全球生物分析服务市场：按检测类型、分子类型、应用和最终用户划分－产业动态、市场规模及预测（2026-2035 年）

生物分析服务市场正处于显着成长的开端，预计营收将从 2025 年的 39.6 亿美元大幅成长至 2035 年的 116.1 亿美元。这意味着在 2026 年至 2035 年的预测期内，复合年增长率将达到 11.6%。这一强劲的成长反映了全球製药和生物技术产业对生物分析服务日益增长的重要性和依赖性。

推动这一成长趋势的因素有很多。药物研发领域对先进分析技术的需求不断增长是主要推动因素，因为现代疗法需要高度精确可靠的检测才能满足严格的监管标准。精准医疗的进步也在推动这项需求。这是因为个人化治疗需要更复杂、更个人化的生物分析评估。 此外，持续的技术创新正为实验室配备先进的工具和研究方法，从而提升其能力和效率。除了这些技术和科学因素外，新兴市场不断涌现的机会也显着推动了市场成长。

市场趋势概览

生物分析服务市场目前正经历一场激烈的“基础设施军备竞赛”，各大公司竞相实现检测能力的本地化和扩展，以满足日益增长的全球需求。引领此竞争格局的主要企业包括 Syneos Health Inc.、Charles River Laboratories Inc.、Laboratory Corporation of America、ICON Plc、SGS SA、Medpace 以及武田药品工业株式会社的子公司 PRA Health Sciences。

为了因应先进侦测能力日益增长的需求，多家公司近期对设施扩建和新业务进行了大量投资。例如，Pace Life Sciences 于 2025 年 6 月宣布将在新罕布夏州塞勒姆和明尼苏达州奥克代尔扩建设施。 这些升级包括新增无菌填充和包装能力，以及专为生物製药和基因治疗药物设计的分析能力。

2025年5月，Ardena在荷兰开设了一家新的生物分析实验室，占地超过3000平方英尺。该实验室配备了LC-MS/MS和Gyrolab系统等尖端技术，可进行大小分子分析，显着提升了公司在临床试验支援方面的能力。

核心成长驱动因子

对生物分析服务需求的快速成长与全球治疗药物研发管线的日益复杂度密切相关。 2024年，美国食品药物管理局（FDA）药物评估与研究中心（CDER）批准了50种新分子实体（NME），这反映了药物发现和开发的强劲势头。新核准药物数量的增加凸显了对全面生物分析检测的需求不断增长，以支持这些新型疗法的评估和验证。 这一趋势中值得关注的是非生物工程药物 (NBE) 的显着增长，2024 年获批的 18 种新分子实体 (NME) 被归类为生物製剂。

新兴机会趋势

生物分析服务市场中最具前景和利润丰厚的机会之一在于罕见疾病和精准医疗的交叉领域。人们越来越关注开发针对罕见疾病的标靶疗法，这为业界的创新和专业化开闢了新的途径。 2024 年，美国食品药物管理局 (FDA) 批准了 25 种用于治疗罕见疾病的新药，凸显了人们对这一小众但重要的医学领域日益增长的关注和投资。这些药物开发计画经常使用生物标记作为替代终点来评估治疗效果，尤其是在患者群体较小，难以衡量传统临床终点的情况下。

优化障碍

监管的复杂性为新型疗法的生物分析方法验证带来了重大挑战，可能阻碍生物分析服务市场的成长。随着创新药物和疗法的不断涌现，监管机构提出了日益严格的要求，以确保这些新疗法的安全性、有效性和品质。遵守这些复杂的法规需要严格的验证流程，这对生物分析服务提供者来说既耗时又耗费资源。

目录

第一章：研究架构

• 研究目标
• 产品概述
• 市场区隔

第二章：研究方法

• 质性研究
  • 一手和二手资料来源
• 量化研究
  • 一手和二手资料来源
• 按地区划分的一手调查受访者组成
• 研究假设
• 市场规模估算
• 资料三角验证

第三章：摘要整理：全球生物分析服务市场

第四章：全球生物分析服务市场

• 产业价值链分析
  • 样本采集
  • 样品製备与验证
  • 服务提供者
  • 最终用户
• 行业展望
  • 生物治疗生物分析技术的进步
• PESTLE 分析
• 波特五力分析
  • 供应商议价能力
  • 买方议价能力
  • 替代品威胁
  • 新进入者威胁
  • 竞争强度
• 市场动态与趋势
  • 成长驱动因素
  • 限制因素
  • 挑战
  • 主要趋势
• 影响评估新冠疫情对市场成长趋势的影响
• 市场成长与展望
  • 市场收入估计与预测（2020-2035）
  • 价格趋势分析（依检测类型）
• 竞争格局概览
  • 市场集中度
  • 公司市占率分析（价值百分比），2025
  • 竞争格局图

