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The global healthcare regulatory affairs outsourcing market size was valued at USD 8.10 billion in 2023, driven by the increasing research and development activities across the globe. The market size is anticipated to grow at a CAGR of 9.5% during the forecast period of 2024-2032 to achieve a value of USD 18.34 billion by 2032.
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Healthcare regulatory affairs outsourcing refers to the practice of engaging external service providers or consulting firms to handle regulatory affairs tasks and responsibilities on behalf of healthcare organizations. Regulatory affairs in the healthcare sector involve navigating and complying with the complex and evolving regulatory landscape that governs the development, manufacturing, and marketing of pharmaceuticals, medical devices, biotechnology products, and other healthcare-related items.
Life sciences companies are increasingly turning to digitization, which has led to changes in the way regulatory publishing and information are managed. These companies face significant constraints in terms of time and the volume of data that needs to be processed. The integration of artificial intelligence is expected to drive growth in this sector. Additionally, increased awareness of the benefits of outsourcing healthcare regulatory affairs is also driving the global healthcare regulatory affairs outsourcing market growth.
The rising number of clinical trials is a major contributor to market growth. This increase is due to the growing demand for research and development in various domains, including the development of new medicines requiring approval from the U.S. Food and Drug Administration. The demand for new treatment therapies and drugs to address various medical conditions is also driving market growth.
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Market Breakup by Services
Market Breakup by Categories
Market Breakup by Region
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The market growth is expected to be driven by a surge in research and development expenditure due to a rising number of clinical trials, and the cost-effectiveness associated with outsourcing. The increasing investments in research and development by pharmaceutical and biotechnology companies are expected to be a key driver, stimulating the demand for regulatory services in the healthcare industry.
The market is further expected to be driven by the escalating outsourcing of clinical trial applications and product registrations. This trend expands across both developed and developing countries, particularly influencing the product registration and clinical trial application segment throughout the forecast period. The increased complexity in the product registration process, coupled with a shortage of industry professionals and internal capabilities, has led pharmaceutical and medical device companies to increasingly opt for third-party service providers for their product registration activities, propelling the global healthcare regulatory affairs outsourcing market growth.
Additionally, the market is characterized by several factors, including heightened R&D investments, a growing number of clinical trials, and the compelling cost advantages associated with outsourcing.
The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:
Please note that this only represents a partial list of companies, and the complete list has been provided in the report.
REPORT FEATURES | DETAILS |
Base Year | 2023 |
Historical Period | 2017-2023 |
Forecast Period | 2024-2032 |
Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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Breakup by Services |
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Breakup by Categories |
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Breakup by Region |
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Market Dynamics |
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Competitive Landscape |
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Companies Covered |
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*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Global Healthcare Regulatory Affairs Outsourcing Market Overview
3.1 Global Healthcare Regulatory Affairs Outsourcing Market Historical Value (2017-2023)
3.2 Global Healthcare Regulatory Affairs Outsourcing Market Forecast Value (2024-2032)
4 Global Healthcare Regulatory Affairs Outsourcing Market Landscape
4.1 Lentiviral Vectors: Developers Landscape
4.1.1 Analysis by Year of Establishment
4.1.2 Analysis by Company Size
4.1.3 Analysis by Region
4.2 Lentiviral Vectors: Product Landscape
4.2.1 Analysis by Type
4.2.2 Analysis by Products
4.2.3 Analysis by Applications
5 Global Healthcare Regulatory Affairs Outsourcing Market Dynamics
5.1 Market Drivers and Constraints
5.2 SWOT Analysis
5.3 Porter’s Five Forces Model
5.4 Key Demand Indicators
5.5 Key Price Indicators
5.6 Industry Events, Initiatives, and Trends
5.7 Value Chain Analysis
6 Global Healthcare Regulatory Affairs Outsourcing Market Segmentation
6.1 Global Healthcare Regulatory Affairs Outsourcing Market by Services
