Complicated Urinary Tract Infections Market Set for Expansion by 2036, Supported by Recent Drug Approvals Including GSK/Spero Therapeutics’ UTEBZI and Wockhardt’s ZAYNICH and Emerging Therapies | DelveInsight

The complicated urinary tract infections market is expected to experience steady growth, driven by the rising prevalence of antimicrobial-resistant pathogens, increasing rates of recurrent and hospital-acquired urinary tract infections, and a growing burden of underlying conditions such as diabetes, chronic kidney disease, and urinary tract abnormalities. Additionally, the approval of drugs including GSK/Spero Therapeutics’ UTEBZI and Wockhardt’s ZAYNICH and the launch of emerging therapies such as Cefepime–taniborbactam (VNRX-5133; Venatorx Pharmaceuticals/Everest Medicines), FOVISCU (cefepime/tazobactam; Wockhardt), OP0595 (Nacubactam; Meiji Seika Pharma), LBP-EC01 (Locus Biosciences), and others will further propel the market growth.

New York, USA, Oct. 12, 2026 (GLOBE NEWSWIRE) -- Complicated Urinary Tract Infections Market Set for Expansion by 2036, Supported by Recent Drug Approvals Including GSK/Spero Therapeutics’ UTEBZI and Wockhardt’s ZAYNICH and Emerging Therapies | DelveInsight

The complicated urinary tract infections market is expected to experience steady growth, driven by the rising prevalence of antimicrobial-resistant pathogens, increasing rates of recurrent and hospital-acquired urinary tract infections, and a growing burden of underlying conditions such as diabetes, chronic kidney disease, and urinary tract abnormalities. Additionally, the approval of drugs including GSK/Spero Therapeutics’ UTEBZI and Wockhardt’s ZAYNICH and the launch of emerging therapies such as Cefepime–taniborbactam (VNRX-5133; Venatorx Pharmaceuticals/Everest Medicines), FOVISCU (cefepime/tazobactam; Wockhardt), OP0595 (Nacubactam; Meiji Seika Pharma), LBP-EC01 (Locus Biosciences), and others will further propel the market growth.  

Recently published Complicated Urinary Tract Infections Market Insights report includes a comprehensive understanding of current treatment practices, complicated urinary tract infections emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Complicated Urinary Tract Infections Market Summary

• The total complicated urinary tract infections treatment market size is expected to grow positively by 2036 in the leading markets.
• The United States accounted for the largest complicated urinary tract infections treatment market size in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• In 2024, the cUTI diagnosed incident cases were approximately 3.5 million in the US.
• Key complicated urinary tract infections companies, including Venatorx Pharmaceuticals, Everest Medicines, Wockhardt, Meiji Seika Pharma, Locus Biosciences, and others, are actively working on innovative complicated urinary tract infections drugs. 
• Some of the key complicated urinary tract infections therapies in clinical trials include Cefepime–taniborbactam (VNRX-5133), FOVISCU (cefepime/tazobactam), OP0595 (Nacubactam), LBP-EC01, and others. These novel complicated urinary tract infections therapies are anticipated to enter the complicated urinary tract infections market in the forecast period and are expected to change the market.

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Key Factors Driving the Growth of the Complicated Urinary Tract Infections Market 

• Rising Prevalence of Complicated UTIs: The increasing incidence of urinary tract infections among patients with underlying conditions such as diabetes, kidney disorders, urinary obstruction, and structural abnormalities is driving demand for effective treatment options.
• Growing Antimicrobial Resistance: The emergence of multidrug-resistant (MDR) and extended-spectrum beta-lactamase (ESBL)-producing pathogens is increasing the need for newer antibiotics and combination therapies, particularly for infections caused by resistant Gram-negative bacteria.
• Advances in Rapid Diagnostic Technologies: Faster pathogen identification and antimicrobial susceptibility testing can enable earlier, more targeted treatment. The adoption of molecular and rapid diagnostic platforms is improving the management of complicated UTIs and supporting market development.
• Launch of Emerging cUTI Drugs: The dynamics of the cUTI market are expected to change in the coming years due to the launch of emerging therapies such as Cefepime–taniborbactam (VNRX-5133; Venatorx Pharmaceuticals/Everest Medicines), FOVISCU (cefepime/tazobactam; Wockhardt), OP0595 (Nacubactam; Meiji Seika Pharma), LBP-EC01 (Locus Biosciences), and others.

Aparna Thakur, Project Manager of Forecasting at DelveInsight, said that the launch of emerging therapies is expected to support growth in the cUTI market by expanding treatment options for patients with multidrug-resistant (MDR) and difficult-to-treat Gram-negative bacterial infections. Newer agents, particularly β-lactam/β-lactamase inhibitor combinations, siderophore cephalosporins, and other antibiotics designed to address resistant pathogens, are likely to strengthen the treatment landscape where conventional antibiotics have limited effectiveness.

