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Regulatory Information Management System Market Size, Share & Trends Analysis Report By End-Use (Pharmaceutical Sector, Medical Device Sector, Other), And Segment Forecasts, 2022 - 2030

August 2022 | 150 pages | ID: RDAA8657208AEN
Grand View Research, Inc.

US$ 5,950.00

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Regulatory Information Management System Market Growth & Trends

The global regulatory information management system market size is expected to reach USD 4.12 billion by 2030, according to a new report by Grand View Research, Inc, expanding at a CAGR of 11.0% from 2022 to 2030. As a result of the rapid adoption of the software by the pharmaceutical companies, competitors in the regulatory information management (RIM) system or software market are seeing enormous growth, and this growth is anticipated to continue.

Furthermore, the pharmaceutical industry nowadays also has a big job when it comes to keeping regulatory data for a product’s life cycle. The complexity is brought on by the enormous amount of fragmented data stored across several systems and supported by inefficient software applications. The complicated rules that are always expanding and changing, the higher standards for product quality, and the quickly changing digital technology environment all present opportunities and obstacles for innovation for medical device companies. For companies to succeed in this climate, they must also figure out how to maximize return on investment by producing goods as cheaply and efficiently as feasible.

Additionally, to compete for business internationally, providers such as medical device providers must supply items under many strict international standards and follow each nation's unique submission method. Additionally, they must consider the evolving and more complex client expectations. These tasks also need to be completed more swiftly as time goes on. Therefore, if medical device businesses are to compete in this competitive climate, they need a more automated and comprehensive method to handle these processes. Systems for regulatory information management (RIM) accomplish precisely that, and as more people use them, thus the market is expected to expand throughout the forecast period.

Furthermore, especially in the food industry, rapid mistake detection is essential to prevent losing R&D time or, worse still, consumer difficulties and non-conformity problems. Managing non-conformity may quickly grow time-consuming and difficult. Furthermore, non-conformity may be costly and damaging to a brand's image. As a result, software providers are steadily increasing their interest in the food industry. Unlike the pharmaceutical industry, one strategy that software providers are using in this expanding market is by providing comprehensive single software as one solution that does provide user management. All of the aforementioned requirements consult for in-hand regulatory information management systems, which is possible with the aid of digital components such as software.

RIM Impact on Companies

System updates on the market and regulatory developments are now being made available in real-time. Companies may quickly modify their submission data by quickly identifying and analyzing these adjustments. These new technologies outperform historic data system features by a wide margin, and they are built to be enhanced in the future as technology develops.

In addition, top-level managers at medical device businesses are far more concerned with regulatory issues now than they were in the past. The majority of these executives are keen to increase registration through the use of trimming technology, which will improve important business KPIs. As a result, these 3rd RIM systems are their best choice for accomplishing this.

In order to take advantage of diverse sorts of services and technological capabilities needed for future success, forward-thinking insurers are widening their options and going beyond conventional methods of marketing. To improve company position in the global market, these companies have used a variety of strategies, including partnerships, collaborations, product launches, and increasing their operational presence. For instance, companies include ClinChoice, which operates in the U.S. and has strengthened its position in China and Japan. This highlights both the company's apparent indication of rising customer interest and the rising need for processing regulatory information.

Regulatory Information Management System Market Report Highlights
  • The need for RIM systems with streamlined, encrypted, unified, and compatible platforms is increasing as a result of the pharmaceutical industry's requirement to manage enormous quantities and diversity of data types. Additionally, as the consumer's goals for development are realized and the RIM suppliers are able to ensure more advanced technologies, automated information merging, and data performance monitoring, thus the pharmaceutical sector is also anticipated to grow over the course of the forecast period
  • With China, India, and Japan all expected to see rapid development throughout the forecast period, the Asia-Pacific region is expected to grow at the fastest rate. These include rising rates of pharmaceutical-based products and medical devices and rising regulatory-related concerns. Additionally, there has been an increase in the need for RIM-related software as a solution due to rising regulatory compliance and associated data maintenance requirements
  • North America dominated the market and accounted for a revenue share of over 67% in 2021, owing to an increase in advancement in the field of pharmaceutical, medtech, and related sectors of end-of-life care, and growing awareness and rising demand for the RIM systems to bring in a better product for the end consumers/manufacturer’s
  • Key players also contribute to the market growth by entering partnerships, mergers and acquisitions, and launching new products. For instance, IQVIA unveiled IQVIA RIM Smart, the industry's first fully integrated, comprehensive regulatory information management system which is cloud-based. Machine learning (ML) and artificial intelligence (AI) are being used more and more by businesses to enable intelligent management of a product portfolio's whole regulatory lifecycle
CHAPTER 1 RESEARCH METHODOLOGY & SCOPE

