Representation
    • 6.3.2. Product Registration and Clinical Trial Applications
    • 6.3.3. Regulatory Writing and Publishing
    • 6.3.4. Regulatory Submission
    • 6.3.5. Regulatory Operations
    • 6.3.6. Others
  • 6.4. Market Attractiveness By Service Type

7. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By Product Development Stage

  • 7.1. Introduction & Definition
  • 7.2. Key Findings / Developments
  • 7.3. Market Value Forecast By Product Development Stage, 2020 to 2035
    • 7.3.1. Preclinical
    • 7.3.2. Clinical
    • 7.3.3. PMA (Post Market Authorization)
  • 7.4. Market Attractiveness By Product Development Stage

8. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By Enterprise Size

  • 8.1. Introduction & Definition
  • 8.2. Key Findings / Developments
  • 8.3. Market Value Forecast By Enterprise Size, 2020 to 2035
    • 8.3.1. Small/Medium Enterprises
    • 8.3.2. Large Enterprises
  • 8.4. Market Attractiveness By Enterprise Size

9. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By Therapeutic Area

  • 9.1. Introduction & Definition
  • 9.2. Key Findings / Developments
  • 9.3. Market Value Forecast By Therapeutic Area, 2020 to 2035
    • 9.3.1. Oncology
    • 9.3.2. Neurology
    • 9.3.3. Cardiology
    • 9.3.4. Immunology
    • 9.3.5. Dermatology
    • 9.3.6. Others
  • 9.4. Market Attractiveness By Therapeutic Area

10. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By End-user

  • 10.1. Introduction & Definition
  • 10.2. Key Findings / Developments
  • 10.3. Market Value Forecast By End-user, 2020 to 2035
    • 10.3.1. Medical Device Companies
    • 10.3.2. Biopharma & Pharmaceutical Companies
    • 10.3.3. Others
  • 10.4. Market Attractiveness By End-user

11. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By Region

  • 11.1. Key Findings
  • 11.2. Market Value Forecast By Region
    • 11.2.1. North America
    • 11.2.2. Europe
    • 11.2.3. Asia Pacific
    • 11.2.4. Latin America
    • 11.2.5. Middle East & Africa
  • 11.3. Market Attractiveness By Region

12. North America Regulatory Affairs Outsourcing Market Analysis and Forecast

  • 12.1. Introduction
    • 12.1.1. Key Findings
  • 12.2. Market Value Forecast By Service Type, 2020 to 2035
    • 12.2.1. Regulatory Consulting and Legal Representation
    • 12.2.2. Product Registration and Clinical Trial Applications
    • 12.2.3. Regulatory Writing and Publishing
    • 12.2.4. Regulatory Submission
    • 12.2.5. Regulatory Operations
    • 12.2.6. Others
  • 12.3. Market Value Forecast By Product Development Stage, 2020 to 2035
    • 12.3.1. Preclinical
    • 12.3.2. Clinical
    • 12.3.3. PMA (Post Market Authorization)
  • 12.4. Market Value Forecast By Enterprise Size, 2020 to 2035
    • 12.4.1. Small/Medium Enterprises
    • 12.4.2. Large Enterprises
  • 12.5. Market Value Forecast By Therapeutic Area, 2020 to 2035
    • 12.5.1. Oncology
    • 12.5.2. Neurology
    • 12.5.3. Cardiology
    • 12.5.4. Immunology
    • 12.5.5. Dermatology
    • 12.5.6. Others
  • 12.6. Market Value Forecast By End-user, 2020 to 2035
    • 12.6.1. Medical Device Companies
    • 12.6.2. Biopharma & Pharmaceutical Companies
    • 12.6.3. Others
  • 12.7. Market Value Forecast By Country, 2020 to 2035
    • 12.7.1. U.S.
    • 12.7.2. Canada
  • 12.8. Market Attractiveness Analysis
    • 12.8.1. By Service Type
    • 12.8.2. By Product Development Stage
    • 12.8.3. By Enterprise Size
    • 12.8.4. By Therapeutic Area
    • 12.8.5. By End-user
    • 12.8.6. By Country

