Complicated Urinary Tract Infections Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• Urinary tract infections (UTIs) are amongst the most frequent bacterial infections. They can manifest clinically in various ways, from relatively benign, uncomplicated infections to complicated UTIs (cUTIs), pyelonephritis, and severe urosepsis. cUTI is a heterogeneous entity comprising multiple forms.
• The clinical presentation of symptomatic infection in patients with complicated urinary infection varies across a wide spectrum, ranging from mild lower tract irritative symptoms, such as frequency and urgency, to severe systemic manifestations, such as bacteremia and sepsis. Complete urinary obstruction or trauma to the bacteriuric genitourinary tract, especially with hematuria, appears to be associated with more severe clinical presentations.
• The diagnosis of a cUTI is based on three main features: the clinical picture, microbiological tests, and radiological investigations. The most common clinical presentations of UTI include acute cystitis, pyelonephritis, and less commonly acute prostatitis, but patients with abnormal urinary tracts can present more atypically. Ultrasound and CT scans may sometimes be useful or even critical for diagnosing a perinephric abscess, urinary retention, hydronephrosis, and obstructive pyelonephritis from stones in septic patients.
• As per analysis, the United States showed the highest number of diagnosed-incident cases of cUTI, accounting for nearly 42% of the diagnosed-incident cases of cUTI in the 7MM in 2023.
• Pharmacotherapy aims to eradicate the infection, prevent complications, and provide symptomatic relief to patients. Early treatment is recommended to reduce the risk of progression to pyelonephritis.
• Currently, there are several types of medications used for treatment purposes, namely beta-lactamase inhibitors, protein synthesis inhibitors, and others. At times, combination therapy and dietary supplementation are also prescribed.
• The potential drugs that can mark a significant change in the forecast period include Cefepime/enmetazobactam, Cefepime/taniborbactam, Cefepime/zidebactam, Nacubactam and cefepime or aztreonam, Tebipenem Poxil Hydrobromide, Imipenem/Cilastatin and XNW4107, and others.
• In the 7MM, cephalosporins accounted for the largest market share in 2023 among all the therapies.
• Among EU4 and the UK, Germany is expected to garner the largest market size during the study period (2020-2034).
• There is a pressing need for alternatives to antibiotics in the prevention and management of UTIs. The rising global disease burden and the knowledge that antibiotic use drives the emergence of drug-resistant bacteria have created a major opportunity for new ways of managing the common infection.

Report Summary

• The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The report also encompasses a comprehensive analysis of the Complicated Urinary Tract Infection (cUTI) market, providing an in-depth examination of its historical and projected market size (2020 - 2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The report includes qualitative insights that provide an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM cUTI market.

Market

Various key players are leading the treatment landscape of cUTI such as Merck Sharp & Dohme, Shionogi, Pfizer, Venatorx Pharmaceuticals, Spero Therapeutics, Allecra, and others. The details of the country-wise and therapy-wise market size have been provided below.

• In 2023, the total market size of cUTI was around USD 1.60 billion which is expected to increase by 2034 during the study period (2020-2034) in the 7MM.
• Among the 7MM, the United States accounted for the highest market size in 2023 followed by Japan and Germany for cUTI.
• Spain had the lowest market size of cUTI in 2023, which accounted for approximately 5% of the total market size.
• By 2034, among the emerging therapies, the highest revenue is expected to be generated by cefepime/AAI101 (enmetazobactam), followed by cefepime/zidebactam and cefepime/VNRX-5133 (taniborbactam) in the EU4 and the UK.

cUTI Drug Chapters

The section dedicated to drugs in the cUTI report provides an in-depth evaluation of late-stage pipeline drugs (Phase III and Phase II) related to cUTI.

The drug chapters section provides valuable information on various aspects related to clinical trials of cUTI, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting cUTI.

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.

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.

cUTI 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.

For treating adult patients with complex urinary tract infections (cUTI), including pyelonephritis, caused by identified susceptible bacteria, such as certain Enterobacteriaceae and Pseudomonas aeruginosa, AVYCAZ was initially licensed in the US in February 2015, and in June 2016 in Europe.

RECARBRIO (Merck), Fetroja (Shionogi), VABOMERE (Melinta therapeutics), and ZEMDRI (Cipla therapeutics) are other few drugs approved by the FDA and EMA for the treatment of cUTI.

In upcoming years, advancements in diagnosis, awareness about the disease, and entry of new therapies with better clinical profiles allow researchers to approach cUTI in new directions and make discoveries. Overall, the increasing prevalence of the disease, along with upcoming novel therapies and increasing awareness, will fuel the market during the forecast period, 2024-2034.

