약물감시 시장 보고서(2026년)
Pharmacovigilance Global Market Report 2026
상품코드 : 1957643
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

약물감시 시장 규모는 최근 급성장하고 있습니다. 2025년 96억 4,000만 달러에서 2026년에는 108억 6,000만 달러에 이르고, CAGR 12.7%의 성장이 전망되고 있습니다. 지난 수년간의 성장은 부작용 보고 증가, 세계 의약품 승인 확대, 임상시험 건수 증가, 국제 의약품 안전 규제 확립, 만성질환 치료제의 사용 확대 등이 요인으로 꼽힙니다.

약물감시 시장 규모는 향후 몇 년간 급성장이 전망됩니다. 2030년에는 174억 1,000만 달러에 이르고, CAGR은 12.5%를 나타낼 전망입니다. 예측 기간 동안의 성장에는 실제 데이터(RWD) 활용 확대, 생물학적 제제 및 바이오시밀러 승인 증가, 병용 요법의 복잡성 증가, 신흥 시장에서의 약물감시 확대, 환자 안전 결과에 대한 관심 증가 등이 영향을 미칠 것으로 보입니다. 예측 기간의 주요 동향으로는 시판 후 조사 활동의 확대, 안전성 모니터링에 대한 실제 데이터 채택 증가, 규제 당국의 감시 강화 및 컴플라이언스 요구 사항 증가, 의약품 안전성 모니터링 서비스 아웃소싱 증가, 다출처 안전성 데이터 플랫폼의 통합 등이 있습니다.

연구개발(R&:D) 활동 증가는 의약품 안전성 모니터링 시장의 성장을 견인할 것으로 예측됩니다. 제약기업은 연구개발에 대한 투자를 통해 안전성 프로파일이 개선된 신약을 개발할 수 있습니다. 의약품 개발 단계의 엄격한 비임상 및 임상시험을 통해 잠재적인 안전성 문제를 조기에 파악할 수 있고, 효과적인 위험 감소 전략을 실행할 수 있습니다. 또한, R&&D는 부작용 모니터링, 데이터 분석, 신호 감지 기술의 발전을 지원하여 시판 후 단계에서 부작용을 적시에 파악할 수 있도록 돕습니다. 예를 들어, 영국 통계청(ONS)에 따르면, 2023년 영국 정부의 연구개발(R&&D) 순지출은 2022년 161억 파운드에서 174억 파운드로 8.2% 증가할 것으로 예상했습니다. 이처럼 연구개발 활동의 확대는 의약품 안전성 모니터링 시장의 성장을 가속하고 있습니다.

의약품 안전성 모니터링 시장의 주요 기업들은 업무 효율성과 정확성을 높이기 위해 인공지능(AI)을 활용하고 있습니다. AI는 의약품 안전성 모니터링 프로세스를 효율화하고, 데이터 관리를 강화하며, 신호 감지를 가속화하고, 궁극적으로 환자의 안전과 치료 결과를 개선하는 데 기여할 수 있습니다. 예를 들어, 2024년 8월 인도 정부는 보건가족복지부 장관과 화학비료부 장관이 도입한 '약물유해반응 모니터링 시스템(ADRMS)' 소프트웨어를 출시하였습니다. 이 약물감시 플랫폼은 의약품 및 의료기기 관련 부작용의 수집 및 분석을 촉진하고, 의료 종사자 및 소비자의 보고 프로세스를 간소화합니다. ADRMS는 종합적인 안전성 데이터 수집을 보장하고, 규제 준수를 강화하며, 세계 제약 산업에서 인도의 위상을 뒷받침함으로써 인도의 약물감시 기반을 강화할 것입니다.

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 is the science and practice of identifying, evaluating, understanding, and mitigating side effects and other issues related to drugs or vaccines. It helps determine whether a medication's benefits outweigh its risks and continues beyond the point of drug approval.

The main types of pharmacovigilance include spontaneous reporting, intensified ADR reporting, targeted spontaneous reporting, cohort event monitoring, and EHR mining. Spontaneous reporting is a passive method that relies on individuals to voluntarily report suspected adverse drug reactions to local or national pharmacovigilance centers. Key process flows involve case data management, signal detection, and risk management systems. Service providers can be in-house or contracted for outsourcing, covering clinical trial phases such as preclinical, Phase I, Phase II, Phase III, and Phase IV. These services are utilized by hospitals, pharmaceutical companies, and other healthcare organizations.

Tariffs have moderately impacted the pharmacovigilance market by increasing the cost of imported IT infrastructure, data management software, and specialized safety monitoring tools used across global operations. These cost pressures particularly affect contract outsourcing providers and EHR mining segments, with Asia-Pacific and parts of Europe experiencing higher operational expenses due to reliance on cross-border technology services. Clinical trial phase IV activities and advanced signal detection processes are also influenced by delayed system upgrades. However, tariffs have encouraged local deployment of pharmacovigilance platforms, regional service partnerships, and investment in domestic data processing capabilities, supporting long-term market resilience.

The pharmacovigilance market research report is one of a series of new reports from The Business Research Company that provides pharmacovigilance market statistics, including pharmacovigilance industry global market size, regional shares, competitors with a pharmacovigilance market share, detailed pharmacovigilance market segments, market trends and opportunities, and any further data you may need to thrive in the pharmacovigilance industry. This pharmacovigilance 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 market size has grown rapidly in recent years. It will grow from $9.64 billion in 2025 to $10.86 billion in 2026 at a compound annual growth rate (CAGR) of 12.7%. The growth in the historic period can be attributed to increasing adverse drug reaction reporting, expansion of global pharmaceutical approvals, rising clinical trial volumes, establishment of international drug safety regulations, growth in chronic disease drug usage.

