Dublin, Jan. 23, 2025 (GLOBE NEWSWIRE) — The “Pharmaceutical Regulatory Affairs Market Size, Share & Trends Analysis Report By Service Provider, By Service, By Category, By Indication, By Development Stage, By Company Size, By Region, And Segment Forecasts, 2025 – 2030” report has been added to ResearchAndMarkets.com’s offering.
The global pharmaceutical regulatory affairs market size is expected to reach USD 14.34 billion by 2030, registering a CAGR of 7.17% from 2025 to 2030
The key factors driving the market growth are the changing regulatory landscape and growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs. There have been significant changes to the FDA’s drug approval processes. Recently, the 21st Century Cures bill was passed, which is expected to speed up the approval process of the FDA for certain types of drugs.
The FDA has launched four programs-Accelerated Approval, Priority Review, Fast Track, and Breakthrough Therapy-to expedite drug reviews for serious and life-threatening diseases. The medicines under these programs are approved faster by regulatory agencies. In addition, in the UK, the launch of The Accelerated Access Collaborative, a government initiative to fast-track patient access to potential breakthrough medicines, is anticipated to boost the availability and accessibility of novel therapies in the country. These changes in approval processes are expected to drive innovation and increase the demand for regulatory service providers who are well-acquainted with recent changes in approval processes globally.
The demand for regulatory specialization in these fields is anticipated to increase with the growth of the markets for biosimilar, orphan medications, personalized medicines, companion diagnostics, adaptive trial designs, and other products. Demand for specialized service providers with expertise in regulatory affairs is increasing as companies expand into different industries and face a growing burden of regulatory compliance. Government financing has considerably accelerated the development of orphan medications, particularly in industrialized economies.
Several companies are involved in collaborations, acquisitions, and new product development to gain a position in the market. For instance, in October 2022, Freyr partnered with an orthopedic implant manufacturing company in Korea, and as per the agreement, provided it with regulatory device registration and legal representation services. Moreover, in January 2022, Parexel International Corporation formed a Regulatory & Access Consulting Organization. This organization was established to provide regulatory support to clinical studies from the early stages.
Pharmaceutical Regulatory Affairs Market Report Highlights
- In terms of category, the drug segment held the largest revenue share of over 55.36% in 2024. The growing population, increasing urbanization, and rising demand for quality healthcare in the country have created a significant potential for pharmaceutical companies that develop and manufacture innovative drugs
- Based on category, the biologics segment is anticipated to register the fastest CAGR of 9.07% over the forecast period owing to the prevalence of diseases such as malaria, HIV/AIDS, and non-communicable diseases
- In terms of indication, the oncology segment dominated the market in 2024. The robust immunology pipeline of pharmaceutical and biopharmaceutical companies is anticipated to further boost segment growth
- The oncology segment dominated the market in 2024 with the largest revenue share of 32.98%. This can be attributed to the high prevalence of cancer, which is boosting the need for safe and effective treatment options
- In terms of development stage, the clinical studies segment held the largest market share in 2024. This can be attributed to the increasing number of clinical trial registrations, which is expected to drive the segment growth
- The preclinical segment is projected to grow at the fastest CAGR of 8.40% during the forecast period. Increasing prevalence of existing diseases such as cancer, CVDs, & neurological diseases are factors driving the market growth
- In terms of service providers, the outsourced regulatory affairs segment held the largest market share in 2024 at 59.07% % and is anticipated to witness the fastest CAGR of 8.76% over the forecast period. The increasing popularity of these services can be attributed to the fact that outsourcing enables healthcare companies to reduce costs, which is a major contributing factor to market growth
Pharmaceutical Regulatory AffairsCompetitive Landscape
- Freyr
- IQVIA Inc
- ICON plc
- WuXi AppTec (WAI)
- Charles River Laboratories International, Inc.
