全球临床诊断展望（2025年）

在新型生物标记、数位服务和自动化的推动下，分子诊断和就地检验(POCT) 变得更加准确、高效，并且可以更早发现疾病。

随着相关人员将注意力转向精准医疗、分散式诊断、软体主导解决方案和产品拓展等高成长领域，全球临床诊断市场预计将迎来强劲成长。各公司持续采用实验室资讯管理系统 (LIMS) 和其他数位化平台，而即时诊断 (POCT) 领域的新商机也进一步推动了市场发展动能。老年人口的成长持续推动慢性病检测的需求。同时，技术进步为基因和生物标记检测带来了新的可能性，使相关人员能够优先考虑个人化医疗，尤其是在那些大力投资临床诊断和医疗基础设施的新兴经济体。

创新者正越来越多地透过基于软体的解决方案和广泛的产品系列来定义这一格局。液态切片技术的开发者透过实现对循环性肿瘤细胞和游离 DNA 的非侵入性检测，彻底改变了癌症诊断。这种转变加剧了传统组织切片检查提供者和分子诊断公司之间的竞争。液态切片测试的日益普及，例如 Delfi Diagnostics 的 FirstLook Lung (LDT) 和 Guardant Health 的用于早期发现结肠癌的 Shield 血液测试，反映了向个性化、非侵入性诊断的转变。製药公司正在透过投资基于生物标记的测试来推动这一趋势，将癌症诊断和罕见疾病诊断定位为关键成长领域。精准医疗和分子诊断的持续进步将提高预测测试的准确性和扩充性。

亚太地区 (APAC) 持续推动市场快速成长。分析师预测，随着印度和中国等国家大规模采用数位病理学和价格合理的分子诊断技术，到 2025 年，该市场的收入将实现两位数成长。华大智造等公司正透过推出自动化次世代定序(NGS) 解决方案来满足这项需求，以扩大诊断管道。此外，华大智造与圣马丁德波雷斯大学合作，透过应用 NGS 识别遗传风险因素并支持未来的公共卫生倡议，从而加强基因研究。在这些市场中，政府主导的医疗改革正在推动产业的长期扩张。

与此同时，大型公司继续在美国看到巨大的商机。行业领导者正在加速整合，透过收购利基技术供应商来增强其产品组合。例如，丹纳赫透过收购Abcam增强了其蛋白质研究和诊断能力。此次整合透过将创新产品融入其现有产品线，推动其2024年的销售额成长10%。

要在2025年取得成功，企业必须行动敏捷，投资高价值领域，并优先考虑创新。拥抱人工智慧、扩展去中心化测试并进入新兴市场的公司将最有可能实现持续成长。

范围：本研究服务提供临床诊断市场的全球展望和2025年至2030年的五年收益预测。研究涵盖四个地区：北美、欧洲、亚太、中东、北非和南亚（MENASA）以及拉丁美洲（LATAM）。

市场区隔涵盖三个核心部分：

1. 重点检测：包括临床化学和免疫检测(CC&IA)、血液学、止血学和分子诊断。本调查详细涵盖了 CC&IA 和分子诊断。

2. 转诊和周边检查：包括组织学诊断和临床微生物学，提供组织学诊断的详细见解。

3.分散式检查：包括POCT和自我血糖监测（SMBG），重点在于POCT部分。

目录

分析亮点

• 2024 年临床诊断产业：预测与表现
• 过去分析
• 2025 年临床诊断主要预测

战略问题

• 为何成长变得越来越困难？
• The Strategic Imperative 8（TM）
• 三大策略挑战对临床诊断产业的影响
• 成长机会驱动Growth Pipeline Engine（TM）™

成长环境

• 分割
• 成长环境

宏观经济因素

• 2024年全球经济成长率将达3.2%，超出预期
• 川普2.0：经济成长放缓与通膨压力
• 全球经济成长放缓至2.8%，2025年避免景气衰退；中国经济疲软拖累亚太地区经济成长
• 2025年全球经济成长将放缓至2.8%，景气衰退已避免；中国经济疲软将拖累亚太地区经济前景
• 全球宏观经济变迁与韧性策略：技术整合、研发与敏捷生产生态系统确保短期韧性

