The global STD diagnostics market was valued at USD 9.25 billion in 2022 and it is predicted to surpass around USD 18.59 billion by 2032 with a CAGR of 7.23% from 2023 to 2032.
The global STD diagnostics market was valued at USD 9.25 billion in 2022 and it is predicted to surpass around USD 18.59 billion by 2032 with a CAGR of 7.23% from 2023 to 2032. The STD diagnostics market in the United States was accounted for USD 3 billion in 2022.
Key Pointers
- North America held a market share of 38% in 2022.
- Asia Pacific is estimated to witness the fastest growth rate over the forecast period.
- The consumables segment dominated the global market in 2022 with a revenue share of 70%.
- The HIV segment dominated the market with a share of 32% in 2022.
- The immunoassay segment dominated the STD diagnostics market in 2022 with a revenue share of 45%.
- The laboratory testing segment dominated the market with a share of 79% in 2022.
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Market Dynamics
Drivers
Increased introduction of new STD testing products
Over the course of the forecast period, the global market for STD diagnostic testing is anticipated to develop as more products in the field of STD testing are introduced. For instance, Molbio Diagnostics Pvt. Ltd., an Indian molecular diagnostics company, stated on January 5, 2023 that Truenat HSV 1/2, a test for the Herpes Simplex Virus, has been introduced. The Central Drugs Standard Control Organisation (CDSCO) has approved the test, and sample-to-test results can be obtained in one hour. With a sample-to-result time of less than an hour, Truenat is a point-of-care portable, battery-operated, IoT-enabled real-time PCR platform. The platform can test for over 40 diseases, including COVID-19, TB, hepatitis, HIV, HPV, dengue, and malaria, according to the business.
Key market players are increasingly using tactics like mergers and acquisitions
The expansion of the global market for STD diagnostic testing is anticipated to be fueled by increasing strategies like mergers and acquisitions by major industry players. For instance, on March 15, 2021, F. Hoffmann-La Roche purchased GenMark Diagnostics Inc., a molecular diagnostics business situated in the United States, for US$24.05 per share on a fully diluted basis. A single patient sample can be used in various molecular diagnostic tests offered by GenMark Diagnostics Inc. The present molecular diagnostics range of F. Hoffmann-La Roche will be complemented by GenMark’s syndromic panel testing portfolio, and the global network of F. Hoffmann-La Roche will enable wider reach for GenMark Diagnostics Inc. products. F. Hoffmann-La Roche Ltd. can use GenMark Diagnostics, Inc.'s unique technologies, including ePlex and eSensor XT-8, to create diagnostics for infectious diseases such as bloodstream infections.
What are the Trends of STD Diagnostics Market?
Introduction of updated tools for STD diagnosis
- The market may expand due to the introduction of updated STD testing kits. For instance, the India-based specialist healthcare provider Invex Health stated on June 20, 2023 that its first oral HIV self-test would soon be available. The only third-generation HIV test that currently employs oral fluid rather than blood is the saliva-based Morcheck test. It can check for HIV types 1 and 2.
Key market players’ cooperative strategies
The expansion of the international market for STD diagnostic testing might be fueled by tactics including collaboration between major industry players. Pinpoint Science Inc., a U.S.-based in-vitro diagnostic company, and Analogue Devices Inc., a U.S.-based semiconductor manufacturing company, announced a strategic partnership to develop and produce novel nanosensor diagnostics that deliver the highest accuracy results in a minute on February 25, 2020. The superior fabrication capabilities of Analogue Devices, Inc. helped Pinpoint Science Inc. develop its nanosensors, which are intended for low-cost, handheld diagnostics and aim to deliver results in under a minute with lab test level precision.
Restraints
Testing for STDs carries a social stigma
Even though STD incidence is relatively high, due to insufficient testing, 37.7 million people who will have HIV in 2020 will not be aware of their HIV status. For instance, 96 cases were taken into account in a study that was published in the Journal of the International AIDS Society on November 16, 2022. When a STI had already been detected, the frequency of subsequent HIV/STI testing was 35.3%, and it was 27.1% for those who had STI symptoms. Different national STI-related policies, a lack of standard operating procedures, factors at the clinician-level, a lack of awareness of and adherence to HIV indicator condition-guided HIV testing, and stigma associated with HIV in comparison to other curable STIs are a few possible explanations for these observations.
An awareness campaign should be launched to eradicate stigma in society in order to counteract this limitation.
Cutting back on funding for STD treatment
Reduced financing for the fight against STDs may impede market expansion during the projection period. For instance, the Centres for Disease Control, a U.S. government agency, cut funding for employees who battle sexually transmitted illnesses in U.S. states on June 13, 2023. The financing was cut by $400 million USD. The debt ceiling agreement that was recently passed stipulates the budget reduction. More government funding for research activities should be supplied to balance out this restriction.
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Market Insights
Application Insights
The HIV segment dominated the market with a share of 32% in 2022 and is anticipated to witness the fastest growth at a CAGR of 9.00% over the forecast period, owing to high testing rate, increased product approvals, such as fourth-generation HIV tests & self-testing kits, and significant R&D initiatives relevant to novel products. The CDC in March 2023 announced the launch of a project, Together TakeMeHome (TTMH), to distribute up to 1 million HIV self-tests over 5 years. These tests can be ordered by people aged 17 years and older in the U.S. including Puerto Rico via an online portal. The test is developed by CDC in partnership with Building Healthy Online Communities (BHOC), OraSure Technologies, Emory University, Signal Group, and NASTAD.
