CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Singapore

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Date: 01-Jun-2017
No. of pages: 182
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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Singapore

Summary

Singapore is known for its world-class biomedical science research facilities and develops pharmaceuticals and medical devices at the medical technology hubs MedTech, Biopolis and Tuas Biomedical Park. The country has emerged as a regional hub for the manufacture and R&D activities of multinational pharmaceutical companies, and offers excellent opportunities for Biomedical Science (BMS) companies via a pro-business environment, low unit labor costs, low corporate tax, and strong government support.

Singapore's healthcare market is driven by universal access to health insurance schemes and world-class biomedical sciences research facilities, although the market is small in comparison to those of other developed countries, primarily due to the small population. The value of the pharmaceuticals market increased from Us$642m in 2009 to Us$903m in 2016 at a Compound Annual Growth Rate (CAGR) of 5% and is expected to increase from 2017 to 2021 at a CAGR of 5%.

In 2010, Singapore was ranked fourth globally for its healthcare infrastructure. The MoH is responsible for providing for the healthcare service needs of the people, through policy planning and co-ordination. Singapore's healthcare institutions consist of public hospitals, private hospitals and specialty centers, covering the entire spectrum of clinical services, from basic health screening to dental surgery and quaternary care. In 2009, the public sector health expenditure share was 35.7%, which increased to an estimated 44.4% in 2016 at a CAGR of 3% (World Bank, 2017q). This is expected to drive the country's healthcare market.

The report "CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Singapore" is an essential source of information on analysis of the healthcare, regulatory and reimbursement landscape in Singapore. It identifies the key trends in the country's healthcare market and provides insights into its demographic, regulatory, and reimbursement landscape and healthcare infrastructure.

In particular, this report -

- Provides an overview of the pharmaceutical and medical device market of Singapore, including the market size; market segmentation by generic, Over-The-Counter (OTC), biologic and biosimilar products; and the key drivers and barriers for the market. The section also includes profiles of the major companies, including a SWOT assessment.

- Covers the country's reimbursement and payer landscape, as well as the regulatory landscape. The reimbursement and payer landscape section elaborates on the features of the healthcare reimbursement process for Singapore.

- Provides a detailed analysis of the political and economic environment of Singapore. It analyzes its economic indicators, demographics, healthcare infrastructure and healthcare expenditure.

- Provides an overview of the opportunities and challenges for growth that exist in the healthcare market of Singapore.

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Singapore, 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: Merck & Co., Sanofi, Hyphens Pharma, Novartis, and Valeant.

- An insightful review of the reimbursement and regulatory landscape, with analysis covering details of the country's healthcare reimbursement process, regulatory agencies and the approval processes for new drugs and medical devices

- Detailed analysis of the country's 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 Singaporean 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 Singapore's healthcare market

- Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact Singapore's healthcare market in the future

- Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing competitors' performance

- Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment and strategic partnership