第五章 生物分析服务市场分析（依检测类型）

• 主要见解
• 市场规模与预测，2020-2035
  • 细胞检测
  • 病毒学检测
  • 物种特异性病毒PCR检测
  • 方法开发、最佳化与验证
  • 血清学检测免疫原性和中和抗体
  • 生物标记检测
  • 药物动力学研究
  • 生物利用度试验
  • 生物等效性试验
  • 其他

第六章：以分子类型划分的生物分析服务市场分析

• 主要见解
• 市场规模及预测（2020-2035）
• 小分子生物分析
• 大分子生物分析
• 其他

第七章：按应用划分的生物分析服务市场分析

• 主要见解
• 市场规模及预测（2020-2035）
  • 肿瘤学
  • 神经病学
  • 传染病学
  • 胃肠病学
  • 心臟病学
  • 其他

第八章：依最终使用者划分的生物分析服务市场分析

• 主要见解
• 市场规模及预测（2020-2035）
  • 製药和生技公司
  • 合约研究组织
  • 其他

第九章：按地区划分的全球生物分析服务市场分析

• 主要见解
• 市场规模及预测（2020-2035）
  • 北美
  • 欧洲
  • 亚太地区
  • 中东和非洲（中东和非洲）
  • 南美洲

第十章：北美生物分析服务市场分析

第十一章：欧洲生物分析服务市场分析

第十二章：亚太地区生物分析服务市场分析

第十三章：中东与非洲生物分析服务市场分析

第十四章：南美洲生物分析服务市场分析

第十五章：公司简介

• PPD公司
• ICON公司
• 查尔斯河实验室国际公司
• 科文斯公司
• IQVIA
• Syneos Health
• SGS SA
• Toxikon
• Intertek集团股份有限公司
• Pace Analytical Services LLC
• NorthEast BioLab
• CD BioSciences
• Eurofins Scientific SE
• 其他

The bioanalytical services market is on the brink of substantial growth, with projections indicating a significant increase in revenue from US$ 3.96 billion in 2025 to an impressive US$ 11.61 billion by 2035. This represents a robust compound annual growth rate (CAGR) of 11.6% over the forecast period from 2026 to 2035. Such dynamic expansion reflects the growing importance and reliance on bioanalytical services across the pharmaceutical and biotechnology industries worldwide.

Several factors are driving this upward trajectory. The increasing demand for sophisticated analytical techniques in drug development is a primary catalyst, as modern therapies require highly precise and reliable testing to meet stringent regulatory standards. Advances in precision medicine further fuel this demand, as tailored treatments necessitate more complex and individualized bioanalytical assessments. Additionally, continuous technological innovations are equipping laboratories with advanced tools and methodologies, enhancing their capabilities and efficiency. Beyond these technological and scientific drivers, expanding opportunities in emerging markets contribute significantly to market growth.

Noteworthy Market Developments

The bioanalytical services market is currently characterized by an intense infrastructure "arms race," as leading companies strive to localize and expand testing capacities to meet growing global demand. This competitive landscape is dominated by major players such as Syneos Health Inc., Charles River Laboratories Inc., Laboratory Corporation of America, ICON Plc, SGS SA, Medpace, and PRA Health Sciences, a subsidiary of Takeda Pharmaceutical Company.

In response to the escalating need for advanced testing capabilities, several companies have recently invested heavily in facility expansions and new operations. For instance, in June 2025, Pace Life Sciences announced expansions to its facilities in Salem, New Hampshire, and Oakdale, Minnesota. These upgrades included the addition of sterile fill-finish and analytical capacities specifically designed for biologics and gene therapies.

In May 2025, Ardena opened a new bioanalytical laboratory spanning over 3,000 square feet in the Netherlands. Equipped with state-of-the-art technologies such as LC-MS/MS and Gyrolab systems for analyzing small and large molecules, this facility significantly enhances Ardena's capacity to support clinical trials.

Core Growth Drivers

The surge in demand for bioanalytical services is closely tied to the increasing complexity of the global therapeutic pipeline. In 2024, the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) approved 50 new molecular entities (NMEs), reflecting a robust pace of drug innovation and development. This growing number of new approvals underscores the expanding need for comprehensive bioanalytical testing to support the evaluation and validation of these novel therapies. A notable aspect of this trend is the significant rise in biologic entities (NBEs), with 18 of the approved NMEs in 2024 classified as biologics.

