Healthcare, Regulatory and Reimbursement Landscape - Canada · SAMPLE. Healthcare, Regulatory and...

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Healthcare, Regulatory and Reimbursement Landscape

Canada

Reference Code: GDHC0023CHR Publication Date: September 2012

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Healthcare, Regulatory and Reimbursement Landscape - Canada

GDHC0023CHR / Published SEP 2012

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form

The rising elderly population and increasing birth rate

and associated disease burden adds to the economic

challenges faced by the Canadian government.

Population Distribution by Age Group, Canada (%), 2005-2020

Source: GlobalData; Statistics Canada, 2012e

The Canadian healthcare market is a mature market

driven by universal healthcare coverage and high access

to healthcare facilities; an increasing elderly population

and the associated disease burden, well-defined

regulatory guidelines, and new drug launches will drive

the growth of Canadian pharmaceutical market.

Pharmaceutical Market, Canada ($bn), 2005-2020

Source: GlobalData; CIHI, 2012; PMPRB, 2012b

* Estimated figures

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Medical Device Market, Canada ($bn), 2006-2020

Source: GlobalData, Medical eTrack [Accessed May 9, 2012]

* Estimated figures

The regulatory authority of Canada provides a

transparent, strong and efficient regulatory system to

facilitate the approval of pharmaceutical products and

medical devices; strong regulatory systems attract

foreign pharmaceutical and medical device companies

and positively influence the growth prospects of the

Canadian healthcare market.

Universal healthcare coverage and easy access to

healthcare facilities and reimbursement are the most

distinguishing features of the Canadian healthcare

system

Country Profile, Canada, 2012

Source: GlobalData

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1 Table of Contents

1 Table of Contents .................................................................................................................................. 4 1.1 List of Tables .................................................................................................................................. 6 1.2 List of Figures ................................................................................................................................. 8

2 Introduction ..........................................................................................................................................10 2.1 GlobalData Report Guidance .........................................................................................................10

3 Overview of the Pharmaceutical and Medical Devices Market .............................................................11 3.1 Pharmaceutical Market ..................................................................................................................11

3.1.1 Market Overview ...................................................................................................................11 3.1.2 Supply Channel ....................................................................................................................14 3.1.3 Pricing...................................................................................................................................14 3.1.4 Market Segments .................................................................................................................16 3.1.5 Major Disease Areas ............................................................................................................20 3.1.6 Major Players ........................................................................................................................22

3.2 Medical Device Market ..................................................................................................................49 3.2.1 Market Overview ...................................................................................................................49 3.2.2 Overview of Top Five Segments ...........................................................................................51 3.2.3 Major Players ........................................................................................................................62

3.3 Market Drivers and Barriers ...........................................................................................................81 3.3.1 Drivers ..................................................................................................................................81 3.3.2 Barriers .................................................................................................................................81

4 Market Access ......................................................................................................................................83 4.1 Overview of the Healthcare System ...............................................................................................83 4.2 Reimbursement and Payer Landscape ..........................................................................................83

4.2.1 Drug Reimbursement Process ..............................................................................................83 4.2.2 Overview of Insurance Providers ..........................................................................................85 4.2.3 Patient Share in Healthcare Spending ..................................................................................87 4.2.4 Patented Drug Price Trend ...................................................................................................88 4.2.5 Pricing Policies .....................................................................................................................88

4.3 Regulatory Landscape ...................................................................................................................89 4.3.1 Overview of Regulatory Agencies .........................................................................................89 4.3.2 New Drug Approval Process .................................................................................................90 4.3.3 New Medical Device Approval Process ................................................................................94 4.3.4 Licensing Process for Pharmaceutical Manufacturing ..........................................................97 4.3.5 Licensing Process for Pharmaceutical Exports and Imports .................................................98 4.3.6 Patent Application Process ...................................................................................................99 4.3.7 Clinical Trial Regulations ....................................................................................................101 4.3.8 Pharmaceutical Advertising Regulations ............................................................................103 4.3.9 Pharmacy Regulations .......................................................................................................103 4.3.10 Labeling and Packaging Regulations .................................................................................104

5 Country Analysis ................................................................................................................................106 5.1 Political Environment ...................................................................................................................106

5.1.1 Political Structure ................................................................................................................106 5.1.2 Analysis of Current Political Environment ...........................................................................107 5.1.3 Healthcare Policy Initiatives ................................................................................................107

5.2 Economic Landscape ..................................................................................................................108 5.3 Economic Indicators ....................................................................................................................109

5.3.1 Gross Domestic Product .....................................................................................................109 5.3.2 Gross National Income .......................................................................................................113 5.3.3 Inflation ...............................................................................................................................114 5.3.4 Currency Exchange Rate....................................................................................................118 5.3.5 Foreign Direct Investment...................................................................................................119 5.3.6 Foreign Exchange Reserves ..............................................................................................120 5.3.7 Trade Balance ....................................................................................................................121 5.3.8 General Government Structural Balance ............................................................................123 5.3.9 General Government Net Debt ...........................................................................................124 5.3.10 Major Industries ..................................................................................................................126

5.4 Demographics..............................................................................................................................128 5.4.1 Population ...........................................................................................................................128

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5.4.2 Education and Literacy .......................................................................................................145 5.4.3 Employment ........................................................................................................................147 5.4.4 Disease Burden ..................................................................................................................148

5.5 Healthcare Infrastructure .............................................................................................................150 5.5.1 Healthcare Facilities ...........................................................................................................150 5.5.2 Healthcare Parameters .......................................................................................................159 5.5.3 Environmental Health .........................................................................................................162 5.5.4 Healthcare Personnel .........................................................................................................164

5.6 Healthcare Expenditures .............................................................................................................165 5.6.1 Overview.............................................................................................................................165 5.6.2 Major Components of Healthcare Spending .......................................................................166 5.6.3 Share of Public and Private Sectors ...................................................................................167 5.6.4 Pharmaceutical R&D Expenditures ....................................................................................169

5.7 Trade Associations ......................................................................................................................170 5.7.1 Canadian Pharmacists Association (CPhA) ........................................................................170 5.7.2 Canadian Association of Professional Regulatory Affairs (CAPRA) ...................................170 5.7.3 Canada Society for Pharmaceutical Sciences (CSPS) .......................................................170 5.7.4 Canadian Society of Hospital Pharmacists (CSHP) ............................................................170 5.7.5 Canadian Generic Pharmaceutical Association (CGPA) ....................................................170

5.8 Trade Fairs ..................................................................................................................................171 6 Opportunities and Challenges ............................................................................................................172

6.1 Opportunities ...............................................................................................................................172 6.2 Challenges ...................................................................................................................................172

7 Appendix ............................................................................................................................................174 7.1 Abbreviations ...............................................................................................................................174 7.2 Bibliography .................................................................................................................................177 7.3 Methodology ................................................................................................................................182

7.3.1 Coverage ............................................................................................................................182 7.3.2 Secondary Research ..........................................................................................................182 7.3.3 Forecasting .........................................................................................................................182 7.3.4 Primary Research ...............................................................................................................183 7.3.5 Expert Panel Validation ......................................................................................................183

7.4 Disclaimer ....................................................................................................................................183

