USD 6.48 billion
Regulatory Affairs Outsourcing Market Size, Share, Growth Analysis, By Services(Regulatory consulting, regulatory writing & publishing), By Company size (Small, medium), By Category(Drugs, biologics), By Indication(Oncology, cardiology neurology), By Stage(Preclinical, clinical), By End-user(Medical device companies, pharmaceutical companies) - Industry Forecast 2024-2031
Report ID:
SQMIG35D2051 |
Region:
Global |
Published Date: February, 2024
Pages:
157
|
Tables:
174 |
Figures:
79
Regulatory Affairs Outsourcing Market Insights
Regulatory Affairs Outsourcing Market size was valued at USD 6.48 billion in 2019 and is poised to grow from USD 7 billion in 2023 to USD 13.99 billion by 2031, growing at a CAGR of 8% in the forecast period (2024-2031).
Regulatory affairs, also known as government affairs, is a job that evaluates and monitors the adequacy and efficiency of products in fields such as agrochemicals, cosmetics, pesticides, medical devices, veterinary medicines, pharmaceuticals, and complementary medicines in order to ensure public health. These services are offered by medical device, biotech, and pharmaceutical manufacturers. Regulatory affairs outsourcing firms assist with obtaining regulatory permits on time. Outsourcing regulatory affairs is becoming increasingly prevalent in the healthcare industry. The implementation of regulatory outsourcing methodologies is anticipated to be supported by an increase in regional expansion activities by businesses seeking quick approvals in local markets. The market is expanding due to an increase in R&D operations, coupled with an increase in the number of clinical trial applications and product registrations.
US Regulatory Affairs Outsourcing Market is poised to grow at a sustainable CAGR for the next forecast year.
Market snapshot - 2024-2031
Global Market Size
Largest Segment
large
Fastest Growth
large
Growth Rate
8% CAGR
Global Regulatory Affairs Outsourcing Market ($ Bn)
Country Share for North America Region (%)
Global Regulatory Affairs Outsourcing Market By Company Size ($ Bn)
Global Regulatory Affairs Outsourcing Market By Company Size (%)
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Regulatory Affairs Outsourcing Market Segmental Analysis
Global Regulatory Affairs Outsourcing Market is segmented based on the services, company size, category, indication, stage, end-user, and region. Based on services, the Regulatory Affairs Outsourcing Market is segmented into regulatory consulting, regulatory writing & publishing, legal representation, product registration & clinical trial applications, and others. Based on company size, the Regulatory Affairs Outsourcing Market is segmented into small, medium, and large. Based on category, the Regulatory Affairs Outsourcing Market is segmented into drugs, biologics, and medical devices. Based on indication, the Regulatory Affairs Outsourcing Market is segmented into oncology, cardiology neurology, immunology, and others. Based on stage, the Regulatory Affairs Outsourcing Market is segmented into preclinical, clinical, and PMA (Post Market Authorization). Based on end-user, the Regulatory Affairs Outsourcing Market is segmented into medical device companies, pharmaceutical companies, biotechnology companies. Based on region, Regulatory Affairs Outsourcing Market is categorized into North America, Europe, Asia-Pacific, Latin America, and MEA.
Regulatory Affairs Outsourcing Market Analysis by Services
Based on services, regulatory affairs outsourcing market is segmented into regulatory consulting, regulatory writing & publishing, legal representation, product registration & clinical trial applications, and others. The regulatory writing and publishing segment led the market in 2021, with a revenue share of over 36.5%, and is expected to maintain its lead throughout the forecast period. From the initial phases of product development to the post-marketing authorization phase, these services are all available. Due to the increasing use of outsourcing of these services by large and mid-sized biopharmaceutical and medical device companies, this segment is projected to lead the market during the forecast period.
Legal representation is expected to expand with the fastest growth rate during the forecast period. This could be attributed to the proliferation of medical device companies, which has increased demand for legal representation around the world.
Regulatory Affairs Outsourcing Market Analysis by Company Size
Based on company size, the regulatory affairs outsourcing market is segmented into small, medium, and large. The large company segment is expected to grow at the fastest rate of more than 9% during the forecast period. Large companies generally prefer to establish long-term relationships with their service providers in order to avoid sudden disruptions in their operations, and thus prefer a service provider who can fulfil their regulatory needs to encourage their various cross-scale and ramp-up operations.
Global Regulatory Affairs Outsourcing Market By Company Size, 2023 (%)
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Regulatory Affairs Outsourcing Market Regional Insights
In 2021, the Asia Pacific region accounted for more than 38% of global revenue, and is further expected to have the significant market share during the forecast period due to an increase in clinical trials coupled with a spike in the proportion of companies trying to break into markets in emerging economies such as India and China. Furthermore, the availability of a qualified manpower in the region at lower costs than in the US is expected to drive regional market growth.
