Acute Pyelonephritis - Market Insights, Epidemiology, and Market Forecast - 2034

Key Highlights:

• The acute pyelonephritis market is projected to grow steadily during the forecast period (2025-2034), driven by emerging therapies, advanced diagnostics, rising disease awareness, and an increasing number of reported cases, creating a promising and evolving market landscape.
• The rising cases of acute pyelonephritis are mainly due to increased urinary tract obstructions (like kidney stones or enlarged prostate), higher rates of diabetes, frequent use of urinary catheters, and a growing population with compromised immunity, all of which make individuals more susceptible to kidney infections.
• Acute pyelonephritis treatment relies on early antibiotic use, guided by severity and risk factors. Oral agents suffice for mild cases, while severe or resistant infections require IV antibiotics and hospitalization. Therapy is refined using culture results, with supportive care as standard. Lack of improvement signals possible complications or resistance.
• The current acute pyelonephritis landscape is competitive, with multiple approved treatment options, including FETROJA (cefiderocol), VABOMERE (meropenem-vaborbactam), and ORLYNVAH (sulopenem etzadroxil and probenecid), among others.
• Despite effective antibiotics, acute pyelonephritis faces key unmet needs due to rising multidrug-resistant (MDR) pathogens, reducing treatment efficacy and increasing reliance on last-resort agents like carbapenems. A lack of comparative data also hampers optimal regimen selection.
• The emerging pipeline for acute pyelonephritis shows moderate competition, with several promising candidates in late-stage development, including tebipenem HBr, ZAYNICH (cefepime-zidebactam; WCK 5222), and cefepime-taniborbactam, among others. These agents aim to address resistance gaps and expand treatment options in a challenging clinical landscape.
• Among the emerging therapies, tebipenem HBr stands out with a planned US FDA filing expected in the second half of 2025, marking a potential milestone in expanding oral treatment options for resistant infections.

DelveInsight's comprehensive report titled "Acute Pyelonephritis - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of acute pyelonephritis. The report presents historical and projected epidemiological data covering total incident cases of acute pyelonephritis, gender-specific incident cases of acute pyelonephritis, and treated cases of acute pyelonephritis. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The report analyzes the existing treatment practices and unmet medical requirements in acute pyelonephritis. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

Acute Pyelonephritis Overview

Acute pyelonephritis is a sudden and severe kidney infection that results from the spread of bacteria, typically originating from a lower urinary tract infection. It is not caused by medications and most often affects women due to anatomical and hormonal factors. While anyone can develop this condition, it is more common in individuals with urinary tract abnormalities or compromised immune systems. Acute pyelonephritis can lead to serious complications if not treated promptly, but most cases respond well to antibiotic therapy.

The primary symptoms of acute pyelonephritis include sudden onset of fever, chills, and pain in the lower back or side, typically on one side of the body. Individuals may also experience frequent and painful urination, a strong urge to urinate, and cloudy or foul-smelling urine. Nausea, vomiting, and general fatigue are also common. In some cases, there may be abdominal discomfort or tenderness over the affected kidney. Symptoms can appear rapidly and may worsen without timely medical attention.

Acute Pyelonephritis Diagnosis and Treatment Algorithm

Diagnosing acute pyelonephritis involves evaluating both clinical presentation and supportive diagnostic findings. Physicians typically consider symptoms such as high fever, chills, flank or back pain, and urinary issues like dysuria or increased frequency-especially in women with a recent or recurrent urinary tract infection.

Urinalysis usually reveals white blood cells, bacteria, and sometimes blood in the urine, while a urine culture is essential to identify the causative organism and guide targeted antibiotic therapy. Blood tests often show elevated white blood cell counts and inflammatory markers such as CRP or ESR. In more complex cases or when response to initial treatment is poor, imaging-typically a renal ultrasound or CT scan-is used to detect complications like obstruction, abscess, or structural abnormalities. Prompt and accurate diagnosis is crucial to initiate appropriate treatment and avoid long-term kidney damage.