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Singapore

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 6
2 Executive Summary 8
3 Introduction 12
3.1 GlobalData Report Guidance 12
4 Overview of Pharmaceutical and Medical Device Markets 13
4.1 Pharmaceutical Market 13
4.1.1 Market Overview 13
4.1.2 Pharmaceutical Exports and Imports 17
4.1.3 Supply Channels 18
4.1.4 Market Segments 18
4.1.5 Overview of Major Disease Areas 20
4.1.6 Major Players 22
4.2 Medical Device Market 51
4.2.1 Market Overview 51
4.3 Market Drivers and Barriers 52
4.3.1 Drivers 52
4.3.2 Barriers 52
5 Market Access 54
5.1 Overview of Healthcare System 54
5.1.1 Reimbursement Process 56
5.1.2 Overview of Insurance Providers 57
5.1.3 Patient Share in Healthcare Expenditure 61
5.1.4 Price Trends in the Healthcare Sector 61
5.1.5 Pricing Policies 62
5.2 Regulatory Landscape 63
5.2.1 Overview of Regulatory Agencies 63
5.2.2 Market Authorization Procedure for Pharmaceutical Products 66
5.2.3 New Medical Device Approval Process 70
5.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 72
5.2.5 Exports and Imports 74
5.2.6 Intellectual Property Rights 77
5.2.7 Clinical Trial Regulations 88
5.2.8 Pharmaceutical Advertising Regulations 92
5.2.9 Pharmacy Regulations 94
5.2.10 Labeling and Packaging Regulations 94
6 Country Analysis 98
6.1 Political Environment 98
6.1.1 Current Political Environment 99
6.1.2 Healthcare Policy Initiatives 99
6.2 Economic Landscape 101
6.3 Economic Indicators 105
6.3.1 Gross Domestic Product 105
6.3.2 Gross National Income 109
6.3.3 Inflation 110
6.3.4 Currency Exchange Rate 114
6.3.5 Foreign Direct Investment 115
6.3.6 Foreign Exchange Reserves 116
6.3.7 Trade Balance 117
6.3.8 Government Structural Balance 119
6.3.9 Government Net Debt 120
6.3.10 Major Industries 122
6.4 Demographics 123
6.4.1 Population 123
6.4.2 Education and Literacy 139
6.4.3 Employment 141
6.4.4 Disease Burden 141
6.5 Healthcare Infrastructure 143
6.5.1 Healthcare Facilities 143
6.5.2 Healthcare Parameters 147
6.5.3 Environmental Health 148
6.5.4 Healthcare Personnel 150
6.6 Healthcare Expenditure 153
6.6.1 Overview 153
6.6.2 Share of Public and Private Sectors 154
6.6.3 Major Components of Healthcare Expenditure 155
6.6.4 Spending in Pharmaceutical R&D 156
6.7 Trade Associations 157
6.7.1 The Singapore Association of Pharmaceutical Industries 157
6.7.2 The Singapore Medical Association 158
6.7.3 The Society for Emergency Medicine in Singapore 158
6.7.4 The Pharmaceutical Society of Singapore 158
6.7.5 The Healthcare Quality Society of Singapore 159
6.8 Trade Fairs 160
7 Opportunities and Challenges 161
7.1 Opportunities 161
7.2 Challenges 162
8 Appendix 163
8.1 Abbreviations 163
8.2 Bibliography 167
8.3 Research Methodology 180
8.3.1 Coverage 180
8.3.2 Secondary Research 180
8.3.3 Forecasts 181
8.3.4 Expert Panel 181
8.4 Contact Us 181
8.5 Disclaimer 182

