The Canadian Pharmaceutical Market Outlook to 2013: Policy environment, market structure, pipeline analysis, growth opportunities

Chapter 2 Overview of Canada 18
Summary 18
Introduction 18
The Canadian economy enters recession 20
An aging Canada 21
Disease burden in Canada – forecast to 2013 23
Arthritis 24
Asthma 24
Chronic obstructive pulmonary disease (COPD) 24
Diabetes 24
Hypertension and heart diseases 25
HIV/AIDS 25
Parkinson’s and Alzheimer’s disease 25
Cancer 25

Chapter 3 Pharmaceutical regulation,
pricing and reimbursement 28
Summary 28
Introduction 29
Pharmaceutical Regulation 30
Intellectual property rights 31
Clinical trial regulation 32
Regulatory submissions and review times 34
Marketing authorization 36
Adverse drug reaction monitoring 37
Pharmaceutical pricing 37
Pricing control policies – an industry perspective 39
Drug coverage and reimbursement 40
Formulary listing 41
Reimbursement 42
Catastrophic drug coverage plan 43
Key trends in regulation, pricing and reimbursement 43
Drug majors unperturbed by the DTCA ban 43
CanWest Mediaworks' legal suit over the DTCA 44
Higher generic drug prices cause concern of rising drug expenditure 44
Introduction of Quebec’s maximum price payable policy 45
Compulsory formulary listing leads to irrational pricing in Quebec 45
BC Pharmacare price referencing system unfriendly to branded drugs 45
Pharmaceutical task force offers hope for drug makers in BC 46
Increased co-insurance and deductibles on pharmaceutical consumption 46
COMPUS is likely to usher in a generic prescription era 46
 

Chapter 4 Pharmaceutical market structure 48
Summary 48
Introduction 49
Pharmaceutical distribution 49
Independent pharmacy distributors (IPD) 49
Self-distributors 50
Retail and hospital pharmacies 50
Independent pharmacies 50
Pharmacy groups 51
Hospital pharmacies 51
Pharmaceutical sales and market analysis 52
Drug sales by province and territory 52
Licensing trends 53
Market analysis by therapeutic area 54
Market analysis by drug classes 56
Market analysis by leading brands 57
Market analysis by key players 58
Branded drug manufacturers 60
Pfizer Canada 60
Sales analysis by therapeutic area 61
Sales analysis of leading brands 62
J&J Canada 63
Sales analysis by therapeutic area 64
Sales analysis of leading brands 66
AstraZeneca Canada 67
Sales analysis by therapeutic area 68
Sales analysis of leading brands 69
GSK Canada 70
Sales analysis by therapeutic area 71
Sales analysis of leading brands 72
Novartis Canada 73
Sales analysis by therapeutic area 74
Sales analysis of leading brands 75
Generic drug manufacturers 76
Apotex Canada 77
Sales analysis by therapeutic area 78
Sales analysis of leading brands 79
Novopharm 80
Sales analysis by therapeutic area 81
Sales analysis of leading brands 82
Canadian biopharmaceutical companies 83
Cangene 83
Product portfolio 83
Pipeline portfolio 84
AEterna Zentaris 85
Product portfolio 85
Pipeline portfolio 86
Canadian market forecast, 2007–2013 87
Market forecast by ATC classes to 2013 87
Market forecast of leading brands to 2013 88
Market forecast of leading companies to 2013 90
 

Chapter 5 Pipeline analysis 94
Summary 94
Introduction 95
Key pipeline compounds 95
Key pipeline compound of major pharmaceutical companies 95
Telaprevir 95
Isentress 97
Prevnar 13vPnC 98
Cervarix 99
Menveo 100
Effient 101
Xarelto 102
Multaq 103
Onglyza 105
Actemra 106
Denosumab 108
Vimpat 110
Telcagepant 111
Axitinib 112
Ixempra 113
Key pipeline compounds of Canadian biopharmaceutical companies 114
Overview of issues encountered by the biopharmaceutical industry 114
Urocidin 115
DM-71 117
Dirucotide 119
Voclosporin 120
Tesamorelin 122
Market forecast of pipeline compounds to 2013 124
 

