Complicated Urinary Tract Infection (cUTI) Market Analysis 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Prevalence, Statistics, Revenue, Therapies, Companies by DelveInsight

Complicated Urinary Tract Infection Market

(Albany, USA) DelveInsight’s “Complicated Urinary Tract Infection (cUTI) Market Insights, Epidemiology, and Market Forecast-2034” report delivers an in-depth understanding of Complicated Urinary Tract Infection (cUTI), historical and forecasted epidemiology as well as the Complicated Urinary Tract Infection (cUTI) market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The Complicated Urinary Tract Infection (cUTI) market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Complicated Urinary Tract Infection (cUTI) market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Complicated Urinary Tract Infection (cUTI) treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Complicated Urinary Tract Infection (cUTI) market.

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Some facts of the Complicated Urinary Tract Infection (cUTI) Market Report are:

• According to DelveInsight, Complicated Urinary Tract Infection (cUTI) market size is expected to grow at a decent CAGR by 2034.
• In June 2025, Menarini Group announced 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 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 June 2025, Venatorx Pharmaceuticals Inc. conducted a Phase 3 study Evaluating the Efficacy, Safety, and Tolerability of Cefepime/VNRX-5133 in Adults With Complicated Urinary Tract Infections (cUTI), Including Acute Pyelonephritis.
• In June 2025, Rempex organized 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, 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.
• Leading Complicated Urinary Tract Infection (cUTI) companies working in the market are Pfizer, Novartis, Spero Therapeutics, Tetraphase Pharmaceuticals, Wockhardt, Venatorx Pharmaceuticals, Cubist Pharmaceuticals, Janssen, Allecra Therapeutics, Nabriva Therapeutics AG, La Jolla Pharmaceutical Company, MerLion Pharmaceuticals, PRA Health Sciences, Qilu Pharmaceutical, Meiji Seika Pharma and others.
• Key Complicated Urinary Tract Infection (cUTI) Therapies expected to launch in the market are Ceftazidime –avibactam, Cefepime, LYS228, Eravacycline, Ertapenem, Levofloxacin, CXA-101, TBPM-PI-HBr, Doripenem, Meropenem- FL058, Piperacillin –tazobactam, aztreonam and nacubactam, cefepime and nacubactam, Sulopenem Etzadroxil/Probenecid, Meropenem, Cefepime-zidebactam (FEP-ZID), and others.
• On June 2023, Meiji Seika Pharma Co 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).
• On May 2023, Wockhardt announced a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem in the treatment of hospitalized adults with Complicated Urinary Tract Infection or AP.

Complicated Urinary Tract Infection (cUTI) Overview

A complicated urinary tract infection (UTI) refers to an infection that occurs in the urinary tract and is associated with additional factors or conditions that make it more challenging to diagnose, treat, or resolve. These factors can include urinary tract abnormalities, obstruction, kidney stones, immunocompromised state, diabetes, pregnancy, catheterization, or antibiotic resistance. Complicated UTIs may involve not only the lower urinary tract (bladder and urethra) but also the upper urinary tract (kidneys and ureters). The complexity of these infections often necessitates a multidimensional approach, including targeted antibiotic therapy, identification and management of underlying factors, and close monitoring for potential complications.

Learn more about Complicated Urinary Tract Infection (cUTI) treatment algorithms in different geographies, and patient journeys. Contact to receive a sample @ Complicated Urinary Tract Infection Treatment Market

Complicated Urinary Tract Infection (cUTI) Market

The Complicated Urinary Tract Infection (cUTI) market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted Complicated Urinary Tract Infection (cUTI) market trends by analyzing the impact of current Complicated Urinary Tract Infection (cUTI) therapies on the market and unmet needs, and drivers, barriers, and demand for better technology.

This segment gives a thorough detail of the Complicated Urinary Tract Infection (cUTI) market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated Complicated Urinary Tract Infection (cUTI) market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

According to DelveInsight, the Complicated Urinary Tract Infection (cUTI) market in 7MM is expected to witness a major change in the study period 2020-2034.

