세계의 규제 정보 관리 시스템 시장 보고서(2025년)
상품코드 : 1807793
리서치사 : The Business Research Company
발행일 : 발행예정
페이지 정보 : 영문 250 Pages

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한글목차

규제 정보 관리 시스템 시장 규모는 향후 수년간 급성장할 것으로 전망됩니다. 2029년에는 CAGR 11.3%로 34억 달러로 성장할 것으로 예상됩니다. 예측기간 성장은 인공지능(AI)과 통합, 규제상황 복잡화, 신흥 시장 림 확대, 클라우드 기반 솔루션에 대한 수요, 실시간 규제 모니터링에 대한 주력 등에 기인할 것으로 예측됩니다. 예측 기간의 주요 동향으로는 기술 진보, 외부 파트너와의 연계와 통합, 데이터 무결성을 위한 블록체인 기술, 모바일 액세스 및 사용자 친화적인 인터페이스, 부서 간 협업 플랫폼 등이 있습니다.

향후 5년간 성장률 11.3%라고 하는 예측은 이 시장의 전회 예측으로부터 0.2%라는 소폭 감소를 반영하고 있습니다. 이 감소는 주로 미국과 다른 국가 간의 관세의 영향 때문입니다. 무역 마찰은 독일과 스위스에서 조달하는 컴플라이언스 추적 소프트웨어 및 문서 관리 플랫폼의 가격을 늘리고 의약품 승인 지연 및 규제 비용 상승으로 이어져 미국 제약 회사에 부담을 줄 수 있습니다. 또한 상호 관세와 무역 긴장 증가와 제한으로 인한 세계 경제와 무역에 대한 악영향으로 인해 그 영향이 더 광범위하게 늘어날 것으로 보입니다.

임상시험 증가는 향후 규제 정보 관리 시스템 시장의 성장에 중요한 역할을 하고 있습니다. 임상시험에는 치료, 수술, 행동 개입의 대상으로 개인을 이용하는 연구가 포함됩니다. 규제 정보 관리 시스템은 임상시험과 관련된 규제 요건과 복잡성을 확대, 추적, 관리 및 간소화하기 위해 채택되었습니다. 예를 들어, 2023년 2월 스위스에 본부를 두는 국제 공중보건에 중점을 둔 정부간기구인 세계보건기구(WHO)는 동남아시아 지역의 임상시험 수가 2021년 1만966건에서 2022년 1만1,030건으로 증가했다고 보고했습니다. 따라서 임상시험의 증가는 규제 정보 관리 시스템 시장을 주도할 것입니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역전쟁과 관세, 그리고 코로나 및 회복이 시장에 미치는 영향을 포함한 거시경제 시나리오

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별/국가별 분석

제8장 아시아태평양 시장

제9장 중국 시장

제10장 인도 시장

제11장 일본 시장

제12장 호주 시장

제13장 인도네시아 시장

제14장 한국 시장

제15장 서유럽 시장

제16장 영국 시장

제17장 독일 시장

제18장 프랑스 시장

제19장 이탈리아 시장

제20장 스페인 시장

제21장 동유럽 시장

제22장 러시아 시장

제23장 북미 시장

제24장 미국 시장

제25장 캐나다 시장

제26장 남미 시장

제27장 브라질 시장

제28장 중동 시장

제29장 아프리카 시장

제30장 경쟁 구도와 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹과 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문, 전략

제36장 부록

SHW
영문 목차

영문목차

A regulatory information management system is a centralized software platform designed to streamline the tracking of product applications and registrations within the regulatory industry. It facilitates the tracking and recording of regulatory processes from initiation to completion, catering to various segments such as pharmaceuticals, biologics, and cosmetics.

