US Molecular Diagnostics Market Size, Growth, Share & Trends Analysis
US Molecular Diagnostics Market by Product & Service (Kits, Instruments, Software), Test Type (Lab, PoC), Sample (Blood, Urine), Technology (PCR, NGS, ISH), Application [Infectious (Hepatitis, HIV, HAI, Flu), Cancer (Breast, Lung)] - Forecast to 2031
OVERVIEW
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
The US molecular diagnostics market, valued at US$8.34 billion in 2025, stood at US$8.93 billion in 2026 and is projected to advance at a resilient CAGR of 9.9% from 2026 to 2031, culminating in a forecasted valuation of US$14.32 billion by the end of the period. This expansion is driven by the high burden of infectious diseases & cancer, which continues to increase testing volumes across clinical settings. The growing use of molecular tests for early diagnosis, treatment selection, and disease monitoring, along with the wider adoption of personalized medicine, is further supporting demand. In addition, ongoing investments in advanced diagnostic technologies and the strong presence of well-established laboratory networks are contributing to sustained market growth.
KEY TAKEAWAYS
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By Product & ServiceBy product & service, the reagents & kits segment is expected to register the highest CAGR of 10.9% during the forecast period.
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By Test TypeBy test type, the lab tests segment accounted for the largest market share of 79.5% in 2025.
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By Sample TypeBy sample type, the blood, serum, and plasma segment accounted for the largest market share of 68.6% in 2025.
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By TechnologyBy technology, the PCR segment accounted for the largest share of the market in 2025.
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By ApplicationBy application, the infectious disease diagnostics segment is expected to dominate the market throughout the forecast period.
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By TechniqueBy technique, multiplex testing accounted for the largest market share in 2025.
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By Clinical ApplicationBy clinical application, the diagnostics segment is expected to dominate the market during the forecast period.
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By End UserBy end user, the diagnostic labs segment is expected to register the highest CAGR during the forecast period.
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Competitive LandscapebioMérieux (France), Hologic (US), Danaher (US), Illumina (US), and Roche (Switzerland) were identified as the star players in the US molecular diagnostics market, supported by their strong market presence and extensive product portfolios.
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Competitive LandscapeVela Diagnostics (Singapore), Savyon Diagnostics (Israel), and Uniogen OY (Finland) have distinguished themselves among startups and SMEs by securing strong footholds in specialized niche areas.
The US molecular diagnostics market is experiencing rapid growth, driven by the rising demand for precise and accurate testing. A key factor in this expansion is the increasing number of tests available for infectious diseases, cancer, and genetic disorders. Additionally, the adoption of molecular diagnostic testing in the US is on the rise, primarily due to technological advancements and the presence of prominent companies in the market.
TRENDS & DISRUPTIONS IMPACTING CUSTOMERS' CUSTOMERS
The US molecular diagnostics (MDx) market is undergoing a notable shift, driven by evolving clinical needs and technological changes. A key trend is the growing use of molecular testing beyond specialized labs, with greater integration into hospital labs and near-patient/POC settings to support faster clinical decision-making. At the same time, advances in next-generation sequencing, multiplex assays, and automation are changing how tests are developed and delivered, enabling higher throughput and broader panels from a single sample. Together, these developments are reshaping testing workflows and expanding the clinical role of MDx across the US healthcare system.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
MARKET DYNAMICS
Level
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Increasing prevalence of infectious diseases and cancer
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Surge in technological advancements
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High cost of molecular diagnostic instruments
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Inadequate reimbursements
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Growing significance of companion diagnostics
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Increasing adoption of automation and digital tools to improve laboratory efficiency
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Operational barriers and labor shortage
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Changing regulatory landscape
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
Driver: Increasing prevalence of infectious diseases and cancer
The rising burden of infectious diseases & cancer in the US continues to drive demand for molecular diagnostics as these tests enable early detection, precise identification of disease subtypes, and effective monitoring of treatment response. Molecular methods are increasingly preferred for their high sensitivity & specificity, supporting timely clinical decision-making and improved patient outcomes across hospitals, diagnostic laboratories, and other end users.
