Antibacterial: Drug Licensing Opportunities, 2002 - Market Research Reports

Contents:

Antibacterial Licensing Opportunities
Analyses, Rating, and Ranking…A Worldwide Study

Table of Contents

Disclaimer ........................................................................................................................................................... i
Therapeutic Overview...................................................................................................................................... iii
I. Introduction to Bacterial Infections and Their Therapy .........................................................................1
1. Introduction to bacteria and bacterial infections .....................................................................................1
2. Bacterial groups..........................................................................................................................................2
2.1 The Gram-Positive Bacteria (Division Firmicutes)....................................................................................... 3
2.1.1 The Clostridia....................................................................................................................................... 3
2.1.2 The Mycoplasmas (Class Mollicutes) ................................................................................................... 3
2.1.3 The ‘Bacilli’ ......................................................................................................................................... 3
2.1.4 The Actinobacteria ............................................................................................................................... 4
2.2 The Spirochetes (Division Spirochaetae) ...................................................................................................... 5
2.3 The Chlamydia ............................................................................................................................................. 5
2.4 The Proteobacteria ....................................................................................................................................... 5
2.4.1 The Alphaproteobacteria ....................................................................................................................... 5
2.4.2 The Betaproteobacteria ......................................................................................................................... 6
2.4.3 The Gammaproteobacteria .................................................................................................................... 6
2.4.4 The Epsilonproteobacteria.................................................................................................................... 7
II. Delphi Panel and Thought Leader Interviews: Discussion and Summary of Antibacterial
Therapeutics Innovation....................................................................................................................................9
1. Introduction ................................................................................................................................................9
2. Results of Delphi Panel interviews .............................................................................................................9
2.1 Common and important pathogenic bacteria................................................................................................. 9
2.2 Emerging bacterial infections..................................................................................................................... 11
2.2.1 New or newly recognized bacterial infections .................................................................................... 12
2.2.2 Re-emerging bacterial infections......................................................................................................... 12
2.2.3 Antibiotic-resistant bacteria ................................................................................................................ 12
2.3 Bacteriological warfare ............................................................................................................................... 13
2.4 Antibiotics and antibiotic resistance ........................................................................................................... 13
2.4.1 Current antibiotics.............................................................................................................................. 13
2.4.2 New antibiotics................................................................................................................................... 14
2.4.3 Combinations of antibiotics ................................................................................................................ 15
2.4.4 Antibiotic resistance........................................................................................................................... 16
2.5 Vaccines ..................................................................................................................................................... 17
2.6 Other future developments .......................................................................................................................... 19
3. Delphi summary........................................................................................................................................21
III. Bacterial Infections by Therapeutic Area............................................................................................23
1. Respiratory tract infections ......................................................................................................................23
1.1 Diseases involved....................................................................................................................................... 23
1.1.1 Current and likely future treatments.................................................................................................... 24
1.1.2 Market analysis .................................................................................................................................. 25
2. Genitourinary (GU) tract infections ........................................................................................................27
2.1 Diseases involved....................................................................................................................................... 27
2.2 Current and likely future treatments............................................................................................................ 27
2.3 Market analysis .......................................................................................................................................... 27
3. Gastrointestinal (GI) tract infections.......................................................................................................31
3.1 Diseases involved....................................................................................................................................... 31
3.2 Current and likely future treatments............................................................................................................ 31
3.3 Market analysis .......................................................................................................................................... 32
4. Skin and soft tissue infections...................................................................................................................33
4.1 Diseases involved....................................................................................................................................... 33
4.2 Current and likely future treatments............................................................................................................ 33
4.3 Market analysis .......................................................................................................................................... 34
5. Other infections.........................................................................................................................................35
5.1 Central nervous system (CNS) infections ................................................................................................... 35
5.2 Intra-abdominal infections .......................................................................................................................... 35
5.3 Ear infections ............................................................................................................................................. 35
5.4 Bacteremia and septicemia......................................................................................................................... 36
5.5 Bone and joint infections ............................................................................................................................ 36
5.6 Stomatological infections........................................................................................................................... 37
IV. Antibiotics..............................................................................................................................................39
1. Introduction to antibiotics ........................................................................................................................39
2. Mechanisms of antibiotic action ...............................................................................................................39
2.1 Inhibition of cell wall synthesis .................................................................................................................. 39
2.2 Disruption of cell membrane structure........................................................................................................ 39
2.3 Inhibition of protein synthesis..................................................................................................................... 39
2.4 Inhibition of DNA transcription.................................................................................................................. 40
3. Classes of antibiotics.................................................................................................................................40
