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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Canada

Published: Jul 5, 2017 | Pages: 228 | Publisher: GlobalData | Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Canada

Summary

GlobalData, the industry analysis specialist, has released its latest report, "CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Canada". The report is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in Canada. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure of Canada. Most importantly, the report provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets. It is built using data and information sourced from proprietary databases, secondary research, and in-house analysis by GlobalData's team of industry experts.

In 2016, Canada population was approximately at 36.3 million. The Canadian pharmaceutical industry is the 10th largest market with a share of 2% of the global market. In 2015, pharmaceutical sales were estimated at $22.1 billion. This rose to about $22.6 billion in 2016 and is forecast to increase to $25 billion in 2021, at a CAGR of 2%. Patented drugs accounted for 61.8% of the total sales in 2015. The medical device market in Canada was worth $8.7 billion in 2009, which increased to $11 billion in 2016. It is expected to grow at a CAGR of 4.2% from $11.5 billion in 2017 to $13.5 billion in 2021. The main segments ophthalmic devices, orthopedic devices, drug delivery devices, in vitro diagnostics and healthcare IT will drive market growth.

These positive trends can primarily be attributed to - 
- Increasing awareness regarding early disease detection and diagnosis
- Advances in medical technology

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Canada, and includes - 
- An overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers
- Profiles and SWOT analyses of the major players in the pharmaceutical market (Johnson & Johnson, Novartis, Teva, Apotex and Gilead) and profiles and SWOT analyses of the major players in the medical device market (Johnson & Johnson, Medtronic, Baxter, Fresenius and Sonova)
- An insightful review of the reimbursement and regulatory landscape, of which analysis includes details of the healthcare reimbursement process, the regulatory agencies and the approval processes for new drugs and medical devices
- Detailed analysis of the political and economic environment, covering economic indicators, demographics, healthcare infrastructure and healthcare expenditure
- An overview of the opportunities for and challenges to growth in the Canadian healthcare market

Reasons To Buy

This report will enhance your decision-making capability by allowing you to - 
- Develop business strategies by understanding the trends shaping and driving the Canadian healthcare market
- Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to impact the healthcare market in the future
- Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors
- Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment, and strategic partnership
- Identify, understand, and capitalize on the opportunities and challenges in the Canadian healthcare market
 Table of Contents
