CountryFocus: Healthcare, Regulatory and Reimbursement Landscape-Russia

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape-Russia


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Executive Summary

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape-Russia

Summary

GlobalData, the industry analysis specialist, has released its latest report, "CountryFocus: Healthcare, Regulatory and Reimbursement Landscape-Russia". This report is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in Russia. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure of Russia. 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, Russia population was approximately at 146.9 million. The government of Russia has been making continuous efforts to strengthen the economy to ensure long-term growth, and the pharmaceutical market is seen as a key industry for the country's future growth. To support this industry, the government has improved regulatory guidelines and initiatives to develop the domestic pharmaceutical market. The Pharmaceutical market was estimated to be worth $20.91 billion in 2016 and expected to reach $38.56 billion by 2021. The market grew at a Compound Annual Growth Rate (CAGR) of 12.9% over the 2009-2021 period. The medical device market was valued at $5.0 billion in 2009 and is expected to reach approximately $8.5 billion by 2021, at a projected CAGR of 4.2%. These positive trends can primarily be attributed to

An increasing elderly population in Russia, leading to increases in disease incidence and prevalence as well as higher need for long-term care and medical devices

Increasing awareness in the medical community and the general population regarding early disease detection and diagnosis, leading to higher rates of adoption of treatments and healthcare

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Russia, 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 (Novartis, Sanofi, Bayer, Roche and Pharmstandard)

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 Russian 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 Russia 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 Russia healthcare market



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1 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 Exports and Imports 20

