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REFERENCE CODE GDHC0077CHR | PUBLICATION DATE FEBRUARY 2015
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – JAPAN
Healthcare, Regulatory and Reimbursement Landscape – Japan 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – JAPAN
Executive Summary
New product launches and the healthcare burden of the elderly population are expected to continue to drive Japan’s pharmaceutical market. However, a focus on generic substitution and a biennial pricing review system may restrain growth.
The pharmaceutical market was valued at $XX
billion in 2008 and grew to $XX billion in 2013 at a
Compound Annual Growth Rate (CAGR) of XX%
due to the appreciation of the yen against the
dollar, and is expected to continue to grow, albeit
at a lower CAGR of XX% during the 2014–2020
period to $XX billion. However, the market declined
to $XX billion in 2012 and $XX billion in 2013 due
to the appreciation of the yen against the dollar, as
well as biennial price cuts and government
strategies to increase generic drug utilization to
account for XX% of all drug use by 2017. The
pharmaceutical market value is based on
pharmaceutical production data. In 2012,
cardiovascular agents, Central Nervous System
(CNS) agents, agents affecting metabolism,
digestive-organ agents, and blood and body-fluid
agents dominated the market.
In 2012, XX drugs were approved, which
represents a slight increase compared to XX in
2011, attributed to an expedited review process.
The median total review time for new drugs was
XX months for priority-review products and XX
months for standard-review products (PMDA,
2014).
In 2013, Japan’s elderly population accounted for
XX% of the overall population, and it is estimated
to account for XX% of the population by 2020
(Statistics Bureau, 2014b). It is growing at a faster
rate than that of the US and Europe due to
improving healthcare facilities and strong financial
support for the elderly. This aging population and
its associated disease burden will further contribute
to pharmaceutical market growth.
In order to reduce the healthcare expenditure
burden, the government is promoting the use of
generics as a cost-containment tool. In 2008,
generics accounted for XX% of the pharmaceutical
market in terms of volume, rising to XX% in 2013.
Drug prices have declined following a revision
based on the biennial pricing system and the drug-
price revision system (JPMA, 2012). In 2014,
prices fell by XX%, excluding the effect of
consumption tax. In September 2013, the Ministry
of Health, Labor and Welfare (MHLW) announced
new price cuts for drugs with generic replacement
of less than XX%. The maximum price cut of XX%
is applied to drugs with generic substitution rates of
less than XX%, while drugs with a generic
replacement rate of less than XX% and less than
XX% will face price cuts of XX% and XX%
respectively (JPMA, 2014b). Increasing generic
substitution and biennial pricing reviews are like to
restrict growth in the pharmaceutical market in the
future.
Healthcare, Regulatory and Reimbursement Landscape – Japan 3 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – JAPAN
Executive Summary
Pharmaceutical Market, Japan, Revenue ($bn), 2008–2020
2008 2013 2015 2020
Rev
enue
($bn
)
CAGR (2008–2020): XX%
Source: MHLW, 2014h *Based on production value
In 2013, the medical device market was valued at
$XX billion, having grown at a CAGR of XX% from
2008. It is expected to reach $XX billion in 2020,
driven by the increasingly elderly population and
the consequent rise in demand for healthcare
products, services and new technologies. The
major segments were ophthalmic devices (XX%),
In Vitro Diagnostics (IVD) (XX%), orthopedic
devices (XX%), diagnostic imaging (XX%), and
healthcare information technology IT (XX%).
Ophthalmic devices accounted for approximately
XX% of the medical device market in Japan,
followed by IVD devices (XX%), orthopedic devices
(XX%), healthcare IT (XX%) and nephrology and
urology devices (XX%).
Medical Device Market, Japan, Revenue ($bn), 2008–2020
2008 2013 2015 2020
Rev
enue
($bn
)
CAGR (2008–2020): XX%
Source: GlobalData, Medical eTrack [Accessed on December 2, 2014]
The government is working to ease the long regulatory process in order to expedite the approval of pharmaceuticals and medical devices and improve access to novel therapeutics, which will not only attract foreign companies but also positively influence the healthcare market.
The MHLW controls all pharmaceutical regulatory
affairs, except veterinary drugs, which fall under
the jurisdiction of the Ministry of Agriculture,
Forestry and Fisheries. The Pharmaceuticals and
Medical Devices Agency (PMDA) provides
consultations for clinical trials of new drugs and
medical devices and conducts approval reviews
and surveys on data reliability.
