Table of Contents
- About the PharmaVitae team
- CHAPTER 1 EXECUTIVE SUMMARY
- Key findings
- Introduction to the PharmaVitae universe
- The outlook for the market is challenging
- Market performance is shaped by key ATC classes
- The three fundamental dimensions of pharma space
- Dimension one: molecule type analysis
- MAbs and therapeutic proteins to provide the greatest overall sales
growth
- Generic erosion wipes out small molecule drug sales
- mAbs driven by ' core' sales
- Dimension two: therapy area analysis
- Oncology and AIID products drive growth across 2006-12
- GI and CV particularly badly hit in 2012
- Targets provide a missing link between drugs and disease
- Dimension three: target family analysis
- ECS target family set for superior performance
- Only the ECS target family will see growth between 2011-12 (the
' patent cliff' )
- Position within the three fundamental dimensions of pharma space
influences commercial outlook
- Introduction
- Novel targets offer reduced competitive pressures
- Superior commercial outlook with increasing target novelty
- New technologies allow expansion into novel target space
- Market growth driven by biologics acting on ECS targets
- Biologics offer insulation from generic erosion
- ECS shielded from generics
- Lifecycle stage dictates performance of small molecule drugs
- Areas of high unmet need facilitate commercial success
- Biologics more warranted in areas of high unmet need
- Certain areas already saturated by cheap options
- Perfomance relates to the balance of key characteristics
- Commercial attractiveness characteristics
- Not all volumes of pharma space are biologically viable
- Mechanism of disease dictates the pharmacologically useful targets
- Small molecule drugs cannot modulate ECS targets
- Biologics cannot access the targets relating to certain diseases
- ATC performance is driven by key characteristics
- Segment 1: High growth biologics
- Segment 2: Declining small molecule drugs
- Segment 3: High growth small molecule drugs
- Considerations beyond 2012
- The need for new technologies
- DNA/RNA therapies hit the central dogma of biology
- Gene therapy
- RNA therapies
- CHAPTER 2 MARKET ANALYSIS
- Key findings
- Introduction
- Total market overview
- Growth drivers and resistors
- Top 25 growth drivers across 2006-12
- Top 25 growth resistors across 2006-12
- Top 25 growth drivers 2012
- Top 25 growth resistors 2012
- Molecule type analysis
- Small molecule drugs account for the bulk of sales
- Generic substitution is greater where more generic alternatives are
available
- Products satisfying high unmet needs are more likely to gain market
share
- Biologic products will make a greater contribution to growth
- Therapy area analysis
- Therapy area growth drivers and resistors
- Oncology and AIID drive growth
- CV and GI set to decline overall
- 2006-11 performance
- 2012 performance
- LCE profile
- CHAPTER 3 TARGET FAMILY CLASSIFICATION
- Key findings
- Introduction
- Targets are a key dimension of pharma space
- The druggable genome
- Druggability by small molecules-the Rule of Five.
- Target family classification
- GPCR target family
- Introduction
- Structure and function
- Subfamilies
- Ion channel target family
- Introduction
- Structure and function
- Subfamilies
- Nuclear receptor target family
- Introduction
- Structure and function
- Subfamilies
- Enzyme target family
- Introduction
- Structure and function
- Subfamilies
- Extracellular signaling (ECS) target family
- Introduction
- Structure and function
- Subfamilies
- Non-human
- Other
- Mixed
- Unclassified
- CHAPTER 4 MARKET ANALYSIS BY TARGET FAMILY
- Key findings
- Overview
- Target family performance
- ECS target family driving overall market growth
- Enzyme and GPCR target families take the greatest hit in 2012
- Therapy area analysis: satisfaction of unmet needs drives success
- GPCR targets take the largest share of the CV and CNS sales
- CV therapy area set for ' boom and bust'
- Without target innovation, CNS products struggle to offset expiries
- ECS targets drive growth of the oncology and AIID therapy areas
- Falling sales of enzyme modulators bring down GI
- Molecule type analysis
- Monoclonal antibody (mAb) sales are driven by ECS targets
- Therapeutic protein analysis
- Small molecule drugs are highly susceptible to generic erosion
- Vaccine sales are entirely derived from non-human targets
- LCE analysis
- CHAPTER 5 NUCLEAR RECEPTOR AND ION CHANNEL TARGET FAMILIES
- Key findings
- Overview: nuclear receptor and ion channel target families
- Contribution to total market sales is set to diminish further
- Ranked amongst the smallest target families by sales
- Forecast to experience the fastest rate of decline
- Scope for expansion is restricted
- Small number of possible nuclear receptor target types
- Nuclear receptors are not readily targeted by biologics
- Ion channels offer significant potential, but are limited by their
high association with CNS disorders
- Therapy area analysis: key areas dictate overall performance
- Diabetes & endocrinology pulls down nuclear receptor-related sales
- Diabetes sales are pulled down by genericization of just one target
type
- Women' s health products generate growth for the nuclear receptor
target family
- Growth despite limited target innovation
- Tougher times ahead?
