Antibacterial Drugs:
World Industry and Market Prospects
2014-2024

©notice
This material is copyright by visiongain. It i...
Contents
1. Executive Summary
1.1 Overview of Findings
1.2 Structure of the Report
1.3 Research and Analysis Methods

2. I...
Contents
3. Antibacterial Drugs: World Market, 2014-2024
3.1 Antibacterials Revenues Plateau between 2009 and 2013
3.1.1 A...
Contents
4.5.1 Continued Growth in the Emerging Markets, Revenue Forecast 2014-2024
4.6 Zinnat/Ceftin – GSK’s Established ...
Contents
5.5 Augmentin – Blockbuster Facing Generic Competition
5.5.1 Augmentin Recalled in Asian and Middle Eastern Marke...
Contents
6.4.3 Inhaled Fluoroquinolone Formulations
6.5 Fluoroquinolone Market Forecast 2014-2024
6.6 Avelox
6.6.1 Safety ...
Contents
7. Macrolide Market Forecast, 2014-2024
7.1 Macrolide Market in 2012-2013
7.2 Changing Market Share for Macrolide...
Contents
8.2 Changing Market Share for Carbapenems, 2014-2024
8.3 Carbapenem Market Forecast, 2014-2024
8.4 Trends in the ...
Contents
9.4.1 New Oxazolidinones Will Drive Growth
9.4.2 New Drug Classes to Drive Submarket Growth to 2023
9.5 Zyvox – T...
Contents
9.11 Sirturo – A New Option for Multi-Drug Resistant TB
9.11.1 Chronic Treatment Schedule and Emerging Demand Dri...
Contents
10.4.4 Incidence of Upper Respiratory Tract Infections in National Markets – Europe Leads the
Way
10.5 Antibacter...
Contents
10.12.2 Sustained Expansion of the Indian Market, Forecast 2014-2024
10.13 Brazilian Antibacterial Market to Doub...
Contents
11.4.3 MK-7655 and Invanz – A Novel β-Lactamase Combination
11.4.4 Omadacycline – Another Phase III Ready Partner...
Contents
12. Qualitative Analysis of the Antibacterials Market, 2014
12.1 SWOT Analysis: Strengths, Weaknesses, Opportunit...
Contents
12.17.1 Therapeutic Success in European Clinical Trials
12.17.2 Poor Primary End Points in FDA Guidelines
12.18 R...
Contents
13.2.3 Focussing on the Domestic US Market
13.2.4 Anionic Activity Opens up Possibilities in treating cUTIs and c...
Contents
List of Tables
Table 1.1 Currency Exchange Rate to USD
Table 2.1 Common Bacterial Infections and Their Causes, 20...
Contents
Table 4.10 Zinnat/Ceftin Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024
Table 4.11 Meiact Foreca...
Contents
Table 6.2 Fluoroquinolone Market by Product: Revenue ($bn) and Market Share (%), 2013
Table 6.3 Fluoroquinolone M...
Contents
Table 7.10 Dificid Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024
Table 7.11 Solithromycin Forec...
Contents
Table 9.10 Tygacil Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024
Table 9.11 TOBI/TOBI Podhaler ...
Contents
Table 10.12 Italian Antibacterial Drugs Market: Revenue Forecast ($bn), Annual Growth (%),
CAGR (%), 2014-2024
Ta...
Contents
Table 12.1 Social, Technological, Economic, and Political Factors Affecting the Antibacterial
Drug Market, 2014-2...
Contents
List of Figures
Figure 2.1 Leading Causes of Infectious Disease Deaths Worldwide, 2010
Figure 2.2 Key Events in t...
Contents
Figure 4.10 Meiact Forecast: Revenue ($bn), 2014-2024
Figure 4.11 Flomox Forecast: Revenue ($bn), 2014-2024
Figur...
Contents
Figure 6.9 Cipro/Ciprobay Forecast: Revenue ($bn), 2014-2024
Figure 6.10 Geninax Forecast: Revenue ($bn), 2014-20...
Contents
Figure 9.5 Zyvox Forecast: Revenue ($bn), 2014-2024
Figure 9.6 Cubicin Forecast: Revenue ($bn), 2014-2024
Figure ...
Contents
Figure 10.12 Japanese Antibacterial Drugs Market: Revenue Forecast ($bn), 2014-2024
Figure 10.13 South Korean Ant...
Contents
Organisations Mentioned in this Report
Abbott
AbbVie
Achaogen
ACS Dobfar
Actavis
Actelion Pharmaceuticals
Aeras
A...
Contents
AstraZeneca
Aurobindo Pharma
Barr Pharmaceuticals
Basilea Pharmaceutica
Bayer
Biomax Biotechnics
Biomedical Advan...
Contents
Cubist Pharmaceuticals
Curetis
Daiichi Sankyo
Dainippon Sumitomo
Destiny Pharma
Discuva
Dr. Reddy’s Laboratories
...
Contents
GlycoVaxyn
Guangdong BeiKang
Hetero
Hi Tech Pharma
Hikma Pharmaceuticals
Hospira
Indian Ministry of Health and Fa...
Contents
Medsintez
Meiji Seika Pharma
Melinta Therapeutics
Merck & Co.
MerLion Pharmaceuticals
Microlabs
MicuRx Pharmaceut...
Contents
Orchid Healthcare
Paratek Pharmaceuticals
Pearl Therapeutics
Pfizer
Phico Therapeutics
Piramal Healthcare,
Plenus...
Contents
Sequella
Shanghai MengKe Pharmaceuticals
Shanghai Zhangjiang Biomedical Industry Venture Capital
Shionogi
Shire
S...
Contents
TTY Biopharma
Unichem Laboratories
University of Leicester
University of Michigan
US Department of Health
Valeant...
Antibacterial Drugs: World Industry
and Market Prospects 2014-2024
7.9 Solithromycin
Cempra Pharmaceutical’s solithromycin...
Antibacterial Drugs: World Industry
and Market Prospects 2014-2024
of Ketek look to solithromycin for the benefits of that...
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Transcript of "Antibacterial drugs world industry and market prospects 2014 2024"

  1. 1. Antibacterial Drugs: World Industry and Market Prospects 2014-2024 ©notice This material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of visiongain. You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each purchase and single copy is for personal use only.