4.1.3 Supply Channels 21

4.1.4 Market Segments 21

4.1.5 Overview of Top Five Disease Areas 22

4.1.6 Major Players 24

4.2 Medical Device Market 54

4.2.1 Market Overview 54

4.2.2 Overview of Top Five Segments 56

4.2.3 Major Players 67

4.3 Market Drivers and Barriers 96

4.3.1 Drivers 96

4.3.2 Barriers 97

5 Market Access 99

5.1 Reimbursement and Payer Landscape 99

5.1.1 Overview of Healthcare System 99

5.1.2 Reimbursement Process 100

5.1.3 Overview of Insurance Providers 101

5.1.4 Patient Share in Healthcare Spending 103

5.1.5 Price Trend in Healthcare Services 104

5.1.6 Pricing Policies 105

5.2 Regulatory Landscape 105

5.2.1 Overview of Regulatory Agencies 105

5.2.2 Market Authorization Procedure for Pharmaceutical Products 107

5.2.3 Market Authorization Procedure for Medical Devices 109

5.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 112

5.2.5 Licensing Process for Pharmaceutical Exports and Imports 112

5.2.6 Intellectual Property Rights 113

5.2.7 Clinical Trial Regulations 114

5.2.8 Pharmaceutical Advertising Regulations 115

5.2.9 Labeling and Packaging Regulations 116

6 Country Analysis 117

6.1 Political Environment 117

6.1.1 Political Structure 117

6.1.2 Analysis of the Current Political Environment 118

6.1.3 Healthcare Policy Initiatives 120

6.2 Economic Landscape 122

6.3 Economic Indicators 126

6.3.1 Gross Domestic Product 126

6.3.2 Gross National Income 130

6.3.3 Inflation 131

6.3.4 Currency Exchange Rate 133

6.3.5 Foreign Direct Investment 134

6.3.6 Foreign Exchange Reserves 135

6.3.7 Trade Balance 136

6.3.8 General Government Structural Balance 137

6.3.9 General Government Gross Debt 139

6.3.10 Major Industries 140

6.4 Demographics 141

6.4.1 Population 141

6.4.2 Education and Literacy 156

6.4.3 Employment 159

6.4.4 Disease Burden 161

6.5 Healthcare Infrastructure 164

6.5.1 Healthcare Facilities 164

6.5.2 Healthcare Parameters 169

6.5.3 Environmental Health 172

6.5.4 Healthcare Personnel 174

6.6 Healthcare Expenditure 175

6.6.1 Overview 175

6.6.2 Public-Private Sector Share 176

6.6.3 Major Components of Healthcare Spending 177

6.6.4 Spending in Science and Technology Research and Development 178

6.7 Trade Associations 179

6.7.1 Association of Russian Pharmaceutical Manufacturers 179

6.7.2 Association of International Pharmaceutical Manufacturers 179

6.7.3 Russian Association of Pharmaceutical Marketing 179

6.8 Trade Fairs 180

7 Opportunities and Challenges 181

7.1 Opportunities 181

7.2 Challenges 181

8 Appendix 184

8.1 Abbreviations 184

8.2 Bibliography 186

8.3 Research Methodology 198

8.3.1 Coverage 198

8.3.2 Secondary Research 199

8.3.3 Forecasts 199

8.3.4 Expert Panel 200

8.4 Contact Us 200

8.5 Disclaimer 200

1.2 List of Figures

Figure 1: Pharmaceutical Market, Russia, Revenue ($bn), 2009-2021 10

Figure 2: Medical Device Market, Russia, Revenue ($bn), 2009-2021 11

Figure 3: Country Profile, Russia, 2016 13

Figure 4: Pharmaceutical Market, Russia, Revenue ($bn), 2009-2016 18

Figure 5: Pharmaceutical Market, Russia, Revenue Forecast ($bn), 2017-2021 19

Figure 6: Pharmaceutical Market, Russia, Pharmaceutical Exports and Imports ($bn), 2009-2015 20

Figure 7: Medical Device Market, Russia, Revenue ($bn), 2009-2016 54

Figure 8: Medical Device Market, Russia, Revenue Forecast ($bn), 2017-2021 55

Figure 9: Medical Device Market, Russia, Revenue by Segment ($m), 2016 56

Figure 10: Ophthalmic Devices Market, Russia, Revenue ($m), 2009-2016 57

Figure 11: Ophthalmic Devices Market, Russia, Market Share of Major Players (%), 2015 58

Figure 12: Wound Care Management Market, Russia, Revenue ($m), 2009-2016 59

Figure 13: Wound Care Management Market, Russia, Market Share of Major Players (%), 2012 60

Figure 14: Cardiovascular Devices Market, Russia, Revenue ($m), 2009-2016 61

Figure 15: Cardiovascular Devices Market, Russia, Market Share of Major Players (%), 2015 62

Figure 16: Orthopedic Devices Market, Russia, Revenue ($m), 2009-2016 63

Figure 17: Orthopedic Devices Market, Russia, Market Share of Major Players (%), 2015 64

Figure 18: Diagnostic Imaging Market, Russia, Revenue ($m), 2009-2016 65

Figure 19: Diagnostic Imaging Market, Russia, Market Share of Major Companies (%), 2015 66

Figure 20: Medical Device Market, Russia, Revenue of Major Companies ($m), 2015 67

Figure 21: Healthcare Market, Russia, Drivers and Barriers, 2016 98

Figure 22: Healthcare Spending, Russia, Out-of-Pocket Expenditure (%), 2009-2015 104

Figure 23: Economic Indicators, Russia, Gross Domestic Product Per Capita ($), 2009-2016 126

Figure 24: Economic Indicators, Russia, Gross Domestic Product per Capita Forecast ($), 2017-2021 127

Figure 25: Economic Indicators, Russia, Gross Domestic Product Annual Growth (%), 2009-2016 128

Figure 26: Economic Indicators, Russia, Gross Domestic Product Annual Growth Forecast (%), 2017-2021 129

Figure 27: Economic Indicators, Russia, Gross National Income per Capita ($), 2009-2016 130

Figure 28: Economic Indicators, Russia, Average Consumer Price Index, 2009-2016 131

Figure 29: Economic Indicators, Russia, Average Consumer Price Annual Change (%), 2009-2016 132

Figure 30: Economic Indicators, Russia, Currency Exchange Rate (RUB per $), 2009-2016 133

Figure 31: Economic Indicators, Russia, Foreign Direct Investment ($bn), 2009-2015 134

Figure 32: Economic Indicators, Russia, Foreign Exchange Reserves ($bn), 2009-2016 135

