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市場調查報告書
商品編碼
2046004

非臨床試驗市場 - 全球產業規模、佔有率、趨勢、機會、預測：按研究類型、試驗類型、治療領域、最終用戶、地區和競爭格局分類，2021-2031年

Non-Clinical Trials Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Study Type, By Test, By Therapeutic Area, By End User, By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 180 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球非臨床試驗市場預計將從 2025 年的 112.3 億美元成長到 2031 年的 166.5 億美元，複合年成長率為 6.78%，因為它包括必要的體外和體內研究，這些研究在人體臨床試驗之前評估候選藥物的安全性、毒性和有效性。

這項市場擴張的主要驅動力是全球對藥物研發管線投入的增加，而這又受到慢性病和複雜疾病日益普遍的推動。預計到2024年，光是歐洲製藥業就將在研發方面投入約550億歐元。然而，該市場面臨許多挑戰，包括圍繞動物實驗的倫理和監管壓力，促使人們轉向電腦建模和晶片類器官技術等替代方法。儘管這些非動物替代方法在倫理上具有進步意義，但將其納入法律規範所涉及的複雜檢驗流程和高成本可能會導致營運延誤，並阻礙市場短期成長。

市場概覽
預測期 2027-2031
市場規模：2025年 112.3億美元
市場規模：2031年 166.5億美元
複合年成長率：2026-2031年 6.78%
成長最快的細分市場 藥物動力學（PK）研究
最大的市場 北美洲

市場促進因素

全球非臨床試驗市場的主要驅動力是製藥和生技產業研發投入的大幅成長。這種投資的增加直接轉化為需要進行嚴格安全評估的候選藥物數量的增加，Astra Zeneca研發投入增加24%至136億美元，以及FDA在2024年核准了50種新藥（所有這些藥物都需要事先進行非臨床試​​驗）都印證了這一點。第二個主要促進因素是將非臨床試驗外包給合約研究組織（CRO）的趨勢日益成長。這使得企業能夠利用外部專業知識，最佳化成本，並將內部資源集中在核心藥物研發活動。因此，像查爾斯河實驗室這樣的服務供應商保持著可觀的收入，預計2025年第三季的收入將達到10億美元。同時，這也縮短了研發週期，並使企業能夠獲得先進的測試技術。

市場挑戰

全球非臨床試驗市場面臨的主要障礙之一是嚴格的監管環境。這主要源自於對動物福利的倫理考量，迫使製藥公司減少對傳統體內試驗模式的依賴。這種強制性轉型造成了瓶頸，因為非動物替代方法的檢驗過程耗時且耗力。這擾亂了工作流程，使安全數據的產生更加複雜，並隨著傳統試驗數量的減少而延緩了整體藥物研發進度。英國政府內政部的一份報告也印證了這種監管收緊的趨勢，該報告指出，到2024年，英國使用活體動物進行的科學實驗數量將降至約264萬例，為2001年以來的最低水平。然而，替代調查方法缺乏普遍的監管核准以及高昂的定製成本正在延長研發週期並增加營運成本，直接阻礙市場的有效擴張。

市場趨勢

將人工智慧 (AI) 應用於預測毒理學和安全性評估，正從根本上改變非臨床工作流程。這使得製藥公司能夠部署機器學習演算法，在進行物理測試之前儘早識別潛在的毒性風險，從而加速候選化合物的篩選並提高安全性評估的準確性。一個典型的例子是賽諾菲在 2024 年與 Formation Bio 和 OpenAI 建立策略性合作關係，共同開發用於藥物開發的 AI 軟體。同時，針對生物製藥和先進治療方法的專業安全性測試也呈現蓬勃發展的趨勢。這源自於研發管線向複雜的細胞和基因療法的轉變，這些療法需要針對免疫抗原性和致癌性等風險制定獨特的方案，從而催生了對高度專業化的毒理學服務的需求。大量資金的流入也支撐了這個趨勢。在後期臨床試驗取得進展的推動下，細胞和基因治療領域的投資在 2024 年上半年達到了 109 億美元，這為這些嚴謹的非臨床試驗提供了資金支持。