The main components utilized in regulatory information management systems include solutions and services. Software solutions are designed to address specific client problems, and deployment options encompass on-premises and cloud-based solutions. These systems are applicable to enterprises of various sizes, including small and medium enterprises as well as large enterprises. The applications covered by these systems include registration management, regulatory intelligence, labeling management, submission planning and tracking management, publishing, document management, and others. These applications find use across various end-users, including the pharmaceutical sector, medical device sector, and others.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sharp rise in U.S. tariffs and the ensuing trade tensions in spring 2025 are taking a toll on the professional services sector, especially within legal, consulting, architectural, and engineering fields. Increased duties on imported technology, software, office hardware, and digital infrastructure have pushed up operational costs for firms that rely on global systems and resources. Cross-border consulting engagements are experiencing delays and higher expenses due to elevated travel costs and limited access to international data and tools. Moreover, industries heavily impacted by tariffs such as manufacturing, construction, and logistics are reducing their reliance on outsourced services, dampening demand for professional support. In response, service providers are reassessing pricing models, strengthening ties with domestic vendors, and accelerating the adoption of AI and automation to maintain profitability and client satisfaction in an increasingly volatile environment.

The regulatory information management system market research report is one of a series of new reports from The Business Research Company that provides regulatory information management system market statistics, including regulatory information management system industry global market size, regional shares, competitors with a regulatory information management system market share, detailed regulatory information management system market segments, market trends and opportunities, and any further data you may need to thrive in the regulatory information management system industry. This regulatory information management system market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The regulatory information management system market size has grown rapidly in recent years. It will grow from $1.99 billion in 2024 to $2.22 billion in 2025 at a compound annual growth rate (CAGR) of 11.8%. The growth in the historic period can be attributed to stringent regulatory compliance requirements, pharmaceutical industry growth, globalization of supply chains, increasing volume of regulatory data, and emphasis on data security.

The regulatory information management system market size is expected to see rapid growth in the next few years. It will grow to $3.4 billion in 2029 at a compound annual growth rate (CAGR) of 11.3%. The growth in the forecast period can be attributed to integration with artificial intelligence (AI), increased complexity of regulatory landscape, expansion of rims in emerging markets, demand for cloud-based solutions, focus on real-time regulatory monitoring. Major trends in the forecast period include advancements in technology, collaboration and integration with external partners, blockchain technology for data integrity, mobile access and user-friendly interfaces, and cross-functional collaboration platforms.

The forecast of 11.3% growth over the next five years reflects a modest reduction of 0.2% from the previous estimate for this market. This reduction is primarily due to the impact of tariffs between the US and other countries. Trade tensions could burden U.S. pharmaceutical companies by inflating prices for compliance tracking software and document management platforms sourced from Germany and Switzerland, leading to delayed drug approvals and higher regulatory costs. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.

The increasing number of clinical trials is playing a significant role in the growth of the regulatory information management system market in the future. Clinical trials involve studies in which individuals are utilized as test subjects for therapeutic, surgical, or behavioral interventions. The regulatory information management system is employed to track, manage, and simplify the expanding regulatory requirements and complexities associated with clinical trials. For example, in February 2023, the World Health Organization (WHO), a Switzerland-based intergovernmental agency focused on international public health, reported that the number of clinical trials in the Southeast Asia region rose from 10,966 in 2021 to 11,030 in 2022. Therefore, the increase in clinical trials will drive the regulatory information management system market.

The continuous growth of digitization is expected to be a significant driver of the regulatory information management system market. Digitization, involving the conversion of analog information into digital data, is increasingly leveraging regulatory information management systems (RIMS) to streamline the management of regulatory data, compliance documentation, and submissions. According to data from Augusta Free Press in December 2022, global spending on digital transformation reached about $1.85 trillion, reflecting a 16% increase from the previous year. This shift toward digitization is a pivotal factor driving the adoption of regulatory information management systems.