1.1 Market Segmentation & Scope
  1.1.1 Estimates And Forecast Timeline
1.2 Research Methodology
1.3 Information Procurement
  1.3.1 Purchased Database:
  1.3.2 Gvr’s Internal Database
  1.3.3 Secondary Sources
  1.3.4 Primary Research:
  1.3.5 Details Of Primary Research
1.4 Information or Data Analysis
  1.4.1 Data Analysis Models
1.5 Market Formulation & Validation
1.6 Model Details
  1.6.1 Commodity Flow Analysis (Model 1)
    1.6.1.1 Approach 1: Commodity Flow Approach
1.7 List Of Secondary Sources
1.8 List Of Primary Sources
1.9 Report Objectives

CHAPTER 2 EXECUTIVE SUMMARY

2.1 Market Outlook
  2.1.1 Regulatory Information Management System Market Outlook, 2017 - 2030 (Million)
2.2 Segment Outlook
2.3 Regulatory Information Management System Market Summary, 2021

CHAPTER 3 REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET VARIABLES, TRENDS & SCOPE

3.1 Penetration & Growth Prospect Mapping
3.2 Regulatory Information Management System Market Dynamics
  3.2.1 Market Driver Analysis
    3.2.1.1 Advancement In The Field Of Pharmaceutical, Medtech And Related Sectors
    3.2.1.2 Periodic Update And Change In The Regulations
    3.2.1.3 Growing Awareness And Rising Demand For The Rim Systems
  3.2.2 Market Restraints Analysis
    3.2.2.1 Limited reach of Document-Driven Systems
  3.2.3 Unmet needs/opportunity analysis
    3.2.3.1 Implementing product bundling and providing end-to-end regulatory-related solutions
3.3 Regulatory Information Management System Market Analysis Tools: Porter’s Five Forces Analysis
  3.3.1 Supplier Power: Moderate-High
  3.3.2 Buyer Power: Moderate-High
  3.3.3 Threat Of Substitutes: Low-Moderate
  3.3.4 Threat Of New Entrants: Moderate- High
  3.3.5 Competitive Rivalry: High
3.4 Pestel Analysis
  3.4.1 Political & Legal Landscape
  3.4.2 Social Landscape
  3.4.3 Technology Landscape
3.5 Regulatory Framework
3.6 Competitor Product Price-Based Analysis
3.7 Covid-19 Impact Analysis
  3.7.1 Current And Future Impact Analysis
  3.7.2 Impact Of Covid-19 On Market Players

CHAPTER 4 REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET: END-USE ESTIMATES & TREND ANALYSIS

4.1 End-Use Movement Analysis, 2021 & 2030
  4.1.1 Pharmaceutical Sector
    4.1.1.1 Pharmaceutical Sector market estimates and forecasts, 2017 - 2030 (Million)
  4.1.2 Medical Device Sector
    4.1.2.1 Medical Device Sector market estimates and forecasts, 2017 - 2030 (Million)
  4.1.3 Other
    4.1.3.1 Other market estimates and forecasts, 2017 - 2030 (Million)

CHAPTER 5 REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET: REGIONAL ESTIMATES & TREND ANALYSIS, BY PRODUCT, COMPONENT, SOLUTION TYPE, DEPLOYMENT MODE, AND END-USE

