Regulatory Reporting and Compliance Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

The Regulatory Reporting and Compliance Market is segmented by Service Type (Regulatory Consulting, Product Registration and Clinical Trial Application, Legal Representation, Regulatory Writing and Publishing, and Other Regulatory Services), Service Provider (In-House and Outsourcing), End User (Pharmaceutical Companies, Medical Device Companies, and Biotechnology Companies), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above-mentioned segments.

Regulatory Reporting & Compliance Market Size

Compare market size and growth of Global Regulatory Reporting and Compliance Market with other markets in Healthcare Industry

Regulatory Reporting & Compliance Market Analysis

The Global Regulatory Reporting and Compliance Market is expected to register a CAGR of 9.17% during the forecast period.

The regulatory bodies remain strict and stick to their regulatory processes. The outbreak of the COVID-19 pandemic enabled flexibility in regulations to make treatment and cure rapidly accessible and developed in challenging times. The regulatory bodies, such as the Medicines and Healthcare products Regulatory Agency (MHRA), the United States Food and Drug Administration (USFDA), and European Medicines Agency(EMA), took proactive steps to support the industry. To accelerate the approval procedure, regularly updated guidelines on flexibility were issued to meet compliance, the routine inspection was postponed, and reporting was shifted to electronic mode. In April 2020, the United States Food and Drug Administration (USFDA) announced Coronavirus Treatment Acceleration Program(CTAP), under which till May 2021, 460+trials are reviewed by the FDA, and 620+ are in the planning stage of the drug development program. Thus, the COVID-19 pandemic is expected to show a positive impact on the regulatory reporting and compliance market, and it could be considered a catalyst for the growth of the market.

The studied market growth is attributed to the growing demand for a faster approval process, the continuously changing regulatory landscape, and the digitalization of the regulatory process. With the emergence of new diseases and new treatment fields, like precision medicine, targeted gene therapy, and specialty medicines, the need for a faster approval process is increasing to benefit the patients at the earliest. In January 2021, the United States Food and Drug Administration (USFDA) reported that in 2020, many innovative and advanced therapy drugs, like the first-ever therapy for Chaga's disease for pediatric patients of less than two years, a new therapy for Parkinson's disease for curing off episodes, was approved. The continuous change in the regulatory landscape, like different analytical criteria and inspection requirements across different regions, is a driver for the regulatory reporting and compliance market. Moreover, the difference in Good Manufacturing Practices (GMP) by different health authorities, like European Medicines Agency(EMA) and the United States Food and Drug Administration (USFDA), makes it difficult for global players to compliance with them. Most regulatory affairs functions rely on a manual process, which becomes unsustainable in the digitally transforming world. The digitalization and involvement of automated technological solutions will provide a significant reduction in time, cost, and efforts to achieve business goals. The unlock to intelligent automation technology will enable publishing, submissions, labeling, and approval notifications to configure to faster design improvement and governance of workflow in a transparent and trackable manner. Thus, the regulatory reporting and compliance market is expected to witness huge growth over the forecast period.

However, regulatory reporting and compliance are mandatory procedures for the healthcare industry. The lack of technologically advanced infrastructure in developing countries and complicated local and global regulatory norms may obstruct the growth of the market.

Regulatory Reporting & Compliance Industry Overview

The regulatory reporting and compliance market is a moderately competitive market with several players across the world. In terms of market share, major players currently dominate the market. With the increasing demand for faster approval procedures, the continuously changing regulatory landscape, and digitalization in regulatory processes, many new players are expected to be part of the regulatory reporting and compliance market over the forecast period. Some of the major players of the market are Genpact Ltd, IQVIA Holdings Inc., Certara LP, Pharmaceutical Product Development LLC (PPD), and Charles River Laboratories International Inc.

Regulatory Reporting & Compliance Market Leaders

  1. Genpact Ltd

  2. IQVIA Holdings Inc

  3. Certara, L.P.

  4. Pharmaceutical Product Development, LLC (PPD)

  5. Charles River Laboratories International, Inc

  6. *Disclaimer: Major Players sorted in no particular order
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Regulatory Reporting & Compliance Market News

In July 2021, the United States of Food and Drug Administration (USFDA) issued final guidelines for providing regulatory submission in alternate electronic format for the industry. The recommendations apply to contents of New Drug Application (NDAs), Abbreviated New Drug Application (ANDAs), Drug Master File (DMFs), Investigational New Drug Application (INDs), and Biologics License Application (BLA) to be submitted to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

In July 2021, ICON PLC announced the acquisition of PRA Health Sciences with transactions valued in cash and stock of USD 12 billion. The union of organizations will enable customers to reduce their developmental costs and time.

