Analysis of the Pharmaceutical Market to 2012 - Segmented by Drug Target Family

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Publication Date: 2007-10-23

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Drug targets are the critical link between drugs and their role in the treatment of medical disorders. By grouping drug targets into key protein families, this report provides a comprehensive analysis of the prescription pharmaceutical market by not just molecule type and therapy area, but also by target family.

Scope

Classification of the specific drug targets relating to over 650 key products across the PharmaVitae universe

Products grouped into major target families, including GPCRs, enzymes, extracellular signalling proteins (ECS), ion channels and nuclear receptors

Comprehensive analysis of forecast sales to 2012 by the three fundamental dimensions of pharma space: molecule type, therapy area and target family

Discussion of the factors driving the variable performance of different ATC drug classes

Report Highlights
Datamonitor has identified three fundamental dimensions that describe a product�s position within the pharma space�molecule type, therapy area and target type. Analysis of sales across these dimensions reveals key attractiveness characteristics that drive performance

The target type acted on by a product dictates its standing against these key characteristics. Products acting on ECS targets tend to rate most highly and will outperform those acting on other target types. Conversely, products addressing ion channels or nuclear receptors rate poorly and face an overall decline across 2006�12

The arrival of monoclonal antibody and therapeutic protein technologies allowed ECS targets to be exploited, expanding the �druggable� target space and driving sales growth across 2006�12. Beyond 2012, further technological revolutions will, however, be required if the success experienced by these product classes is to be repeated

Reasons to Purchase

Identify product positioning not just in terms of molecule type and therapy area, but also according to target family

Rate marketed and pipeline products against the three attractiveness characteristics that determine a product�s likelihood of commercial success

Understand the challenges faced by different product groups depending on the targets that they address

