Complicated Urinary Tract Infections (cUTIs) Market Insight, Epidemiology

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

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Key Takeaways from the Complicated Urinary Tract Infections Market Report

• In January 2025, Wockhardt announced that ZAYNICH demonstrated unprecedented efficacy in a global, pivotal Phase III study for cUTI, achieving a clinical cure rate of 96.8% and successfully meeting superiority criteria for registration.

• In March 2025, Meiji Seika Pharma announced that it had achieved positive results in a global Phase III clinical trial of OP0595, a novel ß-lactamase inhibitor developed to combat AMR. The trial targeted patients with cUTI or acute, uncomplicated pyelonephritis.

• Among the 7MM, the US accounted for approximately 57% of the total cUTIs market share in 2024, with EU4 and the UK accounting for almost 34% and Japan for the remaining market share.

• In 2024, there were approximately 8,266,000 diagnosed incident cases of cUTI in the 7MM, with females accounting for approximately 70% of cases and males accounting for almost 30%.

• In the US, in 2024, the age-specific cases of cUTI showed the highest prevalence in the 65–84 years age group with approximately 1,759,500 cases, followed by the 55–64 years group with 511,500 cases.

• As per DelveInsight estimates, the treated cases of cUTI in 2024 was approximately 10,746,500 in the 7MM, out of which approximately 8,266,500 were first-line treatments and approximately 2,480,000 were recurrent cases.

• The leading Complicated Urinary Tract Infections Companies such as Spero Therapeutics, Wockhardt, Venatorx Pharmaceuticals, Melinta Therapeutics, Menarini Group, Meiji Seika Pharma, Fedora Pharmaceuticals, and others.

• Promising Complicated Urinary Tract Infections Pipeline Therapies such as Tebipenem Pivoxil Hydrobromide (SPR994), ZAYNICH (Cefepime-zidebactam/WCK 5222), Cefepime/Taniborbactam (VNRX-5133), Nacubactam (OP0595), XNW4107, and others.

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Complicated Urinary Tract Infections Epidemiology Segmentation in the 7MM

• Total Complicated Urinary Tract Infections Diagnosed Incident Cases

• Complicated Urinary Tract Infections Gender-specific Cases

• Complicated Urinary Tract Infections Age-specific Cases

• Complicated Urinary Tract Infections Pathogen-specific Cases

• Complicated Urinary Tract Infections Treated Cases (First-line and Recurrent)

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Complicated Urinary Tract Infections Marketed Drugs

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

RECARBRIO is a combination of imipenem (a cell wall inhibitor), cilastatin (a renal dehydropeptidase inhibitor), and relebactam (a beta-lactamase inhibitor). The recommended dose is 1.25 g (imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg) for adult patients with creatinine clearance of 90 mL/min or greater.

In July 2019, the US FDA approved RECARBRIO for treating adults with cUTI. In February 2020, the European Medicines Agency granted marketing authorization for the treatment of gram-negative bacteria. In July 2021, the Ministry of Health, Labour and Welfare (MHLW) approved RECARBRIO in Japan for the treatment of infections caused by RECARBRIO-sensitive pathogens including Escherichia coli, Citrobacter spp, Klebsiella spp, Enterococcus spp, Serratia spp, Pseudomonas aeruginosa, and Acinetobacter spp.

ZERBAXA (ceftolozane/tazobactam): Merck Sharp & Dohme

ZERBAXA is a combination of a cephalosporin antibacterial and beta-lactamase inhibitor administered intravenously. It was approved for adults in the US in 2014, EU in 2015, and Japan in 2019. In 2022, the US FDA expanded approval for patients under 18 years old, addressing the need for effective treatments in pediatric populations with cUTI.

AVYCAZ/ZAVICEFTA (Ceftazidime-Avibactam): AbbVie

AVYCAZ/ZAVICEFTA is a combination of ceftazidime (a cell wall inhibitor) and avibactam (a beta-lactamase inhibitor) administered intravenously. This small molecule received US approval in 2018, EU approval in 2020, and was most recently approved in Japan in 2024, demonstrating its effectiveness against resistant gram-negative pathogens.

FETROJA (cefiderocol): Shionogi

FETROJA is an innovative cell wall inhibitor antibacterial administered intravenously. It was approved in the US in 2019 and the EU in 2020. Cefiderocol represents a novel approach to treating multidrug-resistant gram-negative bacteria through its unique siderophore mechanism.

VABOMERE (Meropenem/vaborbactam): Melinta Therapeutics

VABOMERE is a combination of meropenem (a cell wall inhibitor) and vaborbactam (a beta-lactamase inhibitor). This intravenous small molecule was approved in the US in 2017 and the EU in 2018, providing an important treatment option for carbapenem-resistant Enterobacteriaceae infections.

