약물감시 및 의약품 안전성 소프트웨어 시장 보고서(2026년)
Pharmacovigilance And Drug Safety Software Global Market Report 2026
상품코드 : 1957644
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

의약품 안전성 감시 및 의약품 안전성 소프트웨어 시장 규모는 최근 급성장하고 있습니다. 2025년 25억 3,000만 달러에서 2026년에는 28억 6,000만 달러에 이르고, CAGR 12.8%의 성장이 전망되고 있습니다. 지난 몇 년간의 성장은 부작용 보고 증가, 임상시험의 세계화, 엄격한 의약품 안전 규제, 의약품 생산 확대, 시판 후 조사 요건 강화 등에 기인하는 것으로 보입니다.

약물감시 및 의약품 안전성 소프트웨어 시장 규모는 향후 몇 년간 급성장이 전망됩니다. 2030년에는 46억 달러에 이르고, CAGR은 12.6%를 나타낼 전망입니다. 예측 기간의 성장 요인으로는 AI 기반 신호 감지 확대, 생물학적 제제 및 특수 의약품의 성장, 규제 모니터링 강화, 의약품 안전성 모니터링 서비스 아웃소싱 증가, 실시간 안전성 분석에 대한 수요 증가 등을 꼽았습니다. 예측 기간 동안 주요 동향으로는 클라우드 기반 의약품 안전성 모니터링 플랫폼 도입 확대, 실제 데이터 모니터링에 대한 집중도 강화, 부작용 보고 자동화 발전, 통합 의약품 안전성 시스템 확대, 규제 준수 솔루션에 대한 수요 증가 등이 있습니다.

개인 맞춤형 의료(정밀의료)에 대한 수요 증가는 향후 몇 년 동안 약물감시 및 의약품 안전 소프트웨어 시장의 성장을 견인할 것으로 예측됩니다. 개인 맞춤형 의료는 개인의 유전자 프로파일, 생물학적 요인, 생활습관 특성에 따라 치료 방침을 맞춤화하는 헬스케어 접근법입니다. 개인 맞춤형 의료의 보급 확대는 치료 결과의 향상, 예방 및 조기 진단의 개선, 비용 효율성의 향상에 의해 추진되고 있습니다. 약물 모니터링 및 의약품 안전성 소프트웨어는 약리유전체학, 실시간 데이터 분석, 시판 후 조사를 통합하여 환자 안전 향상, 개인화 치료 추적, 위험 관리 프로세스 강화를 실현하고 맞춤형 의료를 지원합니다. 예를 들어, 2024년 2월 미국 비영리단체인 맞춤형 의료연합(PMC)이 보고한 바에 따르면, FDA는 2023년 희귀질환 환자를 위한 16건의 신규 개인맞춤형 치료제를 승인했으며, 이는 2022년 6건에서 증가한 수치입니다. 그 결과, 개인 맞춤형 의료에 대한 수요 증가는 약물 모니터링 및 의약품 안전성 소프트웨어 시장의 성장을 가속하고 있습니다.

의약품 안전성 모니터링 및 의약품 안전성 소프트웨어 시장에서 활동하는 주요 기업들은 임상시험 및 시판 후 조사를 통해 부작용을 더 잘 감지하고, 규제 준수를 개선하며, 클라우드 기반 데이터 레이크 플랫폼과 같은 첨단 기술을 개발하여 환자 안전성을 향상시키는 데 주력하고 있습니다. 클라우드 기반 데이터 레이크 플랫폼 등 첨단 기술 개발에 주력하고 있습니다. 클라우드 기반의 데이터 레이크 플랫폼은 확장 가능한 중앙집중형 솔루션으로, 구조화 및 비정형화된 대량의 안전 데이터를 저장하고 실시간 분석할 수 있습니다. 이를 통해 고도의 분석, AI/머신러닝 모델 활용, 약물감시 업무의 효율적인 사례관리를 실현할 수 있습니다. 예를 들어, 2023년 12월 미국 소재 바이오테크 기업 써모피셔 사이언티픽(Thermo Fisher Scientific)은 안전 데이터 관리 및 사례 처리 효율을 향상시켜 약물감시 활동을 간소화하는 것을 목표로 하는 독자적인 클라우드 기반 데이터 레이크 플랫폼 'CorEvidence'를 발표했습니다. CorEvidence'를 발표했습니다. 특히, 임상연구 레지스트리의 승인 후 안전성 연구 지원에 중점을 두고 있습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 공급망 분석

