Regulatory Information Management Market

Regulatory Information Management Market Study by Data Management & Information Standards, Dossier Management, Health Authority Management, Product Labelling, and Others from 2023 to 2033

Analysis of Regulatory Information Management Market Covering 30+ Countries Including Analysis of US, Canada, UK, Germany, France, Nordics, GCC countries, Japan, Korea and many more

Regulatory Information Management Market Outlook (2023 to 2033)

Worldwide demand for regulatory information management is projected to increase at a high-value 11.7% CAGR from 2023 to 2033. As a result, the global regulatory information management (RIM) market is projected to increase from a value of US$ 1.99 billion in 2023 to US$ 6.05 billion by the end of 2033.

Compliance with regulatory standards is crucial for product development and commercialization in different industry verticals such as medical devices and pharmaceuticals. Regulatory mandates are also constantly changing and keeping track of these changes is crucial for businesses, which is why demand for regulatory information management is rising.

Increasing complexity of the regulatory landscape is also projected to play a crucial role in augmenting sales of regulatory information management systems over the next ten years. Efforts to fast-track the drug development process and the rising proliferation of digitization in regulatory approach are also creating an opportune scenario for regulatory information management companies going forward.

Organizations are increasingly making efforts to gain additional value from their product data, as they realize the strategically important role data could play in driving new productivity, competence, and competitive differentiation. This, coupled with the growing importance of making product as well as regulatory information more shareable among and beyond specific functions, is driving the deployment of regulatory information management software.

Growing number of clinical trials being performed, rising awareness regarding the regulatory information management benefits, and efforts to improve productivity in all industry verticals are also slated to favor market growth through 2033.

Regulatory information management companies are continually innovating and launching new regulatory information management software and solutions with advanced features to help companies manage their regulatory requirements.

  • In June 2020, ArisGlobal, a leading provider of software solutions for life science organizations, announced the launch of a new cloud-based platform to streamline regulatory information management. LifeSphere Regulatory allows users to handle their entire regulatory management in a single integrated suite.

Companies are facing challenges resulting from high confusion and accumulation of massive documentation due to market-specific and highly dissimilar regulations, which necessitates consulting with professional trainers, thereby, creating further demand for regulatory information management services.

On the contrary, changing product approval requisites and constantly changing regulatory frameworks in different parts of the world are projected to emerge as key restraints for regulatory information management companies in the long run. Operating RIM software requires skilled personnel and the cost of hiring or training a person for the same is not something that all companies can afford thereby limiting demand for regulatory information management solutions in the future.

Report Attributes Details
Regulatory Information Management Market Size (2023) US$ 1.99 Billion
Projected Market Value (2033F) US$ 6.05 Billion
Global Market Growth Rate (2023 to 2033) 11.7% CAGR
North America Market Share (2023) 35%
Pharmaceuticals Industry Market Share (2023) >30%
Key Companies Profiled
  • DXC Technology
  • Ennov SA
  • Sparta Systems Inc.
  • Extedo GmbH
  • NNIT A/S
  • Lorenz Life Sciences
  • Dovel Technologies Inc.
  • PAREXEL International
  • IQVIA Holdings Inc.
  • Synchrogenix Information Strategies Inc.
  • Instem Information Solutions
  • Aris Global LLC
  • Veeva Systems Inc.
  • Navitas Life Sciences Ltd.

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How are Start-ups Navigating the Tricky RIM Business Space?

“New Companies Focusing on Resolving Regulatory Hurdles”

The regulatory landscape for different industry verticals is constantly changing and this also means that the challenges with these changes also evolve over time. Upcoming regulatory information management providers are focusing on overcoming obstacles in regulatory information management limiting the overall market growth potential going forward.

  • In August 2023, Fluree, a database management start-up, and Vitality TechNet collaborated to build a data infrastructure for pharmaceutical companies looking to fast-track the drug discovery process by enabling digital regulatory information management. The partnership is projected to result in much faster and more efficient regulatory reporting to reduce costs and improve drug development pipelines.
  • In June 2021, Greenlight Guru, a start-up focusing on helping medical device companies navigate regulatory hurdles, announced that it had raised US$ 120 million in a finance raise from JMI Equity, an investment firm.

Start-ups can get a more detailed understanding of aspects such as local supply, pricing trends, product standards, safety regulations, and new developments in this regulatory information management market research analysis by skilled analysts at Fact.MR, a market research and competitive intelligence provider.

Regulatory Information Management Market Size, Share, Trends, Growth, Demand and Sales Forecast Report by Fact.MR

Country-wise Insights

The United States and European countries are projected to be the most rewarding markets for all regulatory information management companies in the world. However, small regulatory information management providers looking to enter the market should start by investing in Asian countries such as China, India, and Japan in the future.

What’s Drawing Regulatory Information Management Companies to the United States?

