Market Research Logo

Antibacterial Drug Resistance: Market Landscape, Challenges and Upcoming

Antibacterial Drug Resistance: Market Landscape, Challenges and Upcoming

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 β-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.

SCOPE OF THE REPORT
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.

EXAMPLE HIGHLIGHTS
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.

RESEARCH METHODOLOGY
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 OUTLINES
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.

LIST OF COMPANIES AND ORGANIZATIONS
The following companies and organizations have been mentioned in the report.

1. AAIPharma Services
2. ABAC Therapeutics
3. Abbott Laboratories
4. Abgentis
5. Absynth Biologics
6. Achaogen
7. Acino Holdings
8. Actavis
9. Actelion Pharmaceuticals
10. Adenium Biotech
11. Adimab
12. Aequor
13. AiCuris
14. Alaxia Pharma
15. Allecra Therapeutics
16. Albany Molecular Research (AMRI)
17. Allergan
18. Angelini
19. ANTABIO
20. Antibio Tx
21. Antibiotic Adjuvant
22. Aphios
23. Appili Therapeutics
24. Arietis Pharma
25. Arpida
26. Arsanis
27. Assembly Biosciences
28. AstraZeneca
29. Austell Laboratories
30. Aventis Pharma
31. Basilea Pharmaceutica
32. Bayer Pharma
33. Biocidium Biopharmaceuticals
34. Biocon
35. Biosearch Italia
36. BioVersys
37. Biovertis
38. BKG Pharma
39. Blueberry Therapeutics
40. BUGWORKS
41. C3 Jian
42. Calixa Therapeutics
43. Cantab Anti-infectives
44. Cardiome Pharma
45. Cellceutix Corporation
46. Cempra
47. Cerexa
48. Clinigen Group
49. ContraFect
50. Crestone
51. Crystal Genomics
52. Cubist Pharmaceuticals
53. CyDex Pharmaceuticals
54. Da Volterra
55. Daiichi Sankyo
56. Debiopharm International
57. Deinove
58. Demuris
59. Discuva
60. Dong Wha Pharmaceuticals
61. Dong-A Pharmaceutical
62. DSM Sinochem Pharmaceuticals
63. Durata Therapeutics
64. Eli Lilly
65. Eligo Bioscience
66. EnBiotix
67. Entasis Therapeutics
68. Eurofarma Laboratórios
69. Evolva Holding
70. Evotec
71. Eydo Pharma
72. Fedora Pharmaceuticals
73. FOB Synthesis
74. Forest Laboratories
75. Fujisawa Pharmaceuticals
76. Galapagos
77. GangaGen
78. GeneWEAVE
79. GSK
80. Hikma Pharmaceuticals
81. IASO Pharma
82. Immuron
83. Indel Therapeutics
84. Institute of Metagenomics and Microbial Technologies (IMMT)
85. InterMune
86. iNtRON Biotechnology
87. Ionis Pharmaceuticals
88. Isis Pharmaceuticals
89. Janssen-Ortho
90. Japan Radio Company
91. Johnson & Johnson
92. Kyorin Pharmaceutical
93. LegoChem Biosciences
94. Ligand Pharmaceuticals
95. Lyndra
96. Macrolide Pharmaceuticals
97. MarBiLeads
98. Matinas BioPharma
99. MedImmune
100. Meiji Sieka Pharma
101. Melinta Therapeutics
102. Merck
103. MerLion Pharmaceuticals
104. MethylGene
105. MGB Biopharma
106. Microbecide
107. MicuRx Pharmaceuticals
108. Mirati Therapeutics
109. Monash University
110. Morphochem
111. MorphoSys
112. Motif Bio
113. Mutabilis
114. Nabriva Therapeutics
115. Naicon
116. NanoSafe Coatings
117. Nanotherapeutics
118. Navigen Pharmaceuticals
119. Nemesis Bioscience
120. Nexgen Biosciences
121. Nobelex Biotech
122. Northeastern University
123. Northern Antibiotics
124. Nosopharm
125. NovaBiotics
126. NovaDigm Therapeutics
127. Novexel
128. NovoBiotic Pharmaceuticals
129. Nuprim
130. OJ-Bio
131. Optimer Biotechnology
132. Optimer Pharmaceuticals
133. Osel
134. Pacific Beach BioSciences
135. Par Pharmaceutical
136. Paratek Pharmaceuticals
137. Patheon
138. PENDOPHARM
139. Peninsula Pharmaceuticals
140. Peptilogics
141. Pfizer
142. Pherecydes Pharma
143. Phico Therapeutics
144. Polyphor
145. Procarta Biosystems
146. Pure Actives
147. RaQualia Pharma
148. Rebiotix
149. Redx Pharma
150. Rempex Pharmaceuticals
151. RexC Pharmaceuticals
152. Rib-X Pharmaceuticals
153. Roche
154. R-Pharm
155. RQx Pharmaceuticals
156. Rx3 Pharmaceuticals
157. Sanofi-Aventis
158. SciClone Pharmaceuticals
159. Sequella
160. Seres Therapeutics
161. SetLance
162. Shionogi
163. Shire
164. SinSa Labs
165. Specialised Therapeutics Australia
166. Spero Therapeutics
167. Sumitomo Dainippon Pharma (DSP)
168. Synamp Pharmaceuticals
170. Synthetic Biologics
171. TaiGen Biotechnology
172. Takeda Pharmaceutical
173. Talon Pharmaceuticals
174. Targanta Therapeutics
175. TAXIS Pharmaceuticals
176. TechnoPhage
177. Techulon
178. Tetraphase Pharmaceuticals
179. The Medicines Company
180. TheraBor Pharmaceuticals
181. Theravance Biopharma
182. Treat Systems
183. Trius Therapeutics
184. University of Michigan Life Sciences Institute
185. University of Pittsburgh
186. Vaxdyn
187. VenatoRx Pharmaceuticals
188. Versicor Pharmaceuticals
189. VibioSphen
190. Vicuron Pharmaceuticals
191. ViroPharma
192. Vitas Pharma
193. Vyome Biosciences
194. Wakunaga Pharmaceutical
195. Warner Chillcott
196. Wockhardt
197. Yamanouchi Pharmaceutical
198. Zavante Therapeutics


