The global molecular diagnostic market will experience significant growth due to a broad range of factors, such as increased demand from the COVID-19 pandemic, an increasing number of cancer cases, and the swift evolution of technological capabilities.
Technological advancements, such as polymerase chain reaction (PCR), digital PCR, and next-generation sequencing (NGS), have improved molecular testing accuracy and productivity, enabling personalized treatment.
The forecast analysis is segmented by region and by application. The latter includes infectious disease testing, oncology testing, genetic testing, and other molecular diagnostics. Frost & Sullivan’s forecasts for this industry use a qualitative approach for the growth opportunity analyses due to methodological constraints.
The growing prevalence of cancer has accelerated the need for advanced molecular diagnostic tools, while the rise in chronic diseases, the modernization of government healthcare, and the growing demand for personalized medicine will contribute to the significant growth anticipated in the molecular diagnostics industry. Focused healthcare regulations and substantial R&D investments facilitate this expansion.
Revenue Forecast
The revenue estimate for the base year is not specified, with a CAGR over the study period projected to be between 30% and 40%.

The Impact of the Top 3 Strategic Imperatives on the Global Molecular Diagnostics Industry
Disruptive Technologies
Why
- The field of molecular diagnostics has experienced a dramatic transformation due to disruptive technologies, such as AI and machine learning (ML).
- Illumina is a prime example of a company at the forefront of this transformation. Illumina's innovative sequencing platforms offer accuracy, speed, and affordability, making genetic sequencing more accessible for therapeutic and scientific purposes.
- AI has enhanced the speed and precision of identifying disease-related mutations in genomic data, enabling personalized medicine.
- This integration optimizes diagnostics procedures, generates new opportunities for genetic research, and opens new avenues for quicker research, which reference predictive diagnostics, and personalized healthcare.
Frost Perspective
- AI-driven solutions will grant companies a competitive edge by enabling cost savings, faster diagnostics, and operational improvements.
- Industry players will need to invest in AI-powered platforms for in-depth data analysis, revolutionizing disease identification and improving healthcare outcomes.
- Embracing innovative technologies will keep companies competitive and improve healthcare outcomes.
Competitive Intensity
Why
- Molecular diagnostics players are growing thanks to their strategic alliances and constant innovation.
- The dynamic landscape is shaped by established giants, such as Thermo Fisher Scientific, Roche, Genomica, Grail, and Guardant Health, as well as start-ups, such as Color Genomics and Tempus.
- These companies innovate and specialize in certain fields, such as single-cell genomics, liquid biopsy-based early cancer detection, and accessible genetic testing.
- The dynamic between innovative start-ups and well-established industry players determines the industry's path and fosters advancements in diagnostics, AI integration, and biomarker research.
Frost Perspective
- To secure leadership, established and emerging companies must prioritize innovation, strategic partnerships, and accessibility.
- Success in this dynamic environment requires building an innovative culture through fast training and innovation oriented towards personalized medicine.
- A comprehensive strategy combining strategic alliances with technical advancements is necessary to address changing market demands.
Industry Convergence
Why
- The molecular diagnostics industry is converging with various sectors, including biopharmaceuticals, AI, healthcare, and Internet of Things (IoT).
- Illumina, Qiagen, and Roche are collaborating to develop biopharmaceuticals, while Abbott integrates molecular testing into point-of-care devices.
- This trend bolsters innovation and connectivity in pharmaceuticals and healthcare. Businesses that adapt to these trends will be well-positioned to maintain their lead in the evolving marketplace.
Frost Perspective
- Companies can strategically leverage the convergence trend by encouraging industry-to-industry partnerships, embracing advanced technologies, and seeking innovative collaborations.
- For instance, collaborations with tech firms for advanced data analytics can expand applications.
- Additionally, Foundation Medicine's personalized medicine strategy highlights the significance of adapting to trends by utilizing tumor genome analysis to guide decision treatment.
Scope of Analysis
- Frost & Sullivan provides a global overview of the molecular diagnostics industry.
- The study period encompasses a 6-year industry revenue forecast from 2024 to 2029, focusing on the molecular diagnostics segment. The scope does not include non-molecular diagnostic, in-vitro diagnostics (IVD), medical devices, and diagnostics equipment.
- Frost & Sullivan examines molecular diagnostics systems, reagents, assays, and tests carried out in hospitals, clinics, diagnostics laboratories, research and academic institutions, public health agencies, biobanks, and other such institutes.
- The forecast analysis is segmented by region and by application. The latter includes infectious disease (COVID-19, hepatitis, HIV, respiratory, sexually transmitted infections [STIs], and others), oncology (blood-based and tissue-based diagnostics), genetic (single nucleotide polymorphisms [SNPs], inherited, noninvasive prenatal testing [NIPT], and others), and other molecular diagnostics (blood banking and transplantation molecular diagnostics). These forecasts use a qualitative approach for the growth opportunity analyses due to the industry’s private nature and lack of quantitative measures.
| Scope | |
|---|---|
| Geographic Coverage | Global (North America; Europe; APAC; the Middle East, North Africa, South Asia [MENASA], and Latin America) |
| Study Period | 2023–2029 |
| Base Year | 2023 |
| Forecast Period | 2024–2029 |
| Monetary Unit | US Dollar |
Global Molecular Diagnostics Application Segmentation
Infectious Disease Diagnostics
This includes the identification of pathogens causing infectious diseases through advanced molecular techniques, which enables precise detection and monitoring. This segment caters to COVID-19, hepatitis, HIV, respiratory infections, STIs, and other emerging infectious diseases.
Oncology Diagnostics
Oncology molecular diagnostics involves the comprehensive detection and characterization of cancer using sophisticated molecular methods on blood or tissue samples. This category includes tests for liquid biopsies, circulating tumor DNA analysis, and tissue-based diagnostics for a nuanced understanding of oncological conditions.
Genetic Diagnostics
By detecting DNA mutations, genetic diagnostics assists with treatment and diagnosis plans. Based on blood or saliva samples, results are usually available in a few weeks and include various diseases, such as cancer risk and fragile X syndrome. It covers panel tests, single gene tests, and large-scale tests, such as genome and exome sequencing.
Others Molecular Diagnostics
This includes blood banking molecular diagnostics, blood transfusion safety, and transplantation molecular diagnostics, facilitating compatibility assessments for organ transplants to improve patient outcomes. These techniques enable enhanced precision.
Competitive Environment
| Number of Competitors | 80 to 90 |
| Competitive Factors | Test performance and accuracy, regulatory approvals and compliance, market presence and brand reputation, pricing and cost-effectiveness, product portfolio and innovation |
| Key End-user Industry Verticals | Clinical diagnostics, pharmaceutical, and biotechnology sectors; research and academic institutions, blood banks |
| Revenue Share of Top 5 Companies | 43.2% |
| Major Industry Participants | Danaher, Beckton Dickinson, Roche, Hologic, and Genomic Health (Exact Sciences) |
| Other Notable Industry Participants | PerkinElmer, bioMérieux, Qiagen, Abbott Laboratories, Natera, Illumina, Myriad Genetics, Thermo Fisher Scientific, Agilent Technologies, DiaCarta, Quidel Ortho, Siemens Healthineers, Guardant Health, Veracyte |
| Notable Acquisitions and Mergers | In February 2024, Veracyte acquired C2i Genomics and added whole-genome MRD capabilities to its platform. The company plans to use this technology to develop an MRD test for muscle-invasive bladder cancer, aiming to make significant advancements in cancer care. It can now provide treatment monitoring and early diagnosis services. |
Key Competitors
Market Leaders: Danaher Corporation, F. Hoffmann-La Roche (Roche), BD (Becton, Dickinson and Company), Hologic, Genomic Health (now part of Exact Sciences Corporation), PerkinElmer, bioMérieux, Qiagen
Challengers: Abbott Laboratories, Natera, Illumina, Myriad Genetics, Thermo Fisher Scientific, Bio-Rad Laboratories, Agilent Technologies, Guardant Health, Veracyte, Siemens Healthineers AG, QuidelOrtho Corporation, Menarini Diagnostics, Bicoatis, OncoCyte Corporation, NanoString Technologies, BGI Group
Upcoming Players: Randox Laboratories, Arquer Diagnostics, Novigenix, Asurean, Caris Life Sciences, Exosomal Siena, Elitech Group, OncoDNA, Oxford Cancer Biomarkers, STAT-Diagnostica & Innovation, Vaironist SAS, MD Biosciences, HTG Molecular Diagnostics, Epic Sciences, DiaSorin, Agenda, Vela Diagnostics

Growth Environment
Why is it Increasingly Difficult to Grow?
