Antibiotics: The Quest for New Super Drugs: Technologies, Markets, Competitors and Opportunities: 2017-2022 Analysis and Forecasts

  • ID: 4330304
  • Report
  • Region: Global
  • 299 Pages
  • Amadee & Company, Inc
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FEATURED COMPANIES

  • Achaogen Inc
  • Basilea Pharmaceutica AG
  • Dong Wha Pharmaceuticals
  • Insmed Incorporated
  • Osel Inc
  • Rebiotix, Inc
  • MORE

Antibiotics are drugs used to treat infections that are caused by bacteria. The introduction of antibiotics is recognized as one of the most transformative events in medicine. Prior to the introduction of the first antibiotics in the 1930s and 1940s, bacterial infections were often fatal, and invasive surgery was accompanied by a high risk of infectious complications.

Today, antibiotics are used routinely to treat and prevent infection. However, drug- and multi-drug-resistant bacterial strains pose a serious threat in the clinical setting as they directly contribute to an increase in morbidity and mortality, as compared to the underlying disease itself. Due to antibiotic resistance, new antibiotic super drugs are desperately needed to fight infections like MRSA, CRE, ESBLs and C. difficile. And that is beyond dealing with diseases like drug-resistant Gonorrhea, which affects an estimated 78 million people globally, or TB, which affects 10 million people worldwide, or even the 1 million+ people in the U.S. who get hospitalized with Pneumonia annually. Or bioweapons like Anthrax. Unfortunately, it is hard to discover new antibiotics.

Further compounding the problem, from approximately 20 traditional pharmaceutical companies investing in antibiotic research in the 1980s, there are now only five with significant active internal research programs. As a result, most novel antibiotic development is now being conducted by small biotech companies. Over the last few years there has been a growing realization among the various stakeholders (Industry players, governments, authorities and medical charities) that something needs to be done to address the issues impacting antibiotic R&D, and avoid the looming socio-economic burden of antimicrobial resistance. Current antibiotics work now, for the most part. But if an epidemic of one of the multi-drug-resistant strains rapidly spreading across the globe happens, it will be too late to start funding the discovery of new antibiotics. The need to invest is now, so there are options when the inevitable next black death appears. This report addresses these issues.

Specifically, it provides:

  • Antibiotics Overview.
  • Quest for Super Antibiotic Drugs.
  • Antibiotics Market.
  • Company Profiles.
  • In addition to 37 company profiles, the report contains 14 tables and 62 figures.
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2 of 4

FEATURED COMPANIES

  • Achaogen Inc
  • Basilea Pharmaceutica AG
  • Dong Wha Pharmaceuticals
  • Insmed Incorporated
  • Osel Inc
  • Rebiotix, Inc
  • MORE

1. Introduction

Report Objectives
Methodology and Sources
Statistical Notes

2. Antibiotics Overview

Bacteria Taxonomy
Microbes in Context
Antibiotics Definition
Quest for Super Drugs
Soil Microbes
Antibiotic Categories
Gram-Positive vs. Gram-Negative Bacteria
Static vs. Cidal
Susceptibility, Potency and MIC
Bactericidal Antibiotics
Breakpoint
Efficacy and Safety
Mechanisms of Action
Antibiotic Resistance
Resistance Is Nothing New
Costs of Antibiotic Resistance
Treatment Guidelines
Antibiotic Overuse
ESKAPE
Most Common Infections
Antibiotic Resistance Prevention
National Action Plan for Combating Antibiotic Resistant Bacteria
BARDA and NIAID Budgets
Presidential Advisory Council
United Kingdom Review on Antimicrobial Resistance
Margolis Center for Health Policy
GAIN Act
21st Century Cures Act
MRSA on the Decline
CRE Poses an Urgent Threat
Failure Rate High
Global Problem
U.S. Cases
Carbapenems Use Increasing
ESBLs Pose a Serious Threat
New Delhi Metallo-Beta-Lactamase
Clostridium difficile
Few New Antibiotics Being Produced
Low NPV
Cost of Trials
New Antibiotics Hard to Discover
iChip
Five Pharma Companies Left
Development Now Done by Startups
Numerous Studies on Situation
Disaster Planning
Path Forward
Alternative Is Unimaginable

