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Antibacterial Drug Resistance: Market Landscape, Challenges and Upcoming

NEW YORK, Dec. 5, 2016 /PRNewswire/ --

Since the discovery of penicillin in 1948, antibiotics have emerged as a crucial class of pharmacological interventions responsible for treating several infectious conditions. In addition, antibiotics are also used for prophylactic purposes in patients who have undergone surgery, or immunocompromised patients (cancer patients undergoing chemotherapy). However, the inappropriate use of antibiotics, both in healthcare and food production, has rapidly accelerated an evolutionary response of antibiotic drug resistance in bacteria, rendering most existing antibiotics ineffective. In addition to high mortality rates, antibiotic drug resistance adds considerable costs to the healthcare system, thereby, significantly increasing the economic burden. In the US, antibiotic resistance leads to a loss of USD 20 billion in direct healthcare costs, with additional costs, as high as USD 35 billion per year, to society in terms of lost productivity.

Several companies have made an attempt to develop new generation antibiotics that can combat the widespread antibiotic drug resistance. These antibiotics are either the improved derivatives of existing antibiotics or combination products of antibiotics and ?-lactamase inhibitors. In addition, several players are actively involved in the development of alternative therapies, such as phage based therapies, vaccines and monoclonal antibodies, which can potentially be utilized to target drug-resistant bacteria.

To safeguard the use of antibiotics and support the development of new generation molecules, a myriad of initiatives have been taken by government bodies across the globe. Examples include the Biopharmaceutical companies from Europe innovating in Anti-Microbial resistance (BEAM) Alliance, Driving Reinvestment in Research and Development and Responsible Antibiotic Use (DRIVE-AB), Global Antibiotic Research and Development (GARD, partnership between DNDi and WHO), Global Action Plan on Antimicrobial Resistance (GAP-AMR), National Action Plan for Combating Antibiotic Resistance Bacteria (NAP-CARB), and Biomedical Advanced Research and Development Authority (BARDA). In September 2016, leaders from across the globe decided to meet at the United Nations General Assembly to discuss health concerns related to anti-microbial resistance (AMR).

Various initiatives to classify drug resistant bacteria have been undertaken to assess the varying levels of threats posed by such pathogens and establish appropriate treatment regimens for infections caused by them. For this purpose, the IDSA has identified a set of bacterial pathogens, dubbed ESKAPE (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter spp.) pathogens, which are known to be responsible for high risk and other life threatening conditions. Similarly, the CDC has come up with its own system of categorizing high risk bacterial pathogens; in this system, bacteria are classified as urgent, concerning and serious threats depending upon the severity of infections that they are known to cause. With a considerable number of candidate drugs in the late stages of clinical development and given the existing government support, the new generation antibiotics market is expected to witness significant growth with the launch of multiple drugs over the next decade.

The "Antibacterial Drug Resistance: Market Landscape, Challenges and Upcoming Opportunities, 2016-2026" report provides an extensive study of the current landscape and the growing pipeline of new generation antibiotics targeting drug-resistant bacteria. As indicated earlier, owing to the over-prescription of antibiotics due to improper diagnosis, lack of adherence to proper dosage regimens, their widespread availability as over-the-counter (OTC) drugs, and overuse in agriculture and poultry farming, most antibiotics have been rendered ineffective. Moreover, there currently exists an expanding lag between the pace at which drug resistant bacteria evolve and the time taken for new drugs to reach the market. As a result, antibiotic drug resistance has escalated into a global threat. There are concerns that the lack of effective drugs in this domain may soon trigger the relapse of the pre-antibiotic era, in which individuals died due to day-to-day bacterial infections. According to certain studies, currently, an estimated 700,000 deaths annually are known to occur due to anti-microbial resistance worldwide. In future, the growing threat of antibiotic resistance is anticipated to prove to be more fatal than cancer.

The current scenario depicts an urgent need for new antibiotics with novel mechanisms of action, having the ability to combat antibiotic resistance. The US and EU governments have amended their action plans and conducted many conferences to raise awareness about the situation among both experts in the domain and the general public. Such initiatives are addressed to support R&D strategies of companies engaged in the development of drugs to combat antibiotic resistance. Efforts are underway to assist drug developers in their clinical trial design issues, and even the simplification of regulatory pathways to expedite the time to market for such drugs. In addition, such initiatives endorse public-private partnerships in advancing scientific and clinical efforts in this domain, aid the setting up of surveillance programs to track the widespread use of antibiotics and the development of resistance, and track the growing economic burden due to this phenomenon as well.