1.1 List of Tables
Table 1: Pharmaceutical Market, Singapore, Revenue ($m), 2009-2016 15
Table 2: Pharmaceutical Market, Singapore, Revenue ($m), 2017-2021 16
Table 3: Pharmaceutical Market, Singapore, Exports and Imports ($bn), 2009-2016 17
Table 4: Pharmaceutical Market, Merck & Co., Global, Major Products, 2017 23
Table 5: Pharmaceutical Market, Merck & Co., Global, Late-Stage Pipeline, 2017 25
Table 6: Major Products, Sanofi, Global, 2017 31
Table 7: Late-Stage Pipeline, Sanofi, Global, 2015 32
Table 8: Major Products, Novartis, Global, 2017 38
Table 9: Late-Stage Pipeline, Novartis, Global, 2017 39
Table 10: Pharmaceutical Market, Valeant, Global, Major Products, 2017 46
Table 11: Pharmaceutical Market, Valeant, Global, Late-Stage Pipeline, 2017 47
Table 12: Market Access, Singapore, MediSave Wage Contribution (%), 2014 57
Table 13: Market Access, Singapore, MediShield Premium Payment Scheme by Age Group ($), 2015 58
Table 14: Market Access, Singapore, Medisave-Approved Integrated Shield Plans Withdrawal Limit by Age Group ($), 2014 59
Table 15: Market Access, Singapore, Additional Withdrawal Limit by Age Group ($), 2015 59
Table 16: Healthcare Expenditure, Singapore, Out-of-Pocket Expenditure (%), 2009-2016 61
Table 17: Market Access, Singapore, Healthcare Consumer Price Index Annual Change (%), 2009-2015 62
Table 18: Market Access, Singapore, RegistrationDossier Format, 2016 68
Table 19: Market Access, Singapore, Registration Dossier Format, 2016 69
Table 20: Market Access, Singapore, Registration Dossier Format, 2016 71
Table 21: Market Access, Singapore, GMP Certificate Fees for Medicinal Products and Active Pharmaceutical Ingredients ($), 2016 74
Table 22: Market Access, Singapore, Manufacturer's License Fees for Medicinal Products ($), 2016 74
Table 23: Market Access, Singapore, Manufacturer's License Fees for Medicinal Products ($), 2016 76
Table 24: Market Access, Singapore, Wholesale Dealer's License Fees for Medicinal Products ($), 2016 76
Table 25: Market Access, Singapore, Patent Co-operation Treaty, International Application Process, 2014 82
Table 26: Market Access, Singapore, Patent Filing Fees and Charges, 2017 83
Table 27: Market Access, Singapore, Clinical Trial Certificates Issued, 2009-2015 90
Table 28: Market Access, Singapore, Clinical Trials by Therapeutic Area (%), 2015 91
Table 29: Market Access, Singapore, Target Processing Timelines of Clinical Trial, 2016 92
Table 30: Market Access, Singapore, Fees for Advertisement Permit ($), 2016 93
Table 31: Market Access, Singapore, Labeling Requirements, 2014 96
Table 32: Economic Indicators, Singapore, GDP per Capita ($), 2009-2016 105
Table 33: Economic Indicators, Singapore, GDP per Capita ($), 2017-2021 106
Table 34: Economic Indicators, Singapore, GDP Annual Growth (%), 2009-2016 107
Table 35: Economic Indicators, Singapore, GDP Annual Growth (%), 2017-2021 108
Table 36: Economic Indicators, Singapore, GNI per Capita ($), 2009-2016 109
Table 37: Economic Indicators, Singapore, Consumer Price Index, 2009-2016 110
Table 38: Economic Indicators, Singapore, Average Consumer Price Index, 2017-2021 111
Table 39: Economic Indicators, Singapore, Average Consumer Price Index Annual Change (%), 2009-2016 112
Table 40: Economic Indicators, Singapore, Average Consumer Price Index, Annual Change (%), 2017-2021 113
Table 41: Economic Indicators, Singapore, Currency Exchange Rate (SGD/$), 2009-2016 114
Table 42: Economic Indicators, Singapore, Foreign Direct Investment ($bn), 2009-2016 115
Table 43: Economic Indicators, Singapore, Foreign Exchange Reserves ($bn), 2009-2016 116
