Gonorrhea - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• Gonorrhea is a Sexually Transmitted Infection (STI) caused by the bacteria Neisseria gonorrhea, which is the second most commonly reported sexually transmitted disease in the United States.
• Ceftriaxone, the last effective empiric treatment for Neisseria gonorrhea, is facing rising global resistance with rates reaching up to 40% in some regions, prompting the Centers for Disease Control and Prevention (CDC) to label it an urgent threat and the World Health Organization (WHO) to prioritize the need for new antimicrobials.
• In June 2025, Innoviva Specialty Therapeutics in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for zoliflodacin for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older.
• Gepotidacin developed by GSK was found to be safe and effective in treating gonorrhea in a late-stage clinical trial. If approved, it would become the first new class of antibiotic for the sexually transmitted infection in more than two decades.
• The WHO estimates that 106 million new gonorrhea cases are documented among adults annually worldwide. With more than 500,000 cases noted annually in the United States.

DelveInsight's "Gonorrhea - Market Insight, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of gonorrhea, historical and forecasted epidemiology as well as the gonorrhea market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The gonorrhea market report provides current treatment practices, emerging drugs, gonorrhea share of individual therapies, and current and forecasted gonorrhea market size from 2020 to 2034, segmented by seven major markets. The report also covers current gonorrhea treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Gonorrhea Disease Understanding and Treatment Algorithm

Gonorrhea Overview

Gonorrhea is a STI caused by the bacterium Neisseria gonorrhea. Neisseria gonorrhea is a Gram-negative diplococcus. This highly infectious bacterium colonizes and infects genital mucosa and it may also infect extra genital sites, including the oropharyngeal, conjunctival and anorectal mucosae. Following transmission, Neisseria gonorrhea infects mucosa of exposed anatomic sites, such as the urogenital tract, rectum, pharynx, and conjunctivae. The infection is often asymptomatic, leading to underdiagnosis and under treatment, particularly in women. Untreated Neisseria gonorrhea can result in complications such as vaginal discharge, bleeding, urethritis, cervicitis, pelvic inflammatory disease, ectopic pregnancy, and infertility. Neisseria gonorrhea can develop antimicrobial resistance (AMR) rapidly and has developed resistance to every class of antimicrobial used to treat it; some of these antibiotics are ineffective and are no longer used.

Gonorrhea Diagnosis

Diagnostic laboratory assays are essential to confirm the clinical suspicion of gonorrhea. Laboratory confirmation of Neisseria gonorrhea infection is made by direct detection of the gonococcal pathogen in urogenital, anorectal, pharyngeal, or conjunctival swab specimens or first-catch urine. Populations that engage in anogenital sexual intercourse and/or insertive oral sex will require screening for gonorrhea from the anus and pharynx in addition to urogenital screening. Confirmation of the clinical suspicion of gonorrhea is established by detecting Neisseria gonorrhea or its genetic signature in genital or extragenital samples by light microscopy of stained smears, culture, or nucleic acid amplification tests (NAATs). The routine utilization of NAATs to screen at-risk asymptomatic patients have demonstrated that pharyngeal and rectal gonococcal infections are not uncommon manifestations. NAATs are generally more than 95% sensitive and specific in urethral and cervical swabs and first catch urine of males. The development of commercially available point-of-care assays for Neisseria gonorrhea infection has impacted the time to treatment. However, while these point-of-care assays have few false-positive results, i.e., they demonstrate high levels of specificity, their sensitivity profiles range widely, with false-negative rates varying from 13% to greater than 90%. Repeat laboratory screening after patient and partner treatment for gonococcal infection enhances eradication efforts. Recently, the development of multiplex NAATs allows for the screening of an extensive panel of STDs in addition to Neisseria gonorrhea.

Gonorrhea Treatment

Empiric treatment for gonococcal infections is typically started at the first clinical visit based on symptoms such as abnormal genital discharge or known exposure. In males, uncomplicated urogenital infections are generally treated on an outpatient basis with a single 500 mg IM or IV dose of ceftriaxone (1 g for patient's >=150 kg). If Chlamydia trachomatis co-infection has not been ruled out, doxycycline 100 mg orally twice daily for 7 days is also recommended, unless contraindicated, such as in pregnancy. For complicated infections-such as pelvic inflammatory disease (PID), epididymitis, or proctitis-the same ceftriaxone regimen is combined with doxycycline for 7 days due to its added efficacy.

Directly observed therapy is advised to ensure adherence and reduce treatment failure. With rising global concerns over ceftriaxone-resistant Neisseria gonorrhea, alternative regimens like gentamicin 240 mg IM plus azithromycin 1 g orally are considered in resistant cases. Patients with severe beta-lactam allergies may be treated with IV aztreonam (1-2 g depending on infection site). Hospitalization is typically reserved for serious complications such as disseminated gonococcal infection (DGI), gonococcal arthritis, or corneal involvement, which require IV antibiotics and close monitoring. This comprehensive approach balances effective treatment, resistance management, and individualized care.

