세계의 의약품 안전성 평가 시장 보고서(2025년)
Pharmaceutical Safety Assessment Global Market Report 2025
상품코드 : 1877843
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. 2024년 104억 7,000만 달러로 평가되었고, 2025년에는 113억 2,000만 달러에 달하고, CAGR 8.1%로 확대될 전망입니다. 지난 몇년간의 성장은 전임상 연구에 대한 수요 증가, 의약품 안전성에 관한 규제 요건의 엄격화, CRO(수탁 연구 기관)에의 업무 위탁 확대, 동물 모델 연구의 진전, 세포 기반 분석의 조기 도입 등이 주요 요인입니다.

의약품 안전성 평가 시장 규모는 향후 수년간 강력한 성장이 예상됩니다. 2029년에는 156억 4,000만 달러에 달하고, CAGR은 8.4%를 나타낼 전망입니다. 예측기간의 성장은 생물학적 제제 및 바이오시밀러의 개발 확대, 인실리코 독성학 플랫폼의 도입 증가, 맞춤형 의료에 대한 투자 증가, 대체 시험 방법으로의 규제 전환, 고처리량 스크리닝 기술에 대한 수요 증가와 관련됩니다. 예측기간의 주요 동향으로는 독성 예측에 대한 인공지능(AI)의 통합, 동물실험에서 장기칩 시스템으로의 이행, 안전성 프로파일링을 위한 계산 모델링의 확대, 제약기업과 기술기업 간의 연계 강화, 안전성 평가를 위한 예측 바이오마커에 대한 주력을 들 수 있습니다.

임상시험의 확대는 향후 의약품 안전성 평가 시장의 성장을 지원할 것으로 예측됩니다. 임상시험이란 새로운 의료처치·의약품·개입법의 안전성, 유효성, 부작용을 평가하기 위해 인간을 대상으로 실시되는 연구를 말합니다. 연구자와 의료 제공자가 질병의 예방·관리·치료를 보다 효과적으로 실시하는 요법의 개발에 임하고 있는 중, 신규 한편 유효한 치료법에 대한 수요가 높아지고 있기 때문에 임상시험의 수는 증가 경향에 있습니다. 임상시험은 엄격하게 관리된 연구를 통해 약물의 인간에 미치는 영향을 체계적으로 평가하고, 유해반응을 모니터링하고, 안전한 용량 범위를 결정하고, 규제 당국이 의약품의 유효성과 공중에 대한 안전성을 확인하는 데 사용하는 중요한 데이터를 생성함으로써 의약품 안전성 평가를 강화합니다. 예를 들어, 미국 국립의학 도서관(의학 분야 도서관)에 따르면 2025년 9월 26일 현재 ClinicalTrials.gov에는 총 55만 4,798건의 연구가 등록되어 있습니다. 따라서 임상시험의 확대는 의약품 안전성 평가 시장의 성장을 뒷받침하고 있습니다.

의약품 안전성 평가 시장의 주요 기업은 리스크 관리의 수명 주기 전반에 걸친 접근법과 같은 첨단 전략을 강조하고 있습니다. 이 접근법은 의약품에서 시판 후 조사에 이르는 의약품 개발의 모든 단계에 걸쳐 안전성 평가를 통합하여 지속적인 환자 보호 및 규제 기준 준수를 보장합니다. 라이프사이클 전체에 걸친 접근법은 의약품의 개발, 제조, 실임상 사용에 이르는 전 라이프사이클에 걸쳐 의약품의 안전성을 지속적으로 평가·관리하는 수법입니다. 예를 들어 2024년 10월에는 미국에 본사를 둔 제약과학기술의 발전을 추진하는 단체인 국제제약기술협회(ISPE)가 업계 전체의 혁신 촉진을 목적으로 한 「환자에게 제공을 실현하는 세계 제약 혁신의 촉진」 이니셔티브를 발표했습니다. 이에 앞서 2022년 말에는 ISPE가 신흥기술 개발과 복잡한 규제 프레임워크 대응에 익숙한 업계 전문가 팀을 결성했습니다. 이 팀은 의약품 분야에서 기술 진보와 도입을 저해하는 장벽의 근본 원인, 규모, 영향을 특정하기 위해 종합적인 조사를 실시했습니다. 본 이니셔티브는 궁극적으로 규제면 및 운영면의 과제를 효과적으로 해결하면서 업계 내에서 선진기술의 통합을 가속화하는 것을 목표로 하고 있습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

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

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별/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 구도와 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹과 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문, 전략

제36장 부록

SHW
영문 목차

영문목차

Pharmaceutical safety assessment is the systematic evaluation of drugs and pharmaceutical products to ensure their safety and minimize potential risks to patients. It involves 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 major types in the pharmaceutical safety assessment market include in-vitro safety assessment, in-vivo safety assessment, and computational safety assessment. In-vitro safety assessment refers to the evaluation of the safety and toxicity of drugs, chemicals, or other substances through controlled laboratory tests conducted outside a living organism. The types of drugs assessed include biological drugs and chemical drugs. The process covers multiple phases, including preclinical, clinical (phase I, II, III), and post-market surveillance (phase IV). The key end users are pharmaceutical companies, biotechnology firms, medical device manufacturers, academic and research institutions, and contract research organizations.