  2. 2. Contents 1. Executive Summary 1.1 Overview of Findings 1.2 Structure of the Report 1.3 Research and Analysis Methods 2. Introduction to Antibacterials and Antibacterial Drugs 2.1 Bacterial Infections 2.1.1 How Bacteria Cause Infections 2.1.2 Classification of Bacteria 2.1.3 Types of Bacterial Infection 2.1.4 Leading Causative Bacterium 2.1.5 Incidence and Mortality Profiles for Common Bacterial Infection 2.2 Treating Infections 2.2.1 The History of Antibacterial Drug Development 2.2.2 Mechanisms of Action 2.2.3 Leading Classes of Antibacterial Compounds 2.2.3.1 Cephalosporins 2.2.3.2 Penicillins 2.2.3.3 Carbapenems 2.2.3.4 Fluoroquinolones 2.2.3.5 Macrolides 2.3 Antibacterial Drugs Resistance www.visiongain.com
  3. 3. Contents 3. Antibacterial Drugs: World Market, 2014-2024 3.1 Antibacterials Revenues Plateau between 2009 and 2013 3.1.1 Antibacterial Drugs - Market Segmentation 3.2 Antibacterial Market Forecast, 2014-2024: Decline in Revenues for Fluoroquinolones 3.2.1 Drivers and Restraints in the Antibacterial Market, 2014-2024 3.2.2 Generic Erosion and Prescription Control will Limit Market Growth 3.2.3 Changes in Sector Market Shares, 2014-2024 3.3 Pfizer is the Clear Leader in the Antibacterial Drugs Market 3.3.1 Pfizer Usurped by Cubist as the Leading Antibacterial Drug Manufacturer – Company Revenue Forecasts 2014-2024 3.3.2 Fragmented Market to Fracture Further 3.3.3 Leading Firms without Leading R&D Pipelines 4. Cephalosporin Market Forecast, 2014-2024 4.1 Cephalosporin Market 2012-2013 – No Dominant Brands 4.2 Late-Stage Cephalosporins to Gain Market Share Between 2014 and 2024 4.3 Basilea, Cubist, and Forest Labs to Lead Cephalosporin Market Between 2014 and 2024 4.3.1 Drivers and Restraints in the Cephalosporins Market, 2014-2024 4.3.2 Cephalosporins Lack Market Exclusivity 4.3.3 Strong Pipeline for Novel Cephalosporins 4.4 Rocephin (Roche) – The Only Treatment for Gonorrhoea in the US 4.4.1 Off Patent but not Forgotten 4.4.2 Declining Revenues Owing to Competition - Forecast 2014-2024 4.5 Sulperazon – India’s Leading Treatment for RTIs and UTIs www.visiongain.com
  4. 4. Contents 4.5.1 Continued Growth in the Emerging Markets, Revenue Forecast 2014-2024 4.6 Zinnat/Ceftin – GSK’s Established Cephalosporin 4.6.1 Continued Decline in Revenue - Forecast 2014-2024 4.7 Meiact – A Broad Range Community Antibiotic 4.7.1 Minor Spectracef Sales in the US Leads to Pass the Product 4.7.2 Competition in Japan to Hinder Growth – Revenue Forecast 2014-2024 4.8 Flomox - Shionogi’s Third-Generation Cephalosporin 4.8.1 Patent Issues and Litigation 4.8.2 Genericisation and Safety to Restrict Sales - Forecast 2014-2024 4.9 Zinforo/Teflaro (Ceftaroline Fosamil): The First of the Fifth-Generation Cephalosporins 4.9.1 Unmet Needs in Pneumonia to Drive Growth - Revenue Forecast 2014-2024 4.10 Zeftera (Ceftobiprole): Approved for Pneumonia in Europe 4.10.1 Future Sales Dictated by US Approval - Revenue Forecast 2014-2024 4.11 CXA-201 (Ceftrolozane-Tazobactam): The Next Blockbuster Antibacterial 4.11.1 Broad Label and Spectrum of Activity Leads to Rapid Uptake - Revenue Forecast 20142024 4.12 CAZ-AVI (Ceftazidime-Avibactam): Forest Labs to Enter the Market on Phase II Data 4.12.1 Competition from CXA-201 to Limit Sales - Forecast 2014-2024 5. Penicillin Market Forecast, 2014-2024 5.1 Generics and Augmenting Dominate the Penicillins Market in 2012 and 2013 5.2 Augmentin to lose its Dominance over the Coming 10 Years - Market Shares for Penicillin Drugs, 2014-2024 5.3 Penicillin Antibacterials: Market Forecast 2014-2024 5.4 Drivers and Restraints on the Penicillin Market 2014-2024 www.visiongain.com
  5. 5. Contents 5.5 Augmentin – Blockbuster Facing Generic Competition 5.5.1 Augmentin Recalled in Asian and Middle Eastern Markets 5.5.2 Stable Revenues in Spite of Generic Competition 5.5.3 Revenue Forecast 2014-2024 5.6 Zosyn/Tazocin (Piperacillin-Tazobactam) - Pneumonia Therapeutic 5.6.1 Patent Expiry and Revenue Extension for Pfizer 5.6.2 Historic and Current Revenue Performance 5.6.3 Revenue Forecast 2014-2024 5.7 Unasyn – Gram-negative and Positive Antibiotic 5.7.1 Consistently Falling Revenues - Forecast 2014-2024 5.8 Amoxil (Amoxicillin) – A Historic Antibacterial Brand 5.8.1 Marginal Decline in Revenue - Forecast 2014-2024 5.9 Generic Amoxicillin 5.9.1 Revenue Forecast 2014-2024 5.10 Generic Amoxicillin-Clavulanic Acid 5.10.1 Revenue Forecast 2014-2024 6. Fluoroquinolone Market Forecast, 2014-2024 6.1 The Fluoroquinolone Market 2012-2013 6.2 Changing Market Share for Fluoroquinolone Antibacterials 2014-2024 6.3 Fluoroquinolone Antibacterial Drugs: Market Forecast 2014-2024 6.4 Trends in the Fluoroquinolone Market 6.4.1 Safety Fears for Fluoroquinolones 6.4.2 Avelox Patent Cliff www.visiongain.com
  6. 6. Contents 6.4.3 Inhaled Fluoroquinolone Formulations 6.5 Fluoroquinolone Market Forecast 2014-2024 6.6 Avelox 6.6.1 Safety Profile Hampers Sales 6.6.2 Generic Competition 6.6.3 Revenue Forecast 2014-2024 6.7 Cravit and Levaquin 6.7.1 Generic Competition Affecting Revenue Worldwide 6.7.2 Lifecycle Management for Cravit and Levaquin 6.7.3 Revenue Forecast 2014-2024 6.8 Vigamox 6.8.1 Branded and Generic Challenges 2009-2012 6.8.2 Moxeza: A Next-Generation Form of Vigamox 6.8.3 Revenue Forecast 2014-2024 6.9 Cirpodex and Cipro – Two Preparations of Ciprofloxacin 6.9.1 Ciprodex: A Second-Generation Ophthalmic Antibiotic 6.9.1.1 Revenue Forecast 2014-2024 6.9.2 Cipro Revenue Forecast 2013-2023: Continued Generic Erosion 6.10 Geninax 6.10.1 Revenue Forecast 2014-2024 6.11 Delafloxacin 6.11.1 Revenue Forecast 2014-2024 www.visiongain.com
  7. 7. Contents 7. Macrolide Market Forecast, 2014-2024 7.1 Macrolide Market in 2012-2013 7.2 Changing Market Share for Macrolides, 2014-2024 7.3 Macrolide Antibacterials: Market Forecast 2014-2024 7.4 Trends in the Macrolide Market 7.5 Biaxin/Clarith 7.5.1 Revenue 2012-2013 7.5.2 Lifecycle Management for Continued Market Presence 7.5.3 Revenue Forecast 2014-2024 7.6 Zithromax 7.6.1 Concerns Over Safety and Marketing in the US 7.6.2 Effectiveness in Drug-Resistant Strains 7.6.3 Revenue Forecast 2014-2024 7.7 Dalacin 7.7.1 Revenue Forecast 2014-2024 7.8 Dificid 7.8.1 Rapid Uptake Slowed by High Cost 7.8.2 New Approvals and Expanded Indications 7.8.3 Revenue Forecast 2014-2024 7.9 Solithromycin 7.9.1 Revenue Forecast 2014-2024 8. Carbapenem Market Forecast, 2014-2024 8.1 Carbapenem Market 2012-2013 www.visiongain.com
