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세계의 규제 업무 분야 인공지능(AI) 시장 보고서(2025년)
Artificial Intelligence (AI) In Regulatory Affairs Global Market Report 2025
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리서치사 : The Business Research Company
발행일 : On Demand Report
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한글목차

규제 업무 분야 인공지능(AI) 시장 규모는 최근 급격히 확대되고 있습니다. 2024년 13억 9,000만 달러로 평가되었고, 2025년에는 17억 1,000만 달러에 달할 것으로 추정되며, CAGR 23.2%로 성장할 전망입니다. 지난 수년간의 성장은 세계 규제 요건의 복잡화, 생명 과학 부문의 AI 기술 채택 확대, 신속한 의약품 승인 프로세스에 대한 수요 증가, 규제 데이터 및 문서량 증가, 컴플라이언스 관리의 자동화 수요 증가 등이 요인으로 보입니다.

규제 업무 분야 인공지능(AI) 시장 규모는 향후 수년간 급격한 성장이 예상됩니다. 2029년에는 39억 달러에 달할 것으로 예측되며, CAGR 22.8%로 성장할 전망입니다. 예측 기간의 성장요인으로는 규제 신청에서 인적 미스의 삭감에 대한 주목 고조, 규제 당국과 기술 기업 간 제휴 강화, 디지털 변혁을 추진하는 비용 압력 상승, 규제 의사 결정에 있어서 데이터 분석의 활용 확대, 규제 보고에 있어서 투명성 및 정확성 중시 강화 등을 들 수 있습니다. 예측 기간 주요 동향으로는 규제 문서용 자연 언어 처리 기술의 진보, AI 구동형 컴플라이언스 모니터링 툴의 혁신, 예측적 규제 인사이트용 머신러닝 통합, 제출 및 승인 프로세스의 자동화 진전, 규제 인텔리전스용 데이터 분석 기술의 혁신 등을 들 수 있습니다.

AI 탑재 플랫폼의 통합이 진행됨에 따라 향후 수년간의 규제 업무 분야 인공지능(AI) 시장의 성장이 촉진될 것으로 예측됩니다. AI 탑재 플랫폼은 머신러닝, 자연 언어 처리, 예측 분석 등의 인공지능 기술을 통합한 디지털 시스템 또는 솔루션으로 태스크 자동화, 의사 결정 개선, 다양한 산업의 업무 효율성 향상을 실현합니다. 복잡한 규제 업무 처리에 있어서 자동화 및 효율성에 대한 수요 증가에 의해 AI 탑재 플랫폼의 도입이 증가하고 있습니다. 이를 통해 보다 신속한 데이터 처리와 보다 정확한 의사 결정이 가능합니다. 규제 업무의 AI는 컴플라이언스 프로세스의 합리화, 규제 승인의 신속화, 데이터 정밀도의 향상을 통해 AI 탑재 플랫폼을 지원하여 혁신과 시장 투입 준비를 가속화합니다. 예를 들어 2024년 10월 영국 정부기관인 과학기술성, 혁신기술부(DSIT)가 발표한 보고서에 따르면 영국의 AI 분야는 2023년 163억 2,000만 달러(142억 파운드)의 수익을 창출했으며, 전년 대비 34% 증가를 보였습니다. 또한 AI 관련 직종의 고용은 약 6만 4,500건으로 증가했습니다. 따라서 AI 탑재 플랫폼의 통합이 진행됨에 따라 규제 업무에서 AI 시장의 성장이 촉진되고 있습니다.

규제 업무 분야 인공지능(AI) 시장에서 활동하는 주요 기업은 규제 정보의 집중 관리, 제출 워크플로우의 자동화, 세계 시장의 컴플라이언스 확보, 제품 수명주기 전체의 가시성 향상 등을 목적으로 한 규제 정보 관리(RIM) 등 고급 혁신에 주력하고 있습니다. 규제 정보 관리란 제품의 수명주기를 통해 규제 데이터, 문서, 제출 서류를 체계적으로 수집, 정리 및 관리하는 프로세스를 말하며, 세계의 규제 요건에 대한 컴플라이언스 확보 및 보건 당국과의 원활한 커뮤니케이션을 촉진합니다. 예를 들어, 2024년 7월, 미국 소프트웨어 기업인 ArisGlobal LLC는 엔드 투 엔드 규제 업무 관리를 실현하는 통합 클라우드 시스템 'LifeSphere Regulatory Platform'의 최신 버전을 발표했습니다. 이 플랫폼은 LifeSphere NavaX 엔진을 통해 차세대 GenAI와 대규모 언어 모델(LLM) 기능을 통합하여 컨텐츠 수집, 생성, 깊은 인사이트를 제공합니다. 또한 데이터 컨텐츠 프로세스를 단일 에코시스템에 통합하고 ArisGlobal의 안전 및 품질 시스템과의 상호 운용성을 확보함으로써 50% 이상의 효율 향상을 실현하고 생명과학 부문의 규제 워크플로우를 변화시키는 솔루션으로서의 지위를 확립하고 있습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향 및 전략

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

제5장 세계의 성장 분석 및 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별 및 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 구도 및 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹 및 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문 및 전략

제36장 부록

AJY
영문 목차

영문목차

Artificial intelligence (AI) in regulatory affairs refers to the application of AI technologies such as machine learning, natural language processing, and automation to streamline and enhance regulatory processes in pharmaceuticals, biotechnology, and medical devices. It assists in managing large volumes of regulatory data, accelerating document review, ensuring compliance with evolving regulations, and improving decision-making accuracy. By automating repetitive tasks and analyzing complex datasets, AI enables faster submissions, reduces errors, and facilitates more efficient communication with regulatory authorities.