제4장 세계 시장 동향과 전략

제5장 최종 이용 산업 시장 분석

제6장 시장 : 금리, 인플레이션, 지정학, 무역 전쟁과 관세의 영향, 관세 전쟁과 무역 보호주의의 공급망에 대한 영향, 코로나 팬데믹이 시장에 미치는 영향을 포함한 거시경제 시나리오

제7장 세계 전략 분석 프레임워크, 현재 시장 규모, 시장 비교 및 성장률 분석

제8장 TAM(Total Addressable Market) 규모

제9장 시장 세분화

제10장 지역별/국가별 분석

제11장 아시아태평양 시장

제12장 중국 시장

제13장 인도 시장

제14장 일본 시장

제15장 호주 시장

제16장 인도네시아 시장

제17장 한국 시장

제18장 대만 시장

제19장 동남아시아 시장

제20장 서유럽 시장

제21장 영국 시장

제22장 독일 시장

제23장 프랑스 시장

제24장 이탈리아 시장

제25장 스페인 시장

제26장 동유럽 시장

제27장 러시아 시장

제28장 북미 시장

제29장 미국 시장

제30장 캐나다 시장

제31장 남미 시장

제32장 브라질 시장

제33장 중동 시장

제34장 아프리카 시장

제35장 시장 규제 상황과 투자환경

제36장 경쟁 구도와 기업 개요

제37장 기타 주요 기업 및 혁신 기업

제38장 세계 시장 경쟁 벤치마킹과 대시보드

제39장 주요 인수합병(M&A)

제40장 시장 잠재력이 높은 국가, 부문, 전략

제41장 부록

LSH
영문 목차

영문목차

Pharmacovigilance and drug safety software encompasses a range of digital solutions developed to track, evaluate, and document adverse drug reactions (ADRs) and other safety-related data linked to pharmaceutical and medical products. These tools are essential for safeguarding patient health and meeting regulatory requirements across the entire drug lifecycle, from clinical development through post-marketing monitoring.

The primary software types in pharmacovigilance and drug safety include adverse event reporting software, drug safety audit software, issue tracking software, and fully integrated software. Adverse event reporting software is intended to monitor, record, and manage adverse events associated with pharmaceutical products or medical devices. These solutions are available through on-premise and cloud-based delivery modes and are utilized by a range of end users, including pharmaceutical and biotechnology companies, contract research organizations, business process outsourcing firms, and others.

Tariffs have increased costs for imported software infrastructure components, licensed platforms, and data hosting services used in pharmacovigilance and drug safety software systems. These impacts are most pronounced in Asia Pacific and emerging markets where vendors rely on cross border technology and cloud service providers. Rising tariff related expenses have influenced software pricing models, subscription costs, and implementation budgets for pharmaceutical companies. This has affected adoption timelines and upgrade decisions for compliance driven safety platforms. However, tariffs are also encouraging domestic software development, localized cloud deployments, and stronger regional digital health ecosystems over the long term.