Treatment of acute pyelonephritis centers on timely antibiotic therapy to clear the infection and prevent complications. Oral antibiotics are used in mild to moderate cases, while more severe presentations may require intravenous antibiotics and hospitalization. Therapy typically lasts 7 - 14 days, with the choice of antibiotic guided by urine culture results for targeted effectiveness. Supportive care, including hydration and pain relief, aids recovery. Close monitoring is essential, particularly in individuals with recurrent infections, anatomical abnormalities, or compromised immunity. Patient education on completing treatment and recognizing symptoms of relapse is key to ensuring full recovery and preventing long-term kidney damage.

Acute Pyelonephritis Epidemiology

The epidemiology section of the acute pyelonephritis market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the incidence of acute pyelonephritis. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings

In the US, the incidence of acute pyelonephritis was found to be approximately 250 thousand cases per year.

It was found that acute pyelonephritis in the US disproportionately affects females, with annual rates of 15-17 cases per 10,000 compared to just 3-4 cases per 10,000 in males, highlighting a significant sex-based disparity in disease burden.

In 2019, the incidence of acute pyelonephritis in France was recorded at 19.2 cases per 10,000 population.

In France, acute pyelonephritis was found to be more prevalent among females, who accounted for 76.5% of the cases.

It was observed that in Japan, the incidence of UTI (pyelonephritis or upper UTI) was 12.4 per 10,000 for women and 6.8 per 10,000 for men, highlighting a greater vulnerability among females.

The epidemiology of acute pyelonephritis is expected to change during the forecast period (2025-2034).

Acute Pyelonephritis Market Outlook

The acute pyelonephritis therapeutics market is further expected to increase by the major drivers, such as the rising incidence population, technological advancements, and upcoming therapies in the forecast period (2025-2034).

In October 2024, the US FDA approved ORLYNVAH (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated UTIs in adult women who have limited or no alternative oral treatment options.

With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the acute pyelonephritis market in the 7MM is expected to change significantly during the study period 2020-2034.

Acute Pyelonephritis Drug Chapters

Marketed Acute Pyelonephritis Drugs

FETROJA (cefiderocol): Shionogi

FETROJA (cefiderocol), developed by Shionogi, is a novel siderophore cephalosporin antibiotic designed to combat serious gram-negative bacterial infections, including those caused by multidrug-resistant organisms. It leverages the bacteria's own iron uptake system-specifically, the siderophore-mediated iron transport pathway-to gain entry into the bacterial cell. By mimicking iron, which is essential for bacterial growth, FETROJA is actively transported across the outer membrane of gram-negative pathogens. Once inside, it binds to penicillin-binding proteins (PBPs) and disrupts cell wall synthesis, ultimately leading to bacterial cell death.

FETROJA is approved for the treatment of infections caused by susceptible Gram-negative microorganisms in patients aged 18 years and older, including complicated urinary tract infections (cUTI) such as pyelonephritis.

VABOMERE (meropenem-vaborbactam): Melinta Therapeutics

VABOMERE, developed by Melinta Therapeutics, is a fixed-dose combination of the carbapenem meropenem and the novel beta-lactamase inhibitor vaborbactam. Designed to address serious infections caused by Gram-negative pathogens, it specifically targets beta-lactamase-producing organisms that are resistant to many standard antibiotics. VABOMERE demonstrates strong activity against carbapenem-resistant Enterobacterales (CRE), particularly strains expressing Klebsiella pneumoniae carbapenemase (KPC), the most prevalent and clinically significant form of carbapenem resistance. It is approved for use in patients aged 18 and older for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible bacteria.

In July 2023, Melinta Therapeutics partnered with Biomedical Advanced Research and Development Authority (BARDA) to advance VABOMERE for pediatric use and biothreat preparedness.

ORLYNVAH (sulopenem etzadroxil and probenecid): Iterum Therapeutics

ORLYNVAH is an innovative oral penem antibiotic developed for the treatment of uncomplicated urinary tract infections (uUTIs). It exhibits strong activity against Enterobacterales, including strains that produce extended-spectrum beta-lactamases (ESBL) or AmpC-type beta-lactamases, which commonly drive resistance to third-generation cephalosporins. These resistant pathogens are also frequently implicated in acute pyelonephritis, highlighting ORLYNVAH's potential relevance in managing such infections.

In October 2024, Iterum Therapeutics received US FDA approval for ORLYNVAH, making it the first oral penem antibiotic and only the second US FDA-approved treatment for uncomplicated urinary tract infections (uUTI) in adult women with limited or no alternative oral options.