Complicated Urinary Tract Infections Market Analysis

• Treatment remains largely antibiotic-based, with therapy selected according to the causative pathogen, local resistance patterns, disease severity, and patient characteristics. 
• Marketed therapies include fluoroquinolones such as ciprofloxacin and levofloxacin, trimethoprim/sulfamethoxazole, extended-spectrum cephalosporins such as ceftriaxone and cefepime, carbapenems including meropenem and imipenem/cilastatin, and newer β-lactam/β-lactamase inhibitor (BLI) combinations. 
• These newer agents include ceftazidime/avibactam, ceftolozane/tazobactam, meropenem/vaborbactam, imipenem/cilastatin/relebactam, and cefepime/enmetazobactam (EXBLIFEP), which received FDA approval in 2024 for adults with cUTI, including pyelonephritis.
• The competitive landscape has expanded further with recently introduced therapies targeting multidrug-resistant Gram-negative infections. 
• Cefepime/zidebactam (ZAYNICH), a β-lactam/β-lactam enhancer combination developed by Wockhardt, received approvals in India and the U.S. in May 2026 for adult cUTI, including pyelonephritis, while tebipenem pivoxil hydrobromide became the first oral carbapenem approved in the U.S. for cUTI in June 2026.
• The emerging cUTI pipeline is increasingly focused on novel β-lactam/BLI combinations and orally administered antibiotics that could reduce dependence on prolonged intravenous therapy. 
• Cefepime-taniborbactam demonstrated superior composite clinical and microbiological success compared with meropenem in the Phase III CERTAIN-1 trial and remains an important investigational approach for resistant Gram-negative cUTI.
• Other notable pipeline programs include FOVISCU (cefepime/tazobactam; Wockhardt), OP0595 (Nacubactam; Meiji Seika Pharma), LBP-EC01 (Locus Biosciences), and others.
• Overall, market growth is expected to be supported by rising antimicrobial resistance and demand for therapies active against ESBL- and carbapenemase-producing pathogens, with oral agents representing a particularly important area of future development.

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Complicated Urinary Tract Infections Competitive Landscape

Some of the cUTI drugs under development include Cefepime–taniborbactam (VNRX-5133; Venatorx Pharmaceuticals/Everest Medicines), FOVISCU (cefepime/tazobactam; Wockhardt), OP0595 (Nacubactam; Meiji Seika Pharma), LBP-EC01 (Locus Biosciences), and others. 

Wockhardt’s FOVISCU is a high-dose cefepime/tazobactam combination with activity against resistant Gram-negative pathogens, including ESBL-producing Enterobacterales that are non-susceptible to piperacillin/tazobactam, cefoperazone/sulbactam, or ceftolozane/tazobactam. It has the potential to serve as a carbapenem-sparing, first-line empirical antibiotic and a broad-use treatment option for suspected or confirmed ESBL Gram-negative infections in hospital settings. A Phase 3 clinical study of Foviscu has recently been completed.

Locus Biosciences’ LBP-EC01 is a precision-engineered bacteriophage therapy designed to selectively target Escherichia coli infections. The product is being developed to precisely eliminate E. coli bacteria in patients with urinary tract infections (UTIs). Locus has entered into a partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services (HHS), to advance the development of LBP-EC01. Under the agreement, BARDA may provide up to $109 million to support the clinical development of LBP-EC01 through late-stage trials and the FDA marketing authorization process.

Meiji Seika Pharma’s Nacubactam is a novel β-lactamase inhibitor. When used in combination with existing β-lactam antibiotics, nacubactam is expected to provide activity against carbapenem-resistant Enterobacterales (CRE). In addition to its β-lactamase inhibitory activity, nacubactam targets penicillin-binding protein 2 (PBP2), an enzyme involved in peptidoglycan biosynthesis within the bacterial cell wall. This dual mechanism of action differentiates nacubactam from other β-lactamase inhibitors.

The anticipated launch of these emerging complicated urinary tract infections therapies are poised to transform the complicated urinary tract infections market landscape in the coming years. As these cutting-edge complicated urinary tract infections therapies continue to mature and gain regulatory approval, they are expected to reshape the complicated urinary tract infections market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

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Recent Developments in the Complicated Urinary Tract Infections Market

• In June 2026, GSK plc and Spero Therapeutics announced that the FDA has approved Utebzi, an oral antibiotic for treating complicated urinary tract infections (cUTIs), including pyelonephritis, caused by certain susceptible pathogens in adults with limited or no alternative oral treatment options.
• In May 2026, Wockhardt announced that the U.S. Food and Drug Administration (FDA) has approved ZAYNICH™ (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, in adults caused by susceptible Gram-negative pathogens. ZAYNICH™ had previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.
• In May 2026, Meiji Seika Pharma Co., Ltd. announced the publication in *The Lancet* of results from the Integral-1 study, one of two global Phase III clinical trials investigating the efficacy and safety of its novel β-lactamase inhibitor nacubactam (development code: OP0595).

Complicated Urinary Tract Infections Epidemiology Segmentation

The complicated urinary tract infections epidemiology section provides insights into the historical and current complicated urinary tract infections patient pool and forecasted trends for the leading markets. In 2024, the treated Cases of cUTI were approximately 11 million in the 7MM, out of which ~8 million were 1st line and ~2.4 million were recurrent.