The pharmacovigilance and drug safety software market research report is one of a series of new reports from The Business Research Company that provides pharmacovigilance and drug safety software market statistics, including pharmacovigilance and drug safety software industry global market size, regional shares, competitors with a pharmacovigilance and drug safety software market share, detailed pharmacovigilance and drug safety software market segments, market trends and opportunities, and any further data you may need to thrive in the pharmacovigilance and drug safety software industry. This pharmacovigilance and drug safety software 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 pharmacovigilance and drug safety software market size has grown rapidly in recent years. It will grow from $2.53 billion in 2025 to $2.86 billion in 2026 at a compound annual growth rate (CAGR) of 12.8%. The growth in the historic period can be attributed to increasing adverse drug reaction reporting, globalization of clinical trials, stringent drug safety regulations, growth in pharmaceutical production, rising post-marketing surveillance requirements.

The pharmacovigilance and drug safety software market size is expected to see rapid growth in the next few years. It will grow to $4.6 billion in 2030 at a compound annual growth rate (CAGR) of 12.6%. The growth in the forecast period can be attributed to expansion of ai-driven signal detection, growth in biologics and specialty drugs, rising regulatory scrutiny, increasing outsourcing of pharmacovigilance services, demand for real-time safety analytics. Major trends in the forecast period include growing adoption of cloud-based pharmacovigilance platforms, increasing focus on real-world evidence monitoring, rising automation in adverse event reporting, expansion of integrated drug safety systems, higher demand for regulatory compliance solutions.

The increasing demand for personalized medicine is anticipated to drive the growth of the pharmacovigilance and drug safety software market in the coming years. Personalized medicine, also referred to as precision medicine, is a healthcare approach that customizes treatment decisions based on an individual's genetic profile, biological factors, and lifestyle characteristics. The rising adoption of personalized medicine is driven by better treatment outcomes, improved prevention and early diagnosis, and increased cost efficiency. Pharmacovigilance and drug safety software supports personalized medicine by incorporating pharmacogenomics, real-time data analytics, and post-marketing surveillance to enhance patient safety, track individualized therapies, and reinforce risk management processes. For example, in February 2024, the Personalized Medicine Coalition (PMC), a US-based non-profit organization, reported that the FDA approved 16 new personalized therapies for rare disease patients in 2023, an increase from 6 approvals in 2022. Consequently, the growing demand for personalized medicine is fueling the expansion of the pharmacovigilance and drug safety software market.

Major companies operating in the pharmacovigilance and drug safety software market are concentrating on the development of advanced technologies such as cloud-based data lake platforms to reinforce adverse event detection, enhance regulatory adherence, and improve overall patient safety throughout clinical trials and post-marketing surveillance. A cloud-based data lake platform is a scalable, centralized solution that enables the storage and real-time analysis of large volumes of structured and unstructured safety data, supporting advanced analytics, AI/ML models, and more efficient case management within pharmacovigilance operations. For example, in December 2023, Thermo Fisher Scientific Inc., a US-based biotechnology company, introduced CorEvidence, a proprietary cloud-based data lake platform aimed at streamlining pharmacovigilance activities by enhancing safety data management and case processing efficiency, with a particular focus on supporting post-authorization safety studies in clinical research registries.

In April 2024, Qinecsa, a UK-based company, acquired Insife ApS for an undisclosed amount. This acquisition enhances Qinecsa's end-to-end pharmacovigilance technology capabilities by incorporating Insife's advanced safety software solutions into its digital pharmacovigilance ecosystem. It also strengthens Qinecsa's position in the global pharmacovigilance market by broadening its technology portfolio and supporting its strategy to emerge as a leading provider of digital pharmacovigilance solutions. Insife ApS is a Denmark-based company specializing in pharmacovigilance software.

Major companies operating in the pharmacovigilance and drug safety software market are IQVIA, Oracle Corporation, ArisGlobal, RXLogix, Anju Software Inc., EXTEDO GmbH, Sarjen Systems Pvt Ltd, Ennov Group, AB Cube, Clinevo Technologies, Accenture plc, International Business Machines Corporation, Capgemini SE, Cognizant Technology Solutions, Wipro Limited, Genpact, Indegene Limited, PharmaLex, Deloitte Touche Tohmatsu Limited, Parexel

North America was the largest region in the pharmacovigilance and drug safety software market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the pharmacovigilance and drug safety software market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the pharmacovigilance and drug safety software market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The pharmacovigilance and drug safety software market includes revenues earned by entities by signal detection and management tools, risk assessment, and management software. 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.