3. Quest For Super Antibiotic Drugs

Discovery Platform Has Collapsed
New Antibiotic Discovery Process
Rationally Improve Existing Antibiotics
Rediscover Old Antibiotics
Repurpose Old Drugs
Discover Untested New Chemical Diversity
Community for Open Antimicrobial Drug Discovery
Target-Based Approaches
Long Time-Lower Success Rates
Focus for New Antibiotic Drugs Well Established
Dearth of New Antibiotic Drug Classes
R&D Development and Commercial Challenges
Modest Performance of New Antibiotics
Few Big Players Remain
New Key Initiatives
Growing Wave of Activity in Antibiotics
Activity Mostly Led by Biotechs
Renewed Enthusiasm
Antibiotics in Late Clinical Development
Obtaining Investments for New Antibiotics Is Difficult
Startups Believe They Can Find New Antibiotics
Antibiotics Approved in Recent Years
Stewardship
New Antibiotics That Have Received Marketing Authorization
Disappointing Sales Post-Launch
Generic Competition
Beta-lactamases, Cephalosporinase and Carbapenemase Inhibitors
New Cephalosporins
New Aminoglycosides
New Pleuromutilins
New Tetracyclines
New Macrolides
New Fluoroquinolones and DNA Gyrase Inhibitors
New Oxazolidinones
New Fatty Acid Biosynthesis Inhibitors
New Folate Biosynthesis Inhibitors
Defensin-Mimetic Peptides
Other Classes
Old Antibiotics with New Dosing
Ramoplanin
Fusidane
Fosfomycin
Early-Stage Molecules
Analogs of Existing Classes Still Difficult to Develop
New Oral Antibiotics for Outpatients Urgently Needed
New Oral Antibiotics for Children Urgently Needed
Government Incentives Needed
Options Market for Antibiotics
Antibiotics Prize

4. Antibiotics Market

Antibiotics Production Value
Production Value by Class
Quinolones
Cephalosporins
Marcolides
Penicillins
Carbapenems
Tetracyclines
Sulfonamides
Aminoglycosides
Other Antibiotics
Production by Region
Consumption Volume Data
Antibiotic Market Volume
Consumption by Country
Class Differences by Country
Inappropriate Use
Public Health Issues
Applications
Anti-MRSA Antibiotics
Cubicin
Zyvox
Teflaro
Tygacil
Vibativ
Dalvance
Other
Community Acquired Bacterial Pneumonia
Healthcare-Associated Infections Decreasing
Medicare Part D
Competitive Environment
Large Pharma Exits Antibiotics
Biotech Enters Antibiotics
Antibiotic Deal Making
Competitors
Market Shares
Antibiotic Supply Chains
India and China Antibiotic Supply Chains
Antibiotic Pollution Issues
Chinese Companies
North China Pharmaceutical Group
CSPC Pharmaceutical Group/Inner Mongolia Changsheng Pharmaceuticals
Sinopharm WeiQida
Shandong Lukang Pharmaceuticals
Harbin Pharmaceutical Group
Tonglian Group
United Laboratories
Indian Companies
Aurobindo
Mylan Laboratories Ltd.
Dr Reddy’s
Hetero Drugs Ltd.
Orchid Pharmaceuticals