Healthcare, Regulatory and Reimbursement Landscape – Japan 7 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – JAPAN
1 Table of Contents
1 Table of Contents ....................................................................................................................... 7
1.1 List of Tables .................................................................................................................... 12
1.2 List of Figures ................................................................................................................... 17
2 Introduction ............................................................................................................................... 23
2.1 GlobalData Report Guidance ............................................................................................ 23
3 Overview of the Pharmaceutical and Medical Device Markets .................................................. 24
3.1 Pharmaceutical Market ..................................................................................................... 24
3.1.1 Market Overview ........................................................................................................... 24
3.1.2 Pharmaceutical Imports and Exports ............................................................................. 28
3.1.3 Supply Channels ........................................................................................................... 29
3.1.4 Market Segments .......................................................................................................... 30
3.1.5 Major Therapeutic Areas ............................................................................................... 35
3.1.6 Major Players ................................................................................................................ 42
3.2 Medical Device Market ...................................................................................................... 73
3.2.1 Market Overview ........................................................................................................... 73
3.2.2 Overview of Top-Five Segments ................................................................................... 75
3.2.3 Diagnostics Market ........................................................................................................ 90
3.2.4 Major Players ................................................................................................................ 92
3.3 Market Drivers and Barriers ............................................................................................ 123
3.3.1 Drivers......................................................................................................................... 123
3.3.2 Barriers ....................................................................................................................... 124
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – JAPAN
4 Market Access ........................................................................................................................ 126
4.1 Reimbursement and Payer Landscape ........................................................................... 126
4.1.1 Overview of the Healthcare System ............................................................................ 126
4.1.2 Reimbursement Process ............................................................................................. 127
4.1.3 Overview of Insurance Providers ................................................................................. 130
4.1.4 Patients’ Share of Healthcare Spending ...................................................................... 133
4.1.5 Prescription Drug Price Trend ..................................................................................... 134
4.1.6 Pricing Policies ............................................................................................................ 136
4.2 Regulatory Landscape .................................................................................................... 138
4.2.1 Overview ..................................................................................................................... 138
4.2.2 Regulatory Agencies ................................................................................................... 138
4.2.3 Market Authorization Procedure for Pharmaceutical Products ..................................... 140
4.2.4 New Device Approval Process .................................................................................... 147
4.2.5 Licensing Process for Pharmaceutical and Medical Device Manufacturing .................. 153
4.2.6 Licensing for Pharmaceutical Exports and Imports ...................................................... 155
4.2.7 Intellectual Property Rights.......................................................................................... 155
4.2.8 Clinical Trial Regulations ............................................................................................. 160
4.2.9 Pharmaceutical Advertising Regulations ..................................................................... 161
4.2.10 Pharmacy Regulations ................................................................................................ 162
4.2.11 Labeling and Packaging Regulations .......................................................................... 162
5 Country Analysis ..................................................................................................................... 169
5.1 Political Environment....................................................................................................... 169
5.1.1 Political Structure ........................................................................................................ 169
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – JAPAN
5.1.2 Analysis of Current Political Environment .................................................................... 172
5.1.3 Healthcare Policy Initiatives ......................................................................................... 173
5.2 Economic Landscape ...................................................................................................... 175
5.3 Economic Indicators ........................................................................................................ 178
5.3.1 Gross Domestic Product ............................................................................................. 178
5.3.2 Gross National Income ................................................................................................ 181
5.3.3 Inflation ....................................................................................................................... 182
5.3.4 Currency Exchange Rate ............................................................................................ 186
5.3.5 Foreign Direct Investment ........................................................................................... 188
5.3.6 Foreign Exchange Reserves ....................................................................................... 189
5.3.7 Trade Balance ............................................................................................................. 190
5.3.8 General Government Structural Balance ..................................................................... 192
5.3.9 General Government Gross Debt ................................................................................ 194
