Leading Infectious Diseases in the IVD Market - Women’s Health and Sexually Transmitted Infections

Leading Infectious Diseases in the IVD Market - Women’s Health and Sexually Transmitted Infections

The following analysis is derived from Kalorama Information’s recently released global market research report:The Worldwide Market for Infectious Disease Diagnostic Tests. A more comprehensive report on assorted women’s health diagnostics, including non-infectious disease tests, is available withDiagnostic Markets for Women’s Health (Pregnancy and Ovulation, Bone Density, Prenatal Screening, Ultrasound, Mammography, Pap Smear, Colposcopy, HPV, UTI and Other Testing).

This is the fourth in a series of five posts outlining the leading infectious diseases or infectious disease groups in terms of IVD market sales. Previous posts were for hepatitis,HIV/AIDS,andrespiratory tract infectiontests.

Infectious disease tests for sexually transmitted infections (STIs) and women’s health represent a total IVD market exceeding $3 billion. Within IVD, infectious disease tests for STIs and women’s health typically do not include diagnostics for HIV or viral hepatitis, which independently represent multi-billion-dollar markets. The most significant pathogens in STI and women’s health testing include Chlamydia (CT), gonorrhea (NG), syphilis, ToRCH panel pathogens, and human papillomavirus (HPV). The infections are highly impactful to community health, maternal health, and prenatal and neonatal health. A diverse range of IVD products are used to screen for and assess STIs and other women’s health infections, including cultures, laboratory immunoassays, rapid immunoassays, molecular assays, and high-throughput blood screening assays. Responding to resilient and rebounding rates of STIs and the increasing specialization in medicine to optimally treat female patients and conditions, many in the IVD industry have prioritized assay menus in those areas across platforms, but foremost in molecular diagnostics.

The association of STI testing with women’s health testing is based on the disproportionate health burden STIs pose for female populations including HPV and cervical cancer; vaginitis or vaginosis caused by bacterial pathogens (infections in men are often less symptomatic); and group B streptococcus (GBS) and herpes simplex virus (HSV) and neonatal complications. Chlamydia and gonorrhea infections may progress to sterility, complications or serious health consequences following unnoticeable symptoms in women.

With consistent national reporting in the United States, it has become apparent that STIs have rebounded from reported historical lows and been resilient to eradication goals. Chlamydia has been on the rise since reporting began in the United States. Gonorrhea declined nearly 75% between 1975 and 1997, but thereafter remained roughly constant through 2009 before rising slightly every year through 2012. After declining nearly 90% between 1990 and 2000, syphilis reached its lowest rate in the United States since reporting had begun in 1941. The dramatic decline of syphilis and the regional concentration of the disease lead the Surgeon General to release a national eradication plan in 1999 and later updated in 2006. However, the rate of syphilis subsequently increased each year from 2001 to 2009 and jumped another 22% between 2011 and 2013.

In some cases, the observed increases in STIs may be a result of improved screening efforts rather than an actual groundswell in infections. Among sexually active U.S. women aged 16 to 24 years with commercial insurance plans, Chlamydia screening nearly doubled between 2001 and 2012 to 45% of the subjects. Increased Chlamydia screening has also impacted gonorrhea reporting as multiplex CT/NG testing is highly common.

While truly rising STI incidence in the United States is debatable, the above trends are nonetheless positive for the IVD industry since STI screening is becoming more commonplace in healthcare given an ongoing emphasis upon preventative care and improving national insurance coverage. Positive trends in STI screening rates are also expected in developing healthcare systems.

Syphilis has also re-emerged globally as a significant health problem. The World Health Organization (WHO) estimated there are more than 12 million new cases of syphilis each year around the world: 100,000 in the United States, 140,000 in Western Europe, 4 million in sub-Saharan Africa, 4 million in South and Southeast Asia, and 3 million in Latin America and the Caribbean. Infection rates have increased dramatically in Russia and China over the past decade and also significantly in a number of European countries with single-year increases of more than 30%. Syphilis tests are included on most major analyzer platform assay menus.