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1.1 List of Tables

Table 1: Pharmaceutical Market ($bn), Canada, 2005-2010 ..................................................................12 Table 2: Pharmaceutical Market ($bn), Canada, Forecast, 2011-2020 ..................................................13 Table 3: Classification of Drugs Canada .................................................................................................14 Table 4: Wholesale Mark-Up Charge, Canada, 2012 .............................................................................15 Table 5: Generic Pharmaceuticals, Canada, Revenue ($bn), 2005-2010 ...............................................16 Table 6: Biologics Pharmaceuticals, Canada, Revenue ($bn), 2005-2010 .............................................17 Table 7: Biologics Pharmaceuticals, Canada, Revenue ($bn), 2011-2020 .............................................18 Table 8: OTC Drugs Market, Canada, Revenue ($bn), 2005-2010 .........................................................19 Table 9: Major Disease Areas for Patented Drugs, Canada, Market Share (%), 2010 ...........................20 Table 10: Major Products, Pfizer, Global, Revenue ($m), 2011 ................................................................23 Table 11: Late-Stage Pipeline, Pfizer, 2012..............................................................................................23 Table 12: Major Products, GlaxoSmithKline, Global, Revenue ($m), 2011 ..............................................28 Table 13: Late-Stage Pipeline, GlaxoSmithKline, 2012 ............................................................................29 Table 14: Major Products, Sanofi, Global, Revenue ($m), 2011 ...............................................................34 Table 15: Late-Stage Pipeline, Sanofi, 2012.............................................................................................34 Table 16: Major Products, AstraZeneca, Global, Revenue ($m), 2011 .....................................................38 Table 17: Late-Stage Pipeline, AstraZeneca, 2012 ..................................................................................39 Table 18: Major Products, Apotex, Global, 2012 ......................................................................................44 Table 19: Potential Generic Products, Apotex, 2012 ................................................................................46 Table 20: Medical Device Market ($bn), Canada, 2006-2011 ...................................................................49 Table 21: Medical Device Market ($bn), Canada, Forecast, 2012-2020 ...................................................50 Table 22: Medical Device Market, Canada, Segments, Revenue ($m), 2011...........................................51 Table 23: Ophthalmic Devices Market ($m), Canada, 2006-2011 ............................................................52 Table 24: Sales Trends for Major Players*, Ophthalmic Devices, Canada, 2010 .....................................53 Table 25: Orthopedic Devices Market ($m), Canada, 2006-2011 .............................................................54 Table 26: Sales Trends for Major Players*, Orthopedic Devices, Canada, 2010 ......................................55 Table 27: Cardiovascular Devices Market ($m), Canada, 2006-2011 ......................................................56 Table 28: Sales Trends for Major Players*, Cardiovascular Devices, Canada, 2010 ...............................57 Table 29: In Vitro Diagnostics Market ($m), Canada, 2006-2011 .............................................................58 Table 30: Sales Trends for Major Players*, In Vitro Diagnostics, Canada, 2010 ......................................59 Table 31: Drug Delivery Devices Market ($m), Canada, 2006-2011 .........................................................60 Table 32: Sales Trends for Major Players*, Drug Delivery Devices, Canada, 2010 ..................................61 Table 33: Major Medical Device Companies, Canada, Revenue ($m), 2010 ...........................................62 Table 34: Major Products, Medtronic, Global, Revenue ($m), 2011 .........................................................63 Table 35: Major Products, Siemens, Global, Revenue ($m), 2010 ...........................................................67 Table 36: Major Segments, Essilor International, Global, Revenue ($m), 2010 .......................................70 Table 37: Major Products, GlaxoSmithKline, Global, Revenue ($m), 2010 ..............................................73 Table 38: Levels of Therapeutic Improvement, 2012 ................................................................................84 Table 39: PharmaCare Plans, 2011 ..........................................................................................................85 Table 40: Healthcare Spending, Canada, Patient's Share (%), 2005-2010 ..............................................87 Table 41: Change in Average Price of Patented Drugs (%), Canada, 2005-2010 ....................................88 Table 42: Target Review Times for New Drug Submissions, Canada, 2012 ............................................91 Table 43: Therapeutic Product Submissions to HPFB, Canada, 2010 .....................................................93 Table 44: New Drug Submission Review Decisions, Canada, 2010 .........................................................93 Table 45: Fees for Review of Drug Submissions and Applications, 2012 .................................................94 Table 46: Classes of Medical Devices, 2006 ............................................................................................94 Table 47: Medical Device Licensing Fees (CAD$), Canada, 2012 ...........................................................97 Table 48: Medical Device Licensing, Canada, Time Period, 2012 ............................................................97 Table 49: Target Performance Standings for Drug Submission Review, Canada, 2011 .........................103 Table 50: GDP Per Capita ($), Canada, 2005-2010 ...............................................................................110 Table 51: GDP Per Capita ($), Canada, Forecast, 2011-2020 ...............................................................110 Table 52: GDP, Canada, Annual Growth (%), 2005-2010 ......................................................................111 Table 53: GDP, Canada, Annual Growth (%), Forecast, 2011-2020 ......................................................112 Table 54: GNI Per Capita ($), Canada, 2006-2011 .................................................................................113 Table 55: Average Consumer Price Index, Canada, 2005-2010.............................................................114 Table 56: Average Consumer Price Index, Canada, Forecast, 2011-2020 .............................................115 Table 57: Average Consumer Price, Canada, Annual Change (%), 2005-2010 .....................................116 Table 58: Inflation by Commodity, Canada, 2005-2010 ..........................................................................117 Table 59: Currency Exchange Rate (USD/CAD), Canada, 2006-2011 ...................................................118 Table 60: Foreign Direct Investment ($bn), Canada, 2006-2011 ............................................................119 Table 61: Foreign Exchange Reserves ($bn), Canada, 2006-2011 ........................................................120 Table 62: Imports of Goods and Services ($bn), Canada, 2005-2010 ....................................................121