Restraint: High cost of molecular diagnostic instruments
The high initial cost of molecular diagnostic instruments and the associated expenses for maintenance, consumables, and skilled personnel remain a key restraint for market growth. Smaller laboratories and healthcare facilities may face challenges in adopting advanced molecular platforms, which can limit broader penetration, particularly outside large hospital systems and labs.
Opportunity: Growing significance of companion diagnostics
The growing importance of companion diagnostics presents a major opportunity for the US molecular diagnostics (MDx) market, driven by the expanding use of targeted therapies & personalized medicine. Companion diagnostics play a critical role in identifying patients most likely to benefit from specific treatments, particularly in oncology, thereby increasing their clinical relevance and supporting the wider adoption of molecular testing.
Challenge: Changing regulatory landscape
A continuously evolving regulatory environment poses a challenge for molecular diagnostics (MDx) providers in the US as companies must adapt to updated approval requirements, quality standards, and compliance expectations. Navigating these changes can increase development timelines & operational complexity, especially for innovative and rapidly evolving molecular technologies.
US MOLECULAR DIAGNOSTICS MARKET: COMMERCIAL USE CASES ACROSS INDUSTRIES
| COMPANY | USE CASE DESCRIPTION | BENEFITS |
|---|---|---|
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Application of rapid PCR-based molecular platforms for high-throughput infectious disease testing & decentralized diagnostic workflows. | Supports faster test turnaround, improves scalability, and enables efficient deployment across diverse testing environments. |
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Use of next-generation sequencing (NGS) technologies for oncology profiling, genetic analysis, and large-scale genomic testing programs. | Delivers deep genomic insights, supports precision medicine strategies, and enables scalable high-throughput analysis. |
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Molecular testing solutions focused on women’s health, including HPV & sexually transmitted infection screening. | Enhances early detection, supports preventive care initiatives, and improves long-term clinical outcomes. |
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Integrated molecular diagnostic systems for infectious disease testing, cancer diagnostics, and companion diagnostics in centralized labs. | Delivers high test accuracy, standardized results, and seamless integration across laboratory workflows. |
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MDx solutions for rapid identification of pathogens & monitoring of healthcare-associated infections (HAIs). | Enables timely detection, supports infection control strategies, and improves disease management outcomes. |
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET ECOSYSTEM
The US molecular diagnostics ecosystem consists of key stakeholders and components across the entire value chain, including products & services, test types, sample types, technologies, applications, techniques, clinical applications, and end users. The stakeholders include manufacturers engaged in developing and introducing products, distributors who sell via third parties or e-commerce platforms, and R&D partners offering outsourced development and manufacturing support. End users include hospitals & clinics, diagnostic laboratories, and other end users that apply MDx solutions in carrying out diagnostics. These constitute the key stakeholders in the US molecular diagnostics supply chain.
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET SEGMENTS
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
US Molecular Diagnostics Market, By Product & Service
On the basis of product & service, the market is segmented into reagents & kits, instruments, and services & software. In 2025, the reagents & kits segment accounted for the largest market share, primarily due to their recurring use in every molecular diagnostic test and strong demand across a broad range of applications. High testing volumes, continuous assay consumption, and regular launches of upgraded kits to meet evolving diagnostic needs also support the segment’s leading position.
US Molecular Diagnostics Market, By Test Type
On the basis of test type, the market is segmented into lab tests and PoC tests. In 2025, the lab tests segment held the largest market share, driven by their widespread use for complex and high-volume molecular testing. Lab-based testing supports a broad range of applications, including infectious disease detection, oncology, and genetic testing. It also allows for higher throughput and standardized workflows. The availability of advanced instrumentation and the ability to handle large sample volumes contribute to the dominant position of lab tests.
US Molecular Diagnostics Market, By Sample Type
On the basis of sample type, the market is segmented into blood, serum, and plasma; urine; and other sample types. In 2025, the blood, serum, and plasma segment accounted for the largest market share as these specimens are most commonly used for a wide range of applications. Their compatibility with multiple molecular technologies, reliable biomarker availability, and routine use in clinical testing support high sample volumes and consistent demand, contributing to the segment’s leading position.