Pharmacovigilance And Drug Safety Software Market Global Report 2026 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses pharmacovigilance and drug safety software 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 pharmacovigilance and drug safety software ? 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 pharmacovigilance and drug safety software 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, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

Scope

Added Benefits available all on all list-price licence purchases, to be claimed at time of purchase. Customisations within report scope and limited to 20% of content and consultant support time limited to 8 hours.

Table of Contents

1. Executive Summary

2. Pharmacovigilance And Drug Safety Software Market Characteristics

3. Pharmacovigilance And Drug Safety Software Market Supply Chain Analysis

4. Global Pharmacovigilance And Drug Safety Software Market Trends And Strategies

5. Pharmacovigilance And Drug Safety Software Market Analysis Of End Use Industries

6. Pharmacovigilance And Drug Safety Software Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, Supply Chain Impact from Tariff War & Trade Protectionism, And Covid And Recovery On The Market

7. Global Pharmacovigilance And Drug Safety Software Strategic Analysis Framework, Current Market Size, Market Comparisons And Growth Rate Analysis

8. Global Pharmacovigilance And Drug Safety Software Total Addressable Market (TAM) Analysis for the Market

9. Pharmacovigilance And Drug Safety Software Market Segmentation

10. Pharmacovigilance And Drug Safety Software Market Regional And Country Analysis

11. Asia-Pacific Pharmacovigilance And Drug Safety Software Market

12. China Pharmacovigilance And Drug Safety Software Market

13. India Pharmacovigilance And Drug Safety Software Market

14. Japan Pharmacovigilance And Drug Safety Software Market

15. Australia Pharmacovigilance And Drug Safety Software Market

16. Indonesia Pharmacovigilance And Drug Safety Software Market

17. South Korea Pharmacovigilance And Drug Safety Software Market

18. Taiwan Pharmacovigilance And Drug Safety Software Market

19. South East Asia Pharmacovigilance And Drug Safety Software Market

20. Western Europe Pharmacovigilance And Drug Safety Software Market

21. UK Pharmacovigilance And Drug Safety Software Market

22. Germany Pharmacovigilance And Drug Safety Software Market

23. France Pharmacovigilance And Drug Safety Software Market

24. Italy Pharmacovigilance And Drug Safety Software Market

25. Spain Pharmacovigilance And Drug Safety Software Market

26. Eastern Europe Pharmacovigilance And Drug Safety Software Market

27. Russia Pharmacovigilance And Drug Safety Software Market

28. North America Pharmacovigilance And Drug Safety Software Market

29. USA Pharmacovigilance And Drug Safety Software Market

30. Canada Pharmacovigilance And Drug Safety Software Market

31. South America Pharmacovigilance And Drug Safety Software Market

32. Brazil Pharmacovigilance And Drug Safety Software Market

33. Middle East Pharmacovigilance And Drug Safety Software Market

34. Africa Pharmacovigilance And Drug Safety Software Market

35. Pharmacovigilance And Drug Safety Software Market Regulatory and Investment Landscape

36. Pharmacovigilance And Drug Safety Software Market Competitive Landscape And Company Profiles

37. Pharmacovigilance And Drug Safety Software Market Other Major And Innovative Companies

38. Global Pharmacovigilance And Drug Safety Software Market Competitive Benchmarking And Dashboard

39. Key Mergers And Acquisitions In The Pharmacovigilance And Drug Safety Software Market

40. Pharmacovigilance And Drug Safety Software Market High Potential Countries, Segments and Strategies

41. Appendix

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