全球臨床診斷展望（2025年）

在新型生物標記、數位服務和自動化的推動下，分子診斷和就地檢驗(POCT) 變得更加準確、高效，並且可以更早發現疾病。

隨著相關人員將注意力轉向精準醫療、分散式診斷、軟體主導解決方案和產品拓展等高成長領域，全球臨床診斷市場預計將迎來強勁成長。各公司持續採用實驗室資訊管理系統 (LIMS) 和其他數位化平台，而即時診斷 (POCT) 領域的新商機也進一步推動了市場發展動能。老年人口的成長持續推動慢性病檢測的需求。同時，技術進步為基因和生物標記檢測帶來了新的可能性，使相關人員能夠優先考慮個人化醫療，尤其是在那些大力投資臨床診斷和醫療基礎設施的新興經濟體。

創新者正擴大透過基於軟體的解決方案和廣泛的產品系列來定義這一格局。液態切片技術的開發者透過實現對循環性腫瘤細胞和遊離 DNA 的非侵入性檢測，徹底改變了癌症診斷。這種轉變加劇了傳統組織切片檢查提供者和分子診斷公司之間的競爭。液態切片測試的日益普及，例如 Delfi Diagnostics 的 FirstLook Lung (LDT) 和 Guardant Health 的用於早期發現結腸癌的 Shield 血液測試，反映了向個性化、非侵入性診斷的轉變。製藥公司正在透過投資基於生物標記的測試來推動這一趨勢，將癌症診斷和罕見疾病診斷定位為關鍵成長領域。精準醫療和分子診斷的持續進步將提高預測測試的準確性和擴充性。

亞太地區 (APAC) 持續推動市場快速成長。分析師預測，隨著印度和中國等國家大規模採用數位病理學和價格合理的分子診斷技術，到 2025 年，該市場的收入將實現兩位數成長。華大智造等公司正透過推出自動化次世代定序(NGS) 解決方案來滿足這項需求，以擴大診斷管道。此外，華大智造與聖馬丁德波雷斯大學合作，透過應用 NGS 識別遺傳風險因素並支持未來的公共衛生舉措，從而加強基因研究。在這些市場中，政府主導的醫療改革正在推動產業的長期擴張。

與此同時，大型公司繼續在美國看到巨大的商機。行業領導者正在加速整合，透過收購利基技術供應商來增強其產品組合。例如，丹納赫透過收購Abcam增強了其蛋白質研究和診斷能力。此次整合透過將創新產品融入其現有產品線，推動其2024年的銷售額成長10%。

要在2025年取得成功，企業必須行動敏捷，投資高價值領域，並優先考慮創新。擁抱人工智慧、擴展去中心化測試並進入新興市場的公司將最有可能實現持續成長。

範圍：本研究服務提供臨床診斷市場的全球展望和2025年至2030年的五年收益預測。研究涵蓋四個地區：北美、歐洲、亞太、中東、北非和南亞（MENASA）以及拉丁美洲（LATAM）。

市場區隔涵蓋三個核心部分：

1. 重點檢測：包括臨床化學和免疫檢測(CC&IA)、血液學、止血學和分子診斷。本調查詳細涵蓋了 CC&IA 和分子診斷。

2. 轉診和周邊檢查：包括組織學診斷和臨床微生物學，提供組織學診斷的詳細見解。

3.分散式檢查：包括POCT和自我血糖監測（SMBG），重點在於POCT部分。

目錄

分析亮點

• 2024 年臨床診斷產業：預測與表現
• 過去分析
• 2025 年臨床診斷主要預測

戰略問題

• 為何成長變得越來越困難？
• The Strategic Imperative 8（TM）
• 三大策略挑戰對臨床診斷產業的影響
• 成長機會驅動Growth Pipeline Engine（TM）™

成長環境

• 分割
• 成長環境

宏觀經濟因素

• 2024年全球經濟成長率將達3.2%，超出預期
• 川普2.0：經濟成長放緩與通膨壓力
• 全球經濟成長放緩至2.8%，2025年避免景氣衰退；中國經濟疲軟拖累亞太地區經濟成長
• 2025年全球經濟成長將放緩至2.8%，景氣衰退已避免；中國經濟疲軟將拖累亞太地區經濟前景
• 全球宏觀經濟變遷與韌性策略：技術整合、研發與敏捷生產生態系統確保短期韌性

美國關稅的影響

• 美國關稅：2025年分析
• 美國關稅：對臨床診斷產業主要相關人員的影響
• 貿易關稅正在重塑全球供應鏈

2025年收益趨勢

• 預測考慮因素
• 臨床診斷行業細分
• 各細分市場收益預測
• 各細分市場收益預測
• 集中檢測分部收益預測
• 按細分市場的收益預測－建議測試、外圍測試和分散式檢查
• 集中測試、轉診測試、外圍測試和分散式檢查的最終用戶分析
• 各地區收益預測
• 各地區收益預測分析
• 各地區收益預測分析
• 各地區收益預測分析
• 區域法規結構與報銷政策

競爭環境

• 收益佔有率
• 收益佔有率分析
• 競賽矩陣
• 值得關注的活動

2025 年預測：前 5 名

• 預測一：CDx 將推動精準醫療的新時代，並在 2025 年成為創新的基石
• 預測二：LIMS 整合將徹底改變生命科學，推動超過 20 億美元的數據主導創新
• 預測三：多體學學診斷將帶來疾病表徵的模式轉移
• 預測四：DaaS 將顛覆傳統實驗室，開啟按需測試的新時代
• 預測五：去中心化分子檢測將重新定義新興市場的醫療保健服務，預計到 2025 年全球市場規模將超過 240 億美元

臨床診斷觀點

• 2024年業界概況

CC&IA：2025

• CC&IA 產業概況
• CC&IA 產業：知名公司

分子診斷：2025

• 分子診斷產業概況
• 分子診斷產業：值得關注的公司

即時檢驗：2025

• POCT產業概況
• POCT產業：值得關注的公司

組織診斷：2025

• 組織診斷行業概況
• 組織診斷產業：特色公司

成長機會領域

• 成長機會1：LIMS 輔助改進預測分析
• 成長機會二：伴隨診斷CDx拓展至腫瘤學之外
• 成長機會3：多重即時檢測，快速診斷抗菌藥物抗藥性

結論

• 結論與未來展望

後續步驟Next steps

• 成長機會的益處和影響
• 後續步驟Next steps
• 附表
• 免責聲明

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