STD Diagnostics Market

Market Overview

The global STD diagnostics market size was worth USD 8,783.1 million in 2022. It is estimated to reach USD 16,698 million by 2031, growing at a CAGR of 7.4% during the forecast period (2023–2031). The growing global disease burden of STDs and technological advancements in STD diagnostics stimulate market growth. The increasing launch of multiplex PCR tests for the diagnosis of sexually transmitted diseases (STDs), such as chlamydia, syphilis, gonorrhea, and HPV, is expected to drive market growth further.

Research published in November 2021 by the World Health Organization states that there are more than a million STIs in the world, the majority of which have no symptoms. Due to growing demand in 2022, the kits and reagents segment held the market. In 2022, the segment was dominated by rising chlamydia incidences. Lab testing will be preferred more and take up the majority of the market. Furthermore, it was reported that an estimated 374.0 million new infections occur annually due to 1 out of 4 sexually transmitted diseases, which include syphilis, chlamydia, gonorrhea, and trichomoniasis.

The tests and techniques used to identify and diagnose sexually transmitted illnesses (STIs), such as gonorrhea, chlamydia, HIV/AIDS, syphilis, and herpes, are referred to as STD diagnostics. STD diagnostics are typically used for diagnostic reasons, such as identifying or confirming the existence of an STI and monitoring disease progression or treatment efficacy. Samples from infected locations, such as the genitals, anus, urethra, cervix, throat, or blood test, may be collected. 

Market Dynamics

STD Diagnostics Market Drivers

Growing Global Disease Burden of STDs

In vitro diagnostics are important in STD testing, rendering quick and effective results. The growing incidence of STIs, such as syphilis, gonorrhea, chlamydia, HIV, and HPV, is expected to provide the market with a large target population. According to WHO statistics, around 376 million new cases of syphilis, gonorrhea, chlamydia, and trichomoniasis are recorded every year. In addition, over 500 million people are estimated to have genital HSV, and around 300 million women have HPV infection, which is the leading cause of cervical cancer. An estimated 240 million people worldwide have chronic hepatitis B. Human Papillomavirus (HPV) is the most frequent form of STD in the U.S. and around the world. Thus, the disease burden of STIs is highest in the U.S. among developed economies. Also, aging increases the risk of severe infections, such as hepatitis B and hepatitis C, due to impaired immune response. This will likely boost the demand for STD diagnostics, boosting the market.

Technological Advancements in STD Diagnostics

Technological advancements in accuracy, portability, and cost-effectiveness will likely drive the market over the forecasted period. The important players are expanding their test portfolios, including qPCR instruments, by investing in R&D to develop diagnostic kits to identify emerging diseases or collaborating with other kit manufacturing companies. Furthermore, developing and commercializing advanced products, such as multiplex PCR products and next-generation HIV testing kits, enables physicians to distinguish and diagnose a range of STIs promptly and provide appropriate treatment. Also, the availability of at-home collection and self-testing kits reduces clinic visits and promotes patients' discretion. Moreover, self-testing kits for HIV are attracting more customers.

STD Diagnostics Market Restraint

Vaccination Coverage for STD

The number of government initiatives is increasing to contain the STD epidemic in various regions. These initiatives include regular screening guidelines and vaccination coverage for hepatitis A, hepatitis B, human papillomavirus, and herpes zoster virus, among others. The vaccination coverage for adults and adolescents helps reduce the overall disease burden in the region, which may adversely affect market growth. According to the CDC, the HPV vaccine could aid in the prevention of 32,100 cases of cancer every year. In the U.S., herpes zoster vaccination coverage among adults aged 50 and above and adults aged 60 and above was 24.1% and 34.5%, respectively, in 2018, similar to 2017 estimates.

Overall, herpes zoster vaccination coverage among adults increased from 14.4% to 34.5% between 2010 and 2018, indicating an increase in coverage. Similarly, the vaccination coverage of HBV was found to be around 67% in 2018, which is below the Healthy People 2020 target of 90% but still acts as a restraining factor for market growth. HPV vaccination increased from 2.1% in 2011 to 26.3% in 2018 among men and 20.7% in 2010 to 52.8% in 2018 among women aged 19–26.