5.3.10 Major Industries ........................................................................................................... 195
5.4 Demographics ................................................................................................................. 196
5.4.1 Population ................................................................................................................... 196
5.4.2 Education and Literacy ................................................................................................ 214
5.4.3 Employment ................................................................................................................ 217
5.4.4 Disease Burden ........................................................................................................... 219
5.5 Healthcare Infrastructure ................................................................................................. 223
5.5.1 Healthcare Facilities .................................................................................................... 223
5.5.2 Healthcare Parameters ............................................................................................... 232
5.5.3 Environmental Health .................................................................................................. 235
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – JAPAN
5.5.4 Healthcare Personnel .................................................................................................. 241
5.6 Healthcare Expenditure ................................................................................................... 245
5.6.1 Overview ..................................................................................................................... 245
5.6.2 Major Components of Healthcare Spending ................................................................ 247
5.6.3 Share of Public and Private Sector .............................................................................. 250
5.6.4 Pharmaceutical and Healthcare R&D Expenditure ...................................................... 251
5.7 Trade Associations ......................................................................................................... 252
5.7.1 Japan Pharmaceutical Manufacturers Association ...................................................... 252
5.7.2 Federation of Pharmaceutical Manufacturers’ Associations......................................... 252
5.7.3 Japan Pharmaceutical Traders Association ................................................................. 252
5.7.4 Japan Pharmaceutical Equipment and Machinery Association .................................... 252
5.7.5 Japan Federation of Medical Devices Associations ..................................................... 253
5.7.6 The Federation of Japan Pharmaceutical Wholesalers Association ............................. 253
5.8 Trade Fairs ..................................................................................................................... 253
6 Opportunities and Challenges ................................................................................................. 255
6.1 Opportunities .................................................................................................................. 255
6.2 Challenges ...................................................................................................................... 255
7 Appendix................................................................................................................................. 258
7.1 Abbreviations .................................................................................................................. 258
7.2 Bibliography .................................................................................................................... 261
7.3 Research Methodology ................................................................................................... 271
7.3.1 Coverage .................................................................................................................... 271
7.3.2 Secondary Research ................................................................................................... 272
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – JAPAN
7.3.3 Forecasts .................................................................................................................... 272
7.3.4 Expert Panel................................................................................................................ 272
7.4 Disclaimer ....................................................................................................................... 273
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – JAPAN
1.1 List of Tables
Table 1: Pharmaceutical Market, Japan, Revenue ($bn), 2008–2013 ........................................................ 26
Table 2: Pharmaceutical Market, Japan, Revenue Forecast ($bn), 2014–2020 .......................................... 27
Table 3: Pharmaceutical Market, Japan, Exports and Imports ($bn), 2008–2013 ....................................... 29
Table 4: Pharmaceutical Market, Japan, Generics Market Share (%), 2008–2013 ..................................... 31
Table 5: Pharmaceutical Market, Japan, Biologics Production, 2012 ......................................................... 32
Table 6: Pharmaceutical Market, Japan, Over-the-Counter Production, Revenue ($bn), 2008–2013 .......... 34
Table 7: Pharmaceutical Market, Japan, Major Therapeutic Areas, Pharmaceutical Production, 2012 ....... 36
Table 8: Pharmaceutical Market, Japan, Major Therapeutic Areas, Pharmaceutical Production (%), 2011–
2012............................................................................................................................................ 37
Table 9: Pharmaceutical Market, Japan, Cardiovascular Agents, Segment Shares, 2012 .......................... 38
Table 10: Pharmaceutical Market, Japan, Central Nervous System Agents, Segment Shares, 2012 ............ 39
Table 11: Pharmaceutical Market, Japan, Agents Affecting Metabolism, Segment Shares, 2012 ................. 40
Table 12: Pharmaceutical Market, Japan, Digestive Organ Agents, Segment Shares, 2012 ........................ 41
Table 13: Pharmaceutical Market, Japan, Blood and Body-Fluid Agents, Segment Shares, 2012 ................ 42
Table 14: Pharmaceutical Market, Takeda, Global, Major Products, 2013 ................................................... 43
Table 15: Pharmaceutical Market, Takeda, Global, Late-Stage Pipeline, 2014 ............................................ 44
Table 16: Pharmaceutical Market, Otsuka, Global, Late-Stage Pipeline, 2014 ............................................. 50
Table 17: Pharmaceutical Market, Pfizer, Global, Major Products, Revenue ($bn) and Annual Growth (%),
2013............................................................................................................................................ 54
Table 18: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, 2014* .............................................. 55
Table 19: Pharmaceutical Market, Astellas, Global, Major Products, Revenue ($bn) and Annual Growth (%),
2013............................................................................................................................................ 63
Table 20: Pharmaceutical Market, Astellas, Global, Late-Stage Pipeline, 2013 ............................................ 63