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Table 63: Exports of Goods and Services ($bn), Canada, 2005-2010 ....................................................122 Table 64: General Government Structural Balance ($bn), Canada, 2005-2010 .....................................123 Table 65: General Government Net Debt ($bn), Canada, 2005-2010 ....................................................124 Table 66: General Government Net Debt ($bn), Canada, Forecast, 2011-2020 ....................................125 Table 67: Major Goods Producing Industries, Canada, Gross Output ($m), 2010 ..................................126 Table 68: Major Service-Producing Industries, Canada, Gross Output ($m), 2010 ................................127 Table 69: Population (millions), Canada, 2006-2011 ..............................................................................128 Table 70: Population (millions), Canada, Forecast, 2012-2020 ..............................................................129 Table 71: Urban and Rural Population, Canada, Share (%), 2005-2010 ................................................130 Table 72: Age Groups, Canada, Population Distribution (%), 2005-2010 ...............................................131 Table 73: Age Groups, Canada, Population Distribution (%), Forecast, 2011-2020 ...............................132 Table 74: Births (Per 1000 Population), Canada, 2005-2010 .................................................................133 Table 75: Births (per 1000 Population), Canada, Forecast, 2011-2020 ..................................................134 Table 76: Mortality (Per 1000 Population), Canada, 2005-2010 .............................................................135 Table 77: Major Causes of Mortality (‗000), Canada, 2008 .....................................................................136 Table 78: Children <5 Years Age, Canada, Mortality (Per 1000 Live Births), 2005-2010 .......................137 Table 79: Immunization Rate for Measles and DPT in Children < 1 Years (%), Canada, 2005-2010 .....138 Table 80: Immunization Rate for Influenza in Population > 65 year (%), Canada, 2005-2010 ................139 Table 81: Major Causes of Male Mortality (‗000), Canada, 2008 ............................................................140 Table 82: Major Causes of Female Mortality (‗000), Canada, 2008 ........................................................141 Table 83: Gender Ratio (M/F), Canada, 2005-2010 ...............................................................................142 Table 84: Life Expectancy at Birth (Years), Canada, 2005-2010 ............................................................143 Table 85: Life Expectancy at Birth (Years), Canada, Forecast, 2011-2020 ............................................144 Table 86: Part time and Full-time University Students (‗000s), Canada, 2005-2010...............................145 Table 87: University Graduation Rate (%), Canada, 2005-2010 .............................................................146 Table 88: Unemployment Rate (%), Canada, 2005-2010 .......................................................................147 Table 89: Major Diseases, Canada, Patients in Residential Care (‗000s), 2010-2011 ............................148 Table 90: Major Diseases, Canada, DALYs (Per 100,000 Population), 2004 .........................................149 Table 91: Hospitals, Canada, 2005-2010 ...............................................................................................150 Table 92: Residential Healthcare Facilities by Type of Patients, Canada, 2009 .....................................151 Table 93: Residential Care Facilities by Type of Ownership, Canada, 2009 ..........................................152 Table 94: Hospital Beds, Canada, 2005-2010 ........................................................................................153 Table 95: Beds in Residential Healthcare Facilities by Type of Ownership, Canada, 2009 ....................154 Table 96: Hospital Beds by Type of Care, Canada, 2005-2008 ..............................................................155 Table 97: CT Scanners (per Million Population), Canada, 2005-2010 ....................................................156 Table 98: MRI Machines (per Million Population), Canada, 2005-2010 ..................................................157 Table 99: PET Scanners (per Million Population), Canada, 2005-2010 ..................................................158 Table 100: Hospital Beds (Per 1000 Population), Canada, 2005-2010 ....................................................159 Table 101: Physicians (per 100,000 Population), Canada, 2005-2010 .....................................................160 Table 102: General Practitioners (per 100,000 Population), Canada, 2005-2010 ....................................161 Table 103: PM10 (Thousand Tons), Canada, 2005-2010 .........................................................................162 Table 104: CO2 Emissions (Metric Tons), Canada, 2005-2010 ................................................................163 Table 105: Healthcare Workforce (per 100,000 Population), Canada, 2010 ............................................164 Table 106: Healthcare Expenditures (% of GDP), Canada, 2005-2010 ....................................................165 Table 107: Healthcare Expenditures, Canada, Share of Major Components (%), 2009 ...........................166 Table 108: Healthcare Expenditures, Canada, Public-Private Share (%), 2005-2010 ..............................167 Table 109: Healthcare Expenditures, Canada, Share of Financing Agents (%), 2009..............................168 Table 110: Pharmaceutical R&D Expenditures ($m), Canada, 2005-2010 ...............................................169 Table 111: Major Healthcare Trade Fairs, Canada, 2012 .........................................................................171

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1.2 List of Figures

Figure 1: Pharmaceutical Market ($bn), Canada, 2005-2010 ..................................................................12 Figure 2: Pharmaceutical Market ($bn), Canada, Forecast, 2011-2020 ..................................................13 Figure 3: Pharmaceutical Distribution Channel, Canada, 2010................................................................14 Figure 4: Generic Pharmaceuticals, Canada, Revenue ($bn), 2005-2010 ...............................................16 Figure 5: Biologics Pharmaceuticals, Canada, Revenue ($bn), 2005-2010 .............................................17 Figure 6: Biologics Pharmaceuticals, Canada, Revenue ($bn), 2011-2020 .............................................18 Figure 7: OTC Drugs Market, Canada, Revenue ($bn), 2005-2010 .........................................................19 Figure 8: Major Disease Areas by Sales of Patented Drug Products, Canada ($bn), 2010 .....................20 Figure 9: Medical Device Market, Canada, 2006-2011 ............................................................................49 Figure 10: Medical Device Market, Canada, Forecast, 2012-2020 ............................................................50 Figure 11: Medical Device Market, Canada, Segments, Revenue ($m), 2011...........................................51 Figure 12: Ophthalmic Devices Market ($m), Canada, 2006-2011 ............................................................52 Figure 13: Sales Trends for Major Players, Ophthalmic Devices, Canada, 2006-2010 .............................53 Figure 14: Orthopedic Devices Market ($m), Canada, 2006-2011 .............................................................54 Figure 15: Sales Trends for Major Players, Orthopedic Devices, Canada, 2006-2010 ..............................55 Figure 16: Cardiovascular Devices Market ($m), Canada, 2006-2011 ......................................................56 Figure 17: Sales Trends for Major Players, Cardiovascular Devices, Canada, 2006-2010 ........................57 Figure 18: In Vitro Diagnostics Market ($m), Canada, 2006-2011 .............................................................58 Figure 19: Sales Trends for Major Players, In Vitro Diagnostics Devices, Canada, 2006-2010 .................59 Figure 20: Drug Delivery Devices Market ($m), Canada, 2006-2011 .........................................................60 Figure 21: Sales Trends for Major Players, Drug Delivery Devices, Canada, 2006-2010 ..........................61 Figure 22: Major Medical Device Companies, Canada, Revenue ($m), 2010 ...........................................62 Figure 23: Drivers and Barriers, Healthcare Market, Canada, 2011 ..........................................................82 Figure 24: Drug Reimbursement Process, Canada ...................................................................................84 Figure 25: New Patented Drug Review Process, Canada, 2012................................................................85 Figure 26: Healthcare Spending, Canada, Patient's Share (%), 2005-2010 ..............................................87 Figure 27: Change in Average Price of Patented Drugs (%), Canada, 2005-2010 ....................................88 Figure 28: Health Products and Food Branch, Organization Chart, Canada .............................................89 Figure 29: New Drug Approval Process, Canada, 2012 ............................................................................92 Figure 30: New Drug Submission Review Decisions, Canada, 2010 .........................................................93 Figure 31: Medical Device Approval Process, Canada, 2012 ....................................................................96 Figure 32: Patent Approval Process, Canada, 2011 ................................................................................100 Figure 33: Clinical Trial Regulation Process, Canada, 2011 ....................................................................102 Figure 34: GDP Per Capita ($), Canada, 2005-2010 ...............................................................................109 Figure 35: GDP Per Capita ($), Canada, Forecast, 2011-2020 ...............................................................110 Figure 36: GDP, Canada, Annual Growth (%), 2005-2010 ......................................................................111 Figure 37: GDP, Canada, Annual Growth (%), Forecast, 2011-2020 ......................................................112 Figure 38: GNI Per Capita ($), Canada, 2006-2011 .................................................................................113 Figure 39: Average Consumer Price Index, Canada, 2005-2010.............................................................114 Figure 40: Average Consumer Price Index, Canada, Forecast, 2011-2020 .............................................115 Figure 41: Average Consumer Price, Canada, Annual Change (%), 2005-2010 .....................................116 Figure 42: Inflation by Commodity, Canada, 2005-2010 ..........................................................................117 Figure 43: Currency Exchange Rate (USD/CAD), Canada, 2006-2011 ...................................................118 Figure 44: Foreign Direct Investment ($bn), Canada, 2006-2011 ............................................................119 Figure 45: Foreign Exchange Reserves ($bn), Canada, 2006-2011 ........................................................120 Figure 46: Imports of Goods and Services ($bn), Canada, 2005-2010 ....................................................121 Figure 47: Exports of Goods and Services ($bn), Canada, 2005-2010 ....................................................122 Figure 48: General Government Structural Balance ($bn), Canada, 2005-2010 .....................................123 Figure 49: General Government Net Debt ($bn), Canada, 2005-2010 ....................................................124 Figure 50: General Government Net Debt ($bn), Canada, Forecast, 2011-2020 ....................................125 Figure 51: Major Goods Producing Industries, Canada, Gross Output ($m), 2010 ..................................126 Figure 52: Major Service-Producing Industries, Canada, Gross Output ($m), 2010 ................................127 Figure 53: Population (millions), Canada, 2006-2011 ..............................................................................128 Figure 54: Population (millions), Canada, Forecast, 2012-2020 ..............................................................129 Figure 55: Urban and Rural Population, Canada, Share (%), 2005-2010 ................................................130 Figure 56: Age Groups, Canada, Population Distribution (%), 2005-2010 ...............................................131 Figure 57: Age Groups, Canada, Population Distribution (%), Forecast, 2011-2020 ...............................132 Figure 58: Births (Per 1000 Population), Canada, 2005-2010 .................................................................133 Figure 59: Births (per 1000 Population), Canada, Forecast, 2011-2020 ..................................................134 Figure 60: Mortality (Per 1000 Population), Canada, 2005-2010 .............................................................135 Figure 61: Major Causes of Mortality (‗000s), Canada, 2008 ...................................................................136