  8. 8. Contents 8.2 Changing Market Share for Carbapenems, 2014-2024 8.3 Carbapenem Market Forecast, 2014-2024 8.4 Trends in the Carbapenem Market 8.4.1 Rising Prevalence of Carbapenemases and β-Lactamases 8.4.2 No New Carbapenems in Late-Stage Trials 8.5 Merrem/Meropenem 8.5.1 Generics Affecting Revenue Worldwide 8.5.2 Revenue Forecast 2014-2024 8.6 Primaxin 8.6.1 Combination Therapy for Lifecycle Management 8.6.2 Historic and Current Revenues 8.6.3 Revenue Forecast 2014-2024 8.7 Invanz 8.7.1 Revenue Forecast 2014-2024 8.8 Doribax 8.8.1 Doribax in HAP and VAP 8.8.2 Lifecycle Management in Japan and the Rest of the World 8.8.3 Revenue Forecast 2014-2024 9. Other Antibiotic Drugs: Forecast, 2014-2024 9.1 The Market for Other Classes of Antibacterial Drugs 9.2 Changing Market Share for Fluoroquinolone Antibacterials 2014-2024 9.3 Other Antibacterials: Market Forecast, 2014-2024 9.4 Trends in the Other Classes of Antibacterial Drugs www.visiongain.com
  9. 9. Contents 9.4.1 New Oxazolidinones Will Drive Growth 9.4.2 New Drug Classes to Drive Submarket Growth to 2023 9.5 Zyvox – The Market Leading Antibacterial 9.5.1 MRSA Activity Driving Revenue Growth 9.5.2 Promise in Tuberculosis and Anthrax 9.5.3 Patents, Litigation, and Competition – When and Who Will Produce Generic Linezolid? 9.5.4 Flat Growth to Patent Expiry, Revenue Forecast 2014-2024 9.6 Cubicin – The Leading Brand for ABSSSIs 9.6.1 Revenue Boosted by Approvals Worldwide 9.6.2 Patents, Litigation and Deals – How Long Will Market Exclusivity Last? 9.6.3 Sustained Growth through to 2017, Revenue Forecast 2014-2024 9.7 Tygacil – A Tetracycline With Many Approved Indications 9.7.1 Concerns Limiting Revenue Potential 9.7.2 Competition from Safer Novel Therapies Restricts Growth, Revenue Forecast 2014-2024 9.8 TOBI/TOBI Podhaler – The Market Leading Inhaler for Cystic Fibrosis 9.8.1 Historic and Current Revenue Performance 9.8.2 Approvals and Launches in New Markets to Drive Revenue Growth 9.8.3 Competition to Limit Long-term Growth, Revenue Forecast 2014-2024 9.9 Solodyn – A Treatment for Severe Acne 9.9.1 Generic Competition and Lifecycle Management 9.9.2 Limited Potential for Dermatology, Revenue Forecast 2014-2024 9.10 Vibativ – Limited Potential for Novel Lipoglycopeptide 9.10.1 Astellas Ends its Collaboration with Theravance 9.10.2 Limited HAP Label in the US - Revenue Forecast 2014-2024 www.visiongain.com
  10. 10. Contents 9.11 Sirturo – A New Option for Multi-Drug Resistant TB 9.11.1 Chronic Treatment Schedule and Emerging Demand Drive Revenue Growth, Revenue Forecast 2014-2024 9.12 Tedizolid – Market Leading Follow-on to Zyvox? 9.12.1 Competition Increasing: Revenue Forecast 2014-2024 9.13 Oritavancin – An Antibiotic With a Novel PK Profile 9.13.1 Single Dose Differentiation to Deliver Market Share, Revenue Forecast 2014-2024 9.14 Dalbavancin – Competing in a Crowded Indication 9.14.1 Sustained Growth Over the Coming 10 Years, Revenue Forecast 2014-2024 9.15 Surotomycin – Cubist’s Second Treatment for C. difficile 9.15.1 Delayed Launch to Limit Potential, Revenue Forecast 2014-2024 9.16 Nemonoxacin – Taiwan’s Global Antibacterial Drug 9.16.1 Slow Initial Growth to Accelerate with US Approval, Revenue Forecast 2014-2024 10. The Leading National Markets, 2014-2024 10.1 The US and China Dominate the Global Antibacterial Market, But For Different Reasons 10.2 Above-Average Growth in US: Regional Forecasts, 2014-2024 10.3 China to Slump in Market Share, While Brazil and India Push on 10.4 Incidence of Infection by Country, 2013 10.4.1 Incidence of Pneumonia in National Markets – Pneumonia Predominant in America 10.4.2 Incidence of Community Acquired Urinary Tract Infections in National Markets – High Incidence Rate in the UK, US, and Spain 10.4.3 Incidence of Bacterial Skin and Skin Structure Infections in National Markets – Massive Potential in the US www.visiongain.com
  11. 11. Contents 10.4.4 Incidence of Upper Respiratory Tract Infections in National Markets – Europe Leads the Way 10.5 Antibacterial Drug Consumption by Nation, 2013 10.5.1 Antibacterial Drug Consumption in the Major National Markets 10.5.2 Antibacterial Drug Consumption in Minor National Markets 10.6 The Antibacterials Market in the US 10.6.1 The Continued Dominance of the US Market 10.7 The European Union the Second Largest Regional Market 10.7.1 Marginal Expansion in Antibacterial Spending – Market Forecast 2014-2024 10.7.2 Action to Encourage Antibacterial Drug Development in the EU 10.7.3 Italians Continue to Lead the Way in Antibiotic Use 10.7.4 The French Fascination with Expensive Antibacterial Drugs 10.7.5 Germany – Europe’s Antibiotic Steward 10.7.6 The Rising Use of Antibacterials Drugs Within the UK 10.7.7 Spanish Antibacterial Market to Grow Between 2018 and 2024 10.8 Japan – Still the Third Largest National Market 10.8.1 The Pause Before Growth in the Japanese Market 10.9 Will South Korea Continue Its High Use of Antibiotics? 10.10 BRIC Nation Sales Still Expanding – Market Forecast 2014-2024 10.11 Chinese Antibacterial Market Bloated by Reported Overuse 10.11.1 Developing Antibacterials in China, for China 10.11.2 Government Controls Subdue Recent Growth – Market Forecast 2014-2024 10.12 Indian Market to Expand by 50% Over the Coming Decade 10.12.1 Restricting Antibiotic Use in India www.visiongain.com
  12. 12. Contents 10.12.2 Sustained Expansion of the Indian Market, Forecast 2014-2024 10.13 Brazilian Antibacterial Market to Double in Size 10.13.1 Brazilian Market to Be Driven by Drug Resistance 10.14 Russia, TB Explosion to Drive Growth - Forecast 2014-2024 11. The Antibacterial Drug R&D Pipeline in 2014 11.1 Gram-Positive vs. Gram-Negative 11.2 A Pipeline Dominated by Small Molecule Drugs 11.3 Leading Phase III Pipeline Candidates Treatments 11.3.1 Ceftolozane-Tazobactam – Future Gram-Negative Blockbuster 11.3.2 Ceftazidime-Avibactam – Skipping Phase III Trials 11.3.3 Surotomycin – Broad C. difficile Treatment to Reduce Relapse 11.3.4 Tedizolid – More Potent Than Zyvox with Fewer Doses? 11.3.5 Oritavancin – Differentiated by Dosing 11.3.6 Delafloxacin – A Leading pH Activated, Broad Spectrum Fluoroquinolone 11.3.7 Dalbavancin – A Pharmacoeconomic Proposition 11.3.8 Solithromycin – A Fluroketolide Without the Side-Effects 11.3.9 Finafloxacin – A Second pH Activated Fluoroquinolone with Broad Spectrum Activity 11.3.10 Eravacyline – Treating Gram-Negative cUTIs and cIAIs 11.3.11 Plazomicin – Straight to PIII in Carbapenem Resistant Infections 11.3.12 Cadazolid: Largest PIII C. Difficile Trial 11.4 Leading Phase II Antibacterial Drug Candidates 11.4.1 AZD5847: An Oxazolidinone for TB 11.4.2 Avarofloxacin is Still Waiting for a Partner www.visiongain.com