The key components of artificial intelligence (AI) in regulatory affairs are software or platforms and services. AI in regulatory affairs software refers to tools that leverage artificial intelligence to automate, streamline, and enhance compliance processes, including document management, submission tracking, and data analysis, ensuring faster and more accurate regulatory decision-making. The deployment modes include cloud-based and on-premises. These solutions are used for applications such as regulatory intelligence, data migration and integration, dossier management, product registration and approvals, pharmacovigilance and safety reporting, regulatory submissions and publishing, and others, and are utilized by various end users such as pharmaceutical companies, biotechnology companies, 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 sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.

The artificial intelligence (AI) in regulatory affairs market research report is one of a series of new reports from The Business Research Company that provides artificial intelligence (AI) in regulatory affairs market statistics, including artificial intelligence (AI) in regulatory affairs industry global market size, regional shares, competitors with the artificial intelligence (AI) in regulatory affairs market share, artificial intelligence (AI) in regulatory affairs market segments, market trends, and opportunities, and any further data you may need to thrive in the artificial intelligence (AI) in regulatory affairs industry. This artificial intelligence (AI) in regulatory affairs 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 artificial intelligence (AI) in regulatory affairs market size has grown exponentially in recent years. It will grow from $1.39 billion in 2024 to $1.71 billion in 2025 at a compound annual growth rate (CAGR) of 23.2%. The growth in the historic period can be attributed to the increasing complexity of global regulatory requirements, rising adoption of AI technologies in life sciences, growing need for faster drug approval processes, increasing volume of regulatory data and documentation, and the rising demand for automation in compliance management.

The artificial intelligence (AI) in regulatory affairs market size is expected to see exponential growth in the next few years. It will grow to $3.90 billion in 2029 at a compound annual growth rate (CAGR) of 22.8%. The growth in the forecast period can be attributed to the growing focus on reducing human error in regulatory submissions, increasing collaboration between regulatory bodies and tech firms, rising cost pressures driving digital transformation, growing use of data analytics for regulatory decision-making, and increasing emphasis on transparency and accuracy in regulatory reporting. Key trends in the forecast period include advancement in natural language processing for regulatory documentation, innovation in AI-driven compliance monitoring tools, integration of machine learning for predictive regulatory insights, advancement in automation of submission and approval processes, and innovation in data analytics for regulatory intelligence.

The increasing integration of AI-enabled platforms is expected to drive the growth of the artificial intelligence (AI) in regulatory affairs market in the coming years. AI-enabled platforms are digital systems or solutions that incorporate artificial intelligence technologies such as machine learning, natural language processing, and predictive analytics to automate tasks, improve decision-making, and enhance operational efficiency across various industries. The adoption of AI-enabled platforms is rising due to the growing demand for automation and efficiency in handling complex regulatory tasks, enabling faster data processing and more accurate decision-making. AI in regulatory affairs supports AI-enabled platforms by streamlining compliance processes, facilitating faster regulatory approvals, and improving data accuracy, which accelerates innovation and market readiness. For example, in October 2024, a report published by the Department for Science, Innovation and Technology (DSIT), a UK-based government organization, indicated that the UK's AI sector generated USD 16.32 billion (£14.2 billion) in revenue in 2023, representing a 34% year-on-year increase, while employment in AI-related roles rose to approximately 64,500. Therefore, the growing integration of AI-enabled platforms is propelling the growth of the AI in regulatory affairs market.

Key companies operating in the artificial intelligence (AI) in regulatory affairs market are focusing on advanced innovations such as Regulatory Information Management (RIM) to centralize regulatory data, automate submission workflows, ensure compliance across global markets, and enhance visibility throughout the product lifecycle. Regulatory information management refers to the systematic process of collecting, organizing, and managing regulatory data, documents, and submissions throughout a product's lifecycle to ensure compliance with global regulatory requirements and facilitate communication with health authorities. For instance, in July 2024, ArisGlobal LLC, a US-based software company, launched the latest version of its LifeSphere Regulatory Platform, providing a unified cloud-based system for end-to-end regulatory affairs management. This platform integrates next-generation GenAI and large-language-model (LLM) capabilities through its LifeSphere NavaX engine, enabling content ingestion, generation, and deeper insights while achieving over 50% efficiency gains by unifying data, content, and processes in a single ecosystem and ensuring interoperability with ArisGlobal's safety and quality systems, establishing it as a transformative solution for life-sciences regulatory workflows.