About the PharmaVitae team - page 3

CHAPTER 1 EXECUTIVE SUMMARY - page 4
- Key findings - page 4
- Introduction to the PharmaVitae universe - page 5
- The outlook for the market is challenging - page 6
  - Market performance is shaped by key ATC classes - page 7
- The three fundamental dimensions of pharma space - page 8
  - Dimension one: molecule type analysis - page 8
    - MAbs and therapeutic proteins to provide the greatest overall sales growth - page 8
    - Generic erosion wipes out small molecule drug sales - page 9
    - mAbs driven by 'core' sales - page 11
  - Dimension two: therapy area analysis - page 12
    - Oncology and AIID products drive growth across 2006-12 - page 12
    - GI and CV particularly badly hit in 2012 - page 13
  - Targets provide a missing link between drugs and disease - page 15
    - Target classification - page 16
  - Dimension three: target family analysis - page 17
    - ECS target family set for superior performance - page 17
    - Only the ECS target family will see growth between 2011-12 (the 'patent cliff') - page 18
- Position within the three fundamental dimensions of pharma space influences commercial outlook - page 20
  - Introduction - page 20
  - Novel targets offer reduced competitive pressures - page 20
    - Superior commercial outlook with increasing target novelty - page 20
    - New technologies allow expansion into novel target space - page 21
    - Market growth driven by biologics acting on ECS targets - page 22
  - Biologics offer insulation from generic erosion - page 23
    - ECS shielded from generics - page 23
    - Lifecycle stage dictates performance of small molecule drugs - page 24
  - Areas of high unmet need facilitate commercial success - page 26
    - Biologics more warranted in areas of high unmet need - page 26
    - Certain areas already saturated by cheap options - page 27
- Perfomance relates to the balance of key characteristics - page 28
  - Commercial attractiveness characteristics - page 28
  - Not all volumes of pharma space are biologically viable - page 29
    - Mechanism of disease dictates the pharmacologically useful targets - page 29
    - Small molecule drugs cannot modulate ECS targets - page 30
    - Biologics cannot access the targets relating to certain diseases - page 30
  - ATC performance is driven by key characteristics - page 31
    - Segment 1: High growth biologics - page 34
    - Segment 2: Declining small molecule drugs - page 34
    - Segment 3: High growth small molecule drugs - page 35
- Considerations beyond 2012 - page 37
  - The need for new technologies - page 37
  - DNA/RNA therapies hit the central dogma of biology - page 38
  - Gene therapy - page 39
  - RNA therapies - page 40
CHAPTER 2 MARKET ANALYSIS - page 46
- Key findings - page 46
- Introduction - page 47
- Total market overview - page 48
  - Growth drivers and resistors - page 49
    - Top 25 growth drivers across 2006-12 - page 49
    - Top 25 growth resistors across 2006-12 - page 50
    - Top 25 growth drivers 2012 - page 51
    - Top 25 growth resistors 2012 - page 52
- Molecule type analysis - page 53
  - Small molecule drugs account for the bulk of sales - page 53
    - Generic substitution is greater where more generic alternatives are available - page 54
    - Products satisfying high unmet needs are more likely to gain market share - page 55
  - Biologic products will make a greater contribution to growth - page 55
- Therapy area analysis - page 57
  - Therapy area growth drivers and resistors - page 57
    - Oncology and AIID drive growth - page 58
    - CV and GI set to decline overall - page 58
  - 2006-11 performance - page 60
  - 2012 performance - page 61
- LCE profile - page 62
CHAPTER 3 TARGET FAMILY CLASSIFICATION - page 64
- Key findings - page 64
- Introduction - page 65
  - Targets are a key dimension of pharma space - page 65
  - The druggable genome - page 66
    - Druggability by small molecules-the Rule of Five. - page 67
- Target family classification - page 68
- GPCR target family - page 69
  - Introduction - page 69
  - Structure and function - page 69
  - Subfamilies - page 70
- Ion channel target family - page 71
  - Introduction - page 71
  - Structure and function - page 71
  - Subfamilies - page 72
- Nuclear receptor target family - page 73
  - Introduction - page 73
  - Structure and function - page 73
  - Subfamilies - page 74
- Enzyme target family - page 75
  - Introduction - page 75
  - Structure and function - page 75
  - Subfamilies - page 76
- Extracellular signaling (ECS) target family - page 77
  - Introduction - page 77
  - Structure and function - page 77
  - Subfamilies - page 78
- Non-human - page 79
- Other - page 79
- Mixed - page 79
- Unclassified - page 79
CHAPTER 4 MARKET ANALYSIS BY TARGET FAMILY - page 80
- Key findings - page 80
- Overview - page 81
  - Target family performance - page 81
  - ECS target family driving overall market growth - page 84
  - Enzyme and GPCR target families take the greatest hit in 2012 - page 85
- Therapy area analysis: satisfaction of unmet needs drives success - page 87
  - GPCR targets take the largest share of the CV and CNS sales - page 88