1. PREFACE
1.1. Chapter Overview
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Classification of Bacteria: Gram-Positive and Gram-Negative
3.3. Antibiotics: A Brief History
3.4. Antibiotics: Definition and Use
3.5. Classification of Antibiotics
3.5.1. Broad Spectrum versus Narrow Spectrum
3.5.2. Bactericidal versus Bacteriostatic
3.6. The Concept of Antibiotic Drug Resistance
3.7. History of Development of Antibiotic Drug Resistance
3.8. Evolution of Antibiotic Drug Resistance in Gram-Positive and Gram-Negative Bacteria
3.9. Key Antibacterial Agents and their Mechanism of Action
3.9.1. Cell Wall Synthesis
3.9.1.1. β-lactam based Antibiotics
3.9.1.2. Vancomycin
3.9.2. Cell Membrane Synthesis
3.9.2.1. Polymyxins
3.9.2.2. Bacteriocin
3.9.3. Protein Synthesis
3.9.3.1. Macrolides
3.9.3.2. Aminoglycosides
3.9.3.3. Tetracyclines
3.9.4. Nucleic Acid Synthesis
3.9.4.1. DNA Gyrase: Quinolones
3.9.4.2. RNA Polymerase: Rifampin
3.9.4.3. Folate synthesis: Sulfonamides And Trimethoprim
3.10. Antibiotic-Resistant Bacteria: ESKAPE Pathogens
3.11. Antibiotic-Resistant Bacteria: Urgent, Serious and Concerning Threats
3.11.1. Urgent Threat Bacteria
3.11.2. Serious Threat Bacteria
3.11.3. Concerning Threat Bacteria
3.12. Antibiotic Drug Resistance: Geographical Spread
3.13. Antibiotic Drug Resistance: Government Initiatives
4. ANTIBIOTIC DRUG RESISTANCE: DEVELOPMENT PIPELINE AND MARKET LANDSCAPE
4.1. Chapter Overview
4.2. New Generation Antibiotics: Development Pipeline
4.2.1 Distribution by Phase of Development
4.2.2 Distribution by Spectrum of Activity
4.2.3 Distribution by Urgent Threat
4.2.4 Distribution by Activity against ESKAPE Pathogen
4.2.5 Geographical Distribution of Industry Stakeholders
4.3. Antibiotic Drug Resistance: Alternative Therapies
5. CLINICAL DEVELOPMENT ANALYSIS AND KEY COMPARATOR STUDIES
5.1. Clinical Development Analysis: Spectrum of Activity and Target Bacterial Pathogen
5.2. Clinical Development Analysis: Developer Landscape
5.3. Clinical Development Analysis: Distribution by Highest Phase of Development and Indication
5.4. Analysis on Active Comparator Trials
5.4.1. ABSSSIs: Active Comparator Trials
5.4.2. CAP: Active Comparator Trials
5.4.3. HAP / VAP: Active Comparator Trials
5.4.4. cUTIs: Active Comparator Trials
5.4.5. Gastrointestinal Infections (cIAIs and CDIs): Active Comparator Trials
5.4.6. Infections Caused by CREs: Active Comparator Trials
6. NEW GENERATION ANTIBIOTICS: MARKETED DRUGS
6.1. Chapter Overview
6.2. Telavancin (Vibativ®)
6.2.1. Drug Overview
6.2.2. Mechanism of Action
6.2.3. Drug Dosage and Administration
6.2.4. Historical Sales
6.2.5. Current Status of Development
6.2.6. Collaborations
6.3. Ceftaroline fosamil (Teflaro® / Zinforo)
6.3.1. Drug Overview
6.3.2. Mechanism of Action
6.3.3. Drug Dosage and Administration
6.3.4. Current Status of Development
6.3.5. Collaborations
6.4. Fidaxomicin (Dificid / Dificlir™)
6.4.1. Drug Overview
6.4.2. Mechanism of Action
6.4.3. Drug Dosage and Administration
6.4.4. Historical Sales
6.4.5. Current Status of Development
6.4.6. Collaborations
6.5. Ceftobiprole Medocaril (Zevtera® / Zeftera® / Mabelio®)