13. Europe Regulatory Affairs Outsourcing Market Analysis and Forecast

  • 13.1. Introduction
    • 13.1.1. Key Findings
  • 13.2. Market Value Forecast By Service Type, 2020 to 2035
    • 13.2.1. Regulatory Consulting and Legal Representation
    • 13.2.2. Product Registration and Clinical Trial Applications
    • 13.2.3. Regulatory Writing and Publishing
    • 13.2.4. Regulatory Submission
    • 13.2.5. Regulatory Operations
    • 13.2.6. Others
  • 13.3. Market Value Forecast By Product Development Stage, 2020 to 2035
    • 13.3.1. Preclinical
    • 13.3.2. Clinical
    • 13.3.3. PMA (Post Market Authorization)
  • 13.4. Market Value Forecast By Enterprise Size, 2020 to 2035
    • 13.4.1. Small/Medium Enterprises
    • 13.4.2. Large Enterprises
  • 13.5. Market Value Forecast By Therapeutic Area, 2020 to 2035
    • 13.5.1. Oncology
    • 13.5.2. Neurology
    • 13.5.3. Cardiology
    • 13.5.4. Immunology
    • 13.5.5. Dermatology
    • 13.5.6. Others
  • 13.6. Market Value Forecast By End-user, 2020 to 2035
    • 13.6.1. Medical Device Companies
    • 13.6.2. Biopharma & Pharmaceutical Companies
    • 13.6.3. Others
  • 13.7. Market Value Forecast By Country/Sub-region, 2020 to 2035
    • 13.7.1. Germany
    • 13.7.2. UK
    • 13.7.3. France
    • 13.7.4. Italy
    • 13.7.5. Spain
    • 13.7.6. Switzerland
    • 13.7.7. The Netherlands
    • 13.7.8. Rest of Europe
  • 13.8. Market Attractiveness Analysis
    • 13.8.1. By Service Type
    • 13.8.2. By Product Development Stage
    • 13.8.3. By Enterprise Size
    • 13.8.4. By Therapeutic Area
    • 13.8.5. By End-user
    • 13.8.6. By Country/Sub-region

14. Asia Pacific Regulatory Affairs Outsourcing Market Analysis and Forecast

  • 14.1. Introduction
    • 14.1.1. Key Findings
  • 14.2. Market Value Forecast By Service Type, 2020 to 2035
    • 14.2.1. Regulatory Consulting and Legal Representation
    • 14.2.2. Product Registration and Clinical Trial Applications
    • 14.2.3. Regulatory Writing and Publishing
    • 14.2.4. Regulatory Submission
    • 14.2.5. Regulatory Operations
    • 14.2.6. Others
  • 14.3. Market Value Forecast By Product Development Stage, 2020 to 2035
    • 14.3.1. Preclinical
    • 14.3.2. Clinical
    • 14.3.3. PMA (Post Market Authorization)
  • 14.4. Market Value Forecast By Enterprise Size, 2020 to 2035
    • 14.4.1. Small/Medium Enterprises
    • 14.4.2. Large Enterprises
  • 14.5. Market Value Forecast By Therapeutic Area, 2020 to 2035
    • 14.5.1. Oncology
    • 14.5.2. Neurology
    • 14.5.3. Cardiology
    • 14.5.4. Immunology
    • 14.5.5. Dermatology
    • 14.5.6. Others
  • 14.6. Market Value Forecast By End-user, 2020 to 2035
    • 14.6.1. Medical Device Companies
    • 14.6.2. Biopharma & Pharmaceutical Companies
    • 14.6.3. Others
  • 14.7. Market Value Forecast By Country/Sub-region, 2020 to 2035
    • 14.7.1. China
    • 14.7.2. Japan
    • 14.7.3. India
    • 14.7.4. Australia & New Zealand
    • 14.7.5. South Korea
    • 14.7.6. Rest of Asia Pacific
  • 14.8. Market Attractiveness Analysis
    • 14.8.1. By Service Type
    • 14.8.2. By Product Development Stage
    • 14.8.3. By Enterprise Size
    • 14.8.4. By Therapeutic Area
    • 14.8.5. By End-user
    • 14.8.6. By Country/Sub-region

