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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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 ($bn), Market Shares (%),
CAGRs (%), 2012, 2013, 2018 and 2024
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24. Contents
List of Figures
Figure 2.1 Leading Causes of Infectious Disease Deaths Worldwide, 2010
Figure 2.2 Key Events in the History of Antibacterial Drug Development
Figure 2.3 Structures for β-Lactam Based Antibacterial Compounds
Figure 3.1 Historic Global Market Size ($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
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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
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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
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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
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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
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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
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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
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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
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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
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