STD Diagnostics Market Size and Share
STD Diagnostics Market Analysis by Mordor Intelligence
The STD diagnostics market is valued at USD 18.18 billion in 2025 and is projected to reach USD 25.60 billion by 2030, advancing at a 7.08% CAGR. Growth is propelled by an 80% surge in U.S. syphilis cases—exceeding 207,000 confirmed infections in 2022—and the creation of a federal task force to curb the trend. The World Health Organization now tracks 8 million global syphilis cases for 2022, underscoring the gap to its 2030 goal of a 90% reduction in adult infections. Overall STI incidence has climbed 58.38% since 1990, with the sharpest burdens in low socio-demographic regions. Regulatory momentum continues as the FDA reclassified nucleic-acid STI assays to Class II in May 2025, shortening approval cycles for innovative platforms. Insurers updated preventive-service tables in May 2024 to guarantee zero-cost STD screening, expanding routine testing volumes. Yet 68% of individuals still cite shame and 85% fear provider judgment, fueling demand for home-based and digitally connected diagnostics.
Key Report Takeaways
- By technology, molecular diagnostics commanded 51.34% of STD diagnostics market share in 2024, while next-generation sequencing is forecast to post the fastest 9.29% CAGR through 2030.
- By location, laboratory testing held 62.34% share of the STD diagnostics market size in 2024, whereas point-of-care platforms are advancing at an 8.56% CAGR to 2030.
- By test type, HIV assays led with 28.89% revenue share in 2024; Mycoplasma genitalium tests are projected to expand at a 7.89% CAGR over the same horizon.
- By geography, North America dominated at 42.23% share of the STD diagnostics market in 2024, while Asia-Pacific is expected to record a 10.93% CAGR through 2030.
Global STD Diagnostics Market Trends and Insights
Driver Impact Analysis
| Driver | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Rising global STD incidence | +1.8% | Global, with acute impact in North America & Asia-Pacific | Long term (≥ 4 years) |
| Government-funded screening programmes | +1.5% | North America, Europe, Australia with expansion to emerging markets | Long term (≥ 4 years) |
| Advances in NAAT & rapid PoC platforms | +1.2% | Global, led by developed markets with technology transfer | Short term (≤ 2 years) |
| Home self-testing & digital connectivity | +0.9% | North America & Europe core, expanding to urban Asia-Pacific | Medium term (2-4 years) |
| Multiplex AMR panels for STI pathogens | +0.7% | Global, with priority adoption in North America & Europe | Short term (≤ 2 years) |
| Corporate pre-employment screening in EMs | +0.4% | Emerging markets, particularly Asia-Pacific & Middle East | Medium term (2-4 years) |
| Source: Mordor Intelligence | |||
Rising Global STD Incidence
The World Health Organization recorded more than 1 million new sexually transmitted infection cases every day during 2024[1]World Health Organization, “Sexually Transmitted Infections (STIs),” who.int. Asymptomatic presentations account for roughly 70% of chlamydia and gonorrhea infections, so routine testing is vital to interrupt transmission. Gen Z and young millennials aged 15–24 represent nearly half of new cases, prompting health systems to integrate rapid PoC assays that deliver timely results and curb reinfection chains. The discovery of mpox as a sexually transmitted pathogen in 2024 created further diagnostic demand because clinicians need multiplex panels able to distinguish legacy STIs from emerging threats. Simultaneous detection of pathogens and resistance profiles places nucleic-acid platforms at the center of the expanding STD diagnostics market.
Government-Funded Screening Programmes
The U.S. Preventive Services Task Force broadened its screening guidance in 2024 to recommend annual chlamydia and gonorrhea tests for all sexually active individuals younger than 25[2]U.S. Preventive Services Task Force, “Chlamydia and Gonorrhea Screening,” uspreventiveservicestaskforce.org. Similar moves in Canada earmarked CAD 74 million (USD 54.8 million) to extend testing in Indigenous and remote communities. European Union member states synchronized guidelines that favor FDA-cleared or CE-marked molecular assays. These programs provide predictable procurement streams, reinforce quality benchmarks, and enlarge the STD diagnostics market size across primary care, public health, and community settings.
Advances in NAAT & Rapid PoC Platforms
Modern nucleic-acid amplification tests deliver 99.5% sensitivity for chlamydia and gonorrhea while cutting turnaround to less than 90 minutes. Eight PoC molecular platforms gained FDA clearance in 2024, a sharp jump from three clearances the prior year, aided by the agency’s breakthrough device pathway. Multiplex cartridges process urine, vaginal, and rectal samples on the same run, eliminating redundant workflows and trimming technician time. Digital interfaces automatically upload results into electronic health records, enabling faster partner notification and treatment fulfillment. Such efficiencies help shrink the 25% therapy gap observed when positive results arrive after patients have left the clinic.