6.5.1. Drug Overview
6.5.2. Mechanism of Action
6.5.3. Drug Dosage and Administration
6.5.4. Current Status of Development
6.5.5. Collaborations
6.6. Dalbavancin (Dalvance® / Xydalba™)
6.6.1. Drug Overview
6.6.2. Mechanism of Action
6.6.3. Drug Dosage and Administration
6.6.4. Current Status of Development
6.6.5. Collaborations
6.7. Tedizolid Phosphate (Sivextro®)
6.7.1. Drug Overview
6.7.2. Mechanism of Action
6.7.3. Drug Dosage and Administration
6.7.4. Current Status of Development
6.7.5. Collaborations
6.8. Oritavancin (Orbactiv® / Nuvocid®)
6.8.1. Drug Overview
6.8.2. Mechanism of Action
6.8.3. Drug Dosage and Administration
6.8.4. Current Status of Development
6.8.5. Collaborations
6.9. Ceftolozane-Tazobactam (Zerbaxa®)
6.9.1. Drug Overview
6.9.2. Mechanism of Action
6.9.3. Dosage and Administration
6.9.4. Current Status of Development
6.9.5. Historical Sales
6.9.6. Collaborations
6.10. Ceftazidime-Avibactam (Avycaz® / Zavicefta)
6.10.1. Drug Overview
6.10.2. Mechanism of Action
6.10.3. Drug Dosage and Administration
6.10.4. Current Status of Development
6.10.5. Collaborations
7. NEW GENERATION ANTIBIOTICS: PHASE III DRUGS
7.1. Chapter Overview
7.2. Cadazolid: Current Status and Key Developments
7.3. Carbavance: Current Status and Key Developments
7.4. Cefilavancin: Current Status and Key Developments
7.5. CEM-102: Current Status and Key Developments
7.6. Delafloxacin: Current Status and Key Developments
7.7. Eravacycline: Current Status and Key Developments
7.8. Iclaprim: Current Status and Key Developments
7.9. Lefamulin: Current Status and Key Developments
7.10. Omadacycline: Current Status and Key Developments
7.11. Plazomicin: Current Status and Key Developments
7.12. Relebactam (Imipenem plus Cilastatin): Current Status and Key Developments
7.13. S-649266: Current Status and Key Developments
7.14. Sarecycline: Current Status and Key Developments
7.15. Solithromycin: Current Status and Key Developments
7.16. Zabofloxacin: Current Status and Key Developments
8. EMERGING THERAPIES TO COMBAT ANTIBIOTIC RESISTANCE
8.1. Chapter Overview
8.2. Teixobactin
8.2.1. Overview
8.2.2. Mechanism of Action
8.3. Antimicrobial Peptides
8.3.1. Overview
8.3.2. Classification of Antimicrobial Peptides
8.3.3. Mechanism of Action
8.3.4. Ctriporin: A Novel Antimicrobial Peptide
8.4. Antisense Antibacterials
8.4.1. Overview
8.4.2. Mechanism of Action
8.4.3. RNAP: Novel Target for Antisense Antibacterials
8.5. Quorum Sensing
8.5.1. Overview
8.5.2. Mechanism of Action
8.5.3. Inhibition of Quorum Sensing
8.6. Nano-Metals
8.6.1. Overview
8.6.2. Mechanism of Action
8.7. Restoration of β-Lactam Activity in MRSA
8.7.1. Overview
8.7.2. Mechanism of Action
8.8. Anti-Biofilm Agents
8.8.1. Overview
8.8.2. Mechanism of Action
9. KEY THERAPEUTIC AREAS
9.1. Chapter Overview
9.2. Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
9.2.1. Disease Description
9.2.2. Epidemiology
9.2.3. Current Treatment Plans
9.2.4. ABSSSI: Approved Dosage Regimens
9.3. Clostridium difficile Infections (CDI)
9.3.1. Disease Description
9.3.2. Epidemiology
9.3.3. Current Treatment Plans
