세계의 임상 진단 전망(2025년)

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