目錄

第1章概述

第2章：調查方法

第3章執行摘要

第4章：客戶心聲

第5章：全球非臨床試驗市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 研究類型（動態（PD）研究、藥物動力學（PK）研究、毒性研究）
    • 依測試類型（In Silico、體外、體內）
    • 依治療領域（腫瘤科、循環系統、神經科、免疫科、其他）
    • 按最終用戶分類（製藥和生物技術公司、合約研究組織 (CRO)、學術和政府研究機構、其他）
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美非臨床試驗市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國別分析
    • 美國
    • 加拿大
    • 墨西哥

第7章：歐洲非臨床試驗市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國別分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太地區非臨床試驗市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國別分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第9章：中東和非洲非臨床試驗市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東與非洲：國別分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美非臨床試驗市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國別分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章 市場動態

  • 促進因素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 近期趨勢

第13章：全球非臨床試驗市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的議價能力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

  • Thermo Fisher Scientific Inc.
  • Charles River Laboratories International, Inc.
  • Covance Inc.
  • IQVIA Holdings, Inc.
  • WuXi AppTec Co., Ltd.
  • Eurofins Scientific
  • Evotec SE
  • Envigo RMS, LLC
  • Absorption Systems, LLC

第16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
Product Code: 16882

The Global Non-Clinical Trials Market is forecast to grow from USD 11.23 Billion in 2025 to USD 16.65 Billion by 2031, achieving a 6.78% CAGR, as these essential in vitro and in vivo studies evaluate drug candidate safety, toxicity, and efficacy before human trials. This market expansion is primarily driven by escalating global investment in drug discovery pipelines, prompted by the rising prevalence of chronic and complex diseases, with the European pharmaceutical industry alone investing approximately €55 billion in R&D in 2024. However, the market faces a significant challenge from ethical and regulatory pressures surrounding animal testing, compelling a shift towards alternative methods like computer modeling or organ-on-a-chip technologies; while ethically progressive, the complex validation processes and high costs of integrating these non-animal alternatives into regulatory frameworks can cause operational delays and impede immediate market growth.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 11.23 Billion
Market Size 2031USD 16.65 Billion
CAGR 2026-20316.78%
Fastest Growing SegmentPharmacokinetics (PK) studies
Largest MarketNorth America

Market Driver

The primary catalyst for the Global Non-Clinical Trials Market is the substantial surge in pharmaceutical and biotechnology R&D expenditure, as increased investment directly translates to a higher volume of drug candidates requiring rigorous safety assessments, evidenced by AstraZeneca's 24% rise in R&D expenses to $13.6 billion and the FDA's approval of 50 novel drugs in 2024, each necessitating extensive prior non-clinical testing. A second major driver is the growing trend of outsourcing non-clinical studies to Contract Research Organizations (CROs), which allows companies to leverage specialized external expertise, optimize costs, and focus internal resources on core discovery efforts, maintaining substantial revenue for service providers like Charles River Laboratories, which reported $1.00 billion in revenue for Q3 2025, while also accelerating development timelines and providing access to advanced testing technologies.

Market Challenge

A significant hurdle for the Global Non-Clinical Trials Market is the stringent regulatory landscape, largely fueled by ethical concerns regarding animal welfare, which compels pharmaceutical companies to reduce their reliance on established in vivo testing models. This mandated transition creates a bottleneck due to the resource-intensive and prolonged validation processes for non-animal alternatives, disrupting workflows and leading to a contraction in traditional testing volumes that complicates safety data generation and slows overall drug development timelines. This tightening is evidenced by the UK Home Office's report of a decrease in scientific procedures involving living animals to approximately 2.64 million in Great Britain in 2024, marking the lowest level since 2001; however, the lack of universal regulatory acceptance and costly customization for alternative methodologies extend development timelines and increase operational expenditures, directly impeding efficient market scaling.

