DelveInsight’s “Complicated Urinary Tract Infection Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of Complicated Urinary Tract Infections, historical and forecasted epidemiology, as well as the Complicated Urinary Tract Infections therapeutics 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 April 2025, Rempex announced a 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 April 2025, Menarini Group announced 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 3 months to < 18 years with complicated urinary tract infection (cUTI) including acute pyelonephritis (AP) in need of hospitalisation and intravenous (IV) antibiotic administration.
• In April 2025, Shionogi announced a study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative bacterial infections.
• In the 7MM, nearly 1,000,000 cUTI incident cases progressed from uUTI in the year 2023, which is expected to increase during the forecast period (2024–2034).
• In the US, maximum number of cUTI cases were observed for the age group of 65–84 years, followed by =85 years.
• Among the EU4 and the UK, Germany recorded the highest number of diagnosed-incident cases of cUTI with approximately 26% cases in 2023, which is estimated to rise by 2034, at a CAGR of 0.6%.
• Japan accounted for around 800,000 cases of cUTI in 2023 caused due to Uropathogenic Escherichia coli, followed by 100,000 cases caused by Klebsiella pneumonia.
• The leading Complicated Urinary Tract Infection Companies such as Merck Sharp & Dohme, AbbVie, Pfizer, Allecra Therapeutics, Wockhardt, Spero Therapeutics, Wockhardt, Venatorx Pharmaceuticals, GlaxoSmithKline, Locus Biosciences, Forest Laboratories, Allecra, Xiangbei Welman Pharmaceutical, Bayer, Mepha Ltd., Pinnacle Pharmaceuticals, Inc., Bionorica SE, and others
• Promising Complicated Urinary Tract Infection Therapies such as RECARBRIO (imipenem, cilastatin, and relebactam), AVYCAZ (ceftazidime/avibactam), enmetazobactam, zidebactam (WCK-5222), Tebipenem Pivoxil Hydrobromide (SPR994), Cefepime/zidebactam (WCK-5222), Cefepime/taniborbactam, Gepotidacin, LBP-EC01, Ceftaroline fosamil and NXL104 (q8h), cefepime/AAI101 combination, Piperacillin Sodium and Sulbactam Sodium, Cipro XR (Ciprofloxacin, BAYQ3939), Nitrofurantoin, PP4001, Canephron® N, and others.

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Complicated Urinary Tract Infection Epidemiology Segmentation in the 7MM

• Complicated Urinary Tract Infections Diagnosed Incident cases
• Complicated Urinary Tract Infections Diagnosed Incident cases progressed
• Complicated Urinary Tract Infections Age-specific cases
• Pathogen-specific cases
• Total treated cases of Complicated Urinary Tract Infections

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Complicated Urinary Tract Infections Marketed Therapies

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

RECARBRIO is a combination of imipenem, a penem antibacterial; cilastatin, a renal dehydropeptidase inhibitor; and relebactam, a beta-lactamase inhibitor. It is indicated in patients 18 years of age and older for the treatment of cUTIs, including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa in patients who have limited or no alternative treatment options. In July 2019, the US FDA approved RECARBRIO (imipenem, cilastatin, and relebactam), an antibacterial drug product to treat adults with cUTI.

• AVYCAZ (ceftazidime/avibactam): AbbVie/Pfizer

AVYCAZ is a combination of ceftazidime, a cephalosporin, and avibactam, a beta-lactamase inhibitor, indicated for the treatment of cUTI, including pyelonephritis, in adult and pediatric patients 3 months and older caused by the following susceptible Gram-negative microorganisms. In November 2020, the EMA approved ZAVICEFTA (ceftazidime-avibactam) for the treatment of children aged 3 months and older with cUTIs.

Complicated Urinary Tract Infections Emerging Therapies

• Cefepime/enmetazobactam: Allecra Therapeutics

The combination of enmetazobactam with the fourth-generation cephalosporine, cefepime, is intended to provide a novel therapeutic option addressing this serious threat. Allecra Therapeutics is currently developing the novel ß-lactamase inhibitor enmetazobactam, which has potent activity against Class A serine ß-lactamases, specifically ESBL. Enmetazobactam is a derivative of tazobactam, but from a molecule comparison, there are significant differences to expect higher potency. In June 2023, Allecra Therapeutics submitted an NDA to the US FDA for EXBLIFEP, an antibiotic combination of cefepime/enmetazobactam targeting cUTIs.