Figure 33: Economic Indicators, Russia, Imports of Goods and Services ($bn), 2009-2015 136

Figure 34: Economic Indicators, Russia, Exports of Goods and Services ($bn), 2009-2015 137

Figure 35: Economic Indicators, Russia, Government Structural Balance ($bn), 2009-2016 138

Figure 36: Economic Indicators, Russia, General Government Gross Debt as a Percentage of GDP (%), 2009-2016 139

Figure 37: Economic Indicators, Russia, Major Industries by Revenue Share (%), 2015 140

Figure 38: Demographics, Russia, Population (million), 2009-2016 142

Figure 39: Demographics, Russia, Population Forecast (million), 2017-2021 143

Figure 40: Demographics, Russia, Urban-Rural Population Share (%), 2009-2016 144

Figure 41: Demographics, Russia, Urban-Rural Population Share Forecast (%), 2017-2021 145

Figure 42: Demographics, Russia, Population Distribution by Age Group (%), 2009-2016 146

Figure 43: Demographics, Russia, Population Distribution by Age Group Forecast (%), 2017-2021 147

Figure 44: Demographics, Russia, Births (per 1,000 population), 2009-2016 148

Figure 45: Demographics, Russia, Mortality (per 1,000 population), 2009-2016 149

Figure 46: Demographics, Russia, Major Causes of Mortality, 2015 150

Figure 47: Demographics, Russia, Infant Mortality (per 1,000 live births), 2009-2016 151

Figure 48: Demographics, Russia, Immunization Rate (%), 2009-2016 152

Figure 49: Demographics, Russia, Major Causes of Male Mortality (per 100,000 population), 2015 153

Figure 50: Demographics, Russia, Major Causes of Female Mortality (per 100,000 population), 2015 154

Figure 51: Demographics, Russia, Gender Ratio (M/F), 2009-2015 155

Figure 52: Demographics, Russia, Life Expectancy at Birth (years), 2009-2016 156

Figure 53: Demographics, Russia, Enrollment by Level of Education (%), 2009-2015 158

Figure 54: Demographics, Russia, Unemployment Rate (%), 2009-2015 159

Figure 55: Demographics, Russia, Distribution of Employment by Industry (%), 2015 160

Figure 56: Demographics, Russia, Morbidity ('000), 2015 161

Figure 57: Demographics, Russia, Disability-Adjusted Life Years by Major Disease ('000), 2012 163

Figure 58: Healthcare Infrastructure, Russia, Number of Hospitals ('000), 2009-2015 164

Figure 59: Healthcare Infrastructure, Russia, Number of Outpatient Clinics ('000), 2009-2015 165

Figure 60: Healthcare Infrastructure, Russia, Public and Private Hospitals, 2009-2015 166

Figure 61: Healthcare Infrastructure, Russia, Hospital Beds by Specialization ('000), 2014 167

Figure 62: Healthcare Infrastructure, Russia, Diagnostic Equipment (per million population), 2009-2015 168

Figure 63: Healthcare Infrastructure, Russia, Hospital Beds (per 10,000 population), 2009-2015 169

Figure 64: Healthcare Infrastructure, Russia, Doctors (per 10,000 population), 2009-2015 170

Figure 65: Healthcare Infrastructure, Russia, Doctors by Specialization ('000), 2014 171

Figure 66: Healthcare Infrastructure, Russia, PM2.5 (g per m3), 2009-2015 172

Figure 67: Healthcare Infrastructure, Russia, CO2 Emissions (million metric tons), 2009-2015 173

Figure 68: Healthcare Infrastructure, Russia, Healthcare Personnel ('000), 2014 174

Figure 69: Healthcare Expenditure, Russia, Healthcare Expenditure as a Percentage of GDP (%), 2009-2015 176

Figure 70: Healthcare Expenditure, Russia, Public-Private Share (%), 2009-2015 177

Figure 71: Healthcare Expenditure, Russia, R&D Expenditure as a Percentage of GDP (%), 2009-2015 178

