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市場調查報告書
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1896975

全球生物分析服務市場：按檢測類型、分子類型、應用和最終用戶劃分－產業動態、市場規模及預測（2026-2035 年）

Global Bioanalytical Services Market: By Test Type, Molecule Type, Application, End User - Industry Dynamics, Market Size and Opportunity Forecast for 2026-2035
出版日期: | 出版商: Astute Analytica | 英文 166 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

生物分析服務市場正處於顯著成長的開端，預計營收將從 2025 年的 39.6 億美元大幅成長至 2035 年的 116.1 億美元。這意味著在 2026 年至 2035 年的預測期內，複合年增長率將達到 11.6%。這一強勁的成長反映了全球製藥和生物技術產業對生物分析服務日益增長的重要性和依賴性。

推動這一成長趨勢的因素有很多。藥物研發領域對先進分析技術的需求不斷增長是主要推動因素，因為現代療法需要高度精確可靠的檢測才能滿足嚴格的監管標準。精準醫療的進步也在推動這項需求。這是因為個人化治療需要更複雜、更個人化的生物分析評估。 此外，持續的技術創新正為實驗室配備先進的工具和研究方法，從而提升其能力和效率。除了這些技術和科學因素外，新興市場不斷湧現的機會也顯著推動了市場成長。

市場趨勢概覽

生物分析服務市場目前正經歷一場激烈的“基礎設施軍備競賽”，各大公司競相實現檢測能力的本地化和擴展，以滿足日益增長的全球需求。引領此競爭格局的主要企業包括 Syneos Health Inc.、Charles River Laboratories Inc.、Laboratory Corporation of America、ICON Plc、SGS SA、Medpace 以及武田藥品工業株式會社的子公司 PRA Health Sciences。

為了因應先進偵測能力日益增長的需求，多家公司近期對設施擴建和新業務進行了大量投資。例如，Pace Life Sciences 於 2025 年 6 月宣布將在新罕布夏州塞勒姆和明尼蘇達州奧克代爾擴建設施。 這些升級包括新增無菌填充和包裝能力，以及專為生物製藥和基因治療藥物設計的分析能力。

2025年5月，Ardena在荷蘭開設了一家新的生物分析實驗室，佔地超過3000平方英尺。該實驗室配備了LC-MS/MS和Gyrolab系統等尖端技術，可進行大小分子分析，顯著提升了公司在臨床試驗支援方面的能力。

核心成長驅動因子

對生物分析服務需求的快速成長與全球治療藥物研發管線的日益複雜度密切相關。 2024年，美國食品藥物管理局（FDA）藥物評估與研究中心（CDER）批准了50種新分子實體（NME），這反映了藥物發現和開發的強勁勢頭。新核准藥物數量的增加凸顯了對全面生物分析檢測的需求不斷增長，以支持這些新型療法的評估和驗證。 這一趨勢中值得關注的是非生物工程藥物 (NBE) 的顯著增長，2024 年獲批的 18 種新分子實體 (NME) 被歸類為生物製劑。

新興機會趨勢

生物分析服務市場中最具前景和利潤豐厚的機會之一在於罕見疾病和精準醫療的交叉領域。人們越來越關注開發針對罕見疾病的標靶療法，這為業界的創新和專業化開闢了新的途徑。 2024 年，美國食品藥物管理局 (FDA) 批准了 25 種用於治療罕見疾病的新藥，凸顯了人們對這一小眾但重要的醫學領域日益增長的關注和投資。這些藥物開發計畫經常使用生物標記作為替代終點來評估治療效果，尤其是在患者群體較小，難以衡量傳統臨床終點的情況下。

優化障礙

監管的複雜性為新型療法的生物分析方法驗證帶來了重大挑戰，可能阻礙生物分析服務市場的成長。隨著創新藥物和療法的不斷湧現，監管機構提出了日益嚴格的要求，以確保這些新療法的安全性、有效性和品質。遵守這些複雜的法規需要嚴格的驗證流程，這對生物分析服務提供者來說既耗時又耗費資源。

目錄

第一章：研究架構

  • 研究目標
  • 產品概述
  • 市場區隔

第二章：研究方法

  • 質性研究
    • 一手和二手資料來源
  • 量化研究
    • 一手和二手資料來源
  • 按地區劃分的一手調查受訪者組成
  • 研究假設
  • 市場規模估算
  • 資料三角驗證

第三章：摘要整理：全球生物分析服務市場

第四章：全球生物分析服務市場

  • 產業價值鏈分析
    • 樣本採集
    • 樣品製備與驗證
    • 服務提供者
    • 最終用戶
  • 行業展望
    • 生物治療生物分析技術的進步
  • PESTLE 分析
  • 波特五力分析
    • 供應商議價能力
    • 買方議價能力
    • 替代品威脅
    • 新進入者威脅
    • 競爭強度
  • 市場動態與趨勢
    • 成長驅動因素
    • 限制因素
    • 挑戰
    • 主要趨勢
  • 影響評估新冠疫情對市場成長趨勢的影響
  • 市場成長與展望
    • 市場收入估計與預測（2020-2035）
    • 價格趨勢分析（依檢測類型）
  • 競爭格局概覽
    • 市場集中度
    • 公司市佔率分析（價值百分比），2025
    • 競爭格局圖

第五章 生物分析服務市場分析（依檢測類型）

  • 主要見解
  • 市場規模與預測，2020-2035
    • 細胞檢測
    • 病毒學檢測
    • 物種特異性病毒PCR檢測
    • 方法開發、最佳化與驗證
    • 血清學檢測免疫原性和中和抗體
    • 生物標記檢測
    • 藥物動力學研究
    • 生物利用度試驗
    • 生物等效性試驗
    • 其他

第六章：以分子類型劃分的生物分析服務市場分析

  • 主要見解
  • 市場規模及預測（2020-2035）
  • 小分子生物分析
  • 大分子生物分析
  • 其他

第七章：按應用劃分的生物分析服務市場分析

  • 主要見解
  • 市場規模及預測（2020-2035）
    • 腫瘤學
    • 神經病學
    • 傳染病學
    • 胃腸病學
    • 心臟病學
    • 其他

第八章：依最終使用者劃分的生物分析服務市場分析

  • 主要見解
  • 市場規模及預測（2020-2035）
    • 製藥和生技公司
    • 合約研究組織
    • 其他

第九章：按地區劃分的全球生物分析服務市場分析

  • 主要見解
  • 市場規模及預測（2020-2035）
    • 北美
    • 歐洲
    • 亞太地區
    • 中東和非洲（中東和非洲）
    • 南美洲

第十章：北美生物分析服務市場分析

第十一章：歐洲生物分析服務市場分析

第十二章：亞太地區生物分析服務市場分析

第十三章：中東與非洲生物分析服務市場分析

第十四章：南美洲生物分析服務市場分析

第十五章：公司簡介

  • PPD公司
  • ICON公司
  • 查爾斯河實驗室國際公司
  • 科文斯公司
  • IQVIA
  • Syneos Health
  • SGS SA
  • Toxikon
  • Intertek集團股份有限公司
  • Pace Analytical Services LLC
  • NorthEast BioLab
  • CD BioSciences
  • Eurofins Scientific SE
  • 其他
簡介目錄
Product Code: AA1024952

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