15. Latin America Regulatory Affairs Outsourcing Market Analysis and Forecast

  • 15.1. Introduction
    • 15.1.1. Key Findings
  • 15.2. Market Value Forecast By Service Type, 2020 to 2035
    • 15.2.1. Regulatory Consulting and Legal Representation
    • 15.2.2. Product Registration and Clinical Trial Applications
    • 15.2.3. Regulatory Writing and Publishing
    • 15.2.4. Regulatory Submission
    • 15.2.5. Regulatory Operations
    • 15.2.6. Others
  • 15.3. Market Value Forecast By Product Development Stage, 2020 to 2035
    • 15.3.1. Preclinical
    • 15.3.2. Clinical
    • 15.3.3. PMA (Post Market Authorization)
  • 15.4. Market Value Forecast By Enterprise Size, 2020 to 2035
    • 15.4.1. Small/Medium Enterprises
    • 15.4.2. Large Enterprises
  • 15.5. Market Value Forecast By Therapeutic Area, 2020 to 2035
    • 15.5.1. Oncology
    • 15.5.2. Neurology
    • 15.5.3. Cardiology
    • 15.5.4. Immunology
    • 15.5.5. Dermatology
    • 15.5.6. Others
  • 15.6. Market Value Forecast By End-user, 2020 to 2035
    • 15.6.1. Medical Device Companies
    • 15.6.2. Biopharma & Pharmaceutical Companies
    • 15.6.3. Others
  • 15.7. Market Value Forecast By Country/Sub-region, 2020 to 2035
    • 15.7.1. Brazil
    • 15.7.2. Mexico
    • 15.7.3. Argentina
    • 15.7.4. Rest of Latin America
  • 15.8. Market Attractiveness Analysis
    • 15.8.1. By Service Type
    • 15.8.2. By Product Development Stage
    • 15.8.3. By Enterprise Size
    • 15.8.4. By Therapeutic Area
    • 15.8.5. By End-user
    • 15.8.6. By Country/Sub-region

16. Middle East & Africa Regulatory Affairs Outsourcing Market Analysis and Forecast

  • 16.1. Introduction
    • 16.1.1. Key Findings
  • 16.2. Market Value Forecast By Service Type, 2020 to 2035
    • 16.2.1. Regulatory Consulting and Legal Representation
    • 16.2.2. Product Registration and Clinical Trial Applications
    • 16.2.3. Regulatory Writing and Publishing
    • 16.2.4. Regulatory Submission
    • 16.2.5. Regulatory Operations
    • 16.2.6. Others
  • 16.3. Market Value Forecast By Product Development Stage, 2020 to 2035
    • 16.3.1. Preclinical
    • 16.3.2. Clinical
    • 16.3.3. PMA (Post Market Authorization)
  • 16.4. Market Value Forecast By Enterprise Size, 2020 to 2035
    • 16.4.1. Small/Medium Enterprises
    • 16.4.2. Large Enterprises
  • 16.5. Market Value Forecast By Therapeutic Area, 2020 to 2035
    • 16.5.1. Oncology
    • 16.5.2. Neurology
    • 16.5.3. Cardiology
    • 16.5.4. Immunology
    • 16.5.5. Dermatology
    • 16.5.6. Others
  • 16.6. Market Value Forecast By End-user, 2020 to 2035
    • 16.6.1. Medical Device Companies
    • 16.6.2. Biopharma & Pharmaceutical Companies
    • 16.6.3. Others
  • 16.7. Market Value Forecast By Country/Sub-region, 2020 to 2035
    • 16.7.1. GCC Countries
    • 16.7.2. South Africa
    • 16.7.3. Rest of Middle East & Africa
  • 16.8. Market Attractiveness Analysis
    • 16.8.1. By Service Type
    • 16.8.2. By Product Development Stage
    • 16.8.3. By Enterprise Size
    • 16.8.4. By Therapeutic Area
    • 16.8.5. By End-user
    • 16.8.6. By Country/Sub-region