North America market is anticipated to significantly grow during the projected period owing to the available number of key pharmaceutical & medical device companies coupled with the rise in the research & development activities in the region. The regulatory affairs outsourcing market size is growing as a result of stringent compliances issued by regulatory authorities in North America, which are promoting partnerships among drug developers, clinical research organisations, and contract manufacturing organisations to alleviate potential risks and speed up the approval process.
European market is projected to grow at the highest CAGR due to health care requirements and government funds for scientific efforts in the region over the forecast period. According to the regulatory affairs outsourcing market outlook, several biotech & pharmaceutical firms have begun outsourcing their drug production services to nations such as France, Germany, and Italy, which is driving the market, due to that the market share is increasing. Moreover, medical device and IVD regulatory affairs outsourcing market firms are putting more emphasis on commercializing healthcare company' products while keeping within budget.
Global Regulatory Affairs Outsourcing Market By Region, 2024-2031
- Largest
- Fastest
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Regulatory Affairs Outsourcing Market Dynamics
Regulatory Affairs Outsourcing Market Driver
- The increasing number of chronic illness cases, patent expirations of prescription biologics, brand extensions, immediate access to OTC drugs across various platforms, economic and social factors, increasing healthcare expenditures, and advancements in regulatory affairs outsourcing are the factors increasing the global demand for these services during the forecast period.
Regulatory Affairs Outsourcing Market Restraint
- However, the risks that comes with data sharing and outsourcing are significant factors that are likely to impede the progress of the regulatory outsourcing market during the forecast period.
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Regulatory Affairs Outsourcing Market Competitive Landscape
Global regulatory affairs outsourcing market is highly competitive and somewhat fragmented. To maintain a competitive edge, the major industry participants are continually implementing various growth strategies. Innovations, mergers, and acquisitions, collaborations and partnerships are adopted by these players to thrive in the competitive market. In order to provide industries with the most effective and economical solutions, the major market players are also continually concentrating on R&D.
Regulatory Affairs Outsourcing Market Top Player's Company Profiles
- IQVIA
- PAREXEL International Corporation
- Covance Inc.
- Charles River Laboratories International Inc.
- PRA Health Sciences Inc.
- ICON plc
- Syneos Health Inc.
- Wuxi AppTec Inc.
- FMD K&L Inc.
- Clinilabs Drug Development Corporation
- Premier Research
- Medpace Holdings Inc.
- Novotech Pty Ltd
- Rho Inc.
- Accell Clinical Research LLC
- Genpact Limited
- PharPoint Research Inc.
- Catalyst Clinical Research LLC
- MakroCare
- Criterium Inc.
Regulatory Affairs Outsourcing Market Recent Developments
- In November 2022, Essential Edge Compliance Outsourcing Services, LLC, a regulatory and compliance supervision consultancy for financial services firms, announced the release of its insurance services practise and the advancement of its wealth management expertise with the hiring of industry veterans Lisa Mosley and Dagny Young.
- In July 2022, Celegence, a global provider of regulatory affairs services and solutions for the life sciences industry, acquired Qdossier in order to expand its regulatory consultancy services and pharmaceutical industry solutions.
Regulatory Affairs Outsourcing Key Market Trends
- Increasing R&D investment to produce orphan, biosimilar, and generic drugs, as well as increased investment in clinical research, stringent government regulation, and an increased focus on product development to strengthen supply, are all making a significant contribution to the growth of the global regulatory affairs outsourcing market.
Regulatory Affairs Outsourcing Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Co-relates, and Analyses the Data collected utilizing Primary Exploratory Research backed by the robust Secondary Desk research.
According to our global regulatory affairs outsourcing market analysis, the Asia Pacific region is growing because of the expansion of life sciences companies in countries, such as India & China. Outsourcing of regulatory affairs functions is being driven by a substantial increase in the fixed costs of in-house resources for regulatory affairs and operation activities such as training, technology, specialised knowledge, and facilities during the analysis period. However, many outsourcing partners have access to confidential pharmaceutical or other industry data, which may impede the security and data sharing of companies, resulting in hampering the global market.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 6.48 billion |
| Market size value in 2031 | USD 13.99 billion |
| Growth Rate | 8% |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
|
| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
| Historical Year | 2019 |
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Regulatory Affairs Outsourcing Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Regulatory Affairs Outsourcing Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Regulatory Affairs Outsourcing Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Regulatory Affairs Outsourcing Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Regulatory Affairs Outsourcing Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Regulatory Affairs Outsourcing Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
Regulatory Affairs Outsourcing Market Report Snapshots
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