US Molecular Diagnostics Market, By Technology
On the basis of technology, the market is segmented into PCR, isothermal nucleic acid amplification technology, DNA sequencing & NGS, in situ hybridization, DNA microarrays, and other technologies. In 2025, PCR accounted for the largest market share, driven by its broad use across routine molecular diagnostic applications. PCR remains widely adopted due to its high sensitivity, reliability, and ability to deliver rapid results across infectious disease testing, cancer, and genetic testing.
US Molecular Diagnostics Market, By Application
On the basis of application, the market is segmented into genetic testing, oncology testing, infectious disease diagnostics, and other applications. In 2025, the infectious disease diagnostics segment dominated the market, driven by high testing volumes for a wide range of viral & bacterial infections. The continued need for timely & accurate pathogen detection, routine monitoring, and disease surveillance supports a strong demand for molecular tests in this segment.
US Molecular Diagnostics Market, By Technique
On the basis of technique, the market is segmented into multiplex testing and singleplex testing. In 2025, multiplex testing accounted for the largest market share, driven by its ability to detect multiple targets from a single sample in one run. This approach improves testing efficiency, reduces sample & reagent usage, and supports higher throughput.
US Molecular Diagnostics Market, By Clinical Application
On the basis of clinical application, the market is segmented into diagnostics and screening. In 2025, the diagnostics segment held the largest market share, driven by the strong demand for confirmatory and disease-specific molecular tests used in clinical decision-making.
US Molecular Diagnostics Market, By End User
On the basis of end user, the market is segmented into hospitals & clinics, diagnostic laboratories, and other end users. In 2025, diagnostic laboratories accounted for the largest market share, driven by their high testing volumes and capability to handle complex molecular assays.
US MOLECULAR DIAGNOSTICS MARKET: COMPANY EVALUATION MATRIX
Danaher (Star) is a leading player in the US molecular diagnostics (MDx) market due to its strong portfolio of well-established molecular testing platforms, supported by continuous innovation & automation. The company benefits from broad assay menus and scalable systems, which drive recurring demand for consumables. Additionally, Danaher’s focus on workflow efficiency, test reliability, and strategic acquisitions has enabled it to maintain a strong competitive position across key MDx applications.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
KEY MARKET PLAYERS
MARKET SCOPE
| REPORT METRIC | DETAILS |
|---|---|
| Market Size in 2025 (Value) | USD 8.34 Billion |
| Market Forecast in 2031 (Value) | USD 14.32 Billion |
| Growth Rate | CAGR of 9.9% from 2026–2031 |
| Years Considered | 2024–2031 |
| Base Year | 2024 |
| Forecast Period | 2026–2031 |
| Units Considered | Value (USD Million) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Segments Covered |
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WHAT IS IN IT FOR YOU: US MOLECULAR DIAGNOSTICS MARKET REPORT CONTENT GUIDE
DELIVERED CUSTOMIZATIONS
We have successfully delivered the following deep-dive customizations:
| CLIENT REQUEST | CUSTOMIZATION DELIVERED | VALUE ADDS |
|---|---|---|
| Product Analysis | Product matrix, which provides a detailed comparison of the product portfolio of each company in the US molecular diagnostics market. | Enables easy comparison of competitors’ offerings, helping identify gaps, overlaps, and opportunities for differentiation. |
| Company Information | Additional five company profiles of players operating in the US molecular diagnostics market. | Provides insights into competitors’ strategies, innovation focus, and partnerships, supporting strategic planning. |
RECENT DEVELOPMENTS
- June 2025 : Cepheid (a Danaher subsidiary) announced that Health Canada had issued a medical device license for the Xpert HIV-1 Viral Load XC test. This next-generation, extended-coverage (XC) assay is designed to support the assessment of HIV viral load levels, which are used to monitor the effectiveness of antiretroviral therapy.
