U.S. Sexually Transmitted Disease Testing Market Size, Share & COVID-19 Impact Analysis, By Product Type (Instruments and Reagents & Kits), By Application (Chlamydia, Syphilis, Genital Herpes, Gonorrhea, Human Immunodeficiency Virus, Human Papillomavirus, and Others), By Setting (Laboratory Testing and Point-of-Care) By End User (Hospital & Clinics, Clinical Laboratories, and Others), and Country Forecast, 2023-2030

The U.S. sexually transmitted disease testing market size was worth USD 3.51 billion in 2022 and is projected to grow at a CAGR of 8.7% during the forecast period. 

Every year, millions of new Sexually Transmitted Infections (STIs) are reported in the U.S., with a higher incidence rate of syphilis, gonorrhea, chlamydia, and other infections. For instance, 1 in 5 people in the U.S. have a sexually transmitted infection, according to the 2021 estimates of the Centers for Disease Control and Prevention (CDC). At the same time, funding for its prevention and treatment programmes has increased, resulting in an increase in the number of clinicians involved in the diagnosis and treatment of these diseases.

Increasing awareness about these diseases among the general population is leading to an increase in the number of people undergoing diagnosis. This is anticipated to drive the demand for kits and instruments for testing these diseases.

The outbreak of the COVID-19 pandemic impacted the market negatively due to a decline in sexually transmitted disease testing, which led to an increase in underreported cases and a surge in transmission of these diseases.

LATEST TRENDS

Increasing Preference for Self-Testing Kits

Concerns over privacy, social stigma, and fear of being judged are the primary factors for the rise of the undiagnosed STD population. The advent of home-based sexually transmitted disease testing kits can encourage the diagnosis of these diseases among the population. The ease of its accessibility via online pharmacies or retail pharmacies drives the adoption rate of these products.

For instance, TakeMeHome enables state and local health departments to offer free in-home sexual health tests to eligible community members in the U.S. Such initiatives will encourage the market players to upscale their research and development activities to introduce novel products and meet the growing demand.

DRIVING FACTORS

Increasing Government Initiatives is projected to drive the Testing Rate in the Country

The U.S. government is constantly making efforts to increase awareness of sexually transmitted diseases in the country, intending to reduce the associated economic burden. The government has introduced several policies, programs, and campaigns and is actively investing to support research related to sexually transmitted disease testing.

• For instance, the National HIV/AIDS Strategy and the Ending the HIV Epidemic in the U.S. Initiative emphasize diagnosing individuals as soon as possible and ensuring the availability of multiple HIV testing modalities to meet best the needs of populations with increased risk of transmission.

Such initiatives are anticipated to increase awareness related to STD testing among the patient population, which is projected to lead to a surge in the diagnosis rate for these diseases. This will drive the demand for products used for sexually transmitted disease testing products during the forecast period.

RESTRAINING FACTORS

Limited Knowledge among the Patient Population is Likely to Limit the Adoption Rate

Limited knowledge of these diseases among the patient population and the healthcare provider’s lack of counseling skills is increasing the number of undiagnosed cases. For instance, a study published by the HHS Author Manuscripts in 2022 concluded that the rate of STI testing among sexually active adolescents was low at approximately 20%. Moreover, there is a reluctance towards testing in a large population group due to barriers such as confidentiality and perceived stigma related to STIs.

Another factor affecting the testing provision is the lack of sexual behavior disclosure, especially in men who have sex with men (MSM), as they have a high burden of curable STIs. All these factors cumulatively increase the undiagnosed cases. These high numbers of undiagnosed cases are a result of comparatively lower sexually transmitted disease testing, which is limiting the demand for kits and instruments in the country and overall U.S. sexually transmitted disease testing market growth.

As per the 2021 Sexually Transmitted Disease (STD) Surveillance Report, a total of 1,644,416 cases of chlamydia were reported in 2021, as compared to 1,579,885 in 2020.  

SEGMENTATION

By Product Analysis

The market is segmented by product into instruments and reagents & kits.

The reagents & kits segment dominated the U.S. sexually transmitted disease testing market share in 2022. The segment’s growth is attributed to the various benefits offered by these rapid test kits compared to instruments, as these kits can be used in home care settings. Moreover, these kits eliminate consumers' concerns about privacy and the stigma associated with the test results.

• For instance, rapid antigen tests such as the Gonorrhea Rapid Test Kit of Vitrosens can quickly check for gonorrhea-specific proteins in urine or vaginal swab samples and deliver highly accurate results in minutes.

By Application Analysis

Based on application, the market is classified into chlamydia, syphilis, genital herpes, human immunodeficiency virus (HIV), human papillomavirus (HPV), and others.