17. Competition Landscape

  • 17.1. Market Player - Competition Matrix (By Tier and Size of companies)
  • 17.2. Market Share Analysis By Company (2024)
  • 17.3. Company Profiles
    • 17.3.1. Accell Clinical Research, LLC
      • 17.3.1.1. Company Overview
      • 17.3.1.2. Financial Overview
      • 17.3.1.3. Financial Overview
      • 17.3.1.4. Business Strategies
      • 17.3.1.5. Recent Developments
    • 17.3.2. Genpact
      • 17.3.2.1. Company Overview
      • 17.3.2.2. Financial Overview
      • 17.3.2.3. Financial Overview
      • 17.3.2.4. Business Strategies
      • 17.3.2.5. Recent Developments
    • 17.3.3. CRITERIUM, INC
      • 17.3.3.1. Company Overview
      • 17.3.3.2. Financial Overview
      • 17.3.3.3. Financial Overview
      • 17.3.3.4. Business Strategies
      • 17.3.3.5. Recent Developments
    • 17.3.4. Promedica International
      • 17.3.4.1. Company Overview
      • 17.3.4.2. Financial Overview
      • 17.3.4.3. Financial Overview
      • 17.3.4.4. Business Strategies
      • 17.3.4.5. Recent Developments
    • 17.3.5. WuXi AppTec
      • 17.3.5.1. Company Overview
      • 17.3.5.2. Financial Overview
      • 17.3.5.3. Financial Overview
      • 17.3.5.4. Business Strategies
      • 17.3.5.5. Recent Developments
    • 17.3.6. Medpace
      • 17.3.6.1. Company Overview
      • 17.3.6.2. Financial Overview
      • 17.3.6.3. Financial Overview
      • 17.3.6.4. Business Strategies
      • 17.3.6.5. Recent Developments
    • 17.3.7. Charles River Laboratories
      • 17.3.7.1. Company Overview
      • 17.3.7.2. Financial Overview
      • 17.3.7.3. Financial Overview
      • 17.3.7.4. Business Strategies
      • 17.3.7.5. Recent Developments
    • 17.3.8. ICON plc
      • 17.3.8.1. Company Overview
      • 17.3.8.2. Financial Overview
      • 17.3.8.3. Financial Overview
      • 17.3.8.4. Business Strategies
      • 17.3.8.5. Recent Developments
    • 17.3.9. Parexel International Corporation
      • 17.3.9.1. Company Overview
      • 17.3.9.2. Financial Overview
      • 17.3.9.3. Financial Overview
      • 17.3.9.4. Business Strategies
      • 17.3.9.5. Recent Developments
    • 17.3.10. Freyr
      • 17.3.10.1. Company Overview
      • 17.3.10.2. Financial Overview
      • 17.3.10.3. Financial Overview
      • 17.3.10.4. Business Strategies
      • 17.3.10.5. Recent Developments
    • 17.3.11. PHARMALEX GMBH
      • 17.3.11.1. Company Overview
      • 17.3.11.2. Financial Overview
      • 17.3.11.3. Financial Overview
      • 17.3.11.4. Business Strategies
      • 17.3.11.5. Recent Developments
    • 17.3.12. Labcorp Drug Development
      • 17.3.12.1. Company Overview
      • 17.3.12.2. Financial Overview
      • 17.3.12.3. Financial Overview
      • 17.3.12.4. Business Strategies
      • 17.3.12.5. Recent Developments
    • 17.3.13. Other Prominent Players
      • 17.3.13.1. Company Overview
      • 17.3.13.2. Financial Overview
      • 17.3.13.3. Financial Overview
      • 17.3.13.4. Business Strategies
      • 17.3.13.5. Recent Developments