- CNS pulls down ion channels
- CNS is the largest ion channel therapy area by sales
- New launches are not sufficient to overcome the decline of older
products
- Competition high due to lack of target innovation
- Products not revolutionizing the satisfaction of unmet needs
- Molecule type analysis: exclusively small molecule
- LCE analysis: expiries drag sales into decline
- CHAPTER 6 EXTRACELLULAR SIGNALLING PROTEIN (ECS) TARGET FAMILY
- Key findings
- Overview: ECS target family
- Fastest rate of growth over 2006-12
- Only target family to see growth in 2012
- Therapy area analysis: driving growth of AIID & oncology
- AIID sales growth is entirely reliant on ECS targets
- Sales are largely derived from products acting on TNF-α
- Novel targets generate growth as anti-TNF market slows
- Novel ECS targets drive oncology growth
- Success drawn from ' locking competitors out' of key targets
- Molecule type analysis: new technologies opened up ECS targets
- MAb technology has allowed novel ECS targets to be exploited
- Unique position compared to other target families
- Potential small molecule threat?
- LCE analyis: growth across all LCE components
- Expansion through novel targets
- Free from declining ' expiry' sales
- CHAPTER 7 ENZYME AND GPCR TARGET FAMILIES
- Key findings
- Overview: enzyme and GPCR target families
- The largest target families by sales
- Forecast to see the greatest decline over 2011-12
- Therapy area analysis: novel targets drive growth
- Enzyme sales growth wiped out by declining therapy areas.
- Novel targets drive oncology sales and the enzyme target family
- Transferase targets drive oncology therapy area growth
- Tyrosine kinase inhibitors exemplify novel target value
- Tyrosine kinase inhibitors account for the bulk of enzyme target
family gains
- GI and CV sales hit by loss of patents on key classes
- Heavily reliant on ageing PPIs, GI sales are set decline
- HMG-CoA reductase inhibitors erode enzyme target family growth
- GPCR sales growth across all therapy areas but eroded in 2012
- Angiotensin II receptor antagonists drive CV growth but hit by
genericization
- New CNS launches do little to replace the loss of ' blockbusters'
- Diabetes sales driven by novel targets
- Molecule type analysis: almost entirely small molecule
- LCE analysis: expiries offset growth
- Significant ' launch' gains driven by availability of novel targets
- Massive ' expiry' loss in 2012
- CHAPTER 8 APPENDIX
- Target sub-sub-families
- GPCR sub-sub-families
- Nuclear receptor sub-sub-families
- Enzyme sub-sub-families
- Details of mixed and unclassified
- Avandia
- References
- Abbreviations
- List of Tables
- Table 1: PharmaVitae company coverage by peer set
- Table 2: Target family classification
- Table 3: Datamonitor' s commercial attractiveness characteristics
- Table 4: Top 25 growth drivers, 2006-12 ($m)
- Table 5: Top 25 growth resistors, 2006-12 ($m)
- Table 6: Top 25 growth drivers, 2011-12 ($m)
- Table 7: Top 25 growth resistors, 2011-12 ($m)
- Table 8: Target family classification
- Table 9: GPCR subfamilies
- Table 10: Ion channel subfamilies
- Table 11: Nuclear receptor subfamilies
- Table 12: Enzyme superfamilies
- Table 13: ECS subfamily classification
- Table 14: GPCR sub-sub-families
- Table 15: Nuclear receptor sub-sub-families
- Table 16: Enzyme sub-sub-families
- List of Figures
- Figure 1: Pharmaceutical market performance, sales ($m) and
year-on-year growth (%), 2006-12
- Figure 2: Top 10 growth driver/resistor ATC classes
