Screening the Nation: United States STD Diagnostics Market Forecast 2025–2033

The fight against sexually transmitted diseases (STDs) in the United States is entering a new phase—one defined by advanced diagnostics, expanding home-testing solutions, and stronger public health outreach. As infection rates remain elevated and awareness grows, early detection has become central to prevention strategies.

According to Renub Research, the United States STD Diagnostics Market is projected to expand from US$ 5.06 billion in 2024 to US$ 8.49 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 5.91% from 2025 to 2033. Rising disease prevalence, technological innovation, government-led awareness programs, and increasing healthcare spending are shaping this steady market expansion.

In an era focused on preventive healthcare, diagnostic testing has become a frontline defense in protecting public health.

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United States STD Diagnostics Industry Overview

STD diagnostics include a broad range of medical tests used to detect infections such as:

• Chlamydia
• Gonorrhea
• Syphilis
• HIV
• Human papillomavirus (HPV)
• Herpes simplex virus (HSV)
• Trichomoniasis
• Mycoplasma genitalium

Testing technologies range from laboratory-based molecular assays and immunoassays to rapid point-of-care tests and at-home self-testing kits.

Modern advancements have significantly improved:

• Test sensitivity and specificity
• Turnaround time
• Accessibility outside clinical settings
• Integration with digital health platforms

Early diagnosis plays a crucial role in preventing long-term complications such as infertility, systemic infections, neonatal transmission, and certain cancers. The emphasis on early detection and routine screening is strengthening demand across hospitals, laboratories, and home-care settings.

Key Growth Drivers

Rising STD Prevalence

Increasing infection rates remain a major catalyst for market growth. According to the U.S. Centers for Disease Control and Prevention (CDC), more than 2.4 million cases of chlamydia, gonorrhea, and syphilis were reported in 2023.

Although overall reported cases declined slightly between 2022 and 2023, the long-term trend remains concerning:

• STD cases are approximately 13% higher than a decade ago.
• Congenital syphilis cases have increased dramatically—nearly 700% over ten years, with around 4,000 reported cases in 2024.
• All stages of syphilis saw increases exceeding 80% within a five-year period leading up to 2022.

These statistics underscore the urgent need for expanded screening and improved diagnostic accessibility nationwide.

Technological Advancements Transforming Diagnostics

Innovation is redefining how STDs are detected. Molecular diagnostics, CRISPR-based technologies, and rapid isothermal amplification methods are enabling faster and more accurate results.

In December 2024, OraSure Technologies acquired Sherlock Biosciences in a USD 1.5 billion deal to expand into molecular self-testing. The company is developing a chlamydia and gonorrhea (CT/NG) self-test kit expected to be submitted to the FDA by the end of 2025. The test uses CRISPR-based technology to deliver highly accurate results from self-collected swabs within 30 minutes.

Additionally, in February 2023, Thermo Fisher Scientific Inc. launched the Applied Biosystems TrueMark STI Select Panel, capable of detecting multiple pathogens—including Neisseria gonorrhoeae and Mycoplasma genitalium—within a single PCR-based test.

In May 2025, Visby Medical submitted its Men’s Sexual Health Test to the FDA for clearance and CLIA waiver, expanding at-home molecular testing solutions.

These innovations are narrowing the gap between laboratory-grade accuracy and consumer convenience.

Increased Public Awareness and Screening Initiatives

Public awareness campaigns are significantly contributing to higher testing rates. Government programs, school-based initiatives, and digital outreach platforms are actively reducing stigma and promoting preventive care.

The CDC-supported “Get Yourself Tested (GYT)” campaign has demonstrated measurable success, particularly among adolescents and young adults. Studies show higher testing intentions and behaviors among youth exposed to such campaigns.

Social media platforms and telehealth services have also normalized sexual health discussions, encouraging routine screenings and early intervention. As awareness continues to grow, diagnostic demand is expected to remain strong.

Market Challenges

High Testing Costs

Advanced diagnostic technologies, particularly nucleic acid amplification tests (NAATs) and molecular assays, require expensive equipment, reagents, and skilled personnel.

Challenges include:

• High upfront laboratory infrastructure costs
• Variability in insurance coverage
• Out-of-pocket expenses for uninsured populations
• Limited affordability in rural and underserved regions

While home-testing kits offer convenience, pricing may restrict broader adoption. Reducing test costs and expanding reimbursement coverage will be essential for equitable access.

Regulatory Complexities

The U.S. Food and Drug Administration (FDA) enforces strict approval processes for diagnostic tests. Clinical validation, safety evaluations, and quality assurance requirements can extend development timelines and increase costs.

Smaller diagnostic companies may struggle to navigate complex regulatory pathways, potentially slowing innovation and limiting rapid deployment of new technologies.

Balancing regulatory rigor with timely access to diagnostics remains a central industry challenge.

State-Level Market Insights

California

California represents one of the largest STD diagnostics markets in the country due to its large population and high infection burden in urban centers such as Los Angeles and San Francisco.

Public health agencies emphasize:

• Rapid point-of-care testing
• Community outreach programs
• Screening among underserved populations

Strong awareness initiatives and technological adoption position California as a leading state market.

Texas

Texas faces geographic disparities, with urban areas experiencing higher infection rates while rural regions often lack sufficient testing infrastructure.

Mobile clinics and community partnerships are improving outreach. However, infrastructure limitations and social stigma remain barriers. Expanded digital health platforms are expected to support continued growth.

New York

New York, particularly New York City, benefits from robust public health infrastructure. Numerous clinics provide free or low-cost testing services targeting high-risk populations.

Educational initiatives and community partnerships strengthen screening programs, maintaining the state’s leadership in diagnostic adoption.

Florida

Florida’s market is shaped by diverse demographics and variable healthcare access. Urban centers focus on early detection, while rural regions face service gaps.

Collaborative efforts between public health departments and community organizations are improving screening accessibility and reducing transmission risks.

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
• Biosensor & Microfluidics 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

Competitive Landscape

Major players operating in the U.S. STD diagnostics market include:

• Abbott Laboratories
• F. 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.

Companies are analyzed across:

• Company Overview
• Key Persons
• Recent Developments & Strategies
• SWOT Analysis
• Sales Analysis

Competitive strategies increasingly focus on rapid testing, molecular accuracy, and expanded at-home diagnostic solutions.

Future Outlook

The U.S. STD diagnostics market is steadily advancing toward decentralized and patient-driven testing. Innovations in CRISPR-based detection, portable PCR platforms, and digital health integration are likely to enhance convenience and turnaround time.

Growing emphasis on preventive healthcare and routine screening, combined with policy support and expanding reimbursement frameworks, will sustain long-term demand.

Final Thoughts

The United States STD Diagnostics Market, projected to reach US$ 8.49 billion by 2033, reflects a healthcare system increasingly focused on prevention, early detection, and public health protection.

While challenges such as high costs and regulatory hurdles remain, technological advancements and awareness initiatives are reshaping diagnostic accessibility. As rapid and at-home testing solutions gain regulatory approval and consumer trust, the market will continue evolving toward more convenient and equitable screening options.

In the battle against sexually transmitted infections, diagnostics are not merely tools—they are the foundation of prevention, treatment, and long-term public health resilience.