Table 21: Pharmaceutical Market, Daiichi Sankyo, Global, Late-Stage Pipeline, 2014 ................................. 69
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – JAPAN
Table 22: Medical Device Market, Japan, Revenue ($bn), 2008–2013......................................................... 74
Table 23: Medical Device Market, Japan, Revenue Forecast ($bn), 2014–2020 .......................................... 75
Table 24: Medical Device Market, Japan, Revenue by Segment, 2013 ........................................................ 76
Table 25: Medical Device Market, Japan, Ophthalmic Devices Market, Revenue ($bn), 2008–2013 ............ 78
Table 26: Medical Device Market, Japan, Ophthalmic Devices Market, Sales Trends for Major Players, 2012
................................................................................................................................................... 79
Table 27: Medical Device Market, Japan, In Vitro Diagnostics Market, Revenue ($bn), 2008–2013 ............. 80
Table 28: Medical Device Market, Japan, In Vitro Diagnostics Market, Sales Trends for Major Players, 2012
................................................................................................................................................... 81
Table 29: Medical Device Market, Japan, Cardiovascular Devices Market, Revenue ($bn), 2008–2013 ....... 83
Table 30: Medical Device Market, Japan, Cardiovascular Devices Market, Sales Trends for Major Players,
2012............................................................................................................................................ 84
Table 31: Medical Device Market, Japan, Healthcare IT Market, Revenue ($bn), 2008–2013 ...................... 85
Table 32: Medical Device Market, Japan, Healthcare IT Market, Sales Trends for Major Players, 2012 ....... 86
Table 33: Medical Device Market, Japan, Nephrology and Urology Market, Revenue ($bn), 2008–2013 ...... 88
Table 34: Medical Device Market, Japan, Nephrology and Urology Market, Sales Trends for Major Players,
2012............................................................................................................................................ 89
Table 35: Medical Device Market, Japan, Diagnostics Market, Revenue ($bn), 2008–2013 ......................... 90
Table 36: Medical Device Market, Japan, Diagnostics Market, Revenue Forecast ($bn), 2014–2020 ........... 91
Table 37: Medical Device Market, Japan, Diagnostics Market, Sales Trends for Major Players, 2012 .......... 92
Table 38: Medical Device Market, Abbott, Global, Major Products, 2014 ................................................... 103
Table 39: Medical Device Market, Abbott, Global, Late-Stage Pipeline, 2014 ............................................ 104
Table 40: Medical Device Market, Medtronic, Global, Major Products, 2013 .............................................. 111
Table 41: Medical Device Market, Roche, Global, Major Products, 2014 ................................................... 118
Table 42: Market Access, Japan, Types of Health Insurance, 2011 ........................................................... 132
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Table 43: Market Access, Japan, Out-of-Pocket Payments (% of Healthcare Expenditure), 2008–2013 ..... 134
Table 44: Market Access, Japan, Reduction in Average Price of Prescription Drugs (%), 2004–2014 ........ 136
Table 45: Market Access, Japan, Requirements for Applying Premiums for Drug Prices, 2014 .................. 137
Table 46: Market Access, Japan, Review Time for New Drugs, 2008–2012 ............................................... 146
Table 47: Economic Indicators, Japan, Gross Domestic Product per Capita ($), 2008–2013 ...................... 179
Table 48: Economic Indicators, Japan, Gross Domestic Product per Capita Forecast ($), 2014–2020 ....... 179
Table 49: Economic Indicators, Japan, Gross Domestic Product Annual Growth (%), 2008–2013 ............. 180
Table 50: Economic Indicators, Japan, Gross Domestic Product Annual Growth Forecast (%), 2014–2020
................................................................................................................................................. 181
Table 51: Economic Indicators, Japan, Gross National Income per Capita ($), 2008–2013 ........................ 182
Table 52: Economic Indicators, Japan, Average Consumer Price Index, 2008–2013 ................................. 183
Table 53: Economic Indicators, Japan, Average Consumer Price Index Forecast, 2014–2020 ................... 184
Table 54: Economic Indicators, Japan, Average Consumer Price Annual Change (%), 2008–2013 ........... 185
Table 55: Economic Indicators, Japan, Average Consumer Price Annual Change Forecast (%), 2014–2020
................................................................................................................................................. 186
Table 56: Economic Indicators, Japan, Currency Exchange Rate ($/JPY), 2008–2013 .............................. 187
Table 57: Economic Indicators, Japan, Foreign Direct Investment ($bn), 2008–2013 ................................. 188
Table 58: Economic Indicators, Japan, Foreign Exchange Reserves ($bn), 2008–2013 ............................ 189
Table 59: Economic Indicators, Japan, Imports of Goods and Services ($bn), 2008–2013 ......................... 191
Table 60: Economic Indicators, Japan, Exports of Goods and Services ($bn), 2008–2013......................... 192
Table 61: Economic Indicators, Japan, General Government Structural Balance ($bn), 2008–2013 ........... 193
Table 62: Economic Indicators, Japan, General Government Gross Debt (% of GDP), 2008–2013 ............ 194
Table 63: Economic Indicators, Japan, Major Industries, Output ($bn), 2011 ............................................. 196
Table 64: Demographics, Japan, Population (million), 2008–2013 ............................................................. 197
Table 65: Demographics, Japan, Population Forecast (million), 2014–2020 .............................................. 198
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Table 66: Demographics, Japan, Population, Urban-Rural Population Share (%), 2008–2013 ................... 199
Table 67: Demographics, Japan, Population, Urban-Rural Population Share Forecast (%), 2014–2020..... 200
Table 68: Demographics, Japan, Distribution by Age Group (%), 2008–2013 ............................................ 202
Table 69: Demographics, Japan, Distribution by Age Group Forecast (%), 2014–2020 .............................. 202
Table 70: Demographics, Japan, Births (per 1,000 population), 2008–2013............................................... 204
Table 71: Demographics, Japan, Mortality (per 1,000 population), 2008–2013 .......................................... 205
Table 72: Demographics, Japan, Major Causes of Mortality (per 100,000 population), 2012 ...................... 206
Table 73: Demographics, Japan, Mortality Rate of Children under Five (per 1,000 live births), 2008–2013 207
Table 74: Demographics, Japan, Immunization Rate (%), 2008–2013 ....................................................... 209
Table 75: Demographics, Japan, Major Causes of Male Mortality (per 100,000 population), 2012 ............. 210
Table 76: Demographics, Japan, Major Causes of Female Mortality (per 100,000 population), 2012 ......... 211
Table 77: Demographics, Japan, Gender Ratio (M/F), 2008–2013 ............................................................ 212
Table 78: Demographics, Japan, Life Expectancy at Birth (years), 2008–2013 .......................................... 213
