carbapenem resistant enterobacteriaceae infection market insight

DelveInsight’s ‘Carbapenem-resistant Enterobacteriaceae Infection – Market Insights, Epidemiology, and Market Forecast – 2030’ report delivers an in-depth understanding of the historical and forecasted epidemiology as well as the market trends of Carbapenem-resistant Enterobacteriaceae Infection in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The Carbapenem-resistant Enterobacteriaceae Infection market report provides current treatment practices, emerging drugs, market share of the individual therapies, current and forecasted Carbapenem-resistant Enterobacteriaceae Infection market Size from 2018 to 2030, segmented by seven major markets. The report also covers the current Carbapenem-resistant Enterobacteriaceae Infection treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying market potential.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2018–2030

Carbapenem-resistant Enterobacteriaceae Infection: Disease Understanding and Treatment Algorithm

Carbapenem-resistant Enterobacteriaceae Infection Overview

Carbapenems, a class of ß-lactam antibiotics with a broad spectrum of activity, have been the workhorse for treating difficult Gram-negative infections, but with the increasing use of carbapenems in clinical practice, the emergence of Carbapenem-resistant pathogens now poses a great threat to human health. The Centers for Disease Control and Prevention (CDC) defines Carbapenem-resistant Enterobacteriaceae (CRE) as enterobacteria non-susceptible to any carbapenem or documented to produce carbapenemases. These pathogens have also been described as “nightmare” bacteria by CDC. Also, in 2017, WHO categorized CRE within the critical priority group, against which there is an urgent need to develop new antibiotics.

Symptoms of a CRE infection vary. They may differ with the type of bacteria involved and the part of the body infected. Some general symptoms of a CRE infection include fever and a rapid pulse. Based on carbapenemase production, CRE is classified into carbapenemase-producing CRE and non- carbapenemase-producing CRE.

There are three major mechanisms by which Enterobacteriaceae become resistant to carbapenems: enzyme production (carbapenemases), efflux pumps, and porin mutations. Of these, enzyme production is the main resistance mechanism. CP-CRE can produce a large variety of carbapenemases, divided into three groups according to the Ambler classification: Class A, Class B, and Class D ß-lactamases. There is a fourth class, Ambler class C; however, its clinical relevance remains unknown.

Tests to detect CP-CRE include Chromogenic assays, modified Hodge test, and Metallo- β-lactamase Etest, but these tests do not identify specific carbapenemases. Various rapid diagnostic phenotypic tests (e.g., Carba NP, mCIM, eCIM, and MALDI-TOF MS) may detect carbapenemase production, whereas several rapid diagnostic genotypic tests (e.g., Biofire FilmArray, Verigene System, Xpert Carba-R, GenMark ePlex) may identify specific carbapenemases.

To date, the treatment options for CRE infections remain very limited. Some treatment options for addressing the threat of CRE include tigecycline, polymyxins, aminoglycosides, fosfomycin, meropenem/vaborbactam, and ceftazidime/avibactam.

Due to the reduced number of randomized clinical trials, the therapeutic approaches for CPE infections are mainly based on accumulating clinical experience. A wide heterogeneity of most published studies (different types of infections, different groups of patients, various treatment regimens, different methods, and outcome definitions) can be a severe obstacle in comparing data, which precludes the possibility of a rigorous meta-analysis. Therefore, it is difficult to recommend a single therapeutic approach.

Carbapenem-resistant Enterobacteriaceae Infection Diagnosis and Treatment

It covers the details of conventional and current medical therapies and diagnosis available in the Carbapenem-resistant Enterobacteriaceae Infection market to treat the condition. It also provides country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.

The DelveInsight Carbapenem-resistant Enterobacteriaceae Infection market report gives a thorough understanding of Carbapenem-resistant Enterobacteriaceae Infection by including disease definition, symptoms, causes, pathophysiology, and diagnosis. It also provides the treatment algorithms and treatment guidelines for Carbapenem-resistant Enterobacteriaceae Infection in the US, Europe, and Japan.

Carbapenem-resistant Enterobacteriaceae Infection Epidemiology

The Carbapenem-resistant Enterobacteriaceae Infection epidemiology division provides insights about the historical and current patient pool along with the forecasted trend for every seven major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool, trends, and assumptions.

Key Findings

The disease epidemiology covered in the report provides historical and forecasted Carbapenem-resistant Enterobacteriaceae Infection epidemiology segmented as the Total Incident Cases of Carbapenem-resistant Enterobacteriaceae Infection. The report includes the Incident scenario of Carbapenem-resistant Enterobacteriaceae Infection in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2018 to 2030.

