USD 14 billion
Regulatory Affairs Market Size, Share, Growth Analysis, By Services(Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Writing), By Category(Drugs, Innovator, Preclinical, Clinical), By Company Size(Small, Medium, Large), By Region - Industry Forecast 2025-2032
Report ID:
SQMIG35A2460 |
Region:
Global |
Published Date: March, 2024
Pages:
219
|Tables:
120
|Figures:
76
Regulatory Affairs Market Insights
Regulatory Affairs Market size was valued at USD 15.26 Billion in 2023 and is poised to grow from USD 16.63 Billion in 2024 to USD 33.15 Billion by 2032, growing at a CAGR of 9% during the forecast period (2025-2032).
The primary catalysts of this market include the growth observed in emerging sectors such as orphan drugs, personalized medicines, immunotherapies, specialty therapies, and combination therapies. These advancements are complemented by shifts in regulatory prerequisites and a surge in the prevalence of novel diseases necessitating effective vaccines and treatments. Consequently, regulatory guidelines become imperative to ensure safety, quality, and efficacy. Furthermore, a rising number of industry participants adopting inorganic expansion tactics like mergers, partnerships, and acquisitions are expected to further amplify the expansion of the regulatory affairs market.
Various regulatory authorities issued guidelines pertaining to the pandemic and granted emergency use authorization for several products combating the coronavirus.
The global expansion of biopharmaceutical and medical device firms is poised to emerge as a major market catalyst. Emerging markets in the Asia Pacific, Latin America, and the Middle East & Africa offer cost-efficient product development and manufacturing, tax incentives, and access to skilled labor at reasonable rates, coupled with supportive regulations.
These elements collectively render regional markets appealing prospects for outsourcing and expansion for biopharmaceutical and medical device enterprises, thus spurring the demand for regulatory services. The healthcare sector's focus extends beyond creating new therapies for various ailments to encompass target gene therapy, precision medicine, and specialty drugs tailored for specific disorders. Moreover, medical devices are integrated with some of these products to enhance drug dosing, delivery, and patient monitoring, thereby adding complexity to the regulatory strategy and the pathway to market such innovations.
US Regulatory Affairs Market is poised to grow at a sustainable CAGR for the next forecast year.
Market snapshot - 2025-2032
Global Market Size
Largest Segment
Medium
Fastest Growth
Medium
Growth Rate
9% CAGR
Global Regulatory Affairs Market ($ Bn)
Country Share for Asia Pacific Region (%)
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Regulatory Affairs Market Segmental Analysis
The global regulatory affairs market is segmented on the basis of service, category, indication, stage, company size, service provider, end – use, region. By service, the market is segmented into regulatory consulting, legal representation, regulatory writing & publishing, writing, publishing. By category, the market is segmented into drugs, innovator, preclinical, clinical, post market, generics, preclinical, clinical, post market, biologics, biotech, preclinical, clinical, post market, atmp, preclinical, clinical, post market, biosimilars, preclinical, clinical, post market, medical devices, diagnostics, preclinical, clinical, post market, therapeutics, preclinical, clinical, post Market. By indication, the market is segmented into oncology, neurology, cardiology, immunology, others. By stage, the market is segmented into preclinical, clinical studies, PMA. By service provider, the market is segmented into in-house, outsourced. By company size, the market is segmented into, small, medium, large. By end – use, the market is segmented into medical device companies, pharmaceutical companies, biotechnology companies. By region, the market is segmented into North America, Europe, Latin America, Asia- Pacific, Middle East and Africa.
Regulatory Affairs Market Analysis By Services
In terms of services, the regulatory writing & publishing sector asserted its dominance within the market, contributing to the largest share of revenue at 36.6% in 2022. The driving forces behind the regulatory writing & publishing sector's prominence stem from the heightened outsourcing of these services by both sizable and mid-scale biopharmaceutical and medical device companies. Over the analysis period, substantial biopharmaceutical and medical device firms with well-established regulatory affairs departments are projected to create substantial demand for regulatory writing & publishing services.
Anticipated to exhibit the swiftest CAGR of 9.5% during the projected timeline, the legal representation sector is poised for remarkable expansion. This projection stems from the mounting intricacies of healthcare regulations and the surge in healthcare reforms, particularly in burgeoning regions like the Asia Pacific and the Middle East & Africa. Notably, conducting clinical trials in Europe necessitates sponsors to possess a registered entity within the European Union, mandating the involvement of European-based companies for legal representation. Nevertheless, numerous prominent companies are actively extending their services to foreign territories, which will significantly amplify their regional foothold and augment their market presence.
Regulatory Affairs Market Analysis By Company Size
According to the size of the company, the global market is further divided into small, medium and large companies. The segment of medium-sized companies dominated the global market in 2022 and accounted for the largest share of total turnover, more than 47.0% in the same year. The presence of various medium-sized incumbents, especially privately owned operators, is expected to contribute to the growth of this segment. These companies have a strong presence in several or selected markets around the world and offer a range of services from a few to many.
The high-volume service providers segment is expected to generate a CAGR of 9.1% during the forecast period. High-volume service providers are popular with major pharmaceutical, biotech and medical device manufacturers. Large pharmaceutical companies usually want to have long-term partnerships with their service providers to avoid unexpected interruptions to their operations and thus prefer a service provider that can meet their regulatory needs to support their various ups and downs. functions
Global Regulatory Affairs Market By Company Size
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Regulatory Affairs Market Regional Insights
The Asia Pacific region asserted its dominance within the market, capturing the foremost share of revenue, surpassing 37.5% in 2022. Expected to exhibit the swiftest Compound Annual Growth Rate (CAGR) from 2023 to 2030, the region's expansion is driven by several factors including enhancements in the regulatory landscape, cost-efficiency gains, a burgeoning volume of clinical trials conducted within the area, and an increasing influx of biopharmaceutical companies venturing into this territory. Additionally, the presence of a skilled workforce in the region at a more economical rate compared to the United States is poised to further propel market growth. The escalating demand for biosimilars and medical devices also contributes to the burgeoning biopharmaceutical and medical devices market in the region. A prime example is Biocon, a renowned Indian biopharmaceutical firm, actively engaged in developing diverse novel treatments slated for market launch over the forecast period, consequently driving the demand for regulatory support.
