Molecular diagnostics is the fastest-growing segment of the IVD market, projected to register a CAGR of 14.5% from 2025 to 2030. The COVID-19 pandemic permanently expanded molecular diagnostic infrastructure globally — laboratories that installed PCR platforms for COVID testing are now expanding menus to respiratory syndromic panels, STI testing, and oncology applications. Next-generation sequencing is advancing from research toward clinical routine in oncology somatic mutation testing, germline hereditary cancer testing, and pharmacogenomics. Cepheid's GeneXpert platform has over 50,000 installed instruments globally. Abbott's ID NOW received CE marking for its 2.0 enhanced platform in January 2025. Syndromic testing panels — simultaneously detecting multiple pathogens from a single sample — are reducing sequential testing and shortening time to clinical decision.
92 countries — 38 European, 18 Asia-Pacific, 22 Latin American, 11 Middle Eastern, and 3 North American countries.
This report provides significant competitor information, analysis, and insight critical to the development and implementation of effective marketing and R&D programs.
Topics Covered
• Molecular Diagnostics Market Size and Forecast 2025-2030 by Technology and Application
• PCR — Real-Time PCR, Digital PCR, and Multiplex PCR Market Dynamics
• Syndromic Panels — Respiratory, GI, Meningitis/Encephalitis, and Blood Culture
• Next-Generation Sequencing — Oncology, Infectious Disease, and Rare Disease Applications
• CRISPR-Based Diagnostics — Technology Status and Emerging Commercial Applications
• Point-of-Care Molecular — GeneXpert, ID NOW, and Near-Patient Molecular Testing
• Liquid Biopsy Molecular — ctDNA, cfRNA, and Multi-Cancer Early Detection
• Competitive Landscape — Roche, Cepheid, Abbott, Hologic, bioMérieux, and Challengers
• Investment and Partnership Opportunities
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Table of Contents
1. Executive Summary
- Key findings and strategic implications
- Highest-priority molecular diagnostics opportunities
- Competitive landscape summary
- Strategic recommendations
2. Market Overview
- Market definition, scope and segmentation
- Key demand drivers and restraints
- Regulatory environment
3. PCR and Multiplex PCR
- Real-time PCR market dynamics
- Digital PCR — technology and adoption
- Multiplex PCR syndromic panel competition
4. Syndromic Testing Panels
- Respiratory panels — BioFire, Roche, Abbott, and Hologic
- Gastrointestinal and meningitis/encephalitis panels
- Blood culture identification panels
5. Next-Generation Sequencing in Clinical Diagnostics
- Oncology somatic mutation profiling
- Hereditary cancer and pharmacogenomics testing
- Infectious disease NGS and outbreak surveillance
6. CRISPR-Based Diagnostics
- Technology status and commercial applications
- Key developers and competitive landscape
- Regulatory pathway and market development
7. Point-of-Care Molecular Testing
- GeneXpert and ID NOW platform competition
- Near-patient molecular testing market
- CLIA waiver strategy and laboratory integration
8. Liquid Biopsy Molecular
- ctDNA and cfRNA detection platforms
- Multi-cancer early detection
- Competitive landscape — Guardant, Foundation Medicine, Grail, and Exact Sciences
9. Competitive Landscape
- Roche, Cepheid, Abbott, Hologic, bioMérieux, and challengers
- New entrants and emerging platforms
- M&A and partnership activity 2023-2025
10. Regional Market Analysis
- 10.1 North America (U.S., Canada, Mexico)
- 10.2 Europe (38 countries)
- 10.3 Asia-Pacific (18 countries)
- 10.4 Latin America (22 countries)
- 10.5 Middle East (11 countries)
- 10.6 Africa and Rest of World
11. Strategic Conclusions and Recommendations
- Highest-priority opportunities by segment and region
- Market entry and expansion strategies
- M&A, partnership and investment priorities
12. Appendix
- Research methodology
- Abbreviations and definitions
- List of tables and figures
List of Tables
Table 1. PCR and Multiplex PCR — Platform Comparison and Leading Suppliers 2025
Table 2. Syndromic Testing Panels — Application Landscape and Leading Suppliers 2025
Table 3. Next-Generation Sequencing — Clinical Application Summary 2025
Table 4. CRISPR-Based Diagnostics — Technology Status and Key Developers 2025
Table 5. Point-of-Care Molecular Testing — Platform Comparison 2025
Table 6. Liquid Biopsy Molecular — Platform and Leading Suppliers 2025
Table 7. Leading Suppliers and Competitive Positioning — Molecular Diagnostics 2025
Table 8. M&A and Partnership Activity in Molecular Diagnostics 2023-2025
Table 9. Regulatory Pathway Summary by Application and Region 2025
Table 10. Key Risks and Mitigation Strategies
Abbott Diagnostics
Bio-Rad Laboratories
bioMérieux
Danaher (Beckman Coulter, Cepheid, Radiometer)
DiaSorin
Hologic
QuidelOrtho
Roche Diagnostics
Siemens Healthineers
Sysmex