Complicated Urinary Tract Infections Emerging Drugs

Tebipenem Pivoxil Hydrobromide (SPR994): Spero Therapeutics

Tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is an oral antibiotic cell wall inhibitor used for the treatment of cUTI and acute pyelonephritis to help patients avoid hospitalizations and/or transition patients to home after IV therapy. In March 2019, Spero Therapeutics announced the US FDA grant of Fast Track Designation (FTD) for SPR994 for the treatment of cUTI and AP. Tebipenem HBr has also been granted Qualified Infectious Disease Product (QIDP) designations for cUTI.

ZAYNICH (zidebactam/cefepime, WCK 5222): Wockhardt

ZAYNICH, a combination of zidebactam and cefepime, is Wockhardt's novel proprietary antibiotic targeted towards MDR gram-negative infections. ZAYNICH is a novel ß-lactam enhancer mechanism of action drug, which overcomes all clinically important resistance mechanisms in gram-negative pathogens, including tough-to-treat Pseudomonas, Stenotrophomonas, Acinetobacter, and Klebsiella. ZAYNICH has completed a multi-national Phase III study, which would support its registration/marketing authorization globally. Wockhardt stated in its annual report that global approval for ZAYNICH was expected by the end of 2025 or early 2026. In December 2015, the US FDA granted breakthrough QIDP drug discovery status to WCK-5222.

Cefepime/Taniborbactam (VNRX-5133): Venatorx Pharmaceuticals

Cefepime/Taniborbactam is an intravenous small molecule combination therapy consisting of a cell wall inhibitor and beta-lactamase inhibitor. Currently in Phase III development, this emerging therapy shows promise in addressing resistant gram-negative pathogens commonly associated with cUTIs.

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Complicated Urinary Tract Infections Market Outlook

Complicated urinary tract infections represent one of the most challenging infectious diseases globally, particularly due to the increasing prevalence of antibiotic resistance. UTIs present in various forms, from mild uncomplicated cases to more serious conditions like cUTIs, pyelonephritis, and urosepsis, making patient stratification essential. cUTIs carry a higher risk of recurrence, chronicity, and severe outcomes, largely influenced by host factors rather than pathogens alone.

Treatment for cUTIs typically lasts 7–14 days and often requires hospitalization with IV, broad-spectrum antibiotics, especially in cases involving multidrug-resistant organisms or severe illness. The treatment landscape has evolved significantly with the introduction of newer agents like ceftazidime-avibactam and ceftolozane-tazobactam, which are effective against resistant gram-negative pathogens, including ESBL-producing and fluoroquinolone-resistant strains.

Complicated Urinary Tract Infections Drugs Market Insights

The cUTIs market is characterized by a strong need for effective antibiotics that can overcome resistance mechanisms. Current marketed therapies primarily focus on combination approaches that pair cell wall inhibitors with beta-lactamase inhibitors to combat resistant strains. Empiric therapy may include extended-spectrum cephalosporins, beta-lactam inhibitor combinations, or carbapenems for high-risk patients.

The pipeline continues to expand with innovative therapies such as oral transition options (Tebipenem Pivoxil Hydrobromide) and novel beta-lactam enhancers (ZAYNICH), which address significant unmet needs including reducing hospitalization burden and improving treatment outcomes for patients with multidrug-resistant infections.

Scope of the Complicated Urinary Tract Infections Market Report

• Coverage- 7MM 

• Study Period- 2020-2034

• Forecast Period- 2025-2034

• Complicated Urinary Tract Infections Companies- Spero Therapeutics, Wockhardt, Venatorx Pharmaceuticals, Melinta Therapeutics, Menarini Group, Meiji Seika Pharma, Fedora Pharmaceuticals, and others.

• Complicated Urinary Tract Infections Pipeline Therapies- Tebipenem Pivoxil Hydrobromide (SPR994), ZAYNICH (Cefepime-zidebactam/WCK 5222), Cefepime/Taniborbactam (VNRX-5133), Nacubactam (OP0595), XNW4107, and others.

• Complicated Urinary Tract Infections Market Dynamics: Complicated Urinary Tract Infections Market Drivers and Barriers

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Table of Contents

1. Key Insights

2. Report Introduction

3. Complicated Urinary Tract Infection (cUTI) Market Overview at a Glance

4. Methodology

5. Executive Summary of cUTI

6. Key Events

7. Disease Background and Overview

8. Treatment and Management of cUTIs

9. cUTI Epidemiology and Patient Population

10. Complicated Urinary Tract Infection Patient Journey

11. Complicated Urinary Tract Infection Marketed Therapies

12. Emerging Complicated Urinary Tract Infection Therapies

13. cUTI - Seven Major Market Analysis

14. KOL Views

15. SWOT Analysis

16. Complicated Urinary Tract Infection Unmet Needs

17. Market Access and Reimbursement

18. Appendix

19. DelveInsight Capabilities

20. Disclaimer

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