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Figure 62: Children <5 Years Age, Canada, Mortality (Per 1000 Live Births), 2005-2010 .......................137 Figure 63: Immunization Rate for Measles and DPT in Children < 1 years (%), Canada, 2005-2010 .....138 Figure 64: Immunization Rate for Influenza in Population > 65 Years (%), Canada, 2005-2010 .............139 Figure 65: Major Causes of Male Mortality (‗000), Canada, 2008 ............................................................140 Figure 66: Major Causes of Female Mortality (‗000), Canada, 2008 ........................................................141 Figure 67: Gender Ratio (M/F), Canada, 2005-2010 ...............................................................................142 Figure 68: Life Expectancy at Birth (Years), Canada, 2005-2010 ............................................................143 Figure 69: Life Expectancy at Birth (Years), Canada, Forecast, 2011-2020 ............................................144 Figure 70: Part-time and Full-time University Students (‗000s), Canada, 2005-2010 ..............................145 Figure 71: University Graduation Rate (%), Canada, 2005-2010 .............................................................146 Figure 72: Unemployment Rate (%), Canada, 2005-2010 .......................................................................147 Figure 73: Major Diseases, Canada, Patients in Residential Care (‗000s), 2010-2011 ............................148 Figure 74: Major Diseases, Canada, DALYs (Per 100,000 Population), 2004 .........................................149 Figure 75: Hospitals, Canada, 2005-2010 ...............................................................................................150 Figure 76: Residential Healthcare Facilities by Type of Patients, Canada, Share (%), 2009 ...................151 Figure 77: Residential Care Facilities by Type of Ownership, Canada, 2009 ..........................................152 Figure 78: Hospital Beds, Canada, 2005-2010 ........................................................................................153 Figure 79: Beds in Residential Healthcare Facilities by Type of Ownership, Canada, 2009 ....................154 Figure 80: Hospital Beds by Type of Care, Canada, 2005-2008 ..............................................................155 Figure 81: CT Scanners (per Million Population), Canada, 2005-2010 ....................................................156 Figure 82: MRI Machines (per Million Population), Canada, 2005-2010 ..................................................157 Figure 83: PET Scanners (per Million Population), Canada, 2005-2010 ..................................................158 Figure 84: Hospital Beds (per 1000 Population), Canada, 2005-2010 .....................................................159 Figure 85: Physicians (per 100,000 Population), Canada, 2005-2010 .....................................................160 Figure 86: General Practitioners (per 100,000 Population), Canada, 2005-2010 ....................................161 Figure 87: PM10 (Thousand Tons), Canada, 2005-2010 .........................................................................162 Figure 88: CO2 Emissions (Metric Tons), Canada, 2005-2010 ................................................................163 Figure 89: Healthcare Workforce (Per 100,000 Population), Canada, 2010 ............................................164 Figure 90: Healthcare Expenditures (% of GDP), Canada, 2005-2010 ....................................................165 Figure 91: Healthcare Expenditures, Canada, Share of Major Components (%), 2009 ...........................166 Figure 92: Healthcare Expenditures, Canada, Public-Private Share (%), 2005-2010 ..............................167 Figure 93: Healthcare Expenditures, Canada, Share of Financing Agents (%), 2009..............................168 Figure 94: Pharmaceutical R&D Expenditures ($m), Canada, 2005-2010 ...............................................169 Figure 95: Opportunities and Challenges, Healthcare Market, Canada, 2011 .........................................173

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2 Introduction

2.1 GlobalData Report Guidance

The report begins with an ―Executive Summary,‖ which provides an overview of the healthcare

market of Canada and the key factors driving this market. The ―Executive Summary‖ also provides a

snapshot of the demographic, regulatory, and reimbursement landscape, as well as the healthcare

infrastructure of Canada.

The ―Overview of the Pharmaceutical and Medical Devices Market‖ chapter provides an overview of

the pharmaceutical and medical device market of Canada, including the market size, market

segmentation by generics, over-the-counter (OTC) and biologics/biosimilar products, and the key

drivers and barriers for the market. The section also includes profiles of the major players, including a

SWOT assessment.

The ―Market Access‖ chapter covers the reimbursement and payer landscape, as well as the

regulatory landscape. The reimbursement and payer landscape elaborates on the features of the

healthcare reimbursement process for Canada. It includes details of the reimbursement process, the

insurance providers, pricing policies, and drug price trends in the country. The regulatory landscape

section provides an overview of the regulatory agencies and approval processes for new drugs and

medical devices. The licensing process for the manufacturing and export/import of pharmaceuticals,

the regulations for pharmaceutical advertising, labeling and packaging and clinical trials, and an

overview of the landscape for intellectual property rights are also covered in this chapter.

The ―Country Analysis‖ chapter provides a detailed analysis of the political and economic

environment of Canada. It analyses the economic indicators, demographics, healthcare infrastructure

and healthcare expenditures of Canada.

The ―Opportunities and Challenges‖ chapter provides an overview of the opportunities and

challenges for growth that exist in the healthcare market of Canada.

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GDHC0023CHR / Published SEP 2012 Page 83


4 Market Access

4.1 Overview of the Healthcare System

4.2 Reimbursement and Payer Landscape

4.2.1 Drug Reimbursement Process

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Figure 24: Drug Reimbursement Process, Canada

Source: GlobalData; ISPOR, 2011

The PMPRB’s New Patented Drug Review Process

Table 38: Levels of Therapeutic Improvement, 2012

S.No. Name Definition Recommendation

1.