Home Self-Testing & Digital Connectivity
Four over-the-counter STI kits received FDA authorization in 2024, including the LetsGetChecked Simple 2 kit for chlamydia and gonorrhea. Home sampling paired with telehealth produced 2.3 million completed STI tests in 2024, marking 40% year-on-year growth. Anonymous ordering and mail-back logistics tackle stigma head-on, particularly among digital-native consumers. Europe and Canada are rolling out accommodating regulations, while artificial-intelligence-enhanced result dashboards translate complex molecular outputs into plain-language care advice. Convenience, privacy, and on-demand virtual consults are drawing new users into the STD diagnostics market and widening its addressable population.
Restraint Impact Analysis
| Restraint | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Social stigma & low awareness | -1.4% | Global, most severe in conservative societies and rural areas | Long term (≥ 4 years) |
| Regulatory & reimbursement hurdles | -0.9% | Emerging markets and countries with complex healthcare systems | Medium term (2-4 years) |
| Skilled-lab-staff shortages in LMICs | -0.7% | Low and middle-income countries, rural areas globally | Long term (≥ 4 years) |
| Cross-reactivity-driven false positives | -0.3% | Global, particularly affecting multiplex testing adoption | Short term (≤ 2 years) |
| Source: Mordor Intelligence | |||
Social Stigma & Low Awareness
Survey data show 43% of adults delay or reject STI screening for fear of judgment or privacy breaches. Cultural taboos in certain regions equate testing with promiscuity, disproportionately limiting women’s access to reproductive care. Public-health campaigns launched in 2024 re-frame screening as a routine wellness metric, yet uptake remains uneven. Anonymous home kits and app-scheduled clinic slots alleviate stigma for some users, but legal restrictions on telemedicine in several jurisdictions slow wider adoption. Ongoing school-based sex-education pilots have lifted testing rates by 25% where implemented, suggesting long-run gains once curricula scale nationally.
Regulatory & Reimbursement Hurdles
Clinical-validation studies for novel PoC devices can cost USD 2–5 million per pathogen, stretching timelines for startups. Coding discrepancies mean payers in multiple markets still reimburse only symptomatic testing, discouraging routine screens. Though the Centers for Medicare & Medicaid Services revised molecular STI codes in 2024, coverage gaps persist for multi-analyte panels, muting demand elasticity. Outside the United States, fragmented quality standards force device makers to navigate country-by-country registrations, often adding 12–18 months to launch schedules. These barriers tilt the STD diagnostics industry toward well-capitalized incumbents while delaying game-changing innovations.
Segment Analysis
By Test Type: HIV Testing Dominates Despite Emerging Pathogen Growth
The HIV segment collected 28.89% of 2024 revenue, underscoring entrenched policies that require routine screening in blood services, prenatal care, and high-risk populations. Syphilis anchors the number-two position thanks to prenatal mandates that aim to curb congenital infections. Chlamydia and gonorrhea testing together generated roughly one-third of total revenue, supported by annual testing advice for sexually active youth.
Mycoplasma genitalium reported the quickest 7.89% CAGR outlook through 2030, propelled by growing recognition of its role in persistent urethritis. HPV and HSV segments post steady gains as multiplex NAAT assays streamline differential diagnosis. Trichomonas benefits from same-visit PoC platforms that catch treatable infections before patients leave the clinic. Chancroid remains niche but experiences improved molecular detection accuracy, reducing historical under-diagnosis.
Note: Segment shares of all individual segments available upon report purchase
By Technology: Molecular Diagnostics Lead NGS Innovation
Molecular platforms retained 51.34% share in 2024, delivering rapid, highly sensitive results that support guideline-driven care. Immunoassays remain vital in lower-resource settings, yet accuracy gaps limit additional share gains.
Next-generation sequencing is set for a 9.29% CAGR thanks to simultaneous pathogen and resistance profiling, capabilities prized by surveillance bodies such as the CDC, which purchased fleet NGS systems for USD 45 million in 2024. Biosensor and microfluidic devices integrate sample prep and amplification on a chip, drawing venture funding into portable alternatives that require minimal technician skill[3]Nature Biotechnology, “Lab-on-Chip Technologies for STI Diagnostics,” nature.com. Cost curves remain on a downward slope, opening mid-tier labs to NGS adoption and redefining the competitive stakes within the STD diagnostics market.