    - CV therapy area set for 'boom and bust' - page 88
    - Without target innovation, CNS products struggle to offset expiries - page 89
  - ECS targets drive growth of the oncology and AIID therapy areas - page 91
  - Falling sales of enzyme modulators bring down GI - page 93
- Molecule type analysis - page 94
  - Monoclonal antibody (mAb) sales are driven by ECS targets - page 95
  - Therapeutic protein analysis - page 97
  - Small molecule drugs are highly susceptible to generic erosion - page 99
  - Vaccine sales are entirely derived from non-human targets - page 101
- LCE analysis - page 103
  - Launch - page 104
  - Core - page 107
  - Expiry - page 109
CHAPTER 5 NUCLEAR RECEPTOR AND ION CHANNEL TARGET FAMILIES - page 111
- Key findings - page 111
- Overview: nuclear receptor and ion channel target families - page 112
  - Contribution to total market sales is set to diminish further - page 113
    - Ranked amongst the smallest target families by sales - page 113
    - Forecast to experience the fastest rate of decline - page 114
  - Scope for expansion is restricted - page 115
    - Small number of possible nuclear receptor target types - page 115
    - Nuclear receptors are not readily targeted by biologics - page 115
    - Ion channels offer significant potential, but are limited by their high association with CNS disorders - page 115
- Therapy area analysis: key areas dictate overall performance - page 116
  - Diabetes & endocrinology pulls down nuclear receptor-related sales - page 116
    - Diabetes sales are pulled down by genericization of just one target type - page 117
  - Women's health products generate growth for the nuclear receptor target family - page 118
    - Growth despite limited target innovation - page 118
    - Tougher times ahead? - page 120
  - CNS pulls down ion channels - page 121
    - CNS is the largest ion channel therapy area by sales - page 121
    - New launches are not sufficient to overcome the decline of older products - page 122
    - Competition high due to lack of target innovation - page 123
  - Products not revolutionizing the satisfaction of unmet needs - page 125
- Molecule type analysis: exclusively small molecule - page 126
- LCE analysis: expiries drag sales into decline - page 128
CHAPTER 6 EXTRACELLULAR SIGNALLING PROTEIN (ECS) TARGET FAMILY - page 130
- Key findings - page 130
- Overview: ECS target family - page 131
  - Fastest rate of growth over 2006-12 - page 132
  - Only target family to see growth in 2012 - page 133
- Therapy area analysis: driving growth of AIID & oncology - page 135
  - AIID sales growth is entirely reliant on ECS targets - page 137
    - Sales are largely derived from products acting on TNF-α - page 139
    - Novel targets generate growth as anti-TNF market slows - page 140
  - Novel ECS targets drive oncology growth - page 141
    - Success drawn from 'locking competitors out' of key targets - page 142
- Molecule type analysis: new technologies opened up ECS targets - page 144
  - MAb technology has allowed novel ECS targets to be exploited - page 145
  - Unique position compared to other target families - page 146
  - Potential small molecule threat? - page 147
- LCE analyis: growth across all LCE components - page 148
  - Expansion through novel targets - page 149
  - Free from declining 'expiry' sales - page 149
CHAPTER 7 ENZYME AND GPCR TARGET FAMILIES - page 151
- Key findings - page 151
- Overview: enzyme and GPCR target families - page 152
  - The largest target families by sales - page 153
  - Forecast to see the greatest decline over 2011-12 - page 155
- Therapy area analysis: novel targets drive growth - page 157
  - Enzyme sales growth wiped out by declining therapy areas. - page 157
  - Novel targets drive oncology sales and the enzyme target family - page 159
    - Transferase targets drive oncology therapy area growth - page 159
    - Tyrosine kinase inhibitors exemplify novel target value - page 160
    - Tyrosine kinase inhibitors account for the bulk of enzyme target family gains - page 161
  - GI and CV sales hit by loss of patents on key classes - page 162
    - Heavily reliant on ageing PPIs, GI sales are set decline - page 162
    - HMG-CoA reductase inhibitors erode enzyme target family growth - page 163
  - GPCR sales growth across all therapy areas but eroded in 2012 - page 165
    - Angiotensin II receptor antagonists drive CV growth but hit by genericization - page 166
    - New CNS launches do little to replace the loss of 'blockbusters' - page 167
    - Diabetes sales driven by novel targets - page 168
- Molecule type analysis: almost entirely small molecule - page 169
- LCE analysis: expiries offset growth - page 171
  - Significant 'launch' gains driven by availability of novel targets - page 172
  - Massive 'expiry' loss in 2012 - page 173
CHAPTER 8 APPENDIX - page 174
- Target sub-sub-families - page 174
  - GPCR sub-sub-families - page 174
  - Nuclear receptor sub-sub-families - page 177
  - Enzyme sub-sub-families - page 178
- Details of mixed and unclassified - page 180
- Avandia - page 180
- References - page 181
  - Journals - page 181
  - Websites - page 182
- Abbreviations - page 183

