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High Growth Areas in Molecular Diagnostics, 2026
Publication Date: November 12, 2026
Tags: Cancer, Molecular, Molecular Diagnostics, Molecular Point-of-Care, Molecular Testing, Oncology, Oncology and Cancer, Point of Care, Respiratory Diseases
Pages: 121
SKU: 26-046KA
Molecular diagnostics continues to grow faster than the in vitro diagnostics (IVD) market as a whole, but the market average hides a wide spread. Mature segments such as HIV viral load and laboratory STI testing are growing slowly. Meanwhile, the cluster of oncology, genetic, transplant, and infectious disease categories is growing much faster. Kalorama Information’s High Growth Areas in Molecular Diagnostics, 2026 identifies these categories, sizes them, and examines what is driving and limiting their growth through 2030.
For each category, the report pairs market estimates with product, regulatory, reimbursement and deal activity from January 2024 through September 2026, along with the clinical and trade literature from the same period. IVD manufacturers, investors and business development teams will see where molecular testing revenue is heading. They will also see the coverage decisions, evidence requirements and platform changes that will set the pace.
Report Features
A Defined Framework for High Growth
Kalorama ranks 16 molecular disease-area segments by forecast growth against two thresholds: the revenue-weighted market rate for “above market” categories, and a top-quartile cutoff for “high growth” categories. Every category that meets either threshold is covered in a dedicated chapter.
Category Market Analysis
Chapters cover the following areas:
- Molecular oncology, including cancer assays and companion diagnostics, molecular HPV testing and molecular histology
- Respiratory syndromic and point-of-care panels
- Inherited disease, prenatal and NIPT testing
- Transplantation (HLA) diagnostics
- Molecular urinary tract infection testing
- Molecular tuberculosis testing
- Point-of-care STI and women’s health testing
Each chapter gives base-year market size, forecasts through 2030 with compound annual growth rates (CAGRs), and a regional breakdown for North America, Europe, Asia Pacific and the rest of the world.
Products, Regulation and Deals
Tables in each chapter track product launches and regulatory actions from the FDA, EU notified bodies, China’s NMPA, Japan’s PMDA and WHO prequalification. They also track Medicare and commercial coverage decisions, and acquisitions, partnerships and financings. Companies covered include Abbott, Roche, Thermo Fisher, Illumina, Qiagen, Cepheid, bioMérieux, Hologic, Guardant Health, Natera, CareDx and Visby Medical, along with emerging specialists.
Cross-Category Trends
A closing chapter identifies the forces shared across the high-growth categories:
- Low test uptake among eligible patients
- The move from accuracy data to outcome evidence
- Payers’ power to widen or limit adoption
- The shift of testing toward the patient and into hospital laboratories
- New competition in sequencing platforms and AI-based interpretation
- Consolidation among suppliers
- Diverging regulatory paths in Europe, the United States and global health markets
Research Parameters
High Growth Areas in Molecular Diagnostics, 2026 estimates markets at the level of manufacturer product sales. Laboratory service revenue for liquid biopsy and minimal residual disease (MRD) testing is excluded from the estimates but discussed in the oncology chapter. The base year is 2025, with forecasts through 2030.
The analysis draws on primary research, secondary research and Kalorama’s internal databases. Sources include regulatory registers, SEC filings, product literature, reimbursement schedules, conference materials, trade publications and peer-reviewed clinical studies.