The HPV testing segment is expected to grow at a significant CAGR during the forecast period. Traditionally, the Pap smear has been the primary screening method for cervical cancer. However, there has been a shift towards HPV testing as a more sensitive and reliable method for detecting high-risk HPV strains that are associated with the development of cervical cancer. New product launches specifically by reputed organization such as UNICEF plays an important role in creating awareness for cervical cancer. In January 2023, UNICEF launched a new cervical cancer toolkit, a comprehensive tool including an HPV DNA-based diagnostic tool, a preventive HPV vaccine, and a treatment pool. The launch of this kit will benefit the most for women in lower-income countries.
Technology Insights
The immunoassay segment dominated the STD diagnostics market in 2022 with a revenue share of 45% owing to higher testing rates for Sexually Transmitted Disease (STD) diagnostics. Moreover, the approval of new immunoassay products for the diagnosis of sexually transmitted diseases may impel market growth. For instance, in August 2020, DiaSorin, Inc. received 510 (k) approval from the U.S. FDA for introducing LIAISON XL MUREX anti-HBe, which is used for the diagnosis of HBV infection.
The FDA clearance of the first extragenital diagnostic tests also supports the STD diagnostics market growth. In May 2019, Aptima Combo 2 Assay and Xpert CT/NG were introduced by Hologic, Inc. & Danaher Corporation, respectively, after obtaining the U.S. FDA approval for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae via the throat & rectum. However, these tests were cleared for testing urine, vaginal, and endocervical samples.
The molecular diagnostics segment is expected to exhibit the fastest growth rate over the forecast period. The increase in applications of molecular diagnostics in the fields of STD diagnostics directly influences the demand for PCR technologies. In June 2021, Bio-Rad Laboratories, Inc. entered into a partnership with Seegene, Inc. for the development and commercialization of multiplex PCR-based products for the diagnosis of infectious diseases. Such strategic initiatives may enable market players to introduce innovative products in the STD diagnostics industry.
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Location of Testing Insights
The laboratory testing segment dominated the market with a share of 79% in 2022. Many healthcare institutions are working with laboratories to integrate different tests. For instance, in October 2019, Becton, Dickinson, and Company (BD) and Check-Points Health B.V. received FDA clearance for BD MAX Check-Points CPO assay, which is used with BD MAX System to support clinical microbiology laboratories. This assay helps detect carbapenemase genes and is used as a molecular screening test for antibiotic-resistant, carbapenemase-producing organisms. Syndromic panels for STIs are available on the BD MAX product menu, assisting laboratory professionals in their efforts in providing clinical diagnosis, which helps physicians improve patient outcomes while increasing laboratory efficiency.
The point-of-care testing segment is estimated to witness the fastest growth over the forecast period, owing to the increased preference of patients and increased focus of manufacturers on the development of PoC diagnostics. Key companies are donating devices to hospitals for support and to enable them to provide quality care in diagnosing STDs discreetly amidst the Covid pandemic. In May 2021, OraSure Technologies, Inc. along with its partners, including Insignia Federal Group, LLC, Building Healthy Online Communities (BHOC), and Emory University, was selected by the CDC for the distribution of 100,000 HIV self-test kits in the U.S.
Regional Insights
North America held a market share of 38% in 2022 and is expected to maintain its dominance over the forecast period. This dominance can be attributed to the high testing rates, technological advancements, proactive government measures, improvements in healthcare infrastructure, and the presence of major players. Reimbursement policies and favorable government initiatives are likely to drive market growth. The New Technology Add-on Payment (NTAP) program has been introduced by the CMS to reduce financial losses for hospitals. An increase in the number of partnerships between in-vitro diagnostic companies and non-profit organizations for spreading awareness about STDs is creating lucrative growth opportunities in the STD diagnostics industry. In June 2021, OraSure Technologies, Inc. collaborated with Will Rodgers Liver Health Foundation for increasing awareness about Hepatitis C in the U.S.
Asia Pacific is estimated to witness the fastest growth rate over the forecast period. The high growth rate can be attributed to the rising disease burden of STIs and increasing testing rates. According to The Institute for New Era Strategy, around 641,000 people were infected with HCV in 2020, out of which, more than 530,000 people were aged under 80, and 157,000 were aged under 60 in Japan. Positive changes, such as healthcare benefits by the government, increased awareness among the population, and increased willingness to avail high-end medical facilities are also expected to drive the market growth in the region.
Key Developments
- In February 2022, Lupin Limited, a Mumbai-based Indian Pharmaceutical firm- received approval from the U.S. FDA for the use of its antibiotic Solosec for treating sexually transmitted infections referred to as trichomoniasis and vaginal infection termed as bacterial vaginosis in women.
- In February 2022, Trinity Biotech, a Medical Laboratory Company based in Ireland & specializing in the production and marketing of clinically diagnostic products- has got the approval of the WHO for HIV screening tests.
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Key Players
BD; F. Hoffmann-La Roche Ltd.; Hologic, Inc.; bioMérieux SA; Abbott; Danaher Corporation; Qiagen; Seegene Inc; Thermo Fisher Scientific Inc.; DiaSorin S.p.A; OraSure Technologies Inc.; Bio-Rad Laboratories, Inc
STD Diagnostics Market Segmentations:
By Product
- Instruments and Services
- Consumables
- Software
By Application
- CT/NG testing
- Syphilis testing
- PCR testing
- Non-PCR testing
- Gonorrhea testing
- HSV testing
- PCR testing
- Non-PCR testing
- HPV testing
- HIV testing
- Ureaplasma & Mycoplasma testing
- Trichomonas
- VZV testing
- PCR testing
- Non-PCR testing
- Others
By Technology
- Immunoassay
- Molecular Diagnostics
- Other
By Location of Testing
- Laboratory Testing
- Commercial/Private labs
- Public Health Labs
- Point of Care Testing
By Regional
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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