Regulatory Information Management Market Report, by Product Type (Software and Hardware), by End-user Industry (Pharmaceutical Industry, Biotechnology Industry, and Clinical Research Organizations), and by Region (North America, Europe, Asia Pacific, Latin America, Middle East, and Africa) - Size, Share, trends, and Forecast to 2026

  • Published On : Jul 2018 |
  • Pages : 180 Pages |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

Regulatory Information Management Market

Regulatory information management software consists of software solutions suiting to the respective industry and nature of business, especially for pharmaceutical, biotechnology, and clinical research industries. The software allows manufacturers and respective personnel in the aforementioned industries to ensure strict observance of complex regulations set by regulatory authorities in the respective regions.

Market Driver:

The regulatory scenario in the industries such as biotechnology, pharmaceuticals, and clinical research tend to be highly critical and keeps updating at frequent intervals. This has led to development of competent regulatory information management software to be adopted by industry players. This ever-changing regulatory scenario in such industries proves to be one of the important driving factors for adoption of regulatory information management software. Also, reduction in manual errors in the software designed for regulatory process coupled with easy access are further expected to contribute in growth of global regulatory information management market.

Software segment accounted for largest market share in 2017

Among product type, software segment is expected to account for the largest market share by 2026. Need to cope up with ever-changing regulatory scenario, especially in the field of pharmaceuticals, is increasing and this has led organizations to opt for regulatory information management software. The software for regulatory information management is among the most feasible and easy way to keep track of the production and manufacturing scenario in accordance with the updated regulatory norms in the respective region.

Pharmaceutical industry is expected to hold largest market share by 2026

Regulatory information management software are offered with various features, which help organizations to follow updated regulations. The innovation and advancement in the field of software with improved process to ensure effective management of regulatory information, the software also ensures reduction in turnaround time for any issues or malpractices in the system. Pharmaceutical companies are involved in development, dissemination, and control of the regulatory information throughout the product development cycle. Regulatory information management is an important solution for pharmaceutical companies as it effectively communicates regulations. The technology tools, product & service platforms, creates opportunities for automating business practices resulting in optimum business output with rigid observance of the set norms in the industry by regulatory bodies and government. In pharmaceutical industries, regulatory information management software facilitates robust application of planning, viewing, publishing, registration, and management of products throughout its life cycle. The software also allows effective compliant management of regulations and regulatory information. It has advantages such as submission of plan, e-submission viewer, and product registration and tracking. The software enables tracking the periodic safety updated reports (PSUR) and real time access of regulatory information.

Global regulatory information management market is anticipated to exhibit a significant CAGR during the forecast period

Figure: Global Regulatory Information Management Market Key Impact Forces,

regulatory information management market

Source: Coherent Market Insights Analysis, 2018

North America regulatory information management market is expected to exhibit the highest CAGR over the forecast period

North America is anticipated to be dominant in the regulatory information management market, due to high presence of pharmaceutical companies such as Amgen, GlaxoSmith, Novartis, Johnson & Johnson, and Gilead Sciences among others in countries such as the U.S. and Canada. Furthermore, according to a report by European Federation of Pharmaceutical Industries and Associations (EFPIA), in 2016, North America accounted for 49.0% of world pharmaceutical sales compared to 21.5% of Europe. According to IMS Health data (MIDAS May 2017), 64.7% of sales of new medicines launched during the period 2011-2016 were in the U.S. market, compared to 17.5% in the European market. This depicts the potential of North American as well as European markets for adoption of regulatory information management software. North America is followed by Asia Pacific in terms of market share in the regulatory information management market, owing to growing pharmaceuticals industry in countries such as China and India. This is evident with the fact that, according to International Trade Administration, rising per capita income, aging population, greater access to healthcare, and regulatory reform are key drivers that will enhance the appeal of China's pharmaceutical market.

Key companies

Major players operating in the global regulatory information management market include Acuta, Llc, Parexel, Computer Sciences Corp (CSC), Aris Global, Virtify, Ennov, Amplexor, Samarind Ltd, Dovel Technologies, Inc., and Informa.

Organizations have to adhere to certain regulations for production and development of products, solutions, and services. This software ensures that these organizations adhere to the regulations, which in turn helps them to reduce downtime or production of the products, which are not in line with the set regulatory standards. The software is most suitable for application in industries such as healthcare and life sciences, where the regulations need to be updated regularly and followed strictly, owing to its sensitivity and direct effect on the lives of the consumers of the medicines.

