Complicated Urinary Tract Infections Market Report 2034: Epidemiology Data, Pipeline Therapies, and Latest FDA, EMA, PDMA Approvals | DelveInsight | Featuring Companies: Spero Therapeutics, Wockhardt,

Complicated Urinary Tract Infections companies are Venatorx Pharmaceuticals, Allecra Therapeutics, Nabriva Therapeutics AG, MerLion Pharmaceuticals, and others.
DelveInsight's "Complicated Urinary Tract Infections Market Insights, Epidemiology, and Market Forecast-2034" provides a comprehensive analysis of complicated urinary tract infections (cUTIs), covering historical and projected epidemiological trends as well as market dynamics across the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.

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Some of the key facts of the Complicated Urinary Tract Infections Market Report:

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In October 2025, Wockhardt announced the submission of a New Drug Application (NDA) to the U.S. FDA for its novel antibacterial therapy, Zidebactam-Cefepime injection. The NDA seeks approval for treating complicated urinary tract infections (cUTIs), including pyelonephritis, with or without concurrent bacteremia caused by Gram-negative bacteria, including multidrug-resistant (MDR) strains. In the U.S. and EU, over 8 million cUTI cases are reported annually, underscoring the global burden of Gram-negative infections.

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The cUTI market is projected to grow at a notable CAGR during the study period (2020-2034). Leading companies driving innovation in this space include Merck Sharp & Dohme, Shionogi, Pfizer, Venatorx Pharmaceuticals, Spero Therapeutics, Allecra, and others. In 2023, the total cUTI market in the 7MM was approximately USD 1.6 billion, with the U.S. holding the largest share, followed by Japan and Germany, while Spain accounted for the smallest share (~5%).

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By 2034, emerging therapies such as cefepime/AAI101 (enmetazobactam), cefepime/zidebactam, and cefepime/VNRX-5133 (taniborbactam) are expected to generate significant revenue in the EU4 and UK. The cUTI market growth is fueled by rising awareness, the development of more effective treatments, and the increasing global prevalence of UTIs.

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Urinary tract infections range from uncomplicated cases to more severe forms, including complicated UTIs, pyelonephritis, and urosepsis. Symptomatic cUTIs can present with mild lower urinary tract symptoms, such as frequency and urgency, or severe systemic complications like bacteremia and sepsis, often linked to urinary obstruction or genitourinary trauma.

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Diagnosis typically involves clinical evaluation, microbiological testing, and imaging (ultrasound or CT) to detect conditions like perinephric abscesses, hydronephrosis, or obstructive pyelonephritis. In 2023, the U.S. accounted for ~42% of diagnosed cUTI cases in the 7MM, the highest among these regions.

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Treatment focuses on infection eradication, symptom relief, and prevention of complications, with early intervention essential to prevent progression. Pharmacological options include beta-lactamase inhibitors, protein synthesis inhibitors, and combination therapies, often supplemented with dietary support.

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Several emerging therapies are expected to impact the market during the forecast period, including Cefepime/enmetazobactam, Cefepime/taniborbactam, Cefepime/zidebactam, Nacubactam (with cefepime or aztreonam), Tebipenem Poxil Hydrobromide, and Imipenem/Cilastatin with XNW4107. In 2023, cephalosporins held the largest share among cUTI treatments in the 7MM, with Germany projected to lead the EU4 and UK market.

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The growing global cUTI burden and rising antibiotic resistance underscore the need for alternative strategies beyond traditional antibiotics, creating opportunities for innovative therapies. In the EU4 and UK, Germany reported the highest number of diagnosed cUTI cases (~26% in 2023), expected to grow at a CAGR of 0.6% through 2034.

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Key cUTI Companies: Spero Therapeutics, Wockhardt, Venatorx Pharmaceuticals, Allecra Therapeutics, Nabriva Therapeutics AG, MerLion Pharmaceuticals, and others Key cUTI Therapies: AVYCAZ (ceftazidime/avibactam), RECARBRIO (imipenem, cilastatin, and relebactam), Cefepime/enmetazobactam, Cefepime/zidebactam (WCK-5222), and others

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The cUTI market is expected to expand significantly due to increasing disease prevalence and awareness, with multi-stage pipeline products likely to reshape the market landscape.

Complicated Urinary Tract Infections Overview

Complicated urinary tract infections (cUTIs) are infections that develop in individuals with pre-existing conditions or structural abnormalities in the urinary tract, making treatment more challenging and increasing the risk of serious complications. Unlike uncomplicated UTIs, which typically affect otherwise healthy people, cUTIs are linked to factors such as urinary obstructions, kidney stones, diabetes, or the use of indwelling catheters. These underlying issues elevate the likelihood of recurrent infections, disease progression, and potentially severe systemic outcomes, including sepsis.

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Complicated Urinary Tract Infections Epidemiology

The epidemiology section offers an overview of past, present, and projected trends in the seven major markets (7MM) from 2020 to 2034. It examines the factors driving these trends by reviewing multiple studies and expert opinions. Additionally, the section provides a comprehensive analysis of the diagnosed patient population and anticipated future patterns.

