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The Pharmaceutical Market: Japan
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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. |
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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 |
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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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