  13. 13. Contents 11.4.3 MK-7655 and Invanz – A Novel β-Lactamase Combination 11.4.4 Omadacycline – Another Phase III Ready Partnership 11.4.5 Radezolid – On Melinta’s Back-Burner for Now 11.4.6 AFN-1252: Highly Specific S. Aureus Antibacterial 11.4.7 Sutezolid – Sequella Looking to Combine TB Treatments 11.4.8 Taksta (Fusidic acid) – Cempra’s Second Pipeline Candidate 11.4.9 TD-1792 – A Russian Antibacterial 11.4.10 Brilacidin – A Novel Peptide Antibacterial Agent 11.4.11 POL7080 – Polyphor and Roche in Multi-Million Dollar Deal 11.4.12 BC-3781- Unique Mechanism of Action at 23S? 11.5 Inhaled Antibiotics – Advantages in Lung Infections 11.5.1 Cayston: Competition for Novartis? 11.5.2 ARIKACE – Targeting P. aeruginosa 11.5.3 Aeroquin – Better than Podhaler? 11.5.4 BAYQ3939 – Cystic Fibrosis? Not Anymore 11.5.5 NKTR-061: Targeting Intubated Pneumonia 11.5.6 Pulmaquin: A Second Ciprofloxacin Candidate 11.5.7 AeroVanc Targets MRSA Infections 11.5.8 Inhaled Amikacin-Fosfomycin – Adjunctive Therapy for VAP 11.6 Biologics – Truly Novel Antibacterial Therapeutics 11.6.1 MK-3415A: First Antibacterial mAb to the Market? 11.6.2 KB001A – The Leading Antibody Against P. aeruginosa 11.6.3 Aridis Pharmaceuticals: Targeting P. aeruginosa and S. aureus 11.6.4 MEDI4893 - Early Stage mAb to S. Aureus www.visiongain.com
  14. 14. Contents 12. Qualitative Analysis of the Antibacterials Market, 2014 12.1 SWOT Analysis: Strengths, Weaknesses, Opportunities, and Threats within the Antibacterial Drug Market 12.2 STEP Analysis: Social, Technological, Economic, and Political Factors Affecting the Antibacterial Drug Industry and Market 12.2.1 Social Factors 12.2.2 Technological Developments 12.2.3 Economic Pressures 12.2.4 Political Issues 12.3 Market is Well Established and Demand will Remain Strong 12.4 High Prevalence of Infection Worldwide 12.5 Worldwide Demand for Antibacterials Drugs 12.6 Animal Models of Infection are Highly Predictive Compared with Other Therapeutic Areas 12.7 Cutting Into a Saturated Market 12.8 Superior Benefit over Generics? 12.9 Resistance – Nature’s Patent Expiry 12.10 Acute Treatment Limits Commercial Potential 12.11 Did Big Pharma Back Away from Antibacterial Drugs? 12.12 Resistance Will Continue to Present New Targets 12.13 First Biologic Antibacterials 12.14 Potential for Smaller Firms to Capitalise 12.15 Developing Preventative Vaccines Rather Than Treatments 12.16 Antibacterial Stewardship Reduces Usage 12.17 Clinical Confusion from Inconsistent Guidance Between Regulatory Bodies www.visiongain.com
  15. 15. Contents 12.17.1 Therapeutic Success in European Clinical Trials 12.17.2 Poor Primary End Points in FDA Guidelines 12.18 Reduction in Hospital Infection Rates - Reducing Demand for Antibacterial Drugs 12.19 Enticing Antibacterial Drug Discovery – Push and Pull Incentives 12.19.1 GAIN act: Post-Development Pull Incentives in the US 12.19.2 ADAPT – Building on the GAIN act 12.19.3 EMA Update Guideline – Streamlining Clinical Trials in the EU 12.19.4 Push Incentives for Antibacterial Drug Discovery with Public Funding 12.19.5 IMI: Public-Private Collaboration with GSK and AstraZeneca 12.19.6 Public Finance Pumping Money into Antibacterial Development 13. Research Interviews from Our Survey 13.1 Interview with Dr Vu Truong, Founder & CSO, Aridis Pharmaceuticals, United States 13.1.1 Opportunities for Antibacterial Monoclonal Antibodies 13.1.2 Positioning Monoclonal Antibacterials in the Clinic 13.1.3 Differentiating Factor for Biological Antibacterials 13.1.4 Hazard Pitfalls in Clinical Development 13.1.5 Trends in Antibacterial Drug Market – Novel Targets Rewarded 13.1.6 The Commercial Hazard of Acute Therapeutics 13.1.7 Progress from Government Incentives, But More to Come on the Manufacturing Side 13.1.8 Bacteriophages, Potentially Innovative Therapeutics 13.2 Interview with Lyn Baranowski and Sue Cammarata, Melinta Therapeutics, United States 13.2.1 Opportunities in Treating Skin Infections and Gonorrhoea 13.2.2 Superior Effect in Overweight Populations www.visiongain.com
  16. 16. Contents 13.2.3 Focussing on the Domestic US Market 13.2.4 Anionic Activity Opens up Possibilities in treating cUTIs and cIAIs 13.2.5 Superiority Means Uptake Won’t be Restricted 13.2.6 Clear Regulatory Guidance Clears Paths to Development 13.3 Interview with Tetraphase Pharmaceuticals 14. Antibacterial Drugs Market to 2024: Conclusions 14.1 Three Blockbuster Antibacterials in 2013, Leading Brands of 2013 14.2 The Leading Branded Antibacterial Drugs in 2024 14.3 Signs of Life in the Antibacterial Pipeline 14.4 Stemming the Tide of Antibacterial Drug Resistance 14.5 The Changing Face of Antibacterial Clinical Development Appendices About Visiongain’s Bespoke Research Service Appendix A: About Visiongain Appendix B: Visiongain Report Evaluation Form www.visiongain.com
  17. 17. Contents List of Tables Table 1.1 Currency Exchange Rate to USD Table 2.1 Common Bacterial Infections and Their Causes, 2014 Table 2.2 Details of the ESKAPE Bacteria, 2014 Table 2.3 Leading Causes of Infectious Diseases Deaths Worldwide, 2010 Table 2.4 Mechanisms of Action for Antibacterial Drugs, 2014 Table 3.1 Antibacterial Drugs: Historic Global Market Size ($bn), Annual Growth (%), and Four Year CAGR (%), 2009-2013 Table 3.2 Global Antibacterial Drug Market by Sector: Market Size ($bn) and Share (%), 2013 Table 3.3 Global Antibacterial Drugs Market: Revenue Forecasts by Sector ($bn), Biennial Growth (%), and CAGR, 2014-2024 Table 3.4 Antibacterial Drugs Market: Forecasted Sector Market Shares (%), 2014-2024 Table 3.5 Leading Branded Antibacterials Manufacturers: Revenues ($bn) and Market Shares (%), 2012-2013 Table 3.6 Leading Branded Antibacterial Manufacturers: Forecasted Revenues ($bn) and Market Shares (%), 2012-2024 Table 4.1 Leading Branded Cephalosporin Antibacterial Drugs: Important Facts Table 4.2 Cephalosporin Market by Product: Revenue ($bn) and Market Share (%), 2013 Table 4.3 Cephalosporin Market by Product: Revenue ($bn) and Market Share (%), 2018 Table 4.4 Cephalosporin Market by Product: Revenue ($bn) and Market Share (%), 2024 Table 4.5 Cephalosporin Market Forecast by Product: Revenue ($bn), Biennial Growth (%), CAGR (%), 2014-2024 Table 4.6 Cephalosporin Market Forecast by Product: Market Share (%), 2014-2024 Table 4.7 Rocephin Quarterly Revenue ($bn), 2012-2013 Table 4.8 Rocephin Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 4.9 Sulperazon Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 www.visiongain.com