In a nutshell, few potential therapies are expected to enter the market during the forecast period (2020-2034), and positively transform the treatment landscape. The treatment space is expected to experience a significant impact in the coming years, especially owing to the increasing healthcare spending across the world.

cUTI Disease Understanding and Treatment

cUTI Overview

Urinary tract infections (UTIs) are one of the most frequent infectious illnesses in the world, yet they remain understudied. Although uropathogenic E. coli (UPEC) accounts for a high percentage of UTIs, various bacteria, each of which will have its host-pathogen interactions with the bladder environment, can infect the urinary tract.

UTIs come in various clinical morphologies, ranging from relatively benign, uncomplicated infections to complicated UTIs (cUTIs), pyelonephritis, and severe urosepsis. As a result, the stratification of individuals with UTIs is critical. There are several categorization methods for UTIs, with the common reasoning that complicated UTIs have a greater risk of recurrence, chronification, progression, or catastrophic results than uncomplicated UTIs. Host factors, rather than pathogen characteristics, dictate the pathogenesis and management of cUTIs and pyelonephritis. High antibiotic resistance rates among causative microorganisms are linked to cUTIs and pyelonephritis.

cUTI Diagnosis

This diagnosis of a cUTI is based on three main features: the clinical picture, microbiological tests, and radiological investigations. Physicians should always consider atypical microbiology and the potential for urinary tract obstruction (UTO), which may require prompt drainage in this patient group.

The most common clinical presentations of UTI include acute cystitis, pyelonephritis, and less commonly acute prostatitis, but patients with abnormal urinary tracts can present more atypically. A carefully taken history is an essential diagnostic tool, with particular attention to the symptoms of frequency, dysuria, hematuria, suprapubic, and/or loin pain.

Basic laboratory tests may reveal elevated inflammatory markers, and renal function should be recorded. The urine dipstick is a simple and cheap bedside test and is very useful in confirming a diagnosis of UTI.

Radiological investigations are not helpful in the initial diagnosis of most infections limited to the genitourinary tract, as there should be sufficient clues from the history, physical examination, and laboratory results. Ultrasound and CT scans may sometimes be useful or even critical for diagnosing a perinephric abscess, urinary retention, hydronephrosis, and obstructive pyelonephritis from stones in septic patients.

cUTI Treatment

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.

Broad-spectrum regimens, such as an extended-spectrum cephalosporin with or without an aminoglycoside or combinations of a beta-lactam and a beta-lactamase inhibitor (e.g., ampicillin-sulbactam, ticarcillin-clavulanate, and piperacillin-tazobactam) should be considered for empiric therapy of hospitalized patients.

Oral agents can be considered in clinically stable patients (either as initial therapy or step-down therapy after IV). Trimethoprim-sulfamethoxazole and fluoroquinolones have excellent penetration into genito-urinary tissue and are preferred agents for complicated UTI and pyelonephritis when known susceptibilities.

cUTI Epidemiology

The cUTI epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed incident cases of cUTI, diagnosed incident cases of cUTI progressed from uUTI, age-specific cases, pathogen-specific cases, and total treated cases of cUTI in the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.

• 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 pneumoniae.

KOL Views

To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects of cUTI, including the evolving treatment landscape, patients’ reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.

Our team of analysts connected with more than 15 KOLs across the 7MM. We contacted institutions such as the National Institute for Infectious Diseases, MedStar Health, Robert Wood Johnson Medical School, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the cUTI market, which will assist our clients in analyzing the overall epidemiology and market scenario.

Qualitative Analysis

We perform Qualitative and Market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in trials for cUTI, important primary endpoints are overall response rate, test of cure, microbiological eradication, etc. Based on these parameters, the overall efficacy is evaluated.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, a final weightage score is decided, based on which the emerging therapies are ranked.

Market Access and Reimbursement

Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

cUTI Report Insights

• Patient Population
• Therapeutic Approaches
• cUTI Market Size and Trends
• Existing Market Opportunity

cUTI Report Key Strengths

• Eleven-year Forecast
• The 7MM Coverage
• cUTI Epidemiology Segmentation
• Key Cross Competition

cUTI Report Assessment

• Current Treatment Practices
• Reimbursements
• Market Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis, Unmet needs)

Key Questions

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in cUTI management recommendations?
• Would research and development advances pave the way for future tests and therapies for cUTI?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of cUTI?
• What kind of uptake will the new therapies witness in coming years in cUTI patients?