Market Trends

The Integration of Artificial Intelligence (AI) for predictive toxicology and safety assessment is fundamentally reshaping non-clinical workflows by enabling pharmaceutical companies to deploy machine learning algorithms for early identification of potential toxicity risks before physical testing, thus accelerating candidate selection and enhancing safety profile precision, exemplified by Sanofi's 2024 strategic partnership with Formation Bio and OpenAI to develop AI-powered software for drug development. Concurrently, the Expansion of Specialized Safety Testing for Biologics and Advanced Therapies is gaining momentum as the pipeline shifts towards complex cell and gene therapies requiring bespoke protocols for risks like immunogenicity and tumorigenicity, creating demand for highly specialized toxicology services. This trend is supported by substantial capital inflows, with the cell and gene therapy sector receiving $10.9 billion in investments in the first half of 2024, driven by late-stage clinical progress, ensuring funding for these rigorous non-clinical studies.

Key Market Players

  • Thermo Fisher Scientific Inc.
  • Charles River Laboratories International, Inc.
  • Covance Inc.
  • IQVIA Holdings, Inc.
  • WuXi AppTec Co., Ltd.
  • Eurofins Scientific
  • Evotec SE
  • Envigo RMS, LLC
  • Absorption Systems, LLC

Report Scope

In this report, the Global Non-Clinical Trials Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Non-Clinical Trials Market, By Study Type

  • Pharmacodynamics (PD) studies
  • Pharmacokinetics (PK) studies
  • Toxicology studies

Non-Clinical Trials Market, By Test

  • In silico
  • In vitro
  • In vivo

Non-Clinical Trials Market, By Therapeutic Area

  • Oncology
  • Cardiovascular
  • Neurology
  • Immunology
  • Others

Non-Clinical Trials Market, By End User

  • Pharmaceutical and Biotechnology Companies
  • Contract Research Organizations (CROs)
  • Academic and Government Research Institutes
  • Others

Non-Clinical Trials Market, By Region

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Non-Clinical Trials Market.

Available Customizations:

Global Non-Clinical Trials Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Non-Clinical Trials Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Study Type (Pharmacodynamics (PD) studies, Pharmacokinetics (PK) studies, Toxicology studies)
    • 5.2.2. By Test (In silico, In vitro, In vivo)
    • 5.2.3. By Therapeutic Area (Oncology, Cardiovascular, Neurology, Immunology, Others)
    • 5.2.4. By End User (Pharmaceutical and Biotechnology Companies, Contract Research Organizations (CROs), Academic and Government Research Institutes, Others)
    • 5.2.5. By Region
    • 5.2.6. By Company (2025)
  • 5.3. Market Map

6. North America Non-Clinical Trials Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Study Type
    • 6.2.2. By Test
    • 6.2.3. By Therapeutic Area
    • 6.2.4. By End User
    • 6.2.5. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Non-Clinical Trials Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Study Type
        • 6.3.1.2.2. By Test
        • 6.3.1.2.3. By Therapeutic Area
        • 6.3.1.2.4. By End User
    • 6.3.2. Canada Non-Clinical Trials Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Study Type
        • 6.3.2.2.2. By Test
        • 6.3.2.2.3. By Therapeutic Area
        • 6.3.2.2.4. By End User
    • 6.3.3. Mexico Non-Clinical Trials Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Study Type
        • 6.3.3.2.2. By Test
        • 6.3.3.2.3. By Therapeutic Area
        • 6.3.3.2.4. By End User

7. Europe Non-Clinical Trials Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Study Type
    • 7.2.2. By Test
    • 7.2.3. By Therapeutic Area
    • 7.2.4. By End User
    • 7.2.5. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Non-Clinical Trials Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Study Type
        • 7.3.1.2.2. By Test
        • 7.3.1.2.3. By Therapeutic Area
        • 7.3.1.2.4. By End User
    • 7.3.2. France Non-Clinical Trials Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Study Type
        • 7.3.2.2.2. By Test
        • 7.3.2.2.3. By Therapeutic Area
        • 7.3.2.2.4. By End User
    • 7.3.3. United Kingdom Non-Clinical Trials Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Study Type
        • 7.3.3.2.2. By Test
        • 7.3.3.2.3. By Therapeutic Area
        • 7.3.3.2.4. By End User
    • 7.3.4. Italy Non-Clinical Trials Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Study Type
        • 7.3.4.2.2. By Test
        • 7.3.4.2.3. By Therapeutic Area
        • 7.3.4.2.4. By End User
    • 7.3.5. Spain Non-Clinical Trials Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Study Type
        • 7.3.5.2.2. By Test
        • 7.3.5.2.3. By Therapeutic Area
        • 7.3.5.2.4. By End User

