의약품 안전성 평가 시장 보고서(2026년)
Pharmaceutical Safety Assessment Global Market Report 2026
상품코드 : 1957634
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

의약품 안전성 평가 시장 규모는 최근 현저한 성장을 이루고 있습니다. 2025년 113억 2,000만 달러에서 2026년에는 122억 4,000만 달러에 이르고, CAGR 8.2%로 성장할 전망입니다. 지난 수년간의 성장 요인으로는 의약품 연구개발 파이프라인의 확대, 의약품 안전성에 대한 규제 당국의 감시 강화, 전임상 및 임상시험 건수 증가, in vitro 안전성 평가 방법의 보급 확대, CRO 주도의 안전성 시험 이용 증가 등을 꼽을 수 있습니다.

의약품 안전성 평가 시장 규모는 향후 몇 년간 강력한 성장이 전망됩니다. 2030년에는 169억 7,000만 달러에 이르고, CAGR은 8.5%를 나타낼 전망입니다. 예측 기간 동안 성장 요인으로는 컴퓨터 기반 안전성 평가에 대한 의존도 증가, 맞춤형 의료 개발 확대, 신속한 규제 승인에 대한 수요 증가, 의약품 안전성 워크플로우에 대한 AI 통합 발전, 시판 후 조사 요건 강화 등을 꼽을 수 있습니다. 예측 기간의 주요 동향으로는 AI 기반 독성 예측 툴의 사용 증가, 비실리콘 안전성 평가 모델 채택 확대, 실시간 약물감시 시스템 통합 발전, 자동화된 전임상시험 플랫폼 확대, 규제 준수 안전성 분석에 대한 집중 강화 등이 있습니다.

임상시험의 확대는 향후 몇 년 동안 의약품 안전성 평가 시장의 성장을 견인할 것으로 예측됩니다. 임상시험은 새로운 의료 시술, 의약품, 중재법의 안전성, 유효성, 잠재적 부작용을 평가하기 위해 사람을 대상으로 시행하는 연구입니다. 연구자들과 의료진들이 질병을 보다 효과적으로 예방, 관리, 치료할 수 있는 치료법을 개발하기 위해 노력하는 가운데, 혁신적이고 효과적인 치료법에 대한 수요가 증가함에 따라 임상시험의 수가 증가하는 추세입니다. 임상시험은 엄격하게 통제된 연구를 통해 약물이 인체에 미치는 영향을 체계적으로 검증하고, 부작용을 모니터링하고, 안전한 용량 범위를 결정하고, 규제 당국이 의약품의 대중에 대한 안전성과 유효성을 보장하기 위해 사용하는 중요한 데이터를 제공함으로써 의약품 안전성 평가에 기여합니다. 예를 들어, 미국 국립의학도서관(NLM)이 운영하는 생물의학도서관 'ClinicalTrials.gov'에는 2025년 9월 26일 기준 총 55만 4,798건의 연구가 등록되어 있습니다. 이러한 임상시험 증가는 의약품 안전성 평가 시장의 확대를 뒷받침하고 있습니다.

의약품 안전성 평가 시장의 주요 기업들은 독성 예측과 안전성 프로파일링의 정확성과 효율성을 높이기 위해 AI를 활용한 의사결정 지원 도구 개발에 집중하고 있습니다. AI를 활용한 의사결정 지원 도구는 인공지능을 활용해 데이터를 분석하여 보다 신속하고 정확한 의사결정을 가능하게 하는 인사이트를 제공하는 소프트웨어 시스템입니다. 예를 들어, 2024년 4월 미국 생명과학 기업 찰스 리버 래버러토리스(Charles River Laboratories)는 AI 기반 품질 보증 전문 아일랜드 기업 데시펙스(Desifex)와 함께 의약품 안전성 평가에서 독성 병리학을 혁신하기 위한 AI 기반 의사결정 지원 도구인 'Patholytix Foresight 플랫폼'을 발표했습니다. 의사결정 지원 도구 'Patholytix Foresight 플랫폼'을 발표했습니다. 본 플랫폼은 인공지능을 활용하여 복잡한 전임상 병리 데이터를 신속하게 분석함으로써 잠재적 안전성 위험을 조기에 발견하고 결과의 주관성을 최소화할 수 있도록 지원합니다. 조직 이상 징후를 감지하는 AI 알고리즘, 전 세계 협업을 가능하게 하는 클라우드 기반 시스템, 슬라이드 심사 시간을 단축하고 데이터의 정확성과 일관성을 높이는 확장 가능한 설계 등 특징적인 기능을 제공합니다.