1 Table of Contents 2 1.1 List of Tables 5 1.2 List of Figures 7 2 Executive Summary 9 3 Introduction 14 3.1 GlobalData Report Guidance 14 4 Overview of the Pharmaceutical and Medical Device Markets 15 4.1 Pharmaceutical Market 15 4.1.1 Market Overview 15 4.1.2 Pharmaceutical Imports and Exports 19 4.1.3 Supply Channels 20 4.1.4 Market Segments 21 4.1.5 Overview of Major Therapeutic Areas 25 4.1.6 Overview of Major Drug Classes 27 4.1.7 Major Players 29 4.2 Medical Device Market 62 4.2.1 Market Overview 62 4.2.2 Overview of Top Five Segments 65 4.2.3 Major Players 76 4.3 Market Drivers and Barriers 101 4.3.1 Drivers 101 4.3.2 Barriers 102 5 Market Access 104 5.1 Reimbursement and Payer Landscape 104 5.1.1 Overview of Healthcare System 104 5.1.2 Drug Reimbursement Process 105 5.1.3 Medical Device and Diagnostics Reimbursement Process 108 5.1.4 Overview of Insurance Providers 110 5.1.5 Patient Share in Healthcare Spending 112 5.1.6 Price Trend in Healthcare Services 113 5.1.7 Pricing Policies 115 5.2 Regulatory Landscape 116 5.2.1 Overview of Regulatory Agencies 116 5.2.2 Market Authorization Procedure for Pharmaceutical Products 118 5.2.3 Market Authorization Procedure for Medical Devices 123 5.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 126 5.2.5 Licensing Process for Pharmaceutical Exports and Imports 127 5.2.6 Intellectual Property Rights 128 5.2.7 Clinical Trial Regulations 131 5.2.8 Pharmacy Regulations 134 5.2.9 Labeling and Packaging Regulations 135 6 Country Analysis 137 6.1 Political Environment 137 6.1.1 Political Structure 137 6.1.2 Analysis of the Current Political Environment 139 6.1.3 Healthcare Policy Initiatives 140 6.2 Economic Landscape 142 6.3 Economic Indicators 146 6.3.1 Gross Domestic Product 146 6.3.2 Gross National Income 150 6.3.3 Inflation 152 6.3.4 Currency Exchange Rate 154 6.3.5 Foreign Direct Investment 155 6.3.6 Foreign Exchange Reserves 156 6.3.7 Trade Balance 157 6.3.8 General Government Structural Balance 159 6.3.9 General Government Net Debt 160 6.3.10 Major Industries 161 6.4 Demographics 163 6.4.1 Population 163 6.4.2 Urban-Rural Share 165 6.4.3 Distribution by Age Group 166 6.4.4 Birth Rate 168 6.4.5 Mortality 169 6.4.6 Causes of Mortality 170 6.4.7 Health Status by Gender and Age 171 6.4.8 Education and Literacy 179 6.4.9 Employment 181 6.4.10 Disease Burden 182 6.5 Healthcare Infrastructure 185 6.5.1 Healthcare Facilities 185 6.5.2 Healthcare Parameters 187 6.5.3 Environmental Health 190 6.5.4 Healthcare Personnel 193 6.6 Healthcare Expenditure 197 6.6.1 Overview 197 6.6.2 Public-Private Sector Share 200 6.6.3 Major Components of Healthcare Spending 201 6.6.4 Spending in Science and Technology Research and Development 203 6.7 Trade Associations 204 6.7.1 Canadian Pharmacists Association (CPhA) 204 6.7.2 Canadian Association of Professional Regulatory Affairs 204 6.7.3 Canadian Society for Hospital Pharmacists 204 6.7.4 Canadian Generic Pharmaceutical Association 204 6.8 Trade Fairs 205 7 Opportunities and Challenges 206 7.1 Opportunities 206 7.2 Challenges 206 8 Appendix 208 8.1 Abbreviations 208 8.2 Bibliography 213 8.3 Research Methodology 225 8.3.1 Coverage 226 8.3.2 Secondary Research 226 8.3.3 Forecasts 227 8.3.4 Expert Panel 227 8.4 Contact Us 227 8.5 Disclaimer 228
List of Tables
Table 1: Pharmaceutical Market, Canada, Revenue ($bn), 2009-2016 16 Table 2: Pharmaceutical Market, Canada, Revenue Forecast ($bn), 2017-2021 17 Table 3: Pharmaceutical Market, Canada, Pharmaceutical Spending (% of health spending), 2009-2015 18 Table 4: Pharmaceutical Market, Canada, Pharmaceutical Exports and Imports ($bn), 2009-2016 20 Table 5: Pharmaceutical Market, Canada, Average Price Generic Drug vs. Branded Drug, 2009-2016 22 Table 6: Pharmaceutical Market, Biologics, Canada, Approved Biologics, 2016 23 Table 7: Pharmaceutical Market, Canada, Over-the-Counter Drug Market Revenue ($bn), 2009-2016 24 Table 8: Pharmaceutical Market, Canada, Sales of Patented Drug Products by Major Therapeutic Class ($bn), 2015 26 Table 9: Pharmaceutical Market, Canada, Major Drug