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Molecular Diagnostics Market - Global Forecast 2025-2032

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    Report

  • 194 Pages
  • October 2025
  • Region: Global
  • 360iResearch™
  • ID: 5305518
UP TO OFF until Jan 01st 2026
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The molecular diagnostics market is undergoing significant change as innovation accelerates, healthcare models evolve, and precision medicine shapes organizational strategy. Senior executives are increasingly focused on operational agility, regulatory navigation, and optimizing business outcomes in a competitive environment.

Market Snapshot: Molecular Diagnostics Market Size and Growth

The global molecular diagnostics market expanded from USD 28.02 billion in 2024 to USD 31.86 billion in 2025, with an anticipated compound annual growth rate (CAGR) of 14.29%, ultimately reaching USD 81.60 billion by 2032. Growth is being propelled by advanced technology integration, shifts in healthcare delivery, and substantial investment in both clinical adoption and research innovation. The market’s trajectory is influenced by increased prioritization of disease prevention, early detection, and the need for accessible, scalable solutions. Strategic stakeholders are responding to customer demand for robust and efficient diagnostics, with new advancements solidifying the market’s role in supporting modern healthcare ecosystems.

Scope & Segmentation of the Molecular Diagnostics Market

This research report provides a comprehensive framework for senior decision-makers to assess opportunities and risks within the molecular diagnostics market. The segmentation covers each critical dimension to support targeted strategy and resource allocation:

  • Offerings: Includes instruments, reagents and kits, and software and services, spanning from diagnostic platforms to the analytical and support tools that enable operational efficiency.
  • Technologies: Encompasses methods such as fluorescence in situ hybridization, mass spectrometry, microarray analysis, and next-generation sequencing. This includes exome, RNA, targeted, and whole-genome sequencing, as well as multiple polymerase chain reaction formats (digital, multiplex, real-time), representing the breadth and pace of ongoing innovation.
  • Specimen Types: Covers blood, cerebrospinal fluid, nasal/throat swabs, saliva, stool, tissue biopsies, and urine, aligning each specimen choice with intended clinical applications and diagnostic needs.
  • Test Types: Encompasses laboratory-based testing performed in central, hospital, and independent labs, as well as point-of-care approaches, each selected for logistical fit and analytic requirements.
  • Applications: Addresses genetic testing (carrier, diagnostic, predictive), infectious disease detection (bacterial, parasitic, and viral), oncology (liquid biopsy, residual disease, tissue biopsy), and prenatal testing utilizing both invasive and non-invasive modalities to meet diverse clinical demands and regulatory frameworks.
  • End Users: Comprises academic/research institutes, diagnostic laboratories, hospitals, and clinics—each segment driven by distinct technology needs and workflow processes.
  • Regions: Spans the Americas (with North America and Latin America covered in detail), Europe, the Middle East and Africa, and Asia-Pacific, reflecting variations in regulatory policy, market maturity, and commercial trends that affect diagnostic adoption rates and business priorities.
  • Corporate Developments: Highlights key organizations such as Abbott Laboratories, AstraZeneca, Danaher, Thermo Fisher Scientific, and QIAGEN, emphasizing their technological alliances, investments, and initiatives in market expansion.

Key Takeaways for Senior Decision-Makers

  • Advanced molecular diagnostics platforms are supporting evidence-based decision making, driving tailored care, and enhancing patient outcomes through more precise interventions.
  • Strategic collaborations between diagnostics firms and digital health startups are expanding the reach of companion assays and point-of-care testing, encouraging adaptive business models.
  • Regional regulatory differences present both incentives and compliance complexities, requiring adaptable market approaches to realize optimal commercial outcomes.
  • Supply chain resilience is emerging as a priority, with manufacturers pursuing regionalized sourcing and dual-channel strategies to safeguard operations and manage regulatory shifts.
  • Sustained venture capital and private equity are accelerating innovation, especially in rapid infectious disease detection and the deployment of home-based genetic screening solutions.

Tariff Impact: Navigating U.S. Trade Policy Changes

The implementation of U.S. tariffs on molecular diagnostics instruments and reagents in 2025 has raised cost pressures for suppliers and buyers. In response, companies are regionalizing production, establishing new strategic alliances, and enhancing value-added services to maintain business continuity. Proactive inventory management and dual-sourcing are essential tactics in addressing ongoing trade policy shifts.

Methodology & Data Sources

The analysis integrates primary insights from laboratory directors, procurement professionals, and regulatory authorities, alongside secondary data from peer-reviewed journals and official filings. This approach ensures a balanced blend of qualitative context and quantitative rigor for market assessment.

Why This Report Matters to Industry Leaders

  • Enables identification of emerging growth areas and technology trends, supporting regional and global business expansion.
  • Prepares organizations for evolving regulations and supply challenges, strengthening strategic planning and operational resilience.
  • Supports informed decision-making regarding investments and partnerships in a competitive, fast-changing molecular diagnostics sector.

Conclusion: Strategic Implications & Future Outlook

The sustained evolution of the molecular diagnostics market favors firms emphasizing technology integration, regulatory foresight, and robust operational strategy. Stakeholders leveraging innovation and partnership are well positioned to advance precision medicine leadership.

 

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.
List of Tables
List of Figures

Samples

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Companies Mentioned

The key 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