  18. 18. Contents Table 4.10 Zinnat/Ceftin Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 4.11 Meiact Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 4.12 Flomox Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 4.13 Zinforo in-vitro Antibacterial Activity: Gram-positive and Gram-Negative Bacterium Table 4.14 Zinforo/Teflaro Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 4.15 Zeftera Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 4.16 Ceftrolozane-Tazobactam Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 4.17 Ceftazidime-Avibactam Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 5.1 Leading Branded Penicillin Drugs: Important Facts Table 5.2 Penicillin Market by Product: Revenue ($bn) and Market Share (%), 2013 Table 5.3 Penicillin Market by Product: Revenue ($bn) and Market Share (%), 2018 Table 5.4 Penicillin Market by Product: Revenue ($bn) and Market Share (%), 2024 Table 5.5 Penicillin Market Forecast by Product: Revenue ($bn), Biennial Growth (%), CAGR (%), 2014-2024 Table 5.6 Penicillin Market Forecast by Product: Market Share (%), 2014-2024 Table 5.7 Augmentin Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 5.8 Zosyn/Tazocin Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 5.9 Unasyn Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 5.10 Amoxil Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 5.11 Generic Amoxicillin Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 20142024 Table 5.12 Generic Amoxicillin-Clavulanic Acid Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 6.1 Leading Branded Fluoroquinolone Drugs: Important Facts www.visiongain.com
  19. 19. Contents Table 6.2 Fluoroquinolone Market by Product: Revenue ($bn) and Market Share (%), 2013 Table 6.3 Fluoroquinolone Market by Product: Revenue ($bn) and Market Share (%), 2018 Table 6.4 Fluoroquinolone Market by Product: Revenue ($bn) and Market Share (%), 2024 Table 6.5 Fluoroquinolone Market Forecast by Product: Revenue ($bn), Biennial Growth (%), CAGR (%), 2014-2024 Table 6.6 Fluoroquinolone Market Forecast by Product: Market Share (%), 2014-2024 Table 6.7 Global Patent Expiration Dates for Avelox Table 6.8 Avelox Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 6.9 Generic Manufacturers of Levofloxacin, 2014 Table 6.10 Cravit Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 6.11 Vigamox Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 6.12 Ciprodex Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 6.13 Cipro/Ciprobay Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 6.14 Geninax Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 6.15 Delafloxacin Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 7.1 Leading Branded Macrolides: Important Facts Table 7.2 Macrolide Market by Product: Revenue ($bn) and Market Share (%), 2013 Table 7.3 Macrolide Market by Product: Revenue ($bn) and Market Share (%), 2018 Table 7.4 Macrolide Market by Product: Revenue ($bn) and Market Share (%), 2024 Table 7.5 Macrolide Market Forecasts by Product: Revenues ($bn), Biennial Growth (%), CAGR (%), 2014-2024 Table 7.6 Macrolide Market Forecasts by Product: Market Shares (%), 2014-2024 Table 7.7 Biaxin/Clarith Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 7.8 Zithromax Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 7.9 Dalacin Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 www.visiongain.com
  20. 20. Contents Table 7.10 Dificid Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 7.11 Solithromycin Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 8.1 Leading Branded Carbapenems: Important Facts Table 8.2 Carbapenem Market by Product: Revenue ($bn) and Market Share (%), 2013 Table 8.3 Carbapenem Market by Product: Revenue ($bn) and Market Share (%), 2018 Table 8.4 Carbapenem Market by Product: Revenue ($bn) and Market Share (%), 2024 Table 8.5 Carbapenem Market Forecasts by Product: Revenues ($bn), Biennial Growth (%), CAGR (%), 2014-2024 Table 8.6 Carbapenem Market Forecast by Product: Market Share (%), 2014-2024 Table 8.7 Merrem Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 8.8 Primaxin Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 8.9 Invanz Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 8.10 Doribax Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 9.1 Other Leading Branded Antibacterials: Important Facts Table 9.2 Other Classes of Antibacterial Drugs by Product: Revenue ($bn) and Market Share (%), 2013 Table 9.3 Other Classes of Antibacterial Drugs by Product: Revenue ($bn) and Market Share (%), 2018 Table 9.4 Other Classes of Antibacterial Drugs by Product: Revenue ($bn) and Market Share (%), 2024 Table 9.5 Others Market Forecasts by Product: Revenues ($bn), Biennial Growth (%), CAGR (%), 2014-2024 Table 9.6 Others Market Forecast by Product: Market Share (%), 2014-2024 Table 9.7 Oxazolidinones in Mid to Late Stage Clinical Development, 2014 Table 9.8 Zyvox Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 9.9 Cubicin Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 www.visiongain.com