Emerging Opportunity Trends

One of the most promising and lucrative opportunities in the bioanalytical services market lies at the intersection of rare diseases and precision medicine. The growing focus on developing targeted therapies for rare conditions has opened new avenues for innovation and specialization within the industry. In 2024, the U.S. Food and Drug Administration (FDA) approved 25 novel drugs specifically aimed at treating rare diseases, highlighting the increasing attention and investment in this niche yet critical area of healthcare. These drug development programs frequently rely on biomarkers as surrogate endpoints to evaluate therapeutic effectiveness, especially when traditional clinical endpoints may be difficult to measure due to the small patient populations involved.

Barriers to Optimization

Regulatory complexities present a significant challenge in the validation of bioanalytical methods for novel therapeutics, potentially hindering the growth of the bioanalytical services market. As the development of innovative drugs and therapies advances, regulatory bodies have imposed increasingly stringent requirements to ensure the safety, efficacy, and quality of these new treatments. Navigating these complex regulations demands rigorous validation processes, which can be time-consuming and resource-intensive for bioanalytical service providers.

Detailed Market Segmentation

By Test Type, Cell-based assays have become a cornerstone of the bioanalytical services market, securing a commanding 46.1% share as of 2025. This dominant position highlights the crucial role these assays play in the pharmaceutical and biotechnology industries. Unlike traditional biochemical tests, cell-based assays offer the unique advantage of delivering physiologically relevant data by closely mimicking the natural biological environment. This ability to provide insights into cellular responses and interactions makes them indispensable tools in modern drug discovery and development, where understanding the complex dynamics of living cells is essential for evaluating drug efficacy and safety.

By Molecule Type, small molecules maintain a dominant position in the bioanalytical services market, capturing over 55.4% of the total market share. This significant share underscores the vital role small molecules play within the pharmaceutical and biotechnology industries. Due to their relatively simple structure and widespread application, small molecules have long been the foundation of drug development and therapeutic interventions, driving consistent demand for specialized bioanalytical testing. The extensive global focus on small molecule research and development further elevates the importance of this segment within the bioanalytical services landscape.

By End Users, Pharmaceutical and biotechnology firms stand as the dominant players in the bioanalytical services market, accounting for roughly 52.9% of the overall market share. This substantial influence is primarily driven by their significant financial investments in research and development activities. These companies are at the forefront of developing new drugs and therapies, necessitating extensive bioanalytical testing to ensure the safety, efficacy, and quality of their products. Their commitment to innovation and the advancement of medical science fuels a continuous demand for specialized bioanalytical services.

By Application, in 2025, oncology established itself as the most prominent application segment within the bioanalytical services market, commanding over 32.42% of the total market share. This leading position reflects the urgent and growing global health challenge posed by cancer, which continues to be one of the most critical areas of medical research and treatment development worldwide. The high prevalence and complexity of cancer drive substantial investment in oncology-focused clinical trials, which in turn fuels demand for specialized bioanalytical services.

Segment Breakdown

• By Test Type
• Cell-based Assays
• Virology Testing
• Biomarker Assays

By Molecule Type

• Small Molecule Bioanalysis
• Large Molecule Bioanalysis
• Others

By Application

• Oncology
• Neurology
• Infectious Diseases
• Gastroenterology
• Cardiology
• Others

By End User

• Pharma & Biotechnology Companies
• Contract Research Organizations
• Others

By Region

• North America
• The U.S.
• Canada
• Mexico
• Europe
• Western Europe
• The UK
• Germany
• France
• Italy
• Spain
• Rest of Western Europe
• Eastern Europe
• Poland
• Russia
• Rest of Eastern Europe
• Asia Pacific
• China
• India
• Japan
• Australia & New Zealand
• South Korea
• ASEAN
• Rest of Asia Pacific
• Middle East & Africa (MEA)
• Saudi Arabia
• South Africa
• UAE
• Rest of MEA
• South America
• Argentina
• Brazil
• Rest of South America

Geography Breakdown

• In 2025, North America holds a commanding 45% share of the bioanalytical services market, establishing itself as the clear leader in this sector. This strong position is largely due to the region's unparalleled clinical trial ecosystem, which provides a robust foundation for sustained growth. The United States, in particular, stands out with an exceptionally high concentration of research activity, evidenced by the registration of 162,904 clinical studies as of December 2024. This substantial number of ongoing trials generates a steady and dependable flow of samples to local laboratories, ensuring continuous demand for bioanalytical services.
• Beyond the volume of research, North America's regulatory environment plays a crucial role in reinforcing the region's market dominance. The regulatory framework not only supports but actively encourages rigorous clinical research and development activities, creating a favorable atmosphere for innovation and growth.

