市場調査レポート

商品コード

1561039

レギュラトリーアフェアーズ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、企業規模別、カテゴリー別、適応症別、製品ステージ別、地域別 - 産業予測、2024年～2031年

Regulatory Affairs Outsourcing Market Size, Share, Growth Analysis, By Services, By Company Size, By Category, By Indication, By Product Stage, By Region - Industry Forecast 2024-2031

出版日: 2024年09月21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 5,300 778,146円

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PDF & Excel (Multiple User License)

USD 6,200 910,284円

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PDF & Excel (Enterprise License)

USD 7,100 1,042,422円

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全表示
概要
目次

概要

サンプル依頼リストに入れる

世界のレギュラトリーアフェアーズアウトソーシングの市場規模は2022年に61億米ドルと評価され、2023年の66億5,000万米ドルから2031年には126億2,000万米ドルに成長し、予測期間中（2024-2031年）のCAGRは8.34%で成長する見通しです。

レギュラトリーアフェアーズは、ガバメントアフェアーズと呼ばれることもあり、農薬、化粧品、殺虫剤、医療機器、動物用医薬品、医薬品、補完医薬品など、さまざまな分野の製品の適切性と効率性を評価・監督し、公衆衛生を確保します。これらのサービスは、医療機器、バイオテクノロジー、製薬業界のメーカーが提供しています。レギュラトリーアフェアーズアウトソーシング企業は、規制当局の許認可を効率的かつ期限内に取得する手助けをします。ヘルスケア分野では、レギュラトリーアフェアーズアウトソーシングの動向が拡大しています。このシフトは、地域的な拡大努力により、ローカル市場で迅速な承認が必要とされていることが背景にあります。さらに、研究開発活動の増加、臨床試験申請や製品登録の増加により市場も拡大しています。

市場概要
医薬品
- 規制コンサルティング
- 戦略と開発計画
- QAコンサルティング
- その他
- 法的代理
- 規制文書の執筆と出版
- 製品登録と臨床試験申請
- 規制当局への提出
- 規制業務
- その他のサービス
医療機器
- 規制コンサルティング
- 戦略と開発計画
- QAコンサルティング
- その他
- 法的代理
- 規制文書の執筆と出版
- 製品登録と臨床試験申請
- 規制当局への提出
- 規制業務
- その他のサービス

レギュラトリーアフェアーズアウトソーシング市場：適応症別

市場概要
腫瘍学
神経学
心臓病学
免疫学
その他

レギュラトリーアフェアーズアウトソーシング市場：製品ステージ別

市場概要
前臨床
臨床
PMA（市販後承認）

レギュラトリーアフェアーズアウトソーシング市場：最終用途別

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

レギュラトリーアフェアーズアウトソーシング市場：地域別規模

市場概要
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（MEA）
- GCC諸国
- 南アフリカ
- その他中東・アフリカ地域

競合情勢

上位5社の比較
主要企業の市場ポジショニング（2023年）
主な市場企業が採用した戦略
市場における最近の活動
主要企業の市場シェア（2023年）

主要企業プロファイル

Accell Clinical Research, LLC
Genpact
CRITERIUM, INC
Promedica International
New WuXi Life Science Limited
Medpace
Bausch & Lomb
Freyr
SSI Strategy Holdings LLC
Pharmexon
Quanticate
PharmaLex
Cambridge Regulatory Services
APC Group
Real Regulatory Ltd
Ergomed Plc
Regulatory Pharma Net srl
Excelya Group SAS
BioMapas
REGENOLD GMBH

Product Code: SQMIG35D2051

Global Regulatory Affairs Outsourcing Market size was valued at USD 6.1 billion in 2022 and is poised to grow from USD 6.65 billion in 2023 to USD 12.62 billion by 2031, growing at a CAGR of 8.34% during the forecast period (2024-2031).

Regulatory affairs, sometimes referred to as government affairs, involves evaluating and overseeing the adequacy and efficiency of products across various sectors, including agrochemicals, cosmetics, pesticides, medical devices, veterinary medicines, pharmaceuticals, and complementary medicines, to ensure public health. These services are provided by manufacturers in the medical device, biotechnology, and pharmaceutical industries. Regulatory affairs outsourcing firms help obtain regulatory permits efficiently and on time. The trend of outsourcing regulatory affairs is growing in the healthcare sector. This shift is driven by the need for rapid approvals in local markets due to regional expansion efforts. Additionally, the market is expanding due to increased research and development activities, as well as a rise in clinical trial applications and product registrations.

