세계의 규제 정보 관리 시장 - 산업 규모, 점유율, 동향, 기회, 예측, 구성요소별, 전개 모드별, 용도별, 최종 사용자별, 지역별, 경쟁별(2020-2030년)
Regulatory Information Management Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented by Component, By Deployment Mode, By Application, By End User, By Region and Competition, 2020-2030F
상품코드 : 1785191
리서치사 : TechSci Research
발행일 : 2025년 08월
페이지 정보 : 영문 188 Pages
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한글목차

규제 정보 관리 세계 시장 규모는 2024년에 21억 2,000만 달러로 평가되었고, 예측기간 중 CAGR은 10.41%를 나타내고, 2030년에는 38억 1,000만 달러에 달할 것으로 예측되고 있습니다.

세계의 규제 정보 관리(RIM) 시장은 생명과학기업이 복잡한 규제 프로세스를 효율적으로 처리하는데 있어서 매우 중요한 역할을 하고 있습니다. 규제가 진화하고 지역에 따라 엄격해짐에 따라 제약, 생명공학 및 의료기기 분야의 기업들은 컴플라이언스를 관리하고 위험을 줄이고 시장 출시 시간을 개선하기 위해 간소화된 RIM 시스템에 대한 투자를 늘리고 있습니다. RIM은 신청, 제품 등록, Kiyoclear, 규제 당국과의 상호 작용을 포함한 규제 데이터의 수집, 보관 및 사용을 포괄합니다. 기업은 의사결정을 지원하고 로컬 및 세계 규제 요건을 준수하는 데 도움이 되는 중요한 정보의 중앙 집중식 리포지토리를 유지하기 위해 이러한 시스템에 의존합니다. RIM 시장의 성장 촉진요인 중 하나는 디지털 변환입니다. 클라우드 기반 플랫폼과 자동화 툴은 기존의 수작업을 대신하여 보다 신속하고 정확한 규제 업무를 처리할 수 있습니다. 이러한 최신 시스템은 실시간 협업, 투명성 향상 및 부서 간의 통합을 제공하여 기업이 변화하는 규제 상황의 선점을 지원합니다.

시장 개요
예측 기간 2026-2030
시장 규모 : 2024년 21억 2,000만 달러
시장 규모 : 2030년 38억 1,000만 달러
CAGR 2025-2030년 10.41%
급성장 부문 의약품
최대 시장 북미

예를 들어 2025년 2월에는 전자 품질 관리 시스템(eQMS)의 진화로 의약품 임상시험에서 규제 정보 관리(RIM)의 기능이 크게 향상되었습니다. 최신 eQMS 플랫폼은 실시간 데이터 캡처, 중앙 집중식 문서 보관 및 자동화된 프로토콜 관리를 지원하며 규제 규정 준수 요구 사항과 원활하게 작동합니다. 이러한 향상은 품질과 약사 프로세스의 보다 나은 통합을 가능하게 하고 데이터의 정확성, 감사 준비 및 신청 일정을 개선합니다. 그 결과, eQMS의 혁신은 세계 RIM 전략을 강화하는 데 중요한 핵심 요소가 되고 있습니다.

시장 성장 촉진요인

규제의 복잡화

주요 시장 과제

데이터 표준화 및 통합

주요 시장 동향

클라우드 기반 RIM 플랫폼으로 이동

목차

제1장 개요

제2장 조사 방법

제3장 주요 요약

제4장 세계의 규제 정보 관리 시장 전망

제5장 북미의 규제 정보 관리 시장 전망

제6장 유럽의 규제 정보 관리 시장 전망

제7장 아시아태평양의 규제 정보 관리 시장 전망

제8장 남미의 규제 정보 관리 시장 전망

제9장 중동 및 아프리카의 규제 정보 관리 시장 전망

제10장 시장 역학

제11장 시장 동향과 발전

제12장 경쟁 구도

제13장 전략적 제안

제14장 기업 소개와 면책사항

SHW
영문 목차

영문목차

Global Regulatory Information Management Market was valued at USD 2.12 billion in 2024 and is expected to reach USD 3.81 billion by 2030 with a CAGR of 10.41% during the forecast period. The Global Regulatory Information Management (RIM) market plays a pivotal role in helping life sciences companies efficiently handle complex regulatory processes. As regulations evolve and become more stringent across regions, organizations in the pharmaceutical, biotechnology, and medical device sectors are increasingly investing in streamlined RIM systems to manage compliance, reduce risk, and improve time-to-market. RIM encompasses the collection, storage, and use of regulatory data, including submissions, product registrations, Kiyoclear, and correspondence with regulatory authorities. Companies rely on these systems to maintain a centralized repository of critical information that supports decision-making and ensures adherence to local and global regulatory requirements. A key driver of growth in the RIM market is digital transformation. Cloud-based platforms and automation tools are replacing traditional manual methods, enabling faster, more accurate handling of regulatory tasks. These modern systems offer real-time collaboration, improved transparency, and integration across departments, helping companies stay ahead of shifting regulatory landscapes.

Market Overview
Forecast Period2026-2030
Market Size 2024USD 2.12 Billion
Market Size 2030USD 3.81 Billion
CAGR 2025-203010.41%
Fastest Growing SegmentPharmaceuticals
Largest MarketNorth America

For instance, in Feb 2025, the evolution of electronic Quality Management Systems (eQMS) is significantly advancing the capabilities of Regulatory Information Management (RIM) in pharmaceutical clinical trials. Modern eQMS platforms now support real-time data capture, centralized document storage, and automated protocol management, aligning seamlessly with regulatory compliance requirements. These enhancements enable better integration of quality and regulatory processes, improving data accuracy, audit readiness, and submission timelines. As a result, eQMS innovation is becoming a key enabler in strengthening global RIM strategies.

