약물감시 아웃소싱 시장 보고서(2026년)
Pharmacovigilance Outsourcing Global Market Report 2026
상품코드 : 1957645
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

약물감시 아웃소싱 시장 규모는 최근 급성장하고 있습니다. 2025년 72억 4,000만 달러에서 2026년에는 85억 1,000만 달러에 이르고, CAGR 17.6%의 성장이 전망되고 있습니다. 지난 수년간의 성장 요인으로는 신약 승인 건수 증가, 제약사의 의약품 안전성 모니터링에 대한 인식 제고, 사내 의약품 안전성 모니터링 전문성 부족, 규제 당국의 모니터링 강화, 세계 임상시험 확대 등을 꼽을 수 있습니다.

약물감시 아웃소싱 시장 규모는 향후 몇 년간 급성장이 전망됩니다. 2030년에는 160억 9,000만 달러에 이르고, CAGR은 17.2%를 나타낼 전망입니다. 예측 기간 동안 성장 요인으로는 PV 프로세스에 AI 및 데이터 분석의 통합, CRO 및 BPO 제공업체에 대한 아웃소싱 증가, 클라우드 기반 약물감시 플랫폼 채택, 세계 안전성 보고 요건 확대, IT 인프라 및 기술 지원에 대한 투자 확대 등을 꼽았습니다. 예측 기간 동안 주요 동향으로는 제약사들의 의약품 안전성 모니터링 아웃소싱 서비스 도입 증가, 규제 준수 요건 및 보고 기준 강화, 부작용(ADR) 포착 및 사례 처리 자동화 발전, 지식 관리 및 데이터 통합 솔루션 확대, 리스크 관리 및 품질 보증 서비스 강화 등을 꼽을 수 있습니다. 서비스 강화 등을 꼽을 수 있습니다.

임상시험 건수 증가는 향후 몇 년 동안 의약품 안전성 모니터링 아웃소싱 시장의 성장을 견인할 것으로 예측됩니다. 임상시험은 신약, 치료법, 의료기기의 안전성, 유효성, 잠재적 부작용을 평가하기 위해 실시되는 연구입니다. 임상시험 증가는 정밀의료에 대한 관심 증가, 만성질환의 유병률 증가, 지원적인 규제 프레임워크, 연구 활동의 세계화 등의 요인에 기인합니다. 의약품 안전성 모니터링 아웃소싱은 전문적 지식과 자원을 활용하여 의약품 안전성 모니터링을 강화하고, 규제 준수를 보장하며, 업무 효율성을 향상시킴으로써 임상시험에서 매우 중요한 역할을 합니다. 예를 들어, 영국제약산업협회(ABPI)의 발표에 따르면, 2024년 12월 기준 영국에서 시작된 업계 주도 임상시험 건수는 2022년 411건에서 2023년 426건으로 증가하였습니다. 이러한 임상시험 수 증가는 의약품 안전성 모니터링 아웃소싱 시장의 확대에 기여하고 있습니다.

의약품 안전성 모니터링 아웃소싱 시장에서 사업을 전개하는 주요 기업들은 클라우드 기반 데이터 레이크 플랫폼과 같은 혁신적인 솔루션 개발에 주력하고 있습니다. 이를 통해 의약품 안전성 모니터링 사례 처리 및 안전성 데이터 관리를 최적화하는 동시에 임상연구 레지스트리를 강화하고 규제 준수를 보장하고 있습니다. 클라우드 기반 데이터 레이크 플랫폼은 분석이 필요할 때까지 대량의 원시 데이터를 원시 형태로 저장하고 관리할 수 있는 중앙 집중식 저장소 역할을 합니다. 예를 들어, 2023년 12월, 미국에 본사를 둔 생명공학 및 실험기기 기업 써모피셔 사이언티픽(Thermo Fisher Scientific)은 임상연구 레지스트리를 강화하기 위한 솔루션 'CorEvidence'를 도입했습니다. 이 플랫폼은 여러 데이터 소스를 통합하고 부작용의 코딩, 분류 및 보고를 개선하여 약물감시 사례의 처리를 효율화합니다. 그 중요성은 확장성, 컴플라이언스 준수, 감사 가능한 안전성 관리 제공, CorEvitas 임상 연구 레지스트리 강화, 광범위한 치료 영역에 걸친 장기 시판 후 안전성 조사를 지원하는 데 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 outsourcing refers to the practice of engaging external service providers to perform pharmacovigilance activities on behalf of pharmaceutical companies. These activities involve identifying, evaluating, understanding, and preventing adverse effects or any other issues related to drug use.