  21. 21. Contents Table 9.10 Tygacil Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 9.11 TOBI/TOBI Podhaler Forecast: Revenue ($bn), 2014-2024 Table 9.12 Solodyn Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 9.13 Vibativ Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 9.14 Sirturo Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 9.15 Tedizolid Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 9.16 Oritavancin Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 9.17 Dalbavancin Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 9.18 Surotomycin Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 9.19 Nemonoxacin Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 10.1 Antibacterial Drug Sales by National and Regional Markets: Market Size ($bn) and Share (%), 2013 Table 10.2 Antibacterial Drug Markets: National and Regional Market Sizes ($bn), Biennial Growth (%), and CAGR (%), 2012-2024 Table 10.3 Antibacterial Drug Markets: National and Regional Market Shares (%), 2012-2024 Table 10.4 Incidence of Pneumonia in National Markets, 2014 Table 10.5 Incidence of Community Acquired Urinary Tract Infections in National Markets, 2014 Table 10.6 Incidence of Bacterial Skin and Skin Structure Infections in National Markets, 2014 Table 10.7 Incidence of Upper Respiratory Tract Infections in National Markets, 2014 Table 10.8 Antibacterial Drug Consumption in the Major National Markets: DDD per capita per day and Absolute DDD per year, 2013 Table 10.9 Antibacterial Drug Consumption in the Smaller National Markets: DDD per capita per day and Absolute DDD per year, 2013 Table 10.10 US Antibacterial Drugs Market: Revenue Forecast ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 10.11 EU Antibacterial Drugs Market Overall and by Leading Country (EU5): Revenue Forecasts ($bn), Biennial Growth (%), CAGR (%), 2014-2024 www.visiongain.com
  22. 22. Contents Table 10.12 Italian Antibacterial Drugs Market: Revenue Forecast ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 10.13 French Antibacterial Drugs Market: Revenue Forecast ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 10.14 German Antibacterial Drugs Market: Revenue Forecast ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 10.15 UK Early Stage Antibacterial Drug Developers, 2014 Table 10.16 UK Antibacterial Drugs Market: Revenue Forecast ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 10.17 Spanish Antibacterial Drugs Market: Revenue Forecast ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 10.18 Japanese Antibacterial Drugs Market: Revenue Forecast ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 10.19 South Korean Antibacterial Drugs Market: Revenue Forecast ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 10.20 Antibacterial Drugs Market in BRIC Nations: National Revenue Forecasts ($bn), Biennial Growth (%), CAGR (%), 2014-2024 Table 10.21 Chinese Antibacterial Drugs Market: Revenue Forecast ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 10.22 Indian Antibacterial Drugs Market: Revenue Forecast ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 10.23 Brazilian Antibacterial Drugs Market: Revenue Forecast ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 10.24 Russian Antibacterial Drugs Market: Revenue Forecast ($bn), Annual Growth (%), CAGR (%), 2014-2024 Table 11.1 Small Molecule Antibacterial Drug in Phase III Development , 2014 Table 11.2 Small Molecule Antibacterial Drug in Phase II Development, 2014 Table 11.3 Inhaled Antibacterial Drug Formulations in Mid to Late Stage Clinical Development, 2014 Table 11.4 Biological Antibacterial Therapeutics in Clinical Development, 2014 www.visiongain.com
  23. 23. Contents Table 12.1 Social, Technological, Economic, and Political Factors Affecting the Antibacterial Drug Market, 2014-2024 Table 12.2 Antibacterial Therapies Granted QIDP Status by the FDA, Q3 2012 to Q1 2014 Table 12.3 Bacterial Related Funding for BARDA, 2011-2014 Table 14.1 World Antibacterial Drugs Market by Class: Revenues ($bn), Market Shares (%), CAGRs (%), 2012, 2013, 2018 and 2024 www.visiongain.com
  24. 24. Contents List of Figures Figure 2.1 Leading Causes of Infectious Disease Deaths Worldwide, 2010 Figure 2.2 Key Events in the History of Antibacterial Drug Development Figure 2.3 Structures for β-Lactam Based Antibacterial Compounds Figure 3.1 Historic Global Market Size ($bn) and Annual Growth (%) for Antibacterial Drugs, 2009-2013 Figure 3.2 Global Antibacterial Drug Market by Sector: Sector Market Share (%), 2013 Figure 3.3 Global Antibacterial Drugs Market: Forecasted Sector Revenues ($bn), 2014-2024 Figure 3.4 Antibacterial Drugs Market: Forecasted Sector Market Shares (%), 2018 Figure 3.5 Antibacterial Drugs Market: Forecasted Sector Market Shares (%), 2024 Figure 3.6 Ten Leading Branded Antibacterial Manufacturers: Revenues ($bn), 2013 Figure 3.7 Leading Branded Antibacterial Manufacturers: Forecasted Revenues ($bn), 20122024 Figure 3.8 Ten Leading Branded Antibacterials Manufacturers: Revenues ($bn), 2018 Figure 3.9 Ten Leading Branded Antibacterials Manufacturers: Revenues ($bn), 2024 Figure 4.1 Cephalosporin Market by Product: Market Share (%), 2013 Figure 4.2 Cephalosporin Market by Product: Market Share (%), 2018 Figure 4.3 Cephalosporin Market by Product: Market Share (%), 2024 Figure 4.4 Cephalosporin Market Forecast: Revenue ($bn), 2014-2024 Figure 4.5 Cephalosporin Market: Drivers and Restraints, 2014-2024 Figure 4.6 Rocephin Revenue ($bn), 2012-2013 Figure 4.7 Rocephin Forecast: Revenue ($bn), 2014-2024 Figure 4.8 Sulperazon Forecast: Revenue ($bn), 2014-2024 Figure 4.9 Zinnat/Ceftin Forecast: Revenue ($bn), 2014-2024 www.visiongain.com
  25. 25. Contents Figure 4.10 Meiact Forecast: Revenue ($bn), 2014-2024 Figure 4.11 Flomox Forecast: Revenue ($bn), 2014-2024 Figure 4.12 Zinforo/Teflaro Forecast: Revenue ($bn), 2014-2024 Figure 4.13 Zeftera Forecast: Revenue ($bn), 2014-2024 Figure 4.14 Ceftrolozane-Tazobactam Forecast: Revenue ($bn), 2014-2024 Figure 4.15 Ceftazidime-Avibactam Forecast: Revenue ($bn), 2014-2024 Figure 5.1 Penicillin Market by Product: Market Share (%), 2013 Figure 5.2 Penicillin Market by Product: Market Share (%), 2018 Figure 5.3 Penicillin Market by Product: Market Share (%), 2024 Figure 5.4 Penicillin Market Forecast: Revenue ($bn), 2014-2024 Figure 5.5 Augmentin Forecast: Revenue ($bn), 2014-2024 Figure 5.6 Zosyn/Tazocin Forecast: Revenue ($bn), 2014-2024 Figure 5.7 Unasyn Forecast: Revenue ($bn), 2014-2024 Figure 5.8 Amoxil Forecast: Revenue ($bn), 2014-2024 Figure 5.9 Generic Amoxicillin Forecast: Revenue ($bn), 2014-2024 Figure 5.10 Generic Amoxicillin-Clavulanic Acid Forecast: Revenue ($bn), 2014-2024 Figure 6.1 Fluoroquinolone Market by Product: Market Share (%), 2013 Figure 6.2 Fluoroquinolone Market by Product: Market Share (%), 2018 Figure 6.3 Fluoroquinolone Market by Product: Market Share (%), 2024 Figure 6.4 Fluoroquinolone Market Forecast: Revenue ($bn), 2014-2024 Figure 6.5 Avelox Forecast: Revenue ($bn), 2014-2024 Figure 6.6 Cravit Forecast: Revenue ($bn), 2014-2024 Figure 6.7 Vigamox Forecast: Revenue ($bn), 2014-2024 Figure 6.8 Ciprodex Forecast: Revenue ($bn), 2014-2024 www.visiongain.com