Market Dynamics

Market for regulatory information management is expected to exhibit significant traction, during the forecast period, owing to factors such as increasing stringency of the norms provided by regulatory bodies such as U.S. Food and Drug Administration (FDA), European Medicines Agency, and other similar agencies in the respective regions globally. The regulatory scenario is complex and always changing, therefore to keep up with regulatory requirements across global markets is challenging. According to the European Union Drug Regulating Authorities Pharmacovigilance Medicinal Product Dictionary (EVMPD) regulations, all pharmaceutical companies harmonized exchanged format to manage the drug safety product information, which was effective from July 02, 2012. Pharmaceutical companies tend to adopt advanced technologies such as regulatory information management systems. This enables respective personnel of these companies with easy access to information at any time. The reduction in manual errors in regulatory process coupled with easy access to all the information are further expected to contribute in growth of global regulatory information management market. Apart from healthcare and life sciences, this software is also being adopted in the multiple industries such as biotechnology and clinical research organizations as they vary in terms of degrees of maturity when it comes to regulatory processes.

Key features of the study:

  • This report provides in-depth analysis of regulatory information management market size (US$ Million), and Compound Annual Growth Rate (CAGR %) for the forecast period (2018– 2026), considering 2017 as the base year
  • It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, regional outlook, and competitive strategy adopted by the leading players
  • It profiles leading players in the global regulatory information management market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, regulatory information management market capital, key developments, strategies, and future plans
  • Companies covered as part of this study include Acuta, Llc, Parexel, Computer Sciences Corp (CSC), Aris Global, Virtify, Ennov, Amplexor, Samarind Ltd., Dovel Technologies, Inc., and Informa.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decision regarding their future product launches, product upgrades, market expansion, and marketing tactics
  • The global regulatory information management market report caters to various stakeholders in this industry including investors, suppliers, manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global regulatory information management market.

Detailed Segmentation:

  • Global Regulatory Information Management Market, By Product Type:
    • Software
    • Hardware
  • Global Regulatory Information Management Market, By End-user Industry:
    • Pharmaceutical Industry
    • Biotechnology Industry
    • Clinical Research organizations
  • Global Regulatory Information Management Market, By Geography:
    • North America
      • By Product Type
      • By End-user Industry
      • By Country:
        • U.S.
        • Canada
    • Europe
      • By Product Type
      • By End-user Industry
      • By Country:
        • Germany
        • UK
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Product Type
      • By End-user Industry
      • By Country:
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Latin America
      • By Product Type
      • By End-user Industry
      • By Country:
        • Brazil
        • Mexico
        • Rest of Latin America
    • Middle East
      • By Product Type
      • By End-user Industry
      • By Country:
        • GCC Countries
        • Israel
        • Rest of Middle East
    • Africa
      • By Product Type
      • By End-user Industry
      • By Country:
        • Northern Africa
        • Central Africa
        • South Africa
  • Company Profiles
    • Acuta, Llc.
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Key Strategies
      • Recent Developments/ Updates
    • Parexel
    • Computer Science Corp (CSC)
    • Aris Global
    • Virtify
    • Ennov
    • Amplexor
    • Samarind Ltd.
    • Dovel Technologies, Inc.
    • Informa

“*” marked represents similar segmentation in other categories in the respective section.

Table of Content

Section 1

Global Regulatory Information Management Market

  • Market Overview
  • Market Introduction

Section 2

Global Regulatory Information Management Market Analysis

  • Market By Product Type
    • Market Overview
    • Software
    • Hardware
  • Market By End User Industry
    • Pharmaceutical Industry
    • Biotechnology Industry
    • Clinical Research organizations
  • Market By Region
    • North America
    • Europe
    • Asia-Pacific
    • South America
    • Middle East
    • Africa
  • Market Dynamics
    • Drivers
    • Opportunity
    • Challenge

Section 2

Manufacturer’s Profile

  • Acuta, Llc
  • Parexel
  • Computer Sciences Corp (CSC)
  • Aris Global
  • Virtify
  • Ennov
  • Amplexor
  • Samarind Ltd
  • Dovel Technologies, Inc
  • Informa

Section 3

Global Regulatory Information Management Market Share and Competitive Landscape

  • Market Concentration Study
  • Top 6 Regulatory Information Management Software Providers
  • Market Competition Trend

Section 4

Global Regulatory Information Management Market Analysis by Regions

  • Regional Analysis, 2016-2026
  • North America Regulatory Information Management Sales and Growth Rate (2016-2026)
  • Europe Regulatory Information Management Sales and Growth Rate (2016-2026)
  • Asia-Pacific Regulatory Information Management Sales and Growth Rate (2016-2026)
  • South America Regulatory Information Management Sales and Growth Rate (2016-2026)
  • Middle East and Africa Regulatory Information Management Sales and Growth Rate (2016-2026)