2.

3.

4.

Source: GlobalData; PMPRB, 2012c

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Figure 25: New Patented Drug Review Process, Canada, 2012

Source: GlobalData; PMPRB, 2012c

4.2.2 Overview of Insurance Providers

4.2.2.1 Public Insurance

Table 39: PharmaCare Plans, 2011

Plan Description

Source: GlobalData; Ministry of Health, 2011

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7 Appendix

7.1 Abbreviations

ADP: Assistive Devices Program

AESGP: Association of the European Self-Medication Industry

ANDA: Abbreviated New Drug Application

ANDS: Abbreviated New Drug Submission

ASC: Advertising Standards Canada

BGM: Blood Glucose Monitoring

BKA: Bundeskartellamt

BMS: Bristol-Myers Squibb

BPH: Benign Prostatic Hyperplasia

CADTH: Canadian Agency for Drugs and Technologies in Health

CAGR: Compounded Annual Growth Rate

CAPDM: Canadian Association of Pharmacy Distribution

CAPRA: Canadian Association of Professional Regulatory Affairs

CDR: Common Drug Review

CGM: Continuous Glucose Monitor

cGMP: Current Good Manufacturing Practice

CGPA: Canadian Generic Pharmaceutical Association

CHA: Canada Health Act

CIHI: Canadian Institute for Health Information

CIHR: Canadian Institutes of Health Research

CIPO: Canadian Intellectual Property Office

CMDCAS: Canadian Medical Devices Conformity Assessment System

CMS: Centers for Medicare & Medicaid Services

CNS: Central Nervous System

COPD: Chronic Obstructive Pulmonary Disease

CPhA: Canadian Pharmacists Association

CPI: Consumer Price Index

CR: Central Registry

CRDM: Cardiac Rhythm Disease Management

CSHP: Canadian Society of Hospital Pharmacists

CSPS: Canada Society for Pharmaceutical Sciences

CT: Computed Tomography

CTA: Clinical Trial Application

CTA-As: Clinical Trial Application-Amendments

cTnl: Cardiac Troponin

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CVD: Cardiovascular Disease

DALYs: Disability Adjusted Life Years

DBS: Deep Brain Stimulation

DEA: Drug Enforcement Administration

DHHS: Department of Health and Human Services

DIN: Drug Identification Number

DIN-HM: Drug Identification number - Homeopathic Medicine

DMHI: Department of Measurement and Health Information

DPT: Diphtheria Tetanus Pertussis

DRL: Dr. Reddy‘s Laboratories

EHR: Electronic Health Record

EMA: European Medicines Agency

ETS: Environmental Tobacco Smoke

EU: European Commission

EU: European Union

FDA: Food and Drug Administration

FDAAA: Food and Drug Administration Amendments Act

FDI: Foreign Direct Investment

FTA: Free Trade Agreement

GAVI: Global Alliance for Vaccines and Immunization

GDP: Gross Domestic Product

GERD: Gastroesophageal Reflux Disease

GENT: Dimension Vista Gentamicin

GMP: Good Manufacturing Practices

GMS: Global Manufacturing and Supply

GNI: Gross National Income

GSK: GlaxoSmithKline

HCV: Hepatitis C Virus

HDAP: Human Drug Advisory Panel

HPFB: Health Products and Food Branch

IC: Interventional Cardiology

ICD: Implantable Cardioverter Defibrillator

IDA: Industrial Development Agency

IMF: International Monetary Fund

IMGs: International Medical Graduates

ISO: International Organization for Standardization

ISPOR: International Society for Pharmacoeconomics and Outcomes Research

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MDB: Medical Devices Bureau

MHPD: Marketed Health Products Directorate

MIS: Minimally Invasive Solution Procedures

MMV: Medicines for Malaria Venture

MoHs: Ministries of Health

MPPs: Members of Provincial Parliament

MPs: Members of Parliament

MRI: Magnetic Resonance Imaging

MSO: Medtronic Singapore Operations

MTC: Medullary Thyroid Cancer

NAFTA: North American Free Trade Agreement

NAS: New Active Substance

NDS: New Drug Submission

NIH: National Institutes of Health

NME: New Molecular Entity

NOC: Notice of Compliance

NOD: Notice of Deficiency

NOL: No Objection Letter

NON: Notice of Non-Compliance

NPN: Natural Product Number

NRC: National Research Council

NSN: Non Satisfactory Notice

OCD: Obsessive Compulsive Disorder

OECD: Organization for Economic Co-operation and Development

OHIP: Ontario Health Insurance Plan

OSP: Orthopaedic Surgical Products

OTC: Over The Counter

P/E: Price/Earnings

P&T: Pharmacy & Therapeutics Committee

PA: Pseudomonas aeruginosa

PAAB: Pharmaceutical Advertising Advisory Board

pCODR: pan-Canadian Oncology Drug Review

PBS: Pharmaceutical Benefits Scheme

PEBC: Pharmacy Examining Board of Canada

PET: Positron Emission Tomography

PHCTF: Primary Health Care Transition Fund

PHN: Public Health Network

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GDHC0023CHR / Published SEP 2012 7


PMPRB: Patented Medicine Prices Review Board

PSI: Patient Specific Instruments

QMS: Quality Management System

R&D: Research and Development

RCC: Regulatory Cooperation Council

ROE: Return on Equity

SAP: Special Access Program

SCC: Standards Council of Canada

SEB: Subsequent Entry Biologics

SIPD: Submission and Information Policy Division

SNDS: Supplemental New Drug Submission

TIC: Travel Insurance Coordinators

TPD: Therapeutic Products Directorate

TCC: Therapeutic Class Comparison

UNCTAD: United Nations Conference on Trade and Development

UNFCCC: United Nations Framework Convention on Climate Change

UNGASS: United Nations General Assembly Special Session

UNPD: United Nations Population Division

UTI: Urinary Tract Infection

VCU: Voluntary Compliance Undertaking

VMS: Vitamins and Minerals Supplements

WHO: World Health Organization

WTO: World Trade Organization

ZBRS: Zimmer Blood Reinfusion System

7.2 Bibliography

Association of the European Self-Medication Industry (2011). Economic and Legal Framework for

Non-Prescription Medicines. Available from:

http://www.chpcanada.ca/index.cfm?fuseaction=main.dspFile&FileID=172. [Accessed June 5, 2012].

BizTradeShows (2012). Medical and Pharmaceutical Trade Shows in Canada. Available from:

http://www.biztradeshows.com/canada/canada-tradeshows.mp?industry=medical-pharma. [Accessed

June 7, 2012].

Canadian Agency for Drugs and Technologies in Health (2012). Common Drug Review. Available

from: http://www.cadth.ca/en/products/cdr/cdr-overview. [Accessed April 9, 2012].

Canadian Association of Pharmacy Distribution Management (2012). Pharmaceutical Pricing and

Reimbursement Policies in Canada. Available from http://www.oecd.org/canada/37868186.pdf.

Canadian Generic Pharmaceutical Association (2010). Biologic Drugs and the SEB. Available from:

http://www.canadiangenerics.ca/seb/en/biologics.asp. [Accessed April 15, 2012].