5.1 Regional Market Snapshot
5.2 North America
  5.2.1 North America Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (Million)
  5.2.2 U.S.
    5.2.2.1 U.S. Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (Million)
  5.2.3 Canada
    5.2.3.1 Canada Regulatory Information Management System Market Estimates And Forecasts, 2017 -2030(Million)
5.3 Europe
  5.3.1 Europe Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (Million)
  5.3.2 U.K.
    5.3.2.1 U.K. Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030(Million)
  5.3.3 Germany
    5.3.3.1 Germany Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (Million)
  5.3.4 Switzerland
    5.3.4.1 Switzerland Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (Million)
5.4 Asia Pacific
  5.4.1 Asia Pacific Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (Million)
  5.4.2 Japan
    5.4.2.1 Japan Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (Million)
  5.4.3 China
    5.4.3.1 China Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (Million)
  5.4.4 India
    5.4.4.1 India Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (Million)
5.5 Latin America
  5.5.1 Latin America Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (Million)
  5.5.2 Brazil
    5.5.2.1 Brazil Regulatory Information Management System Market estimates and forecasts, 2017 - 2030 (Million)
5.5 MEA
  5.5.1 MEA Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (Million)
  5.5.2 South Africa
    5.5.2.1 South Africa Regulatory Information Management System Market Estimates And Forecasts, 2017 - 2030 (Million)

CHAPTER 6 COMPETITIVE LANDSCAPE

6.1 Market participation categorization
6.2 Companies
  6.2.1 Company market position analysis
  6.2.2 Major Deals & Strategic Alliances
  6.2.3 Detailed List of players

CHAPTER 7 COMPANY PROFILE

7.1 Veeva system
  7.1.1 Company Overview
  7.1.2 Financial Performance
  7.1.3 Product Benchmarking
  7.1.4 Strategic Initiatives
7.2 Kalypso
  7.2.1 Company Overview
  7.2.2 Financial Performance
  7.2.3 Product Benchmarking
  7.2.4 Strategic Initiatives
7.3 DDI
  7.3.1 Company Overview
  7.3.2 Financial Performance
  7.3.3 Product Benchmarking
7.4 Korber AG
  7.4.1 Company Overview
  7.4.2 Financial Performance
  7.4.3 Product Benchmarking
  7.4.4 Strategic Initiatives
7.5 ArisGlobal
  7.5.1 Company Overview
  7.5.2 Financial Performance
  7.5.3 Product Benchmarking
  7.5.4 Strategic Initiatives
7.6 PhlexGlobal
  7.6.1 Company Overview
  7.6.2 Financial Performance
  7.6.3 Product Benchmarking
  7.6.4 Strategic Initiatives
7.7 AmpleLogic
  7.7.1 Company Overview
  7.7.2 Financial Performance
  7.7.3 Product Benchmarking
  7.7.4 Strategic Initiatives
7.8 Calyx
  7.8.1 Company Overview
  7.8.2 Financial Performance
  7.8.3 Product Benchmarking
  7.8.4 Strategic Initiatives
7.9 Amplexor Life Sciences
  7.9.1 Company Overview
  7.9.2 Product Benchmarking
  7.9.3 Strategic Initiatives
7.10 Ennov
  7.10.1 Company Overview
  7.10.2 Financial Performance
  7.10.3 Product Benchmarking
  7.10.4 Strategic Initiatives
7.11 MastarControl
  7.11.1 Company Overview
  7.11.2 Financial Performance
  7.11.3 Product Benchmarking
  7.11.4 Strategic Initiatives
7.12 Rimsys
  7.12.1 Company Overview
  7.12.2 Financial Performance
  7.12.3 Product Benchmarking
  7.12.4 Strategic Initiatives
7.13 Ithos Global Inc.
  7.13.1 Company Overview
  7.13.2 Financial Performance
  7.13.3 Product Benchmarking
  7.13.4 Strategic Initiatives
7.14 Lorenz
  7.14.1 Company Overview
  7.14.2 Financial Performance
  7.14.3 Product Benchmarking
  7.14.4 Strategic Initiatives
LIST OF TABLES

