实验室开发的测试市场- 按测试类型（临床生物化学、免疫学、血液学、微生物学、分子诊断、流式细胞仪、组织学/细胞学）、应用（肿瘤学、遗传学、神经学） 、最终用途和预测，2024 - 2032

由于诊断技术的进步以及不断变化的监管变化和指南，全球实验室开发的测试市场从 2024 年到 2032 年的复合年增长率将达到 6.4%。这些发展使实验室能够快速创建和部署高度专业化的测试，以更高的准确性和效率满足不同的临床需求。法规更新确保严格的品质保证，增强人们对 LDT 可靠性和安全性的信心。随着医疗保健转向个人化医疗，对根据患者个体情况量身定制的 LDT 的需求将会增长，从而推动诊断创新这一关键领域的显着扩张。

例如，2024 年 4 月，FDA 发布了一项最终规则，将实验室开发的测试 (LDT) 定义为体外诊断，并根据 FD&C 法案接受 FDA 的监督，这标誌着美国对 LDT 的监管发生重大转变。这项发展意味着 LDT 的开发、验证和行销方式可能会发生变化，从而影响合规要求、创新时间表和市场进入策略。在全球范围内，这种监管转变可能会影响 LDT 的国际标准，进而影响市场动态，包括竞争力、创新步伐以及患者获得先进诊断技术的机会。

实验室开发的测试行业根据测试类型、应用、最终用途和地区进行分类。

由于其在诊断代谢紊乱、荷尔蒙失衡和其他健康状况方面的关键作用，临床生化领域将在 2024 年至 2032 年间显着增长。随着医疗保健提供者越来越依赖生化检测来进行精确的患者评估和治疗监测，对先进 LDT 的需求不断增长。这部分的重点是分析生物标记和生化参数，为个人化医疗计划提供至关重要的支持，确保准确的诊断和治疗干预。随着分析技术的不断进步，临床生物化学仍然处于最前沿，塑造着诊断测试的未来。

凭藉其提供综合诊断解决方案的专业能力的推动，诊断中心部门到 2032 年将取得显着收益。这些中心提供根据患者个别需求量身定制的各种 LDT，包括基因检测和个人化医疗。随着医疗保健需求的增加和对早期疾病检测的关注，诊断中心在扩大先进诊断的覆盖范围方面发挥关键作用。他们与医疗保健提供者的策略合作以及对品质保证的承诺使他们在实验室开发的测试市场前景中占据显着地位。

在医疗保健基础设施快速发展和个人化医疗需求不断增长的推动下，亚太地区将在 2024 年至 2032 年间获得大量市场份额。该地区庞大的人口、不断增加的医疗保健支出以及先进诊断技术的采用促成了其主导地位。随着慢性病和传染病负担的日益加重，亚太地区对全球实验室开发的检测行业增长的贡献是巨大的，强调了其作为医疗保健诊断和患者护理进步的关键贡献者的作用。

目录

第 1 章：方法与范围

第 2 章：执行摘要

第 3 章：产业洞察

• 产业生态系统分析
• 产业影响力
  • 成长动力
    • 癌症和遗传性疾病发生率增加
    • 传染病和慢性病盛行率上升
    • 提高对早期疾病检测的认识与关注
  • 产业陷阱与挑战
    • 替代测试方法的可用性
• 成长潜力分析
• 监管环境
• 报销场景
• 技术进步
• 波特的分析
• PESTEL分析
• 未来市场趋势

第 4 章：竞争格局

• 介绍
• 公司矩阵分析
• 公司市占率分析
• 竞争定位矩阵
• 战略仪表板

第 5 章：市场估计与预测：按测试类型，2021 - 2032 年

• 主要趋势
• 临床生化
• 免疫学
• 血液学
• 微生物学
• 分子诊断
• 流式细胞仪
• 组织学/细胞学
• 其他测试类型

第 6 章：市场估计与预测：按应用分类，2021 - 2032

• 主要趋势
• 肿瘤学
• 遗传学
• 传染病
• 自体免疫疾病
• 神经病学
• 精神/行为障碍
• 营养与代谢疾病
• 其他应用

第 7 章：市场估计与预测：按最终用途，2021 - 2032 年

• 主要趋势
• 医院实验室
• 诊断中心
• 临床研究机构
• 学术及研究机构
• 其他最终用户

第 8 章：市场估计与预测：按地区划分，2021 - 2032 年

• 主要趋势
• 北美洲
  • 我们
  • 加拿大
• 欧洲
  • 德国
  • 英国
  • 法国
  • 义大利
  • 西班牙
  • 荷兰
  • 欧洲其他地区
• 亚太地区
  • 中国
  • 日本
  • 印度
  • 澳洲
  • 韩国
  • 亚太地区其他地区
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
  • 拉丁美洲其他地区
• 中东和非洲
  • 沙乌地阿拉伯
  • 南非
  • 阿联酋
  • 中东和非洲其他地区

第 9 章：公司简介

• 23andMe, Inc.
• Abbott
• Bio-Rad Laboratories, Inc.
• Eurofins Scientific
• F. Hoffmann-La Roche Ltd.
• Illumina, Inc.
• NeoGenomics Laboratories
• OPKO Health, Inc.
• QIAGEN
• Quest Diagnostics Incorporated

Global Laboratory Developed Tests Market will reach a 6.4% CAGR from 2024 to 2032, attributed to advancements in diagnostic technologies along with evolving regulatory changes and guidelines. These developments enable labs to create and deploy highly specialized tests swiftly, catering to diverse clinical needs with greater accuracy and efficiency. Regulatory updates ensure rigorous quality assurance, boosting confidence in LDTs' reliability and safety. As healthcare shifts towards personalized medicine, the demand for LDTs tailored to individual patient profiles will grow, driving noteworthy expansion in this pivotal segment of diagnostic innovation.