9.3.4. CDI: Approved Dosage Regimens
9.4. Complicated Intra-Abdominal Infections (cIAIs)
9.4.1. Disease Description
9.4.2. Epidemiology
9.4.3. Current Treatment Plans
9.4.4. cIAI: Approved Dosage Regimens
9.5. Complicated Urinary Tract Infections (cUTIs)
9.5.1. Disease Description
9.5.2. Epidemiology
9.5.3. Current Treatment Plans
9.5.4. cUTI: Approved Dosage Regimens
9.6. Hospital-acquired / Ventilator-acquired / Community-acquired Pneumonia (HAP / VAP / CAP)
9.6.1. Disease Description
9.6.2. Epidemiology
9.6.3. Current Treatment Plans
9.6.4. HAP / CAP / VAP: Approved Dosage Regimens
10. MARKET FORECAST AND OPPORTUNITY ANALYSIS
10.1. Chapter Overview
10.2. Forecast Methodology
10.3. New Generation Antibiotics Market: Key Assumptions
10.4. Overall New Generation Antibiotics Market, 2016-2026
10.4.1. New Generation Antibiotics Market, 2016-2026: Distribution by Disease Area
10.4.1.1. New Generation Antibiotics Market in CAP, 2016-2026
10.4.1.2. New Generation Antibiotics Market in ABSSSIs, 2016-2026
10.4.1.3. New Generation Antibiotics Market in cUTIs, 2016-2026
10.4.1.4. New Generation Antibiotics Market in HAP / VAP, 2016-2026
10.4.1.5. New Generation Antibiotics Market in cIAIs, 2016-2026
10.4.1.6. New Generation Antibiotics Market in CDIs, 2016-2026
11. CONCLUSION
11.1. Antibiotic Drug Resistance: An Impending Threat to Global Healthcare
11.2. Novel Antibiotic Classes with Innovative Mechanisms of Action Are Currently Being Investigated
11.3. An Active Support from Regional Governments has Encouraged Clinical Development
11.4. Highly Potent Strains of MDR Bacteria have Evolved to Cause Potentially Life Threatening Diseases
12. INTERVIEW TRANSCRIPTS
12.1. Chapter Overview
12.2. Interview Transcript 1: Dr. Marilyn Bruno, CEO, Aequor
12.3. Interview Transcript 2: Dr. Mike Dawson, CEO, Cantab Anti-infectives
12.4. Interview Transcript 3: Dr. Kristin Thompson, Business Development Manager, Da Volterra
12.5. Interview Transcript 4: Dr. Deborah A O'Neil, CEO & CSO, NovaBiotics
12.6. Interview Transcript 5: Elhan Webb, CFA, Morphochem
13. APPENDIX 1: TABULATED DATA
14. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS 
LIST OF FIGURES
Figure 3.1 Patients with High Risk of Infection
Figure 3.2 Key Milestones for Emergence of Antibiotic Resistance
Figure 3.3 Antibiotics: Important Targets and Drug Classes
Figure 3.4 Sulfonamides and Trimethoprim: Target Enzymes in the Folic Acid Metabolic Pathway
Figure 3.5 Antibiotic-Resistant Bacteria: Urgent, Serious and Concerning Threats
Figure 4.1 New Generation Antibiotics Development Pipeline: Distribution by Phase of Development
Figure 4.2 New Generation Antibiotics Development Pipeline: Distribution by Spectrum of Activity
Figure 4.3 New Generation Antibiotics Development Pipeline: Distribution by Activity against Urgent Threats
Figure 4.4 New Generation Antibiotics Development Pipeline: Distribution by Type of Urgent Threat Bacteria Targeted
Figure 4.5 New Generation Antibiotics Development Pipeline: Distribution by Activity against ESKAPE Pathogens
Figure 4.6 New Generation Antibiotics: Geographical Distribution of Key Industrial Players