The new generation antibiotics pipeline comprises of several molecules that target infections caused by deadly pathogens classified under ESKAPE or as urgent threats by the CDC. Several start-ups have entered the market and undertaken various initiatives to develop novel antibiotics with unique mechanisms of action. The report features:
- An overview of the current state of the market with respect to the key players involved, phase of development of pipeline products (clinical and preclinical / discovery), target classes of pathogens (Gram-negative versus Gram-positive), drug classes and key disease indications. In addition, we have included an insightful representation of the developer landscape, highlighting the geographical presence of key players in the industry.
- Detailed profiles of approved drugs, as well as those in phase III of clinical development, highlighting information on clinical trials, their current status of development, recent developments and associated collaborations.
- Insights on novel alternative therapies that are being explored / evaluated to target antibiotic resistant pathogenic bacteria; these include teixobactin, anti-microbial peptides, antisense antibacterials, quorum sensing inhibition, nano-metal based therapies and anti-biofilm agents.
- Details on the most popular therapeutic areas, namely acute bacterial skin and skin structure infections (ABSSSIs), community-acquired pneumonia (CAP) Clostridium difficile infections (CDIs), complicated intra-abdominal infections (cIAIs), complicated urinary tract infections (cUTIs) and hospital-acquired pneumonia / ventilator-associated pneumonia (HAP / VAP). For each indication, we have provided a brief description of the disease, information on its epidemiology, available treatment plans and active comparator studies of approved drug candidates that are prescribed for the aforementioned indications.
- An illustrative grid representation and a bulls-eye analysis of the pipeline molecules, based on their development stage, spectrum of activity and the key indications.
- Future commercial potential of the market based on a detailed opportunity analysis, for the period between 2016 and 2026. The research, analysis and insights presented in this report include potential sales of approved antibiotics and those in late stages of development.

The opinions and insights, presented in this study, were also influenced by discussions conducted with experts in this field. These included contributions from senior representatives at Aequor, Cantab Anti-infectives, Da Volterra, Morphochem and NovaBiotics. All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Most of the data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information. The secondary sources of information include
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Industry analysts' views

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

Chapter 2 presents an executive summary of the report. It offers a high level view on the research and analysis presented in the report, highlighting where the new generation antibiotics market is headed in the mid-long term.

Chapter 3 provides a general introduction to antibiotics, featuring information on their serendipitous discovery, their use, a detailed classification of the various types of antibiotics based on multiple parameters and information on their respective mechanisms of action. Additionally, the chapter highlights the underlying concepts related to the development of antibiotic drug resistance and how it spreads. The chapter also includes a discussion on the most hazardous pathogen species, such as the ones categorized under ESKAPE pathogens and those considered as urgent threats. Further, it presents details on the global prevalence of antibiotic resistant disease, highlighting the geographies where they occur most frequently, and the important government initiatives undertaken to address this global threat.

Chapter 4 provides a comprehensive overview of the current landscape of the new generation antibiotics market. It includes information on potential drug candidates that are currently marketed and those that are in different stages of development (both clinical and preclinical / discovery). It presents a detailed analysis of the pipeline of products in this domain, including information on the most commonly targeted indications, current stage of development of pipeline molecules, highlighting their spectrum of activity, the drug class they represent and the key players involved in their development.

Chapter 5 presents detailed illustrations on active comparator studies of approved and phase III drugs that have been / are being developed for various indications, such as respiratory disorders (CAP, HAP / VAP), gastrointestinal disorders (cIAIs, CDIs), skin infections (ABSSSIs / cSSSIs), CRE infections and UTIs. The chapter includes a detailed bull's eye analysis on the late stage clinical molecules and a grid analysis of the pipeline, highlighting the most popular infectious diseases against which new generation antibiotics are being developed. It also presents a detailed developer landscape, highlighting the start-ups, small / mid-sized companies and the pharma giants that are involved in this field.

Chapter 6 is focused on the new generation antibiotics that have been recently approved. It provides comprehensive profiles, containing a brief description of the drugs, geographical areas where they are approved, their respective mechanisms of action, dosage regimens, information on revenues generated on product sales and current status of development. In addition, the chapter also offers details on the recent collaborations that have been inked related to each of the profiled drugs.

Chapter 7 provides in-depth information on the antibiotics that are in phase III of clinical development. It features drug profiles highlighting relevant information on licensing, drug class, mechanism of action, route of administration, current status of development, key insights from clinical studies, recent collaborations and specific designations or statuses granted to each drug (if any).