- Figure 3: Change in total market sales by molecule type, 2006-12 ($m)
- Figure 4: Molecule type sales growth by LCE stage, 2006-12 (%)
- Figure 5: Change in total market sales by therapy area, 2006-12 ($m)
- Figure 6: Dynamics of key therapy area sales, 2006-12 ($m)
- Figure 7: Three dimensions of pharma space
- Figure 8: Change in total market sales by target family, 2006-12 ($m)
- Figure 9: Target family growth rates, 2006-12 (CAGR %)
- Figure 10: Change in total market sales by target family, 20011-12 ($m)
- Figure 11: Technological advances expand the ' druggable' space
- Figure 12: Molecule type sales by target family, 2006 (%)
- Figure 13: Change in year-on-year sales by LCE stage, 2006-12 ($m)
- Figure 14: Therapy area sales by target family, 2006 ($m)
- Figure 15: Key characteristics influencing commercial attractiveness
- Figure 16: Factors limiting the exploitable pharma space
- Figure 17: Key ATC class outlook and position against commercial
attractiveness characteristics, change in sales 2006-12
- Figure 18: Key market segments, 2006-12
- Figure 19: The central dogma of biology and potential role of DNA/RNA
therapies in relation to traditional ' drugging' approaches
- Figure 20: Gene ' silencing' by short interefering RNA (siRNA)
- Figure 21: Report structure
- Figure 22: Total market sales, 2003-12 ($m)
- Figure 23: Total market sales by molecule type, 2003-12 ($m)
- Figure 24: Substitution of branded small molecule drugs for generics
- Figure 25: Change in total market sales by molecule type, 2006-12 ($m)
- Figure 26: Total market sales by therapy area, 2003-12 ($m)
- Figure 27: Change in total market sales by therapy area, 2006-12 ($m)
- Figure 28: Change in total market sales by therapy area, 2006-11 ($m)
- Figure 29: Change in total market sales by therapy area, 2011-12 ($m)
- Figure 30: Change in total market sales by LCE stage, 2006-12 ($m)
- Figure 31: Change in year-on-year sales by LCE stage, 2006-12 ($m)
- Figure 32: The role of drug targets in disease treatment
- Figure 33: The commercially useful subset of the human genome
- Figure 34: GPCRs structure
- Figure 35: Functional architecture of an ion channel
- Figure 36: Structural organization of nuclear receptors
- Figure 37: Epidermal growth factor receptor (EGFR) structure
- Figure 38: Total market sales by target family, 2006 ($m)
- Figure 39: Target family sales CAGR, 2006-12 (%)
- Figure 40: Total market sales by target family, 2006-12 ($m)
- Figure 41: Total market sales by target family, 2011-12 ($m)
- Figure 42: Year-on-year change in target family sales, weighted as a
proportion of change in total sales, 2004-12 (%)
- Figure 43: CV therapy area sales by target family, 2003-12 ($m)
- Figure 44: CNS therapy area sales by target family, 2003-12 ($m)
- Figure 45: Oncology therapy area sales by target family, 2003-12 ($m)
- Figure 46: AIID therapy area sales by target family, 2003-12 ($m)
- Figure 47: GI therapy area sales by target family, 2003-12 ($m)
- Figure 48: Monoclonal antibody sales by target family, 2003-12 ($m)
- Figure 49: Therapeutic protein sales by target family, 2003-12 ($m)
- Figure 50: Therapeutic protein sales by target family, 2003-12 ($m)
- Figure 51: Small molecule drug sales by target family, 2003-12 ($m)
- Figure 52: Small molecule drug sales by target family, 2006-12 ($m)
- Figure 53: Vaccine sales by target family, 2003-12 ($m)
- Figure 54: 2003-12 ' launch' portfolio sales by target family ($m)