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

Pharmaceutical safety assessment involves the systematic evaluation of drugs and pharmaceutical products to confirm their safety and reduce potential risks to patients. It includes the analysis of preclinical and clinical data, monitoring of adverse effects, and adherence to regulatory standards. This process supports informed decision-making regarding the approval, labeling, and safe use of medications.

The main types in the pharmaceutical safety assessment market include in-vitro safety assessment, in-vivo safety assessment, and computational safety assessment. In-vitro safety assessment involves evaluating the safety and toxicity of drugs, chemicals, or other substances through controlled laboratory tests conducted outside a living organism. The different types of drugs comprise biological drugs and chemical drugs. It covers multiple stages, such as preclinical, clinical (phase I, II, III), and post-market surveillance (phase IV). Major end users consist of pharmaceutical companies, biotechnology firms, medical device manufacturers, academic and research institutions, and contract research organizations (CROs).

Tariffs are influencing the pharmaceutical safety assessment market by increasing costs of imported laboratory instruments, analytical software platforms, high-throughput screening systems, and specialized testing equipment used across in-vitro, in-vivo, and computational assessments. Pharmaceutical and biotechnology companies in North America and Europe are most affected due to dependence on imported analytical technologies, while Asia-Pacific faces cost pressure on outsourced safety testing services. These tariffs are increasing operational costs and extending assessment timelines. However, they are also encouraging domestic development of safety assessment tools, regional CRO expansion, and increased adoption of software-based and in-silico safety solutions.

The pharmaceutical safety assessment market research report is one of a series of new reports from The Business Research Company that provides pharmaceutical safety assessment market statistics, including pharmaceutical safety assessment industry global market size, regional shares, competitors with a pharmaceutical safety assessment market share, detailed pharmaceutical safety assessment market segments, market trends and opportunities, and any further data you may need to thrive in the pharmaceutical safety assessment industry. This pharmaceutical safety assessment 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 pharmaceutical safety assessment market size has grown strongly in recent years. It will grow from $11.32 billion in 2025 to $12.24 billion in 2026 at a compound annual growth rate (CAGR) of 8.2%. The growth in the historic period can be attributed to expansion of pharmaceutical R&D pipelines, increasing regulatory scrutiny on drug safety, growth in preclinical and clinical testing volumes, wider adoption of in-vitro safety assessment methods, rising use of CRO-led safety studies.

The pharmaceutical safety assessment market size is expected to see strong growth in the next few years. It will grow to $16.97 billion in 2030 at a compound annual growth rate (CAGR) of 8.5%. The growth in the forecast period can be attributed to increasing reliance on computational safety assessment, expansion of personalized medicine development, rising demand for faster regulatory approvals, growing integration of ai in drug safety workflows, increased post-market surveillance requirements. Major trends in the forecast period include increasing use of ai-based toxicity prediction tools, rising adoption of in-silico safety assessment models, growing integration of real-time pharmacovigilance systems, expansion of automated preclinical testing platforms, enhanced focus on regulatory-compliant safety analytics.

The expansion of clinical trials is anticipated to drive the growth of the pharmaceutical safety assessment market in the coming years. Clinical trials are research studies conducted in humans to assess the safety, efficacy, and potential side effects of new medical treatments, drugs, or interventions. The number of clinical trials is increasing due to the rising demand for novel and effective therapies, as researchers and healthcare providers strive to develop treatments that can better prevent, manage, or cure diseases. Clinical trials contribute to pharmaceutical safety assessment by systematically examining a drug's impact on humans through carefully controlled studies, monitoring for adverse effects, determining safe dosage ranges, and providing critical data that regulatory authorities use to ensure medications are both safe and effective for public use. For example, as of September 26, 2025, the National Library of Medicine (NLM), a US-based biomedical library, reported that a total of 554,798 studies were registered on ClinicalTrials.gov. Thus, the growth of clinical trials is supporting the expansion of the pharmaceutical safety assessment market.

Major companies in the pharmaceutical safety assessment market are concentrating on developing AI-powered decision support tools to improve the accuracy and efficiency of toxicity prediction and safety profiling. An AI-powered decision support tool is a software system that employs artificial intelligence to analyze data and provide insights that facilitate faster and more precise decision-making. For example, in April 2024, Charles River Laboratories, a US-based life sciences company, in collaboration with Deciphex, an Ireland-based company specializing in AI-driven quality assurance, launched the Patholytix Foresight platform, an AI-powered decision support tool aimed at transforming toxicologic pathology in pharmaceutical safety assessment. The platform utilizes artificial intelligence to rapidly analyze complex preclinical pathology data, assisting in the earlier identification of potential safety risks and minimizing subjectivity in results. It provides distinctive features such as an AI algorithm for detecting tissue abnormalities, a cloud-based system for global collaboration, and a scalable design that reduces slide review time while enhancing data accuracy and consistency.