Classes by Annual Growth Rate (%), 2012-2015 29 Table 10: Pharmaceutical Market, Johnson & Johnson, Canada, Major Products, 2016 30 Table 11: Pharmaceutical Market, Johnson & Johnson, Planned Filings, 2017-2020 32 Table 12: Pharmaceutical Market, Novartis, Canada, Major Products, 2017 40 Table 13: Pharmaceutical Market, Novartis, Planned Filings, 2017-2020 42 Table 14: Pharmaceutical Market, Teva, Late-Stage Pipeline, 2017 48 Table 15: Pharmaceutical Market, Gilead, Major Products, 2017 57 Table 16: Pharmaceutical Market, Gilead, Global, Late-Stage Pipeline, 2017 58 Table 17: Medical Device Market, Canada, Revenue ($bn), 2009-2016 63 Table 18: Medical Device Market, Canada, Revenue Forecast ($bn), 2017-2021 64 Table 19: Medical Device Market, Canada, Revenue ($bn) and Market Share ($bn) by Segment, 2016 65 Table 20: Orthopedic Devices Market, Canada, Revenue ($bn), 2009-2016 66 Table 21: Orthopedic Devices Market, Canada, Revenue ($m) and Market Share (%) of Major Companies, 2016 67 Table 22: Ophthalmic Devices Market, Canada, Revenue ($bn), 2009-2016 68 Table 23: Ophthalmic Devices Market, Canada, Revenue ($m) and Market Share (%) of Major Companies, 2016 69 Table 24: Drug Delivery Devices Market, Canada, Revenue ($bn), 2009-2016 70 Table 25: Ophthalmic Devices Market, Canada, Revenue ($m) and Market Share (%) of Major Companies, 2016 71 Table 26: Cardiovascular Devices Market, Canada, Revenue of Major Players ($m), 2009-2016 72 Table 27: IVD Market, Canada, Revenue ($m) and Market Share (%) of Major Companies, 2015 73 Table 28: IVD Market, Canada, Revenue ($bn), 2009-2016 74 Table 29: Healthcare IT Market, Canada, Revenue ($m) and Market Share (%) of Major Companies, 2016 75 Table 30: Medical Device Market, Canada, Revenue ($m) of Major Companies, 2012 76 Table 31: Medical Device Market, Johnson & Johnson, Major Medical Device Sales, 2016 77 Table 32: Medical Device Market, Medtronic, Major Products, 2016 82 Table 33: Medical Device Market, Baxter, Global, Major Products, 2017 89 Table 34: Medical Device Market, Fresenius Medical Care, Global, Major Products, 2016 94 Table 35: Medical Device Market, Sonova, Global, Major Products, 2017 99 Table 36: Market Access, Canada, Out-of-Pocket Expenditure (% of total expenditure on health), 2009-2016 112 Table 37: Market Access, Canada, Annual Rate of Change (%), Patented Medicines Price Index, 2009-2015 113 Table 38: Market Access, Canada, Average Ratio of International Price to Canadian Price, 2009-2015 114 Table 39: Market Access, Target Review Times for New Drug Submissions, Canada, 2016 120 Table 40: Market Access, Classes of Medical Devices, 2016 124 Table 41: Economic Indicators, Canada, Gross Domestic Product per Capita ($), 2009-2016 147 Table 42: Economic Indicators, Canada, Gross Domestic Product per Capita Forecast ($), 2017-2021 148 Table 43: Economic Indicators, Canada, Gross Domestic Product Annual Growth (%), 2009-2016 149 Table 44: Economic Indicators, Canada, Gross Domestic Product Annual Growth Forecast (%), 2017-2021 150 Table 45: Economic Indicators, Canada, Gross National Income per Capita ($), 2009-2016 151 Table 46: Economic Indicators, Canada, Average Consumer Price Index, 2009-2016 152 Table 47: Economic Indicators, Canada, Average Consumer Price Annual Change (%), 2009-2016 153 Table 48: Economic Indicators, Canada, Currency Exchange Rate (CAD per $), 2009-2016 154 Table 49: Economic Indicators, Canada, Foreign Direct Investment ($bn), 2009-2015 155 Table 50: Economic Indicators, Canada, Foreign Exchange Reserves ($bn), 2009-2016 156 Table 51: Economic Indicators, Canada, Imports of Goods and