• Cefepime/zidebactam (WCK-5222): Wockhardt

WCK-5222 (cefepime/zidebactam) is a novel ß-lactam enhancer mechanism-of-action based antibiotic designed to address the myriad of ß-lactamases that keep evolving and rendering even newer ß-lactam-based antibiotics ineffective. Zidebactam is a first-in-class ß-lactam enhancer with potent inhibition of penicillin-binding protein (PBP) 2 of all the clinically relevant Gram-negative organisms, including Pseudomonas aeruginosa, Acinetobacter baumannii, and Enterobacterales. It is currently being investigated in a Phase III, randomized, double-blind, multicenter, comparative study to determine the efficacy and safety of cefepime-zidebactam vs meropenem in the treatment of complicated urinary tract infection or acute pyelonephritis in adults. The study is expected to be completed by April 2024.

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Complicated Urinary Tract Infections Companies

Merck Sharp & Dohme, AbbVie, Pfizer, Allecra Therapeutics, Wockhardt, Spero Therapeutics, Wockhardt, Venatorx Pharmaceuticals, GlaxoSmithKline, Locus Biosciences, Forest Laboratories, Allecra, Xiangbei Welman Pharmaceutical, Bayer, Mepha Ltd., Pinnacle Pharmaceuticals, Inc., Bionorica SE, and others.

Complicated Urinary Tract Infections Market Outlook

One of the most common bacterial illnesses is a Urinary Tract Infection. UTIs can manifest clinically in various ways, from relatively benign, uncomplicated infections to complicated UTIs (cUTIs), pyelonephritis, and severe urosepsis. Antimicrobial therapy is the first choice of therapy for patients diagnosed with cUTI. ZERBAXA (ceftolozane/tazobactam), designed by Cubist pharmaceuticals, was the first approved drug for adults diagnosed with cUTI in 2014. Later the drug was acquired by Merck & Dohme.

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Scope of the Complicated Urinary Tract Infection Market Report

• Coverage- 7MM
• Study Period- 2020-2034
• Complicated Urinary Tract Infection Companies- Merck Sharp & Dohme, AbbVie, Pfizer, Allecra Therapeutics, Wockhardt, Spero Therapeutics, Wockhardt, Venatorx Pharmaceuticals, GlaxoSmithKline, Locus Biosciences, Forest Laboratories, Allecra, Xiangbei Welman Pharmaceutical, Bayer, Mepha Ltd., Pinnacle Pharmaceuticals, Inc., Bionorica SE, and others.
• Complicated Urinary Tract Infection Therapies- RECARBRIO (imipenem, cilastatin, and relebactam), AVYCAZ (ceftazidime/avibactam), enmetazobactam, zidebactam (WCK-5222), Tebipenem Pivoxil Hydrobromide (SPR994), Cefepime/zidebactam (WCK-5222), Cefepime/taniborbactam, Gepotidacin, LBP-EC01, Ceftaroline fosamil and NXL104 (q8h), cefepime/AAI101 combination, Piperacillin Sodium and Sulbactam Sodium, Cipro XR (Ciprofloxacin, BAYQ3939), Nitrofurantoin, PP4001, Canephron® N, 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 Content

1. Key Insights

2. Report Introduction

3. Complicated Urinary Tract Infection Market Overview at a Glance

4. Executive Summary of Complicated Urinary Tract Infection

5. Key Events

6. Complicated Urinary Tract Infections Market Disease Background and Overview

7. Complicated Urinary Tract Infections Treatment and Management

8. Methodology

9. Complicated Urinary Tract Infections Epidemiology and Patient Population

10. Complicated Urinary Tract Infections Patient Journey

11. Complicated Urinary Tract Infections Marketed Drugs

12. Complicated Urinary Tract Infections Emerging Therapies

13. Complicated Urinary Tract Infection Market- Seven Major Market Analysis

14. Complicated Urinary Tract Infections KOL Views

15. Complicated Urinary Tract Infections Unmet Needs

16. Complicated Urinary Tract Infections SWOT Analysis

17. Complicated Urinary Tract Infections Market Access and Reimbursement

18. The United States

19. EU4 and the UK

20. Japan

21. Appendix

22. DelveInsight Capabilities

23. Disclaimer

24. About DelveInsight

About Us

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