Country-wise Carbapenem-resistant Enterobacteriaceae Infection Epidemiology

The epidemiology segment also provides the Carbapenem-resistant Enterobacteriaceae Infection epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

The Incident population of Carbapenem-resistant Enterobacteriaceae Infection in the 7MM countries was estimated to be 22,243 cases in 2020.

Carbapenem-resistant Enterobacteriaceae Infection Drug Chapters

To date, the treatment options for CRE infections remain very limited. Polymyxins (colistin or polymyxin B) and tigecycline have been historically considered drugs of choice for infections caused by CRE. However, resistance to these antibiotics is increasing. In addition to polymyxins and tigecycline, fosfomycin and aminoglycosides are occasionally used.

Carbapenems still play a role in treating CRE infections, particularly when used in treating CRE with lower MICs, either in higher doses, in combination with other active anti-CRE agents, or through double-carbapenem therapy (DCT).

Older antibiotics such as minocycline, doxycycline, trimethoprim/sulfamethoxazole, and chloramphenicol may be effective for some CRE isolates.

Recently, novel β-lactamase inhibitor combinations have provided new therapeutic options for CRE infections. However, these new β-lactamase inhibitors are not active against all carbapenemases. Avibactam inhibits both Class A KPC and Class D OXA-48, while vaborbactam and relebactam inhibit only Class A KPC.

Other new agents, such as Plazomicin and Eravacycline were approved by the FDA in 2018 against MDR-Enterobacteriaceae. Cefiderocol, approved by FDA in 2019, is the first siderophore antibiotic indicated for treating infections caused by susceptible Gram-negative microorganisms.

Products detail in the report…

Carbapenem-resistant Enterobacteriaceae Infection Emerging Drugs

WCK 5222/ FEP-ZID/Zidebactam-Cefepime (Wockhardt) is a combination of cefepime and zidebactam; this super drug introduces an entirely new class of antibiotic treatment. Earlier US FDA has granted a breakthrough fast-track clinical trial and approval process Qualified Infectious Disease Product (QIDP) status for this drug. Zidebactam is an antibiotic with a novel β-lactam enhancer mechanism that facilitates overcoming multiple resistance mechanisms in Gram-negative superbugs, including the most dreaded mechanism called New Delhi Metallo β-lactamase (NDM) which renders the last line of antibiotics carbapenems ineffective. It has a dual mechanism of action involving high-affinity penicillin-binding protein 2 (PBP2) binding as well as inhibition of Ambler class A and C enzymes. An abridged Phase III global study protocol in complicated urinary tract infection (cUTI) was ¬finalized in consultation with US FDA and EMA in approximately 504 patients. This was based on evaluating its preclinical and clinical data of Phase I establishing safety and clinical scope of efficacy for the drug. The study was estimated to commence in the second half of 2020.

ATM-AVI/Aztreonam-avibactam (Pfizer/AbbVie) is an investigational, fixed-dose, intravenous combination antibiotic against Metallo β-lactamase (MBL)-producing Gram-negative pathogens, for which there are currently very limited treatment options. Although aztreonam is not inactivated by MBLs, as a single agent, it has limited utility because the vast majority of MBL-producing pathogens also express serine-β-lactamases that can inactivate it. When combined with avibactam’s ability to inhibit many serine-β-lactamases, aztreonam’s activity is restored against pathogens that co-produce MBLs and serine enzymes. ATM-AVI is currently being evaluated in two Phase III trials as a fixed-dose, intravenous combination therapy to treat serious infection due to Gram-negative bacteria. US FDA granted QIDP Designation and Fast Track Designation for ATM-AVI for the treatment of cIAI, cUTI, and hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP)

Products detail in the report…

Carbapenem-resistant Enterobacteriaceae Infection Market Outlook

The Carbapenem-resistant Enterobacteriaceae Infection market outlook of the report builds a detailed comprehension of the historical, current, and forecasted Carbapenem-resistant Enterobacteriaceae Infection market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers, and demand for better technology.

This segment gives a thorough detail of Carbapenem-resistant Enterobacteriaceae Infection 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’s, mechanism of action, compliance rate, growing need for 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 market data are presented with relevant tables and graphs to clearly view the market at first sight.

According to DelveInsight, the Carbapenem-resistant Enterobacteriaceae Infection market in the 7MM is expected to change in the study period 2018–2030.

The increasingly daunting task of finding and developing novel antibiotics and uncertainty around market size is not the only problems for the CRE market. Financial disinvestment is another tipping point. One of the developers of the new anti-CRE drugs—Achaogen—declared bankruptcy in April 2019 because of its steep losses. Several other smaller companies with commercialized antibiotics have had to file for bankruptcy or seek an acquisition, negatively impacting career opportunities for skilled researchers, as well as commercial diversification.