Table 44: Economic Indicators, Singapore, Imports of Goods and Services ($bn), 2009-2016 117
Table 45: Economic Indicators, Singapore, Exports of Goods and Services ($bn), 2009-2016 118
Table 46: Economic Indicators, Singapore, General Government Structural Balance ($bn), 2009-2016 119
Table 47: Economic Indicators, Singapore, Government Net Debt as a Percentage of GDP (%), 2009-2016 120
Table 48: Economic Indicators, Singapore, Government Net Debt as a Percentage of GDP (%), 2017-2021 121
Table 49: Economic Indicators, Singapore, Value Added by Major Industries ($bn), 2015 122
Table 50: Demographics, Singapore, Population (million), 2009-2016 124
Table 51: Demographics, Singapore, Population (million), 2017-2021 125
Table 52: Demographics, Singapore, Urban-Rural Population Share (%), 2009-2016 126
Table 53: Demographics, Singapore, Urban-Rural Population Share (%), 2017-2021 127
Table 54: Demographics, Singapore, Population Distribution by Age Group (%), 2009-2016 128
Table 55: Demographics, Singapore, Population Distribution by Age Group (%), 2017-2021 129
Table 56: Demographics, Singapore, Births (per 1,000 Population), 2009-2016 130
Table 57: Demographics, Singapore, Mortality (per 1,000 Population), 2009-2016 131
Table 58: Demographics, Singapore, Major Causes of Mortality (%), 2015 132
Table 59: Demographics, Singapore, Mortality Rate of Children Under Five (per 1,000 live births), 2009-2016 133
Table 60: Demographics, Singapore, Immunization Rate (%), 2009-2016 134
Table 61: Demographics, Singapore, Major Causes of Male Mortality (‘000), 2015 135
Table 62: Demographics, Singapore, Major Causes of Female Mortality (‘000), 2015 136
Table 63: Demographics, Singapore, Gender Ratio (M/F), 2009-2016 137
Table 64: Demographics, Singapore, Life Expectancy at Birth (years), 2009-2016 138
Table 65: Demographics, Singapore, Life Expectancy at Birth (years), 2017-2021 139
Table 66: Demographics, Singapore, Student Enrollment by Level of Education (%), 2015 140
Table 67: Demographics, Singapore, Unemployment Rate (%), 2009-2016 141
Table 68: Demographics, Singapore, Disability-Adjusted Life Years by Major Disease (‘000), 2015 142
Table 69: Healthcare Infrastructure, Singapore, Hospitals, 2009-2016 144
Table 70: Healthcare Infrastructure, Singapore, Public and Private Hospitals, 2009-2016 145
Table 71: Healthcare Infrastructure, Singapore, Hospitals Beds by Sector, 2009-2016 146
Table 72: Healthcare Infrastructure, Singapore, Hospitals Beds (per 1,000 population), 2009-2016 147
Table 73: Healthcare Infrastructure, Singapore, Doctors (per 1,000 population), 2009-2016 148
Table 74: Healthcare Infrastructure, Singapore, PM2.5 (µg per m³), 2009-2016 149
Table 75: Healthcare Infrastructure, Singapore, CO2 Emissions (metric tons per capita), 2009-2016 150
Table 76: Healthcare Infrastructure, Singapore, Nurses (per 1,000 population), 2009-2016 151
Table 77: Healthcare Infrastructure, Singapore, Pharmacists, 2009-2016 152
Table 78: Healthcare Infrastructure, Singapore, Dentists, 2009-2016 153
Table 79: Healthcare Infrastructure, Singapore, Healthcare Expenditure as Percentage of GDP (%), 2009-2016 154
Table 80: Healthcare Infrastructure, Singapore, Public-Private Share of Expenditure (%), 2009-2016 155
Table 81: Healthcare Infrastructure, Singapore, Major Components of Healthcare Expenditure (%), 2016 156
Table 82: Healthcare Infrastructure, Singapore, R&D Expenditure ($m), 2009-2016 157
Table 83: Healthcare Expenditure, Singapore, Major Healthcare Trade Fairs, 2017 160