The primary types of pharmacovigilance outsourcing include adverse drug reaction capture (ADR), case processing, reporting and submission, report publishing, quality checks, risk management, knowledge management, and enabling architecture. Adverse drug reaction capture involves the identification, documentation, and analysis of harmful or unintended responses to medications, helping ensure drug safety and enhance patient care. These outsourcing services are delivered by organizations such as contract research organizations and business process outsourcing companies. The end users of these services include pharmaceutical companies, research organizations, and others.

Tariffs have influenced the pharmacovigilance outsourcing market by increasing costs of imported software, IT infrastructure, and analytics tools used in ADR capture, case processing, and reporting services. Service providers relying on imports are most affected, particularly in North America and Europe. While tariffs have led to higher operational costs and slowed deployment of new technologies, they have also encouraged investment in local IT solutions, promoted domestic service capabilities, and fostered innovation in automation and data integration platforms.

The pharmacovigilance outsourcing market research report is one of a series of new reports from The Business Research Company that provides pharmacovigilance outsourcing market statistics, including pharmacovigilance outsourcing industry global market size, regional shares, competitors with a pharmacovigilance outsourcing market share, detailed pharmacovigilance outsourcing market segments, market trends and opportunities, and any further data you may need to thrive in the pharmacovigilance outsourcing industry. This pharmacovigilance outsourcing 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 outsourcing market size has grown rapidly in recent years. It will grow from $7.24 billion in 2025 to $8.51 billion in 2026 at a compound annual growth rate (CAGR) of 17.6%. The growth in the historic period can be attributed to rising number of new drug approvals, increasing pharmacovigilance awareness among pharma companies, lack of in-house pv expertise, growing regulatory scrutiny, expansion of global clinical trials.

The pharmacovigilance outsourcing market size is expected to see rapid growth in the next few years. It will grow to $16.09 billion in 2030 at a compound annual growth rate (CAGR) of 17.2%. The growth in the forecast period can be attributed to integration of ai and data analytics in pv processes, increasing outsourcing to cro and bpo providers, adoption of cloud-based pharmacovigilance platforms, expansion of global safety reporting requirements, growing investment in it infrastructure and technology support. Major trends in the forecast period include increasing adoption of outsourced pharmacovigilance services by pharma companies, rising regulatory compliance requirements and reporting standards, growth in automation of adr capture and case processing, expansion of knowledge management and data integration solutions, enhanced focus on risk management and quality assurance services.

The increasing number of clinical trials is anticipated to drive the growth of the pharmacovigilance outsourcing market in the coming years. Clinical trials are research studies carried out to assess the safety, effectiveness, and potential side effects of new drugs, treatments, or medical devices. The rise in clinical trials is attributed to factors such as the growing emphasis on precision medicine, the increasing prevalence of chronic diseases, supportive regulatory frameworks, and the globalization of research activities. Pharmacovigilance outsourcing plays a vital role in clinical trials by strengthening drug safety monitoring through the use of specialized expertise and resources, ensuring regulatory compliance, and improving operational efficiency. For example, in December 2024, according to the Association of the British Pharmaceutical Industry (ABPI), a UK-based trade association, the number of industry-sponsored clinical trials initiated in the UK increased to 426 in 2023, up from 411 in 2022. Consequently, the growing number of clinical trials is contributing to the expansion of the pharmacovigilance outsourcing market.

Major companies operating in the pharmacovigilance outsourcing market are concentrating on the development of innovative solutions, such as cloud-based data lake platforms, to optimize pharmacovigilance case processing and safety data management while enhancing clinical research registries and ensuring regulatory compliance. A cloud-based data lake platform serves as a centralized repository that enables the storage and management of large volumes of raw data in its original format until required for analysis. For instance, in December 2023, Thermo Fisher Scientific Inc., a US-based biotechnology and laboratory equipment company, introduced CorEvidence, a solution designed to enhance clinical research registries. The platform streamlines pharmacovigilance case processing by integrating multiple data sources and improving the coding, classification, and reporting of adverse events. Its importance lies in delivering scalable, compliant, and auditable safety management, strengthening CorEvitas clinical research registries, and supporting long-term post-authorization safety studies across a wide range of therapeutic areas.

