HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – JAPAN · PDF fileHealthcare, Regulatory and Reimbursement Landscape – Japan 2 ... XX% of the medical device market in Japan,

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.


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.



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.


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


7.3.3 Forecasts .................................................................................................................... 272

7.3.4 Expert Panel................................................................................................................ 272

7.4 Disclaimer ....................................................................................................................... 273


Table of Contents


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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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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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


Table of Contents


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


Table of Contents


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



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.


Overview of the Pharmaceutical and Medical Device Markets


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


Overview of the Pharmaceutical and Medical Device Markets


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


Appendix


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


Appendix


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


Appendix


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


Appendix


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]


Appendix


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).


Appendix


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.


Appendix


7.4 Disclaimer

All Rights Reserved.

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

form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior

permission of the publisher, GlobalData.

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