The traditional protocol for serological syphilis testing begins with a non-Treponema assay such as the Venereal Disease Research Laboratory test (VDRL) or rapid plasma regain (RPR) test for screening followed by a Treponema-specific (antibody test) test on reactive samples. The CDC reiterated its preference for the VDRL-immunoassay testing sequence, but has acquiesced to alternative protocols given the prevalence of automated antibody immunoassays on industry platforms. Syphilis antibody tests have found greater regulatory approval in recent years and may eventually phase out non-treponemal tests in screening applications.

The syphilis screening lab immunoassay could in turn be challenged by increasingly available rapid syphilis tests. In December 2014, FDA granted the first-ever CLIA waiver for a rapid syphilis test to Trinity Biotech. The test also detects anti-Treponema (IgG and IgM) antibodies. The test may become preferred in outpatient settings for screening, particularly in sexual health clinics and public health programs, and when sending out samples for lab testing is cost-prohibitive or otherwise unfeasible.

ToRCH is a standardized panel for prenatal or maternal screening of Toxoplasma gondii, rubella, cytomegalovirus, and herpes simplex virus. The pathogens can cause illness in pregnant women, but are more hazardous for embryonic development. The individual assays or entire panel are available on practically all laboratory immunoanalyzers to assess risks of birth defects and implement preventative therapy.

The high majority of clinical screening tests for CT/NG, syphilis and ToRCH pathogens are performed on laboratory immunoassay platforms that represent predominantly mature markets with marginal growth expected outside of developing healthcare systems. Chlamydia, gonorrhea and syphilis already represent some of the most commonly run assays on lab immunoanalyzers. Rapid tests for STIs can expect to see stronger, though only periodic growth associated with rising regional rates of infection and the implementation of screening programs in the developing world. Recent significant product introductions in the area of STI immunoassays have included improved syphilis (anti-Treponema) immunoassays and multiplex HIV-syphilis rapid immunoassays.

Molecular diagnostics has been the most dynamic IVD space for STI and women’s health tests. Moderate-complexity and other ease-of-use molecular analyzers released in the past five years have heavily targeted sexually transmitted diseases and women’s health pathogens. The platforms are also critical to expanded testing outside of central labs in settings such as hospital labs, outpatient clinics, and physician offices. Molecular testing can offer best-available sensitivity, specificity and rapidity to users outside of central and specialty labs. Rapidity allows test results to be communicated to the patient during the same office visit, significantly improving the chances of intervention and the implementation of treatment. Sensitivity and specificity not only improves the accuracy of results, but can also provide more meaningful characterization of infections include drug resistance or traits such as HPV oncogenes.

Women’s health infectious diseases and STIs are behind only healthcare-acquired infections (HAIs) and antimicrobial resistance (AMR) markers in terms of recent and planned assay menu additions on molecular analyzers. Companies such as Becton, Dickinson & Co. (BD MAX), Cepheid (GeneXpert), Roche (4800 and 6800/8800 systems), Beckman Coulter (DxN Veris), QIAGEN (careHPV) and Meridian Bioscience (illumigene) have heavily targeted molecular test markets for HPV, CT/NG, GBS, vaginitis and HSV. Growth prospects for those assays are prefaced on expanded test indications, product applicability towards multiplex syndromic testing (vaginitis), and expanded use of molecular assays throughout healthcare settings including outpatient sexual health clinics, OB/GYN clinics and maternity wards.

Chlamydia and gonorrhea (CT/NG) were two of the first infectious disease targets for commercialized clinical molecular tests and represent established test markets among central labs in the developed world. Digene (QIAGEN) developed DNA assays for HPV in the 1990s, but medical and payer acceptance of HPV screening has since proven hard-won. Continued growth in demand for molecular HPV assays is expected as a result of assays’ expanded indications, the introduction of near-patient and POC assays, and improved insurance coverage and reimbursement. Remaining women’s health pathogens and STIs represent significantly lesser molecular test markets, but remain underserved in terms of testing and are set for expanded usage.