In November 2023, Permira Advisers LLP, a UK-based investment firm, acquired Ergomed PLC for $0.904 billion. This acquisition is intended to support Ergomed's next phase of growth by utilizing Permira's expertise, financial resources, and global network to expand Ergomed's commercial, technological, and geographic reach, as well as to enable strategic acquisitions within the contract research organization and pharmacovigilance sectors. Ergomed PLC is a UK-based company that provides drug development services, including pharmacovigilance.

Major companies operating in the pharmacovigilance outsourcing market are ACCENTURE PLC, International Business Machines Corporation (IBM), Tata Consultancy Services, Capgemini SE, Cognizant Technology Solutions Corporation, IQVIA Holdings Inc., Wipro Limited, ICON PLC, Syneos Health, Genpact limited, Parexel International Corp, Veeva Systems Inc., Medpace Holdings Inc., ProPharma Group, Pharmalex GmbH, PrimeVigilance Ltd., Veristat LLC, United BioSource LLC, Lambda Therapeutic Research, ArisGlobal, Biomapas

North America was the largest region in the pharmacovigilance outsourcing market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the pharmacovigilance outsourcing 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 outsourcing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The pharmacovigilance outsourcing market includes revenues earned by entities by providing services such as pharmacovigilance database management, assessment services, medical information call center services, regulatory consulting and strategy services, pharmacovigilance compliance and auditing, and aggregate reporting and benefit-risk evaluation. 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 Outsourcing 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 outsourcing 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 outsourcing ? 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 outsourcing 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 Outsourcing Market Characteristics

3. Pharmacovigilance Outsourcing Market Supply Chain Analysis

4. Global Pharmacovigilance Outsourcing Market Trends And Strategies

5. Pharmacovigilance Outsourcing Market Analysis Of End Use Industries

6. Pharmacovigilance Outsourcing 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 Outsourcing Strategic Analysis Framework, Current Market Size, Market Comparisons And Growth Rate Analysis

8. Global Pharmacovigilance Outsourcing Total Addressable Market (TAM) Analysis for the Market

9. Pharmacovigilance Outsourcing Market Segmentation

10. Pharmacovigilance Outsourcing Market Regional And Country Analysis

11. Asia-Pacific Pharmacovigilance Outsourcing Market

12. China Pharmacovigilance Outsourcing Market

13. India Pharmacovigilance Outsourcing Market

14. Japan Pharmacovigilance Outsourcing Market

15. Australia Pharmacovigilance Outsourcing Market

16. Indonesia Pharmacovigilance Outsourcing Market

17. South Korea Pharmacovigilance Outsourcing Market

18. Taiwan Pharmacovigilance Outsourcing Market

19. South East Asia Pharmacovigilance Outsourcing Market

20. Western Europe Pharmacovigilance Outsourcing Market

21. UK Pharmacovigilance Outsourcing Market

22. Germany Pharmacovigilance Outsourcing Market

23. France Pharmacovigilance Outsourcing Market

24. Italy Pharmacovigilance Outsourcing Market

25. Spain Pharmacovigilance Outsourcing Market

26. Eastern Europe Pharmacovigilance Outsourcing Market

27. Russia Pharmacovigilance Outsourcing Market

28. North America Pharmacovigilance Outsourcing Market

29. USA Pharmacovigilance Outsourcing Market

30. Canada Pharmacovigilance Outsourcing Market

31. South America Pharmacovigilance Outsourcing Market

32. Brazil Pharmacovigilance Outsourcing Market

33. Middle East Pharmacovigilance Outsourcing Market

34. Africa Pharmacovigilance Outsourcing Market

35. Pharmacovigilance Outsourcing Market Regulatory and Investment Landscape

36. Pharmacovigilance Outsourcing Market Competitive Landscape And Company Profiles

37. Pharmacovigilance Outsourcing Market Other Major And Innovative Companies

38. Global Pharmacovigilance Outsourcing Market Competitive Benchmarking And Dashboard

39. Key Mergers And Acquisitions In The Pharmacovigilance Outsourcing Market

40. Pharmacovigilance Outsourcing Market High Potential Countries, Segments and Strategies

41. Appendix

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