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 pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

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 $10.47 billion in 2024 to $11.32 billion in 2025 at a compound annual growth rate (CAGR) of 8.1%. The growth in the historic period is driven by increasing demand for preclinical research, stricter regulatory requirements for drug safety, expansion of outsourcing to contract research organizations, advancements in animal model studies, and early adoption of cell-based assays.

The pharmaceutical safety assessment market size is expected to see strong growth in the next few years. It will grow to $15.64 billion in 2029 at a compound annual growth rate (CAGR) of 8.4%. The growth in the forecast period can be connected to expansion of biologics and biosimilars development, increasing adoption of in silico toxicology platforms, rising investment in personalized medicine, regulatory shift toward alternative testing methods, growing demand for high throughput screening technologies. Major trends in the forecast period include integration of artificial intelligence in toxicity prediction, shift from animal testing to organ on chip systems, expansion of computational modeling for safety profiling, rising collaborations between pharma and tech firms, focus on predictive biomarkers for safety assessment.

The expansion of clinical trials is expected to support the growth of the pharmaceutical safety assessment market going forward. Clinical trials refer to research studies conducted in humans to evaluate the safety, effectiveness, and side effects of new medical treatments, drugs, or interventions. The number of clinical trials is increasing due to the growing need for new and effective treatments, as researchers and healthcare providers work to develop therapies that can better prevent, manage, or cure diseases. Clinical trials strengthen pharmaceutical safety assessment by systematically evaluating a drug's effects on humans through carefully controlled studies, monitoring adverse reactions, determining safe dosage ranges, and generating essential data that regulatory authorities use to confirm that medications are both effective and safe for public use. For instance, in September 2025, according to the National Library of Medicine, a United States-based biomedical library, as of September 26, 2025, a total of 554,798 studies were registered on ClinicalTrials.gov. Therefore, the expansion of clinical trials is supporting the growth of the pharmaceutical safety assessment market.

Leading companies in the pharmaceutical safety assessment market are emphasizing advanced strategies such as the lifecycle-wide approach to risk management, which incorporates safety evaluation throughout all phases of drug development, from discovery to post-marketing surveillance, ensuring continuous patient protection and adherence to regulatory standards. The lifecycle-wide approach involves the ongoing assessment and management of pharmaceutical safety across the entire lifespan of a drug, covering development, manufacturing, and real-world use. For example, in October 2024, the International Society for Pharmaceutical Engineering (ISPE), a US-based organization dedicated to advancing pharmaceutical science and technology, introduced the initiative *Enabling Global Pharma Innovation Delivering for Patients* to promote innovation across the sector. Earlier, in late 2022, ISPE assembled a team of industry specialists experienced in developing emerging technologies and navigating complex regulatory frameworks. This team conducted a comprehensive survey to identify the root causes, scale, and impact of barriers that impede technological advancement and adoption in the pharmaceutical field. The initiative ultimately aims to accelerate the integration of advanced technologies within the industry while effectively addressing regulatory and operational challenges.

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 aims to strengthen its pharmacovigilance and clinical safety expertise, expand its footprint across Europe, and deliver more integrated regulatory and safety solutions to pharmaceutical and biotechnology clients. Stragen Services SAS is a France-based company specializing in pharmaceutical safety assessment, also known as pharmacovigilance.

Major players 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 2024. 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, 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, 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 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 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, 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. Pharmaceutical Safety Assessment Market Characteristics

3. Pharmaceutical Safety Assessment Market Trends And Strategies

4. Pharmaceutical Safety Assessment 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 Pharmaceutical Safety Assessment Growth Analysis And Strategic Analysis Framework

6. Pharmaceutical Safety Assessment Market Segmentation

7. Pharmaceutical Safety Assessment Market Regional And Country Analysis

8. Asia-Pacific Pharmaceutical Safety Assessment Market

9. China Pharmaceutical Safety Assessment Market

10. India Pharmaceutical Safety Assessment Market

11. Japan Pharmaceutical Safety Assessment Market

12. Australia Pharmaceutical Safety Assessment Market

13. Indonesia Pharmaceutical Safety Assessment Market

14. South Korea Pharmaceutical Safety Assessment Market

15. Western Europe Pharmaceutical Safety Assessment Market

16. UK Pharmaceutical Safety Assessment Market

17. Germany Pharmaceutical Safety Assessment Market

18. France Pharmaceutical Safety Assessment Market

19. Italy Pharmaceutical Safety Assessment Market

20. Spain Pharmaceutical Safety Assessment Market

21. Eastern Europe Pharmaceutical Safety Assessment Market

22. Russia Pharmaceutical Safety Assessment Market

23. North America Pharmaceutical Safety Assessment Market

24. USA Pharmaceutical Safety Assessment Market

25. Canada Pharmaceutical Safety Assessment Market

26. South America Pharmaceutical Safety Assessment Market

27. Brazil Pharmaceutical Safety Assessment Market

28. Middle East Pharmaceutical Safety Assessment Market

29. Africa Pharmaceutical Safety Assessment Market

30. Pharmaceutical Safety Assessment Market Competitive Landscape And Company Profiles

31. Pharmaceutical Safety Assessment Market Other Major And Innovative Companies

32. Global Pharmaceutical Safety Assessment Market Competitive Benchmarking And Dashboard

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

34. Recent Developments In The Pharmaceutical Safety Assessment Market

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

36. Appendix

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