- Figure 55: 2006-12 ' launch' portfolio sales by target family ($m)
- Figure 56: 2003-12 ' core' portfolio sales by target family ($m))
- Figure 57: 2006-12 ' core' portfolio sales by target family ($m)
- Figure 58: 2003-12 ' expiry' portfolio sales by target family ($m)
- Figure 59: 2003-12 ' expiry' portfolio sales by target family ($m)
- Figure 60: Nuclear receptor and ion channel target family
characteristics
- Figure 61: Total market sales by target family, 2006 ($m)
- Figure 62: Target family 2006-12 CAGR (%)
- Figure 63: Nuclear receptor target sales by therapy area, 2006-12 ($m)
- Figure 64: Sales of diabetes & endocrinology products that act on
nuclear receptor or ion channel targets, 2003-12 ($m)
- Figure 65: Sales of women' s health products targeting nuclear
receptors, 2003-12 ($m)
- Figure 66: Ion channel sales by therapy area, 2003-12 ($m)
- Figure 67: Ion channel sales by therapy area, 2006-12 ($m)
- Figure 68: Sales of CNS therapy area products acting on ion channel
targets, 2003-12 ($m)
- Figure 69: Combined nuclear receptor & ion channel sales by
molecule type, 2003-12 ($m)
- Figure 70: Nuclear receptor & ion channel LCE profile, 2006-12 ($m)
- Figure 71: Nuclear receptor & ion channel progressive LCE profile
($m)
- Figure 72: ECS target family characteristics
- Figure 73: Total market sales by target family, 2006 ($m)
- Figure 74: Target family 2006-12 CAGR (%)
- Figure 75: Total market sales by target family, 2011-12 ($m)
- Figure 76: ECS target sales by therapy area, 2006-12 ($m)
- Figure 77: ECS target sales by therapy area, 2006-12 ($m)
- Figure 78: AIID therapy area sales by target family, 2003-12 ($m)
- Figure 79: AIID therapy area sales by target family, 2006-12 ($m)
- Figure 80: AIID therapy area sales from products acting on ECS
targets, 2003-12 ($m)
- Figure 81: Oncology therapy area sales by target type, 2003-12 ($m)
- Figure 82: ECS targets in the oncology therapy area, 2003-12 ($m)
- Figure 83: ECS target family sales by molecule type, 2003-12 ($m)
- Figure 84: ECS target family sales by molecule type, 2006-12 ($m)
- Figure 85: Proportion of target family sales by molecule type, 2006 (%)
- Figure 86: ECS target family LCE profile, 2006-12 ($m)
- Figure 87: Enzyme and GPCR target family characteristics
- Figure 88: Total market sales by target family, 2006 ($m)
- Figure 89: Target family 2006-12 CAGR (%)
- Figure 90: Total market sales by target family, 2006-12 ($m)
- Figure 91: Total market sales by target family, 2011-12 ($m)
- Figure 92: Enzyme target family sales by therapy area, 2006-12 ($m)
- Figure 93: Enzyme-targeting product sales by therapy area, 2003-12 ($m)
- Figure 94: Sales of oncology products by enzyme subfamily, 2006-12 ($m)
- Figure 95: Total enzyme target family sales by subfamily, 2006-12 ($m)
- Figure 96: GI product sales from enzyme targets, 2003-12 ($m)
- Figure 97: CV product sales from oxidoreductase targets, 2003-12 ($m)
- Figure 98: GPCR-targeting product sales by therapy area, 2003-12 ($m)
- Figure 99: GPCR target family sales by therapy area, 2006-12 ($m)
- Figure 100: Enzyme and GPCR target family sales by molecule type,
2003-12 ($m)
- Figure 101: Enzyme & GPCR target family LCE profile, 2006-12 ($m)
- Figure 102: 2006-12 ' launch' portfolio sales by target family ($m)
- Figure 103: Enzyme & GPCR target family progressive LCE profile
($m)
- Figure 104: Target family sales growth rates including ' mixed'
components, CAGR 2006-12 (%)
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