Key Findings

This section includes a glimpse of the Carbapenem-resistant Enterobacteriaceae Infection market in the 7MM. The market size of Carbapenem-resistant Enterobacteriaceae Infection in the seven major markets was USD 182.6 million in 2020.

The United States: Market Outlook

This section provides Carbapenem-resistant Enterobacteriaceae Infection market size and market size by therapies of Carbapenem-resistant Enterobacteriaceae Infection in the 7MM market.

The United States accounts for the largest market size of Carbapenem-resistant Enterobacteriaceae Infection compared to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.

Antimicrobial resistance is a grave threat to public health, with concern over carbapenem resistance due to the lack of effective and safe alternative treatment options. The present CRE therapeutic landscape includes drugs like Polymyxins, Meropenem, Colistimethate, Aminoglycosides, Tetracyclines, ceftazidime-avibactam, Plazomicin, Eravacycline, Imipenem-Cilastatin-Relebactam, etc. But some of these drugs now have limited usefulness.

Aminoglycosides have been used to treat serious infections for over 50 years now. Resistance against them has lessened down the usage of some common aminoglycosides such as streptomycin, gentamicin, etc. To overcome this, Plazomicin was designed. It is a synthetic derivative of sisomicin with hydroxyl-aminobutyric acid at position 1 and 2-hydroxyethyl group. However, it is not active against many strains producing NDM carbapenemases because of frequent coproduction of 16S ribosomal RNA (rRNA) methyltransferases that protect the aminoglycoside binding site of 16S rRNA and consequently confer high-level resistance to amikacin, gentamicin, tobramycin, and plazomicin. Likewise, Eravacycline is a synthetic tetracycline with a fluorine atom at C-7 and a pyrrolidinoacetamido group at the C-9 position in the tetracycline D-ring which has activity against gram-negative pathogens including CRE, Carbapenem-resistant strains of A. baumannii, and S. maltophilia, but not those of P. aeruginosa. Among Carbapenem-resistant gram-negative pathogens, tigecycline is active against the majority of CRE, A. baumannii, and S. maltophilia strains. Despite its in vitro activity against these problematic pathogens, data regarding clinical efficacy have been mixed, with an excess mortality risk shown in comparative clinical trials.

In December 2020, Merck temporarily suspended sales of Zerbaxa and subsequently issued a product recall, following the identification of product sterility issues. The company does not anticipate that Zerbaxa will return to the market before 2022. However, new beta-lactamase combinations have been made available within the last few years, and early results suggest they are safer and more efficacious for the treatment of CRE infections compared with some of the older agents, particularly polymyxin regimens, but none represent a magic bullet for the substantial problems that CRE infections present.

With this inappropriate access, we are now left with only a handful of large research companies; losing any of these will make it extremely hard to ramp up effective drug discovery and development operations. The introduction of more appropriate marketing practices can be crucial for sustainability. Along these lines, some major steps have been put forward like, Centers for Medicare and Medicaid Services (CMS) has waived the “substantial clinical improvement” criterion for qualified infectious diseases product (QIDP) antibiotics to be eligible for new technology add-on payments (NTAP), an important development since antibiotics generally are approved by the FDA based on non-inferiority data for treatment of predominantly non-MDR infections.

EU-5 Countries: Market Outlook

The total Carbapenem-resistant Enterobacteriaceae Infection market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are also mentioned.

Japan Market Outlook

The total Carbapenem-resistant Enterobacteriaceae Infection market size and market size by therapies of Carbapenem-resistant Enterobacteriaceae Infection in Japan are also mentioned.

Carbapenem-resistant Enterobacteriaceae Infection Drugs Uptake

This section focuses on the uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2018–2030. The analysis covers Carbapenem-resistant Enterobacteriaceae Infection market uptake by drugs, patient uptake by therapies, and sales of each drug. 

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allow the comparison of the drugs based on market share and size, which again will be useful in investigating factors important in the market uptake and in making financial and regulatory decisions.

Carbapenem-resistant Enterobacteriaceae Infection Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, and Phase I/II stage. It also analyses Carbapenem-resistant Enterobacteriaceae Infection key players involved in developing targeted therapeutics.