Chapter 1: Executive Summary
About Kalorama Information
Overview
Defining High Growth
- Table 1-1: Molecular Diagnostics Growth Benchmarks, 2025-2030
Size and Growth of the Market
- Figure 1-1: Forecast Growth of Molecular Diagnostics Categories Above the Market Rate, 2025-2030 (%)
- Table 1-2: Molecular Diagnostics Categories Growing Above the Market Rate, Ranked by Forecast Growth
Trends in High-Growth Molecular Diagnostics
Leading Competitors
Scope and Methodology
Chapter 2: Molecular Oncology: Cancer Assays, Companion Diagnostics and HPV Testing
Introduction
Market Size and Growth
- Table 2-1: High Growth Molecular Oncology Market Segments, 2025 and 2030 (US$ millions)
- Figure 2-1: High Growth Molecular Oncology Market Segments, 2025 and 2030 (US$ millions)
- Table 2-2: Select High Growth Molecular Oncology Market, by Region, 2025 (US$ millions)
- Figure 2-2: Select High Growth Molecular Oncology Market, by Region, 2025 (US$ millions)
Products and Regulatory Announcements
- Table 2-3: Selected Product Introductions and Regulatory Announcements: Oncology, 2024-Sept. 2026
Deals, Partnerships and Financings
- Table 2-4: Selected Deals, Partnerships and Financings: Oncology, 2024-Sept. 2026
Trends
Most Eligible Cancer Patients Still Go Untested
Comprehensive Profiling Displaces Hotspot Panels as Drug Access Lags
Kitted NGS Moves Profiling Into Hospital Laboratories
Regulators Lower Barriers to Companion Diagnostics
MRD Trials Confirm Prognosis but Not Yet Treatment Benefit
Blood Screening Advances From Colorectal to Multi-Cancer Tests
Sequencer Competition and China Trade Reshape the Platform Layer
Self-Collection Evidence Moves From Accuracy to Outcomes
National Programs Make Self-Testing the Default Offer
US Guidelines and Coverage Converge on Primary HPV
US Self-Collection Uptake Lags the Approvals
Approvals Tie Self-Collection to Specific PCR Workflows
Triage Becomes the Bottleneck for Self-Sampling
WHO Prequalification Meets the Limits of Elimination
Chapter 3: Respiratory Infection Testing: Syndromic Panels and Point-of-Care
Introduction
Market Size and Growth
- Table 3-1: High Growth Molecular Respiratory Testing Market Segments, 2025 and 2030 (US$ millions)
- Figure 3-1: High Growth Molecular Respiratory Testing Market Segments, 2025 and 2030 (US$ millions)
- Table 3-2: High Growth Molecular Respiratory Testing Market by Region, 2025 (US$ millions)
- Figure 3-2: High Growth Molecular Respiratory Testing Market by Region, 2025 (US$ millions)
Products and Regulatory Announcements
- Table 3-3: Selected Product Introductions and Regulatory Announcements: Respiratory, 2024-Sept. 2026
Deals, Partnerships and Financings
- Table 3-4: Selected Deals, Partnerships and Financings: Respiratory, 2024-Sept. 2026
Trends
Flexible Syndromic Panels Let Laboratories Pay per Target
Payers and Decision Support Rein In Large Panel Use
CLIA-Waived PCR Displaces Antigen Testing in Outpatient Care
Hub-and-Spoke Networks and Connectivity Shape Implementation
Home Molecular Tests Commoditize as Early Entrants Exit
Consolidation and Price Pressure Among Point-of-Care Vendors
Menus Expand Beyond the Viral Four-Plex
Chapter 4: Molecular Genetic Testing: Inherited Disease, Prenatal and NIPT
Introduction
Market Size and Growth
- Table 4-1: High Growth Molecular Genetic Testing Market, 2025 and 2030 (US$ millions)
- Figure 4-1: High Growth Molecular Genetic Testing Market, 2025 and 2030 (US$ millions)
- Table 4-2: High Growth Molecular Genetic Testing Market, by Region, 2025 (US$ millions)
- Figure 4-2: High Growth Molecular Genetic Testing Market, by Region, 2025 (US$ millions)
- Table 4-3: Genetic Testing Subsegment Estimates, 2025-2030 (US$ millions)
Products and Regulatory Announcements
- Table 4-4: Selected Product Introductions and Regulatory Announcements: Genetic Testing, 2024-Sept. 2026
Deals, Partnerships and Financings
- Table 4-5: Selected Deals, Partnerships and Financings: Genetic Testing, 2024-Sept. 2026
Trends
Genomic Newborn Screening Moves From Pilots to Policy
Rapid Genomes Become Front-Line Tests in Intensive Care
Long-Read Sequencing Targets Short-Read Blind Spots
AI Interpretation Becomes Core to Clinical Genomics
Platform Competition and Trade Policy Reshape Sequencer Supply
Prenatal Screening Expands Beyond the Common Trisomies
Carrier Screening Shifts to Pan-Ethnic Panels and IVDR Kits
Hereditary Cancer and Pharmacogenomic Testing Enter Routine Care
Chapter 5: Transplantation Diagnostics
Introduction
Market Size and Growth
- Table 5-1: Molecular Transplantation (HLA) Testing Market, 2025 and 2030 (US$ millions)