Table 79: Demographics, Japan, Student Enrollment by Level of Education (‘000), 2013 .......................... 216
Table 80: Demographics, Japan, Unemployment Rate (%), 2008–2013 .................................................... 218
Table 81: Demographics, Japan, Unemployment Rate by Age and Gender, 2013 ..................................... 218
Table 82: Demographics, Japan, Major Diseases, Inpatients (per 1,000 population), 2011 ........................ 220
Table 83: Demographics, Japan, Major Diseases, Outpatients (per 1,000 population), 2011 ..................... 221
Table 84: Demographics, Japan, Disability-Adjusted Life Years (per 100,000 population), 2004 ................ 222
Table 85: Healthcare Infrastructure, Japan, Hospitals, 2008–2013 ............................................................ 224
Table 86: Healthcare Infrastructure, Japan, Hospitals by Services, 2008–2013 ......................................... 225
Table 87: Healthcare Infrastructure, Japan, Clinics by Type, 2008–2013 ................................................... 227
Table 88: Healthcare Infrastructure, Japan, Medical Clinics, 2008–2013 ................................................... 228
Table 89: Healthcare Infrastructure, Japan, Hospital Beds (‘000), 2008–2013 ........................................... 229
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Table 90: Healthcare Infrastructure, Japan, Hospitals by Bed Size, 2008–2013 ......................................... 230
Table 91: Healthcare Infrastructure, Japan, Diagnostic units (per million population), 2008–2013 .............. 231
Table 92: Healthcare Infrastructure, Japan, Hospital Beds (per 100,000 population), 2008–2013 .............. 232
Table 93: Healthcare Infrastructure, Japan, Physicians (per 1,000 population), 2008–2013 ....................... 234
Table 94: Healthcare Infrastructure, Global Comparison, Environment-Attributable Deaths (per 100,000
population), 2004 ...................................................................................................................... 236
Table 95: Healthcare Infrastructure, Japan, CO2 Emissions (million metric tons), 2008–2013 .................... 237
Table 96: Healthcare Infrastructure, Japan, CO2 Emissions by Sector (%), 2012 ....................................... 238
Table 97: Healthcare Infrastructure, Japan, PM10 Emissions (µg/m3), 2008–2013 .................................... 240
Table 98: Healthcare Infrastructure, Japan, Municipal Waste (million tons), 2008–2013 ............................ 241
Table 99: Healthcare Infrastructure, Japan, Pharmacist (per 100,000 population), 2008–2013 .................. 242
Table 100: Healthcare Infrastructure, Japan, Dentists (per 100,000 population), 2008–2013 ....................... 243
Table 101: Healthcare Infrastructure, Japan, Nurses and Assistant Nurses (per 100,000 population), 2008–
2013.......................................................................................................................................... 244
Table 102: Healthcare Expenditure, Japan, Gross Domestic Product as Percentage of Healthcare Expenditure
(%), 2008–2013 ......................................................................................................................... 246
Table 103: Healthcare Expenditure, Japan, Share of Major Components (%), 2009 .................................... 247
Table 104: Healthcare Expenditure, Japan, Healthcare Expenditure on Elderly ($bn), 2008–2013 ............... 248
Table 105: Healthcare Expenditure, Japan, Research and Development Expenditure % 2008–2013 ........... 249
Table 106: Healthcare Expenditure, Japan, Public-Private Share (%), 2008–2013 ...................................... 250
Table 107: Healthcare Expenditure, Japan, Research and Development Expenditure ($bn), 2008–2013 ..... 251
Table 108: Trade Fairs, Japan, Major Healthcare Trade Fairs, 2015 ........................................................... 254
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – JAPAN
1.2 List of Figures
Figure 1: Pharmaceutical Market, Japan, Revenue ($bn), 2008–2013 ........................................................ 26
Figure 2: Pharmaceutical Market, Japan, Revenue Forecast ($bn), 2014–2020 .......................................... 27
Figure 3: Pharmaceutical Market, Japan, Imports and Exports ($bn), 2008–2013 ....................................... 28
Figure 4: Pharmaceutical Market, Japan, Distribution Channel, 2014.......................................................... 29
Figure 5: Pharmaceutical Market, Japan, Generics Market Share (%), 2008–2013 ..................................... 31
Figure 6: Pharmaceutical Market, Japan, Biologics Market Share (%), 2012 ............................................... 32
Figure 7: Pharmaceutical Market, Japan, Over-the-Counter Production, Revenue ($bn), 2008–2013 .......... 34
Figure 8: Pharmaceutical Market, Japan, Major Therapeutic Areas, Pharmaceutical Production (%), 2012 . 35
Figure 9: Pharmaceutical Market, Japan, Major Therapeutic Areas, Pharmaceutical Production (%), 2011–
2012............................................................................................................................................ 36
Figure 10: Pharmaceutical Market, Japan, Cardiovascular Agents, Segment Shares (%), 2012 .................... 37
Figure 11: Pharmaceutical Market, Japan, Central Nervous System Agents, Segment Shares (%), 2012 ..... 38
Figure 12: Pharmaceutical Market, Japan, Agents Affecting Metabolism, Segment Shares (%), 2012 ........... 39
Figure 13: Pharmaceutical Market, Japan, Digestive Organ Agents, Segment Shares (%), 2012 .................. 40
Figure 14: Pharmaceutical Market, Japan, Blood and Body-Fluid Agents, Segment Shares (%), 2012 .......... 41
Figure 15: Medical Device Market, Japan, Revenue ($bn), 2008–2013......................................................... 74
Figure 16: Medical Device Market, Japan, Revenue Forecast ($bn), 2014–2020 .......................................... 75
Figure 17: Medical Device Market, Japan, Revenue by Segment ($bn), 2013 ............................................... 76
Figure 18: Medical Device Market, Japan, Ophthalmic Devices Market, Revenue ($bn), 2008–2013 ............ 77
Figure 19: Medical Device Market, Japan, Ophthalmic Devices Market, Sales Trends for Major Players ($m),
2008–2012 .................................................................................................................................. 78
Figure 20: Medical Device Market, Japan, In Vitro Diagnostics Market, Revenue ($bn), 2008–2013 ............. 80
Figure 21: Medical Device Market, Japan, In Vitro Diagnostics Market, Sales Trends for Major Players ($m),
2008–2012 .................................................................................................................................. 81
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Figure 22: Medical Device Market, Japan, Cardiovascular Devices Market, Revenue ($bn), 2008–2013 ....... 82
Figure 23: Medical Device Market, Japan, Cardiovascular Devices Market, Sales Trends for Major Players
($m), 2008–2012 ......................................................................................................................... 83
Figure 24: Medical Device Market, Japan, Healthcare IT Market, Revenue ($bn), 2008–2013 ...................... 85
Figure 25: Medical Device Market, Japan, Healthcare IT Market, Sales Trends for Major Players ($m), 2008–
