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Pharmaceutical Pricing and Reimbursement in Japan

Published by: Decision Resources

Published: Nov. 13, 2006 - 38 Pages

Price reduced due to age.

Table of Contents


Executive Summary

Strategic Considerations

Stakeholder Implications

Introduction

The National Health Insurance System

Health Care Expenditures

The Pharmaceutical Pricing Environment

Initial Pricing of Branded Prescription Drugs

Methods for Calculating Reimbursement Prices

Similar-Efficacy Comparison Methods

"Me-Too" Drugs

Price Comparators

Cost Calculation Method

Foreign Price Adjustment Rule

Price Premiums

Biennial Price Revision

Repricing

Price Cuts for Long-Listed Drugs

Ongoing Discussions on the Future Pricing System

Cost-Containment

Prescriber-Targeted Measures

Patient-Targeted Measures

Sales and Prescribing Trends

Generic Drugs

Current Status of the Generics Market in Japan

Participants in the Generics Market in Japan

Market Leaders

New Entrants

Recent Changes in the Generics Market

The Japanese Government's Stance on Generics

Introduction of the New Prescription Form

Generics Use in the Diagnosis-Procedure System

Increasing Public Awareness of Generics

Efforts to Improve the Reliability of Generic Drugs and Generics Manufacturers

Outlook for the Generics Market in Japan

Outlook for the Japanese Pricing and Reimbursement Environment

Tables

1. Methods Used for Pricing New Drugs in Japan, June 2002-September 2006

2. Initial Prices of Molecular-Targeted Oncology Drugs Marketed in Japan

3. Hierarchy of National Health Insurance Price Premiums

4. Number of New Drugs Awarded Price Premiums for Therapeutic Advances, June 2002-September 2006

5. Revision Rates for Japanese Reimbursement Prices, 1994-2006

6. Percentage Reductions in Average NHI Prices for Leading Pharmaceutical Companies in Japan, 2006

7. Reimbursement Price Reductions for Selected Drug Classes in Japan, April 2006

8. Selected Drugs Targeted for Repricing in Japan

9. The Ten Best-Selling Drug Classes in Japan, 2004 and 2005

10. The Ten Best-Selling Drugs in Japan, 2004 and 2005

11. Sales of the Four Largest Generics Manufacturers in Japan, 2005

12. Prescription Data for Nihon Chouzai, April-June 2006

13. Effects of the Introduction of the DPC System on the Use of Generics, July 2002-June 2004

Figures

1. Ratio of Drug Costs to Total Health Care Expenditures in Japan, 1991-2002

2. Procedure for Setting National Health Insurance Reimbursement Prices for New Prescription Drugs

3. Criteria for Determining the Pricing Method Used for New Prescription Drugs

4. Size of the Japanese Pharmaceutical Market, 2002-2005

5. Generics' Share of Major Pharmaceutical Markets, by Sales Volume, 2004

6. Generics' Share of the Japanese Pharmaceutical Market, by Prescription Volume, 2002-2004

Appendix

Glossary of Japanese Terms Used in This Report

Abstract

Japan is the world's largest price-controlled market for prescription drugs. With few exceptions, the Japanese government sets the reimbursement prices for all newly launched drugs. If pharmaceutical firms hope to survive-and thrive-in the Japanese market, they must thoroughly understand the unique Japanese pricing system and acquaint themselves with its recent changes.

Get the Answers You Need to Shape Your Strategy
To control Japan's total health care expenditures devoted to drugs, the government sets the reimbursement prices for new branded drugs, rewarding companies that manufacture innovative products. The government also mandates revisions in the prices of all drugs every other year. How are drug prices currently calculated, and how does the Japanese government plan to enhance its control over drug prices? What is the pharmaceutical industry's best hope in infl uencing the pricing system?

Growth of the Japanese generics market is expected as generics substitution expands and higher copayments compel patients to seek out lower-cost alternatives. However, the market is still relatively underdeveloped. What factors contribute to the relatively small market share for generics? Will the government's intent to encourage use of generics prompt greater expansion?

The Japanese pharmaceutical market is likely to continue to grow modestly through 2011. Competition among companies (including generics manufacturers) is expected to grow ever fiercer, as domestic and foreign firms battle for shares of this rich market. What strategies should companies, particularly smaller ones, pursue to ensure their survival?

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