TABLE 1 List of secondary sources
TABLE 2 Major Deals & Strategic Alliances
TABLE 3 Detailed List of players
TABLE 4 North America Regulatory Information Management System Market estimates and forecasts, by End-Use, 2017 - 2030 (Million)
TABLE 5 U.S. Regulatory Information Management System Market estimates and forecasts, by End-Use, 2017 - 2030 (Million)
TABLE 6 Canada Regulatory Information Management System Market estimates and forecasts, by End-Use, 2017 - 2030 (Million)
TABLE 7 Europe Regulatory Information Management System Market estimates and forecasts, by End-Use, 2017 - 2030 (Million)
TABLE 8 U.K. Regulatory Information Management System Market estimates and forecasts, by End-Use, 2017 - 2030 (Million)
TABLE 9 Germany Regulatory Information Management System Market estimates and forecasts, by End-Use, 2017 - 2030 (Million)
TABLE 10 Switzerland Regulatory Information Management System Market estimates and forecasts, by End-Use, 2017 - 2030 (Million)
TABLE 11 Asia Pacific Regulatory Information Management System Market estimates and forecasts, by End-Use, 2017 - 2030 (Million)
TABLE 12 China Regulatory Information Management System Market estimates and forecasts, by End-Use, 2017 - 2030 (Million)
TABLE 13 Japan Regulatory Information Management System Market estimates and forecasts, by End-Use, 2017 - 2030 (Million)
TABLE 14 India Regulatory Information Management System Market estimates and forecasts, by End-Use, 2017 - 2030 (Million)
TABLE 15 Latin America Regulatory Information Management System Market estimates and forecasts, by End-Use, 2017 - 2030 (Million)
TABLE 16 Brazil Regulatory Information Management System Market estimates and forecasts, by End-Use, 2017 - 2030 (Million)
TABLE 17 MEA Regulatory Information Management System Market estimates and forecasts, by End-Use, 2017 - 2030 (Million)
TABLE 18 South Africa Regulatory Information Management System Market estimates and forecasts, by End-Use, 2017 - 2030 (Million)
LIST OF FIGURES

FIG. 1 Market segmentation
FIG. 2 Market research process
FIG. 3 Data triangulation techniques
FIG. 4 Primary research pattern
FIG. 4 Market research approaches
FIG. 5 Value-chain-based sizing & forecasting
FIG. 7 QFD Modeling for market share assessment
FIG. 8 Market formulation & validation
FIG. 9 Commodity flow analysis
FIG. 10 Segment-Based Penetration Model
FIG. 7 Market summary (2021, Million)
FIG. 12 Segment outlook, End-Use
FIG. 13 FIG. 14 Penetration & growth prospect mapping
FIG. 14 Market variable analysis
FIG. 15 Market driver relevance analysis (Current & future impact)
FIG. 16 Market restraint relevance analysis (Current & future impact)
FIG. 17 Regulatory Information Management System Market : End-Use Movement Analysis
FIG. 18 Pharmaceutical Sector market, 2017 - 2030 (Million)
FIG. 19 Medical Device Sector market, 2017 - 2030 (Million)
FIG. 20 Other market, 2017 - 2030 (Million)
FIG. 21 Regional marketplace: Key takeaways
FIG. 22 Regional outlook, 2021 & 2030
FIG. 23 North America Regulatory Information Management System Market, 2017 - 2030 (Million)
FIG. 24 U.S. Regulatory Information Management System Market, 2017 - 2030 (Million)
FIG. 25 Canada Regulatory Information Management System Market, 2017 - 2030 (Million)
FIG. 26 Europe Regulatory Information Management System Market, 2017 - 2030 (Million)
FIG. 27 U.K. Regulatory Information Management System Market, 2017 - 2030 (Million)
FIG. 28 Germany Regulatory Information Management System Market, 2017 - 2030 (Million)
FIG. 29 Switzerland Regulatory Information Management System Market, 2017 - 2030 (Million)
FIG. 30 Asia Pacific Regulatory Information Management System Market, 2017 - 2030 (Million)
FIG. 31 Japan Regulatory Information Management System Market, 2017 - 2030 (Million)
FIG. 32 China Regulatory Information Management System Market, 2017 - 2030 (Million)
FIG. 33 India America Regulatory Information Management System Market, 2017 - 2030 (Million)
FIG. 34 Latin America Regulatory Information Management System Market, 2017 - 2030 (Million)
FIG. 35 Brazil Regulatory Information Management System Market, 2017 - 2030 (Million)
FIG. 36 MEA Regulatory Information Management System Market, 2017 - 2030 (Million)
FIG. 37 South Africa Regulatory Information Management System Market, 2017 - 2030 (Million)
FIG. 38 Market Participation Categorization
FIG. 39 Company market position analysis


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