2012............................................................................................................................................ 86
Figure 26: Medical Device Market, Japan, Nephrology and Urology Market, Revenue ($bn), 2008–2013 ...... 88
Figure 27: Medical Device Market, Japan, Nephrology and Urology Market, Sales Trends for Major Players
($m), 2008–2012 ......................................................................................................................... 89
Figure 28: Medical Device Market, Japan, Diagnostics Market, Revenue ($bn), 2008–2013 ......................... 90
Figure 29: Medical Device Market, Japan, Diagnostics Market, Revenue Forecast ($bn), 2014–2020 ........... 91
Figure 30: Medical Device Market, Japan, Diagnostics Market, Revenue Forecast ($m), 2012 ..................... 92
Figure 31: Healthcare Market, Japan, Drivers and Barriers, 2014 ............................................................... 125
Figure 32: Market Access, Japan, MHLW, Organizational Structure, 2014 .................................................. 127
Figure 33: Market Access, Japan, Reimbursement Pricing for New Drugs, 2014 ........................................ 129
Figure 34: Market Access, Japan, Health Insurance System, 2014 ............................................................. 132
Figure 35: Market Access, Japan, Health Insurers, Market Share (%), 2011 ............................................... 133
Figure 36: Market Access, Japan, Out-of-Pocket Payments (% of Healthcare Expenditure), 2008–2013 ..... 134
Figure 37: Market Access, Japan, Reduction in Average Price of Prescription Drugs (%), 2004–2014 ........ 136
Figure 38: Market Access, Japan, Organizational Structure of PMDA and PFSB, 2014 .............................. 139
Figure 39: Market Access, Japan, New Drug Development and Approval Process, 2014 ............................ 141
Figure 40: Market Access, Japan, Approval Review Process, 2014 ............................................................ 144
Figure 41: Market Access, Japan, Standard Review Timeline for New Drug, 2014 ...................................... 146
Figure 42: Market Access, Japan, Medical Device Classification, 2014....................................................... 149
Figure 43: Market Access, Japan, Medical Device Approval Process, 2007 ................................................ 150
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Figure 44: Market Access, Japan, Highly Controlled Medical Devices Approval Process, 2007 ................... 152
Figure 45: Market Access, Japan, Licensing Process for Drug Manufacture, Domestic Manufacturers, 2014
................................................................................................................................................. 154
Figure 46: Market Access, Japan, Licensing Process for Manufacturing of Drugs, Overseas Manufacturers,
2014.......................................................................................................................................... 154
Figure 47: Market Access, Japan, Patent Approval Process, 2014 ............................................................. 156
Figure 48: Market Access, Japan, Patent Right Extension Process, 2014 ................................................... 157
Figure 49: Market Access, Japan, Trademark Approval Process, 2014....................................................... 159
Figure 50: Market Access, Japan, Clinical Trial Regulation Process, 2014.................................................. 161
Figure 51: Economic Indicators, Japan, Gross Domestic Product per Capita ($), 2008–2013 ...................... 178
Figure 52: Economic Indicators, Japan, Gross Domestic Product per Capita Forecast ($), 2014–2020 ....... 179
Figure 53: Economic Indicators, Japan, Gross Domestic Product Annual Growth (%), 2008–2013 ............. 180
Figure 54: Economic Indicators, Japan, Gross Domestic Product Annual Growth Forecast (%), 2014–2020
................................................................................................................................................. 181
Figure 55: Economic Indicators, Japan, Gross National Income per Capita ($), 2008–2013 ........................ 182
Figure 56: Economic Indicators, Japan, Average Consumer Price Index, 2008–2013 ................................. 183
Figure 57: Economic Indicators, Japan, Average Consumer Price Index Forecast, 2014–2020 ................... 184
Figure 58: Economic Indicators, Japan, Average Consumer Price Annual Change (%), 2008–2013 ........... 185
Figure 59: Economic Indicators, Japan, Average Consumer Price Annual Change Forecast (%), 2014–2020
................................................................................................................................................. 186
Figure 60: Economic Indicators, Japan, Currency Exchange Rate ($/JPY), 2008–2013 .............................. 187
Figure 61: Economic Indicators, Japan, Foreign Direct Investment ($bn), 2008–2013 ................................. 188
Figure 62: Economic Indicators, Japan, Foreign Exchange Reserves ($bn), 2008–2013 ............................ 189
Figure 63: Economic Indicators, Japan, Imports of Goods and Services ($bn), 2008–2013 ......................... 190
Figure 64: Economic Indicators, Japan, Exports of Goods and Services ($bn), 2008–2013......................... 192
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Figure 65: Economic Indicators, Japan, General Government Structural Balance ($bn), 2008–2013 ........... 193
Figure 66: Economic Indicators, Japan, General Government Gross Debt (% of GDP), 2008–2013 ............ 194
Figure 67: Economic Indicators, Japan, Major Industries, Output ($bn), 2011 ............................................. 195
Figure 68: Demographics, Japan, Population (million), 2008–2013 ............................................................. 197
Figure 69: Demographics, Japan, Population Forecast (million), 2014–2020 .............................................. 198
Figure 70: Demographics, Japan, Population, Urban-Rural Population Share (%), 2008–2013 ................... 199
Figure 71: Demographics, Japan, Population, Urban-Rural Population Share Forecast (%), 2014–2020..... 200
Figure 72: Demographics, Japan, Distribution by Age Group (%), 2008–2013 ............................................ 201
Figure 73: Demographics, Japan, Distribution by Age Group Forecast (%), 2014–2020 .............................. 202
Figure 74: Demographics, Japan, Births (per 1,000 population), 2008–2013............................................... 203
Figure 75: Demographics, Japan, Mortality (per 1,000 population), 2008–2013 .......................................... 204
Figure 76: Demographics, Japan, Major Causes of Mortality (per 100,000 population), 2012 ...................... 205
Figure 77: Demographics, Japan, Mortality Rate of Children under Five (per 1,000 live births), 2008–2013 207
Figure 78: Demographics, Japan, Immunization Rate (%), 2008–2013 ....................................................... 208
Figure 79: Demographics, Japan, Major Causes of Male Mortality (per 100,000 population), 2012 ............. 209
Figure 80: Demographics, Japan, Major Causes of Female Mortality (per 100,000 population), 2012 ......... 210
Figure 81: Demographics, Japan, Gender Ratio (M/F), 2008–2013 ............................................................ 212
Figure 82: Demographics, Japan, Life Expectancy at Birth (years), 2008–2013 .......................................... 213