- May 2025 : F. Hoffmann-La Roche Ltd. (Switzerland) collaborated with Broad Clinical Labs (US) to advance & pilot innovative applications using Roche’s newly launched next-generation sequencing technology, Sequencing by Expansion (SBX). The collaboration aimed to explore the potential of SBX in advancing clinical genomics and biomedical research.
- February 2025 : Hologic, Inc. (US) received 510(k) clearance for its Aptima SARS-CoV-2 assay. The assay had previously been granted Emergency Use Authorization (EUA) in May 2020, and the clearance reflects its transition to full regulatory approval status.
- October 2024 : Illumina, Inc. (US) launched the MiSeq i100 Series, a next-generation sequencing instrument designed to deliver high benchtop speed and simplified workflows. The system is designed to support efficient and accessible NGS adoption by improving ease of use and operational efficiency.
Table of Contents
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Methodology
The study involved major activities in estimating the current market size for the global US Molecular Diagnostics Market. Exhaustive secondary research was done to collect information on the US Molecular Diagnostics Market. The next step was to validate these findings, assumptions, and sizing with industry experts across the value chain using primary research. Different approaches, such as top-down and bottom-up, were employed to estimate the total market size. After that, the market breakup and data triangulation procedures were used to estimate the market size of the segments and subsegments of the US Molecular Diagnostics Market.
The four steps involved in estimating the market size are as follows:
Secondary Research
In the secondary research process, various secondary sources such as annual reports, press releases & investor presentations of companies, white papers, certified publications, articles by recognized authors, gold-standard & silver-standard websites, regulatory bodies, and databases (such as D&B Hoovers, Bloomberg Business, and Factiva) were referred to, to identify and collect information for this study.
Primary Research
In the primary research process, various sources from the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. Primary sources mainly include industry experts from the core and related industries and preferred suppliers, manufacturers, distributors, service providers, technology developers, researchers, and organizations related to all segments of this industry’s value chain. In-depth interviews were conducted with primary respondents, including key industry participants, subject-matter experts, C-level executives of key market players, and industry consultants, to obtain and verify critical qualitative and quantitative information and assess prospects.
Market Size Estimation
The top-down and bottom-up approaches were used to estimate and validate the US Molecular Diagnostics Market’s total size. These methods were also used extensively to estimate the size of various subsegments in the market.
- The key players in the industry have been identified through extensive secondary research.
- Primary and secondary research have determined the revenues generated by leading players operating in the US Molecular Diagnostics Market.
- All percentage share, splits, and breakdowns have been determined using secondary sources and verified through primary sources.
Data Triangulation
After arriving at the overall market size by applying the process mentioned above, the total market was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides.
Market Definition
Molecular diagnostics is a technique used to identify and analyze nucleic acids or proteins at a molecular level. This technique assesses an individual’s genetic makeup to identify a predisposition to any particular disease or condition and diagnose it.
Stakeholders
- Senior Management
- End Users
- Finance/Procurement Department
- R&D Department
Report Objectives
- To define, describe, segment, and forecast the global US Molecular Diagnostics Market by product & service, test type, sample type, technology, application, technique, clinical application, end user, and region
- To provide detailed information regarding the major factors (such as drivers, restraints, opportunities, and challenges) influencing market growth
- To analyze the micromarkets1 concerning individual growth trends, prospects, and contributions to the overall US Molecular Diagnostics Market
- To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
- To forecast the size of the market with respect to five regions, namely North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa
- To profile the key players and comprehensively analyze their product portfolios, market positions, and core competencies2
- To track and analyze company developments, such as product launches & approvals, partnerships, acquisitions, agreements, and other developments
- To benchmark players within the US Molecular Diagnostics Market using the Company Evaluation Matrix framework, which analyzes market players on various parameters within the broad categories of business strategy, market share, and product offerings
- To study the impact of AI/Gen AI on the US Molecular Diagnostics Market, along with the macroeconomic outlook for each region
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Growth opportunities and latent adjacency in US Molecular Diagnostics Market