The chlamydia segment held a larger market share in 2022. Chlamydia is one of the most common infections in the U.S., and the availability of many home-to-lab tests for its diagnosis drives the adoption rate of these products in the country.

• According to the Centers for Control and Prevention 2021 data, chlamydia is common among men who have sex with men (MSM). Among MSM screened for rectal chlamydial infection, positivity ranges from 3.0% to 10.5%, whereas for pharyngeal chlamydial infection, positivity ranges from 0.5% to 2.3%.

By Setting Analysis

By setting, the market is divided into laboratory testing and point-of-care testing.

The laboratory testing segment dominated the U.S. market in 2022. The number of clinical laboratories nationwide is increasing, providing more accurate results than point-of-care. Moreover, skilled healthcare professionals can perform certain techniques only in a laboratory setting. These factors influence the patient's preference in opting for laboratory settings for STD testing nationwide, subsequently driving the segment’s growth.

• For instance, Quest Diagnostics offers OraRisk HPV, a laboratory-developed PCR-based test to detect high- or low-risk HPV types in saliva rinses.

By End User Analysis

Based on end user, the market is segmented into hospitals and clinics, clinical laboratories, and others.

The clinical laboratories segment held a larger share of the market in 2022. Diagnostic centers waiting time is comparatively lower as they extend the ease of testing by collecting samples at home or sending them, influencing the patient population’s preference for diagnostic centers. Cumulatively, all these factors are projected to drive the segment’s growth during the forecast period.

• According to the Centers for Medicare and Medicaid Services (CMS) data, the number of clinical laboratory improvement amendments (CLIA) certified clinical laboratories in the United States increased by about 13 percent, from 286,396 to 323,086 in 2020 to 2021 respectively.

KEY INDUSTRY PLAYERS

The U.S. sexually transmitted disease testing market is fragmented, with many prominent players offering a wide range of products for multiple indications. Tier 1 players include market players like Abbott, bioMerieux Inc., and Bio Rad Laboratories Inc., which hold a considerable share in the U.S. market. Abbott and Bio Rad Laboratories Inc. are focused on launching products such as Alinity m STI assay and BioPlex 2200 Syphilis Total & RPR assay, respectively. These products can detect and differentiate multiple diseases in one test. bioMerieux Inc. emphasizes getting regulatory approval for its product to increase its adaptability in hospitals, institutions, and laboratories.

Some other key players in the U.S. market are DiaSorin S.p.A, Cepheid (Danaher), Hologic, Inc., and F. Hoffmann-La Roche Ltd. These companies are focusing on expanding their geographical footprints through strategic alliances. In 2021, Hologic, Inc. announced the acquisition of Diagenode, a molecular diagnostic company. This has strengthened the diagnostic product portfolio of Hologic, Inc. Such strategic moves are expected to expand companies' product presence further in this market.

LIST OF KEY COMPANIES PROFILED:

• F. Hoffmann-La Roche Ltd. (Switzerland)


• Abbott (U.S.)


• BD (U.S.)


• Hologic, Inc. (U.S.)


• Thermo Fisher Scientific Inc. (U.S.)


• bioMerieux, Inc. (France)


• Cepheid (Danaher Corporation)(U.S.)


• Bio-Rad Laboratories, Inc. (U.S.)


• DiaSorin S.p.A (Italy)

KEY INDUSTRY DEVELOPMENTS: 

• March 2023 – Visby Medical received 510 (k) clearance from the U.S. FDA approval for its second-generation point-of-care test i.e., Sexual Health Click Test. It is a fast, polymerase chain reaction (PCR) diagnostic test for detecting Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in women.


• May 2022 – Abbott announced the U.S. FDA clearance for Alinity m STI Assays. It is a 4-in-1 multiplex assay that can detect and differentiate Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) to aid in the infection caused by these organisms.


• December 2021 – Hologic Inc. launched Panther Trax in the U.S., Europe, Canada, Australia, and New Zealand. The Panther system offers a broad assay menu, including tests for women’s health, sexually transmitted infections (STIs), respiratory health, viral load, and COVID-19 testing.

REPORT COVERAGE

The U.S. sexually transmitted disease testing market report provides a detailed market analysis. It focuses on key aspects such as the incidence of key diseases in the U.S., and an overview of technological advancements. Additionally, it includes an overview of the regulatory scenario, key industry developments, new product launches, and the impact of COVID-19 on the market. Besides this, the report also offers insights into the market trends and highlights key industry dynamics. In addition to the aforementioned factors, it encompasses several factors that have contributed to the market growth over recent years.

Report Scope & Segmentation