Complicated Urinary Tract Infection (cUTI) Epidemiology

The Complicated Urinary Tract Infection (cUTI) epidemiology section provides insights into the historical and current Complicated Urinary Tract Infection (cUTI) patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Complicated Urinary Tract Infection (cUTI) market report also provides the diagnosed patient pool, trends, and assumptions.

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Complicated Urinary Tract Infection (cUTI) Drugs Uptake

This section focuses on the uptake rate of the potential Complicated Urinary Tract Infection (cUTI) drugs recently launched in the Complicated Urinary Tract Infection (cUTI) market or expected to be launched in 2020-2034. The analysis covers the Complicated Urinary Tract Infection (cUTI) market uptake by drugs, patient uptake by therapies, and sales of each drug.

Complicated Urinary Tract Infection (cUTI) Drugs Uptake helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on Complicated Urinary Tract Infection (cUTI) market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Complicated Urinary Tract Infection (cUTI) Pipeline Development Activities

The Complicated Urinary Tract Infection (cUTI) report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Complicated Urinary Tract Infection (cUTI) key players involved in developing targeted therapeutics.

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Complicated Urinary Tract Infection (cUTI) Therapeutics Assessment

Major key companies are working proactively in the Complicated Urinary Tract Infection (cUTI) Therapeutics market to develop novel therapies which will drive the Complicated Urinary Tract Infection (cUTI) treatment markets in the upcoming years are Pfizer, Novartis, Spero Therapeutics, Tetraphase Pharmaceuticals, Wockhardt, Venatorx Pharmaceuticals, Cubist Pharmaceuticals, Janssen, Allecra Therapeutics, Nabriva Therapeutics AG, La Jolla Pharmaceutical Company, MerLion Pharmaceuticals, PRA Health Sciences, Qilu Pharmaceutical, Meiji Seika Pharma and others.

Learn more about the emerging Complicated Urinary Tract Infection (cUTI) therapies & key companies @ Complicated Urinary Tract Infection Clinical Trials and FDA Approvals

Complicated Urinary Tract Infection (cUTI) Report Key Insights

1. Complicated Urinary Tract Infection (cUTI) Patient Population

2. Complicated Urinary Tract Infection (cUTI) Market Size and Trends

3. Key Cross Competition in the Complicated Urinary Tract Infection (cUTI) Market

4. Complicated Urinary Tract Infection (cUTI) Market Dynamics (Key Drivers and Barriers)

5. Complicated Urinary Tract Infection (cUTI) Market Opportunities

6. Complicated Urinary Tract Infection (cUTI) Therapeutic Approaches

7. Complicated Urinary Tract Infection (cUTI) Pipeline Analysis

8. Complicated Urinary Tract Infection (cUTI) Current Treatment Practices/Algorithm

9. Impact of Emerging Therapies on the Complicated Urinary Tract Infection (cUTI) Market

Table of Contents

1. Key Insights

2. Executive Summary

3. Complicated Urinary Tract Infection (cUTI) Competitive Intelligence Analysis

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

5. Complicated Urinary Tract Infection (cUTI) Disease Background and Overview

6. Complicated Urinary Tract Infection (cUTI) Patient Journey

7. Complicated Urinary Tract Infection (cUTI) Epidemiology and Patient Population

8. Complicated Urinary Tract Infection (cUTI) Treatment Algorithm, Current Treatment, and Medical Practices

9. Complicated Urinary Tract Infection (cUTI) Unmet Needs

10. Key Endpoints of Complicated Urinary Tract Infection (cUTI) Treatment

11. Complicated Urinary Tract Infection (cUTI) Marketed Products

12. Complicated Urinary Tract Infection (cUTI) Emerging Therapies

13. Complicated Urinary Tract Infection (cUTI) Seven Major Market Analysis

14. Attribute Analysis

15. Complicated Urinary Tract Infection (cUTI) Market Outlook (7 major markets)

16. Complicated Urinary Tract Infection (cUTI) Access and Reimbursement Overview

17. KOL Views on the Complicated Urinary Tract Infection (cUTI) Market

18. Complicated Urinary Tract Infection (cUTI) Market Drivers

19. Complicated Urinary Tract Infection (cUTI) Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

About DelveInsight

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