  26. 26. Contents Figure 6.9 Cipro/Ciprobay Forecast: Revenue ($bn), 2014-2024 Figure 6.10 Geninax Forecast: Revenue ($bn), 2014-2024 Figure 6.11 Delafloxacin Forecast: Revenue ($bn), 2014-2024 Figure 7.1 Macrolide Market by Product: Market Share (%), 2013 Figure 7.2 Macrolide Market by Product: Market Share (%), 2018 Figure 7.3 Macrolide Market by Product: Market Share (%), 2024 Figure 7.4 Macrolide Market Forecast: Revenue ($bn), 2014-2024 Figure 7.5 Biaxin/Clarith Forecast: Revenue ($bn), 2014-2024 Figure 7.6 Zithromax Forecast: Revenue ($bn), 2014-2024 Figure 7.7 Dalacin Forecast: Revenue ($bn), 2014-2024 Figure 7.8 Dificid Forecast: Revenue ($bn), 2014-2024 Figure 7.9 Solithromycin Forecast: Revenue ($bn), 2014-2024 Figure 8.1 Carbapenem Market by Product: Market Share (%), 2013 Figure 8.2 Carbapenem Market by Product: Market Share (%), 2018 Figure 8.3 Carbapenem Market by Product: Market Share (%), 2024 Figure 8.4 Carbapenem Market Forecast: Revenue ($bn), 2014-2024 Figure 8.5 Merrem Forecast: Revenue ($bn), 2014-2024 Figure 8.6 Primaxin Forecast: Revenue ($bn), 2014-2024 Figure 8.7 Invanz Forecast: Revenue ($bn), 2014-2024 Figure 8.8 Doribax Forecast: Revenue ($bn), 2014-2024 Figure 9.1 Other Classes of Antibacterial Drugs by Product: Market Share (%), 2013 Figure 9.2 Other Classes of Antibacterial Drugs by Product: Market Share (%), 2018 Figure 9.3 Other Classes of Antibacterial Drugs by Product: Market Share (%), 2024 Figure 9.4 Others Market Forecast by Product: Revenue ($bn), 2014-2024 www.visiongain.com
  27. 27. Contents Figure 9.5 Zyvox Forecast: Revenue ($bn), 2014-2024 Figure 9.6 Cubicin Forecast: Revenue ($bn), 2014-2024 Figure 9.7 Tygacil Forecast: Revenue ($bn), 2014-2024 Figure 9.8 TOBI/TOBI Podhaler Forecast: Revenue ($bn), 2014-2024 Figure 9.9 Solodyn Forecast: Revenue ($bn), 2014-2024 Figure 9.10 Vibativ Forecast: Revenue ($bn), 2014-2024 Figure 9.11 Sirturo Forecast: Revenue ($bn), 2014-2024 Figure 9.12 Tedizolid Forecast: Revenue ($bn), 2014-2024 Figure 9.13 Oritavancin Forecast: Revenue ($bn), 2014-2024 Figure 9.14 Dalbavancin Forecast: Revenue ($bn), 2014-2024 Figure 9.15 Surotomycin Forecast: Revenue ($bn), 2014-2024 Figure 9.16 Nemonoxacin Forecast: Revenue ($bn), 2014-2024 Figure 10.1 Antibacterial Drug Sales by National and Regional Markets: Market Share (%), 2013 Figure 10.2 Antibacterial Drug Market Forecasts: National and Regional Market Sizes ($bn), 2013-2024 Figure 10.3 Absolute Annual Antibacterial Drug Consumption by Nation, 2013 Figure 10.4 Per Capita Antibacterial Drug Consumption by Nation, 2013 Figure 10.5 US Antibacterial Drugs Market: Revenue Forecast ($bn), 2014-2024 Figure 10.6 EU Antibacterial Drugs Market by Leading Country (EU5): Revenue Forecasts ($bn), 2014-2024 Figure 10.7 Italian Antibacterial Drugs Market: Revenue Forecast ($bn), 2014-2024 Figure 10.8 French Antibacterial Drugs Market: Revenue Forecast ($bn), 2014-2024 Figure 10.9 German Antibacterial Drugs Market: Revenue Forecast ($bn), 2014-2024 Figure 10.10 UK Antibacterial Drugs Market: Revenue Forecast ($bn), 2014-2024 Figure 10.11 Spanish Antibacterial Drugs Market: Revenue Forecast ($bn), 2014-2024 www.visiongain.com
  28. 28. Contents Figure 10.12 Japanese Antibacterial Drugs Market: Revenue Forecast ($bn), 2014-2024 Figure 10.13 South Korean Antibacterial Drugs Market: Revenue Forecast ($bn), 2014-2024 Figure 10.14 Antibacterial Drugs Market in BRIC Nations: National Revenue Forecasts ($bn), 2014-2024 Figure 10.15 Chinese Antibacterial Drugs Market: Revenue Forecast ($bn), 2014-2024 Figure 10.16 Indian Antibacterial Drugs Market: Revenue Forecast ($bn), 2014-2024 Figure 10.17 Brazilian Antibacterial Drugs Market: Revenue Forecast ($bn), 2014-2024 Figure 10.18 Russian Antibacterial Drugs Market: Revenue Forecast ($bn), 2014-2024 Figure 12.1 Strengths and Weaknesses of the Antibacterial Drug Market, 2014-2024 Figure 12.2 Opportunities and Threats for the Antibacterial Drug Market, 2014-2024 Figure 12.3 Strategies and Technologies to Prevent Hospital Acquired Infections, 2014 www.visiongain.com
  29. 29. Contents Organisations Mentioned in this Report Abbott AbbVie Achaogen ACS Dobfar Actavis Actelion Pharmaceuticals Aeras Affinium Pharmaceuticals Alcon Alkem Laboratories Allied Pharma AmpliPhi Bioscience Apotex APP Pharmaceuticals Aptalis Pharma Aquapharm Biodiscovery Aradigm Aridis Pharmaceuticals Arsanis Biosciences Ascend Therapeutics Aspen Astellas Pharma www.visiongain.com
  30. 30. Contents AstraZeneca Aurobindo Pharma Barr Pharmaceuticals Basilea Pharmaceutica Bayer Biomax Biotechnics Biomedical Advanced Research and Development Authority Biomedical Advanced Research and Development Authority (BARDA) Brazilian National Health Surveillance Agency Cadila Healthcare Calixa Therapeutics Cardeas Pharma Cellceutix Cempra Pharmaceuticals Centers for Disease Control and Prevention (CDC) Chinese Ministry of Health Chiron Cipla Claris Lifesciences Clinigen Cornerstone Therapeutics Corona Remedies Critical Therapeutics www.visiongain.com
  31. 31. Contents Cubist Pharmaceuticals Curetis Daiichi Sankyo Dainippon Sumitomo Destiny Pharma Discuva Dr. Reddy’s Laboratories Duke University Durata Therapeutics Eli Lilly Emcure Pharmaceuticals Eros Pharma European Federation of Pharmaceutical Industries and Associations (EFPIA) European Medicines Agency (EMA) Fitch Ratings Agency Food and Drug Administration (US FDA) Forest Laboratories Fraunhofer-Gesellschaft Furiex Pharmaceuticals Gate Pharma Gilead Sciences GlaxoSmithKline (GSK) Glenmark Generics www.visiongain.com