Services ($bn), 2009-2016 157 Table 52: Economic Indicators, Canada, Exports of Goods and Services ($bn), 2009-2016 158 Table 53: Economic Indicators, Canada, Government Structural Balance ($bn), 2009-2016 159 Table 54: Economic Indicators, Canada, General Government Net Debt ($bn), 2009-2016 160 Table 55: Economic Indicators, Canada, Major Industries by Gross Value Added (percentage of GDP), 2016 162 Table 56: Demographics, Canada, Population (million), 2009-2016 163 Table 57: Demographics, Canada, Population (million), 2017-2021 164 Table 58: Demographics, Canada, Urban-Rural Population Share (%), 2009-2016 165 Table 59: Demographics, Canada, Population Distribution by Age Group (%), 2009-2016 166 Table 60: Demographics, Canada, Population Distribution by Age Group Forecast (%), 2017-2021 167 Table 61: Demographics, Canada, Births (per 1,000 population), 2009-2015 168 Table 62: Demographics, Canada, Mortality (per 1,000 population), 2009-2015 169 Table 63: Demographics, Canada, Major Causes of Mortality, 2015 171 Table 64: Demographics, Canada, Infant Mortality (per 1,000 live births), 2009-2016 172 Table 65: Demographics, Canada, Immunization Rate (%), 2009-2016 173 Table 66: Demographics, Canada, Major Causes of Male Mortality, 2015 175 Table 67: Demographics, Canada, Major Causes of Female Mortality, 2015 176 Table 68: Demographics, Canada, Gender Ratio (M/F), 2009-2016 177 Table 69: Demographics, Canada, Life Expectancy at Birth (years), 2009-2016 179 Table 70: Demographics, Canada, Part-Time and Full-Time University Students ('000), 2009-2015 180 Table 71: Demographics, Canada, Unemployment Rate (%), 2009-2016 181 Table 72: Demographics, Canada, Most Frequently Diagnosed Diseases ('000), 2015 183 Table 73: Demographics, Canada, Disability-Adjusted Life Years by Major Disease ('000), 2015 184 Table 74: Healthcare Infrastructure, Canada, Number of Hospitals, 2009-2015 185 Table 75: Healthcare Infrastructure, Canada, Diagnostic Equipment (per million population), 2009-2015 186 Table 76: Healthcare Infrastructure, Canada, Hospital Beds (per 1,000 population), 2009-2015 187 Table 77: Healthcare Infrastructure, Canada, Acute Care Hospital Beds (per 1,000 population), 2009-2015 188 Table 78: Healthcare Infrastructure, Canada, Psychiatric Hospital Beds (per 1,000 population), 2009-2015 189 Table 79: Healthcare Infrastructure, Canada, PM2.5 (µg per m3), 2009-2015 191 Table 80: Healthcare Infrastructure, Canada, CO2 Emissions (million tons), 2009-2015 192 Table 81: Healthcare Infrastructure, Canada, Physicians (per 1,000 population), 2009-2015 193 Table 82: Healthcare Infrastructure, Canada, Dentists, 2009-2015 194 Table 83: Healthcare Infrastructure, Canada, Pharmacists, 2009-2015 195 Table 84: Healthcare Infrastructure, Canada, Nurses (per 1,000 population), 2009-2015 196 Table 85: Healthcare Expenditure, Canada, Healthcare Expenditure as Percentage of GDP (%), 2009-2016 198 Table 86: Healthcare Expenditure, Canada, Healthcare Expenditure ($bn), 2014-2019 199 Table 87: Healthcare Expenditure, Canada, Public-Private Share (%), 2009-2015 200 Table 88: Healthcare Expenditure, Canada, Major Components of Healthcare Spending (%), 2014 201 Table 89: Healthcare Expenditure, Canada, Share of Financing Agents (%), 2016 202 Table 90: Healthcare Expenditure, Canada, R&D Expenditure as Percentage of GDP (%), 2009-2015 203 Table 91: Healthcare Expenditure, Canada, Major Healthcare Trade Fairs, 2017 205


List of Figures
