요로감염증(UTI)은 가장 흔한 세균 감염 중 하나입니다. 비교적 양성이고 합병증이 없는 감염에서 복잡한 요로감염(cUTI), 신우신염, 심각한 요독증에 이르기까지 다양한 형태로 임상증상이 나타날 수 있습니다.
복잡한 요로 감염 환자에서 증상성 감염의 임상 증상은 빈뇨, 절박감 등 경미한 하지 자극 증상부터 균혈증, 패혈증 등 심각한 전신 증상까지 매우 다양합니다. 세균성 비뇨 생식기에 대한 완전한 소변 폐쇄 또는 외상, 특히 혈뇨는 더 심각한 임상상과 관련이 있는 것으로 보입니다.
cUTI의 진단은 임상상, 미생물 검사 및 방사선 검사의 세 가지 주요 특징을 기반으로합니다. 요로결석증의 가장 흔한 임상 증상으로는 급성 방광염, 신우 신염, 흔하지는 않지만 급성 전립선염이 있으며, 요로에 이상이있는 환자는 더 비정형적인 증상을 보일 수 있습니다. 초음파 검사 및 CT 검사는 패혈증 환자의 신주위 농양, 요폐, 수액 신증, 결석에 의한 폐색성 신우신염 등의 진단에 유용하거나 중요할 수 있습니다.
현재 치료 목적으로 사용되는 약물에는 β-락타마제 억제제, 단백질 합성 억제제 등 여러 유형이 있습니다. 또한 병용요법이나 건강보조식품이 처방되기도 합니다.
주요 7개국의 복잡성 요로감염증 시장 규모는 2023년 약 16억 달러에 달할 것으로 예상됩니다. 이 시장은 조사 기간(2020-2034년) 동안 확대될 것으로 예상됩니다. 주요 7개국 중 미국이 2023년 cUTI 시장 규모가 가장 컸고, 일본과 독일이 그 뒤를 이었으며, 스페인이 2023년 cUTI 시장 규모가 가장 작아 전체 시장 규모의 약 5%를 차지했습니다.
주요 7개국의 복잡성 요로감염증 시장에 대해 조사했으며, 시장의 개요와 역학, 환자 동향, 새로운 치료법, 2034년까지의 시장 규모 예측 및 의료 미충족 요구 등을 제공하고 있습니다.
Report Summary
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.
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 B-lactamase inhibitor enmetazobactam, which has potent activity against Class A serine B-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 B-lactam enhancer mechanism-of-action based antibiotic designed to address the myriad of B-lactamases that keep evolving and rendering even newer B-lactam-based antibiotics ineffective. Zidebactam is a first-in-class B-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.
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.
Further details are provided in the report...
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.
Further details are provided in the report...
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.
Further details related to country-based variations are provided in the report...
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.
Further details related to treatment and management are provided in the report...
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.
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 at Delveinsight 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.