Figure 72: Healthcare Market, Russia, Opportunities and Challenges, 2016 183

1.1 List of Tables

Table 1: Pharmaceutical Market, Russia, Revenue ($bn), 2009-2016 18

Table 2: Pharmaceutical Market, Russia, Revenue Forecast ($bn), 2017-2021 19

Table 3: Pharmaceutical Market, Russia, Pharmaceutical Exports and Imports ($bn), 2009-2015 20

Table 4: Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2015 25

Table 5: Pharmaceutical Market, Novartis, Planned Filings, 2016-2018 26

Table 6: Sanofi, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2015 34

Table 7: Pharmaceutical Market, Sanofi, Global, Late-stage Pipeline, 2016 34

Table 8: Bayer, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2015 39

Table 9: Pharmaceutical Market, Roche, Global, Revenue ($m) and Annual Growth (%) of Major Products, 2016* 44

Table 10: Pharmaceutical Market, Roche, Global, Late-stage Pipeline, 2016 45

Table 11: Medical Device Market, Russia, Revenue ($bn), 2009-2016 55

Table 12: Medical Device Market, Russia, Revenue Forecast ($bn), 2017-2021 55

Table 13: Medical Device Market, Russia, Revenue by Segment ($m), 2016 56

Table 14: Ophthalmic Devices Market, Russia, Revenue ($m), 2009-2016 57

Table 15: Ophthalmic Devices Market, Russia, Revenue ($m) and Market Share (%) of Major Companies, 2015 58

Table 16: Wound Care Management Market, Russia, Revenue ($m), 2009-2016 59

Table 17: Wound Care Management Market, Russia, Revenue ($m) and Market Share (%) of Major Companies, 2012 60

Table 18: Cardiovascular Devices Market, Russia, Revenue ($m), 2009-2016 61

Table 19: Cardiovascular Devices Market, Russia, Revenue ($m) and Market Share (%) of Major Companies, 2015 62

Table 20: Orthopedic Devices Market, Russia, Revenue of Major Players ($m), 2009-2016 63

Table 21: Orthopedic Devices Market, Russia, Revenue ($m) and Market Share (%) of Major Companies, 2015 64

Table 22: Diagnostic Imaging Market, Russia, Revenue ($m), 2009-2016 65

Table 23: Diagnostic Imaging Market, Russia, Revenue ($m) and Market Share (%) of Major Companies, 2015 66

Table 24: Medical Device Market, Russia, Revenue ($m) and Market Share (%) of Major Companies, 2015 67

Table 25: Medical Device Market, Medtronic, Major Products, 2016 74

Table 26: Baxter International, Global, Major Products, 2016 80

Table 27: Roche, Global, Major Products, 2015 85

Table 28: Medical Device Market, Roche, Global, Late-Stage Pipeline, 2016 86

Table 29: Healthcare Spending, Russia, Out-of-Pocket Expenditure (%), 2009-2015 104

Table 30: Medical Equipment Classification, Russia, 2016 110

Table 31: Medical Equipment Classification Based on Level of Risk, 2016 110

Table 32: Economic Indicators, Russia, Gross Domestic Product per Capita ($), 2009-2016 126

Table 33: Economic Indicators, Russia, Gross Domestic Product per Capita Forecast ($), 2017-2021 127

Table 34: Economic Indicators, Russia, Gross Domestic Product Annual Growth (%), 2009-2016 128

Table 35: Economic Indicators, Russia, Gross Domestic Product Annual Growth Forecast (%), 2017-2021 129

Table 36: Economic Indicators, Russia, Gross National Income per Capita ($), 2009-2016 130

Table 37: Economic Indicators, Russia, Average Consumer Price Index, 2009-2016 131

Table 38: Economic Indicators, Russia, Average Consumer Price Annual Change (%), 2009-2016 132

Table 39: Economic Indicators, Russia, Currency Exchange Rate (RUB per $), 2009-2016 133

Table 40: Economic Indicators, Russia, Foreign Direct Investment ($bn), 2009-2015 134