Figure 5.1 New Generation Antibiotics: Grid Analysis, Distribution by Target Bacterial Pathogen, Spectrum of Activity and Phase of Development
Figure 5.2 New Generation Antibiotics: Landscape Analysis, Distribution by Developer and Phase of Development
Figure 5.3 New Generation Antibiotics: Bull’s Eye Analysis, Distribution by Highest Phase of Development and Indication
Figure 5.4 ABSSSI: Active Comparator Trials
Figure 5.5 CAP: Active Comparator Trials
Figure 5.6 HAP / VAP: Active Comparator Trials
Figure 5.7 cUTI: Active Comparator Trials
Figure 5.8 Gastrointestinal Infections (CDIs and cIAIs): Active Comparator Trials
Figure 5.9 Infections Caused by CRE: Active Comparator Trials
Figure 8.1 Antimicrobial Peptides: Mechanisms of Action
Figure 8.2 Antisense Antibacterials: Mechanism of Action
Figure 8.3 The Process of Quorum Sensing
Figure 8.4 Quorum Sensing Inhibition: Mechanism of Action
Figure 8.5 Nanotechnology in Healthcare: Applications
Figure 8.6 Nano-Metals as Antibacterial Agents: Mechanism of Action
Figure 8.7 β-lactamase Mediated Antibiotic Resistance in MRSA
Figure 8.8 Restoration of β-lactam Activity in MRSA
Figure 8.9 Natural Anti-Biofilm Agents
Figure 9.1 cIAI: Clinical Symptoms
Figure 9.2 Pathophysiology of cUTI
Figure 10.1 New Generation Antibiotics Market, 2016-2026, Base Scenario (USD Billion)
Figure 10.2 New Generation Antibiotics Market (USD Billion): Distribution by Disease Area, 2026
Figure 10.3 CAP: New Generation Antibiotics Market, Base Scenario (USD Million), 2016, 2021, 2026
Figure 10.4 ABSSSI: New Generation Antibiotics Market, Base Scenario (USD Million), 2016, 2021, 2026
Figure 10.5 cUTI: New Generation Antibiotics Market, Base Scenario (USD Million), 2016, 2021, 2026
Figure 10.6 HAP / VAP: New Generation Antibiotics Market, Base Scenario (USD Million), 2016, 2021, 2026
Figure 10.7 cIAI: New Generation Antibiotics Market, Base Scenario (USD Million), 2016, 2021, 2026
Figure 10.8 CDI: New Generation Antibiotics Market, Base Scenario (USD Million), 2016, 2021, 2026
LIST OF TABLES
Table 3.1 Gram-Positive and Gram-Negative Bacteria: Key Differences
Table 3.2 Antibiotics: Common Instances of Misuse
Table 3.3 ESKAPE Pathogens: Hospital-Acquired Infections
Table 3.4 Urgent Threat Bacteria: Epidemiology of Infectious Agents
Table 3.5 Serious Threat Bacteria: Epidemiology of Infectious Agents
Table 3.6 Concerning Threat Bacteria: Epidemiology of Infectious Agents
Table 3.7 Projects Funded by BARDA for Antibiotic Development
Table 4.1 New Generation Antibiotics Development Pipeline: Infections Caused by Gram-Positive Bacteria
Table 4.2 New Generation Antibiotics Development Pipeline: Infections Caused by Gram-Negative Bacteria
Table 4.3 New Generation Antibiotics Development Pipeline: Infections Caused by Gram-Negative / Positive Bacteria
Table 4.4 New Generation Antibiotics Development Pipeline: Alternative Therapies
Table 6.1 New Generation Antibiotics: Approved Drugs (2010 onwards)
Table 6.2 Telavancin: Dosage Regimen
Table 6.3 Telavancin: Current Status of Development
Table 6.4 Telavancin: Current Product Development Partners
