The global regulatory affairs outsourcing market revenue was around US$ 4.5 billion in 2022 and is estimated to reach US$ 21.5 billion by 2031, growing at a compound annual growth rate (CAGR) of 19% during the forecast period from 2023 to 2031.
Regulatory affairs, also called government affairs, is a field concerned with providing the public's health through the monitoring and analysis of products from industries like cosmetics, agrochemicals, medical devices, pesticides, pharmaceuticals, veterinary medicines, and complementary medicine. Regulatory affairs outsourcing services are available to companies that make biomedical devices, pharmaceuticals, and medical supplies.
Market Driving Factors
A surge in investments by key players in research and development for regulatory affairs outsourcing creates a positive impact on the market. As new medicines and therapies are introduced to the market, the field of medicine continues to evolve. Several public-private institutes and businesses concentrate on research to discover novel medicines. For instance, Bayer AG's pharmaceutical division revealed a cell and gene therapy platform.
Growth in regulatory complexity propels the market. Many businesses are finding it difficult to keep up with the evolving regulatory requirements due to the complexity of global rules. This has led to a risen demand for regulatory affairs outsourcing services, as companies seek to leverage the expertise of regulatory affairs professionals.
Time-to-market boosts the market. Time to market is the overall amount of time it takes to bring a product and make it available on the market. Companies operating in highly regulated industries like medical devices, pharmaceuticals, and biotechnology need to get their products to market fast to remain competitive. Outsourcing regulatory affairs can assist in expediting the regulatory approval process, lowering time-to-market, and raising the speed of product launches.
Short-term regulatory affairs outsourcing contracts are possible, which might make it challenging for outsourcing companies to manage their resources and make long-term investments. Thus, this factor impedes the market growth.
Regional Analysis
North America is estimated to dominate the market in terms of the CAGR over the projection period. This is due to the existence of significant medical and pharmaceutical device companies and the rise in R&D spending in the region. Furthermore, due to the existence of two significant international regulatory organizations, the European Medicines Agency (EMA) and the U.S. FDA, which supervise more than half of all medical devices globally. It boasts a well-established and cutting-edge healthcare infrastructure and numerous international biotech and pharmaceutical companies that carry out multiple clinical trials.
Segmentation Insights
In terms of service, the regulatory writing and publishing segment dominates the market over the forecast period. This segment is considered to be an essential part of the research. A broad variety of documents are produced throughout the clinical trial phases. Furthermore, the regulatory writers are considered to be essential communicators between the drug developers and the approving regulatory authorities such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). The regulatory writers also play a crucial role in the advertising of any latest drug or medical device. Therefore, the importance of regulatory writing and publication activities has made this the leading segment of the world.
Prominent Companies
Segmentation Outline
The global regulatory affairs outsourcing market segmentation focuses on Service, and Region.
By Service
By Region
[TABLE OF CONTENTS]