For instance, in April 2024, the FDA issued a final rule defining laboratory-developed tests (LDTs) as in vitro diagnostics, subjecting them to FDA oversight under the FD&C Act, marking a significant regulatory shift for LDTs in the US. This development implies potential shifts in how LDTs are developed, validated, and marketed, impacting compliance requirements, innovation timelines, and market entry strategies. Globally, this regulatory shift may influence international standards for LDTs, affecting market dynamics, including competitiveness, innovation pace, and patient access to advanced diagnostic technologies.

The laboratory-developed tests industry is classified based on test type, application, end-use, and region.

The clinical biochemistry segment will see a notable surge between 2024 and 2032, owing to its pivotal role in diagnosing metabolic disorders, hormonal imbalances, and other health conditions. As healthcare providers increasingly rely on biochemical assays for precise patient assessment and treatment monitoring, the demand for advanced LDTs grows. This segment's focus on analyzing biomarkers and biochemical parameters crucially supports personalized medicine initiatives, ensuring accurate diagnostics and therapeutic interventions. With ongoing advancements in analytical techniques, clinical biochemistry remains at the forefront, shaping the future of diagnostic testing.

The diagnostic centers segment will amass remarkable gains through 2032, propelled by its specialized capabilities in providing comprehensive diagnostic solutions. These centers offer a wide array of LDTs tailored to individual patient needs, including genetic testing and personalized medicine. With increasing healthcare demands and a focus on early disease detection, diagnostic centers play a critical role in expanding access to advanced diagnostics. Their strategic collaborations with healthcare providers and commitment to quality assurance position them prominently in the laboratory developed tests market outlook.

Asia Pacific will secure a substantial market presence from 2024 to 2032, driven by rapid healthcare infrastructure development and rising demand for personalized medicine. The region's expansive population, increasing healthcare expenditure, and adoption of advanced diagnostic technologies contribute to its dominance. With a growing burden of chronic diseases and infectious ailments, Asia Pacific's contribution to the global laboratory developed tests industry growth is significant, emphasizing its role as a key contributor to advancements in healthcare diagnostics and patient care.

Table of Contents

Chapter 1 Methodology & Scope

• 1.1 Market scope & definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates & calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Increasing incidence of cancer and genetic disorders
    • 3.2.1.2 Rising prevalence of infectious and chronic diseases
    • 3.2.1.3 Growing awareness and focus on early disease detection
  • 3.2.2 Industry pitfalls & challenges
    • 3.2.2.1 Availability of alternative testing methods
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Reimbursement scenario
• 3.6 Technological advancements
• 3.7 Porter's analysis
• 3.8 PESTEL analysis
• 3.9 Future market trends

Chapter 4 Competitive Landscape, 2023

• 4.1 Introduction
• 4.2 Company matrix analysis
• 4.3 Company market share analysis
• 4.4 Competitive positioning matrix
• 4.5 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Test Type, 2021 - 2032 ($ Mn)

• 5.1 Key trends
• 5.2 Clinical biochemistry
• 5.3 Immunology
• 5.4 Haematology
• 5.5 Microbiology
• 5.6 Molecular diagnostics
• 5.7 Flow cytometry
• 5.8 Histology/Cytology
• 5.9 Other test types

Chapter 6 Market Estimates and Forecast, By Application, 2021 - 2032 ($ Mn)

• 6.1 Key trends
• 6.2 Oncology
• 6.3 Genetics
• 6.4 Infectious diseases
• 6.5 Autoimmune disorders
• 6.6 Neurology
• 6.7 Mental/behavioral disorder
• 6.8 Nutritional & metabolic diseases
• 6.9 Other applications

Chapter 7 Market Estimates and Forecast, By End-use, 2021 - 2032 ($ Mn)

• 7.1 Key trends
• 7.2 Hospital laboratories
• 7.3 Diagnostic centers
• 7.4 Clinical research organizations
• 7.5 Academic and research institutes
• 7.6 Other end-users

Chapter 8 Market Estimates and Forecast, By Region, 2021 - 2032 ($ Mn)

• 8.1 Key trends
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 UK
  • 8.3.3 France
  • 8.3.4 Italy
  • 8.3.5 Spain
  • 8.3.6 Netherlands
  • 8.3.7 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Australia
  • 8.4.5 South Korea
  • 8.4.6 Rest of Asia Pacific
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Mexico
  • 8.5.3 Argentina
  • 8.5.4 Rest of Latin America
• 8.6 Middle East and Africa
  • 8.6.1 Saudi Arabia
  • 8.6.2 South Africa
  • 8.6.3 UAE
  • 8.6.4 Rest of Middle East and Africa

Chapter 9 Company Profiles

• 9.1 23andMe, Inc.
• 9.2 Abbott
• 9.3 Bio-Rad Laboratories, Inc.
• 9.4 Eurofins Scientific
• 9.5 F. Hoffmann-La Roche Ltd.
• 9.6 Illumina, Inc.
• 9.7 NeoGenomics Laboratories
• 9.8 OPKO Health, Inc.
• 9.9 QIAGEN
• 9.10 Quest Diagnostics Incorporated