The pharmacovigilance market size is expected to see rapid growth in the next few years. It will grow to $17.41 billion in 2030 at a compound annual growth rate (CAGR) of 12.5%. The growth in the forecast period can be attributed to real-world data utilization growth, rising biologics and biosimilars approvals, increasing complexity of combination therapies, expansion of pharmacovigilance in emerging markets, growing focus on patient safety outcomes. Major trends in the forecast period include expansion of post-marketing surveillance activities, growing adoption of real-world evidence in safety monitoring, increasing regulatory scrutiny and compliance requirements, rising outsourcing of pharmacovigilance services, integration of multisource safety data platforms.

The increasing research and development (R&D) activities are expected to drive the growth of the pharmacovigilance market. By investing in R&D, pharmaceutical companies can develop new drugs with improved safety profiles. Rigorous preclinical and clinical testing during drug development enables the early identification of potential safety concerns, allowing for the implementation of effective risk mitigation strategies. Additionally, R&D supports the advancement of technologies for adverse event monitoring, data analysis, and signal detection, facilitating the timely identification of adverse drug reactions in the post-marketing phase. For instance, in 2023, according to the Office for National Statistics, a UK-based government agency, the UK government's net spending on R&D increased to £17.4 billion in 2023, up from £16.1 billion in 2022, marking an 8.2% rise. Therefore, increasing R&D activities are fueling the growth of the pharmacovigilance market.

Key companies in the pharmacovigilance market are leveraging artificial intelligence (AI) to improve operational efficiency and accuracy. AI streamlines pharmacovigilance processes, enhances data management, accelerates signal detection, and ultimately contributes to better patient safety and outcomes. For example, in August 2024, the Government of India launched the Adverse Drug Reaction Monitoring System (ADRMS) software, introduced by the Minister of Health & Family Welfare and the Minister of Chemicals and Fertilizers. This pharmacovigilance platform facilitates the collection and analysis of adverse events related to medicines and medical devices, simplifying the reporting process for healthcare professionals and consumers. ADRMS strengthens India's pharmacovigilance infrastructure by ensuring comprehensive safety data capture, enhancing regulatory compliance, and supporting the country's position in the global pharmaceutical industry.

In January 2023, AmerisourceBergen, a US-based pharmaceutical wholesale company, acquired Pharma Lex for an undisclosed amount. This acquisition expands AmerisourceBergen's capabilities in supporting pharmaceutical and biotechnology companies across the product lifecycle. Pharma Lex, a Germany-based company, provides end-to-end pharmacovigilance solutions, including systems and operations management as well as benefit-risk assessment services, enhancing the overall safety monitoring infrastructure for its clients.

Major companies operating in the pharmacovigilance market are IQVIA, Cognizant, ICON Plc, Accenture plc, PAREXEL International Corporation, United BioSource LLC, ArisGlobal, Quanticate, Wipro Limited, Linical Americas, Novotech CRO, EXTEDO, Arriello, PrimeVigilance, Axios International, C3i Solutions, Secure AI Labs, OmniSol dot Tech, Prevnos Inc., Lifescient Inc, QuintilesIMS, Labcorp Drug Development, Pharmaceutical Product Development Inc., PRA Health Sciences, Synowledge LLC, RAPAhub, illuminate health, Invenio Medical, ClinChoice Inc., Novasyte, Fortrea Holdings Inc., Syneos Health Clinical, Telerx Marketing Inc.

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

The pharmacovigilance market includes revenues earned by collecting, analyzing, monitoring, and preventing adverse effects in drugs and therapies. 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 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 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 ? 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 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 Market Characteristics

3. Pharmacovigilance Market Supply Chain Analysis

4. Global Pharmacovigilance Market Trends And Strategies

5. Pharmacovigilance Market Analysis Of End Use Industries

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

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

9. Pharmacovigilance Market Segmentation

10. Pharmacovigilance Market Regional And Country Analysis

11. Asia-Pacific Pharmacovigilance Market

12. China Pharmacovigilance Market

13. India Pharmacovigilance Market

14. Japan Pharmacovigilance Market

15. Australia Pharmacovigilance Market

16. Indonesia Pharmacovigilance Market

17. South Korea Pharmacovigilance Market

18. Taiwan Pharmacovigilance Market

19. South East Asia Pharmacovigilance Market

20. Western Europe Pharmacovigilance Market

21. UK Pharmacovigilance Market

22. Germany Pharmacovigilance Market

23. France Pharmacovigilance Market

24. Italy Pharmacovigilance Market

25. Spain Pharmacovigilance Market

26. Eastern Europe Pharmacovigilance Market

27. Russia Pharmacovigilance Market

28. North America Pharmacovigilance Market

29. USA Pharmacovigilance Market

30. Canada Pharmacovigilance Market

31. South America Pharmacovigilance Market

32. Brazil Pharmacovigilance Market

33. Middle East Pharmacovigilance Market

34. Africa Pharmacovigilance Market

35. Pharmacovigilance Market Regulatory and Investment Landscape

36. Pharmacovigilance Market Competitive Landscape And Company Profiles

37. Pharmacovigilance Market Other Major And Innovative Companies

38. Global Pharmacovigilance Market Competitive Benchmarking And Dashboard

39. Key Mergers And Acquisitions In The Pharmacovigilance Market

40. Pharmacovigilance Market High Potential Countries, Segments and Strategies

41. Appendix

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