Leading Market Participants

• PPD, Inc.
• ICON Plc
• Charles River Laboratories International
• Covance, Inc.
• IQVIA
• Syneos Health
• SGS SA
• Toxikon
• Intertek Group Plc
• Pace Analytical Services LLC
• NorthEast BioLab
• CD BioSciences
• Eurofins Scientific SE
• Other Prominent Players

Table of Content

Chapter 1. Research Framework

• 1.1. Research Objective
• 1.2. Product Overview
• 1.3. Market Segmentation

Chapter 2. Research Methodology

• 2.1. Qualitative Research
  • 2.1.1. Primary & Secondary Sources
• 2.2. Quantitative Research
  • 2.2.1. Primary & Secondary Sources
• 2.3. Breakdown of Primary Research Respondents, By Region
• 2.4. Assumption for the Study
• 2.5. Market Size Estimation
• 2.6. Data Triangulation

Chapter 3. Executive Summary: Global Bioanalytical Service Market

Chapter 4. Global Bioanalytical Service Market Overview

• 4.1. Industry Value Chain Analysis
  • 4.1.1. Sample Collection
  • 4.1.2. Sample Preparation & Validation
  • 4.1.3. Service Provider
  • 4.1.4. End User
• 4.2. Industry Outlook
  • 4.2.1. Advancement in bioanalytical Techniques for Biotherapeutics
• 4.3. PESTLE Analysis
• 4.4. Porter's Five Forces Analysis
  • 4.4.1. Bargaining Power of Suppliers
  • 4.4.2. Bargaining Power of Buyers
  • 4.4.3. Threat of Substitutes
  • 4.4.4. Threat of New Entrants
  • 4.4.5. Degree of Competition
• 4.5. Market Dynamics and Trends
  • 4.5.1. Growth Drivers
  • 4.5.2. Restraints
  • 4.5.3. Challenges
  • 4.5.4. Key Trends
• 4.6. Covid-19 Impact Assessment on Market Growth Trend
• 4.7. Market Growth and Outlook
  • 4.7.1. Market Revenue Estimates and Forecast (US$ Bn), 2020 - 2035
  • 4.7.2. Price Trend Analysis, By Type Test
• 4.8. Competition Dashboard
  • 4.8.1. Market Concentration Rate
  • 4.8.2. Company Market Share Analysis (Value %), 2025
  • 4.8.3. Competitor Mapping

Chapter 5. Bioanalytical Service Market Analysis, By Test Type

• 5.1. Key Insights
• 5.2. Market Size and Forecast, 2020 - 2035 (US$ Bn)
  • 5.2.1. Cell-based Assays
    • 5.2.1.1. Bacterial cell-based assays
    • 5.2.1.2. Viral cell-based assays
  • 5.2.2. Virology Testing
    • 5.2.2.1. In Vitro Virology Testing
    • 5.2.2.2. In Vivo Virology Testing
  • 5.2.3. Species-specific Viral PCR Assays
  • 5.2.4. Method Development Optimization and Validation
  • 5.2.5. Serology, Immunogenicity, and Neutralizing Antibodies
  • 5.2.6. Biomarker Assays
    • 5.2.6.1. LBA/LC-MS/MS
  • 5.2.7. Pharmacokinetic Testing
  • 5.2.8. Bioavailability Studies
  • 5.2.9. Bioequivalence Studies
  • 5.2.10. Others

Chapter 6. Bioanalytical Service Market Analysis, By Molecule Type

• 6.1. Key Insights
• 6.2. Market Size and Forecast, 2020 - 2035 (US$ Bn)
  • 6.2.1. Small Molecule Bioanalysis
  • 6.2.2. Large Molecule Bioanalysis
  • 6.2.3. Others

Chapter 7 Bioanalytical Service Market Analysis, By Application

• 7.1. Key Insights
• 7.2. Market Size and Forecast, 2020 - 2035 (US$ Bn)
  • 7.2.1. Oncology
  • 7.2.2. Neurology
  • 7.2.3. Infectious Diseases
  • 7.2.4. Gastroenterology
  • 7.2.5. Cardiology
  • 7.2.6. Others