Anticipated to witness a substantial CAGR of 8.8% from 2023 to 2030, North America is expected to experience notable growth. Renowned for having one of the most robust regulatory systems globally, this region's market expansion is fueled by various factors. These include an upsurge in biologics approvals, an augmented trend of outsourcing regulatory affairs services by major biopharmaceutical corporations, and escalating Research and Development (R&D) investments. North America is acknowledged for maintaining a rigorous regulatory framework, and the remarkable increase in biologics approvals, accounting for 39.0% of total new drug approvals in 2021, underscores the burgeoning pipeline of biotechnology products. With stringent regulatory procedures and amplified R&D spending, the demand for outsourced regulatory affairs services by prominent biopharmaceutical companies in North America is poised to surge.
Global Regulatory Affairs Market By Geography
- Largest
- Fastest
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Regulatory Affairs Market Dynamics
Regulatory Affairs Market Drivers
Globalization of Biopharmaceuticals
- The expansion of biopharmaceutical companies into emerging markets, especially in Asia Pacific, Latin America, and the Middle East, demands comprehensive regulatory strategies to address diverse regional requirements.
Rising Number of Clinical Trials
- The rise in clinical trials, particularly in emerging regions, demands robust regulatory support for trial approvals, monitoring, and reporting to ensure adherence to global standards and patient safety.
Regulatory Affairs Market Restraints
Resource and Cost Intensive
- Regulatory compliance requires substantial resources, including skilled personnel and financial investments, which can strain budgets and hinder smaller companies' growth.
Geopolitical Uncertainties
- Geopolitical factors, such as trade tensions and regulatory changes due to political shifts, can create uncertainties for international regulatory strategies and market access.
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Regulatory Affairs Market Competitive Landscape
The competitive landscape of the global regulatory affairs market is characterized by a dynamic interplay of established industry leaders and innovative emerging players. Key players like IQVIA Holdings Inc., PAREXEL International Corporation, and ICON plc hold prominent positions owing to their extensive experience, global reach, and diverse service portfolios. These industry giants leverage their deep regulatory expertise, technological capabilities, and strong client relationships to offer comprehensive regulatory solutions.
Alongside these incumbents, a wave of emerging firms, such as Criterium, Inc., Medpace Holdings, Inc., and WuXi AppTec Inc., are gaining traction. These players often bring fresh perspectives, technological innovations, and agile approaches to the market. This intensified competition fosters innovation and encourages the adoption of advanced technologies, like AI and data analytics, to streamline regulatory processes.
Regulatory Affairs Market Top Player’s Company Profiles
- Parexel International Corporation
- QuintilesIMS (Now IQVIA)
- ICON plc
- PRA Health Sciences
- Covance Inc. (a subsidiary of LabCorp)
- Wuxi AppTec
- Charles River Laboratories
- Medpace Holdings, Inc.
- Syneos Health
- Certara
- Intertek Group plc
- Premier Research
- DIA (Drug Information Association)
- NSF International
- Freyr Solutions
- RAPS (Regulatory Affairs Professionals Society)
- PharmaLex
- ProPharma Group
- ERA Consulting Group
- Regulatory Compliance Associates Inc.
Regulatory Affairs Market Recent Developments
- On March 8, 2023, The US Food and Drug Administration (FDA) issued a new guidance on the use of artificial intelligence (AI) in medical devices.
- On February 14, 2023, The European Medicines Agency (EMA) published a new guideline on the development and evaluation of gene therapy medicinal products.
- On January 20, 2023, The World Health Organization (WHO) released a new report on the global regulatory landscape for medical products.
Regulatory Affairs Key Market Trends
- Accelerated Approval Programs: Regulatory authorities are implementing expedited approval pathways for critical drugs, such as orphan drugs and breakthrough therapies, to address unmet medical needs.
- Focus on Patient Engagement: Regulatory agencies are emphasizing patient engagement in the regulatory process to incorporate patient perspectives into drug development and regulatory decision-making.
Regulatory Affairs Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Product types team that Collects, Collates, Co-relates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
According to our global regulatory affairs market analysis, the global regulatory affairs market is poised for continued growth, driven by the ever-evolving healthcare landscape and the demand for stringent regulatory oversight. Established industry leaders and emerging players are shaping a competitive landscape characterized by innovation, strategic partnerships, and technology adoption. The market's expansion is fueled by advancements in healthcare technologies, a growing number of clinical trials, and the globalization of biopharmaceuticals.
However, challenges such as stringent regulatory processes and diverse regional requirements remain. Industry players must navigate these complexities while embracing digital transformation and real-world evidence integration. Collaborative efforts among international regulatory bodies and a focus on patient engagement are contributing to a more efficient and patient-centric regulatory ecosystem. As sustainability and environmental considerations gain prominence, companies must align their strategies with evolving regulatory standards. In essence, the regulatory affairs market's trajectory reflects a balance between established expertise and emerging trends, driven by the shared goal of ensuring safe, effective, and innovative healthcare products for global populations.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 15.26 Billion |
| Market size value in 2032 | USD 33.15 Billion |
| Growth Rate | 9% |
| Base year | 2024 |
| Forecast period | 2025-2032 |
| 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:-
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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 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 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 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 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 Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Regulatory Affairs 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.
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