United States STD Diagnostics Market Size & Forecast (2025–2033)

According to Renub Research United States STD Diagnostics Market is projected to grow from US$ 5.06 billion in 2024 to US$ 8.49 billion by 2033, registering a CAGR of 5.91% between 2025 and 2033. Growth is driven by the rising prevalence of sexually transmitted infections (STIs), intensified awareness campaigns, advancements in diagnostic technologies, strong government initiatives supporting early screening, increased adoption of point-of-care and at-home tests, and higher healthcare spending enabling routine and preventive testing.

United States STD Diagnostics Industry Overview

STD diagnostics involve clinical and point-of-care tests used to detect infections such as HIV, syphilis, chlamydia, gonorrhea, HPV, HSV, trichomonas, and mycoplasma genitalium. These diagnostics rely on multiple technologies including molecular assays, immunoassays, cultures, biosensors, and rapid testing platforms. Their primary role is to ensure early detection, timely treatment, reduced transmission, and prevention of long-term complications like infertility, pelvic inflammatory disease, systemic infections, and reproductive cancers.

The U.S. market is experiencing steady growth due to:

• Rising STD incidence
• Public health campaigns improving screening rates
• Wider availability of rapid point-of-care and home-based self-tests
• Improved diagnostic accuracy via advanced molecular platforms
• Strong reimbursement environment
• Partnerships between diagnostics companies, clinics, and public health organizations

As healthcare systems place greater emphasis on routine screening and early detection, demand for accessible, rapid, and precise diagnostic solutions continues to strengthen across different testing environments, including hospitals, laboratories, retail pharmacies, and homes.

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Key Growth Drivers for the United States STD Diagnostics Market

1. Rising STD Prevalence

Increasing STD incidence in the U.S. remains a central driver of diagnostic demand.
According to the CDC, over 2.4 million cases of chlamydia, gonorrhea, and syphilis were reported in 2023, with the burden still 13% higher than a decade ago despite minor year-over-year fluctuations.

Key concerns include:

• Congenital syphilis rising to ~4,000 cases in 2024, a nearly 700% increase over 10 years
• Over 80% rise in all stages of syphilis within five years (by 2022)
• Sustained high incidence among adolescents and young adults

This sharp increase underscores the urgent need for widespread, frequent, and accurate diagnostic testing across states.

2. Technological Advancements

Innovation is transforming the U.S. STD diagnostics landscape.

A major breakthrough occurred in December 2024, when OraSure Technologies acquired Sherlock Biosciences (US$ 1.5 billion), paving the way for CRISPR-based, rapid molecular self-testing kits for chlamydia and gonorrhea. The forthcoming CT/NG self-test—expected for FDA submission by 2025—promises:

• Lab-grade accuracy
• Results under 30 minutes
• Home-collected swab compatibility

This trend toward next-generation molecular diagnostics, combined with advances in isothermal amplification, biosensors, microfluidics, and next-generation sequencing (NGS), is enabling faster, more sensitive, and consumer-friendly STD testing technologies.

3. Increased Awareness and Preventive Screening

Public awareness initiatives significantly boost screening uptake. Campaigns like the CDC-led Get Yourself Tested (GYT) program have demonstrated measurable improvements in testing intentions and behaviors among adolescents and young adults.

Other awareness trends include:

• Digital health platforms promoting sexual health education
• Social media campaigns reducing stigma
• Targeted outreach in schools, colleges, and underserved communities

Improved awareness not only enhances testing frequency but also promotes adherence to preventive care guidelines, accelerating market expansion.

Challenges in the United States STD Diagnostics Market

1. High Testing Costs

High costs remain a barrier for many individuals and healthcare providers. Advanced molecular assays (e.g., NAATs) require:

• Expensive reagents
• Laboratory infrastructure
• Skilled personnel

Home self-testing kits, while convenient, are also costly, limiting repeat use. Variations in insurance coverage and reimbursement rates create further barriers to access, particularly in low-income and rural areas where STD burdens are often highest.

2. Regulatory Hurdles

Diagnostic manufacturers face stringent FDA approval requirements, including:

• Large clinical trials
• Extensive validation
• Quality assurance protocols

Compliance with state and federal regulatory frameworks adds complexity, especially for smaller companies. Lengthy approval timelines can delay commercialization of urgently needed tests, limiting rapid innovation despite rising public health demands.