1 INTRODUCTION OF GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET
1.1 OVERVIEW OF THE MARKET
1.2 SCOPE OF REPORT
1.3 ASSUMPTIONS
2 EXECUTIVE SUMMARY: REGULATORY AFFAIRS OUTSOURCING MARKET
3 RESEARCH METHODOLOGY
3.1 DATA MINING
3.2 VALIDATION
3.3 PRIMARY INTERVIEWS
3.4 LIST OF DATA SOURCES
3.5 ANALYST TOOLS AND MODELS
4 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET OUTLOOK
4.1 OVERVIEW
4.2 MARKET DYNAMICS AND TRENDS
4.2.1 DRIVERS
4.2.2 RESTRAINTS
4.2.3 OPPORTUNITIES
4.3 PORTERS FIVE FORCE ANALYSIS
4.4 VALUE CHAIN ANALYSIS
4.5 MARKET GROWTH AND OUTLOOK
4.5.1 PRICE TREND ANALYSIS
4.5.2 OPPORTUNITY SHARE
5 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET, BY SERVICE
5.1 OVERVIEW
5.2 REGULATORY AFFAIRS
5.3 CLINICAL TRIAL APPLICATIONS AND PRODUCT REGISTRATIONS
5.4 REGULATORY WRITING AND PUBLISHING
5.5 REGULATORY CONSULTING AND LEGAL REPRESENTATION
5.6 OTHERS
6 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET, BY GEOGRAPHY
6.1 OVERVIEW
6.2 NORTH AMERICA
6.2.1 NORTH AMERICA MARKET SNAPSHOT
6.2.2 U.S.
6.2.3 CANADA
6.2.4 MEXICO
6.3 EUROPE
6.3.1 EUROPE MARKET SNAPSHOT
6.3.2 WESTERN EUROPE
6.3.2.1 THE UK
6.3.2.2 GERMANY
6.3.2.3 FRANCE
6.3.2.4 ITALY
6.3.2.5 SPAIN
6.3.2.6 REST OF WESTERN EUROPE
6.3.3 EASTERN EUROPE
6.3.3.1 POLAND
6.3.3.2 RUSSIA
6.3.3.3 REST OF EASTERN EUROPE
6.4 ASIA PACIFIC
6.4.1 ASIA PACIFIC MARKET SNAPSHOT
6.4.2 CHINA
6.4.3 JAPAN
6.4.4 INDIA
6.4.5 AUSTRALIA & NEW ZEALAND
6.4.6 ASEAN
6.4.7 REST OF ASIA PACIFIC
6.5 MIDDLE EAST & AFRICA
6.5.1 MIDDLE EAST & AFRICA MARKET SNAPSHOT
6.5.2 UAE
6.5.3 SAUDI ARABIA
6.5.4 SOUTH AFRICA
6.5.5 REST OF MEA
6.6 SOUTH AMERICA
6.6.1 SOUTH AMERICA MARKET SNAPSHOT
6.6.2 BRAZIL
6.6.3 ARGENTINA
6.6.4 REST OF SOUTH AMERICA
7 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET COMPETITIVE LANDSCAPE
7.1 OVERVIEW
7.2 COMPANY MARKET RANKING
7.3 KEY DEVELOPMENT STRATEGIES
7.4 COMPETITIVE DASHBOARD
7.5 PRODUCT MAPPING
7.6 TOP PLAYER POSITIONING, 2022
7.7 COMPETITIVE HEATMAP
7.8 TOP WINNING STRATEGIES
8 COMPANY PROFILES
8.1 ACCELL CLINICAL RESEARCH LLC
8.1.1 OVERVIEW
8.1.2 FINANCIAL PERFORMANCE
8.1.3 PRODUCT OUTLOOK
8.1.4 KEY DEVELOPMENTS
8.1.5 KEY STRATEGIC MOVES AND DEVELOPMENTS
8.2 CHARLES RIVER LABORATORIES INTERNATIONAL, INC
8.2.1 OVERVIEW
8.2.2 FINANCIAL PERFORMANCE
8.2.3 PRODUCT OUTLOOK
8.2.4 KEY DEVELOPMENTS
8.2.5 KEY STRATEGIC MOVES AND DEVELOPMENTS
8.3 CLINILABS, INC
8.3.1 OVERVIEW
8.3.2 FINANCIAL PERFORMANCE
8.3.3 PRODUCT OUTLOOK
8.3.4 KEY DEVELOPMENTS
8.3.5 KEY STRATEGIC MOVES AND DEVELOPMENTS
8.4 COVANCE, INC
8.4.1 OVERVIEW
8.4.2 FINANCIAL PERFORMANCE
8.4.3 PRODUCT OUTLOOK
8.4.4 KEY DEVELOPMENTS
8.4.5 KEY STRATEGIC MOVES AND DEVELOPMENTS
8.5 CRITERIUM, INC
8.5.1 OVERVIEW
8.5.2 FINANCIAL PERFORMANCE
8.5.3 PRODUCT OUTLOOK
8.5.4 KEY DEVELOPMENTS
8.5.5 KEY STRATEGIC MOVES AND DEVELOPMENTS
8.6 ICON PLC
8.6.1 OVERVIEW
8.6.2 FINANCIAL PERFORMANCE
8.6.3 PRODUCT OUTLOOK
8.6.4 KEY DEVELOPMENTS
8.6.5 KEY STRATEGIC MOVES AND DEVELOPMENTS
8.7 MEDPACE, INC
8.7.1 OVERVIEW
8.7.2 FINANCIAL PERFORMANCE
8.7.3 PRODUCT OUTLOOK
8.7.4 KEY DEVELOPMENTS
8.7.5 KEY STRATEGIC MOVES AND DEVELOPMENTS
8.8 PAREXEL INTERNATIONAL CORPORATION
8.8.1 OVERVIEW
8.8.2 FINANCIAL PERFORMANCE
8.8.3 PRODUCT OUTLOOK
8.8.4 KEY DEVELOPMENTS
8.8.5 KEY STRATEGIC MOVES AND DEVELOPMENTS
8.9 PHARMACEUTICAL PRODUCT DEVELOPMENT LLC (PPD)
8.9.1 OVERVIEW
8.9.2 FINANCIAL PERFORMANCE
8.9.3 PRODUCT OUTLOOK
8.9.4 KEY DEVELOPMENTS
8.9.5 KEY STRATEGIC MOVES AND DEVELOPMENTS
8.10 PROMEDICA INTERNATIONAL
8.10.1 OVERVIEW
8.10.2 FINANCIAL PERFORMANCE
8.10.3 PRODUCT OUTLOOK
8.10.4 KEY DEVELOPMENTS
8.10.5 KEY STRATEGIC MOVES AND DEVELOPMENTS
8.11 QUINTILES TRANSNATIONAL CORPORATION
8.11.1 OVERVIEW
8.11.2 FINANCIAL PERFORMANCE
8.11.3 PRODUCT OUTLOOK
8.11.4 KEY DEVELOPMENTS
8.11.5 KEY STRATEGIC MOVES AND DEVELOPMENTS
8.12 WUXI APPTEC
8.12.1 OVERVIEW
8.12.2 FINANCIAL PERFORMANCE
8.12.3 PRODUCT OUTLOOK
8.12.4 KEY DEVELOPMENTS
8.12.5 KEY STRATEGIC MOVES AND DEVELOPMENTS
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