Table 6.5 Telavancin: Recent Collaborations
Table 6.6 Ceftaroline Fosamil: Dosage Regimen
Table 6.7 Ceftaroline Fosamil: Current Status of Development
Table 6.8 Ceftaroline Fosamil: Current Product Development Partners
Table 6.9 Ceftaroline Fosamil: Recent Collaborations
Table 6.10 Fidaxomicin: Dosage Regimen
Table 6.11 Fidaxomicin: Current Status of Development
Table 6.12 Fidaxomicin: Current Product Development Partners
Table 6.13 Fidaxomicin: Recent Collaborations
Table 6.14 Ceftobiprole Medocaril: Dosage Regimen
Table 6.15 Ceftobiprole Medocaril: Current Status of Development
Table 6.16 Ceftobiprole Medocaril: Current Product Development Partners
Table 6.17 Ceftobiprole Medocaril: Recent Collaborations
Table 6.18 Dalbavancin: Dosage Regimen
Table 6.19 Dalbavancin: Current Status of Development
Table 6.20 Dalbavancin: Current Product Development Partners
Table 6.21 Dalbavancin: Recent Collaborations
Table 6.22 Tedizolid Phosphate: Dosage Regimen
Table 6.23 Tedizolid Phosphate: Current Status of Development
Table 6.24 Tedizolid Phosphate: Current Product Development Partners
Table 6.25 Tedizolid Phosphate: Recent Collaborations
Table 6.26 Oritavancin: Dosage Regimen
Table 6.27 Oritavancin: Current Status of Development
Table 6.28 Oritavancin: Current Product Development Partners
Table 6.29 Oritavancin: Recent Collaborations
Table 6.30 Ceftolozane-Tazobactam: Dosage Adjustments
Table 6.31 Ceftolozane-Tazobactam: Dosage Regimen
Table 6.32 Ceftolozane-Tazobactam: Current Status of Development
Table 6.33 Ceftolozane-Tazobactam: Current Product Development Partners
Table 6.34 Ceftolozane-Tazobactam: Recent Collaborations
Table 6.35 Ceftazidime-Avibactam: Dosage Adjustments
Table 6.36 Ceftazidime-Avibactam: Dosage Administration
Table 6.37 Ceftazidime-Avibactam: Current Status of Development
Table 6.38 Ceftizidime-Avibactam: Current Product Development Partners
Table 6.39 Ceftazidime-Avibactam: Recent Collaborations
Table 7.1 New Generation Antibiotics: Phase III Drugs
Table 7.2 Drug Profile: Cadazolid
Table 7.3 Drug Profile: Carbavance®
Table 7.4 Drug Profile: Cefilavancin
Table 7.5 Drug Profile: CEM-102
Table 7.6 Drug Profile: Delafloxacin
Table 7.7 Drug Profile: Eravacycline
Table 7.8 Drug Profile: Iclaprim
Table 7.9 Drug Profile: Lefamulin
Table 7.10 Drug Profile: Omadacycline
Table 7.11 Drug Profile: Plazomicin
Table 7.12 Drug Profile: Relebactam (Imipenem plus Cilastatin)
Table 7.13 Drug Profile: S-649266
Table 7.14 Drug Profile: Sarecycline
Table 7.15 Drug Profile: Solithromycin
Table 7.16 Drug Profile: Zabofloxacin
Table 8.1 Nano-Metals as Antimicrobial Agents: Mechanism of Action
Table 9.1 Key Indications and Causative Pathogen
Table 9.2 ABSSSI: Dosage Regimen for Approved Drugs
Table 9.3 CDI: Dosage Regimen for Approved Drugs
Table 9.4 cIAI: Current Treatment Plans
Table 9.5 cIAI: Dosage Regimen for Approved Drugs
Table 9.6 cUTI: Dosage Regimen for Approved Drugs
Table 9.7 HAP / CAP / VAP: Dosage Regimen for Approved Drugs
Table 10.1 New Generation Antibiotics Market: List of Forecasted Molecules (Approved / Phase III / Phase II)