Table 41: Economic Indicators, Russia, Foreign Exchange Reserves ($bn), 2009-2016 135

Table 42: Economic Indicators, Russia, Imports of Goods and Services ($bn), 2009-2015 136

Table 43: Economic Indicators, Russia, Exports of Goods and Services ($bn), 2009-2015 137

Table 44: Economic Indicators, Russia, Government Structural Balance ($bn), 2009-2016 138

Table 45: Economic Indicators, Russia, General Government Gross Debt as a Percentage of GDP (%), 2009-2016 139

Table 46: Economic Indicators, Russia, Major Industries by Revenue Share (%), 2015 141

Table 47: Demographics, Russia, Population (million), 2009-2016 142

Table 48: Demographics, Russia, Population Forecast (million), 2017-2021 143

Table 49: Demographics, Russia, Urban-Rural Population Share (%), 2009-2016 144

Table 50: Demographics, Russia, Urban-Rural Population Share Forecast (%), 2017-2021 145

Table 51: Demographics, Russia, Population Distribution by Age Group (%), 2009-2016 146

Table 52: Demographics, Russia, Population Distribution by Age Group Forecast (%), 2017-2021 147

Table 53: Demographics, Russia, Births (per 1,000 population), 2009-2016 148

Table 54: Demographics, Russia, Mortality (per 1,000 population), 2009-2016 149

Table 55: Demographics, Russia, Major Causes of Mortality, 2015 150

Table 56: Demographics, Russia, Infant Mortality (per 1,000 live births), 2009-2016 151

Table 57: Demographics, Russia, Immunization Rate (%), 2009-2016 152

Table 58: Demographics, Russia, Major Causes of Male Mortality (per 100,000 population), 2015 153

Table 59: Demographics, Russia, Major Causes of Female Mortality (per 100,000 population), 2015 154

Table 60: Demographics, Russia, Gender Ratio (M/F), 2009-2015 155

Table 61: Demographics, Russia, Life Expectancy at Birth (years), 2009-2016 156

Table 62: Demographics, Russia, Enrollment by Level of Education (%), 2009-2015 158

Table 63: Demographics, Russia, Unemployment Rate (%), 2009-2015 159

Table 64: Demographics, Russia, Distribution of Employment by Industry (%), 2015 160

Table 65: Demographics, Russia, Morbidity ('000), 2015 162

Table 66: Demographics, Russia, Disability-Adjusted Life Years by Major Disease ('000), 2012 163

Table 67: Healthcare Infrastructure, Russia, Number of Hospitals ('000), 2009-2015 164

Table 68: Healthcare Infrastructure, Russia, Number of Outpatient Clinics ('000), 2009-2015 165

Table 69: Healthcare Infrastructure, Russia, Public and Private Hospitals, 2009-2015 166

Table 70: Healthcare Infrastructure, Russia, Hospital Beds by Specialization ('000), 2014 167

Table 71: Healthcare Infrastructure, Russia, Diagnostic Equipment (per million population), 2009-2015 168

Table 72: Healthcare Infrastructure, Russia, Hospital Beds (per 10,000 population), 2009-2015 169

Table 73: Healthcare Infrastructure, Russia, Doctors (per 10,000 population), 2009-2015 170

Table 74: Healthcare Infrastructure, Russia, Doctors by Specialization ('000), 2014 171

Table 75: Healthcare Infrastructure, Russia, PM2.5 (g per m3), 2009-2015 173

Table 76: Healthcare Infrastructure, Russia, CO2 Emissions (million metric tons), 2009-2015 174

Table 77: Healthcare Infrastructure, Russia, Healthcare Personnel ('000), 2014 175

Table 78: Healthcare Expenditure, Russia, Healthcare Expenditure as a Percentage of GDP (%), 2009-2015 176

Table 79: Healthcare Expenditure, Russia, Public-Private Share (%), 2009-2015 177

Table 80: Healthcare Expenditure, Russia, R&D Expenditure as a Percentage of GDP (%), 2009-2015 178

Table 81: Healthcare Expenditure, Russia, Major Healthcare Trade Fairs, 2017 180

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