STD Diagnostics Market Opportunities

Government Initiatives Encouraging Early Diagnosis and Treatment

The governments of developed economies are undertaking initiatives to promote the early diagnosis of STDs. The Sexually Transmitted Infections National Strategic Plan is a ground-breaking, first-of-its-kind five-year plan aimed at reversing the United States' recent fast increase in STIs. The STI Plan offers a vision for dealing with the STI issue and objectives, goals, and techniques. Indicators with measurable targets are also included to track progress. According to national statistics from the United States, the STI Plan focuses on gonorrhea, chlamydia, syphilis, and HPV, which have the highest morbidity rates, the most persistent and widespread STI disparities, and the greatest impact on people's health.

This national strategy focuses on raising awareness about STIs and providing access to high-quality, low-cost STI screening, diagnosis, and treatment. Another major STI—HIV—is the subject of a separate HIV National Strategic Plan. The HIV National Strategic Plan is a blueprint for ending the U.S. HIV epidemic by 2030. Similarly, the Viral Hepatitis National Strategic Plan is focused on hepatitis B and C, which can be transmitted sexually, and many more. Therefore, based on nationwide statistics, the plan identifies populations with the disease burden of viral hepatitis to enable federal agencies and other stakeholders to target their resources to achieve the largest impact.

Regional Analysis

North America Dominates the Global Market

Based on region, the global STD diagnostics market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global STD diagnostics market shareholder and is estimated to grow at a CAGR of 8.7% over the forecast period. Favorable government initiatives and reimbursement policies are also likely to drive market growth. The North American STD diagnostics market will remain dominant over the projected period. This market expansion might be linked to a growing number of government initiatives, such as the Antimicrobial Stewardship Project, to accelerate the development and use of fast diagnostic tools. Moreover, the rise in the number of partnerships between in vitro diagnostic companies and non-profit organizations for spreading awareness about STDs is creating lucrative opportunities for growth in the STD diagnostics market.

Asia-Pacific is anticipated to exhibit a CAGR of 8.5% over the forecast period. The STD diagnostics market is driven by increasing emphasis on preventive healthcare and improving the economy. Increasing pro-health initiatives, a rise in the adoption of better technologies, and increased consumer awareness are among the factors driving market growth in this region. Furthermore, increased STD prevalence, an expanding need for cost-effective diagnostics, and a growing population all contribute considerably to market growth. China, Australia, Korea, and Taiwan already have healthcare reimbursement systems that include in vitro diagnostic testing coverage. Some of the key growth drivers of this market include the availability of untapped prospects in the form of unmet medical demands, increased efforts for scientific research, and good economic growth.

Furthermore, an improved healthcare regulatory environment in emerging nations will entice foreign businesses to participate and capitalize on potential possibilities. Positive improvements, such as higher government healthcare benefits, increased public knowledge, and an increased willingness to seek high-end medical treatment, are also predicted to boost market expansion in the area.

In Europe, the growth can be due to an increased incidence of STDs, rapid technological advancements, and proactive government initiatives. However, an uneven reimbursement policy is expected to restrain market growth. This region is the second-largest market due to an increase in understanding of the enormous potential of STD diagnostic devices. This has driven European firms to invest considerably in developing IVD devices and kits. Also, the local presence of regulatory entities is expected to propel the growth of the STD diagnostics market shortly. This is major because these organizations are critical in raising public awareness about the potential advantages of early detection of infectious illnesses.

In Latin America, technological developments in STD diagnostics, such as multiplex NAAT tests, are expected to contribute to market growth. In addition, an increase in government spending, the presence of skilled healthcare professionals, a rise in the focus of multinational diagnostic companies on the development of advanced and novel IVD products, and an increase in patient awareness are among the factors likely to drive the growth of the STD diagnostics market in Latin America. Low awareness about the prevention and treatment of infectious diseases in underdeveloped areas and a lack of favorable reimbursement policies coupled with vaccination coverage for HPV are some of the key factors restraining market growth. However, rising disposable income and growing consumer awareness are among the factors promoting market growth.