List of Tables
Table 1: PharmaVitae company coverage by peer set - page 5
Table 2: Target family classification - page 16
Table 3: Datamonitor's commercial attractiveness characteristics - page 31
Table 4: Top 25 growth drivers, 2006-12 ($m) - page 49
Table 5: Top 25 growth resistors, 2006-12 ($m) - page 50
Table 6: Top 25 growth drivers, 2011-12 ($m) - page 51
Table 7: Top 25 growth resistors, 2011-12 ($m) - page 52
Table 8: Target family classification - page 68
Table 9: GPCR subfamilies - page 70
Table 10: Ion channel subfamilies - page 72
Table 11: Nuclear receptor subfamilies - page 74
Table 12: Enzyme superfamilies - page 76
Table 13: ECS subfamily classification - page 78
Table 14: GPCR sub-sub-families - page 174
Table 15: Nuclear receptor sub-sub-families - page 177
Table 16: Enzyme sub-sub-families - page 178

List of Figures
Figure 1: Pharmaceutical market performance, sales ($m) and year-on-year growth (%), 2006-12 - page 6
Figure 2: Top 10 growth driver/resistor ATC classes - page 7
Figure 3: Change in total market sales by molecule type, 2006-12 ($m) - page 9
Figure 4: Molecule type sales growth by LCE stage, 2006-12 (%) - page 10
Figure 5: Change in total market sales by therapy area, 2006-12 ($m) - page 12
Figure 6: Dynamics of key therapy area sales, 2006-12 ($m) - page 14
Figure 7: Three dimensions of pharma space - page 15
Figure 8: Change in total market sales by target family, 2006-12 ($m) - page 17
Figure 9: Target family growth rates, 2006-12 (CAGR %) - page 18
Figure 10: Change in total market sales by target family, 20011-12 ($m) - page 19
Figure 11: Technological advances expand the 'druggable' space - page 21
Figure 12: Molecule type sales by target family, 2006 (%) - page 22
Figure 13: Change in year-on-year sales by LCE stage, 2006-12 ($m) - page 25
Figure 14: Therapy area sales by target family, 2006 ($m) - page 27
Figure 15: Key characteristics influencing commercial attractiveness - page 28
Figure 16: Factors limiting the exploitable pharma space - page 29
Figure 17: Key ATC class outlook and position against commercial attractiveness characteristics, change in sales 2006-12 - page 32
Figure 18: Key market segments, 2006-12 - page 33
Figure 19: The central dogma of biology and potential role of DNA/RNA therapies in relation to traditional 'drugging' approaches - page 39
Figure 20: Gene 'silencing' by short interefering RNA (siRNA) - page 41
Figure 21: Report structure - page 47
Figure 22: Total market sales, 2003-12 ($m) - page 48
Figure 23: Total market sales by molecule type, 2003-12 ($m) - page 53
Figure 24: Substitution of branded small molecule drugs for generics - page 54
Figure 25: Change in total market sales by molecule type, 2006-12 ($m) - page 56
Figure 26: Total market sales by therapy area, 2003-12 ($m) - page 57
Figure 27: Change in total market sales by therapy area, 2006-12 ($m) - page 59
Figure 28: Change in total market sales by therapy area, 2006-11 ($m) - page 60
Figure 29: Change in total market sales by therapy area, 2011-12 ($m) - page 61
Figure 30: Change in total market sales by LCE stage, 2006-12 ($m) - page 62
Figure 31: Change in year-on-year sales by LCE stage, 2006-12 ($m) - page 63
Figure 32: The role of drug targets in disease treatment - page 65
Figure 33: The commercially useful subset of the human genome - page 66
Figure 34: GPCRs structure - page 69
Figure 35: Functional architecture of an ion channel - page 71
Figure 36: Structural organization of nuclear receptors - page 73
Figure 37: Epidermal growth factor receptor (EGFR) structure - page 77
Figure 38: Total market sales by target family, 2006 ($m) - page 82
Figure 39: Target family sales CAGR, 2006-12 (%) - page 83
Figure 40: Total market sales by target family, 2006-12 ($m) - page 84
Figure 41: Total market sales by target family, 2011-12 ($m) - page 85
Figure 42: Year-on-year change in target family sales, weighted as a proportion of change in total sales, 2004-12 (%) - page 86
Figure 43: CV therapy area sales by target family, 2003-12 ($m) - page 88
Figure 44: CNS therapy area sales by target family, 2003-12 ($m) - page 89
Figure 45: Oncology therapy area sales by target family, 2003-12 ($m) - page 91
Figure 46: AIID therapy area sales by target family, 2003-12 ($m) - page 92
Figure 47: GI therapy area sales by target family, 2003-12 ($m) - page 93
Figure 48: Monoclonal antibody sales by target family, 2003-12 ($m) - page 95
Figure 49: Therapeutic protein sales by target family, 2003-12 ($m) - page 97