3.1 Penicillins, cephalosporins, and other β-lactams ........................................................................................ 40
3.1.1 Overview............................................................................................................................................ 40
3.1.2 Utility ................................................................................................................................................. 40
3.1.3 Strengths and weaknesses ................................................................................................................... 41
3.1.4 Noteworthy developments................................................................................................................... 41
3.1.5 Forecast .............................................................................................................................................. 42
3.2 Aminoglycosides........................................................................................................................................ 42
3.2.1 Overview............................................................................................................................................ 42
3.2.2 Utility ................................................................................................................................................. 43
3.2.3 Strengths and weaknesses ................................................................................................................... 43
3.2.4 Noteworthy developments................................................................................................................... 43
3.2.5 Forecast .............................................................................................................................................. 43
3.3 Tetracyclines .............................................................................................................................................. 44
3.3.1 Overview............................................................................................................................................ 44
3.3.2 Utility ................................................................................................................................................. 44
3.3.3 Strengths and weaknesses ................................................................................................................... 44
3.3.4 Noteworthy developments................................................................................................................... 44
3.3.5 Forecast .............................................................................................................................................. 45
3.4 Macrolides.................................................................................................................................................. 45
3.4.1 Overview............................................................................................................................................ 45
3.4.2 Utility ................................................................................................................................................. 45
3.4.3 Strengths and weaknesses ................................................................................................................... 46
3.4.4 Noteworthy developments................................................................................................................... 46
3.4.5 Forecast .............................................................................................................................................. 46
3.5 Streptogramins ........................................................................................................................................... 47
3.5.1 Overview............................................................................................................................................ 47
3.5.2 Utility ................................................................................................................................................. 47
3.5.3 Strengths and weaknesses ................................................................................................................... 47
3.5.4 Noteworthy developments................................................................................................................... 47
3.5.5 Forecast .............................................................................................................................................. 48
3.6 Rifamycins ................................................................................................................................................. 48
3.6.1 Overview............................................................................................................................................ 48
3.6.2 Utility ................................................................................................................................................. 48
3.6.3 Strengths and weaknesses ................................................................................................................... 48
3.6.4 Noteworthy developments................................................................................................................... 48
3.6.5 Forecast .............................................................................................................................................. 48
3.7 Glycopeptides and other peptide antibiotics ............................................................................................... 48
3.7.1 Overview............................................................................................................................................ 48
3.7.2 Utility ................................................................................................................................................. 49
3.7.3 Strengths and weaknesses ................................................................................................................... 49
3.7.4 Noteworthy developments................................................................................................................... 49
3.7.5 Forecast .............................................................................................................................................. 51
3.8 Quinolones ................................................................................................................................................. 51
3.8.1 Overview............................................................................................................................................ 51
3.8.2 Utility ................................................................................................................................................. 51
3.8.3 Strengths and weaknesses ................................................................................................................... 52
3.8.4 Noteworthy developments................................................................................................................... 53
3.8.5 Forecast .............................................................................................................................................. 54
3.9 Oxazolidinones........................................................................................................................................... 54
3.10 Other antibiotics......................................................................................................................................... 55
3.10.1 Overview............................................................................................................................................ 55
3.10.2 Utility ................................................................................................................................................. 55
3.10.3 Strengths and weaknesses ................................................................................................................... 55
3.10.4 Noteworthy developments................................................................................................................... 56
3.10.5 Forecast .............................................................................................................................................. 56
4. Mechanisms of antibiotic resistance.........................................................................................................56
4.1 Antibiotic inactivation................................................................................................................................ 56
4.2 Antibiotic entry and efflux .......................................................................................................................... 56
4.3 Mutation of the antibiotic target site ........................................................................................................... 56
4.4 Alternative metabolic pathways .................................................................................................................. 57
V. Technology Platforms Other Than Antibiotics.......................................................................................59
1. Other low-molecular-weight therapeutics...............................................................................................59
1.1 Trimethoprim and sulfonamides ................................................................................................................. 59
1.1.1 Overview............................................................................................................................................ 59
1.1.2 Utility ................................................................................................................................................. 59
1.1.3 Strengths and weaknesses ................................................................................................................... 59