Chapter 6 Appendix 128
IMS Data 128
Anatomical Therapeutic Classification (ATC) 128
C: Cardiovascular system 128
N: Nervous system 128
A: Alimentary tract and metabolism 128
L: Antineoplastic and immunomodulating agents 129
J: General anti-infectives systemic 129
R: Respiratory system 129
M: Musculo-skeletal system 129
G: Genito-urinary system and sex hormones 129
B: Blood and blood forming organs 129
D: Dermatologicals 130
T: Diagnostic agents 130
H: Systemic hormonal preparations 130
S: Sensory organs 130
V: Various 130
Licensing status as per IMS Health 130
Original brand 130
Other brand 131
Licensed brand 131
Patent N/A brands 131
Unbranded/generic product 131
Glossary 132
Index 134

List of Figures
Figure 3.1: Overview of regulation of access to drugs in Canada 30
Figure 3.2: Clinical trial regulations governed by the TPD 33
Figure 3.3: Reimbursement process 40
Figure 3.4: Formulary listing 42
Figure 4.5: Pharmaceutical sales by provinces and territories, 2006–2007 52
Figure 4.6: Sales of types of brands in Canada, 2006–2007 53
Figure 4.7: Competitive analysis of Canadian market by leading therapeutic areas, 2006–2007 55
 

List of Tables
Table 2.1: Socioeconomic indicators, 2007 20
Table 2.2: Demographic indicators, 2007 21
Table 2.3: Forecast epidemiology in Canada 23
Table 3.4: Different forms of regulatory submission in Canada 34
Table 3.5: Review times of major drugs approved after January 2005 35
Table 3.6: PMPRB drug categories 38
Table 4.7: Canadian market by therapeutic area, 2006–2007 54
Table 4.8: Leading drug classes in the Canadian market, 2006–2007 56
Table 4.9: Leading brands in the Canadian market, 2006–2007 57
Table 4.10: Key players in the Canadian market, 2006–2007 58
Table 4.11: Ranking of companies across ATC classes in Canada by sales 2007 ($m) 59
Table 4.12: Pfizer sales by therapeutic areas, 2006–2007 61
Table 4.13: Leading brands of Pfizer, 2006–2007 62
Table 4.14: J&J sales by therapeutic areas, 2006–2007 64
Table 4.15: Leading brands of J&J, 2006–2007 66
Table 4.16: AstraZeneca sales by therapeutic areas, 2006–2007 68
Table 4.17: Leading brands of AstraZeneca, 2006–2007 69
Table 4.18: GlaxoSmithKline sales by therapeutic areas, 2006–2007 71
Table 4.19: Leading brands of GlaxoSmithKline, 2006–2007 72
Table 4.20: Novartis sales by therapeutic areas, 2006–2007 74
Table 4.21: Leading brands of Novartis, 2006–2007 75
Table 4.22: Apotex sales by therapeutic areas, 2006–2007 78
Table 4.23: Leading brands of Apotex, 2006–2007 79
Table 4.24: Novopharm sales by therapeutic areas, 2006–2007 81
Table 4.25: Leading brands of Novopharm, 2006–2007 82
Table 4.26: Pipeline portfolio of Cangene 84
Table 4.27: Pipeline portfolio of AEterna Zentaris 86
Table 4.28: ATC sales forecast, 2008–13 87
Table 4.29: Leading brands sales forecast, 2008–13 88
Table 4.30: ATC sales forecast, 2008–13 90
Table 5.31: An overview of telaprevir 95
Table 5.32: An overview of Isentress 97
Table 5.33: An overview of Prevnar 13vPnC 98
Table 5.34: An overview of Cervarix 99
Table 5.35: An overview of Menveo 100
Table 5.36: An overview of Effient 101
Table 5.37: An overview of Xarelto 102
Table 5.38: An overview of Multaq 103
Table 5.39: An overview of Onglyza 105
Table 5.40: An overview of Actemra 106
Table 5.41: An overview of denosumab 108
Table 5.42: An overview of Vimpat 110
Table 5.43: An overview of Telcagepant 111
Table 5.44: Results of Phase III trial of telcagepant in migraine 111
Table 5.45: An overview of axitinib 112
Table 5.46: An overview of Ixempra 113
Table 5.47: An overview of Urocidin 115
Table 5.48: An overview of DM-71 117
Table 5.49: An overview of Dirucotide 119
Table 5.50: An overview of voclosporin 120
Table 5.51: An overview of Tesamorelin 122
Table 5.52: Pipeline sales forecast, 2008–13 124