Figure 1: Pharmaceutical Market, Canada, Revenue ($bn), 2009-2021 10 Figure 2: Medical Device Market, Canada, Revenue ($bn), 2009-2021 11 Figure 3: Country Profile, Canada, 2017 13 Figure 4: Pharmaceutical Market, Canada, Revenue ($bn), 2009-2016 16 Figure 5: Pharmaceutical Market, Canada, Revenue Forecast ($bn), 2017-2021 17 Figure 6: Pharmaceutical Market, Canada, Pharmaceutical Spending as Percentage of Health Spending (%), 2009-2015 18 Figure 7: Pharmaceutical Market, Canada, Pharmaceutical Exports and Imports ($bn), 2009-2016 19 Figure 8: Pharmaceutical Market, Canada, Supply Channels, 2016 21 Figure 9: Pharmaceutical Market, Canada, Average Price Generic Drug vs. Branded Drug, 2009-2016 22 Figure 10: Pharmaceutical Market, Canada, Over-the-Counter Drug Market Revenue ($bn), 2009-2016 24 Figure 11: Pharmaceutical Market, Canada, Sales of Patented Drug Products by Major Therapeutic Class, 2015 25 Figure 12: Pharmaceutical Market, Canada, Major Drug Classes by Annual Growth Rate (%), 2012-2015 28 Figure 13: Medical Device Market, Canada, Revenue ($bn), 2009-2016 63 Figure 14: Medical Device Market, Canada, Revenue Forecast ($bn), 2017-2021 64 Figure 15: Medical Device Market, Canada, Revenue by Segment ($bn), 2016 65 Figure 16: Orthopedic Devices Market, Canada, Revenue ($bn), 2009-2016 66 Figure 17: Orthopedic Devices Market, Canada, Market Share of Major Players (%), 2016 67 Figure 18: Ophthalmic Devices Market, Canada, Revenue ($bn), 2009-2016 68 Figure 19: Ophthalmic Devices Market, Canada, Market Share of Major Players (%), 2016 69 Figure 20: Drug Delivery Devices Market, Canada, Revenue ($bn), 2009-2016 70 Figure 21: Drug Delivery Devices Market, Canada, Market Share of Major Players (%), 2016 71 Figure 22: In Vitro Diagnostics Market, Canada, Revenue ($bn), 2009-2016 72 Figure 23: In Vitro Diagnostics Market, Canada, Market Share of Major Players (%), 2015 73 Figure 24: Healthcare IT Market, Canada, Revenue ($bn), 2009-2016 74 Figure 25: Healthcare IT Market, Canada, Market Share of Major Companies (%), 2016 75 Figure 26: Medical Device Market, Canada, Revenue of Major Companies ($m), 2012 76 Figure 27: Pharmaceutical Market, Canada, Drivers and Barriers, 2017 103 Figure 28: Market Access, Canada, Reimbursement Process, 2017 107 Figure 29: Market Access, Canada, Medical Device and Diagnostics Reimbursement Process, 2017 109 Figure 30: Market Access, Canada, Out-of-Pocket Expenditure (% of total expenditure on health), 2009-2016 112 Figure 31: Market Access, Canada, Annual Rate of Change (%), Patented Medicines Price Index, 2009-2015 113 Figure 32: Market Access, Canada, Average Ratio of International Price to Canadian Price, 2009-2015 114 Figure 33: Health Products and Food Branch, Organization Chart, Canada, 2015 117 Figure 34: New Drug Approval Process, Canada, 2017 122 Figure 35: Patent Approval Process, Canada, 2015 130 Figure 36: Clinical Trial Regulation Process, Canada, 2016 133 Figure 37: Economic Indicators, Canada, Gross Domestic Product per Capita ($), 2009-2016 147 Figure 38: Economic Indicators, Canada, Gross Domestic Product per Capita Forecast ($), 2017-2021 148 Figure 39: Economic Indicators, Canada, Gross Domestic Product Annual Growth (%), 2009-2016 149 Figure 40: Economic Indicators, Canada, Gross Domestic Product Annual Growth Forecast (%), 2017-2021 150 Figure 41: Economic Indicators, Canada, Gross National Income per Capita ($), 2009-2016 151 Figure 42: Economic Indicators, Canada, Average Consumer Price Index, 2009-2016 152 Figure 43: Economic Indicators, Canada, Average Consumer Price Annual Change (%), 2009-2016 153 Figure 44: Economic Indicators, Canada, Currency Exchange Rate (CAD per $), 2009-2016 154 Figure 45: Economic Indicators, Canada, Foreign Direct Investment ($bn), 2009-2015 