- Labcorp Drug Development
- Parexel International Corporation
- Pharmalex GmbH
- Pharmexon
- Genpact
Key Attributes:
| Report Attribute | Details |
| No. of Pages | 150 |
| Forecast Period | 2024 – 2030 |
| Estimated Market Value (USD) in 2024 | $9.47 billion |
| Forecasted Market Value (USD) by 2030 | $14.34 billion |
| Compound Annual Growth Rate | 7.1% |
| Regions Covered | Global |
Key Topics Covered:
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Snapshot
2.3. Competitive Landscape Snapshot
Chapter 3. Pharmaceutical Regulatory Affairs Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent Market Outlook
3.1.2. Ancillary Market Outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.1.1. Changing Regulatory Landscape
3.2.1.2. Life Sciences Companies Focusing on Their Core Competencies
3.2.1.3. Economic and Competitive Pressures
3.2.1.4. Demand for the Faster Approval Process for Breakthrough Drugs and Devices
3.2.1.5. Entry of Companies into the Global Market
3.2.1.6. Growth in Emerging Areas such as Personalized Medicine, Biosimilars, and Orphan Drugs
3.2.2. Market Restraint Analysis
3.2.2.1. Risk Associated with Data Security
3.2.2.2. Monitoring Issues and Lack of Standardization
3.3. Service Gap Analysis
3.3.1. Market Opportunities
3.3.1.1. Service Upgrade
3.3.1.2. Technological Advancements
3.3.1.3. Latest Trends
3.3.2. Market Challenges Analysis
3.3.2.1. Analysis Pertaining to Existing Gaps & Shortcomings in the Regulatory Services
3.3.2.2. Bottlenecks Faced by Companies Seeking Regulatory Approvals or Maintaining Compliance
3.4. Clinical Trials Volume Analysis, 2024
3.4.1. Total Number of Clinical Trials, by Region (2024)
3.4.2. Total Number of Clinical Trials, by Phase (2024)
3.4.3. Total Number of Clinical Trials, by Study Design (2024)
3.4.4. Total Number of Clinical Trials, by Key Therapeutic Area (2024)
3.5. Market Analysis Tools
3.5.1. Porter’s Five Forces Analysis
3.5.2. PESTEL Analysis
3.5.3. COVID-19 Impact Analysis
3.6. Best Practices and Case Study Pertaining to Regulatory Affairs Services
Chapter 4. Pharmaceutical Regulatory Affairs Market: Service Provider Estimates & Trend Analysis
4.1. Segment Dashboard
4.2. Global Pharmaceutical Regulatory Affairs Market Movement Analysis
4.3. Global Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, by Service Provider, 2018 to 2030 (USD Million)
4.4. In-house
4.5. Outsourcing
Chapter 5. Pharmaceutical Regulatory Affairs Market: Service Estimates & Trend Analysis
5.1. Segment Dashboard
5.2. Global Pharmaceutical Regulatory Affairs Market Movement Analysis
5.3. Global Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, by Service, 2018 to 2030 (USD Million)
5.4. Regulatory Consulting
5.5. Legal Representation
5.6. Regulatory Writing & Publishing
5.6.1. Regulatory Writing & Publishing Market Estimates and Forecasts, 2018 to 2030 (USD Million)
5.6.2. Writing
5.6.3. Publishing
5.7. Product Registration & Clinical Trial Applications
Chapter 6. Pharmaceutical Regulatory Affairs Market: Category Estimates & Trend Analysis
6.1. Segment Dashboard
6.2. Global Pharmaceutical Regulatory Affairs Market Movement Analysis
6.3. Global Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, by Category, 2018 to 2030 (USD Million)
6.4. Drugs
6.4.1. Drugs Market Estimates and Forecasts, 2018 to 2030 (USD Million)
6.4.2. Innovator
6.4.3. Generics
6.5. Biologics
6.5.1. Biologics Market Estimates and Forecasts, 2018 to 2030 (USD Million)
6.5.2. Biotech
6.5.3. ATMP
6.5.4. Biosimilars
Chapter 7. Pharmaceutical Regulatory Affairs Market: Indication Estimates & Trend Analysis
7.1. Segment Dashboard
7.2. Global Pharmaceutical Regulatory Affairs Market Movement Analysis
7.3. Global Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, Indication, 2018 to 2030 (USD Million)
7.4. Oncology
7.5. Neurology
7.6. Cardiology
7.7. Immunology
Chapter 8. Pharmaceutical Regulatory Affairs Market: Development Stage Estimates & Trend Analysis
8.1. Segment Dashboard
8.2. Global Pharmaceutical Regulatory Affairs Market Movement Analysis
8.3. Global Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, Development Stage, 2018 to 2030 (USD Million)
8.4. Preclinical
8.5. Clinical studies
8.6. Post Market Approval (PMA)
Chapter 9. Pharmaceutical Regulatory Affairs Market: Company Size Estimates & Trend Analysis
9.1. Segment Dashboard
9.2. Global Pharmaceutical Regulatory Affairs Market Movement Analysis
9.3. Global Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, Company Size, 2018 to 2030 (USD Million)
9.4. Small
9.5. Medium
9.6. Large
Chapter 10. Pharmaceutical Regulatory Affairs Market: Regional Estimates & Trend Analysis
10.1. Regional Market Dashboard
10.2. Global Regional Market Snapshot
10.3. Market Size, & Forecasts Trend Analysis, 2018 to 2030
For more information about this report visit https://www.researchandmarkets.com/r/hexnhf
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