Figure 50: Therapeutic protein sales by target family, 2003-12 ($m) - page 98
Figure 51: Small molecule drug sales by target family, 2003-12 ($m) - page 99
Figure 52: Small molecule drug sales by target family, 2006-12 ($m) - page 100
Figure 53: Vaccine sales by target family, 2003-12 ($m) - page 101
Figure 54: 2003-12 'launch' portfolio sales by target family ($m) - page 104
Figure 55: 2006-12 'launch' portfolio sales by target family ($m) - page 105
Figure 56: 2003-12 'core' portfolio sales by target family ($m)) - page 107
Figure 57: 2006-12 'core' portfolio sales by target family ($m) - page 108
Figure 58: 2003-12 'expiry' portfolio sales by target family ($m) - page 109
Figure 59: 2003-12 'expiry' portfolio sales by target family ($m) - page 110
Figure 60: Nuclear receptor and ion channel target family characteristics - page 112
Figure 61: Total market sales by target family, 2006 ($m) - page 113
Figure 62: Target family 2006-12 CAGR (%) - page 114
Figure 63: Nuclear receptor target sales by therapy area, 2006-12 ($m) - page 116
Figure 64: Sales of diabetes & endocrinology products that act on nuclear receptor or ion channel targets, 2003-12 ($m) - page 117
Figure 65: Sales of women's health products targeting nuclear receptors, 2003-12 ($m) - page 119
Figure 66: Ion channel sales by therapy area, 2003-12 ($m) - page 121
Figure 67: Ion channel sales by therapy area, 2006-12 ($m) - page 122
Figure 68: Sales of CNS therapy area products acting on ion channel targets, 2003-12 ($m) - page 124
Figure 69: Combined nuclear receptor & ion channel sales by molecule type, 2003-12 ($m) - page 126
Figure 70: Nuclear receptor & ion channel LCE profile, 2006-12 ($m) - page 128
Figure 71: Nuclear receptor & ion channel progressive LCE profile ($m) - page 129
Figure 72: ECS target family characteristics - page 131
Figure 73: Total market sales by target family, 2006 ($m) - page 132
Figure 74: Target family 2006-12 CAGR (%) - page 133
Figure 75: Total market sales by target family, 2011-12 ($m) - page 134
Figure 76: ECS target sales by therapy area, 2006-12 ($m) - page 135
Figure 77: ECS target sales by therapy area, 2006-12 ($m) - page 136
Figure 78: AIID therapy area sales by target family, 2003-12 ($m) - page 137
Figure 79: AIID therapy area sales by target family, 2006-12 ($m) - page 138
Figure 80: AIID therapy area sales from products acting on ECS targets, 2003-12 ($m) - page 139
Figure 81: Oncology therapy area sales by target type, 2003-12 ($m) - page 141
Figure 82: ECS targets in the oncology therapy area, 2003-12 ($m) - page 142
Figure 83: ECS target family sales by molecule type, 2003-12 ($m) - page 144
Figure 84: ECS target family sales by molecule type, 2006-12 ($m) - page 145
Figure 85: Proportion of target family sales by molecule type, 2006 (%) - page 146
Figure 86: ECS target family LCE profile, 2006-12 ($m) - page 148
Figure 87: Enzyme and GPCR target family characteristics - page 152
Figure 88: Total market sales by target family, 2006 ($m) - page 153
Figure 89: Target family 2006-12 CAGR (%) - page 154
Figure 90: Total market sales by target family, 2006-12 ($m) - page 155
Figure 91: Total market sales by target family, 2011-12 ($m) - page 156
Figure 92: Enzyme target family sales by therapy area, 2006-12 ($m) - page 157
Figure 93: Enzyme-targeting product sales by therapy area, 2003-12 ($m) - page 158
Figure 94: Sales of oncology products by enzyme subfamily, 2006-12 ($m) - page 159
Figure 95: Total enzyme target family sales by subfamily, 2006-12 ($m) - page 161
Figure 96: GI product sales from enzyme targets, 2003-12 ($m) - page 162
Figure 97: CV product sales from oxidoreductase targets, 2003-12 ($m) - page 164
Figure 98: GPCR-targeting product sales by therapy area, 2003-12 ($m) - page 165
Figure 99: GPCR target family sales by therapy area, 2006-12 ($m) - page 166
Figure 100: Enzyme and GPCR target family sales by molecule type, 2003-12 ($m) - page 169
Figure 101: Enzyme & GPCR target family LCE profile, 2006-12 ($m) - page 171
Figure 102: 2006-12 'launch' portfolio sales by target family ($m) - page 172
Figure 103: Enzyme & GPCR target family progressive LCE profile ($m) - page 173
Figure 104: Target family sales growth rates including 'mixed' components, CAGR 2006-12 (%) - page 180

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Analysis of the Pharmaceutical Market to 2012 - Segmented by Drug Target Family

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