Key Market Drivers

Increasing Regulatory Complexity

Increasing regulatory complexity is one of the most significant drivers shaping the Global Regulatory Information Management (RIM) market. Across the pharmaceutical, biotechnology, and medical device industries, companies are facing a rapidly evolving landscape of compliance requirements imposed by national and international regulatory bodies. Health authorities such as the U.S. FDA, the European Medicines Agency (EMA), and regulatory agencies in Asia and Latin America are frequently updating their guidelines, introducing new formats for submissions, and enforcing stricter requirements around data integrity, traceability, and transparency. This growing complexity places immense pressure on regulatory affairs teams to stay current with the latest regulatory changes while managing a rising volume of product data, documentation, and submission timelines. Each country or region often maintains distinct and detailed expectations for product approval, post-market surveillance, and lifecycle management. As companies expand into global markets, the need to navigate overlapping and sometimes contradictory regulations becomes more pronounced.

The introduction of initiatives like Identification of Medicinal Products (IDMP), electronic Common Technical Document (eCTD) requirements, and increased scrutiny over pharmacovigilance reporting have added new layers of data governance obligations. Companies must not only prepare documentation accurately but also ensure that all regulatory content is consistent, traceable, and compliant across different jurisdictions. Errors or delays in regulatory submissions can result in significant business consequences, including product launch delays, market withdrawals, or financial penalties. In response to this environment, organizations are turning to RIM solutions to gain control over their regulatory data, automate repetitive processes, and build a centralized framework that can adapt to changing global requirements. These systems provide structured workflows, version control, and real-time visibility into regulatory activities. By helping organizations stay ahead of evolving regulations, RIM platforms play a critical role in ensuring compliance, reducing risk, and maintaining business continuity in a complex regulatory ecosystem.

Key Market Challenges

Data Standardization and Integration

Data standardization and integration are critical challenges facing the Regulatory Information Management (RIM) market. In the life sciences industry, regulatory processes involve vast volumes of structured and unstructured data originating from multiple departments such as research and development, clinical trials, manufacturing, and quality assurance. Each department often uses its own systems and formats, leading to data silos, duplication, and inconsistencies. Without standardization, it becomes difficult to ensure the accuracy, traceability, and completeness of regulatory submissions. Inconsistent data formats and naming conventions can delay submission approvals, increase the risk of compliance errors, and reduce operational efficiency. For global organizations, this issue is magnified when dealing with multiple regulatory bodies, each with distinct requirements for data presentation and content structure. Standardizing data across internal systems helps establish a single source of truth, which is essential for preparing timely and compliant submissions.

Effective integration of RIM platforms with other enterprise systems-such as document management systems, enterprise resource planning (ERP), and clinical trial management systems-allows for seamless data exchange and end-to-end visibility. Without strong integration capabilities, companies struggle to keep regulatory information current and aligned across departments. Manual data reconciliation not only consumes time but also introduces a higher risk of human error. RIM solutions must be built to support interoperable, scalable data models that align with global standards such as IDMP and HL7. Ensuring proper data flow and connectivity across systems enables faster decision-making, better collaboration, and more proactive compliance management. In a complex regulatory environment, data standardization and integration form the foundation of a resilient and efficient RIM strategy.

Key Market Trends

Shift Toward Cloud-Based RIM Platforms

The shift toward cloud-based Regulatory Information Management (RIM) platforms is transforming how life sciences companies manage regulatory operations. As the industry faces increasing pressure to streamline global submissions, ensure compliance, and respond quickly to changing regulatory requirements, cloud-based systems offer a more agile and scalable approach compared to traditional on-premise solutions. These platforms provide centralized access to regulatory data, allowing teams across geographies to collaborate in real time and maintain a single source of truth. Cloud-based RIM solutions reduce the burden of maintaining infrastructure, enabling companies to allocate resources toward core regulatory tasks rather than IT management. System updates, data backups, and security protocols are handled by the vendor, ensuring the platform remains current with evolving standards and best practices. This model supports faster deployment and more predictable operational costs, which is particularly valuable for companies managing diverse product portfolios across multiple markets.

Remote access to regulatory data is increasingly essential as organizations embrace hybrid and distributed work models. Cloud platforms make it possible for regulatory affairs teams to access, review, and submit documents without being tied to a single location or network. This level of flexibility improves responsiveness and decision-making during time-sensitive regulatory events. Security and compliance capabilities built into cloud-based RIM systems have advanced significantly. These platforms now include robust encryption, audit trails, and role-based access controls to safeguard sensitive information. As regulatory landscapes grow more complex, cloud provides the flexibility and reliability that life sciences companies need to stay competitive, compliant, and efficient in managing global regulatory demands.

Key Market Players

Report Scope:

In this report, the Global Regulatory Information Management Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Regulatory Information Management Market, By Component:

Regulatory Information Management Market, By Deployment Mode:

Regulatory Information Management Market, By Application:

Regulatory Information Management Market, By End User:

Regulatory Information Management Market, By Region:

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Regulatory Information Management Market.

Available Customizations:

Global Regulatory Information Management Market report with the given Market data, TechSci Research, offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

Table of Contents

1. Product Overview

2. Research Methodology

3. Executive Summary

4. Global Regulatory Information Management Market Outlook

5. North America Regulatory Information Management Market Outlook

6. Europe Regulatory Information Management Market Outlook

7. Asia-Pacific Regulatory Information Management Market Outlook

8. South America Regulatory Information Management Market Outlook

9. Middle East and Africa Regulatory Information Management Market Outlook

10. Market Dynamics

11. Market Trends & Developments

12. Competitive Landscape

13. Strategic Recommendations

14. About Us & Disclaimer

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