Canadian Generic Pharmaceutical Association (2011a). The Contribution of Generic Pharmaceutical

Industry, Health System and the Economy of Ontario. Available from:

http://www.canadiangenerics.ca/en/advocacy/docs/GenericContribution_OntarioHealth-

care&Economy-Eng.pdf.

http://www.oecd.org/canada/37868186.pdf

SAMPLE




Canadian Generic Pharmaceutical Association. (2011b). The Real Story Behind R&D Spending.

Available from: http://www.canadiangenerics.ca/en/news/docs/TheRealStory2011.pdf.

Consumer Health Products Canada (2011). Economic and Legal Framework for Non-Prescription

Medicines. Available from: http://www.chpcanada.ca/index.cfm?fuseaction=main.dspFile&FileID=172.

[Accessed on June 8, 2012]

Canadian Institute for Health Information (2009a). Drug Expenditure in Canada, 1985-2011. Available

from: https://secure.cihi.ca/estore/productFamily.htm?locale=en&pf=PFC1761. [Accessed May 15,

2012].

Canadian Institute for Health Information (2009b). National Health Expenditures Highlights. Available

from:

http://www.google.co.in/url?sa=t&rct=j&q=cihi%20health%20care%20expenditure%2C%202009%20

ppt&source=web&cd=2&sqi=2&ved=0CFEQFjAB&url=http%3A%2F%2Fwww.cihi.ca%2FCIHI-ext-

portal%2Fppt%2Finternet%2Fnhex_presentation_2011_en&ei=vXL6T9G8KsPyrQer2dzbBg&usg=AF

QjCNH9F6tBkbf82P3EBD9bjqb1k3sG9Q. [Accessed May 15, 2012].

Canadian Institute for Health Information (2009c). Public and Private Sector Health Expenditures by

Use of Funds. Available from:

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=pce_pub_en&pwd=&evt=2048001&visualizationMode=0&documentID=9D0E83BC4BACDADE9D49

38B338C6B6D5. [Accessed May 16, 2012].

Canadian Institute for Health Information (2009d). Statistics on Workforce. Available from:

http://www.cihi.ca/CIHI-ext-

portal/internet/EN/Quick_Stats/quick+stats/quick_stats_main?xTopic=Workforce&pageNumber=1&re

sultCount=10&filterTypeBy=undefined&filterTopicBy=16&autorefresh=1. [Accessed May 17, 2012].

Canadian Institute for Health Information (2010a). Canada‘s Health Expenditure. Available from:

http://www.ic.gc.ca/eic/site/lsg-pdsv.nsf/eng/h_hn01703.html. [Accessed May 18, 2012].

Canadian Institute for Health Information (2010b). Available via: CBC News. Drug Spending in

Canada hits $30 billion. Available from:

http://www.cbc.ca/news/health/story/2010/04/22/pharmaceutical-drug-spending-canada.html

[Accessed on May, 18, 2012]

Canadian Institute for Health Information (2011a). Health Care Cost Drivers: The Facts. Available

from: https://secure.cihi.ca/free_products/health_care_cost_drivers_the_facts_en.pdf.

Canadian Institute for Health Information (2011b). Top 10 Drug Classes by Total Public Drug

Program Spending on Seniors. Available from: http://www.cihi.ca/CIHI-ext-

portal/internet/en/Document/types+of+care/pharmaceutical/STAT_TOP10_DRUG_SPEND_08.

[Accessed May 21, 2012].

Canadian Institute for Health Information (2011c). Drug Expenditure in Canada, 1985-2011. Available

from: https://secure.cihi.ca/free_products/DEIC_1985_2011_EN.pdf..

Canadian Institutes of Health Research (2004). Health Research Investing in Canada‘s Future 2003-

2004. Available from: http://www.cihr-irsc.gc.ca/e/24936.html. [Accessed June 4, 2012].

Canadian Intellectual Property Office (2011). A Guide to Patents. Available from:

http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr01094.html [Accessed on June 4,

2012]

Canadian Pharmacists Association (2011). Canadian Pharmacists Association. Available from:

http://www.pharmacists.ca/cpha-ca/assets/File/cpha-on-the-issues/DrugShortagesGuide. [Accessed

June 6, 2012]

College of Pharmacists (2012). Pharmacy Licensure in British Columbia. Available from:

http://library.bcpharmacists.org/E-Registration_Licensure/E-3_Pharmacy/5033-Guide-

CommunityPcyLicensure.pdf.

Government of Canada (2011). UNGASS Country Progress Report. Available from:

http://www.unaids.org/en/dataanalysis/monitoringcountryprogress/progressreports/2012countries/ce_

CA_Narrative_Report[1].pdf.

http://www.chpcanada.ca/index.cfm?fuseaction=main.dspFile&FileID=172

http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr01094.html

SAMPLE




Health Canada (2006). Access to Therapeutic Products: The Regulatory Process in Canada.

Available from: http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/access-therapeutic_acces-

therapeutique-eng.php. [Accessed May 25, 2012].

Health Canada (2010). Drug and Health Products. Available from: http://www.hc-sc.gc.ca/dhp-

mps/consultation/drug-medic/draft_ebauche_label_guide-eng.php. [Accessed June 5, 2012].

Health Canada (2011a). Article. World TB Day. Available from: http://www.hc-sc.gc.ca/ahc-

asc/minist/messages/_2011/2011_03_24-eng.php. [Accessed on June 6, 2012].

Health Canada (2011b). Canada‘s Healthcare System. Available from: http://www.hc-sc.gc.ca/hcs-

sss/pubs/system-regime/2011-hcs-sss/index-eng.php. [Accessed June 7, 2012].

Health Canada (2012). Health Canada Annual Report 2010-2011. Available from: http://www.hc-

sc.gc.ca/hcs-sss/pubs/cha-lcs/2011-cha-lcs-ar-ra/index-eng.php. [Accessed June 7, 2012].

Health Products and Food Branch (2012). Access to Therapeutics Products: The Regulatory Process

in Canada. Available from: http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/access-

therapeutic_acces-therapeutique-eng.php#7.7 [Accessed on June 8, 2012]

Health Products and Food Branch (2010). Therapeutic Products Directorate Drug Submission

Performance Annual Report. Available from:

http://www.jptcp.com/files/tpd_dpt_annual_annuel_10_eng.pdf

Health Policy Monitor (2009a). Health Human Resources and Foreign Medical Graduates. Available

from: http://www.hpm.org/en/Surveys/CPRN_-

_Canada/14/Pandemic_%28H1N1%29_2009_in_Canada.html. [Accessed May 28, 2012].

Health Policy Monitor (2009b). Implementing Electronic Health Records. Available from:

http://hpm.org/en/Surveys/CPRN_-_Canada/14/Implementing_Electronic_Health_Records.html.


Health Policy Monitor (2010). Public Pay Change for Generic Drugs - Ontario, Canada. Available

from: http://www.hpm.org/en/Surveys/CHEPA_-_Canada/16/Public_pay_change_for_Generic_Drugs-

Ontario_Canada.html. [Accessed May 28, 2012].

Industry Canada (2012). Pharmaceutical Industry Profile. Available from:

http://www.ic.gc.ca/eic/site/lsg-pdsv.nsf/eng/h_hn01703.html [Accessed June 8, 2012].

