Regulatory Reporting and Compliance Market Size & Share Analysis - Growth Trends & Forecasts (2023 - 2028)

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

Regulatory reporting and compliance market
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Study Period 2018 - 2028
Base Year For Estimation 2022
CAGR 9.17 %
Fastest Growing Market Asia-Pacific
Largest Market North America
Market Concentration Medium

Major Players

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*Disclaimer: Major Players sorted in no particular order

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Need a report that reflects how COVID-19 has impacted this market and its growth?

Regulatory Reporting & Compliance Market Analysis

The regulatory reporting and compliance market studied is expected to register a CAGR of 9.17% over 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 Market Trends

This section covers the major market trends shaping the Regulatory Reporting & Compliance Market according to our research experts:

The Outsourcing Regulatory Reporting and Compliance Services Segment is Expected to Hold Significant Market Share Over the Forecast Period

Regulatory reporting and compliance outsourcing means contracting with a third party in the form of an agreement or deal for handling those particular segments for the business. The regulatory functions are challenging in a highly regulated industry, and hiring a third party to foresee these functions has become increasingly important to thrive in a competitive and innovative industry such as healthcare. The need to maintain compliance, obtain approval for new products, early release in the market, reporting publishing, and submissions require large budgets. The outsourcing regulatory reporting and compliance market was fueled up by the availability of technologically aided solutions, like automated software and big data management software. In January 2021, Genpact Ltd announced that it acquired 'Enquero,' a data engineering and data-led digital transformation service organization. The acquisition will increase Genpact's ability to leverage data and cloud technologies to drive digital transformation services through advanced analytics. Moreover, organizations, like Celegence and Freyr Solutions, offer a wide range of regulatory services from publishing, labeling, compliance consulting, and regulatory operation management to life science organizations with their software-aided solutions to large organizations. As the integration of information technology to make regulatory reporting and compliance boosts the outsourcing segment, the demand is expected to increase over the forecast period.

regulatory reporting and compliance market 1

North America Holds Major Share in the Market and Expected to Grow in the Forecast Period

North America has a very well-developed, advanced, and regulated healthcare infrastructure. North America dominates the regulatory reporting and compliance market with the most prominent regulatory authority, i.e., the United States Food and Drug Administration (USFDA), and a large presence of multinational pharmaceuticals, biotechnology, and medical device companies engaged in innovative products manufacturing and marketing. The need for advanced regulatory reporting and compliance solutions is increasing, making North America a preferable region by the players.

According to the World Trade Organization (WTO) Report April 2020, the United States was the largest importer of medical products from 2017 to 2019, accounting for 19% of the total world import of medical import. This implies that a larger portion of pharmaceuticals and medical devices organizations from other parts of the world are entering the United States, generating a need for faster regulatory approval from the United States Food and Drug Administration (USFDA) to gain a competitive edge. This is expected to increase the demand for technologically advanced software solution services in the regulatory reporting and compliance market. Thus, a large pool of life science players and technologically advanced infrastructure encourages the players to enter the North American regulatory reporting and compliance market.

Regulatory Reporting and Compliance Market 2

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

*Disclaimer: Major Players sorted in no particular order

Regulatory Reporting and compliance market concentration.jpg

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. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Growing Demand For Faster Approval Process

      2. 4.2.2 Continuously Changing Regulatory Landscape

      3. 4.2.3 Digitalization of Regulatory Processes

    3. 4.3 Market Restraints

      1. 4.3.1 Lack of Technological Advanced Infrastructure in Developing Countries

      2. 4.3.2 Complicated Local and Global Regulatory Norms

    4. 4.4 Porter's Five Force Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION

    1. 5.1 By Service Type

      1. 5.1.1 Regulatory Consulting

      2. 5.1.2 Product Registration and Clinical Trial Applications

      3. 5.1.3 Legal Representation

      4. 5.1.4 Regulatory Writing and Publishing

      5. 5.1.5 Others Regulatory Services

    2. 5.2 By Service Provider Type

      1. 5.2.1 In-House

      2. 5.2.2 Out-Sourcing

    3. 5.3 By End User

      1. 5.3.1 Pharmaceuticals Companies

      2. 5.3.2 Medical Devices Companies

      3. 5.3.3 Biotechnology Companies

    4. 5.4 By Geography

      1. 5.4.1 North America

        1. 5.4.1.1 United States

        2. 5.4.1.2 Canada

        3. 5.4.1.3 Mexico

      2. 5.4.2 Europe

        1. 5.4.2.1 Germany

        2. 5.4.2.2 United Kingdom

        3. 5.4.2.3 France

        4. 5.4.2.4 Italy

        5. 5.4.2.5 Spain

        6. 5.4.2.6 Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. 5.4.3.1 China

        2. 5.4.3.2 Japan

        3. 5.4.3.3 India

        4. 5.4.3.4 Australia

        5. 5.4.3.5 South Korea

        6. 5.4.3.6 Rest of Asia-Pacific

      4. 5.4.4 Middle-East and Africa

        1. 5.4.4.1 GCC

        2. 5.4.4.2 South Africa

        3. 5.4.4.3 Rest of Middle-East and Africa

      5. 5.4.5 South America

        1. 5.4.5.1 Brazil

        2. 5.4.5.2 Argentina

        3. 5.4.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Genpact Ltd

      2. 6.1.2 Charles River Laboratories International Inc.

      3. 6.1.3 ICON PLC

      4. 6.1.4 Labcorp Drug Development (Covance)

      5. 6.1.5 Paraxel International Corporation

      6. 6.1.6 Freyr Solutions

      7. 6.1.7 Medelis Inc.

      8. 6.1.8 Pharmaceutical Product Development LLC (PPD)

      9. 6.1.9 Clinilabs Inc.

      10. 6.1.10 IQVIA Holdings Inc.

      11. 6.1.11 Certara LP

      12. 6.1.12 ProPharma Group

      13. 6.1.13 Celegence LLC

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Competitive Landscape covers Business Overview, Financials, Products and Strategies, and Recent Developments

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

The Global Regulatory Reporting and Compliance Market is projected to register a CAGR of 9.17% during the forecast period (2023-2028).

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.

Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2023-2028).

In 2023, the North America accounts for the largest market share in the Global Regulatory Reporting and Compliance Market.

Global Regulatory Reporting and Compliance Industry Report

Statistics for the 2023 Global Regulatory Reporting and Compliance market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Global Regulatory Reporting and Compliance analysis includes a market forecast outlook to 2028 and historical overview. Get a sample of this industry analysis as a free report PDF download.

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