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市場調查報告書

商品編碼

1529562

醫藥外包市場：依服務類型、最終用戶、階段、治療領域、地區

Regulatory Affairs Outsourcing Market, By Service Type, By End User, By Stage, By Therapeutic Area, By Geography

出版日期: 2024年07月24日 | 出版商:

Coherent Market Insights | 英文 166 Pages | 商品交期: 2-3個工作天內

價格

簡介目錄

預計2024年全球醫藥外包市場規模為84.1億美元，2031年將達171億美元，2024年至2031年複合年成長率為10.7%。

報告範圍		報告詳情
基準年	2023年	2024年市場規模	84.1億美元
實際資料	2019-2023	預測期	2024-2031
2024-2031 年預測期複合年成長率	10.70%	2031 年金額預測	171億美元

圖. 醫藥外包市場佔有率（%）（依地區分類，2024年）

法律規範，正在推動全球醫藥外包市場的成長。每個地區的監管要求變得越來越嚴格，需要專業知識和資源來實現合規。此外，藥物開發過程已受到高度監管，需要在從臨床開發到核准的各個階段密切監測和控制合規性。因此，包括醫療設備製造商在內的製藥和生物技術公司擴大轉向專業的第三方服務供應商來外包其業務。監管外包幫助公司簡化流程、降低成本並將資源集中在核心競爭力上。

市場動態：

全球監管外包市場的成長受到製藥和生技公司研發費用增加、嚴格的法規環境和成本壓力等因素的推動。然而，資料隱私和安全問題以及品管問題可能會阻礙市場成長。隨著外包和臨床試驗活動轉向亞太和拉丁美洲的低成本目的地，新興市場可能會提供重大商機。受監管服務供應商採用的併購和聯盟策略數量不斷增加，也導致其能力和全球企業發展的擴大，記錄了新的成長機會。

本研究的主要特點

本報告對全球醫藥外包市場進行了詳細分析，並介紹了以 2023 年為基準年的預測期（2024-2031 年）的市場規模（十億美元）和年複合成長率（CAGR%）。
它還揭示了各個細分市場的潛在商機，並說明了該市場有吸引力的投資提案矩陣。
它還提供了有關市場促進因素、限制因素、機會、新產品發布和核准、市場趨勢、區域前景、主要企業採取的競爭策略等的重要見解。
該報告根據公司亮點、產品系列、主要亮點、財務業績和策略等參數，對全球監管外包市場的主要企業進行了介紹。
該報告的見解使負責人和公司經營團隊能夠就未來的產品發布、升級、市場擴張和行銷策略做出明智的決策。
全球監管外包市場報告針對該行業的各個相關人員，如投資者、供應商、產品製造商、經銷商、新進業者和財務分析師。
透過用於全球製藥外包市場分析的各種策略矩陣，將促進相關人員的決策。

公司簡介
- Accell Clinical Research, LLC
- Genpact
- CRITERIUM, INC.
- PRA Health Sciences
- Promedica International
- WuXiAppTec
- Medpace
- PPD Inc.
- Charles River Laboratories
- ICON plc
- Covance
- Parexel International Corporation
- Freyr
- Navitas Clinical Research, Inc.
- Medelis, Inc.
- Sciformix
- Tech Tammina
- Acorn Regulatory Consultancy Services Ltd.
- BIOMAPAS
- REGULATORY PROFESSIONALS
- CompareNetworks, Inc.

第11章分析師建議

上升和下降
綜合機會圖

第12章參考文獻與調查方法

參考
調查方法

簡介目錄

Product Code: CMI2751

Global regulatory affairs outsourcing market is estimated to be valued at USD 8.41 Bn 2024 and is expected to reach USD 17.10 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 10.7% from 2024 to 2031.

Report Coverage		Report Details
Base Year:	2023	Market Size in 2024:	US$ 8.41 Bn
Historical Data for:	2019 to 2023	Forecast Period:	2024 to 2031
Forecast Period 2024 to 2031 CAGR:	10.70%	2031 Value Projection:	US$ 17.10 Bn

Figure. Regulatory Affairs Outsourcing Market Share (%), By Region 2024

Regulatory Affairs Outsourcing Market - IMG1

Global regulatory affairs outsourcing market growth is driven by increasing complexity of regulatory frameworks. Regulatory requirements have become more stringent across regions necessitating specialized expertise and resources for compliance. Furthermore, drug development process has become highly regulated requiring close monitoring and management of compliance at various stages from clinical development to approvals. This has prompted pharmaceutical and biotech companies including medical device manufacturers to rely on third-party service providers with domain expertise to outsource regulatory functions. Regulatory outsourcing helps firms streamline processes, reduce costs, and focus resources on core competencies.

Market Dynamics:

Global regulatory affairs outsourcing market growth is driven by factors such as increasing R&D expenditure of pharmaceutical and biotechnology firms, stringent regulatory environment, and cost pressures. However, data privacy & security concerns and quality control issues can hamper the market growth. Emerging markets can offer significant opportunities due to outsourcing and clinical trial activities shifting to low-cost destinations in Asia Pacific and Latin America. Increased mergers and acquisitions and partnership strategies adopted by regulatory service providers can also expand their capabilities and global footprint, thus, offering new growth opportunities.