Regulatory Reporting & Compliance Market Report - Table of Contents

1. INTRODUCTION

  • 1.1 Study Assumptions and Market Definition
  • 1.2 Scope of the Study

2. RESEARCH METHODOLOGY

3. EXECUTIVE SUMMARY

4. MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Growing Demand For Faster Approval Process
    • 4.2.2 Continuously Changing Regulatory Landscape
    • 4.2.3 Digitalization of Regulatory Processes
  • 4.3 Market Restraints
    • 4.3.1 Lack of Technological Advanced Infrastructure in Developing Countries
    • 4.3.2 Complicated Local and Global Regulatory Norms
  • 4.4 Porter's Five Force Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5. MARKET SEGMENTATION

  • 5.1 By Service Type
    • 5.1.1 Regulatory Consulting
    • 5.1.2 Product Registration and Clinical Trial Applications
    • 5.1.3 Legal Representation
    • 5.1.4 Regulatory Writing and Publishing
    • 5.1.5 Others Regulatory Services
  • 5.2 By Service Provider Type
    • 5.2.1 In-House
    • 5.2.2 Out-Sourcing
  • 5.3 By End User
    • 5.3.1 Pharmaceuticals Companies
    • 5.3.2 Medical Devices Companies
    • 5.3.3 Biotechnology Companies
  • 5.4 By Geography
    • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
    • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
    • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
    • 5.4.4 Middle-East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle-East and Africa
    • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6. COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 Genpact Ltd
    • 6.1.2 Charles River Laboratories International Inc.
    • 6.1.3 ICON PLC
    • 6.1.4 Labcorp Drug Development (Covance)
    • 6.1.5 Paraxel International Corporation
    • 6.1.6 Freyr Solutions
    • 6.1.7 Medelis Inc.
    • 6.1.8 Pharmaceutical Product Development LLC (PPD)
    • 6.1.9 Clinilabs Inc.
    • 6.1.10 IQVIA Holdings Inc.
    • 6.1.11 Certara LP
    • 6.1.12 ProPharma Group
    • 6.1.13 Celegence LLC
  • *List Not Exhaustive

7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Competitive Landscape covers Business Overview, Financials, Products and Strategies, and Recent Developments
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Regulatory Reporting & Compliance Industry Segmentation

As per the scope of the report, regulatory compliance means being adherence to the legal, ethical, and professional standards led down by regulatory agencies of that region and violation of which may lead to punishments and fines. Meeting these regulatory requirements is essential for players of the regulated industry like pharmaceuticals, medical devices, and other healthcare sectors. The regulations are drawn by regulatory agencies, like the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), and Health Canada (HC), to make sure the quality and safety of available products by organizations in the healthcare industry. Regulatory reporting is the submission of raw or summary data needed by regulators to evaluate an organizations' operations, thereby determining the status of compliance with the applicable regulatory provision. The regulatory reporting and compliance market are segmented by service type (regulatory consulting, product registration, and clinical trial application, legal representation, regulatory writing and publishing, and other regulatory services), service provider (in-house and outsourcing), end user (pharmaceutical companies, medical device companies, and biotechnology companies), and geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above-mentioned segments.

By Service Type Regulatory Consulting
Product Registration and Clinical Trial Applications
Legal Representation
Regulatory Writing and Publishing
Others Regulatory Services
By Service Provider Type In-House
Out-Sourcing
By End User Pharmaceuticals Companies
Medical Devices Companies
Biotechnology Companies
By Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle-East and Africa GCC
South Africa
Rest of Middle-East and Africa
South America Brazil
Argentina
Rest of South America
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Regulatory Reporting & Compliance Market Research FAQs

What is the current Global Regulatory Reporting and Compliance Market size?

The Global Regulatory Reporting and Compliance Market is projected to register a CAGR of 9.17% during the forecast period (2025-2030)

Who are the key players in Global Regulatory Reporting and Compliance Market?

Genpact Ltd, IQVIA Holdings Inc, Certara, L.P., Pharmaceutical Product Development, LLC (PPD) and Charles River Laboratories International, Inc are the major companies operating in the Global Regulatory Reporting and Compliance Market.

Which is the fastest growing region in Global Regulatory Reporting and Compliance Market?

Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).

Which region has the biggest share in Global Regulatory Reporting and Compliance Market?

In 2025, the North America accounts for the largest market share in Global Regulatory Reporting and Compliance Market.

What years does this Global Regulatory Reporting and Compliance Market cover?

The report covers the Global Regulatory Reporting and Compliance Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Global Regulatory Reporting and Compliance Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.

Global Regulatory Reporting and Compliance Industry Report

The Regulatory Reporting and Compliance Market is segmented by service type, service provider, end user, and geography. The market size is analyzed in terms of value for various segments, including regulatory consulting, product registration and clinical trial application, legal representation, regulatory writing and publishing, and other regulatory services. The industry analysis provides an in-depth look at the market trends and market leaders in the field.

The market forecast offers insights into the market growth and market outlook, projecting the market value and market segmentation up to the forecast period. The industry overview gives a historical perspective and the industry outlook highlights future market predictions. The market data is derived from extensive industry research and industry reports, providing a comprehensive market review.

The report also includes a sample report PDF for further reference. The industry information and industry statistics are crucial for understanding the industry size and industry sales. The market trends and market growth rate are key indicators of the market's health and potential. The market research and market analysis are essential tools for research companies and other stakeholders in the market.

In summary, the Regulatory Reporting and Compliance Market report offers a detailed analysis of the market, including industry trends, market forecast, and market segmentation. The report example and report PDF provide additional insights and data to support the findings.

Global Regulatory Reporting and Compliance Report Snapshots

Regulatory Reporting and Compliance Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)