5. Company Profiles

Achaogen Inc - (Company Overview, CRE, Plazomicin, Trials, EPIC, CARE, Launch, QIDP Designation, BARDA, Pipeline, C-Scape, LpxC, P. aeruginosa, Antibacterial Monoclonal Antibodies, Other Monoclonal Antibody Programs, Intellectual Property, Competition, Financial)
Actelion Ltd.  - (Company Overview)
AstaZeneca plc - (Company Overview, Small Molecule Unit)
Atox Bio - (Company Overview)
Basilea Pharmaceutica AG - (Company Overview, Ceftobiprole)
Cempra Inc - (Company Overview, Solithromycin, Applications, BARDA, Fusidic Acid, ABSSSI)
CrystalGenomics, Inc. - (Company Overview, CG400549)
Cubist Pharmaceuticals, Inc. - (Company Overview, Sivextro)
Destiny Pharma Ltd. - (Company Overview, Pipeline)
Dong Wha Pharmaceuticals  - (Company Overview)
Durata Therapeutics, Inc. - (Company Overview)
Eisai Co., Ltd. - (Company Overview)
Furiex Pharmaceuticals, Inc. - (Company Overview)
GlaxoSmithKline, Plc.  - (Company Overview, Gepotidacin)
Grupo Ferrer Internacional S.A. - (Company Overview, Ozenoxacin)
Insmed Incorporated  - (Company Overview, ARIKAYCE, Approvals, Patent, INS1007)
KaloBios Pharmaceuticals, Inc. - (Company Overview, Technology, KB001-A)
Melinta Therapeutics, Inc. - (Company Overview, Baxdela)
Merck & Co., Inc. - (Company Overview, Cubicin, Primaxin, Zerbaxa, Sivextro, MK-7655A, Acute Care Position)
MerLion Pharmaceuticals Pte Ltd - (Company Overview, Finafloxacin, MRSA, Intraabdominal Infections, Chronic Obstructive Pulmonary Disease, Cystic Fibrosis, Other Hospital and Critical Care Infections, Helicobacter pylori)
MicuRx Pharmaceuticals, Inc.  - (Company Overview)
Nabriva Therapeutics AG - (Company Overview, Lefamulin, BC-7013)
Osel Inc - (Company Overview, LACTIN-V, CBM588)
Novartis AG - (Company Overview, Sandoz, Antibiotics)
Otonomy, Inc. - (Company Overview)
Otsuka Pharmaceutical Co. Ltd. - (Company Overview, Tuberculosis Effects More Than 10 Million, Delamanid, Bedaquiline)
Paratek Pharmaceuticals, Inc. - (Company Overview)
Pfizer Inc - (Company Overview, AstraZeneca Acquisition, Antibiotics, Tygacil)
Polyphor Ltd. - (Company Overview, Technology, Murepavadin, Roche Collaboration)
Rebiotix, Inc. - (Company Overview, RBX2660)
Roche Holding AG - (Company Overview, Antibiotics, OP0595)
Savara Pharmaceuticals - (Company Overview)
Sequella, Incorporated - (Company Overview, Available Markets)
Seres Therapeutics, Inc. - (Company Overview, SER-109)
Summit, plc - (Company Overview)
TaiGen Biotechnology Co., Ltd. - (Company Overview, Taigexyn®)
Tetraphase Pharmaceuticals, Inc. - (Company Overview, Eravacycline, TP-271, TP-6076, QIDP, Licensed from Harvard, BARDA)
The Medicines Company  - (Company Overview, Infectious Disease Business, Meropenem-Vaborbactam, MINOCIN®, ORBACTIV®, R&D)
Theravance Biopharma Inc - (Company Overview, VIBATIV, Competition)

Appendix 1: Antibiotic Classes
Aminoglycosides
ß-Lactams
ß-Lactam Resistance
Penicillins
Carbapenems
Cephalosporins
Fluoroquinolones
Lipoglycopeptides
Lipopeptides
Oxazolidinones
Macrolides
Tetracyclines