International Monetary Fund (2012). World Economic Outlook. Available from:

http://www.imf.org/external/country/CAN/index.htm. [Accessed June 18, 2012].

International Society for Pharmacoeconomics and Outcomes Research (2011). ISPOR Global

Healthcare System. Available from: http://www.ispor.org/htaroadmaps/canadapharm.asp. [Accessed

June 18, 2012].

Kurtz S, et al. (2007). Projections of primary and revision hip and knee arthroplasty in the United

States from 2005 to 2030. Journal of Bone and Joint Surgery;(89): 780‐85.

Laine C, et al. (2007). Osteoarthritis. Annals of Internal Medicine; 147(3): ITC8-1.

Ministry of Environment (2011). Available via: BBCNews. Canada to withdraw from Kyoto Protocol.

Available from: http://www.bbc.co.uk/news/world-us-canada-16151310. [Accessed June 26, 2012].

Ministry of Health (2011). PharmaCare and You. Available from:

http://www.health.gov.bc.ca/pharmacare/generalinfo/generalinfoindex.html. [Accessed June 26,

2012].

OANDA (2012). Historical Exchange Rates. Available from http://www.oanda.com/currency/historical-

rates/ [Accessed on June 4, 2012].

Organization of Economic Co-operation and Development (2012). Available from:

http://stats.oecd.org/. [Accessed May 29, 2012].

Patented Medicine Prices Review Board (2012a). Wholesale Up-Charge Policies of Canada‘s Public

Drug Plans. Available from: http://www.pmprb-cepmb.gc.ca/english/view.asp?x=1591&mid=1491.

[Accessed June 8, 2012].

http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/access-therapeutic_acces-therapeutique-eng.php#7.7

http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/access-therapeutic_acces-therapeutique-eng.php#7.7

http://www.ic.gc.ca/eic/site/lsg-pdsv.nsf/eng/h_hn01703.html

http://www.oanda.com/currency/historical-rates/

http://www.oanda.com/currency/historical-rates/

SAMPLE




Patented Medicine Prices Review Board (2012b). Pharmaceutical Industry Profile. Available from:

http://www.ic.gc.ca/eic/site/lsg-pdsv.nsf/eng/h_hn01703.html. [Accessed June 8, 2012].

Patented Medicine Prices Review Board (2012c). Compendium of Policies, Guidelines and

Procedures. http://www.pmprb-cepmb.gc.ca/english/view.asp?x=1206&all=true#982. [Accessed June

8, 2012].

Patented Medicine Prices Review Board (2010). Annual Report- 2010. Available from:

http://www.pmprb-cepmb.gc.ca/english/view.asp?x=1503&mid=1329. [Accessed June 11, 2012].

Statistics Canada (2009a). Pharmaceutical Industry Profile. Available from:

http://www.statcan.gc.ca/pub/82-003-x/2009001/article/10801-eng.pdf

Statistics Canada (2009b). Residential Care Facilities by Ownership. Available from:

http://www.statcan.gc.ca/pub/83-237-x/2012001/tablesectlist-listetableauxsect-eng.htm. [Accessed

May 16, 2012].

Statistics Canada (2011a). Pharmaceutical Industry Profile. Available from:

http://www.ic.gc.ca/eic/site/lsg-pdsv.nsf/eng/h_hn01703.html. [Accessed June 11, 2012].

Statistics Canada (2011b). Smoking, 2010. Available from: http://www.statcan.gc.ca/pub/82-625-

x/2011001/article/11468-eng.htm. [Accessed June 12, 2012].

Statistics Canada (2011c). Economic Accounts. Available from: http://www.statcan.gc.ca/pub/11-402-

x/2011000/pdf/economic-economique-eng.pdf.

Statistics Canada (2012a). Asthma by Sex, Provinces and Territories. Available from:

http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/health50a-eng.htm. [Accessed June 13,

2012].

Statistics Canada (2012b). Estimates of Population by Age-Group and Sex, Canada - Provinces and

Territories. Available from:

http://www5.statcan.gc.ca/cansim/a26?lang=eng&retrLang=eng&id=0510001&tabMode=dataTable&s

rchLan=-1&p1=-1&p2=9. [Accessed May 14, 2012].

Statistics Canada (2012c). Life Expectancy, Abridged Life Table at Birth and at Age 65. Available

from: http://www.statcan.gc.ca/pub/12-581-x/12-581-x2007001-eng.pdf. [Accessed May 18, 2012].

Statistics Canada (2012d). Population and Demography. Available from:

http://www.statcan.gc.ca/pub/91-214-x/2009000/related-connexes-eng.htm. [Accessed May 17,

2012].

Statistics Canada (2012e). Population Distribution by Age-Group. Available from:

http://www.statcan.gc.ca/pub/91-214-x/2009000/related-connexes-eng.htm. [Accessed May 17,

2012].

Statistics Canada (2012f). Public Postsecondary Enrolments by Institution Type, Sex and Fields of

Study. Available from: http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/educ72a-

eng.htm. [Accessed June 15, 2012].

Statistics Canada (2012g). Major Industries, Inflation by Commodities.. Available from:

http://www.statcan.gc.ca/ads-annonces/11-402-x/index-eng.htm. [Accessed June 15, 2012].

The Heart & Stroke Foundation (2010). Reference for Statistics. Available from:

http://www.heartandstroke.com/site/c.ikIQLcMWJtE/b.3483991/k.34A8/Statistics.htm#stroke.

[Accessed June 15, 2012].

The World Bank (2012a). Birth Rate, Crude (per 1,000 people). The World Bank. Available from:

http://data.worldbank.org/indicator/SP.DYN.CBRT.IN. [Accessed May 14, 2012].

The World Bank (2012b). Carbon Emission, Country Level. Available from:

http://data.worldbank.org/indicator/EN.ATM.PM10.MC.M3/countries/1W-AU?display=graph.


The World Bank (2012c). Death Rate, Crude (Per 1,000 people). The World Bank. Available from:

http://data.worldbank.org/indicator/SP.DYN.CBRT.IN. [Accessed May 14, 2012].

http://www.statcan.gc.ca/pub/82-003-x/2009001/article/10801-eng.pdf

http://www.statcan.gc.ca/ads-annonces/11-402-x/index-eng.htm

SAMPLE




The World Bank (2012d). Foreign Direct Investment, Net Inflows (Bop, current US$). The World

Bank. Available from: http://data.worldbank.org/indicator/BX.KLT.DINV.CD.WD. [Accessed June 21,

2012].

The World Bank (2012e). GNI Per Capita, Atlas Method (current US$). The World Bank. Available

from: http://data.worldbank.org/indicator/NY.GNP.PCAP.CD. [Accessed June 21, 2012].

The World Bank (2012f). Hospital Beds, (per 1,000 people). The World Bank. Available from:

http://data.worldbank.org/indicator/SH.MED.BEDS.ZS. [Accessed June 21, 2012].

The World Bank (2012g). Immunization, DPT (% of children ages 12-23 months). The World Bank.

Available from: http://data.worldbank.org/indicator/SH.IMM.IDPT. [Accessed May 28, 2012].

