CHAPTER 1 EXECUTIVE SUMMARY 4
Scope of the report 4
Key findings 5
CHAPTER 2 OVERVIEW OF THE CANADIAN GENERICS MARKET 8
Scope 8
Introduction to the Canadian pharmaceutical market 8
Canada's pharmaceutical market has experienced double-digit prescription sales growth since 2002 8
The generics market represents a significant proportion of both prescription volume and total market value 11
Key issues affecting the Canadian generics market 14
The establishment of the Canadian generics market 14
Differences in healthcare environment and cost-containment initiatives between provinces increase the complexity of operating in the Canadian generics market 14
Key drivers and resistors impacting the Canadian Generics Market 15
A range of resistors impact generic market growth 16
Market exclusivity extension: generics companies must wait longer for generic entry 16
Pseudo-generics: inhibiting 'real' generic growth 17
A number of drivers are helping to drive generics market growth in Canada 18
Compulsory licensing for export to developing countries: theoretically an opportunity for generic growth, but in practice proving complex 18
High cost of generic drugs in Canada relative to rest of world favors generic manufacturers 19
Early working exception policy accelerating speed to market for generic drugs in Canada 21
Biosimilars - a potential new industry 21
CHAPTER 3 KEY GENERICS COMPANIES OPERATING IN THE CANADIAN MARKET 23
Introduction 23
Apotex - the largest Canadian-owned generics manufacturer in Canada 24
Overview 24
Company strategy 24
Speed to market 25
Patent challenges 25
Diversification into biosimilars 26
Access to niche markets via Cangene 26
Diversification into proprietary drugs 26
Apotex's domestic position 27
Company outlook 27
Teva 28
Overview 28
Company strategy 28
First to file patent challenges 28
Good distribution infrastructure in Canada 29
Proprietary drug development 29
Expansion into biosimilar market 29
Company outlook 30
Merck KGaA (Merck Serono) 30
Overview 30
Company strategy 30
Growing pipeline 31
Diversification into more specialist areas 31
Geographic growth by M&A 32
Company outlook 32
ratiopharm 32
Overview 32
Company strategy 33
Geographical expansion 33
Expansion into controlled release delivery market 33
Expansion into biosimilar market 34
Pharmascience - the second largest Canadian-owned generics manufacturer 34
Overview 34
Company strategy 35
Pipeline expansion 35
Manufacturing facilities 35
International ventures 35
Diversification into OTC business 35
Company outlook 36
Other generic pharmaceutical companies 36
Cobalt Pharma 36
Stiefel Laboratories 36
Axcan Pharma 37
Mayne Pharma 37
Ranbaxy 37
Taro Pharmaceuticals 37
Sandoz (Novartis) 38
CHAPTER 4 BIBLIOGRAPHY 39
List of Tables
Table 1: Estimates of Canadian market size, 2003 and 2005 10
Table 2: Comparison of drug sales per capita 11
List of Figures
Figure 1: Ethical sales in Canada 2003-05: $5 billion increase in prescription sales 9
Figure 2: Total market sales and generic sector sales 2002-05 12
Figure 3: The generic market share as a percentage of total pharmaceutical sales varies across markets 13
Figure 4: Key issues in Canadian generic industry, 2007 16
Figure 5: Purpose of launching pseudo-generics/licensed generics globally 17