美国关税的影响

• 美国关税：2025年分析
• 美国关税：对临床诊断产业主要相关人员的影响
• 贸易关税正在重塑全球供应链

2025年收益趋势

• 预测考虑因素
• 临床诊断行业细分
• 各细分市场收益预测
• 各细分市场收益预测
• 集中检测分部收益预测
• 按细分市场的收益预测－建议测试、外围测试和分散式检查
• 集中测试、转诊测试、外围测试和分散式检查的最终用户分析
• 各地区收益预测
• 各地区收益预测分析
• 各地区收益预测分析
• 各地区收益预测分析
• 区域法规结构与报销政策

竞争环境

• 收益占有率
• 收益占有率分析
• 竞赛矩阵
• 值得关注的活动

2025 年预测：前 5 名

• 预测一：CDx 将推动精准医疗的新时代，并在 2025 年成为创新的基石
• 预测二：LIMS 整合将彻底改变生命科学，推动超过 20 亿美元的数据主导创新
• 预测三：多体学学诊断将带来疾病表征的模式转移
• 预测四：DaaS 将颠覆传统实验室，开启按需测试的新时代
• 预测五：去中心化分子检测将重新定义新兴市场的医疗保健服务，预计到 2025 年全球市场规模将超过 240 亿美元

临床诊断观点

• 2024年业界概况

CC&IA：2025

• CC&IA 产业概况
• CC&IA 产业：知名公司

分子诊断：2025

• 分子诊断产业概况
• 分子诊断产业：值得关注的公司

即时检验：2025

• POCT产业概况
• POCT产业：值得关注的公司

组织诊断：2025

• 组织诊断行业概况
• 组织诊断产业：特色公司

成长机会领域

• 成长机会1：LIMS 辅助改进预测分析
• 增长机会二：伴随诊断CDx拓展至肿瘤学之外
• 增长机会3：多重即时检测，快速诊断抗菌药物抗药性

结论

• 结论与未来展望

后续步骤Next steps

• 成长机会的益处和影响
• 后续步骤Next steps
• 附表
• 免责声明

Driven by Novel Biomarkers, Digital Services, and Automation, Industry is Accelerating Precision, Efficiency, and Early Disease Detection in Molecular Diagnostics and Point-of-care Testing (POCT)

The global clinical diagnostics market is poised for strong growth as stakeholders shift focus toward high-growth segments such as precision medicine, decentralized diagnostics, software-driven solutions, and product expansion. Companies continue to adopt LIMS and other digital platforms while emerging opportunities in the POCT sector further drive market momentum. The growing elderly population continues to drive demand for chronic disease testing. At the same time, advances in technology are opening new possibilities in genetic and biomarker testing, allowing stakeholders to prioritize personalized medicine-particularly in developing countries that are investing heavily in clinical diagnostics and healthcare infrastructure.

Innovators are increasingly defining the landscape through software-based solutions and broader product portfolios. Developers of liquid biopsy technologies have transformed oncology diagnostics by enabling the non-invasive detection of circulating tumor cells and cell-free DNA. This shift has intensified competition between traditional tissue biopsy providers and molecular diagnostics firms. The growing adoption of liquid biopsy tests, such as Delfi Diagnostics' FirstLook Lung (LDT) and Guardant Health's Shield blood test for early colorectal cancer detection, reflects this transition toward personalized, non-invasive diagnostics. Pharmaceutical companies are driving this trend by investing in biomarker-based tests, which position oncology and rare disease diagnostics as key growth areas. Continued progress in precision medicine and molecular diagnostics enhances the accuracy and scalability of predictive testing.

Asia-Pacific (APAC) continues to drive the market's fastest growth. Analysts project double-digit sales increases in 2025, as countries like India and China adopt digital pathology and affordable molecular diagnostics at scale. Companies such as MGI Tech are meeting this demand by launching automated next-generation sequencing (NGS) solutions to expand diagnostic access. In collaboration with Universidad de San Martin de Porres, MGI also strengthens genetic research by applying NGS to identify genetic risk factors that support future public health initiatives. Across these markets, government-led healthcare reforms are enabling long-term industry expansion.

Meanwhile, large companies continue to find substantial opportunities in the United States. Industry leaders are accelerating consolidation by acquiring niche technology providers to enhance their portfolios. For example, Danaher strengthened its protein research and diagnostics capabilities by acquiring Abcam. This integration contributed to a 10% revenue increase over 2024 by incorporating innovative products into existing offerings.

To succeed in 2025, companies must act with agility, invest in high-value areas, and prioritize innovation. Those that adopt AI, expand decentralized testing, and enter emerging markets will be best positioned for sustained growth.

Scope of Study This research service provides a global outlook for the clinical diagnostics market, along with a 5-year revenue forecast from 2025 to 2030. The geographic scope includes four regions: North America, Europe, APAC, the Middle East, North Africa and South Asia (MENASA), and Latin America (LATAM).