155 Figure 46: Economic Indicators, Canada, Foreign Exchange Reserves ($bn), 2009-2016 156 Figure 47: Economic Indicators, Canada, Imports of Goods and Services ($bn), 2009-2016 157 Figure 48: Economic Indicators, Canada, Exports of Goods and Services ($bn), 2009-2016 158 Figure 49: Economic Indicators, Canada, Government Structural Balance ($bn), 2009-2016 159 Figure 50: Economic Indicators, Canada, General Government Net Debt ($bn), 2009-2016 160 Figure 51: Economic Indicators, Canada, Major Industries by Gross Value Added (percentage of GDP), 2016 161 Figure 52: Demographics, Canada, Population (million), 2009-2016 163 Figure 53: Demographics, Canada, Population (million), 2017-2021 164 Figure 54: Demographics, Canada, Urban-Rural Population Share (%), 2009-2016 165 Figure 55: Demographics, Canada, Population Distribution by Age Group (%), 2009-2016 166 Figure 56: Demographics, Canada, Population Distribution by Age Group Forecast (%), 2017-2021 167 Figure 57: Demographics, Canada, Births (per 1,000 population), 2009-2015 168 Figure 58: Demographics, Canada, Mortality (per 1,000 population), 2009-2015 169 Figure 59: Demographics, Canada, Major Causes of Mortality, 2015 170 Figure 60: Demographics, Canada, Infant Mortality (per 1,000 live births), 2009-2016 172 Figure 61: Demographics, Canada, Immunization Rate (%), 2009-2016 173 Figure 62: Demographics, Canada, Major Causes of Male Mortality, 2015 174 Figure 63: Demographics, Canada, Major Causes of Female Mortality, 2015 176 Figure 64: Demographics, Canada, Gender Ratio (M/F), 2009-2016 177 Figure 65: Demographics, Canada, Life Expectancy at Birth (years), 2009-2016 178 Figure 66: Demographics, Canada, Part-Time and Full-Time University Students ('000), 2009-2015 180 Figure 67: Demographics, Canada, Unemployment Rate (%), 2009-2016 181 Figure 68: Demographics, Canada, Patients ('000s), 2015-2016 182 Figure 69: Demographics, Canada, Disability-Adjusted Life Years by Major Disease ('000), 2015 184 Figure 70: Healthcare Infrastructure, Canada, Number of Hospitals, 2009-2015 185 Figure 71: Healthcare Infrastructure, Canada, Diagnostic Equipment (per million population), 2009-2015 186 Figure 72: Healthcare Infrastructure, Canada, Hospital Beds (per 1,000 population), 2009-2015 187 Figure 73: Healthcare Infrastructure, Canada, Acute Care Hospital Beds (per 1,000 population), 2009-2015 188 Figure 74: Healthcare Infrastructure, Canada, Psychiatric Hospital Beds (per 1,000 population), 2009-2015 189 Figure 75: Healthcare Infrastructure, Canada, PM2.5 (µg per m3), 2009-2015 191 Figure 76: Healthcare Infrastructure, Canada, CO2 Emissions (million tons), 2009-2015 192 Figure 77: Healthcare Infrastructure, Canada, Physicians, 2009-2015 193 Figure 78: Healthcare Infrastructure, Canada, Dentists, 2009-2015 194 Figure 79: Healthcare Infrastructure, Canada, Pharmacists, 2009-2015 195 Figure 80: Healthcare Infrastructure, Canada, Nurses, 2009-2015 196 Figure 81: Healthcare Expenditure, Canada, Healthcare Expenditure as Percentage of GDP (%), 2009-2016 198 Figure 82: Healthcare Expenditure, Canada, Healthcare Expenditure ($bn), 2014-2019 199 Figure 83: Healthcare Expenditure, Canada, Public-Private Share (%), 2009-2015 200 Figure 84: Healthcare Expenditure, Canada, Major Components of Healthcare Spending (%), 2014 201 Figure 85: Healthcare Expenditure, Canada, Share of Financing Agents (%), 2016 202 Figure 86: Healthcare Expenditure, Canada, R&D Expenditure as Percentage of GDP (%), 2009-2015 203 Figure 87: Healthcare Market, Canada, Opportunities and Challenges, 2017 207

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