Gonorrhea Epidemiology

The gonorrhea epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total prevalent cases of gonorrhea, type-specific cases of gonorrhea, gender-specific cases of gonorrhea, and age-specific cases of gonorrhea, in the 7MM market covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In Europe, the prevalent rate in 2023 was 25.0 per 100,000 population for countries with comprehensive surveillance systems.
• In 2020, a total of 677,769 cases were reported in the United States.
• Age-specific rates for women were highest among those aged 20-24 years (72 cases per 100,000 population) and for men aged 25-34 years (131 cases per 100,000 population) in the EU4 and the UK.
• The prevalence of pharyngeal gonorrhea was 2.1% in women, 2.2% in men. In a study of heterosexual men in Japan, the prevalence of pharyngeal gonorrhea was 11.9% among patients with urethritis. Moreover, of the patients with gonorrhea caused by urethral infection, 25.0% had a concomitant pharyngeal infection.

Gonorrhea Drug Chapters

The current key players for emerging drugs and their respective drug candidates include GlaxoSmithKline (BLUJEPA), Innoviva Specialty Therapeutics (Zoliflodacin), and others. The drug chapter also helps understand the gonorrhea clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details, and the latest news and press releases.

Emerging Drugs

Zoliflodacin: Innoviva Specialty Therapeutics

Zoliflodacin is a potential first-in-class, orally administered, single dose antibiotic with a novel mechanism of action that is currently in development for the treatment of uncomplicated gonorrhea. In a Phase III clinical trial, zoliflodacin met the primary efficacy endpoint by demonstrating non-inferiority compared to a globally recognized standard of care regimen.

• In April 2024, Innoviva Specialty Therapeutics announced that positive results from the Phase III oral zoliflodacin trial were highlighted in an oral presentation given by the GARDP at the European Society of Clinical Microbiology and Infectious Disease Global Congress (ESCMID) in Spain.
• In June 2025, Innoviva Specialty Therapeutics in collaboration with the GARDP, announced that the US FDA has accepted its NDA for zoliflodacin for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older.

BLUJEPA (Gepotidacin): GlaxoSmithKline

BLUJEPA is the first in a new class of antibiotics, called triazaacenaphthylene topoisomerase inhibitors, developed at GSK in 2007 with a novel "dual targeting" mechanism of action and oral formulation. Its mechanism of action is distinct from any currently approved antibiotic. Gepotidacin works by selectively interacting with two key bacterial enzymes, DNA gyrase and topoisomerase IV (type II topoisomerases), responsible for bacterial replication. The novel MOA confers activity against most target pathogens resistant to established antibiotics, including fluoroquinolones.

In April 2024, GlaxoSmithKline announced positive results from the pivotal EAGLE-1 Phase III trial for gepotidacin for uncomplicated urogenital gonorrhea in adolescents and adults. These results were presented at the ESCMID Global in Spain.

Drug Class Insight

The drug classes currently in development for the treatment of gonorrhea encompass a wide range of mechanisms, including topoisomerase inhibitors (BLUJEPA), spiropyrimidinetriones antibiotics (Zoliflodacin), among others.

Topoisomerase Inhibitors

Topoisomerase inhibitors are chemical compounds that block the action of topoisomerases, which are classified into two main types: type I and type II. These enzymes play key roles in DNA replication and organization by mediating the cleavage of single- or double-stranded DNA to relax supercoils, untangle catenanes, and condense chromosomes in eukaryotic cells. Topoisomerase inhibitors disrupt these processes some prevent DNA strand breaks, while others, known as topoisomerase poisons, bind to topoisomerase-DNA complexes and inhibit the re-ligation step. These trapped complexes cause cytotoxic single- and double-stranded breaks, leading to apoptosis and cell death. Due to this mechanism, topoisomerase inhibitors are of interest as treatments for infections and cancer.

Spiropyrimidinetriones Antibiotics

Spiropyrimidinetriones represent a new class of antibacterial agent that operate by inhibition of DNA gyrase in a manner differentiated from fluoroquinolones such as moxifloxacin and other DNA gyrase-inhibiting antibacterial, including ATP-competitive (GyrB) inhibitors such as novobiocin and GSK000. The antibacterial spectrum of the SPT class includes activity against Gram-positive and fastidious Gram-negative pathogens, with the most advanced member, zoliflodacin, and currently in Phase III clinical trials for the treatment of gonorrhea caused by Neisseria gonorrhea.