Section 5

North America Regulatory Information Management by Countries

  • North America Regulatory Information Management Revenue and Market Share by Countries (2016-2026)
    • United States Regulatory Information Management Sales and Growth Rate (2016-2026)
    • Canada Regulatory Information Management Sales and Growth Rate (2016-2026)
    • Mexico Regulatory Information Management Sales and Growth Rate (2016-2026)

Section 6

Europe Regulatory Information Management by Countries

  • Europe Regulatory Information Management Revenue and Market Share by Countries (2016-2026)
    • Germany Regulatory Information Management Sales and Growth Rate (2016-2026)
    • France Regulatory Information Management Sales and Growth Rate (2016-2026)
    • UK Regulatory Information Management Sales and Growth Rate (2016-2026)
    • Russia Regulatory Information Management Sales and Growth Rate (2016-2026)
    • Italy Regulatory Information Management Sales and Growth Rate (2016-2026)
    • Rest of Europe Regulatory Information Management Sales and Growth Rate (2016-2026)

Section 7

Asia Pacific Regulatory Information Management by Countries

  • Asia Pacific Regulatory Information Management Revenue and Market Share by Countries (2016-2026)
    • China Regulatory Information Management Sales and Growth Rate (2016-2026)
    • Japan Regulatory Information Management Sales and Growth Rate (2016-2026)
    • Korea Regulatory Information Management Sales and Growth Rate (2016-2026)
    • India Regulatory Information Management Sales and Growth Rate (2016-2026)
    • Southeast Asia Regulatory Information Management Sales and Growth Rate (2016-2026)
    • Rest of Asia Pacific Regulatory Information Management Sales and Growth Rate (2016-2026)

Section 8

Latin America Regulatory Information Management by Countries

  • Latin America Regulatory Information Management Revenue and Market Share by Countries (2016-2026)
    • Brazil Regulatory Information Management Sales and Growth Rate (2016-2026)
    • Mexico Regulatory Information Management Sales and Growth Rate (2016-2026)
    • Rest of Latin America Regulatory Information Management Sales and Growth Rate (2016-2026)

Section 9

Middle East Regulatory Information Management by Countries

  • Middle East Regulatory Information Management Revenue and Market Share by Countries (2016-2026)
    • GCC Countries Regulatory Information Management Sales and Growth Rate (2016-2026)
    • Israel Regulatory Information Management Sales and Growth Rate (2016-2026)
    • Rest of Middle East Regulatory Information Management Sales and Growth Rate (2016-2026)

Section 10

Africa Regulatory Information Management by Countries

  • Africa Regulatory Information Management Revenue and Market Share by Countries (2016-2026)
    • Northern Africa Regulatory Information Management Sales and Growth Rate (2016-2026)
    • Central Africa Regulatory Information Management Sales and Growth Rate (2016-2026)
    • South Africa Regulatory Information Management Sales and Growth Rate (2016-2026)

Section 11

Global Regulatory Information Management Market Segment by Product Type

  • Global Regulatory Information Management Revenue and Market Share by Product Type (2016-2026)
    • Software
    • Hardware

Section 12

Global Regulatory Information Management Market Segment by End User Industry

  • Global Regulatory Information Management Revenue and Market Share by End User Industry (2016-2026)
    • Pharmaceutical Industry
    • Biotechnology Industry
    • Clinical Research organizations

Section 13

Global Regulatory Information Management Market Forecast

  • Global Regulatory Information Management Revenue and Growth Rate (2016-2026)
    • Regulatory Information Management Market Forecast by Regions (2016-2026)
      • North America Regulatory Information Management Market Forecast (2016-2026)
        • By Country
        • By Product Type
        • By End User Industry
      • Europe Regulatory Information Management Market Forecast (2016-2026)
        • By Country
        • By Product Type
        • By End User Industry
      • Asia-Pacific Regulatory Information Management Market Forecast (2016-2026)
        • By Country
        • By Product Type
        • By End User Industry
      • Latin America Regulatory Information Management Market Forecast (2016-2026)
        • By Country
        • By Product Type
        • By End User Industry
      • Middle East Regulatory Information Management Market Forecast (2016-2026)
        • By Country
        • By Product Type
        • By End User Industry
      • Africa Regulatory Information Management Market Forecast (2016-2026)
        • By Country
        • By Product Type
        • By End User Industry
      • Global Regulatory Information Management Market Forecast by Product Type (2016-2026)
      • Global Regulatory Information Management Sales Forecast by End User Industry (2016-2026)

Section 14

Global Regulatory Information Management Market: Sales Channel Analysis

Section 15

Research Findings and Conclusion

Section 16

  • References
  • Research Methodology
  • About us and Sales Contact

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


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Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

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Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization:

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

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