Chapter 8 elaborates on the various alternative forms of treatment that are being explored to combat antibiotic drug resistance. These emerging therapies include teixobactin, anti-microbial peptides, antisense antibacterials, quorum sensing inhibition based therapies, nano-metals and anti-biofilm agents. The chapter provides brief overviews of the different types of therapies and details on their respective mechanisms of action.

Chapter 9 provides information on the most popular disease indications in this space. These include ABSSSI, CAP, CDI, IAI, HAP / VAP, and UTI. The chapter presents brief descriptions of the aforementioned diseases, their epidemiology and current treatment plans for each indication. In addition, the chapter highlights the names of the various pathogens that have been shown to cause these diseases. It also includes a detailed comparison of the dosage regimens of the approved drugs that are currently prescribed for the treatment of each of the aforementioned disease indications.

Chapter 10 provides a comprehensive market forecast analysis, highlighting the future potential of the market till 2026. The analysis takes into consideration the molecules that are approved and those that are in advanced stages of development (phase III, phase II/III and phase II). Projections of the future sales potential and growth opportunity are based on target patient populations, existing / future competition, likely adoption rates and the overall market size of each therapeutic area.

Chapter 11 summarizes the overall report. In this chapter, we have provided a recap of the key takeaways from the study and also presented our independent opinion based on the research and analysis described in the previous chapters.

Chapter 12 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. In this chapter, we have presented the details provided to us by Dr. Marilyn Bruno (CEO, Aequor), Dr. Mike Dawson (CEO, Cantab Anti-infectives), Dr. Kristin Thompson (Business Development Manager, Da Volterra), Elhan Webb (Business Development / Investor Relations, Morphochem) and Dr. Deborah A O'Neil (CEO & CSO, NovaBiotics).

Chapter 13 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 14 is an appendix, which provides the list of companies and organizations mentioned in the report.

1. There are close to 200 new generation antibiotics that are currently approved (after 2010) or in clinical / preclinical stages of development; of these, 70% molecules demonstrate activity against IDSA identified resistant ESKAPE pathogens, while 22% of candidate drugs are being developed against infections caused by CDC-identified urgent threat bacteria, namely CRE, Clostridium difficile and drug-resistant Neisseria gonorrhoeae.
2. 16% of the pipeline represents late stage products (phase III and phase II), while only 11% products are in phase I of clinical development. It is worth noting that drug candidates in the preclinical and discovery stages make up the major proportion of the new generation antibiotics pipeline.
3. It is important to highlight that even though a significant number of the late stage antibiotic candidates target infections primarily caused by Gram-positive bacteria, more than 50% of the antibiotic drugs in the preclinical and discovery stages are being developed for the treatment of infections that are caused by Gram-negative bacteria.
4. The innovation in this emerging field is primarily being led by start-ups / small companies. Notable examples include (in alphabetical order) Alaxia Pharma, Allecra Therapeutics, Biocidium Biopharmaceuticals, Cellceutix Corporation, Cempra, ContraFect, EYDO Pharma, Kyorin Pharmaceutical, Melinta Therapeutics, MerLion Pharmaceuticals, MGB-Biopharma, MicuRx Pharmaceuticals, Paratek Pharmaceuticals, Phico Therapeutics, Summit Therapeutics and Zavante Therapeutics. In addition, a number of large companies are also developing assets in this field. Prominent players under this category include (in alphabetical order) AstraZeneca, Allergan, Actelion, Daiichi Sankyo, GSK, Merck, Pfizer, Roche, R-Pharm and Shionogi.
5. Several mid-sized pharma players are also making notable contributions in this domain; examples include (in alphabetical order) DebioPharm, Evotec Pharmaceuticals, Galapagos, Meiji Seika Pharma, Northern Antibiotics, The Medicines Company and Theravance Biopharma. In addition to the developers of new generation antibiotics, some industry players, such as Aequor, Bugworks and SinSa Labs, are attempting to develop novel anti-biofilm agents to prevent bacteria from forming biofilms and, thereby, developing resistance to the host's immune system, as well as antibiotics.
6. With close to 10 commercialized products (approved after 2010) and over 30 in higher stages of development (phase II and above), we anticipate the new generation antibiotics market to grow at an annualized rate of over 30% till 2026. Specifically, the CAP market is likely to capture the maximum market share in 2026, owing to a large patient population and high incidence of treatment failure (10%-15%). This is likely to be followed by the ABSSSIs market that is expected to capture a 24% share of the overall new generation antibiotics market.

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