1.1.4 Noteworthy developments................................................................................................................... 59
1.1.5 Forecast .............................................................................................................................................. 60
1.2 Metronidazole ............................................................................................................................................ 60
1.3 Nitrofurantoin and other nitrofurans ........................................................................................................... 60
2. Vaccines and immunotherapies................................................................................................................60
2.1 Vaccines ..................................................................................................................................................... 60
2.1.1 Overview............................................................................................................................................ 60
2.1.2 Utility ................................................................................................................................................. 61
2.1.3 Strengths and weaknesses ................................................................................................................... 61
2.1.4 Noteworthy developments................................................................................................................... 61
2.1.5 Forecast .............................................................................................................................................. 64
2.2 Antibodies .................................................................................................................................................. 64
2.3 Other immunotherapies.............................................................................................................................. 65
3. Other technologies ....................................................................................................................................65
3.1 Overview.................................................................................................................................................... 65
3.2 Noteworthy development ............................................................................................................................ 66
VI. Overall Analysis and Forecast for Antibacterials...............................................................................67
1. Product technology analysis and forecast................................................................................................67
2. Market analysis and forecast....................................................................................................................82
3. Evaluation of licensing opportunities – ratings and rankings ...............................................................85
VII. Company Profiles of Innovative Firms Representing Acquisitions, Licensing, and Co-marketing
Opportunities in Antibacterial Therapy .........................................................................................................95
Glossary of Terms ..........................................................................................................................................111
List of acronyms ............................................................................................................................................115
Antibacterial Licensing Opportunities
Analyses, Rating, and Ranking…A Worldwide Study
List of Figures
Figure ES-1 Product development activity in antibacterial therapy by indication........................................................ v
Figure ES-2 Product development activity in antibacterial therapy by phase of development in the US.................... vi
Figure ES-3 Product development activity in antibacterial therapy by phase of development in the world................ vi
Figure ES-4 Active development programs in each bacterial indication by phase of development ........................... vii
Figure ES-5 Active development programs in each phase of development by bacterial indication ........................... vii
Figure ES-6 Unpartnered vs partnered programs by phase of development in the US. .............................................viii
Figure ES-7 WW market activity in 2001 by indication............................................................................................ xiv
Figure ES-8 WW market activity in 2011 by indication............................................................................................ xiv
Figure 3.1 WW forecast for RTI treatment by technology platform........................................................................... 24
Figure 3.2 WW forecast for GU tract infection treatment by technology platform.................................................... 28
Figure 3.3 WW forecast for GI tract infection treatment by technology platform...................................................... 32
Figure 3.4 WW forecast for skin and soft tissue infection treatment by technology .................................................. 35
Figure 6.1 Market impact matrix for technology platforms in bacterial infection treatment ...................................... 67
Figure 6.2 WW forecast for bacterial infection therapeutics by technology platform................................................ 68
Antibacterial Licensing Opportunities
Analyses, Rating, and Ranking…A Worldwide Study
List of Tables
Table ES-1 US market forecast summary of bacterial infections by technology (antibiotics and low-
molecular-weight therapeutics)............................................................................................................................ x
Table ES-2 US antibiotic market forecast summary by indication .............................................................................. xi
Table ES-3 WW market forecast summary of bacterial infections by technology (antibiotics and low-
molecular-weight therapeutics).......................................................................................................................... xii
Table ES-4 WW antibiotic market forecast summary by indication..........................................................................xiii
Table ES-5 Opportunity sorting matrix for all antibacterial therapies by total score.................................................. xv
Table ES-6 Opportunity sorting matrix for all antibacterial therapies by company................................................... xvi
Table 1.1 Bacterial toxins ............................................................................................................................................ 2
Table 3.1 US market forecast for RTI therapy by technology (antibiotics and low-molecular-weight
therapeutics)....................................................................................................................................................... 25
Table 3.2 WW market forecast for RTI therapy by technology (antibiotics and low-molecular-weight
therapeutics)....................................................................................................................................................... 26
Table 3.3 US market forecast for GU tract infection therapy by technology (antibiotics and low-molecular-
weight therapeutics) ........................................................................................................................................... 29
Table 3.4 WW market forecast for GU tract infection therapy by technology (antibiotics and low-molecular-
weight therapeutics) ........................................................................................................................................... 30
Table 3.5 US market forecast for GI tract infection therapy by technology (antibiotics and low-molecular-
weight therapeutics) ........................................................................................................................................... 33
Table 3.6 WW market forecast for GI tract infection therapy by technology (antibiotics and low-molecular-
weight therapeutics) ........................................................................................................................................... 34
Table 3.7 US market forecast for skin and soft tissue infection therapy by technology (antibiotics and lowmolecular-
weight therapeutics).......................................................................................................................... 36
Table 3.8 WW market forecast for skin and soft tissue infection therapy by technology (antibiotics and lowmolecular-
weight therapeutics).......................................................................................................................... 37
Table 6.1 Product development activity for antibacterial therapeutics by phase of development .............................. 69
Table 6.2 Product development activity for antibacterial therapeutics ....................................................................... 70
Table 6.3 US market forecast summary of bacterial infections by technology (antibiotics and low-molecular-
weight therapeutics) ........................................................................................................................................... 82
Table 6.4 WW market forecast summary of bacterial infections by technology (antibiotics and low-molecularweight
therapeutics) ........................................................................................................................................... 83
Table 6.5 US antibiotic market forecast summary by indication ................................................................................ 84
Table 6.6 WW antibiotic market forecast summary by indication.............................................................................. 84
Table 6.7 Opportunity sorting matrix for antibiotics and other non-immunotherapeutic antibacterial therapy.......... 86
Table 6.8 Opportunity sorting matrix for antibacterial vaccines................................................................................. 86