By Location of Testing: Point-of-Care Disrupts Laboratory Dominance
Laboratories still processed 62.34% of specimens in 2024, but growth momentum is shifting toward decentralized formats. Point-of-care systems, advancing at an 8.56% CAGR, align with provider goals for immediate treatment initiation and with patient desire for discreet same-visit results. FDA-cleared CLIA-waived devices like cobas liat demonstrate that complex molecular workflows can fit onto countertop instruments. Telemedicine channels further expand reach by linking remote testing stations to virtual consults, lowering the need for bricks-and-mortar facilities.
Home testing remains a nascent yet explosive niche. The market witnessed its first FDA-authorized at-home multiplex panel in 2025, moving self-collection from mail-in models to real-time molecular detection. This evolution dovetails with rising e-pharmacy networks that dispense antibiotics based on verified home results, accelerating care pathways. While central labs preserve a competitive edge for culture-based susceptibility testing, the broader trend favors distributed models that minimize friction and democratize access
Note: Segment shares of all individual segments available upon report purchase
By End User: Home Care Segment Challenges Hospital Dominance
Hospitals and clinics captured 43.82% of the STD disgnostics market size in 2024, driven by bundled services that integrate counseling and immediate therapy. Yet the home-care channel is expanding at a 10.07% CAGR, catalyzed by legislative support for over-the-counter availability and interoperable digital platforms. Diagnostic laboratories remain indispensable for high-complexity workflows, but many are pivoting to white-label home-test fulfillment to offset volume erosion. Telehealth providers are forging direct partnerships with kit manufacturers, creating vertically integrated ecosystems that bypass traditional referral pipelines.
Corporate wellness programs in emerging markets are adding pre-employment STD panels to routine screening, further diversifying the end-user mix. Universities and community clinics are also trialing vending-machine distribution models that dispense anonymized test kits on demand. Together these trends underscore rising consumer agency, prompting incumbents to rethink value propositions beyond pure analytical accuracy toward holistic user experience.
Geography Analysis
North America commanded 42.23% of global revenue in 2024, sustained by insurance mandates that make preventive STD services cost-free and by robust federal coordination to counter the syphilis surge. High discretionary healthcare spending and rapid regulatory approvals keep the region at the innovation vanguard. Nevertheless, intra-regional gaps prevail; Southern states report above-average infection rates, signaling under-served pockets even within a mature market.
Europe follows with a stable base built on universal health coverage and pan-regional regulatory harmonization, yet faces budgetary pressure that favors cost-effective point-of-care models. Asia-Pacific is the fastest-growing territory at a forecast 10.93% CAGR, driven by urbanization, public-health investments, and an 11.6% STI prevalence among reproductive-age women in Southeast Asia. China’s anti-corruption clampdown in healthcare briefly slowed foreign diagnostic imports in 2024, but infrastructure spending across ASEAN and India is widening test access.
Latin America and the Middle East & Africa together form an emerging corridor where rising awareness and mobile-health penetration offset infrastructure deficits. WHO-backed funding for integrated diagnostics and low-cost multiplex panels is steering donor capital into these regions. South Africa records the world’s highest age-standardized STI rates, making it a focal point for donor-supported pilot projects that could shape future expansion models. Overall, geographic diversification strategies will define revenue resilience for vendors competing in the global STD Diagnostics market.
Competitive Landscape
The market is moderately fragmented, with scale advantages accruing to firms that offer multipathogen portfolios and digital connectivity. Roche leverages its cobas liat platform to capture high-margin point-of-care demand, while continuous firmware updates extend usable life cycles. Thermo Fisher and Danaher subsidiaries such as Cepheid compete on assay menu breadth and cartridge throughput, fueling a technology arms race.
Strategic acquisitions are reshaping boundaries. OraSure agreed in December 2024 to acquire Sherlock Biosciences, aiming to commercialize a molecular CT/NG self-test under FDA review. Visby Medical secured landmark FDA home-testing clearance in March 2025 and filed a men’s panel two months later, underscoring its intent to build gender-specific franchises. Laboratories including Labcorp and Quest Diagnostics are evolving into omni-channel service hubs, layering logistics, data analytics, and remote sampling to protect volumes amid decentralization.