8. Asia Pacific Non-Clinical Trials Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Study Type
    • 8.2.2. By Test
    • 8.2.3. By Therapeutic Area
    • 8.2.4. By End User
    • 8.2.5. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Non-Clinical Trials Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Study Type
        • 8.3.1.2.2. By Test
        • 8.3.1.2.3. By Therapeutic Area
        • 8.3.1.2.4. By End User
    • 8.3.2. India Non-Clinical Trials Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Study Type
        • 8.3.2.2.2. By Test
        • 8.3.2.2.3. By Therapeutic Area
        • 8.3.2.2.4. By End User
    • 8.3.3. Japan Non-Clinical Trials Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Study Type
        • 8.3.3.2.2. By Test
        • 8.3.3.2.3. By Therapeutic Area
        • 8.3.3.2.4. By End User
    • 8.3.4. South Korea Non-Clinical Trials Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Study Type
        • 8.3.4.2.2. By Test
        • 8.3.4.2.3. By Therapeutic Area
        • 8.3.4.2.4. By End User
    • 8.3.5. Australia Non-Clinical Trials Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Study Type
        • 8.3.5.2.2. By Test
        • 8.3.5.2.3. By Therapeutic Area
        • 8.3.5.2.4. By End User

9. Middle East & Africa Non-Clinical Trials Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Study Type
    • 9.2.2. By Test
    • 9.2.3. By Therapeutic Area
    • 9.2.4. By End User
    • 9.2.5. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Non-Clinical Trials Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Study Type
        • 9.3.1.2.2. By Test
        • 9.3.1.2.3. By Therapeutic Area
        • 9.3.1.2.4. By End User
    • 9.3.2. UAE Non-Clinical Trials Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Study Type
        • 9.3.2.2.2. By Test
        • 9.3.2.2.3. By Therapeutic Area
        • 9.3.2.2.4. By End User
    • 9.3.3. South Africa Non-Clinical Trials Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Study Type
        • 9.3.3.2.2. By Test
        • 9.3.3.2.3. By Therapeutic Area
        • 9.3.3.2.4. By End User

10. South America Non-Clinical Trials Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Study Type
    • 10.2.2. By Test
    • 10.2.3. By Therapeutic Area
    • 10.2.4. By End User
    • 10.2.5. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Non-Clinical Trials Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Study Type
        • 10.3.1.2.2. By Test
        • 10.3.1.2.3. By Therapeutic Area
        • 10.3.1.2.4. By End User
    • 10.3.2. Colombia Non-Clinical Trials Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Study Type
        • 10.3.2.2.2. By Test
        • 10.3.2.2.3. By Therapeutic Area
        • 10.3.2.2.4. By End User
    • 10.3.3. Argentina Non-Clinical Trials Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Study Type
        • 10.3.3.2.2. By Test
        • 10.3.3.2.3. By Therapeutic Area
        • 10.3.3.2.4. By End User

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global Non-Clinical Trials Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. Thermo Fisher Scientific Inc.
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. SWOT Analysis
  • 15.2. Charles River Laboratories International, Inc.
  • 15.3. Covance Inc.
  • 15.4. IQVIA Holdings, Inc.
  • 15.5. WuXi AppTec Co., Ltd.
  • 15.6. Eurofins Scientific
  • 15.7. Evotec SE
  • 15.8. Envigo RMS, LLC
  • 15.9. Absorption Systems, LLC

16. Strategic Recommendations

17. About Us & Disclaimer