1.2 List of Figures
Figure 1: Pharmaceutical Market, Singapore, Revenue ($bn), 2009-2021 9
Figure 2: Country Profile, Singapore, 2017 11
Figure 3: Pharmaceutical Market, Singapore, Revenue ($m), 2009-2016 15
Figure 4: Pharmaceutical Market, Singapore, Revenue ($m), 2017-2021 16
Figure 5: Pharmaceutical Market, Singapore, Exports and Imports ($bn), 2009-2016 17
Figure 6: Pharmaceutical Market, Singapore, Distribution Channels (%), 2016 18
Figure 7: Healthcare Market, Singapore, Drivers and Barriers, 2017 53
Figure 8: Market Access, Singapore, Healthcare Insurance System, 2015 55
Figure 9: Market Access, Singapore, Healthcare Financing System, 2015 56
Figure 10: Healthcare Expenditure, Singapore, Out-of-Pocket Expenditure (%), 2009-2016 61
Figure 11: Market Access, Singapore, Healthcare Consumer Price Index Annual Change (%), 2009-2015 62
Figure 12: Market Access, Singapore, Organizational Structure of Drug Regulatory Authority, 2016 63
Figure 13: Market Access, Singapore, Structure of Health Sciences Authority, 2014 65
Figure 14: Market Access, Singapore, New Drug Application Types, 2014 67
Figure 15: Market Access, EU, Centralized Procedure for Market Authorization, Pre-submission, 2016 70
Figure 16: Market Access, EU, Conformity Assessment of Class I Medical Devices, 2016 74
Figure 17: : Market Access, Singapore, Licensing Process for Import/Export, 2016 76
Figure 18: Market Access, Singapore, National Patent Approval Process, 2017 80
Figure 19: Market Access, Singapore, Patent Co-operation Treaty National Phase Entry Process, 2016 81
Figure 20: Market Access, Singapore, International Patent Approval Process, 2016 82
Figure 21: Market Access, Singapore, National Trademark Approval Process, 2017 87
Figure 22: Market Access, Singapore, International Trademark Approval Process, 2017 88
Figure 23: Market Access, Singapore, Clinical Trial Certificates Issued, 2009-2015 90
Figure 24: Market Access, Singapore, Clinical Trials by Therapeutic Area (%), 2015 91
Figure 25: Economic Indicators, Singapore, GDP Per Capita ($), 2009-2016 105
Figure 26: Economic Indicators, Singapore, GDP per Capita ($), 2017-2021 106
Figure 27: Economic Indicators, Singapore, GDP Annual Growth (%), 2009-2016 107
Figure 28: Economic Indicators, Singapore, GDP Annual Growth (%), 2017-2021 108
Figure 29: Economic Indicators, Singapore, GNI per Capita ($), 2009-2016 109
Figure 30: Economic Indicators, Singapore, Consumer Price Index, 2009-2016 110
Figure 31: Economic Indicators, Singapore, Average Consumer Price Index, 2017-2021 111
Figure 32: Economic Indicators, Singapore, Average Consumer Price Index, Annual Change (%), 2009-2016 112
Figure 33: Economic Indicators, Singapore, Average Consumer Price Index, Annual Change (%), 2017-2021 113
Figure 34: Economic Indicators, Singapore, Currency Exchange Rate (SGD/$), 2009-2016 114
Figure 35: Economic Indicators, Singapore, Foreign Direct Investment ($bn), 2009-2016 115
Figure 36: Economic Indicators, Singapore, Foreign Exchange Reserves ($bn), 2009-2016 116
Figure 37: Economic Indicators, Singapore, Imports of Goods and Services ($bn), 2009-2016 117
Figure 38: Economic Indicators, Singapore, Exports of Goods and Services ($bn), 2009-2016 118
Figure 39: Economic Indicators, Singapore, Government Structural Balance ($bn), 2009-2016 119
Figure 40: Economic Indicators, Singapore, Government Net Debt as a Percentage of GDP (%), 2009-2016 120
Figure 41: Economic Indicators, Singapore, Government Net Debt as a Percentage of GDP (%), 2017-2021 121
Figure 42: Economic Indicators, Singapore, Value Added by Major Industries ($bn), 2015 122
Figure 43: Demographics, Singapore, Population (million), 2009-2016 124
Figure 44: Demographics, Singapore, Population (million), 2017-2021 125
Figure 45: Demographics, Singapore, Urban-Rural Population Share (%), 2009-2016 126
Figure 46: Demographics, Singapore, Urban-Rural Population Share (%), 2017-2021 127
Figure 47: Demographics, Singapore, Population Distribution by Age Group (%), 2009-2016 128
Figure 48: Demographics, Singapore, Population Distribution by Age Group (%), 2017-2021 129
Figure 49: Demographics, Singapore, Births (per 1,000 Population), 2009-2016 130
Figure 50: Demographics, Singapore, Mortality (per 1,000 Population), 2009-2016 131
Figure 51: Demographics, Singapore, Major Causes of Mortality (%), 2015 132
Figure 52: Demographics, Singapore, Mortality Rate of Children Under Five (per 1,000 live births), 2009-2016 133
Figure 53: Demographics, Singapore, Immunization Rate (%), 2009-2016 134
Figure 54: Demographics, Singapore, Major Causes of Male Mortality (‘000), 2015 135
Figure 55: Demographics, Singapore, Major Causes of Female Mortality (‘000), 2015 136
Figure 56: Demographics, Singapore, Gender Ratio (M/F), 2009-2016 137
Figure 57: Demographics, Singapore, Life Expectancy at Birth (years), 2009-2016 138
Figure 58: Demographics, Singapore, Life Expectancy at Birth (years), 2017-2021 139
Figure 59: Demographics, Singapore, Student Enrollment by Level of Education (%), 2015 140
Figure 60: Demographics, Singapore, Unemployment Rate (%), 2009-2016 141
Figure 61: Demographics, Singapore, Major Diseases, Disability-Adjusted Life Years by Major Disease (‘000s), 2015 142
Figure 62: Healthcare Infrastructure, Singapore, Hospitals, 2009-2016 144
Figure 63: Healthcare Infrastructure, Singapore, Public and Private Hospitals, 2009-2016 145
Figure 64: Healthcare Infrastructure, Singapore, Hospitals Beds by Sector, 2009-2016 146
Figure 65: Healthcare Infrastructure, Singapore, Hospitals Beds (per 1,000 population), 2009-2016 147
Figure 66: Healthcare Infrastructure, Singapore, Doctors (per 1,000 population), 2009-2016 148
Figure 67: Healthcare Infrastructure, Singapore, PM2.5 (µg per m³), 2009-2016 149
Figure 68: Healthcare Infrastructure, Singapore, CO2 Emissions (metric tons per capita), 2009-2016 150
Figure 69: Healthcare Infrastructure, Singapore, Nurses (per 1,000 population), 2009-2016 151
Figure 70: Healthcare Infrastructure, Singapore, Pharmacists, 2009-2016 152
Figure 71: Healthcare Infrastructure, Singapore, Dentists, 2009-2016 153
Figure 72: Healthcare Infrastructure, Singapore, Healthcare Expenditure as Percentage of GDP (%), 2009-2016 154
Figure 73: Healthcare Infrastructure, Singapore, Public-Private Share of Expenditure (%), 2009-2016 155
Figure 74: Healthcare Infrastructure, Singapore, Major Components of Healthcare Expenditure (%), 2016 156
Figure 75: Healthcare Infrastructure, Singapore, R&D Expenditure ($m), 2009-2016 157
Figure 76: Healthcare Market, Singapore, Opportunities and Challenges, 2016 162
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