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The Pharmaceutical Market: Japan


Description: Despite its prolonged economic troubles in recent years, Japan remains the world's second largest pharmaceutical market, after the USA. It also remains one of the less penetrable. A strong and highly advanced domestic manufacturing industry, an opaque regulatory system and extensive cultural differences make the Japanese market a difficult and long-term prospect. There have however been recent signs that Japan is attempting to improve the drug approval process and move more into line with Western countries regarding regulatory laws. Significant cuts in government reimbursement levels in recent years have affected the market for pharmaceuticals, already depressed by the country's faltering economy, while recent court judgments have weakened the country's intellectual property laws. The overall costs of healthcare threatened to bankrupt the health insurance system in 2002, and have lead to a greater focus on price cuts as a politically easier alternative to widespread reform of the healthcare system, and these have been introduced by the Ministry of Health, Labour and Welfare (MHLW), in the face of staunch opposition by drug manufacturers.

Increases in health insurance payments from workers and the gradual eradication of over-prescribing by doctors through effective legislation and the promotion of cheaper generic products all provide the government with the potential for easing the healthcare expenditure burden. This is in spite of the disquiet of domestic pharmaceutical firms and to the detriment of market growth.

The Pharmaceuticals and Medical Devices Agency (PMDA) was created in 2004, in an attempt to improve drug approval times and bring them more in to line with their US and European counterparts. The market is therefore increasingly open to overseas products, and many domestic companies are being forced into measures such as mergers and the expansion of R&D facilities in a bid to ensure survival in the marketplace.


Contents: EXECUTIVE SUMMARY 1
Introduction 2

Pharmaceutical Market Analysis 3
Size 3
Market Structure 3
Generics Sector 3
OTC Sector 4
JSMI 5
Projections & Outlook 6
Imports 7
Domestic Manufacturing 9
Domestic Production 9
Shionogi Buys US Company Sciele Pharma 10
Daiichi Acquires Ranbaxy 10
Daiichi Sankyo Acquires German Biomedical Firm 10
Takeda to Buy Millennium for US$8.8 Billion 11
Kirin Holdings Announces Takeover Bid of Kyowa Hakko Kogyo 11
Fujifilm to Buy Toyama Chemical for US$1.4 Billion 11
Takeda buys Amgen’s Japanese Subsidiary 11
Israel’s Teva in JV with Kowa 11
India’s Zydus Plans Expansion Following Nippon Universal Takeover 11
Local Manufacturers 12
Multinational Manufacturers 13
Exports 14
Research & Development 15

Pharmaceutical Regulatory Analysis 16
Pharmaceutical Regulation 16
Pharmaceutical Bureau 16
Pharmaceutical Registration 16
Clinical Trials/GCP 17
Drug Lag 18
NCE Approvals 19
Post-Marketing Surveillance 19
Re-examination 19
Periodic safety reporting 19
Re-evaluation 20
ADR reporting 20
Pricing & Reimbursement 20
Yakkasa 20
Price reductions 20
Generic drug pricing 21
Intellectual Property 21
Data exclusivity 21

Pharmaceutical Distribution 22
Wholesaling 23
Wholesalers 23
JPWA 23

Healthcare Analysis 24
Demographics 24
Population 24
Birth Rate 25
Death Rate 25
Infant Mortality 25
Life Expectancy at Birth 25
Public Health 25
Causes of Death 25
Incidence of Communicable Diseases 25
HIV/AIDS 26
Healthcare System 26
Health Insurance 27
Health Expenditure 28
Healthcare Infrastructure 28
Inpatient Analysis 29
Healthcare Personnel 32

DIRECTORY 33
Government Organisations 33
Trade Associations 33
Methodology & Sources 34

List of Tables
Summary of Key Data Projections, 2008-2013 2
Summary of the Japanese Pharmaceutical Market, 2008 3
Domestic Generic Drug Market Share by Company, 2005 3
JSMI Member Companies, 2008 5
Market Projections, 2008-2013 6
SWOT Analysis of the Japanese Pharmaceutical Market, 2008 7
Summary Pharmaceutical Imports, 2002-2006 (US$000s) 7
Import trends 7
Leading Suppliers of Raw Materials, 2006 (US$000s) 8
Leading Suppliers of Medicaments, 2006 (US$000s) 8
Number of Pharmaceutical Manufacturers, 1995-2003 9
Pharmaceutical Production in Japan, 1989-2005 (¥ billions) 9
Major Domestic Producers, Total Pharmaceutical Sales, 2004-2007 (¥ millions) 12
Major Domestic Producers, Domestic Pharmaceutical Sales, 2004-2007 (¥ millions) 12
Major Domestic Producers, Operating Income, 2002-2007 (¥ millions) 12
Major Domestic Producers, Number of Employees, 2001-2007 13
Selected Multinational Pharmaceutical Sales in Japan, 1999-2005 (US$ millions) 13
Summary Pharmaceutical Exports, 2002-2006 (US$000s) 14
Export trends 14
Leading Destinations of Raw Materials, 2006 (US$000s) 14
Leading Destinations of Medicaments, 2006 (US$000s) 15
R&D Expenditure of Leading Japanese Manufacturers, 2002-2007 (¥ million) 15
New Drug Application Process 17
NCEs Approved, 1995-2005 19
Number of Pharmacies, 1997-2006 22
Summary of Demographic Data, 2006 24
Projected Population, 2008-2013 24
Healthcare Expenditure, 2005 28
Projected Health Expenditure, 2008-2013 28
Hospitals & Beds, 2006 28
Hospital Bed Projections, 2008-2013 29
Hospital Throughput, 2000-2006 29
ALOS by Type of Bed, 1998-2006 (Days) 29
Average Length of Hospital Stay, 1990-2005 (Days) 30
Bed Occupancy Rates, 1996-2006 (%) 30
Daily Average Distribution of Inpatients at Hospitals & Clinics, 2005 (000s) 31
Projected Number of Physicians, 2008-2013 32

List of Charts
JPWA Member Companies, 1987-2008 23


Summary: Our in-depth pharmaceutical market reports are ideal for executives wanting to understand the key drivers in pharmaceutical markets and have access to a wealth of statistical data. Each report opens with an outlook section that provides analysis of the market, 5-year market forecasts, national data projections, market outlook and key developments such as regulation, pricing/reimbursement, intellectual property, health facilities and government policy. The report also provides extensive background information, population trends, health status, health expenditure, organisation & administration, hospital services, medical personnel, healthcare development, market access information, trade data for raw materials and finished products and essential industry contacts. Included with the report are 3 free quarterly updated outlook reports, enabling you to keep up to date with market developments for a year.




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