United States Molecular Diagnostics Market Trends & Summary

The United States molecular diagnostics market continues to strengthen its position as a global powerhouse, driven by innovations in technology, rising cases of infectious diseases and cancer, and accelerated adoption of personalized medicine. According to Renub Research, the U.S. market stood at USD 4.91 billion in 2024 and is projected to reach USD 8.40 billion by 2033, expanding at a CAGR of 6.15% from 2025 to 2033. This momentum reflects the nation’s focus on improving early detection, enhancing treatment accuracy, and supporting a healthcare ecosystem increasingly reliant on genetic insight.

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A Closer Look: The U.S. Molecular Diagnostics Landscape

Molecular diagnostics—once a niche scientific application—has evolved into one of the most influential pillars of modern medicine. By analyzing DNA, RNA, and proteins, these tests uncover genetic mutations, detect infectious pathogens, and identify biomarkers that guide highly personalized medical decisions.

Across the United States, molecular diagnostics have become central to the detection and management of COVID-19, HIV, influenza, and a growing list of emerging infectious threats. In oncology, these technologies are unlocking new approaches to diagnosing cancers such as breast, lung, and colorectal cancer, where molecular biomarkers determine the most effective targeted therapies.

Additionally, the U.S. healthcare system is prioritizing precision medicine, prenatal testing, and pharmacogenomics—all areas that heavily depend on sophisticated molecular insights. Hospitals, clinical laboratories, and research institutions are scaling up molecular capabilities, accelerating both healthcare innovation and patient outcomes.

Major Growth Drivers of the U.S. Molecular Diagnostics Market

1. Rising Infectious Disease Burden and Cancer Incidence

The U.S. continues to face a high prevalence of infectious diseases—COVID-19, respiratory viruses, sexually transmitted infections, and HIV among them. Molecular diagnostics deliver the rapid and accurate detection required for early treatment and outbreak control.

Cancer, one of the leading causes of death in the country, is another major driver. The U.S. is expected to witness 2,041,910 new cancer cases and 618,120 deaths in 2025, reinforcing the urgent need for improved screening tools. Advances such as liquid biopsies and next-generation sequencing (NGS) are enabling earlier detection and personalized oncology treatments, fueling market expansion.

Despite improvements in cancer mortality rates since 1991—preventing nearly 4.5 million deaths—significant disparities remain. Certain minority communities, including Native American and Black populations, continue to experience notably higher cancer mortality, heightening the need for equitable access to molecular testing.

2. Breakthrough Technological Innovation and Automation

Technology remains the backbone of the sector’s rapid ascent. Emerging platforms such as:

Digital PCR

CRISPR-based diagnostics

AI-driven data analysis

High-throughput sequencing

Portable point-of-care (POC) test devices

…have transformed the accuracy, speed, and accessibility of molecular diagnostics.

Automation, in particular, is reducing human error, increasing throughput, and expanding clinical testing capacity. A notable example from January 2024 is diagnostics firm 3EO Health, which released a low-cost COVID-19 test for U.S. consumers and healthcare providers. Advances like this are bringing molecular testing closer to homes and frontline clinics.

3. A National Shift Toward Personalized Medicine

The U.S. healthcare system is rapidly shifting away from a “one-size-fits-all” model and toward precision medicine, driven by genomic insights. Molecular diagnostics are crucial here, especially in:

Selecting personalized drug therapies

Adjusting dosages based on genetic metabolism

Identifying genetic risk factors

Guiding targeted cancer treatment

In 2023, the FDA approved 16 new personalized drugs for rare diseases, compared to only six approvals in 2022. Severe conditions—many previously untreatable—now benefit from individualized approaches made possible by genomic diagnostics.

Market Challenges: Barriers to Widespread Adoption

1. High Testing Costs and Reimbursement Limitations

Molecular tests often require expensive equipment, specialized instruments, and trained professionals. That drives up the cost of testing, which can be a barrier for smaller hospitals and uninsured or underinsured patients.

While insurance coverage has broadened, reimbursement policies—especially for Medicare and private insurers—remain inconsistent and complex. Many high-end molecular tests still face coverage limitations, slowing adoption across the U.S.

2. Regulatory Complexity and Compliance Pressures

Regulation is another significant challenge. The FDA maintains strict oversight for molecular diagnostic test approvals, which can stretch timelines and raise development costs for manufacturers.