In January 2025, Groupe ProductLife S.A.S., a France-based life sciences services company, acquired Stragen Services SAS for an undisclosed amount. Through this acquisition, ProductLife Group intends to strengthen its pharmacovigilance and clinical safety capabilities, broaden its presence in the European market, and offer more comprehensive regulatory and safety support to pharmaceutical and biotech clients. Stragen Services SAS is a France-based company that focuses on pharmaceutical safety assessment, also known as pharmacovigilance.

Major companies operating in the pharmaceutical safety assessment market are IQVIA Holding Inc., LabCorp (formerly Covance), Thermo Fisher Scientific (PPD), Charles River Laboratories, ICON plc, Parexel International Corp., Syneos Health, Eurofins Scientific SE, Wuxi Biologics Inc., SGS SA, Medpace Holdings Inc., Fujifilm Wako (Fujifilm Corp.), Pharmaron Beijing Co. Ltd., Inotiv (incl. Envigo), Evotec (Cyprotex), Intertek Group, Altasciences Inc., Aragen Life Sciences Ltd., CTI Clinical Trial and Consulting Inc., ChemDiv Inc., Frontage Laboratories, Medicilon Inc., Biotoxtech Co. Ltd., BioIVT, Accelera Srl.

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

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

The pharmaceutical safety assessment market includes revenues earned by entities by providing services such as post-marketing surveillance, safety pharmacology, regulatory consulting and compliance, bioanalytics and biomarker services, and in silico and computational toxicology. 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.

Pharmaceutical Safety Assessment 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 pharmaceutical safety assessment 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 pharmaceutical safety assessment ? 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 pharmaceutical safety assessment 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. Pharmaceutical Safety Assessment Market Characteristics

3. Pharmaceutical Safety Assessment Market Supply Chain Analysis

4. Global Pharmaceutical Safety Assessment Market Trends And Strategies

5. Pharmaceutical Safety Assessment Market Analysis Of End Use Industries

6. Pharmaceutical Safety Assessment 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 Pharmaceutical Safety Assessment Strategic Analysis Framework, Current Market Size, Market Comparisons And Growth Rate Analysis

8. Global Pharmaceutical Safety Assessment Total Addressable Market (TAM) Analysis for the Market

9. Pharmaceutical Safety Assessment Market Segmentation

10. Pharmaceutical Safety Assessment Market Regional And Country Analysis

11. Asia-Pacific Pharmaceutical Safety Assessment Market

12. China Pharmaceutical Safety Assessment Market

13. India Pharmaceutical Safety Assessment Market

14. Japan Pharmaceutical Safety Assessment Market

15. Australia Pharmaceutical Safety Assessment Market

16. Indonesia Pharmaceutical Safety Assessment Market

17. South Korea Pharmaceutical Safety Assessment Market

18. Taiwan Pharmaceutical Safety Assessment Market

19. South East Asia Pharmaceutical Safety Assessment Market

20. Western Europe Pharmaceutical Safety Assessment Market

21. UK Pharmaceutical Safety Assessment Market

22. Germany Pharmaceutical Safety Assessment Market

23. France Pharmaceutical Safety Assessment Market

24. Italy Pharmaceutical Safety Assessment Market

25. Spain Pharmaceutical Safety Assessment Market

26. Eastern Europe Pharmaceutical Safety Assessment Market

27. Russia Pharmaceutical Safety Assessment Market

28. North America Pharmaceutical Safety Assessment Market

29. USA Pharmaceutical Safety Assessment Market

30. Canada Pharmaceutical Safety Assessment Market

31. South America Pharmaceutical Safety Assessment Market

32. Brazil Pharmaceutical Safety Assessment Market

33. Middle East Pharmaceutical Safety Assessment Market

34. Africa Pharmaceutical Safety Assessment Market

35. Pharmaceutical Safety Assessment Market Regulatory and Investment Landscape

36. Pharmaceutical Safety Assessment Market Competitive Landscape And Company Profiles

37. Pharmaceutical Safety Assessment Market Other Major And Innovative Companies

38. Global Pharmaceutical Safety Assessment Market Competitive Benchmarking And Dashboard

39. Key Mergers And Acquisitions In The Pharmaceutical Safety Assessment Market

40. Pharmaceutical Safety Assessment Market High Potential Countries, Segments and Strategies

41. Appendix

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