- Figure 5-1: Molecular Transplantation (HLA) Testing Market, 2025 and 2030 (US$ millions)
- Table 5-2: Molecular Transplantation (HLA) Testing Market, by Region, 2025 (US$ millions)
- Figure 5-2: Molecular Transplantation (HLA) Testing Market by Region, 2025 (US$ millions)
Products and Regulatory Announcements
- Table 5-3: Selected Product Introductions and Regulatory Announcements: Transplantation, 2024-Sept. 2026
Deals, Partnerships and Financings
- Table 5-4: Selected Deals, Partnerships and Financings: Transplantation, 2024-Sept. 2026
Trends
dd-cfDNA Performance Depends on the Rejection Type
Heart, Lung, and Multiorgan Recipients Test the Limits
Medicare Sets Caps and Makes Documentation the Issue
Kitted dd-cfDNA Heads for FDA Review
Long-Read HLA Typing Consolidates Among Kit Specialists
Virtual Crossmatch Widens Access for Sensitized Patients
Chimerism and Infection Monitoring Remain Unstandardized
Chapter 6: Molecular Urinary Tract Infection Testing
Introduction
Market Size and Growth
- Table 6-1: Molecular UTI Testing Market for Female Patients, 2025 and 2030 (US$ millions)
- Figure 6-1: Molecular UTI Testing Market for Female Patients, 2025 and 2030 (US$ millions)
- Table 6-2: Molecular UTI Testing Market for Female Patients, by Region, 2025 (US$ millions)
- Figure 6-2: Molecular UTI Testing Market for Female Patients, by Region, 2025 (US$ millions)
Products and Regulatory Announcements
- Table 6-3: Selected Product Introductions and Regulatory Announcements: Molecular UTI, 2024-Sept. 2026
Deals, Partnerships and Financings
- Table 6-4: Selected Deals, Partnerships and Financings: Molecular UTI, 2024-Sept. 2026
Trends
PCR Finds More Organisms Than Culture, With Unclear Meaning
Trial Data Center on Time to Therapy, but Remain Thin
Guidelines and Long-Term Care Societies Keep Culture as Standard
Diagnostic Stewardship Shifts Focus to Host Response
Payers and Medicare Program Integrity Target Multiplex Panels
Direct-From-Urine Rapid Susceptibility Emerges as an Alternative
Chapter 7: Molecular Tuberculosis Testing
Introduction
Market Size and Growth
- Table 7-1: Molecular Tuberculosis Testing Market, 2025 and 2030 (US$ millions)
- Figure 7-1: Molecular Tuberculosis Testing Market, 2025 and 2030 (US$ millions)
- Table 7-2: Molecular Tuberculosis Testing Market, by Region, 2025 (US$ millions)
- Figure 7-2: Molecular Tuberculosis Testing Market, by Region, 2025 (US$ millions)
Products and Regulatory Announcements
- Table 7-3: Selected Product Introductions and Regulatory Announcements: Molecular TB, 2024-Sept. 2026
Deals, Partnerships and Financings
- Table 7-4: Selected Deals, Partnerships and Financings: Molecular TB, 2024-Sept. 2026
Trends
Near-POC NAATs Push Molecular Testing Into Primary Care
Non-Sputum Samples Widen Access with a Cost in Sensitivity
WHO Prequalification Becomes the Gate for TB Procurement
Donor Funding Cuts Threaten Volumes
Drug-Resistance Testing Tiers Toward Reference Laboratories
Manufacturers From India and China Compete on Price and Access
Chapter 8: Sexually Transmitted Infections and Women’s Health: Molecular Point-of-Care Testing
Introduction
Market Size and Growth
- Table 8-1: Molecular Point-of-Care STI Testing Market, 2025 and 2030 (US$ millions)
- Figure 8-1: Molecular Point-of-Care STI Testing Market, 2025 and 2030 (US$ millions)
- Table 8-2: Molecular Point-of-Care STI Testing Market, by Region, 2025 (US$ millions)
- Figure 8-2: Molecular Point-of-Care STI Testing Market, by Region, 2025 (US$ millions)
Products and Regulatory Announcements
- Table 8-3: Selected Product Introductions and Regulatory Announcements: STI & Women’s Health, 2024-Sept. 2026
Deals, Partnerships and Financings
- Table 8-4: Selected Deals, Partnerships and Financings: STI & Women’s Health, 2024-Sept. 2026
Trends
CLIA-Waived Chlamydia and Gonorrhea Tests Match Laboratory Accuracy
Emergency Departments Build the Value Case
Syphilis Surge and Flat Funding Drive Test-and-Treat Models
Home Molecular STI Testing Opens a Consumer Channel
Molecular Vaginitis Panels Replace Microscopy and Symptoms
Bundled Vaginitis and STI Testing on One Specimen
Resistance Markers and Broader Menus Extend Near-Patient Testing
Chapter 9: Overall Trends
Trends
Uptake Is the Binding Constraint on Growth
Evidence Standards Move From Accuracy to Outcomes
Payers Set the Pace in Both Directions
Testing Moves Toward the Patient and Into Hospital Laboratories
The Sequencing and Interpretation Layer Is Contested
Consolidation Reshapes the Supplier Base
Regulatory Paths Diverge by Region and Market
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