GONORRHEA DIAGNOSTIC MARKET ANALYSIS

Ease of Testing: Can be done on non-invasive and self-collected specimens

Sexually transmitted Diseases (STDs) are one of the leading health problems globally, affecting the quality of life and triggering serious morbidity and mortality. Gonorrhea is the most common among the various sexually transmitted diseases with the age group of 15 to 24 years being the largest affected group. Around 350,062 gonorrhea cases were reported in the U.S. in 2014, with the national gonorrhea rate increasing to 110.7 cases per 100,000 population. There are major complications when infected with sexually transmitted infections, which have a detrimental effect on the reproductive system and can adversely affect health of the child conceived by an infected mother. Infertility, cancers, and pregnancy complications are among the major complications that can arise from the disease. Symptoms of gonorrhea in men include painful urination, swelling of testicles and pus discharge. In women, symptoms encompass excessive vaginal discharge, painful urination, and abdominal pain. Various complications such as ectopic pregnancy, Pelvic Inflammatory Disease (PID) and Epididymitis are most common among females.

Thus, these complications further indirectly impact through facilitating sexual transmission of deadly virus such as human immunodeficiency virus (HIV) and therefore, it also significantly adds to disease burden. In 2012, approximately 357 million new cases of curable STIs (gonorrhea, chlamydia, syphilis and trichomoniasis) were reported worldwide, which include 78 million cases of gonorrhea occurring at the age group of 15–49 year-olds. More than a million Sexually Transmitted Infections are acquired every day of which around 50% infections turn into Sexually Transmitted Diseases.

Uncomplicated Gonorrhea: Developing Drugs for Treatment

Factors driving growth of the gonorrhea diagnostic market include increase in transmission of sexually transmitted infection. For instance, according to Centers for Disease Control and Prevention data on STD Surveillance Report, in 2013, there were around 1.4 million reported cases of chlamydia, a rate of 456.1 cases per 100,000 population and in 2014, there were 350,062 reported cases of gonorrhea (a rate of 110.7 per 100,000) in the U.S.  Lack of biomedical products is a serious factor contributing to high incidence rate of STDs in low income countries. For instance, estimates by the International Conference on Population and Development (2011), for Sub-Saharan Africa, indicates that only nine organizations donated condoms per year to people in the age group of 15–49-years and that only one female condom per year is available for every 10 women of the same age range. Condom supplies in many high-burden countries are still inadequate. Lower treatment cost for the test, where STI prevention counseling and HIV screenings are some of many free preventive care benefits under the Affordable Care Act, though the tests themselves may cost you. In the U.S., private health centers charge up to US$ 79 for individual STI tests and US$ 249 for comprehensive STI tests. The Florida Department of Health, for instance, charges only $45 for its comprehensive STI test. However, lack of STI prevention counselling and dearth of trained laboratory specialists are some of the factors restraining growth of the global gonorrhea diagnostics market.

Artificial intelligence and diagnostic imaging are in the testing phases and expected to dominate the gonorrhea diagnostic market

The global gonorrhea diagnostic market is segmented on the basis of diagnostic type, end user, and geography. On the basis of diagnostic type, the gonorrhea diagnostic market is divided into diagnostic imaging, molecular diagnostics, flow cytometry, chromatography, gel micro droplets, liposomes, differential light scattering (DLS), artificial intelligence, and monoclonal antibodies test. Molecular Diagnostic is sub-segmented into Nucleic Acid Amplification Tests (NAAT) and swab tests.

On the basis of end user, the gonorrhea diagnostic market is classified into hospitals, ambulatory surgical centers, diagnostic centers, clinics, and others.

Gonorrhea diagnostic market traction is expected to be fueled by Growing Prevalence of STDs in Asia Pacific

Regional segmentation by Coherent Market Insights comprises North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. North America accounts for the largest market share, mainly due to presence of major players and adoption of advanced medical technologies in countries such as U.S. and Canada. In 2013, according to the U.S. Center for Disease Control and Prevention (CDC) there were over 3.3 million cases of gonorrhea registered. Europe is the second-largest gonorrhea diagnostic market, owing to the increasing prevalence of the disease in the region and largely unmet needs in effective diagnosis and treatments. In 2013, according to European Centre for Disease Prevention and Control, 52,995 gonorrhea cases were reported across 28 countries in the region; 61% of all cases were reported in the U.K. Growing disposable income and increasing awareness levels among the populace in Asia Pacific, along with a large population base is expected to drive the market in Asia Pacific in the near future.

Licensing approval: Approved for endocervical, vaginal, urethral, urine specimens

Key players operating the gonorrhea diagnostic market include Becton, Dickinson and Company, Baxter International, Inc., Pfizer Inc., B. Braun Melsungen AG, Fresenius SE & CO. KGaA, Medtronic plc, Smiths Group plc, Terumo Corporation, Moog, Inc., F. Hoffmann-la Roche Ltd., and Johnson & Johnson. Major companies in the market are constantly working towards introducing innovative tests and lower the costs in order to improve patient outcomes and enhance profitability.

Key Developments

1. Major companies in the market are focused on various business strategies such as gaining approval from regulatory authorities, in order to provide better diagnostic solutions for gonorrhea. For instance, in August 2019, binx health received the U.S. Food and Drug Administration (FDA) 510 (k) clearance for its rapid point of care platform binx io. The binx io platform is used for detection of gonorrhea and chlamydia.
2. Major companies in the market are focused on various business strategies such as gaining approval from regulatory authorities, in order to provide better diagnostic solutions for gonorrhea. For instance, in May 2019, Hologic, Inc. received the U.S. FDA 510 (k) approval for its gonorrhea and chlamydia diagnostic test Aptima Combo 2 Assays. It is one of the first testing devices cleared for testing of these sexually transmitted diseases.
3. Major companies in the market are focused on various business strategies such as gaining approval from regulatory authorities, in order to provide better diagnostic solutions for gonorrhea. For instance, in May 2019, Cepheid, Inc. received the U.S. FDA 510 (k) clearance for testing rectal and throat specimens with Xpert CT/NG test. This devices provide accurate detection of gonorrhea and chlamydia.