Key Features of the Study:

This report provides in-depth analysis of the global regulatory affairs outsourcing market, and provides market size (USD Billion) and compound annual growth rate (CAGR%) for the forecast period (2024-2031), considering 2023 as the base year
It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players
It profiles key players in the global regulatory affairs outsourcing market based on the following parameters - company highlights, products portfolio, key highlights, financial performance, and strategies
Key companies covered as a part of this study include Prophecy, PAREXEL, Clinitec, ICON, Accell, and Covance
Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
Global regulatory affairs outsourcing market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global regulatory affairs outsourcing market

Detailed Segmentation-

By Service Type
- Regulatory Consulting and Legal Representation
- Product Registration and Clinical Trial Applications
- Regulatory Writing and Publishing
- Regulatory Submission
- Regulatory Operations
- Others
By End User
- Medical Device Companies
- Pharmaceutical Companies
- Biotechnology Companies
By Stage
- Preclinical
- Clinical
- PMA (Post Market Authorization)
By Therapeutic Area
- Oncology
- Neurology
- Cardiology
- Immunology
- Others
By Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East
- Africa
Company Profiles:
- Accell Clinical Research, LLC
- Genpact
- CRITERIUM, INC.
- PRA Health Sciences
- Promedica International
- WuXiAppTec
- Medpace
- PPD Inc.
- Charles River Laboratories
- ICON plc
- Covance
- Parexel International Corporation
- Freyr
- Navitas Clinical Research, Inc.
- Medelis, Inc.
- Sciformix
- Tech Tammina
- Acorn Regulatory Consultancy Services Ltd.
- BIOMAPAS
- REGULATORY PROFESSIONALS
- CompareNetworks, Inc.

1. Research Objectives and Assumptions

Research Objectives
Assumptions
Abbreviations

2. Market Purview

Report Description
- Market Definition and Scope
Executive Summary
- Market Snapshot, By Service Type
- Market Snapshot, By End User
- Market Snapshot, By Stage
- Market Snapshot, By Therapeutic Area
- Market Snapshot, By Region
Coherent Opportunity Map (COM)

3. Market Dynamics, Regulations, and Trends Analysis

Market Dynamics
- Drivers
- Restraints
- Opportunities
Impact Analysis
Market Trends
Key Developments
Regulatory Scenario
Acquisitions and Partnerships Scenario
Funding and Investments
PEST Analysis
Porter's Analysis

4. Global Regulatory Affairs Outsourcing Market - Impact of Coronavirus (COVID-19) Pandemic

Overall Impact
Government Initiatives
COVID-19 Impact on the Market

5. Global Regulatory Affairs Outsourcing Market, By Service Type, 2019 - 2031, (USD Bn)

Overview
- Market Share Analysis, 2024 and 2031 (%)
- Y-o-Y Growth Analysis, 2019 - 2031
- Segment Trends
Regulatory Consulting and Legal Representation
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Product Registration and Clinical Trial Applications
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Regulatory Writing and Publishing
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Regulatory Submission
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Regulatory Operations
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Others
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

6. Global Regulatory Affairs Outsourcing Market, By End User, 2019 - 2031, (USD Bn)

Overview
- Market Share Analysis, 2024 and 2031 (%)
- Y-o-Y Growth Analysis, 2019 - 2031
- Segment Trends
Medical Device Companies
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Pharmaceutical Companies
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Biotechnology Companies
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

7. Global Regulatory Affairs Outsourcing Market, By Stage, 2019 - 2031, (USD Bn)

Overview
- Market Share Analysis, 2024 and 2031 (%)
- Y-o-Y Growth Analysis, 2019 - 2031
- Segment Trends
Preclinical
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Clinical
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
PMA (Post Market Authorization)
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

8. Global Regulatory Affairs Outsourcing Market, By Therapeutic Area, 2019 - 2031, (USD Bn)

Overview
- Market Share Analysis, 2024 and 2031 (%)
- Y-o-Y Growth Analysis, 2019 - 2031
- Segment Trends
Oncology
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Neurology
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Cardiology
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Immunology
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Others
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

9. Global Regulatory Affairs Outsourcing Market, By Region, 2019 - 2031, (USD Bn)

Introduction
- Market Share Analysis, By Region, 2024 and 2031 (%)
- Y-o-Y Growth Analysis, For Region, 2019-2031
- Regional Trends
  - North America
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2019 - 2031, (USD Bn)
  - U.S.
  - Canada
Latin America
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2019 - 2031, (USD Bn)
  - Brazil
  - Mexico
  - Argentina
  - Rest of Latin America
Europe
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area. 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2019 - 2031, (USD Bn)
  - U.K.
  - Germany
  - Italy
  - France
  - Spain
  - Russia
  - Rest of Europe
Asia Pacific
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2019 - 2031, (USD Bn)
  - China
  - India
  - Japan
  - ASEAN
  - Australia
  - South Korea
  - Rest of Asia Pacific
Middle East
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2019 - 2031, (USD Bn)
  - GCC Countries
  - Israel
  - Rest of Middle East
  - Africa
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country/Sub-region, 2019 - 2031, (USD Bn)
  - North Africa
  - Central Africa
  - South Africa

10. Competitive Landscape

Company Profiles
- Accell Clinical Research, LLC
  - Company Highlights
  - Service Type Portfolio
  - Key Highlights
  - Financial Performance
  - Market Strategies
- Genpact
- CRITERIUM, INC.
- PRA Health Sciences
- Promedica International
- WuXiAppTec
- Medpace
- PPD Inc.
- Charles River Laboratories
- ICON plc
- Covance
- Parexel International Corporation
- Freyr
- Navitas Clinical Research, Inc.
- Medelis, Inc.
- Sciformix
- Tech Tammina
- Acorn Regulatory Consultancy Services Ltd.
- BIOMAPAS
- REGULATORY PROFESSIONALS
- CompareNetworks, Inc.