The World Bank (2012h). Immunization, Measles (% of children ages 12-23 months). The World

Bank. Available from: http://data.worldbank.org/indicator/SH.IMM.IDPT. [Accessed May 29, 2012].

The World Bank (2012i). PM10, Country Level. Available from:

http://data.worldbank.org/indicator/EN.ATM.PM10.MC.M3/countries/1W-AU?display=graph.


The World Bank (2012j). Total Reserves (includes gold, current US$). The World Bank. Available

from: http://data.worldbank.org/indicator/FI.RES.TOTL.CD. [Accessed June 22, 2012].

The World Bank (2012k). Unemployment, total (% of total labor force). The World Bank. Available

from: http://data.worldbank.org/indicator/SL.UEM.TOTL.ZS. [Accessed June 22, 2012].

The World Bank (2012l). Urban population (% of total). The World Bank. Available from:

http://data.worldbank.org/indicator/SP.URB.TOTL.IN.ZS. [Accessed June 23, 2012].

The World Bank (2012m). GDP Per Capita, Atlas Method (current US$). The World Bank. Available

from: http://data.worldbank.org/indicator/NY.GDP.PCAP.CD. [Accessed on June 21, 2012].

The World Bank (2012n). GDP Growth (Annual. The World Bank. Available from:

http://data.worldbank.org/indicator/NY.GDP.MKTP.KD.ZG. [Accessed on June 21, 2012].

The World Bank (2012o). Consumer Prices (Annual %). The World Bank. Available from:

http://data.worldbank.org/indicator/FP.CPI.TOTL.ZG. [Accessed on June 21, 2012].

The World Bank (2012p). Life Expectancy at birth (total years). The World Bank. Available from:

http://data.worldbank.org/indicator/SP.DYN.LE00.IN. [Accessed on June 21, 2012].

United Nations Conference on Trade and Development Statistical (2009). Available via: The Financial

Express. FDI growth up 85% in ‘08, highest globally. Available from:

http://www.financialexpress.com/news/fdi-growth-up-85-in-08-highest-globally/463892/0. [Accessed

on August 31, 2012]

United Nations International Children‘s Emergency Fund (2001). Available from:

http://www.unicef.org/infobycountry/canada_statistics.html. [Accessed on July 8, 2012].

US Census Bureau (2012). International Database. US Census Bureau. Available from:

http://www.census.gov/population/international/data/idb/region.php. [Accessed May 27, 2012].

US Department of State (2011). Canada Profile. Available from:

http://www.state.gov/outofdate/bgn/canada/192344.htm. [Accessed April 23, 2012].

World Health Organization (2005). Health Systems in Transition. Available from:

http://www.euro.who.int/__data/assets/pdf_file/0009/80568/E87954.pdf..

World Health Organization (2011). Global Health Observatory Data Repository. Available from

http://apps.who.int/ghodata/. [Accessed on April 24, 2012].

Yale and the Mayo Clinic (2012). Available via: The Huffington Post. Drug Approval Faster In U.S.

Than Canada, Europe: Study. Available from: http://www.huffingtonpost.com/2012/05/17/drug-

approval-faster-united-states-canada-europe_n_1524527.html. [Accessed on August 31, 2012]

http://data.worldbank.org/indicator/NY.GDP.PCAP.CD

http://data.worldbank.org/indicator/NY.GDP.MKTP.KD.ZG

http://data.worldbank.org/indicator/FP.CPI.TOTL.ZG

http://data.worldbank.org/indicator/SP.DYN.LE00.IN

http://www.unicef.org/infobycountry/canada_statistics.html

http://apps.who.int/ghodata/

http://www.huffingtonpost.com/2012/05/17/drug-approval-faster-united-states-canada-europe_n_1524527.html

http://www.huffingtonpost.com/2012/05/17/drug-approval-faster-united-states-canada-europe_n_1524527.html

SAMPLE




7.3 Methodology

GlobalData‘s dedicated research and analysis teams consist of experienced professionals with advanced

statistical expertise and marketing, market research and consulting backgrounds in the pharmaceutical

industry.

GlobalData adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and the

Strategic and Competitive Intelligence Professionals (www.scip.org).

All GlobalData databases are continuously updated and revised. The following research methodology is

followed for all databases and reports.

7.3.1 Coverage

The objective of updating GlobalData‘s coverage is to ensure that it represents the most up to date vision

of the industry possible.

Changes to the industry taxonomy are built on the basis of extensive research of company, association

and competitor sources.

Company coverage is based on three key factors: revenues, products and media

attention/innovation/market potential.

The estimated revenues of all major companies, including private and governmental, are gathered

and used to prioritize coverage.

Companies which are making the news or which are of particular interest due to their innovative

approach are prioritized.

GlobalData aims to cover all major news events and deals in the pharmaceutical industry, updated on a

daily basis.

The coverage is further streamlined and strengthened with additional inputs from GlobalData‘s expert

panel (see below).

7.3.2 Secondary Research

The research process begins with exhaustive secondary research on internal and external sources being

carried out to source qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and US

Securities and Exchanges Commission (SEC) filings

Industry trade journals, scientific journals and other technical literature

Internal and external proprietary databases

Relevant patent and regulatory databases

National government documents, statistical databases and market reports

Procedure registries

News articles, press releases and web-casts specific to the companies operating in the market.

The country reports are largely based on secondary research and make use of reliable and authoritative

sources such as the IMF, The World Bank, OECD, WHO, UNICEF, UNStats, MHLW, NHS, and BEA,

among others.

7.3.3 Forecasting

For the country reports, GlobalData uses the data available from reliable and authoritative secondary

sources to forecast the future trends for the healthcare market for the country, as well as the parameters

related to the economy and healthcare infrastructure and expenditure of the country. The trends are

further validated through the secondary sources.

http://www.mrs.org.uk/

http://www.scip.org/

SAMPLE




7.3.4 Primary Research

GlobalData conducts hundreds of primary interviews a year with industry participants and commentators

in order to validate its data and analysis. A typical research interview fulfills the following functions:

It provides first-hand information on the market size, market trends, growth trends, competitive

landscape and future outlook of a market.

It helps in validating and strengthening secondary research findings.

It develops the analysis team‘s expertise and market understanding.

Primary research involves email correspondence and telephone interviews as well as face-to-face

interviews for each market, category, segment and sub-segment across the geographies covered.

The participants who typically take part in such a process include, but are not limited to:

Industry participants: Chief Executive Officers (CEOs), Vice Presidents (VPs), marketing/product

managers, market intelligence managers and national sales managers.

Hospital stores, pharmacies, distributors and paramedics.

Outside experts: investment bankers, valuation experts, research analysts specializing in specific

pharmaceutical markets.

Key Opinion Leaders (KOLs): Physicians and surgeons specializing in different therapeutic areas

corresponding to different kinds of pharmaceuticals.

7.3.5 Expert Panel Validation

GlobalData uses a panel of experts to cross verify its databases and forecasts.

GlobalData‘s expert panel comprises marketing managers, product specialists, international sales

managers from pharmaceutical companies; academics from research universities, KOLs from hospitals,

consultants from venture capital funds, and distributors/suppliers of pharmaceuticals and supplies.

Historic data and forecasts are relayed to GlobalData‘s expert panel for feedback and adjusted in

accordance with their feedback.

7.4 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by

any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of

the publisher, GlobalData.

.

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