6.1.1 Market Overview
6.1.2 Regulatory Consulting
6.1.3 Legal Representation
6.1.4 Regulatory Writing and Publishing
6.1.5 Product Registration and Clinical Trial Applications
6.2 Global Healthcare Regulatory Affairs Outsourcing Market by Categories
6.2.1 Market Overview
6.2.2 Drugs
6.2.3 Biologics
6.2.4 Medical Devices
6.3 Global Healthcare Regulatory Affairs Outsourcing Market by Region
6.3.1 Market Overview
6.3.2 North America
6.3.3 Europe
6.3.4 Asia Pacific
6.3.5 Latin America
6.3.6 Middle East and Africa
7 North America Healthcare Regulatory Affairs Outsourcing Market
7.1 Market Share by Country
7.2 United States of America
7.3 Canada
8 Europe Healthcare Regulatory Affairs Outsourcing Market
8.1 Market Share by Country
8.2 United Kingdom
8.3 Germany
8.4 France
8.5 Italy
8.6 Others
9 Asia Pacific Healthcare Regulatory Affairs Outsourcing Market
9.1 Market Share by Country
9.2 China
9.3 Japan
9.4 India
9.5 ASEAN
9.6 Australia
9.7 Others
10 Latin America Healthcare Regulatory Affairs Outsourcing Market
10.1 Market Share by Country
10.2 Brazil
10.3 Argentina
10.4 Mexico
10.5 Others
11 Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market
11.1 Market Share by Country
11.2 Saudi Arabia
11.3 United Arab Emirates
11.4 Nigeria
11.5 South Africa
11.6 Others
12 Funding and Investment Analysis
12.1 Analysis by Funding Instances
12.2 Analysis by Type of Funding
12.3 Analysis by Funding Amount
12.4 Analysis by Leading Players
12.5 Analysis by Leading Investors
12.6 Analysis by Geography
13 Partnership and Collaborations Analysis
13.1 Analysis by Partnership Instances
13.2 Analysis by Type of Partnership
13.3 Analysis by Leading Players
13.4 Analysis by Geography
14 Supplier Landscape
14.1 Accell Clinical Research
14.1.1 Financial Analysis
14.1.2 Product Portfolio
14.1.3 Demographic Reach and Achievements
14.1.4 Mergers and Acquisitions
14.1.5 Certifications
14.2 Takeda Pharmaceutical Company Limited
14.2.1 Financial Analysis
14.2.2 Product Portfolio
14.2.3 Demographic Reach and Achievements
14.2.4 Mergers and Acquisitions
14.2.5 Certifications
14.3 Genpact
14.3.1 Financial Analysis
14.3.2 Product Portfolio
14.3.3 Demographic Reach and Achievements
14.3.4 Mergers and Acquisitions
14.3.5 Certifications
14.4 Promedica International
14.4.1 Financial Analysis
14.4.2 Product Portfolio
14.4.3 Demographic Reach and Achievements
14.4.4 Mergers and Acquisitions
14.4.5 Certifications
14.5 WuXi AppTec, Inc.
14.5.1 Financial Analysis
14.5.2 Product Portfolio
14.5.3 Demographic Reach and Achievements
14.5.4 Mergers and Acquisitions
14.5.5 Certifications
14.6 PRA Health Sciences
14.6.1 Financial Analysis
14.6.2 Product Portfolio
14.6.3 Demographic Reach and Achievements
14.6.4 Mergers and Acquisitions
14.6.5 Certifications
14.7 Medpace
14.7.1 Financial Analysis
14.7.2 Product Portfolio
14.7.3 Demographic Reach and Achievements
14.7.4 Mergers and Acquisitions
14.7.5 Certifications
14.8 Charles River Laboratories International
14.8.1 Financial Analysis
14.8.2 Product Portfolio
14.8.3 Demographic Reach and Achievements
14.8.4 Mergers and Acquisitions
14.8.5 Certifications
14.9 PAREXEL International Corp.
14.9.1 Financial Analysis
14.9.2 Product Portfolio
14.9.3 Demographic Reach and Achievements
14.9.4 Mergers and Acquisitions
14.9.5 Certifications
14.10 Covance, Inc.
14.10.1 Financial Analysis
14.10.2 Product Portfolio
14.10.3 Demographic Reach and Achievements
14.10.4 Mergers and Acquisitions
14.10.5 Certifications
15 Key Opinion Leaders (KOL) Insights (Additional Insight)
16 Company Competitiveness Analysis (Additional Insight)
16.1 Very Small Companies
16.2 Small Companies
16.3 Mid-Sized Companies
16.4 Large Companies
16.5 Very Large Companies
17 Payment Methods (Additional Insight)
17.1 Government Funded
17.2 Private Insurance
17.3 Out-of-Pocket
*Additional insights provided are customisable as per client requirements.
The market attained a value of about USD 8.10 billion in 2023, driven by the increased FDA approvals.
The market is anticipated to grow at a CAGR of 9.5% during the forecast period of 2024-2032 and is likely to reach a market value of USD 18.34 billion by 2032.
The market growth is driven by the increased integration of advanced technologies in the procedure to process a huge amount of data.
The increasing number of research activities and the rapid development of the healthcare sector are the major factors driving the market growth.
The major regions of the market include North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. North America is currently leading the global market.
Services such as regulatory consulting, legal representation, regulatory writing & publishing, product registration, and clinical trial applications are covered in healthcare regulatory affairs outsourcing.
The categories in the market include includes drugs, biologics, and medical devices.
Key players involved in the market are Accell Clinical Research, Takeda Pharmaceutical Company Limited, Genpact, Promedica International, WuXi AppTec, Inc., Covance, Inc., Medpace, Charles River Laboratories International, PAREXEL International Corp., and PRA Health Sciences.
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