Platform differentiation now revolves around user interface, result integration, and antimicrobial resistance analytics rather than hardware alone. AI-driven triage algorithms, such as those under development for risk-based screening, promise further separation between innovators and fast followers. Suppliers that combine rapid diagnostics with seamless e-prescription workflows are well-positioned to command premium pricing and to deepen customer lock-in over the next five years
STD Diagnostics Industry Leaders
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Diasorin S.p.A
-
Hologic, Inc
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Danaher Corporation(Cephied)
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Siemens Healthineers AG
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Abbott
- *Disclaimer: Major Players sorted in no particular order
Recent Industry Developments
- May 2025: Visby Medical submitted its Men’s Sexual Health Test to the FDA for clearance and CLIA waiver, extending its at-home portfolio beyond the Women’s kit approved two months earlier
- December 2024: OraSure Technologies completed the USD 1.5 billion acquisition of Sherlock Biosciences to enter the molecular self-testing arena with a CT/NG kit slated for FDA submission by late 2025
Global STD Diagnostics Market Report Scope
As per the scope of the report, STDs are infections that transmit from one person to another during oral, anal, and vaginal sex. Bacteria, parasites, yeast, and viruses are the main causes of STDs. Rapid and early diagnosis of STDs will limit the effects and progression of the disease. If the STDs are left untreated, they can lead to more serious and long-term health complications. The STD diagnostics market is segmented by type of disease, location of diagnostic test, device, and geography. By type, the market is segmented into chlamydia, gonorrhea, syphilis, genital herpes, hepatitis B, HIV/AIDS (human immunodeficiency virus and acquired immune deficiency syndrome), human papillomavirus, and other diseases. By devices, the market is segmented into laboratory devices (thermal cyclers - PCR, lateral flow readers immunochromatographic assays, flow cytometers, absorbance microplate reader - enzyme-linked immunosorbent assay (ELISA), and other laboratory devices) and point-of-care devices, phone chips (microfluidics + ICT), and portable/benchtop/rapid diagnostic kits). By geography, the market is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America. The report also covers the estimated market sizes and trends for 17 countries across significant global regions. The report offers the value (in USD) for the above segments.
| Syphilis Testing |
| HPV Testing |
| HSV Testing |
| HIV Testing |
| Trichomonas Testing |
| Mycoplasma Genitalium Testing |
| Chancroid Testing |
| Chlamydia Testing |
| Gonorrhea Testing |
| Immunoassay‐based Methods |
| Molecular Diagnostics |
| Next-Generation Sequencing |
| Biosensor / Microfluidics & Other Emerging Platforms |
| Central & Hospital Laboratories |
| Rapid Point-of-Care Platforms |
| Over-the-Counter / Home Self-Testing |
| Hospitals & Clinics |
| Diagnostic Laboratories |
| Home Care / OTC |
| North America | United States |
| Canada | |
| Mexico | |
| Europe | Germany |
| United Kingdom | |
| France | |
| Italy | |
| Spain | |
| Rest of Europe | |
| Asia-Pacific | China |
| India | |
| Japan | |
| South Korea | |
| Australia | |
| Rest of Asia-Pacific | |
| South America | Brazil |
| Argentina | |
| Rest of South America | |
| Middle East and Africa | GCC |
| South Africa | |
| Rest of Middle East and Africa |
| By Test Type | Syphilis Testing | |
| HPV Testing | ||
| HSV Testing | ||
| HIV Testing | ||
| Trichomonas Testing | ||
| Mycoplasma Genitalium Testing | ||
| Chancroid Testing | ||
| Chlamydia Testing | ||
| Gonorrhea Testing | ||
| By Technology | Immunoassay‐based Methods | |
| Molecular Diagnostics | ||
| Next-Generation Sequencing | ||
| Biosensor / Microfluidics & Other 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 Geography | North America | United States |
| Canada | ||
| Mexico | ||
| Europe | Germany | |
| United Kingdom | ||
| France | ||
| Italy | ||
| Spain | ||
| Rest of Europe | ||
| Asia-Pacific | China | |
| India | ||
| Japan | ||
| South Korea | ||
| Australia | ||
| Rest of Asia-Pacific | ||
| South America | Brazil | |
| Argentina | ||
| Rest of South America | ||
| Middle East and Africa | GCC | |
| South Africa | ||
| Rest of Middle East and Africa | ||
Key Questions Answered in the Report
How large will the STD diagnostics market be by 2030?
Forecasts point to USD 25.60 billion by 2030, translating to a 7.08% CAGR from 2025.
Which pathogen test currently generates the most revenue?
HIV tests led 2024 revenue, capturing 28.89% of spending.
What technology is growing the fastest?
Next-generation sequencing is projected to expand at a 9.29% CAGR through 2030.
Which region offers the highest growth potential?
Asia-Pacific is expected to record a 10.93% CAGR as infrastructure and awareness improve.
How fast is the home-testing channel expanding?
Home-care and over-the-counter kits are slated for a 10.07% CAGR, the fastest among end users.
What drives adoption of point-of-care platforms?
FDA fast-track clearances, 30-minute turnaround times, and integration with electronic health records are accelerating PoC uptake.
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