In October 2025, Ernst & Young Global Limited, a UK-based professional services firm, acquired Aqurance A.E. for an undisclosed amount. This acquisition aims to strengthen Ernst & Young Global Limited's capabilities in regulatory affairs and life sciences consulting by integrating the expertise of Aqurance A.E., enhancing its ability to provide advanced digital and AI-driven regulatory solutions, streamline compliance processes, and support global pharmaceutical and biotechnology clients in navigating complex regulatory environments. Aqurance A.E. is a Greece-based technology company specializing in AI in regulatory affairs.

Major companies operating in the artificial intelligence (ai) in regulatory affairs market are Freyr Software Services Private Limited, Celegence LLC, Wipro Limited, Indegene Limited, Clarivate Plc, Zenovel Pharma Services LLP, RegDesk Inc, Compliance.ai Inc, IONI AI INC., Interfacing Technologies Corporation, OneTrust LLC, Xapien Ltd., SpringsApps Technologies Pvt Ltd., Fairnow Inc., Navitas Life Sciences Private Limited, S&P Global Inc., International Business Machines Corporation, ZS Associates International Inc., Vistaar Technologies Inc., Lexim AI Inc.

North America was the largest region in the artificial intelligence (AI) in regulatory affairs market in 2024. Asia Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in artificial intelligence (AI) in regulatory affair report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the artificial intelligence (AI) in regulatory affairs market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The artificial intelligence (AI) in regulatory affairs market consists of revenues earned by entities by providing services such as risk assessment services, change management services, audit support services, pharmacovigilance services, and regulatory submission automation services. The market value includes the value of related goods sold by the service provider or included within the service offering. The artificial intelligence (AI) in regulatory affairs market also includes sales of regulatory tools, and assessment tools. Values in this market are 'factory gate' values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

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.

Artificial Intelligence (AI) In Regulatory Affairs 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 artificial intelligence (ai) in regulatory affairs 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 artificial intelligence (ai) in regulatory affairs ? 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 artificial intelligence (ai) in regulatory affairs 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. Artificial Intelligence (AI) In Regulatory Affairs Market Characteristics

3. Artificial Intelligence (AI) In Regulatory Affairs Market Trends And Strategies

4. Artificial Intelligence (AI) In Regulatory Affairs 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 Artificial Intelligence (AI) In Regulatory Affairs Growth Analysis And Strategic Analysis Framework

6. Artificial Intelligence (AI) In Regulatory Affairs Market Segmentation

7. Artificial Intelligence (AI) In Regulatory Affairs Market Regional And Country Analysis

8. Asia-Pacific Artificial Intelligence (AI) In Regulatory Affairs Market

9. China Artificial Intelligence (AI) In Regulatory Affairs Market

10. India Artificial Intelligence (AI) In Regulatory Affairs Market

11. Japan Artificial Intelligence (AI) In Regulatory Affairs Market

12. Australia Artificial Intelligence (AI) In Regulatory Affairs Market

13. Indonesia Artificial Intelligence (AI) In Regulatory Affairs Market

14. South Korea Artificial Intelligence (AI) In Regulatory Affairs Market

15. Western Europe Artificial Intelligence (AI) In Regulatory Affairs Market

16. UK Artificial Intelligence (AI) In Regulatory Affairs Market

17. Germany Artificial Intelligence (AI) In Regulatory Affairs Market

18. France Artificial Intelligence (AI) In Regulatory Affairs Market

19. Italy Artificial Intelligence (AI) In Regulatory Affairs Market

20. Spain Artificial Intelligence (AI) In Regulatory Affairs Market

21. Eastern Europe Artificial Intelligence (AI) In Regulatory Affairs Market

22. Russia Artificial Intelligence (AI) In Regulatory Affairs Market

23. North America Artificial Intelligence (AI) In Regulatory Affairs Market

24. USA Artificial Intelligence (AI) In Regulatory Affairs Market

25. Canada Artificial Intelligence (AI) In Regulatory Affairs Market

26. South America Artificial Intelligence (AI) In Regulatory Affairs Market

27. Brazil Artificial Intelligence (AI) In Regulatory Affairs Market

28. Middle East Artificial Intelligence (AI) In Regulatory Affairs Market

29. Africa Artificial Intelligence (AI) In Regulatory Affairs Market

30. Artificial Intelligence (AI) In Regulatory Affairs Market Competitive Landscape And Company Profiles

31. Artificial Intelligence (AI) In Regulatory Affairs Market Other Major And Innovative Companies

32. Global Artificial Intelligence (AI) In Regulatory Affairs Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Artificial Intelligence (AI) In Regulatory Affairs Market

34. Recent Developments In The Artificial Intelligence (AI) In Regulatory Affairs Market

35. Artificial Intelligence (AI) In Regulatory Affairs Market High Potential Countries, Segments and Strategies

36. Appendix

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