  32. 32. Contents GlycoVaxyn Guangdong BeiKang Hetero Hi Tech Pharma Hikma Pharmaceuticals Hospira Indian Ministry of Health and Family Welfare Insmed Intercell Itochu Chemical Frontier Janssen Pharmaceutica Japanese Ministry of Health Labor and Welfare Johns Hopkins University School of Medicine Johnson & Johnson KaloBios Kenta Biotech Kuhnil Pharm Lupin Macleod Pharmaceuticals Medicines and Healthcare Products Regulatory Agency Medicis MedImmune Medison Pharma www.visiongain.com
  33. 33. Contents Medsintez Meiji Seika Pharma Melinta Therapeutics Merck & Co. MerLion Pharmaceuticals Microlabs MicuRx Pharmaceuticals Ministry of Health, Labour and Welfare (MHLW, Japan) Mpex Pharmaceuticals Mylan Nabriva Therapeutics Nalneva National Institute for Health and Clinical Excellence National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH) Neiss Labs Nektar Therapeutics Nichi-Iko Pharmaceuticals Nipro Pharma Novacta Biosystems Novartis Novexel Optimer Pharmaceuticals www.visiongain.com
  34. 34. Contents Orchid Healthcare Paratek Pharmaceuticals Pearl Therapeutics Pfizer Phico Therapeutics Piramal Healthcare, Plenus Pharmaceuticals Pliva Polyphor Procarta Biosystems Procter & Gamble Ranbaxy Labs Redx Pharma Roche Roxane R-Pharma RQx Pharmaceutical Sagent Pharmaceuticals Sandoz Sanofi Sanofi Pasteur Savara Pharmaceuticals Sawai Pharmaceutical www.visiongain.com
  35. 35. Contents Sequella Shanghai MengKe Pharmaceuticals Shanghai Zhangjiang Biomedical Industry Venture Capital Shionogi Shire Sidmak Labs Sistema Nacional de Gerenciamento de Produtos Controlados Solitaire Pharmacia Specialised Therapeutics Sunovion Pharma TaiGen Biotechnology Taisho Pharmaceuticals Taiyo Yakuhin Takeda TAP Holdings Targanta Therapeutics Tedec-Meiji Farma Tetraphase Pharmaceuticals Teva Pharmaceutical Industries The Medicines Company Theravance Torrent Pharmaceuticals Trius Therapeutics www.visiongain.com
  36. 36. Contents TTY Biopharma Unichem Laboratories University of Leicester University of Michigan US Department of Health Valeant Pharmaceuticals Vansen Pharma Vicuron ViroPharma Warner Chilcott Watson Wockhardt World Health Organization (WHO) Zhejiang Medicine Company Zuelig Pharma Zydus Pharmaceuticals www.visiongain.com
  37. 37. Antibacterial Drugs: World Industry and Market Prospects 2014-2024 7.9 Solithromycin Cempra Pharmaceutical’s solithromycin is the only new macrolide antibiotic in phase II or III trials identified by visiongain. The drug is fluoroketolide, a new class of macrolide that has shown greater activity against macrolide-susceptible bacteria than currently marketed macrolides in pre-clinical models. The drug is similar to the original fluoroketolide, Ketek (telithromycin), though problems associated with off-target effects have been great reduced according to Cempra. Telithromycin contains a pyridine moiety. This moiety has reportedly been shown to affect cholinergic receptors on some nerves. This is likely to be responsible for apparent potential side-effects on the liver, prolonger QTc interval, and visual disturbances. Solithromycin does not contain this moiety and does not produce inhibition of the same cholinergic receptor, and is not predicted to have the same off target adverse effects. The drug is potent in treating bacterial infections that have become resistant to Zithromax; with a mechanism of action that involves the bind of three sites on the bacterial ribosome (other macrolide compounds only bind two sites). The drug can be administered orally or intravenously, and has completed phase II trials in CAP, in which the drug compared favourably in terms of safety and efficacy to levofloxacin. In June 2012, a phase II trial of solithromycin in gonorrhoea was also conducted in 22 patients. Results from this single dose clinical trial demonstrated cleared infection in all subjects; no plans have been announced for a PIII trial. There is great demand for new treatments in this indication, with most current therapies encountering resistance. Cempra has initiated two phase III trials in the primary indication of CAP, comparing efficacy of oral and I.V to oral solithromycin against Avelox. The oral only treatment trial has an enrolment target of 860 and Cempra expects it to be completed in the July of 2014. The trial has been designed with FDA-recommended endpoints. To better differentiate its pipeline product from antibacterials on the market and in development for CAP, Cempra has partnered with Curetis, a molecular diagnostics manufacturer. Cempra is using Curetis’ Unyvero pneumonia molecular diagnostic in its phase III CAP trial in order to improve the pathogen-specific diagnosis of patients in the trial. In September 2013, the FDA granted QIDP status to solithromycin for the treatment of CAP. This shall fast track the approval process following NDA application and add an extra five years of market exclusivity following launch. 7.9.1 Revenue Forecast 2014-2024 Visiongain anticipates a late 2015 launch for oral solithromycin, with a further I.V launch the year after. For 2016, the first full year of sales, we anticipate solithromycin will generate $0.06bn in revenue. Growth over the next two years will be relatively rapid as physicians aware of the benefits www.visiongain.com Page 156
  38. 38. Antibacterial Drugs: World Industry and Market Prospects 2014-2024 of Ketek look to solithromycin for the benefits of that drug, without the adverse side-effects. Anticipated worldwide revenues for 2018 are $0.28bn. Revenue growth will continue between 2018 and 2024, at a predicted CAGR of 13.1%. Visiongain anticipates that at the end of the forecast period, annual sales will reach $0.59bn, having growth at a CAGR of 55.6% since launch in 2015 (Table 7.11 Figure 7.9). Table 7.11 Solithromycin Forecast: Revenue ($bn), Annual Growth (%), CAGR (%), 2014-2024 Solithromycin ($bn) Annual Growth (%) CAGR (%) 2012 0.00 Solithromycin ($bn) Annual Growth (%) CAGR (%) 2013 0.00 2014 0.00 2015 0.01 2016 0.06 460.0 2017 0.15 148.2 2018 0.28 84.3 194.8 2019 0.40 42.6 2020 0.49 21.6 2021 0.53 9.0 2022 0.56 4.6 2023 0.58 3.5 2024 0.59 2.0 13.1 Source: visiongain 2014 – CAGR values for period 2015 to 2018 and 2018 to 2024 Figure 7.9 Solithromycin Forecast: Revenue ($bn), 2014-2024 0.70 Revenue ($bn) 0.60 0.50 0.40 0.30 0.20 0.10 0.00 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Source: visiongain 2014 www.visiongain.com Page 157

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