The complicated urinary tract infections market report proffers epidemiological analysis for the study period 2022–2036 in the leading markets segmented into:

• Diagnosed Incident Cases of cUTI
• Age-specific Cases of cUTI
• Gender-specific Cases of cUTI
• Pathogen-specific Cases of cUTI
• Treated Cases of cUTI

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Complicated Urinary Tract Infections Market Report Metrics	Details
Study Period	2022–2036
Complicated Urinary Tract Infections Market Report Coverage	7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]
Complicated Urinary Tract Infections Market Epidemiology Segmentation	Diagnosed Incident Cases of cUTI, Age-specific Cases of cUTI, Gender-specific Cases of cUTI, Pathogen-specific Cases of cUTI, and Treated Cases of cUTI
Key Complicated Urinary Tract Infections Companies	Venatorx Pharmaceuticals, Everest Medicines, Wockhardt, Meiji Seika Pharma, Locus Biosciences, GSK, Spero Therapeutics, and others
Key Complicated Urinary Tract Infections Therapies	Cefepime–taniborbactam (VNRX-5133), FOVISCU (cefepime/tazobactam), OP0595 (Nacubactam), LBP-EC01, UTEBZI, ZAYNICH, and others

Scope of the Complicated Urinary Tract Infections Market Report

• Complicated Urinary Tract Infections Patient Population Forecast
• Complicated Urinary Tract Infections Therapeutics Market Size
• Complicated Urinary Tract Infections Pipeline Analysis
• Complicated Urinary Tract Infections Market Size and Trends
• Complicated Urinary Tract Infections Market Opportunity
• Complicated Urinary Tract Infections Market Unmet Needs
• KOL’s Views on Complicated Urinary Tract Infections
• Complicated Urinary Tract Infections Market Access and Reimbursement

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Table of Contents

1	Complicated Urinary Tract Infections Market Key Insights
2	Complicated Urinary Tract Infections Market Report Introduction
3	Executive Summary
4	Key Events
5	Epidemiology and Market Forecast Methodology
6	Complicated Urinary Tract Infections (cUTIs) Market Overview at a Glance
7	Disease Background and Overview of Complicated Urinary Tract Infections (cUTIs)
8	Treatment and Management
9	Epidemiology and Patient Population of Complicated Urinary Tract Infections (cUTIs)
9.1	Key Findings
9.2	Assumptions and Rationale
9.3	Complicated Urinary Tract Infections Prevalent Cases in the 7MM
9.4	The United States
9.5	EU4 and the UK
9.6	Japan
10	Patient Journey of Complicated Urinary Tract Infections (cUTIs)
11	Marketed Therapies
11.1	Competitive landscape of marketed therapies
11.2	UTEBZI: GSK/Spero Therapeutics
11.2.1	Drug Description
11.2.2	Regulatory Milestones
11.2.3	Other Developmental Activities
11.2.4	Summary of Pivotal Trials
11.2.5	Clinical Development
11.2.5.1	Clinical Trial Information
11.2.6	Analyst's Views
11.3	ZAYNICH: Wockhardt
Note: List to be continued in the report
12	Emerging Complicated Urinary Tract Infections Drugs
12.1	Competitive landscape of emerging therapies
12.2	Cefepime–taniborbactam (VNRX-5133): Venatorx Pharmaceuticals/Everest Medicines
12.2.1	Drug Description
12.2.2	Other Developmental Activities
12.2.3	Clinical Development
12.2.3.1	Clinical Trials Information
12.2.4	Analyst's Views
12.3	FOVISCU (cefepime/tazobactam):  Wockhardt
Note: List to be continued in the report
13	Complicated Urinary Tract Infections Market: 7MM Analysis
13.1	Key Findings
13.2	Market Outlook of cUTIs
13.3	Conjoint Analysis of cUTIs
13.4	Key Complicated Urinary Tract Infections Market Forecast Assumptions
13.5	Total Market Size of cUTIs in the 7MM
13.6	Total Market Size of cUTIs by Therapies in the 7MM
13.7	The United States Complicated Urinary Tract Infections Market
13.7.1	Total Market Size of cUTIs in the United States
13.7.2	Total Market Size of cUTIs by Therapies in the United States
13.8	EU4 and the UK Complicated Urinary Tract Infections Market
13.9	Japan Complicated Urinary Tract Infections Market
14	Unmet Needs of Complicated Urinary Tract Infections (cUTIs)
15	SWOT Analysis of Complicated Urinary Tract Infections (cUTIs)
16	KOL Views of Complicated Urinary Tract Infections (cUTIs)
17	Market Access and Reimbursement of Complicated Urinary Tract Infections (cUTIs)
17.1	The United States
17.2	EU4 and the UK
17.3	Japan
17.4	Market Access and Reimbursement of Complicated Urinary Tract Infections Therapies
18	Bibliography
19	Complicated Urinary Tract Infections Market Report Methodology

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