Summary

The Regulatory Reporting and Compliance market studied is expected to grow with a CAGR of 9.17%, over the forecast period.

The regulatory bodies remain strict and stick to their regulatory process but with the outbreak of the COVID-19 pandemic, they enabled flexibility in regulations to make treatment and cure rapidly accessible and developed in these tough 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 are issued to meet compliance, the routine inspection was postponed and reporting was shifted to electronic mode. Moreover, 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 FDA, and 620+ are in the planning stage of the drug development program. Thus, COVID-19 is expected to show a positive impact on the regulatory reporting and compliance market and in fact, 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, continuously changing regulatory landscape and digitalization of regulatory process. With the emergence of new diseases and new treatment fields like precision medicine, targeted gene therapy, specialty medicines, etc. The need for a faster approval process is increasing to benefit the patients at the earliest. Further, In January 2021, the United States Food and Drug Administration (USFDA), reported that in the year 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 episode and so on getting approved. The continuous change in the regulatory landscape like different analytical criteria and inspection requirements across different regions acts as 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 of the regulatory affairs functions rely on a manual process which becomes unsustainable in this digital transforming world. The digitalization and involvement of automated technological solutions would provide a significant reduction in time, cost, and efforts to achieve business goals. The unlock to intelligent automation technology will enable publishing, submissions, labeling, approval notifications to configure to faster design improvement and governance of workflow in a transparent and trackable manner. Thus, concerning the above-mentioned facts, the regulatory reporting and compliance market is expected to witness huge growth over the forecast period.

However, regulatory reporting and compliance are the mandatory procedure 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.

Key Market Trends

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 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 requires large budgets. The outsourcing regulatory reporting and compliance market have been fueled up by the availability of technologically aided solution like automated software, big data management software, etc. Further, in January 2021, Genpact Ltd announced that it has 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, Freyr Solutions offers wide range regulatory services from publishing, labeling, compliance consulting, regulatory operation management and, so on to the life science organization with their software aided solutions to large organization. Since the integration of Information Technology for making regulatory reporting and compliance boosts the outsourcing segment the demand is expected to increase over the forecast period.

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

North America with the United States has a very well-developed, advanced, and regulated healthcare infrastructure. North American region dominates the regulatory reporting and compliance market with the most prominent regulatory authority i.e. the United States Food and Drug Administration (USFDA). With the 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.

Moreover, According To World Trade Organization (WTO) Report April 2020, the United States was the largest importer of medical products in the period of 2017 to 2019 that accounts 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 ultimately would 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.

Competitive Landscape

The Regulatory Reporting and Compliance Market is a moderately competitive market with several players across the globe. 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, L.P., Pharmaceutical Product Development, LLC (PPD), and Charles River Laboratories International, Inc.

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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 L.P.
6.1.12 ProPharma Group
6.1.13 Celegence LLC

7 MARKET OPPORTUNITIES AND FUTURE TRENDS