Complicated Urinary Tract Infections Market Size in the 7MM is projected to grow at a CAGR of 5.7% by 2034, estimates DelveInsight

DelveInsight's "Complicated Urinary Tract Infection Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Complicated Urinary Tract Infection, historical and forecasted epidemiology, as well as the Complicated Urinary Tract Infection 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 Infection Market Report
• In December 2025, Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC) conducted a phase 2 study is to assess the safety and tolerability of meropenem-vaborbactam administered by intravenous (IV) infusion in children 3 months and above to less than 12 years with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).
• In December 2025, Meiji Seika Pharma Co. Ltd announced a Phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AP).
• In December 2025, Menarini Group initiated a clinical trial is to assess the pharmacokinetic (PK) and safety and tolerability of Vaborem (fixed combination of meropenem and vaborbactam) in the paediatric population aged from birth to < 18 years with suspected or confirmed Gram negative infections in need of hospitalisation and intravenous (IV) antibiotic administration.
• In 2024, the Complicated Urinary Tract Infection Diagnosed Incident Cases were approximately 3,558,000 in the US.
• In 2024, the age-specific cases of cUTI were approximately 40,000, 268,000, 247,000, 511,500, 1,759,500 and 732,000 cases for 0-17 years, 18-44 years, 45-54 years, 55-64 years, 65-84 years and =85 years, respectively, in the US.
• In the US, male accounted for approximately 30% cases and female accounted for ~70% cases of cUTI in 2024.
• In 2024, the treated Cases of cUTI was approximately 10,746,500 in the 7MM, out of which ~ 8,266,500 were 1st line and ~ 2,480,000 were recurrent rate.
• 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 Therapies such as Ceftazidime -avibactam, Cefepime, Eravacycline, Ertapenem, CXA-101, Sulopenem, NXL104/ceftazidime, Imipenem/Cilastatin and others.

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Complicated Urinary Tract Infection Epidemiology Segmentation in the 7MM
• 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 Infection Marketed Drugs
• EXBLIFEP (Cefepime/Enmetazobactam): Allecra Therapeutics
EXBLIFEP (cefepime/enmetazobactam), a novel intravenous antibiotic targeting MDR gram-negative bacteria particularly ESBL-producing strains. Approved by the FDA in February 2024 for cUTI. Despite demonstrating strong clinical efficacy, especially against resistant pathogens, the drug was unexpectedly withdrawn from the US market. In March 2024, the European Commission granted marketing authorisation for EXBLIFEP for the treatment of adult patients with cUTI, including pyelonephritis.

• 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.

Complicated Urinary Tract Infection Emerging Drugs
• Tebipenem Pivoxil Hydrobromide (SPR994): Spero Therapeutics
Tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is an oral antibiotic used for the treatment of cUTI and AP 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 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 the 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. In December 2015, the US FDA granted breakthrough QIDP drug discovery status to WCK-5222.

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Complicated Urinary Tract Infection Companies
Spero Therapeutics, Wockhardt, Venatorx Pharmaceuticals, Melinta Therapeutics, Menarini Group, Meiji Seika Pharma, Fedora Pharmaceuticals, and others

Complicated Urinary Tract Infection Market Outlook
The Complicated Urinary Tract Infections market outlook of the report helps to build the detailed comprehension of the historic, current, and forecasted Complicated Urinary Tract Infections market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers and demand of better technology.

Complicated Urinary Tract Infection Treatment Market
Treatment for complicated UTIs tends to take longer compared with simple UTIs, and may take between 7 and 14 days. While a course of antibiotics may treat a typical UTI at home, complicated cases may require broad-spectrum, intravenous antibiotics as well as hospitalization. The exact treatment timeline depends on how soon patient's body responds to broad-spectrum antibiotics, as well as whether any complications develop. The treatment goals are to get rid of the infection, prevent complications, and help provide symptomatic relief. In order to lower the risk of developing pyelonephritis, early treatment is recommended. When considering empirical antimicrobial selection, it is critical to recognize antimicrobial resistance trends. The main course of treatment for individuals with lower UTIs is an oral medication with an empirically selected antibiotic that is effective against Gram-negative aerobic coliform bacteria, such as Escherichia coli.

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Scope of the Complicated Urinary Tract Infection Market Report
• Coverage- 7MM
• Study Period- 2020-2034
• Complicated Urinary Tract Infection Companies- Spero Therapeutics, Wockhardt, Venatorx Pharmaceuticals, Melinta Therapeutics, Menarini Group, Meiji Seika Pharma, Fedora Pharmaceuticals, and others
• Complicated Urinary Tract Infection Therapies- Ceftazidime -avibactam, Cefepime, Eravacycline, Ertapenem, CXA-101, Sulopenem, NXL104/ceftazidime, Imipenem/Cilastatin and others.
• Complicated Urinary Tract Infection Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Complicated Urinary Tract Infection Unmet Needs, KOL's views, Analyst's views, Complicated Urinary Tract Infection Market Access and Reimbursement

Table of Contents
1: Key Insights
2: Complicated Urinary Tract Infection Market Report Introduction
3: Complicated Urinary Tract Infection Market Overview at a Glance
4: Complicated Urinary Tract Infection Epidemiology and Market Methodology
5: Complicated Urinary Tract Infection Executive Summary
6: Key Events
7: Complicated Urinary Tract Infection Background and Overview
8: Complicated Urinary Tract Infection Epidemiology and Patient Population
9: Complicated Urinary Tract Infection Patient Journey
10: Complicated Urinary Tract Infection Marketed drugs
11: Complicated Urinary Tract Infection Emerging Drugs
12. Key Cross Competition
13: Complicated Urinary Tract Infection Unmet Needs
14: Complicated Urinary Tract Infection SWOT Analysis
15: Key Opinion Leaders' Views
16: Reimbursement and Market Access
17: Appendix
18: DelveInsight Capabilities
19: Disclaimer
20: About DelveInsight

About Us

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