Gonorrhea Market Outlook

The treatment landscape for gonorrhea continues to rely heavily on well-established antibiotics, with limited innovation in novel therapeutic agents despite the increasing global threat of antimicrobial resistance. Ceftriaxone remains the gold-standard treatment for uncomplicated gonococcal infections due to its potent efficacy and favorable safety profile. However, rising resistance particularly in certain regions has highlighted the urgent need for new therapies. Currently, the drug development pipeline for gonorrhea remains sparse, though a few promising candidates are in late-stage clinical trials. Among them, zoliflodacin is being actively investigated for the treatment of uncomplicated gonorrhea, including strains resistant to current therapies. Phase III trials have shown encouraging results, particularly for urogenital and rectal infections, although its efficacy against pharyngeal gonorrhea remains under evaluation. Gepotidacin, a novel antibiotic with a unique mechanism, is one of the few promising agents under investigation for drug-resistant Neisseria gonorrheae.

In clinical practice, off-label use of alternative regimens is sometimes necessary when resistance or allergies limit standard treatment. These include gentamicin with azithromycin, and aztreonam for patients with severe beta-lactam allergies, though these options are less effective for extragenital infections. Despite growing resistance concerns, no new antibiotics have received FDA approval specifically for gonorrhea in recent years. Most recent advances have occurred in diagnostics and surveillance, including enhanced nucleic acid amplification tests (NAATs), antimicrobial resistance monitoring programs, and public health tools like digital contact tracing. While these approaches support better disease management, they do not resolve the urgent need for new, effective antimicrobials. As gonorrhea cases rise globally and resistance to ceftriaxone and azithromycin becomes more widespread, investments in targeted drug development such as zoliflodacin, gepotidacin, and other innovative agents-are critical to securing future treatment options.

Gonorrhea Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034. The landscape of gonorrhea treatment has experienced a profound transformation with the uptake of novel medicines. These innovative therapies are redefining standards of care.

Gonorrhea Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I/II stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for gonorrhea emerging therapies.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, Professor and Vice Chair of the Department of Rheumatology and Director, PhD, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or gonorrhea market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Delveinsight's analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the Washington University School of Medicine, University Medical Center Hamburg-Eppendorf, and University Graduate School of Medicine etc. were contacted. Their opinion helps understand and validate gonorrhea epidemiology and market trends.

Qualitative Analysis

We perform qualitative and market intelligence analysis using various approaches, such as SWOT and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial's primary and secondary outcome measures are evaluated.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a descriptive overview of gonorrhea, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into gonorrhea epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for gonorrhea is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the gonorrhea market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM gonorrhea market.

Gonorrhea Report Insights

Gonorrhea Report Insights

• Patient Population
• Therapeutic Approaches
• Gonorrhea Pipeline Analysis
• Gonorrhea Market Size and Trends
• Market Opportunities
• Impact of Upcoming Therapies

Gonorrhea Report Key Strengths

• Ten Years Forecast
• 7MM Coverage
• Gonorrhea Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake and Key Market Forecast Assumptions

Gonorrhea Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

• What was the gonorrhea market share (%) distribution in 2020 and what it would look like in 2034?
• What would be the gonorrhea total market size as well as market size by therapies across the 7MM during the study period (2020-2034)?
• What are the key findings about the market across the 7MM and which country will have the largest gonorrhea market size during the study period (2020-2034)?
• At what CAGR, the gonorrhea market is expected to grow at the 7MM level during the study period (2020-2034)?
• What would be the gonorrhea market growth till 2034 and what will be the resultant market size in the year 2034?
• What are the disease risks, burdens, and unmet needs of gonorrhea?
• What is the historical gonorrhea patient pool in the United States, EU4 (Germany, France, Italy, and Spain), and the UK, and Japan?
• What would be the forecasted patient pool of gonorrhea at the 7MM level?
• What will be the growth opportunities across the 7MM concerning the patient population of gonorrhea?
• Amon the 7MM which country would have the most prevalent cases of gonorrhea during the study period (2020-2034)?
• At what CAGR the population is expected to grow across the 7MM during the study period (2020-2034)?
• How many companies are developing therapies for the treatment of gonorrhea?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of gonorrhea?
• What are the key collaborations (industry-industry, industry-academia), Mergers and acquisitions, and licensing activities related to gonorrhea therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What are the clinical studies going on for gonorrhea and their status?
• What are the key designations that have been granted for the emerging therapies for gonorrhea?
• What are the 7MM historical and forecasted market of gonorrhea?

Reasons to buy:

• The report will help in developing business strategies by understanding trends shaping and driving the gonorrhea market.
• To understand the future market competition in the gonorrhea market and insightful review of the SWOT analysis of gonorrhea.
• Organize sales and marketing efforts by identifying the best opportunities for gonorrhea in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the gonorrhea market.
• To understand the future market competition in the gonorrhea.