In the Middle East and Africa, the market is driven by a high incidence of STDs, a rise in consumer awareness, and improvements in healthcare infrastructure. As a result, MEA represents a mostly unexplored market for STD testing. The prevalence of large unmet healthcare requirements in emerging nations such as South Africa is a key driver of market expansion. Hence, the presence of major untapped opportunities and the high need for early diagnosis of diseases is anticipated to boost the market. There is a high prevalence of communicable and infectious diseases in this region. However, ethical reasons, poor infrastructure, and low affordability may hamper market growth.

Segmental Analysis

The global STD diagnostics market is bifurcated into products, applications, technology, and location of testing.

Based on products, the global STD diagnostics market is bifurcated into instruments and services, consumables, and software.

The consumable segment dominates the global market and will likely exhibit a CAGR of 7.6% over the forecast period. Protein biomarker-specific antibodies, washing buffers, and fluorescent tags are some of the most commonly used consumables for immunoassays. On the other hand, primers and fluorescently labeled nucleotides are the primary and most frequently used reagents during molecular diagnostic techniques. This segment is projected to witness steady growth, owing to extensive R&D initiatives undertaken by companies for the development of novel biomarker kits.

In September 2021, a group of researchers discovered Tp0369, a novel and promising biomarker candidate, in the serum of syphilis patients using mass spectrometry. This discovery could promote the development of new syphilis diagnostic tests. Consumables are also employed in microbiology, where substantial testing for pathogen identification is undertaken, which is likely to boost market growth.

Based on application, the global STD diagnostics market is bifurcated into chlamydia, syphilis, gonorrhea, herpes simplex virus, human papillomavirus, human immunodeficiency virus, trichomonas, ureaplasma and mycoplasma, varicella-zoster virus, and others.

The HIV segment owns the global market and will likely exhibit a CAGR of 9% over the forecast period. HIV infection can be detected using immunoassays, molecular testing, and PoC products. Several products also identify HIV-2 and rare HIV-1 variations, like group N and group O. In less than 20 minutes, doctors can make a preliminary diagnosis of HIV infection using rapid PoC HIV tests. Many of the rapid antibody assays become responsive later in the course of HIV infection, in contrast to traditional laboratory-based assays; they can result in false negatives in acutely infected people. In addition, HIV home-test kits only detect HIV antibodies, not acute HIV infection.

The HIV/AIDs testing techniques have rapidly developed over the past decade, and with the development of third- and fourth-generation ELISA immunoassays, HIV diagnostic testing has significantly contributed to the HIV testing segment. Due to the high prevalence of HIV, major participants in the market are focused on developing efficient molecular testing products. Molecular PoC tests for the diagnosis of HIV will be particularly helpful in low- and middle-income countries.

Based on technology, the global STD diagnostics market is segmented into immunoassay, molecular diagnostics, and other technologies.

The immunoassay segment dominates the global market and is predicted to exhibit a CAGR of 6.7% during the forecast period. An increase in outbreaks of sexually transmitted diseases and a rise in the need for early diagnosis are among the key drivers responsible for the increased demand for immunoassay methods involving different types of enzyme-linked immunosorbent assays (ELISA). According to the WHO, around 6.3 million new cases of syphilis are diagnosed every year. In addition, developing new antibodies for sexually transmitted diseases is expected to drive the market over the forecast period.

Based on the testing location, the global STD diagnostics market is divided into laboratory and point-of-care testing.

The laboratory testing segment is the most significant contributor to the market and will likely depict a CAGR of 8.5% over the forecast period. This high share can be attributed to an increase in the number of laboratories in emerging and undeveloped regions. With increasing demand for STI diagnosis, the need for PoC products to assist patients in conducting self-tests is growing. Players are interested in developing innovative products to reduce turnaround time, allowing healthcare practitioners to make quick treatment decisions in their offices.

Recent Developments

• May 2023: Quest Diagnostics introduced QueSTDirect STD Testing, a mail-in test that allows people to get tested for STDs without visiting a doctor's office.
• February 2023: Abbott released the Alere iQ Chlamydia and Gonorrhoea Assay, a quick, point-of-care test that can identify both chlamydia and gonorrhea in only 15 minutes.