Major players include Wockhardt, Venatorx Pharmaceuticals, Pfizer/ AbbVie, and others, whose key products are expected to launch in the US market by 20XX.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Carbapenem-resistant Enterobacteriaceae Infection emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SME??s opinion working in the Carbapenem-resistant Enterobacteriaceae Infection domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps understand and validate current and emerging therapies treatment patterns or Carbapenem-resistant Enterobacteriaceae Infection market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform Competitive and Market Intelligence analysis of the Carbapenem-resistant Enterobacteriaceae Infection market by using various Competitive Intelligence tools: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of Carbapenem-resistant Enterobacteriaceae Infection, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies
• Comprehensive insight has been provided into the Carbapenem-resistant Enterobacteriaceae Infection epidemiology and treatment in the 7MM
• Additionally, an all-inclusive account of both the current and emerging therapies for Carbapenem-resistant Enterobacteriaceae Infection is provided, along with the assessment of new therapies which will impact the current treatment landscape.
• A detailed review of the Carbapenem-resistant Enterobacteriaceae Infection market; historical and forecasted, is included in the report, covering drug outreach in the 7MM
• The report provides an edge while developing business strategies by understanding trends shaping and driving the global Carbapenem-resistant Enterobacteriaceae Infection market

Report Highlights

• In the coming years, the Carbapenem-resistant Enterobacteriaceae Infection market is set to change due to the rising awareness of the disease and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
• The companies and academics are working to assess challenges and seek opportunities that could influence Carbapenem-resistant Enterobacteriaceae Infection R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
• Major players are involved in developing therapies for Carbapenem-resistant Enterobacteriaceae Infection. The launch of emerging therapies will significantly impact the Carbapenem-resistant Enterobacteriaceae Infection market
• A better understanding of disease pathogenesis will also contribute to developing novel therapeutics for Carbapenem-resistant Enterobacteriaceae Infection.
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competitor, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities

Carbapenem-resistant Enterobacteriaceae Infection Report Insights

• Patient Population
• Therapeutic Approaches
• Carbapenem-resistant Enterobacteriaceae Infection Pipeline Analysis
• Carbapenem-resistant Enterobacteriaceae Infection Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Carbapenem-resistant Enterobacteriaceae Infection Report Key Strengths

• 10-years Forecast
• 7MM Coverage
• Carbapenem-resistant Enterobacteriaceae Infection Epidemiology Segmentation
• Key Competitors
• Highly Analyzed Market
• Drugs Uptake

Carbapenem-resistant Enterobacteriaceae Infection Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers

Key Questions

Market Insights:

• What was the Carbapenem-resistant Enterobacteriaceae Infection Market share (%) distribution in 2018, and how would it look like in 2030?
• What would be the Carbapenem-resistant Enterobacteriaceae Infection total market Size and market Size by therapies across the 7MM during the forecast period (2018–2030)?
• What are the key findings pertaining to the market across 7MM, and which country will have the largest Carbapenem-resistant Enterobacteriaceae Infection market Size during the forecast period (2018–2030)?
• At what CAGR, the Carbapenem-resistant Enterobacteriaceae Infection market is expected to grow in the 7MM during the forecast period (2018–2030)?
• What would be the Carbapenem-resistant Enterobacteriaceae Infection market outlook across the 7MM during the forecast period (2018–2030)?
• What would be the Carbapenem-resistant Enterobacteriaceae Infection market growth till 2030, and what will be the resultant market Size in the year 2030?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the disease risk, burden, and unmet needs of Carbapenem-resistant Enterobacteriaceae Infection?
• What is the historical Carbapenem-resistant Enterobacteriaceae Infection patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What would be the forecasted patient pool of Carbapenem-resistant Enterobacteriaceae Infection in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What will be the growth opportunities in the 7MM with respect to the patient population pertaining to Carbapenem-resistant Enterobacteriaceae Infection?
• Out of all 7MM countries, which country would have the highest Incidence of Carbapenem-resistant Enterobacteriaceae Infection during the forecast period (2018–2030)?
• At what CAGR the population is expected to grow in the 7MM during the forecast period (2018–2030)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Carbapenem-resistant Enterobacteriaceae Infection?
• What are the current treatment guidelines for treating Carbapenem-resistant Enterobacteriaceae Infection in the US, Europe, and Japan?
• What are the Carbapenem-resistant Enterobacteriaceae Infection marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of Carbapenem-resistant Enterobacteriaceae Infection?
• How many therapies are developed by each company for the treatment of Carbapenem-resistant Enterobacteriaceae Infection?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Carbapenem-resistant Enterobacteriaceae Infection?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Carbapenem-resistant Enterobacteriaceae Infection therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Carbapenem-resistant Enterobacteriaceae Infection and their status?
• What are the key designations that have been granted for the emerging therapies for Carbapenem-resistant Enterobacteriaceae Infection?
• What are the global historical and forecasted market for Carbapenem-resistant Enterobacteriaceae Infection?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving the Carbapenem-resistant Enterobacteriaceae Infection market
• To understand the future market competition in the Carbapenem-resistant Enterobacteriaceae Infection market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Carbapenem-resistant Enterobacteriaceae Infection in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
• Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Carbapenem-resistant Enterobacteriaceae Infection market.
• To understand the future market competition in the Carbapenem-resistant Enterobacteriaceae Infection market.