A noteworthy trend is the emphasis on product innovations by major companies. To maintain a competitive edge, these companies are launching innovative products tailored to the unique demands of the life sciences and medical device sectors. For instance, in February 2023, ArisGlobal, LLC introduced the Investigational Product Regulatory Information Management System (RIMS), a pre-validated turnkey solution designed to meet the specific needs of life sciences and medical device firms during the research and development stages of drug development. This product incorporates features such as clinical trial authorization tracking, investigational submission and dossier planning, and health authority commitment management to enhance efficiency and compliance.

Strategic partnerships are playing a crucial role in simplifying the adoption of efficient sharing of regulatory information in the regulatory information management system market. Companies are leveraging strategic partnerships to enhance their strengths and resources for mutual benefits and success. For instance, in August 2023, Vitality TechNet Inc. partnered with Fluree, aiming to enable pharmaceutical regulatory information management and expedite drug discovery processes.

In May 2023, Ennov, a France-based provider of content and data management software for the life sciences industry, acquired Samarind Limited, a UK-based provider of regulatory information management (RIM) software and services. This strategic acquisition enriches Ennov's position in the regulatory information management system market, particularly in the medical device sector.

Major companies operating in the regulatory information management system market include Deloitte Touche Tohmatsu Limited, DXC Technology Company, IQVIA Inc., Wipro Ltd, Parexel International Corporation, Korber Pharma, Veeva Systems Inc, Dovel Technologies Inc., Calyx, ArisGlobal LLC, DDi Inc., NNIT A/S, Freyr Software Services Private Limite, Navitas Life Sciences, MasterControl Solutions Inc., Sparta Systems Inc., Instem PLC, Phlexglobal Ltd., Ennov SA, LORENZ Life Sciences Group, Extedo GmbH, Gimmal, Dot Compliance Ltd., Kalypso LP, Rimsys Inc., Virtify Inc., Glemser Technologies Corporation, RegDesk, AmpleLogic, Ithos Global Inc.

North America was the largest region in the regulatory information management system market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the regulatory information management system market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the regulatory information management system market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The regulatory information management system market consists of revenues earned by providing services such as data management, dossier management, product registration lifecycle management services, and easy-to-configure dashboards and reports. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Regulatory Information Management System Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on regulatory information management system market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for regulatory information management system ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The regulatory information management system market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. Regulatory Information Management System Market Characteristics

3. Regulatory Information Management System Market Trends And Strategies

4. Regulatory Information Management System Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Regulatory Information Management System Growth Analysis And Strategic Analysis Framework

6. Regulatory Information Management System Market Segmentation

7. Regulatory Information Management System Market Regional And Country Analysis

8. Asia-Pacific Regulatory Information Management System Market

9. China Regulatory Information Management System Market

10. India Regulatory Information Management System Market

11. Japan Regulatory Information Management System Market

12. Australia Regulatory Information Management System Market

13. Indonesia Regulatory Information Management System Market

14. South Korea Regulatory Information Management System Market

15. Western Europe Regulatory Information Management System Market

16. UK Regulatory Information Management System Market

17. Germany Regulatory Information Management System Market

18. France Regulatory Information Management System Market

19. Italy Regulatory Information Management System Market

20. Spain Regulatory Information Management System Market

21. Eastern Europe Regulatory Information Management System Market

22. Russia Regulatory Information Management System Market

23. North America Regulatory Information Management System Market

24. USA Regulatory Information Management System Market

25. Canada Regulatory Information Management System Market

26. South America Regulatory Information Management System Market

27. Brazil Regulatory Information Management System Market

28. Middle East Regulatory Information Management System Market

29. Africa Regulatory Information Management System Market

30. Regulatory Information Management System Market Competitive Landscape And Company Profiles

31. Regulatory Information Management System Market Other Major And Innovative Companies

32. Global Regulatory Information Management System Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Regulatory Information Management System Market

34. Recent Developments In The Regulatory Information Management System Market

35. Regulatory Information Management System Market High Potential Countries, Segments and Strategies

36. Appendix

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