The market analysis covers three core segments:

1. Centralized Testing: Includes clinical chemistry and immunoassays (CC&IA), hematology, hemostasis, and molecular diagnostics. The study provides detailed coverage of CC&IA and molecular diagnostics.

2. Referral and Peripheral Testing: Includes tissue diagnostics and clinical microbiology, with detailed insights into tissue diagnostics.

3. Decentralized Testing: Includes POCT and self-monitoring blood glucose (SMBG), with an in-depth focus on the POCT segment.

Table of Contents

Analysis Highlights

• The 2024 Clinical Diagnostics Industry: Forecast vs. Actual
• Historical Analytics
• Top Clinical Diagnostics Predictions for 2025

Strategic Imperatives

• Why is it Increasingly Difficult to Grow?
• The Strategic Imperative 8™
• The Impact of the Top 3 Strategic Imperatives on the Clinical Diagnostics Industry
• Growth Opportunities Fuel the Growth Pipeline Engine™

Growth Environment

• Segmentation
• Growth Environment

Macroeconomic Factors

• Global Economy Beat Expectations in 2024, Growing at 3.2%
• Trump 2.0 to Drive Growth Slowdown and Inflationary Pressures
• Global Growth Slowdown to 2.8%, Avoiding a Recession in 2025; Weaker China to Weigh on Asia Pacific Growth
• Global Growth Slows to 2.8% in 2025, Recession Averted; Weaker China Expected to Weigh on APAC Outlook
• Global Macroeconomic Shifts and Resilience Strategies: Tech Integration, R&D, and Agile Production Ecosystems Will Ensure Short-term Resiliency

Impact of US Tariffs

• US Tariffs-2025 Analysis
• US Tariffs-Implications for Key Stakeholders in the Clinical Diagnostics Industry
• Global Supply Chains Are Being Reshaped by Trade Tariffs, Which Will Drive Decentralization and Open New Growth Opportunities in the Clinical Diagnostics Industry

Revenue Trends, 2025

• Forecast Considerations
• Clinical Diagnostics Industry by Segment
• Revenue Forecast by Subsegment
• Revenue Forecast by Subsegment
• Revenue Forecast by Segment-Centralized Testing
• Revenue Forecast by Segment-Referral and Peripheral and Decentralized Testing
• End User Analysis for Centralized, Referral and Peripheral, and Decentralized Testing
• Revenue Forecast by Region
• Revenue Forecast Analysis by Region
• Revenue Forecast Analysis by Region
• Revenue Forecast Analysis by Region
• Regional Regulatory Framework and Reimbursement Policy

Competitive Environment

• Revenue Share
• Revenue Share Analysis
• Competitor Matrix
• Notable Activities

Top 5 Predictions-2025

• Prediction 1-CDx to Drive the Next Era of Precision Medicine, Becoming the Cornerstone of Innovation by 2025
• Prediction 2-LIMS Integration to Revolutionize Life Sciences, Driving Data-driven Innovation Beyond $2 Billion
• Prediction 3-Multi-omics Diagnostics to Propel a Paradigm Shift in Disease Characterization
• Prediction 4-DaaS to Disrupt Traditional Labs and Usher in a New Era of On-demand Testing
• Prediction 5-Decentralized Molecular Testing to Redefine Healthcare Access in Emerging Markets, with Global Market Expected to Surpass $24 Billion by 2025

Clinical Diagnostics Outlook

• 2024 Industry Snapshot

CC&IA-2025

• CC&IA Industry Snapshot
• CC&IA Industry-Companies to Watch

Molecular Diagnostics-2025

• Molecular Diagnostics Industry Snapshot
• Molecular Diagnostics Industry-Companies to Watch

POCT-2025

• POCT Industry Snapshot
• POCT Industry-Companies to Watch

Tissue Diagnostics-2025

• Tissue Diagnostics Industry Snapshot
• Tissue Diagnostics Industry-Companies to Watch

Growth Opportunity Universe

• Growth Opportunity 1: LIMS for Improved Predictive Analysis
• Growth Opportunity 2: Companion Diagnostics CDx Expanding Beyond Oncology
• Growth Opportunity 3: Multiplex POCT for Rapid AMR Antimicrobial Resistance Diagnostics

Conclusions

• Conclusions and Future Outlook

Next Steps

• Benefits and Impacts of Growth Opportunities
• Next Steps
• List of Exhibits
• Legal Disclaimer