Figure 83: Demographics, Japan, Student Enrollment by Level of Education (‘000), 2013 .......................... 216
Figure 84: Demographics, Japan, Unemployment Rate (%), 2008–2013 .................................................... 217
Figure 85: Demographics, Japan, Unemployment Rate by Age and Gender (%), 2013 ............................... 218
Figure 86: Demographics, Japan, Major Diseases, Inpatients (per 1,000 population), 2011 ........................ 219
Figure 87: Demographics, Japan, Major Diseases, Outpatients (per 1,000 population), 2011 ..................... 220
Figure 88: Demographics, Japan, Disability-Adjusted Life Years (per 100,000 population), 2004 ................ 222
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Figure 89: Healthcare Infrastructure, Japan, Hospitals, 2008–2013 ............................................................ 224
Figure 90: Healthcare Infrastructure, Japan, Hospitals by Services, 2008–2013 ......................................... 225
Figure 91: Healthcare Infrastructure, Japan, Clinics by Type, 2008–2013 ................................................... 226
Figure 92: Healthcare Infrastructure, Japan, Medical Clinics, 2008–2013 ................................................... 228
Figure 93: Healthcare Infrastructure, Japan, Hospital Beds (‘000), 2008–2013 ........................................... 229
Figure 94: Healthcare Infrastructure, Japan, Hospitals by Bed Size, 2008–2013 ......................................... 230
Figure 95: Healthcare Infrastructure, Japan, Diagnostic Units (per million population), 2008–2013 ............. 231
Figure 96: Healthcare Infrastructure, Japan, Hospital Beds (per 100,000 population), 2008–2013 .............. 232
Figure 97: Healthcare Infrastructure, Japan, Physicians (per 1,000 population), 2008–2013 ....................... 234
Figure 98: Healthcare Infrastructure, Global Comparison, Environment-Attributable Deaths (per 100,000
population), 2004 ...................................................................................................................... 235
Figure 99: Healthcare Infrastructure, Japan, CO2 Emissions (million metric tons), 2008–2013 .................... 237
Figure 100: Healthcare Infrastructure, Japan, CO2 Emissions by Sector (%), 2012 ....................................... 238
Figure 101: Healthcare Infrastructure, Japan, PM10 Emissions ((µg/m3), 2008–2013 ................................... 240
Figure 102: Healthcare Infrastructure, Japan, Municipal Waste (million tons), 2008–2013 ............................ 241
Figure 103: Healthcare Infrastructure, Japan, Pharmacists (per 100,000 population), 2008–2013 ................. 242
Figure 104: Healthcare Infrastructure, Japan, Dentists (per 100,000 population), 2008–2013 ....................... 243
Figure 105: Healthcare Infrastructure, Japan, Nurses and Assistant Nurses (per 100,000 population), 2008–
2013.......................................................................................................................................... 244
Figure 106: Healthcare Expenditure, Japan, Gross Domestic Product as Percentage of Healthcare Expenditure
(%), 2008–2013 ......................................................................................................................... 246
Figure 107: Healthcare Expenditure, Japan, Share of Major Components (%), 2009 .................................... 247
Figure 108: Healthcare Expenditure, Japan, Healthcare Expenditure on Elderly ($bn), 2008–2013 ............... 248
Figure 109: Healthcare Expenditure, Japan, Pharmaceutical Research and Development Expenditure (% of
total healthcare expenditure), 2008–2013 .................................................................................. 249
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Figure 110: Healthcare Expenditure, Japan, Public-Private Share (%), 2008–2013 ...................................... 250
Figure 111: Healthcare Expenditure, Japan, Research and Development Expenditure ($bn), 2008–2013 ..... 251
Figure 112: Healthcare Market, Japan, Opportunities and Challenges, 2014 ................................................ 257
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – JAPAN
Introduction
2 Introduction
2.1 GlobalData Report Guidance
Report begins with an executive summary, which gives an overview of Japan’s healthcare
market and its key driving factors. It also gives a snapshot of the demographic, regulatory and
reimbursement landscape, and healthcare infrastructure.
Chapter three provides an overview of Japan’s pharmaceutical and medical device markets,
covering the market size and generic, Over-the-Counter (OTC) and biologic/biosimilar product
segment shares, as well as the market’s key drivers and barriers. It also includes SWOT
assessments and profiles of the major market players.
Chapter four analyzes the reimbursement and payer landscape, covering the reimbursement
process, insurance providers, pricing policies and drug price trends in Japan. It also looks at
the regulatory landscape and provides an overview of the regulatory agencies and approval
processes for new drugs and medical devices. Also covered are the licensing processes for the
manufacture, export and import of pharmaceuticals and the regulations in place for
pharmaceutical advertising, labeling, packaging and clinical trials. An overview of intellectual
property rights is also provided.
Chapter five analyzes the political and economic environment in Japan, covering economic
indicators, demographics, and healthcare infrastructure and expenditure.
Chapter six provides an overview of the opportunities for and challenges facing the growth of
Japan’s healthcare market.
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Overview of the Pharmaceutical and Medical Device Markets
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – JAPAN
3.1.2 Pharmaceutical Imports and Exports
Pharmaceutical imports were worth $XX billion in 2008 and are estimated to reach $XX billion in
2013 at a CAGR of XX%. The major sources of pharmaceutical imports are the US, which
contributes XX% of total imports, followed by China, Switzerland, South Korea and the Republic of
Ireland, with XX%, XX%, XX% and XX%, respectively.
Pharmaceutical exports decreased from $XX billion in 2008 to $XX billion in 2013, at a negative
CAGR of XX%. Export value increased between 2008 and 2011 but declined in 2012 and 2013,
owing to the depreciation of the yen against the US dollar (ITC, 2014).
Figure 3: Pharmaceutical Market, Japan, Imports and Exports ($bn), 2008–2013
2008 2009 2010 2011 2012 2013
Rev
enue
($bn
)
Export Import
Source: ITC, 2014
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Overview of the Pharmaceutical and Medical Device Markets
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – JAPAN
3.1.4.2 Biologics/Biosimilars
Biological products are defined as products that include ingredients derived from human or
biological sources (excluding plants) such as cells, tissues, blood, and body fluids (PMDA, 2007).
The quality standards laid down in the Japanese Pharmacopoeia, Japanese Pharmaceutical
Codex, Japanese Pharmaceutical Excipients, and other similar standards specify that biological
products based on batch tests must not be marketed or supplied without government certification.
In 2012, the biologics market comprised blood-type biologics (XX%), vaccine-type biologics (XX%),
other biological products (XX%), mixed biological preparations (XX%), toxins and toxoids (XX%)
and anti-leptospiral biologics (XX%) (MHLW, 2014i).