State-Level Market Overviews

California

As one of the largest markets, California relies heavily on STD diagnostics due to high infection rates in major cities like Los Angeles, San Francisco, and San Diego.
Strengths include:

• Widespread adoption of rapid and point-of-care tests
• Strong public health initiatives targeting at-risk populations
• Large network of clinics and community programs

California’s focus on reducing stigma and improving access makes it a leader in early diagnosis and intervention.

Texas

Texas faces unique challenges due to its vast geography and rural-urban divide. Testing access can be limited outside major cities. Key trends include:

• Expansion of mobile clinics
• Partnerships with local organizations
• Public campaigns targeting stigma
• Growing investment in rapid testing technologies

Efforts center on improving access and reducing disparities in high-risk communities.

New York

New York—especially New York City—benefits from strong diagnostic infrastructure and extensive public health outreach. The state prioritizes:

• Routine screening for high-risk groups
• Free or low-cost testing in many clinics
• Comprehensive educational campaigns

Urban centers drive high testing volumes, although rural areas still face access challenges.

Florida

Florida’s diverse population and high burden of sexually transmitted infections make it a major market for diagnostics. Key initiatives include:

• Broad community outreach
• Targeted education in urban areas
• Mobile testing and public clinic expansion
• Preventive care programs aimed at early detection

Florida’s mix of public health efforts and demographic needs continues to increase diagnostic demand.

Recent Developments in the U.S. STD Diagnostics Market

• January 2025 – OraSure Technologies receives FDA CBER approval for updated OraQuick HIV Self-Test labeling, lowering the eligible age from 17 to 14, expanding access for adolescents.
• May 2025 – Visby Medical submits its Men’s Sexual Health Test to FDA for clearance and CLIA waiver, expanding its at-home testing portfolio.
• February 2023 – Thermo Fisher Scientific launches TrueMark STI select PCR panel, capable of detecting multiple STIs in a single test, strengthening its competitive position.

United States STD Diagnostics Market Segmentation

By Test Type

• Chlamydia Testing
• Gonorrhea Testing
• Syphilis Testing
• HPV Testing
• HSV Testing
• HIV Testing
• Trichomonas Testing
• Mycoplasma genitalium Testing
• Chancroid Testing

By Technology

• Immunoassay-Based Methods
• Molecular Diagnostics
• Next-Generation Sequencing (NGS)
• Biosensor / Microfluidics & Emerging Platforms

By Location of Testing

• Central & Hospital Laboratories
• Rapid Point-of-Care Platforms
• Over-the-Counter / Home Self-Testing

By End User

• Hospitals & Clinics
• Diagnostic Laboratories
• Home Care / OTC

By State (29 Viewpoints)

Includes:
California, Texas, New York, Florida, Illinois, Pennsylvania, Ohio, Georgia, New Jersey, Washington, North Carolina, Massachusetts, Virginia, Michigan, Maryland, Colorado, Tennessee, Indiana, Arizona, Minnesota, Wisconsin, Missouri, Connecticut, South Carolina, Oregon, Louisiana, Alabama, Kentucky, and Rest of the U.S.

Competitive Landscape (5 Viewpoints)

Company Overview – Key Persons – Recent Developments – SWOT Analysis – Sales Analysis

Key Players

• Abbott Laboratories
• Hoffmann-La Roche AG
• Hologic Inc.
• Becton Dickinson and Company
• Danaher Corporation (Cepheid)
• Siemens Healthineers AG
• bioMérieux SA
• Thermo Fisher Scientific Inc.
• Qiagen N.V.
• Bio-Rad Laboratories Inc.

These companies are actively investing in molecular diagnostics, rapid testing, and self-testing platforms—driving innovation and accessibility in the U.S. STD diagnostics landscape.

Conclusion

The U.S. STD Diagnostics Market is on a strong growth trajectory, set to reach US$ 8.49 billion by 2033. The rise in infection rates, increasing awareness, and rapid progress in diagnostic technology are key drivers. Although challenges such as high costs and regulatory hurdles persist, ongoing innovations—particularly in point-of-care and at-home testing—are reshaping the market and improving access across diverse populations.