Chapter 8. Bioanalytical Service Market Analysis, By End User

• 8.1. Key Insights
• 8.2. Market Size and Forecast, 2020 - 2035 (US$ Bn)
  • 8.2.1. Pharma & Biotechnology Companies
  • 8.2.2. Contract Research Organizations
  • 8.2.3. Others

Chapter 9. Global Bioanalytical Service Market Analysis, By Region

• 9.1. Key Insights
• 9.2. Market Size and Forecast, 2020 - 2035 (US$ Bn)
  • 9.2.1. North America
    • 9.2.1.1. The U.S.
    • 9.2.1.2. Canada
    • 9.2.1.3. Mexico
  • 9.2.2. Europe
    • 9.2.2.1. Western Europe
      • 9.2.2.1.1. The UK
      • 9.2.2.1.2. Germany
      • 9.2.2.1.3. France
      • 9.2.2.1.4. Italy
      • 9.2.2.1.5. Spain
      • 9.2.2.1.6. Rest of Western Europe
    • 9.2.2.2. Eastern Europe
      • 9.2.2.2.1. Poland
      • 9.2.2.2.2. Russia
      • 9.2.2.2.3. Rest of Eastern Europe
  • 9.2.3. Asia Pacific
    • 9.2.3.1. China
    • 9.2.3.2. India
    • 9.2.3.3. Japan
    • 9.2.3.4. South Korea
    • 9.2.3.5. Australia & New Zealand
    • 9.2.3.6. ASEAN
    • 9.2.3.7. Rest of Asia Pacific
  • 9.2.4. Middle East & Africa (MEA)
    • 9.2.4.1. UAE
    • 9.2.4.2. Saudi Arabia
    • 9.2.4.3. South Africa
    • 9.2.4.4. Rest of MEA
    • 9.2.3.7. Rest of Asia Pacific
  • 9.2.5. South America
    • 9.2.5.1. Brazil
    • 9.2.5.2. Argentina
    • 9.2.5.3. Rest of South America

Chapter 10. North America Bioanalytical Service Market Analysis

• 10.1. Key Insights
• 10.2. Market Size and Forecast, 2020 - 2035 (US$ Bn)
  • 10.2.1. By Test Type
  • 10.2.2. By Molecule Type
  • 10.2.3. By Application
  • 10.2.4. By End User
  • 10.2.5. By Country

Chapter 11. Europe Bioanalytical Service Market Analysis

• 11.1. Key Insights
• 11.2. Market Size and Forecast, 2020 - 2035 (US$ Bn)
  • 11.2.1. By Test Type
  • 11.2.2. By Molecule Type
  • 11.2.3. By Application
  • 11.2.4. By End User
  • 11.2.5. By Country

Chapter 12. Asia Pacific Bioanalytical Service Market Analysis

• 12.1. Key Insights
• 12.2. Market Size and Forecast, 2020 - 2035 (US$ Bn)
  • 12.2.1. By Test Type
  • 12.2.2. By Molecule Type
  • 12.2.3. By Application
  • 12.2.4. By End User
  • 12.2.5. By Country

Chapter 13. Middle East & Africa Bioanalytical Service Market Analysis

• 13.1. Key Insights
• 13.2. Market Size and Forecast, 2020 - 2035 (US$ Bn)
  • 13.2.1. By Test Type
  • 13.2.2. By Molecule Type
  • 13.2.3. By Application
  • 13.2.4. By End User
  • 13.2.5. By Country

Chapter 14. South America Bioanalytical Service Market Analysis

• 14.1. Key Insights
• 14.2. Market Size and Forecast, 2020 - 2035 (US$ Bn)
  • 14.2.1. By Test Type
  • 14.2.2. By Molecule Type
  • 14.2.3. By Application
  • 14.2.4. By End User
  • 14.2.5. By Country

Chapter 15. Company Profile (Company Overview, Financial Matrix, Key Product landscape, Key Personnel, Key Competitors, Contact Address, and Business Strategy Outlook)

• 15.1. PPD, Inc.
• 15.2. ICON Plc
• 15.3. Charles River Laboratories International
• 15.4. Covance, Inc.
• 15.5. IQVIA
• 15.6. Syneos Health
• 15.7. SGS SA
• 15.8. Toxikon
• 15.9. Intertek Group Plc
• 15.10. Pace Analytical Services LLC
• 15.11. NorthEast BioLab
• 15.12. CD BioSciences
• 15.13. Eurofins Scientific SE
• 15.14. Others