Table 10.2 Key Resistant Bacterial Infections : Estimated Market Growth Rate
Table 10.3 Key Resistant Bacterial Infections: Estimated Penetration (By 2026)
Table 10.4 Previous Generation Popular Antibiotics: Sales (USD Million)
Table 15.1 New Generation Antibiotics Development Pipeline: Distribution by Phase of Development
Table 15.2 New Generation Antibiotics Development Pipeline: Distribution by Activity against ESKAPE Pathogens
Table 15.3 New Generation Antibiotics Development Pipeline: Distribution by Activity against Urgent Threats
Table 15.4 New Generation Antibiotics Development Pipeline: Distribution by Type of Urgent Threat Bacteria Targeted
Table 15.5 New Generation Antibiotics Market, 2016-2026, Base Case (USD Billion)
Table 15.6 New Generation Antibiotics Market, 2016-2026, Optimistic Case (USD Billion)
Table 15.7 New Generation Antibiotics Market, 2016-2026, Conservative Case (USD Billion)
Table 15.8 New Generation Antibiotics Market (USD Million): Distribution by Disease Area, 2026
Table 15.9 CAP: New Generation Antibiotics Market (USD Million), Base Case 2016, 2021, 2026
Table 15.10 CAP: New Generation Antibiotics Market (USD Million), Optimistic Case 2016, 2021, 2026
Table 15.11 CAP: New Generation Antibiotics Market (USD Million), Conservative Case 2016, 2021, 2026
Table 15.12 ABSSSI: New Generation Antibiotics Market (USD Million), Base Case 2016, 2021, 2026
Table 15.13 ABSSSI: New Generation Antibiotics Market (USD Million), Optimistic Case 2016, 2021, 2026
Table 15.14 ABSSS: New Generation Antibiotics Market (USD Million), Conservative Case 2016, 2021, 2026
Table 15.15 cUTI: New Generation Antibiotics Market (USD Million), Base Case 2016, 2021, 2026
Table 15.16 cUTI: New Generation Antibiotics Market (USD Million), Optimistic Case 2016, 2021, 2026
Table 15.17 cUTI: New Generation Antibiotics Market (USD Million), Conservative Case 2016, 2021, 2026
Table 15.18 HAP / VAP: New Generation Antibiotics Market (USD Million), Base Case 2016, 2021, 2026
Table 15.19 HAP / VAP: New Generation Antibiotics Market (USD Million), Optimistic Case 2016, 2021, 2026
Table 15.20 HAP / VAP: New Generation Antibiotics Market (USD Million), Conservative Case 2016, 2021, 2026
Table 15.21 cIAI: New Generation Antibiotics Market (USD Million), Base Case 2016, 2021, 2026
Table 15.22 cIAI: New Generation Antibiotics Market (USD Million), Optimistic Case 2016, 2021, 2026
Table 15.23 cIAI: New Generation Antibiotics Market (USD Million), Conservative Case 2016, 2021, 2026
Table 15.24 CDI: New Generation Antibiotics Market (USD Million), Base Case 2016, 2021, 2026
Table 15.25 CDI: New Generation Antibiotics Market (USD Million), Optimistic Case 2016, 2021, 2026
Table 15.26 CDI: New Generation Antibiotics Market (USD Million), Conservative Case 2016, 2021, 2026
Table 15.27 New Generation Antibiotics Market Summary, 2016, 2021, 2026 (USD Million)

Download our eBook: How to Succeed Using Market Research

Learn how to effectively navigate the market research process to help guide your organization on the journey to success.

Download eBook

Share this report