Emerging Acute Pyelonephritis Drugs

The acute pyelonephritis market is expected to experience gradual changes, mainly due to the limited availability of emerging therapies in this area. Key market players, including Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr), Cefepime-taniborbactam and Cefepime-zidebactam (WCK 5222) have demonstrated a keen interest in this condition and are actively pursuing the development of potential treatments.

Tebipenem HBr (Tebipenem Pivoxil Hydrobromide): Spero Therapeutics/GSK

Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) is an oral carbapenem prodrug developed for the treatment of serious Gram-negative infections, including complicated urinary tract infections (cUTIs) and acute pyelonephritis. It provides a convenient and effective oral alternative to intravenous antibiotics. The US FDA has granted tebipenem HBr both Qualified Infectious Disease Product (QIDP) and Fast Track designations (FTD).

In May 2025, the pivotal Phase III PIVOT-PO trial evaluating tebipenem HBr met its primary endpoint, prompting an early termination of the study due to demonstrated efficacy. The result paves the way for a planned US FDA filing in the second half of 2025.

In September 2022, Spero entered into an exclusive licensing agreement with GSK for the development and commercialization of tebipenem HBr across all markets except certain Asian territories. As part of the agreement, GSK sub-licensed back to Spero the rights and responsibility to conduct specific development activities, including the pivotal Phase III PIVOT-PO trial. Following the trial's completion, sponsorship of the new drug application (NDA) will be transferred from Spero to GSK.

ZAYNICH (Cefepime-zidebactam; WCK 5222): Wockhardt

Cefepime-zidebactam (WCK 5222) is an investigational combination of cefepime, a fourth-generation cephalosporin, and zidebactam, a B-lactam enhancer that uniquely targets penicillin-binding protein 2. This dual-action approach delivers strong activity against multidrug-resistant Gram-negative pathogens, including carbapenem-resistant Enterobacterales (CRE) and Pseudomonas aeruginosa, by addressing B-lactamase-mediated resistance. Currently in global Phase III trials, the combination is being evaluated for complicated urinary tract infections, including acute pyelonephritis. It has been granted QIDP status by the US FDA.

In January 2025, ZAYNICH successfully completed a global, pivotal, registration-enabling Phase III trial, demonstrating superiority over meropenem based on the primary efficacy endpoint defined by both the US FDA and EMA as the combined clinical cure and microbiologic eradication at the test-of-cure visit.

Cefepime-taniborbactam: Venatorx Pharmaceuticals

Cefepime-taniborbactam, developed by Venatorx Pharmaceuticals, is a beta-lactam/beta-lactamase inhibitor (BLI) combination designed to address serious Gram-negative infections such as cUTIs and hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP). By pairing cefepime-a fourth-generation cephalosporin with established safety and broad-spectrum activity-with taniborbactam, a potent beta-lactamase inhibitor, this therapy effectively targets drug-resistant pathogens, including carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA). The US FDA has recognized its clinical relevance with both QIDP and FTD.

In February 2024, the US FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of cefepime-taniborbactam. Although no concerns were raised regarding safety or efficacy and no additional clinical trials were required, the US FDA requested additional chemistry, manufacturing, and controls (CMC) information.

Acute Pyelonephritis Market Segmentation

DelveInsight's 'Acute Pyelonephritis - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a detailed outlook of the current and future acute pyelonephritis market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

Acute Pyelonephritis Market Size by Countries

The acute pyelonephritis market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) acute pyelonephritis market, primarily attributed to the country's higher incidence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Acute Pyelonephritis Market Size by Therapies

Acute Pyelonephritis Market Size by Therapies is categorized into current and emerging markets for the study period 2020-2034.

Acute Pyelonephritis Drugs Uptake

This section focuses on the sales uptake of potential acute pyelonephritis drugs that have recently been launched or are anticipated to be launched in the acute pyelonephritis market between 2020 and 2034. It estimates the market penetration of acute pyelonephritis drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the acute pyelonephritis market.

The emerging acute pyelonephritis therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the acute pyelonephritis market.

Acute Pyelonephritis Market Access and Reimbursement

DelveInsight's 'Acute Pyelonephritis - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of acute pyelonephritis.