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 Segmental Analysis

Global Regulatory Affairs Outsourcing Market is segmented by Services, Company Size, Category, Indication, Product Stage, End Use, and Region. Based on Services, the market is segmented into Regulatory Consulting (Strategy & Development Planning, QA Consulting, Others), Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Product Stages, Regulatory Submission, Regulatory Operations, Other Services. Based on Company Size, the market is segmented into Small, Medium, Large. Based on Category, the market is segmented into Pharmaceuticals (Regulatory Consulting (Strategy & Development Planning, QA Consulting, Others), Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Product Stages, Regulatory Submissions, Regulatory Operations, Other Services), Medical Device (Regulatory Consulting (Strategy & Development Planning, QA Consulting, Others), Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Product Stages, Regulatory Submissions, Regulatory Operations, Other Services). Based on Indication, the market is segmented into Oncology, Neurology, Cardiology, Immunology, Others. Based on Product Stage, the market is segmented into Preclinical, Clinical, PMA (Post Market Authorization). Based on End Use, the market is segmented into Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Drivers of the Global Regulatory Affairs Outsourcing Market

The global demand for these services during the forecast period is being driven by several factors, including a rise in chronic illnesses, the expiration of patents for prescription biologics, brand extensions, and the easy availability of over-the-counter (OTC) drugs through various platforms. Additionally, economic and social factors, rising healthcare expenditures, and advancements in regulatory affairs outsourcing are contributing to this growing demand.

Restraints in the Global Regulatory Affairs Outsourcing Market

Nevertheless, the substantial risks associated with data sharing and outsourcing pose significant challenges that are expected to hinder the advancement of the regulatory outsourcing market throughout the forecast period. These concerns, stemming from data security and management issues, could considerably affect the market's growth trajectory and overall progress.

Market Trends of the Global Regulatory Affairs Outsourcing Market

The growth of the global regulatory affairs outsourcing market is significantly driven by several factors. These include a rise in research and development investments aimed at creating orphan, biosimilar, and generic drugs, alongside increased funding for clinical research. Additionally, stringent government regulations and a heightened emphasis on product development to enhance supply chains are playing crucial roles in this expansion.

Introduction

Objectives of the Study
Definitions
Market Scope

Research Methodology

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

Executive Summary

Market Overview Outlook
Supply Demand Trend Analysis
Segmental Opportunity Analysis

Market Dynamics & Outlook

Market Dynamics
- Drivers
- Opportunities
- Restraints
- Challenges
Porters Analysis
- Competitive rivalry
- Threat of Substitute Products
- Bargaining Power of Buyers
- Threat of New Entrants
- Bargaining Power of Suppliers

Key Market Insights

Technology Analysis
Ecosystem of the Market
Patent Analysis
Pricing Analysis
PESTEL Analysis
Regulatory Landscape
Innovation Matrix
Top Investment Analysis
Key Success Factor
Degree of Competition

Regulatory Affairs Outsourcing Market by Services

Market Overview
Regulatory Consulting
- Strategy & Development Planning
- QA Consulting
- Others
Legal Representation
Regulatory Writing & Publishing
Product Registration & Clinical Trial Applications
Regulatory Submission
Regulatory Operations
Other Services

Regulatory Affairs Outsourcing Market by Company Size

Market Overview
Small
Medium
Large

Regulatory Affairs Outsourcing Market by Category

Market Overview
Pharmaceuticals
- Regulatory Consulting
- Strategy & Development Planning
- QA consulting
- Others
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Regulatory Submissions
- Regulatory Operations
- Other Sevices
Medical Device
- Regulatory Consulting
- Strategy & Development Planning
- QA Consulting
- Others
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Regulatory Submissions
- Regulatory Operations
- Other Services

Regulatory Affairs Outsourcing Market by Indication

Market Overview
Oncology
Neurology
Cardiology
Immunology
Others

Regulatory Affairs Outsourcing Market by Product Stage

Market Overview
Preclinical
Clinical
PMA (Post Market Authorization)

Regulatory Affairs Outsourcing Market by End Use

Market Overview
Medical Device Companies
Pharmaceutical Companies
Biotechnology Companies

Regulatory Affairs Outsourcing Market Size by Region

Market Overview
North America
- USA
- Canada
Europe
- Germany
- Spain
- France
- UK
- Italy
- Rest of Europe
Asia Pacific
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
Latin America
- Brazil
- Rest of Latin America
Middle East & Africa (MEA)
- GCC Countries
- South Africa
- Rest of MEA

Competitive Landscape

Top 5 Player Comparison
Market Positioning of Key Players, 2023
Strategies Adopted by Key Market Players
Recent Activities in the Market
Key Companies Market Share (%), 2023

Key Company Profiles

Accell Clinical Research, LLC
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Genpact
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
CRITERIUM, INC
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Promedica International
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
New WuXi Life Science Limited
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Medpace
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Bausch & Lomb
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Freyr
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
SSI Strategy Holdings LLC
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Pharmexon
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Quanticate
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
PharmaLex
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Cambridge Regulatory Services
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
APC Group
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Real Regulatory Ltd
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Ergomed Plc
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Regulatory Pharma Net srl
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Excelya Group SAS
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
BioMapas
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
REGENOLD GMBH
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments