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Molecular Diagnostics Market - Global Forecast 2025-2032

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    Report

  • 194 Pages
  • November 2025
  • Region: Global
  • 360iResearch™
  • ID: 5305518
UP TO OFF until Jan 01st 2026
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Molecular diagnostics is rapidly transforming healthcare by enabling more precise, data-driven decision-making and reshaping clinical pathways across disease management. Industry leaders are leveraging evolving technology and regulatory trends to optimize solutions, strengthen competitive positioning, and address the growing complexity of today's diagnostic needs.

Molecular Diagnostics Market Snapshot

The molecular diagnostics market is experiencing robust expansion, growing from USD 28.02 billion in 2024 to USD 31.86 billion in 2025, and is projected to achieve a CAGR of 14.29% through 2032, reaching USD 81.60 billion. Strategic drivers include the integration of advanced sequencing and analytics platforms, expanded reimbursement frameworks, and a convergence of patient-centric care models with technological innovation. Regulatory evolution and strong investment momentum have spurred the adoption of innovative assay formats and automated laboratory solutions, benefiting applications spanning oncology, infectious disease, genetics, and prenatal testing.

Scope & Segmentation

This report delivers nuanced insights on molecular diagnostics by examining major segments, geographic reach, technology use, and application areas:

  • Offering: Instruments; Reagents & Kits; Software & Services
  • Technology: Fluorescence In Situ Hybridization; Mass Spectrometry; Microarray Analysis; Next-Generation Sequencing (including Exome, RNA, Targeted, Whole Genome approaches); Polymerase Chain Reaction (including Digital, Multiplex, Real-Time PCR)
  • Specimen Type: Blood; Cerebrospinal Fluid; Nasal/Throat Swabs; Saliva; Stool; Tissue Biopsies; Urine
  • Test Type: Laboratory Based (Central Lab, Hospital Lab, Independent Lab); Point Of Care
  • Application: Genetic Testing (Carrier, Diagnostic, Predictive); Infectious Disease (Bacterial, Parasitic, Viral); Oncology (Liquid Biopsy, Minimal Residual Disease, Tissue Biopsy); Prenatal Testing (Invasive, Non-Invasive)
  • End User: Academic & Research Institutes; Diagnostic Laboratories; Hospitals & Clinics
  • Geographies: Americas (North America, Latin America); Europe, Middle East & Africa; Asia-Pacific
  • Key Companies: Abbott Laboratories Inc., ADT Biotech Co., AstraZeneca plc, Becton Dickinson, Bio-Rad, Biocartis, bioMérieux, Castle Biosciences, Danaher, Diasorin, Exact Sciences, Roche, Grifols, Guardant Health, Hologic, Illumina, LabCorp, Myriad Genetics, Oxford Nanopore, QIAGEN, Siemens Healthineers, Source BioScience, Sysmex, Thermo Fisher

Key Takeaways for Senior Decision-Makers

  • Technological convergence—especially via next-generation sequencing and digital pathology—is enabling new diagnostic insights and rapidly expanding the utility of molecular diagnostics solutions.
  • Integrating clinical and lab data through interoperable platforms supports population health initiatives and empowers predictive analytics, improving both clinical outcomes and operational efficiency.
  • Patient demands for accessible and rapid testing are driving growth of point-of-care systems and decentralized diagnostic capabilities, placing pressure on established centralized laboratory models.
  • Strategic collaborations between diagnostic leaders, digital health startups, and academic institutions are fuelling pipeline innovation and enabling adaptive, patient-centric service models.
  • Organizations prioritizing agile R&D investment, regulatory intelligence, and supply chain resilience are best positioned to maintain market access and adapt to evolving healthcare and policy landscapes.

Tariff Impact and Supply Chain Response

The implementation of United States tariffs in 2025 has introduced significant cost pressures for molecular diagnostics stakeholders, affecting both manufacturers and providers. Import duties on instruments and reagents have required firms to invest in regional manufacturing, diversify sourcing, and optimize inventory management. In response to cost shifts, some providers have explored alternative assay formats and value-added service models, such as reagent rental programs, to sustain client relationships. Ongoing trade policy uncertainties have reinforced the importance of scenario planning and procurement agility to ensure uninterrupted market access and innovation pathways.

Methodology & Data Sources

This research report combines primary interviews with laboratory directors, regulatory specialists, and procurement experts, with secondary analysis of journals, financial filings, and regulatory documents. Data analysis integrates both qualitative and quantitative methods to map technology adoption and innovation trajectories in the molecular diagnostics space.

Why This Report Matters

  • Gain a comprehensive, actionable understanding of the molecular diagnostics landscape—including segmentation, emerging technologies, and regional dynamics—at a strategic level.
  • Leverage in-depth insight into regulatory shifts and market drivers to inform investment, partnership, and procurement decisions.
  • Equip your leadership team to anticipate risk, navigate supply chain complexities, and accelerate precision medicine adoption with data-backed confidence.

Conclusion

Molecular diagnostics will continue to define the future of precision medicine and healthcare transformation. Organizations able to adapt, innovate, and partner across the value chain will secure sustainable competitive advantage in this dynamic landscape.

 

Additional Product Information:

  • Purchase of this report includes 1 year online access with quarterly updates.
  • This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.

Table of Contents

1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Integration of AI-driven analysis platforms to transform high-throughput molecular diagnostics workflows
5.2. Adoption of decentralized next-generation sequencing panels empowering precision medicine in remote healthcare settings
5.3. Emergence of multiplexed liquid biopsy assays enabling noninvasive cancer screening and monitoring capabilities
5.4. Increasing regulatory approvals for companion diagnostics fueling personalized oncology treatment selection globally
5.5. Expanding use of CRISPR-based point-of-care diagnostic assays facilitating rapid pathogen detection
5.6. Advancements in microfluidic lab-on-a-chip platforms to reduce assay volumes and turnaround times for molecular testing
5.7. Rising implementation of digital PCR technologies to enhance sensitivity and quantification accuracy in rare mutation detection
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Molecular Diagnostics Market, by Offering
8.1. Instruments
8.2. Reagents & Kits
8.3. Software & Services
9. Molecular Diagnostics Market, by Technology
9.1. Fluorescence In Situ Hybridization
9.2. Mass Spectrometry
9.3. Microarray Analysis
9.4. Next-Generation Sequencing
9.4.1. Exome Sequencing
9.4.2. RNA Sequencing
9.4.3. Targeted Sequencing
9.4.4. Whole Genome Sequencing
9.5. Polymerase Chain Reaction
9.5.1. Digital PCR
9.5.2. Multiplex PCR
9.5.3. Real-Time PCR
10. Molecular Diagnostics Market, by Specimen Type
10.1. Blood
10.2. Cerebrospinal Fluid (CSF)
10.3. Nasal/Throat Swabs
10.4. Saliva
10.5. Stool
10.6. Tissue Biopsies
10.7. Urine
11. Molecular Diagnostics Market, by Test Type
11.1. Laboratory Based
11.1.1. Central Lab
11.1.2. Hospital Lab
11.1.3. Independent Lab
11.2. Point Of Care
12. Molecular Diagnostics Market, by Application
12.1. Genetic Testing
12.1.1. Carrier Testing
12.1.2. Diagnostic Testing
12.1.3. Predictive Testing
12.2. Infectious Disease
12.2.1. Bacterial
12.2.2. Parasitic
12.2.3. Viral
12.3. Oncology
12.3.1. Liquid Biopsy
12.3.2. Minimal Residual Disease
12.3.3. Tissue Biopsy
12.4. Prenatal Testing
12.4.1. Invasive
12.4.2. Non-Invasive
13. Molecular Diagnostics Market, by End User
13.1. Academic & Research Institutes
13.2. Diagnostic Laboratories
13.3. Hospitals & Clinics
14. Molecular Diagnostics Market, by Region
14.1. Americas
14.1.1. North America
14.1.2. Latin America
14.2. Europe, Middle East & Africa
14.2.1. Europe
14.2.2. Middle East
14.2.3. Africa
14.3. Asia-Pacific
15. Molecular Diagnostics Market, by Group
15.1. ASEAN
15.2. GCC
15.3. European Union
15.4. BRICS
15.5. G7
15.6. NATO
16. Molecular Diagnostics Market, by Country
16.1. United States
16.2. Canada
16.3. Mexico
16.4. Brazil
16.5. United Kingdom
16.6. Germany
16.7. France
16.8. Russia
16.9. Italy
16.10. Spain
16.11. China
16.12. India
16.13. Japan
16.14. Australia
16.15. South Korea
17. Competitive Landscape
17.1. Market Share Analysis, 2024
17.2. FPNV Positioning Matrix, 2024
17.3. Competitive Analysis
17.3.1. Abbott Laboratories Inc.
17.3.2. ADT Biotech Co., Ltd.
17.3.3. AstraZeneca plc
17.3.4. Becton, Dickinson, and Company
17.3.5. Bio-Rad Laboratories, Inc.
17.3.6. Biocartis Group NV
17.3.7. bioMérieux SA
17.3.8. Castle Biosciences, Inc.
17.3.9. Danaher Corporation
17.3.10. Diasorin S.p,A.
17.3.11. Exact Sciences Corporation
17.3.12. F. Hoffmann-La Roche AG
17.3.13. Grifols S.A.
17.3.14. Guardant Health, Inc.
17.3.15. Hologic, Inc.
17.3.16. Illumina, Inc.
17.3.17. Laboratory Corporation of America Holdings
17.3.18. Myriad Genetics, Inc.
17.3.19. Oxford Nanopore Technologies
17.3.20. QIAGEN N.V.
17.3.21. Siemens Healthineers AG
17.3.22. Source BioScience
17.3.23. Sysmex Corporation by Oxford Gene Technology
17.3.24. Thermo Fisher Scientific Inc.

Companies Mentioned

The companies profiled in this Molecular Diagnostics market report include:
  • Abbott Laboratories Inc.
  • ADT Biotech Co., Ltd.
  • AstraZeneca plc
  • Becton, Dickinson, and Company
  • Bio-Rad Laboratories, Inc.
  • Biocartis Group NV
  • bioMérieux SA
  • Castle Biosciences, Inc.
  • Danaher Corporation
  • Diasorin S.p,A.
  • Exact Sciences Corporation
  • F. Hoffmann-La Roche AG
  • Grifols S.A.
  • Guardant Health, Inc.
  • Hologic, Inc.
  • Illumina, Inc.
  • Laboratory Corporation of America Holdings
  • Myriad Genetics, Inc.
  • Oxford Nanopore Technologies
  • QIAGEN N.V.
  • Siemens Healthineers AG
  • Source BioScience
  • Sysmex Corporation by Oxford Gene Technology
  • Thermo Fisher Scientific Inc.

Table Information