The Strategic Imperative 8™
The Impact of the Top 3 Strategic Imperatives on the Global Molecular Diagnostics Industry
Strategic Imperatives for Global Molecular Diagnostics Companies
Growth Opportunities Fuel the Growth Pipeline Engine™
Scope of Analysis
Global Molecular Diagnostics Application Segmentation
Growth Metrics
Growth Drivers
Growth Restraints
Forecast Assumptions
Revenue Forecast
Global Molecular Diagnostics Revenue Forecast Analysis
Global Molecular Diagnostics Revenue Forecast Analysis (continued)
Revenue Forecast by Region
Global Molecular Diagnostics Revenue Forecast Analysis by Region
Global Molecular Diagnostics Revenue Forecast Analysis by Region (continued)
Global Molecular Diagnostics Revenue Forecast Analysis by Region (continued)
Global Molecular Diagnostics Market Analysis by Technology
Global Molecular Diagnostics Market Analysis by Technology (continued)
Revenue Forecast by Application
Global Molecular Diagnostics Revenue Forecast by Application
Global Molecular Diagnostics Revenue Forecast by Application (continued)
Global Molecular Diagnostics Revenue Forecast by Application (continued)
Global Molecular Diagnostics Revenue Forecast by Application (continued)
Competitive Environment
Global Molecular Diagnostics Revenue Share by Player
Global Molecular Diagnostics Revenue Share Analysis
Key Competitors
Competitive Mapping by Molecular Diagnostics Offering
Competitive Mapping by Molecular Diagnostics Offering (continued)
Global Molecular Diagnostics Market: Notable M&A
Global Molecular Diagnostics Market: Notable M&A (continued)
Molecular Diagnostics Companies to Watch
Growth Opportunity Summary
Growth Opportunity 1: Advancements in Point-of-care Testing
Growth Opportunity 1: Advancements in Point-of-care Testing (continued)
Growth Opportunity 2: Personalized Cancer Treatment Unveiling Genetic Markers and Therapies
Growth Opportunity 2: Personalized Cancer Treatment Unveiling Genetic Markers and Therapies (continued)
Growth Opportunity 3: Leveraging Next-gen Molecular Diagnostics Technologies for Biomarker Development and Companion Diagnostics Integration
Growth Opportunity 3: Leveraging Next-gen Molecular Diagnostics Technologies for Biomarker Development and Companion Diagnostics Integration (continued)
Growth Opportunity 4: Enhancing Home Health Monitoring
Growth Opportunity 4: Enhancing Home Health Monitoring (continued)
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- Molecular Diagnostics Industry: Growth Drivers, Global, 2024–2029
- Molecular Diagnostics Industry: Growth Restraints, Global, 2024–2029
- Molecular Diagnostics Industry: Revenue Forecast, Global, 2023–2029
- Molecular Diagnostics Industry: Revenue Forecast by Region, Global, 2023–2029
- Molecular Diagnostics Industry: Revenue Forecast by Application, Global, 2023–2029
- Molecular Diagnostics Industry: Competitive Environment, Global, 2023
- Molecular Diagnostics Industry: Revenue Share by Player, Global, 2023
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| Deliverable Type | Market Research |
|---|---|
| Author | Chandni Hussain |
| Industries | Chemicals and Materials |
| No Index | No |
| Is Prebook | No |
| Keyword 1 | Point Of Care Molecular Diagnostics |
| Keyword 2 | Healthcare Diagnostics Trends |
| Keyword 3 | Molecular Diagnostics Applications |
| List of Charts and Figures | Molecular Diagnostics Industry: Growth Drivers, Global, 2024–2029~ Molecular Diagnostics Industry: Growth Restraints, Global, 2024–2029~ Molecular Diagnostics Industry: Revenue Forecast, Global, 2023–2029~ Molecular Diagnostics Industry: Revenue Forecast by Region, Global, 2023–2029~ Molecular Diagnostics Industry: Revenue Forecast by Application, Global, 2023–2029~ Molecular Diagnostics Industry: Competitive Environment, Global, 2023~ Molecular Diagnostics Industry: Revenue Share by Player, Global, 2023~ |
| Podcast | No |
| WIP Number | PFEE-01-00-00-00 |
Global Molecular Diagnostics Market, Forecast to 2029
Molecular Diagnostics Unleash Growth Opportunities, Steering Innovation Personalized Medicine
22-Apr-2024
Global
Market Research