Figure 6: Pharmaceutical Market, Japan, Biologics Market Share (%), 2012
Blood products
Vaccines
Other biological products
Mixed biological products Toxins and toxoids
Source: MHLW, 2014i
Table 5: Pharmaceutical Market, Japan, Biologics Production, 2012 Sub-category Production ($m) Share (%)
Blood products
Vaccines
Other biological products
Mixed biological products
Toxins and toxoids
Source: MHLW, 2014i
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Appendix
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7 Appendix
7.1 Abbreviations
µg/m3: micrograms per cubic meter
ALK: Anaplastic Lymphoma Kinase
CAGR: Compound Annual Growth Rate
CRDM: Cardiac Rhythm Disease Management
CNS: Central Nervous System
CO2: Carbon dioxide
CPI: Consumer Price Index
CRL: Complete Response Letter
CT: Computed Tomography
DALY: Disability-Adjusted Life Year
DPT: Diphtheria, Pertussis and Tetanus
EHI: Employees’ Health Insurance
ENT: Ear, Nose and Throat
FDA: Food and Drug Administration
FDI: Foreign Direct Investment
Forex: Foreign exchange
FPMAJ: Federation of Pharmaceutical Manufacturers’ Association of Japan
GCP: Good Clinical Practice
GDP: Gross Domestic Product
GEMRAD: Global Executive Meeting of Research and Development
GMP: Good Manufacturing Practice
GNI: Gross National Income
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GSK: GlaxoSmithKline
ICC: In-Country Caretaker
ICH: International Conference on Harmonization
IFPMA: International Federation of Pharmaceutical Manufacturers and Associations
ISO: International Organization for Standardization
IVD: In Vitro Diagnostics
JHIA: Japan Health Insurance Association
JPMA: Japan Pharmaceutical Manufacturers Association
JPO: Japan Patent Office
LCD: Liquid-Crystal-Display
LDP: Liberal Democratic Party
MAH: Market Authorization Holder
MEXT: Ministry of Education, Culture, Sports, Science and Technology
MHLW: Ministry of Health, Labor and Welfare
MMR: Maternal Mortality Rate
MoE: Ministry of the Environment
MRI: Magnetic Resonance Imaging
NDA: New Drug Application
NHI: National Health Insurance
NSCLC: Non-Small-Cell Lung Cancer
OECD: Organization for Economic Co-operation and Development
OOP: Out-of-Pocket
OTC: Over-the-Counter
PAFSC: Pharmaceutical Affairs Food Sanitation Council
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Appendix
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – JAPAN
PAL: Pharmaceutical Affairs Law
PCR: Polymerase Chain Reaction
PFSB: Pharmaceutical Food and Safety Bureau
PM10: Particulate Matter up to 10 micrometers in size
PMDA: Pharmaceuticals and Medical Devices Agency
SDR: Special Drawing Right
TB: Tuberculosis
TRIPS: Trade-Related Aspects of Intellectual Property Rights
UNICEF: United Nations Children’s Fund
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Appendix
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7.2 Bibliography
10times (2015). Medical and pharmaceutical trade shows in USA. 10times. Available from:
http://10times.com/japan/medical-pharma/tradeshows [Accessed on December 21, 2014]
ADB (2010). Fiscal Policy Coordination in Asia: East Asian Infrastructure Investment Fund.
Asian Development Bank Institute. Available from:
http://www.adbi.org/files/2010.07.30.wp232.fiscal.policy.coordination.asia.pdf
American Chamber of Commerce in Japan (2011). Investing in Health as a Competitive
Advantage. American Chamber of Commerce in Japan. Available from:
http://accj.or.jp/images/downloads/public/en/healthcare/survey/Full_SV_ENG.PDF.
Astellas (2013). Sales of major products. Astellas. Available from:
http://www.astellas.com/en/ir/finance/sale_products.html [Accessed on December 4, 2013]
Astellas (2014). R&D pipeline, 2014. Astellas. Available from:
https://www.astellas.com/en/ir/library/pdf/2q2015_rd_en.pdf
BBC (2014). Japan’s economy makes surprise fall into recession. BBC. Available from:
http://www.bbc.com/news/business-30077122 [Accessed on November 10, 2014]
BOJ (2011). Outlook for economic activity and prices. Bank of Japan. Available from:
http://www.boj.or.jp/en/mopo/outlook/gor1104b.pdf
BOJ (2014). Outlook for Economic Activity and Prices (October 2014). Bank of Japan.
Available from: https://www.boj.or.jp/en/mopo/outlook/gor1410a.pdf
Daiichi Sankyo (2014a). Daiichi Sankyo Group Value Reports, 2014. Daiichi Sankyo. Available
from:
http://www.daiichisankyo.com/media_investors/investor_relations/annual_reports/pdf/2014/ds_
value2014_Eng.pdf
Daiichi Sankyo (2014b).Major R&D Pipeline, October, 2014. Daiichi Sankyo. Available from:
http://www.daiichisankyo.com/rd/pipeline/pdf/Pipeline_EN.pdf [
Forbes (2013). “The Abe/Aso Government "Three Arrows" Agenda for Economic Revival”,
Forbes. Available from: http://www.forbes.com/sites/stephenharner/2013/02/03/the-abeaso-
government-three-arrows-agenda-for-economic-revival/ [Accessed on November 10, 2013]
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7.3 Research 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
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: revenue; products; and media attention,
innovation and market potential.
The estimated revenue of all major companies, including private and governmental, are
gathered and used to prioritize coverage.
Companies that are making the news or 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 input from GlobalData’s
expert panel (see below).
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7.3.2 Secondary Research
The research process begins with extensive secondary research using internal and external
sources to gather 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
SEC filings
Industry trade journals, scientific journals and other technical literature
Internal 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 CountryFocus reports are largely based on secondary research and use reliable and
authoritative sources such as the IMF, the World Bank, OECD, WHO, UNICEF, UNStats, BEA,
MHLW and NHS, among others.
7.3.3 Forecasts
The CountryFocus reports use the data available from the secondary sources to forecast and
validate the future trends for a country’s healthcare market, as well as parameters related to the
economy and healthcare infrastructure and expenditure.
7.3.4 Expert Panel
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, consultants from
venture capital funds, and distributors/suppliers of pharmaceuticals and supplies.
Historic data and forecasts are relayed to GlobalData’s expert panel and adjusted in accordance
with their feedback.
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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.