This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

KOL Views

To keep up with current acute pyelonephritis market trends and fill gaps in secondary findings, we interview KOLs and SMEs' working in the acute pyelonephritis domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or acute pyelonephritis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the acute pyelonephritis unmet needs.

Acute Pyelonephritis: KOL Insights

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as the University of Minnesota, US; University Hospital Munich, Germany; University of Tours, France; Bologna General Hospital, Italy; Kobe University, Japan, and others.

"Acute pyelonephritis is a serious bacterial infection affecting the kidney parenchyma, with the potential to cause organ damage or become life-threatening. The infection typically arises from bacteria ascending the lower urinary tract, though it can also result from hematogenous spread. Prompt recognition and appropriate treatment are crucial in acute pyelonephritis, as timely intervention significantly reduces the risk of complications such as kidney scarring and systemic illness."

"Pregnant patients diagnosed with acute pyelonephritis should be admitted to the hospital due to the increased risk of complications such as preterm labor. Initial evaluation should include an ultrasound to assess the urinary tract. If the diagnosis remains uncertain and given that CT imaging is generally avoided during pregnancy further evaluation may involve MRI or cystoscopy with retrograde pyelography, particularly when obstructive pyelonephritis is suspected."

"In cases of acute pyelonephritis, imaging frequently revealed abnormalities, and both the use of imaging and the presence of such findings were linked to increased rates of hospital ward admission. These observations highlight the potential value of conducting early and routine imaging in patients with acute pyelonephritis, as it may assist clinicians in making timely and informed decisions regarding patient management and appropriate level of care."

Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the acute pyelonephritis Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Acute Pyelonephritis Pipeline Development Activities

The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for acute pyelonephritis. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging acute pyelonephritis therapies.

Acute Pyelonephritis Report Insights

• Acute Pyelonephritis Patient Population
• Therapeutic Approaches
• Acute Pyelonephritis Pipeline Analysis
• Acute Pyelonephritis Market Size and Trends
• Acute Pyelonephritis Market Opportunities
• Impact of Upcoming Therapies

Acute Pyelonephritis Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• Acute Pyelonephritis Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Acute Pyelonephritis Market
• Acute Pyelonephritis Drugs Uptake

Acute Pyelonephritis Report Assessment

• Acute Pyelonephritis Current Treatment Practices
• Unmet Needs
• Acute Pyelonephritis Pipeline Product Profiles
• Acute Pyelonephritis Market Attractiveness

Key Questions:

• How common is acute pyelonephritis?
• What are the key findings of acute pyelonephritis epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020-2034)?
• What are the currently available treatments for acute pyelonephritis?
• What are the disease risk, burden, and unmet needs of acute pyelonephritis?
• At what CAGR is the acute pyelonephritis market and its epidemiology is expected to grow in the 7MM during the forecast period (2025-2034)?
• How would the unmet needs impact the acute pyelonephritis market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of acute pyelonephritis in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025-2034)?
• How many companies are currently developing therapies for the treatment of acute pyelonephritis?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the acute pyelonephritis market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of current treatment in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions:

1. What are the treatment goals for acute pyelonephritis?

The primary goals of treating acute pyelonephritis are to eliminate the infection, prevent complications such as renal scarring or sepsis, relieve symptoms, and reduce the risk of recurrence through appropriate antimicrobial therapy and supportive care.

2. What are the challenges in managing acute pyelonephritis?

Key challenges include rising antimicrobial resistance, delays in diagnosis, complications in high-risk populations (e.g., pregnant women or immunocompromised individuals), and differentiating uncomplicated from complicated cases requiring tailored intervention.

3. What are the key factors driving the growth of the acute pyelonephritis market?

The acute pyelonephritis market is driven by increasing incidence of urinary tract infections, rising antibiotic resistance, demand for novel oral and IV therapies, and advances in diagnostic technologies enhancing early and accurate detection.

4. How will the acute pyelonephritis Market and Epidemiology Forecast Report benefit the clients?

The report will provide comprehensive insights into the current acute pyelonephritis landscape, pipeline developments, competitive trends, clinical guidelines, and evolving patient needs, enabling informed decision-making, strategic planning, and identification of growth opportunities for stakeholders.