Ongoing debate around laboratory-developed tests (LDTs) further complicates the regulatory landscape. Laboratories must also meet stringent quality control standards, cybersecurity requirements for patient data, and evolving federal policies—factors that increase operational difficulty and slow market entry.

Technology Segment Insights

Chips and Microarrays

Microarray technology plays a pivotal role in analyzing gene expression, detecting mutations, and screening for genetic disorders. Its high-throughput capacity and growing integration with bioinformatics make it a critical tool for cancer diagnostics and pharmacogenomics in the U.S.

PCR (Polymerase Chain Reaction)

PCR remains the gold standard for infectious disease detection and genetic testing. It was instrumental during the COVID-19 pandemic and continues to dominate routine diagnostic workflows. Newer advancements like digital PCR and multiplex PCR are further improving sensitivity and processing speed, sustaining the segment’s growth.

NGS & Infectious Disease Diagnostics

Next-generation sequencing and rapid PCR methods are essential for detecting pathogens including COVID-19 variants, hepatitis viruses, respiratory infections, and emerging biological threats. Strong federal and private investments in pandemic preparedness and antimicrobial resistance are boosting this segment.

Oncology: Leading the Precision Medicine Revolution

Molecular diagnostics are redefining cancer treatment. Technologies such as NGS, tumor profiling, and liquid biopsies are now routinely used to detect cancer mutations, monitor treatment response, and guide targeted therapies.

Given the rising incidence of cancer and a national push for early detection, this segment is expected to see strong and steady growth through 2033.

Instruments: The Backbone of Molecular Testing

High-throughput PCR machines, sequencers, microarray scanners, and automated analyzers are in growing demand across laboratories and hospitals. Miniaturized and portable molecular devices are expanding point-of-care capabilities, enabling faster diagnosis in clinics, pharmacies, and even homes.

Investment Outlook: A Rapidly Expanding Innovation Ecosystem

In January 2025, the U.S. Department of Health and Human Services announced $263 million (FY 2022) in funding through its DDDI program. The investment supports:

Advanced diagnostics for biothreats

Antimicrobial resistance solutions

Biodosimetry

Influenza and COVID-19 testing

Respiratory protection devices

This demonstrates ongoing national commitment to accelerating innovation across multiple diagnostic applications.

Recent Company Developments Shaping the Market

ELITechGroup (January 2024)

Launched the GI Bacterial PLUS ELITe MGB® Kit, targeting pathogens responsible for major foodborne and hospital-acquired infections.

QIAGEN (August 2023)

Received FDA clearance for the Therascreen PDGFRA RGQ PCR kit, enabling more accurate detection in gastrointestinal stromal tumor (GIST) patients.

BD & CerTest Biotec (January 2023)

Received EUA approval for the VIASURE Monkeypox Virus Real-Time PCR Reagents, addressing a sudden global outbreak.

Lucira Health (March 2023)

Introduced the first-ever at-home combined COVID-19 and flu test, marking a breakthrough in U.S. over-the-counter molecular diagnostics.

United States Molecular Diagnostics Market Segmentation

Technology

Chips and Microarrays

In Situ Hybridization

Sequencing

Mass Spectrometry (MS)

PCR

Other Technologies

Application

Pharmacogenomics

Infectious Disease

Genetic Disease Screening

Oncology

Blood Screening

Microbiology

Human Leukocyte Antigen (HLA) Typing

Product

Instruments

Reagents

Other Products

End User

Hospitals

Laboratories

Other End Users

Leading Companies in the U.S. Molecular Diagnostics Market

Each major player is evaluated based on Overview, Key Persons, Recent Developments, and Revenue:

F. Hoffmann-La Roche Ltd

Illumina Inc.

Hologic Inc.

Agilent Technologies Inc.

QIAGEN NV

Myriad Genetics

Abbott Laboratories

Danaher Corporation

Becton, Dickinson and Company

Final Thoughts

The United States molecular diagnostics market is entering a transformative era. With the rise of precision medicine, rapid advancements in genomic technology, and an urgent need for early and accurate disease detection, molecular diagnostics will continue to shape the future of American healthcare.

While regulatory challenges and cost barriers remain, the momentum of innovation—supported by strategic funding, scientific breakthroughs, and growing public health needs—positions the U.S. as a trailblazer in diagnostic excellence.

As personalized healthcare becomes the new standard, molecular diagnostics will stand at the center of medical decision-making, offering patients faster, more accurate, and more individualized care than ever before.