Appendix 2: Regulation
Food, Drug, and Cosmetic Act
Approval Process
Preclinical Studies
Clinical Trials
Marketing Approval
Foreign Clinical Trials
Approval Letter
Special FDA Expedited Review and Approval Programs
Breakthrough Therapy
Post-Approval Requirements
Section 505(b)(2)
Qualified Infectious Disease Product Exclusivity

List of Tables
1. Microbes Vs. Humans by Factor
2. Characteristics of Antibiotics by Class
3. Antibiotics Currently in Clinical Development: March 2017
4. Global Antibiotics Market ($ Million): 2017-2022
5. Global Antibiotics Market by Class ($ Million): 2017-2022
6. Global Antibiotics Production in U.S., EU, Rest of World ($ Million): 2017-2022
7. MRSA Cases, I.V. MRSA Treatment Days, U.S. Market for Anti-MRSA Antibiotics by Drug and Producer ($ Million): 2017-2022
8. 10 Most Common Antibiotics Prescribed to Medicare Part D Beneficiaries (Million Claims, $ Million): 2013
9. 222 Companies Producing or Doing R&D on Antibiotics, Headquarters Country and Website: 2017
10. Antibiotics Production and Market Shares by Company ($ Million, %): 2016
11. Achaogen Inc Income Statement ($ Thousand): 2012-2016
12. AstraZeneca’s Small Molecule Antibiotic Products
13. Merck Revenue by Segment and Products ($ Million): 2016
14 Pfizer Anti-Infective U.S. and Non-U.S. Sales by Product ($ Million): 2013-2020
15. Classes of Antibiotics by Type and Generic, Brand, Target, MOA, Formulation, AE

List of Figures
1. Living Organism Taxonomy
2. Taxonomy of E. coli
3. Gram Staining and Cell Wall Composition
4. Bacteriostatic vs. Bactericidal Antibiotics
5. Time-Dependent vs. Concentration-Dependent Bactericidal Effects
6. Antibiotic Mechanisms of Action
7. Publications Citing Antibiotic Resistance (Number): 1987-2015
8. Antibiotic Mechanisms of Resistance
9. Costs of the Five Most Common Hospital-Acquired Infections (HAIs in the U.S. ($ Billion)
10. Bacterial Infections by Pathogen Species, by CDC Threat Level (Urgent, Serious, Concerning), by Infections/Year (Number), by Drug-Resistant Infections (Number), by Lethal Infections (Number), by MDR Infections (Number), by G+/G-
11. Percentage of Staphylococcus Aureus Isolates That Are Methicillin Resistant (MRSA by Country: 2011-2014
12. Percentage of Carbapenem-Resistant Klebsiella Pneumoniae by Country: 2011-2014
13. Percentage of Extended-Spectrum Beta-Lactamase Producing Escherichia Coli by Country: 2011-2014
14. Spread of New Delhi Metallo-Beta-Lactamase-1: First Detection
15. Different Approaches to Discover New Antibiotics
16. Examples of Rediscovered Antibiotics
17. Approved or Late-Stage Clinical Antibiotics That Do Not Obey Drug-Like Rules for Oral Availability
18. Approved or Late-Stage Clinical Antibiotics with Undesirable Chemical Functional Groups
19. The CO-ADD Screening Workflow
20. Target-Based Antibiotics
21. Typical Antibiotic Drug Development Pathway
22. Top Antibiotic Resistance Threats Categorized by Level of Concern
23. New Classes of Antibiotics Discovered by Decade (Number): 1890s-2010s
24. Generations of Approved Antibiotics
25. Antibiotic New Molecular Entity Drugs Launched Worldwide (Number): 1980-2015
26. Past and Forecast Performance of Six Recently Launched Antibiotic Drugs ($ Million): 2014-2022
27. M&A and Pharma R&D Departure for the Antibiotic Space (Deal Count Number): 1995-2015
28. Key Antibiotic Initiatives: 2010-2014
29. U.S. Antibiotic Initiatives and Their Value Chain Targets
30. European Antibiotic Initiatives and Their Value Chain Targets
31. Other Antibiotic Initiatives and Their Value Chain Targets
32. U.S. Venture Capital Raised for Infectious Disease Companies by Novel R&D and Drug Improvement R&D ($ Million, Number of Companies Funded): 2007-2016
33. Biotech M&A Deals by Therapeutic Area (%): 2013-2015
34. Developers of Clinical Stage Antibiotics by Type (%): 2016
35. Venture Capital Antibiotic Startup Investments: 2016
36. Big Pharma Renewed Interest in Antibiotics: 2016
37. Product Launches: New Antibiotics vs. Other Brands ($ Million): Two years Post-Launch
38. Global Antibiotic Consumption by Class (Standard Units): 2000-2010
39. Antibiotics Consumption Per Person and Growth Rate of Antibiotic Drug Consumption (Standard Units): 2000-2010
40. Antibiotics Consumption by Class in the U.S., France, Germany, China, India, UK (Standard Units): 2000-2010
41. Peak Month for Antibiotic Consumption and Correlation Between Consumption and Its 12 Month Harmonic: 2000-2010
42. U. S. Hospital Discharges for Pneumonia (Number): 1993-2011
43. Macrolide Market Opportunity: 2017
44. CABP Antibiotic Retail RXs by Class, Number and Brand: 2016
45. Small Group Writes a Disproportionate Share of AZ and LEVO CABP Prescriptions
46. 80,000 Prescribers are Responsible for 60% of TRx Volume
47. Cumulative Sales of Selected IV Antibiotics Post Launch ($ Million
48. Global Antibiotic Supply Chain
49. China and India Antibiotic Supply Chain
50. Zhuhai United Laboratories, NCPC, Shandong Lukang, CPSC Zhongnuo, Harbin Pharmaceutical Supply Chains
51. Aurobindo Supply Chain
52. Orchid Pharmaceuticals and Mylan Supply Chains
53. Achaogen Product Offering
54. Plazomicin Trials
55. Achaogen Products Pipeline
56. Cempra Portfolio
57. Solithromycin Range of Indications
58. Binding of Lefamulin to the PTC
59. Nabriva Product Candidates and the Status of Development.
60. Otonomy Product and Product Candidate Pipeline
61. OTIVIDEX Commercial Opportunity in U.S.
62. OTIPRIO Commercial Opportunity in U.S.

