Regulatory Information Management Market Accelerates at 11.7% CAGR to Hit US$ 6.05 Billion by 2033 | Fact.MR


The increasing emphasis on electronic submissions and electronic regulatory information exchange is a primary driver shaping industry growth

Rockville, Dec. 07, 2023 (GLOBE NEWSWIRE) — As per Fact.MR, a provider of market research and competitive intelligence, the global Regulatory Information Management Market is likely to increase at a CAGR of 11.7% to reach a US value of $6.05 Bn by the end of 2033.

Regulatory Information Management (RIM) is a modern approach used by regulated industries like pharmaceuticals and medical devices to efficiently handle regulatory information throughout a product’s life cycle. Unlike traditional methods, RIM centralizes all regulatory data in one system, streamlining submission management and compliance tracking workflows. This centralized approach ensures real-time collaboration among stakeholders and provides features like version control and audit trails, preventing errors and maintaining accurate regulatory histories.


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Key Segments of Regulatory Information Management Industry Research Report

By Solution By Company Size By Category By Vertical
  • Software
    • Cloud
    • On-premise
  • Services
    • Training & Support
    • Consulting
  • Small & Medium Enterprises (SMEs)
  • Large Enterprises
  • Data Management & Information Standards
  • Dossier Management
  • Health Authority Management
  • Product Labelling
  • Product Registration Management
  • Reporting & Analytics
  • Touchpoint
  • Others
  • Pharmaceuticals
  • Cosmetics
  • Medical Devices
  • Biologics
  • Nutraceuticals

The expansion of this sector is mostly driven by the escalating complexity of global regulatory requirements in industries like pharmaceuticals and healthcare. With an increasing emphasis on electronic submissions and information exchange, organizations are turning to RIM solutions to centralize and streamline regulatory processes, ensuring compliance and accelerating time-to-market.

The industry encounters significant challenges due to the constantly changing and diverse nature of regulatory environments across various industries and regions. Many organizations face challenges due to limited budgets and a shortage of skilled personnel. Allocating enough resources for implementing, maintaining, and improving regulatory information management systems is a struggle.

Key Takeaways:

  • The North American market is expected to witness a market share of 35% in 2023.
  • As per end-use, the pharmaceutical Industry market share is expected to be more than 30% in 2023.
  • The US market is expected to move at a rapid pace due to a high focus on the optimization of the drug development pipeline in the region.
  • The pharmaceutical market in China is rapidly expanding and this makes the region highly profitable. The growth in the market is driven by increasing pharmaceutical manufacturing activity in the region.

Increasing regulatory complexity, a widespread shift towards digital transformation, and the global expansion of life sciences and healthcare sectors are factors that are propelling the market – Says Fact.MR Expert

Market Competition

The regulatory information management market comprises key suppliers that are concentrating on the introduction of innovative products equipped with advanced features to enhance their global sales and revenue generation capabilities. Key players in the market are DXC Technology, Ennov SA, Sparta Systems Inc., Extedo GmbH, NNIT A/S, Lorenz Life Sciences, Dovel Technologies Inc., PAREXEL International, and IQVIA Holdings Inc

  • In February 2023, ArisGlobal, a well-known player in the life sciences sector, unveiled a new product designed to assist medical device providers in navigating the investigational phases of drug development.
  • In August 2023, Boyds, a worldwide drug development consultancy, revealed the introduction of its new regulatory operations service, aiming to assist clients throughout the entire lifecycle of their drug development projects. The service is entirely conducted in-house, and the company utilizes LORENZ docuBridge, a widely used software for regulatory information management.

Winning strategies

  • It is crucial for major players in the industry to prioritize smooth integration with regulatory databases, ensuring their platforms offer immediate access to the most up-to-date regulatory information and updates.
  • A successful strategy involves creating customized solutions tailored to the unique regulatory challenges in the life sciences and healthcare sectors. This strategy includes designing platforms with features specifically crafted to ensure compliance with industry-specific regulations.
  • It’s important for leading companies to create adaptable solutions that suit the needs and budgets of small and medium-sized enterprises (SMEs). These tailored solutions allow SMEs to meet regulatory requirements without requiring extensive resources.

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Report Attribute Details
Value Projection (2033) USD 6.05 Billion
Growth Rate (2023-2033) 11.7% CAGR
No. of pages 170 Pages
No. of Tables 82 Tables
No. of Figures 101 Figures

The European Medicines Agency (EMA) and various regulatory bodies in Europe uphold stringent standards for product approval submissions. This is expected to drive the demand for regulatory information management services and software throughout the forecast period. Additionally, growing collaborations between European entities and organizations from global regions are anticipated to further fuel the demand for regulatory information management systems in European countries until 2033.

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