“High Focus on Optimization of Drug Development Pipeline”

The presence of key pharmaceutical companies and high investments in life science R&D are projected to be key prospects for government regulatory information management demand in the United States over the coming years. Moreover, the high adoption and availability of advanced regulatory information management software and solutions in the country also contribute to the significant market share of this country in the North American region.

Growing focus on enhancing drug development for better treatment access to people is promoting the demand for advanced regulatory information management systems in the United States.

  • In May 2022, Rimsys, a United States-based provider of regulatory information management solutions, announced the launch of a new RIM software called Rimsys 5 at an event in Spain.

Why are Regulatory Information Management Companies Rushing to China?

“Increasing Pharmaceutical Manufacturing Activity Creating Huge Business Scope”

The pharmaceutical industry in China is rapidly expanding and this is what makes it a highly profitable market in the East Asian region going forward. Any company looking to do business in China should strictly adhere to the regulatory mandates of the country and this is projected to promote the use of RIM systems and software through 2033.

Increasing cross-border collaboration and adoption of global standardization initiatives by the Chinese government are also forecasted to boost demand for RIM software and services over the coming years. Frequent updation of the regulatory framework in China to keep up with global standards is also slated to bolster the adoption of regulatory information management in the country over the next ten years and beyond.

Should RIM Providers Invest in European Countries?

“Presence of Stringent Submission Norms Driving Demand for RIM Services”

European Medicines Agency (EMA) and other regulatory authorities in the European region have very strict requirements for product approval submissions and this is projected to bolster demand for regulatory information management services and software across the study period. Increasing collaborations between European companies and organizations from other parts of the world are also slated to benefit the demand for regulatory information management systems in European countries through 2033.

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Category-wise Insights

Regulatory information management companies are focusing on providing solutions and services for the pharmaceutical industry as it presents highly rewarding business opportunities going forward.

Which Vertical Holds a Prominent Share in This Market?

“Pharmaceutical Industry to Spearhead Revenue Generation”

Surging prevalence of chronic diseases across the world is driving demand for different kinds of pharmaceuticals and medications. Pharmaceutical companies need to comply with standards set by regulatory bodies at all stages of drug development and maintaining a track of these standards can be a taxing task. This is why pharmaceutical companies are deploying regulatory information management systems and software to ensure regulatory compliance and fast-track the process of taking drugs from their development phase to the commercialization phase.

The world is driven by the ever-increasing demand for speed to market, which continues to make it difficult for brands to maintain pharmaceutical regulatory compliance. Unification of information enabled by an efficient regulatory information management software coupled with benefits such as improved consistency and reduced wasted efforts is favoring its deployment across all industry verticals including pharmaceuticals.

  • In 2023, demand for regulatory information management in the pharmaceutical industry vertical accounts for more than 30% share of the global marketplace.

Competitive Landscape

Regulatory information management system vendors are focusing on launching new products with advanced features to improve their sales and revenue generation potential around the world.

  • In February 2023, ArisGlobal, a renowned name in the life sciences space, announced the launch of its new offering that helps medical device providers navigate the investigational stages of drug development. Investigational Product RIMS is a perfect fit for life sciences and medical device suppliers who still haven’t received marketing authorization for their offerings.
  • In August 2023, Boyds, a global drug development consultancy, announced the launch of its new regulatory operations service to support its clients’ full lifecycle of drug development projects. The service is completely in-house and the company uses LORENZ docuBridge, a popular regulatory information management software.

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Regulatory Information Management Market Research Segments

  • By Solution :

    • Software
      • Cloud
      • On-premise
    • Services
      • Training & Support
      • Consulting
  • By Company Size :

    • Small & Medium Enterprises (SMEs)
    • Large Enterprises
  • By Category :

    • Data Management & Information Standards
    • Dossier Management
    • Health Authority Management
    • Product Labelling
    • Product Registration Management
    • Reporting & Analytics
    • Touchpoint
    • Others
  • By Vertical :

    • Pharmaceuticals
    • Cosmetics
    • Medical Devices
    • Biologics
    • Nutraceuticals
  • By Region :

    • North America
    • Latin America
    • Europe
    • East Asia
    • South Asia & Oceania
    • Middle East & Africa

- FAQs -

What is the regulatory information management market size?

The global regulatory information management market stands at a value of US$ 1.99 billion in 2023.

How big will regulatory information management demand be in the future?

The market for regulatory information management is forecasted to reach US$ 6.05 billion by 2033-end.

At what CAGR will the global market expand through 2033?

Demand for regulatory information management is projected to increase at 11.7% CAGR over the next ten years.

Which region leads global market growth?

North America is projected to lead global regulatory information management demand and holds a market share of 35% in 2023.

Who are the key regulatory information management providers?

NNIT A/S, Lorenz Life Sciences, Dovel Technologies Inc., PAREXEL International, and IQVIA Holdings Inc. are leading companies in this market.

Regulatory Information Management Market

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