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  • Achaogen Inc
  • Actelion Ltd.
  • AstaZeneca plc
  • Atox Bio
  • Basilea Pharmaceutica AG
  • Cempra Inc
  • CrystalGenomics, Inc.
  • Cubist Pharmaceuticals, Inc.
  • Destiny Pharma Ltd.
  • Dong Wha Pharmaceuticals
  • Durata Therapeutics, Inc.
  • Eisai Co., Ltd.
  • Furiex Pharmaceuticals, Inc.
  • GlaxoSmithKline, Plc.
  • Grupo Ferrer Internacional S.A.
  • Insmed Incorporated
  • KaloBios Pharmaceuticals, Inc.
  • Melinta Therapeutics, Inc.
  • Merck & Co., Inc
  • MerLion Pharmaceuticals Pte Ltd
  • MicuRx Pharmaceuticals, Inc.
  • Nabriva Therapeutics AG
  • Novartis AG
  • Osel Inc
  • Otonomy, Inc
  • Otsuka Pharmaceutical Co. Ltd.
  • Paratek Pharmaceuticals, Inc.
  • Pfizer Inc
  • Polyphor Ltd.
  • Rebiotix, Inc
  • Roche Holding AG
  • Savara Pharmaceuticals
  • Sequella, Incorporated
  • Seres Therapeutics, Inc.
  • Summit, plc
  • TaiGen Biotechnology Co., Ltd.
  • Tetraphase Pharmaceuticals, Inc
  • The Medicines Company
  • Theravance Biopharma Inc
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5 of 4
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