Complicated Urinary Tract Infections Epidemiology Segmentation:

The Complicated Urinary Tract Infections market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

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Diagnosed Prevalence of Complicated Urinary Tract Infections in Adults

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Diagnosed Prevalence of Complicated Urinary Tract Infections in Pediatrics

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Diagnosed Prevalence of Complicated Urinary Tract Infections by Types

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Diagnosed Prevalence of Complicated Urinary Tract Infections by Location

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Diagnosed Prevalence of Complicated Urinary Tract Infections by Severity

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Complicated Urinary Tract Infections Marketed Drugs

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RECARBRIO (imipenem, cilastatin, and relebactam): Merck Sharp & Dohme

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AVYCAZ (ceftazidime/avibactam): AbbVie/Pfizer

Complicated Urinary Tract Infections Marketed Drugs

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Cefepime/enmetazobactam: Allecra Therapeutics

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Cefepime/zidebactam (WCK-5222): Wockhardt

Complicated Urinary Tract Infections Therapies: AVYCAZ (ceftazidime/avibactam), RECARBRIO (imipenem, cilastatin, and relebactam), Cefepime/enmetazobactam, Cefepime/zidebactam (WCK-5222), and others

Complicated Urinary Tract Infections Key Companies: Spero Therapeutics, Wockhardt, Venatorx Pharmaceuticals, Allecra Therapeutics, Nabriva Therapeutics AG, MerLion Pharmaceuticals, and others

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Complicated Urinary Tract Infections Market Outlook

Urinary tract infections (UTIs) rank among the most common bacterial infections, ranging from mild, uncomplicated cases to more severe forms such as complicated UTIs (cUTIs), pyelonephritis, and urosepsis.

Antibiotic therapy remains the cornerstone of treatment for cUTIs. ZERBAXA (ceftolozane/tazobactam), developed by Cubist Pharmaceuticals and later acquired by Merck & Dohme, became the first drug approved for adult cUTI treatment in 2014.

AVYCAZ, indicated for cUTIs including pyelonephritis caused by bacteria like Enterobacteriaceae and Pseudomonas aeruginosa, received U.S. approval in February 2015 and European approval in June 2016.

Other FDA- and EMA-approved cUTI therapies include RECARBRIO (Merck), Fetroja (Shionogi), VABOMERE (Melinta Therapeutics), and ZEMDRI (Cipla Therapeutics).

Looking ahead, improvements in diagnostic techniques, growing awareness of cUTIs, and the launch of new therapies with enhanced clinical profiles are expected to drive advancements in the field. Rising prevalence, coupled with innovations in treatment and increased global healthcare investment, is anticipated to support market growth from 2024 to 2034.

Overall, the introduction of several promising therapies is set to reshape the cUTI treatment landscape and significantly improve management of the condition.

Scope of the Complicated Urinary Tract Infections Market Report

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Study Period: 2020-2034

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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

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Key Complicated Urinary Tract Infections Companies: Spero Therapeutics, Wockhardt, Venatorx Pharmaceuticals, Allecra Therapeutics, Nabriva Therapeutics AG, MerLion Pharmaceuticals, and others

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Key Complicated Urinary Tract Infections Therapies: AVYCAZ (ceftazidime/avibactam), RECARBRIO (imipenem, cilastatin, and relebactam), Cefepime/enmetazobactam, Cefepime/zidebactam (WCK-5222), and others

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Complicated Urinary Tract Infections Therapeutic Assessment: Complicated Urinary Tract Infections current marketed and Complicated Urinary Tract Infections emerging therapies

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Complicated Urinary Tract Infections Market Dynamics: Complicated Urinary Tract Infections market drivers and Complicated Urinary Tract Infections market barriers

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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies

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Complicated Urinary Tract Infections Unmet Needs, KOL's views, Analyst's views, Complicated Urinary Tract Infections Market Access and Reimbursement

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Table of Contents

1. Complicated Urinary Tract Infections Market Report Introduction

2. Executive Summary for Complicated Urinary Tract Infections

3. SWOT analysis of Complicated Urinary Tract Infections

4. Complicated Urinary Tract Infections Patient Share (%) Overview at a Glance

5. Complicated Urinary Tract Infections Market Overview at a Glance

6. Complicated Urinary Tract Infections Disease Background and Overview

7. Complicated Urinary Tract Infections Epidemiology and Patient Population

8. Country-Specific Patient Population of Complicated Urinary Tract Infections

9. Complicated Urinary Tract Infections Current Treatment and Medical Practices

10. Complicated Urinary Tract Infections Unmet Needs

11. Complicated Urinary Tract Infections Emerging Therapies

12. Complicated Urinary Tract Infections Market Outlook

13. Country-Wise Complicated Urinary Tract Infections Market Analysis (2020-2034)

14. Complicated Urinary Tract Infections Market Access and Reimbursement of Therapies

15. Complicated Urinary Tract Infections Market Drivers

16. Complicated Urinary Tract Infections Market Barriers

17. Complicated Urinary Tract Infections Appendix

18. Complicated Urinary Tract Infections Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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"Complicated Urinary Tract Infections Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Complicated Urinary Tract Infections market. A detailed picture of the Complicated Urinary Tract Infections pipeline landscape is provided, which includes the disease overview and Complicated Urinary Tract Infections treatment guidelines.

Complicated Urinary Tract Infections Epidemiology

DelveInsight's 'Complicated Urinary Tract Infections Epidemiology Forecast to 2034' report delivers an in-depth understanding of the disease, historical and forecasted Complicated Urinary Tract Infections epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

About DelveInsight

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It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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