中国の医薬品業界：戦略、動向と市場機会

ABSTRACT

China is expected to become the fifth largest drug market in the world by 2010. Growth will be driven by factors such as an increasingly ageing population, large market size (urban and rural), government support in restructuring the highly fragmented industry, IPR policies, as well as increasing life expectancy.

China will remain an attractive location to foreign drug companies, because China offers many advantages in terms of the size of its marketplace, the relatively easy access to patients who are available for clinical trials, and lower clinical trial costs.

China has made considerable progress towards an improved standard of living for its population, including better health, reduced levels of poverty, and strong macroeconomic growth. The market for high quality, patient-oriented healthcare services is small, but growing steadily. Most Chinese lack health insurance and only a fraction of the population can afford top-end Western medical care. Currently, there are many successful foreign and joint venture healthcare service providers already in China. Their experiences point to growing opportunities for foreign companies looking to invest in this segment of the market.

TABLE OF CONTENTS

INDUSTRY GROWTH

INDUSTRY GROWTH

PHARMACEUTICAL MARKET

POTENTIAL

DRIVERS OF CHINESE

PHARMACEUTICAL INDUSTRY

INDUSTRY CHARACTERISTICS

DOMESTIC INDUSTRY

DISEASE PROFILE

DRUGS WITH LARGEST MARKET

SCOPE

PRODUCT STRATEGIES

KEY TRENDS

INDUSTRY CHALLENGES

IMPACT OF WTO MEMBERSHIP

INDUSTRY CONSOLIDATION

ROLE OF GOVERNMENT

IMPORTS VS. EXPORTS

INCENTIVE STRUCTURES

INDUSTRY IN TRANSITION

REGULATIONS

R&D INVESTMENTS

R&D EXTERNALISATION

MANUFACTURING

DISTRIBUTION

EXPORTS

COLLABORATION WITH

MULTINATIONALS

ADVANTAGES FOR CHINESE ENTITIES

ADVANTAGES FOR MULTINATIONALS

MULTINATIONAL MANUFACTURING

FACILITIES

INTERACTIONS WITH US FDA

CHALLENGES

FUTURE OUTLOOK POST-REFORM

GOVERNMENT POLICIES

PHARMACEUTICAL PRICING POLICY

DRUG PRICING REFORMS PRICING OF DRUGS PROFIT MARGINS

MARKET LIBERALISATION REGULATORY FRAMEWORKS INCENTIVES

RATIONALISATION OF MARKET SFDA CLASSIFICATION

SOCIAL AND CULTURAL ISSUES

CHINESE BUSINESS NETWORKS NEGOTIATION

THE POLITICAL SYSTEM THE LEGAL SYSTEM

MACRO ECONOMIC ENVIRONMENT TECHNOLOGICAL ENVIRONMENT

BIOTECHNOLOGY INDUSTRY

GOVERNMENT ROLE RESEARCH INITIATIVES CHALLENGES

CHINESE HEALTHCARE SYSTEM

KEY TRENDS IN HEALTHCARE

MAJOR DISEASES

DISEASE PREVENTION MECHANISMS

PAST EXPERIENCES

HEALTH CARE DELIVERY NETWORK EVOLVING HEALTH CARE DELIVERY NETWORK

HEALTHCARE SYSTEM CHANGES STRUCTURE OF CHINA S HEALTHCARE SYSTEM

HEALTHCARE FINANCING

REGULATIONS

KEY PLAYERS IN THE CHINESE HEALTHCARE SYSTEM

HOSPITALS

STATE-OWNED HOSPITALS HOSPITAL FUNDING

FOREIGN INVESTORS IN CHINESE HEALTHCARE

JOINT VENTURES

LESSONS FROM THE PAST CHALLENGES FOR FOREIGN INVESTORS

POLICY RECOMMENDATIONS

RURAL HEALTHCARE

URBAN HEALTHCARE HEALTHCARE PERSONNEL GOVERNMENTAL PRIORITIES IN HEALTHCARE

HEALTHCARE REFORMS IN CHINA HEALTHCARE POLICY

RECOMMENDATIONS

HEALTHCARE FINANCING REFORMS

NATIONAL ESSENTIAL DRUG LIST (NEDL)

HEALTHCARE INSURANCE IN CHINA

CHARACTERISTICS

HEALTHCARE INSURANCE REFORMS

MEDICAL EQUIPMENTS AND DEVICES MARKET

TOP SELLING PRODUCT CATEGORIES MARKET DYNAMICS

MULTINATIONAL PRESENCE COMPETITION

KEY MARKET CHARACTERISTICS OPPORTUNITIES TO EXPLOIT MARKET REGULATORS AND THEIR ROLES

CHALLENGES

STRATEGIES FOR SUCCESS

CHINA S MEDICAL INSURANCE MARKET

IMPACT OF WTO

INSURANCE REGULATIONS IN CHINA LIBERALISATION OF INSURANCE INDUSTRY

DOMESTIC AND FOREIGN INSURANCE COMPANIES

RECOMMENDATIONS

POTENTIAL FOR INSURANCE MARKET IN CHINA

URBAN MEDICAL INSURANCE RURAL MARKET FOR MEDICAL INSURANCE

INDUSTRY CHALLENGES FUTURE DIRECTIONS

CHINA S DRUG PRICING REFORM AND DRUG PRICING POLICY

CHALLENGES IN THE CHINESE DRUG PRICING SYSTEM

CHINA S DRUG PRICING REFORMS FUTURE OF CHINA S DRUG PRICING REFORMS

CHINA S OTC DRUG MARKET

FOREIGN ENTRANTS REGIONAL VARIATIONS RETAIL MARKET

COSMETICS MARKET

CLINICAL TRIALS MARKET

CLINICAL TRIAL REQUIREMNETS FOR THE LOCAL MARKET

CLINICAL TRIAL REGULATIONS CLINICAL TRIALS AND CONTRACT RESEARCH ORGANIZATIONS IN CHINA BENEFITS FOR CHINESE INDUSTRY BENEFITS FOR FOREIGN PLAYERS CHALLENGES

RECOMMENDATIONS

PHARMACEUTICAL DISTRIBUTION IN CHINA

STATE CONTROL OF DISTRIBUTION CHANNELS

REGULATORY ISSUES FOR NEW DRUGS IN CHINA

HISTORY OF NEW DRUG REGULATION IN CHINA

CLASSIFICATION OF NEW DRUGS IN CHINA

DRUG REVIEW PROCESS

NEW DRUG REVIEW TIME

NEW DRUG MARKETING EXCLUSIVITY CLINICAL REQUIREMENTS

IMPORTED DRUGS

CLASS 1 NCE REGISTRATION

INTELLECTUAL PROPERTY PROTECTION ISSUES

INTELLECTUAL PROPERTY PROTECTION IN CHINA ADMINISTRATIVE PROTECTION CHANGING IP PROTECTION REGIME ADAPTATION OF CHINESE FIRMS

TRADITIONAL CHINESE MEDICINE

POPULARITY OF TRADITIONAL CHINESE MEDICINE (TCM) IN CHINA FORMS OF TCM

TCM DRIVING THE HEALTH FOOD INDUSTRY

POPULARITY OF TCM OUTSIDE OF CHINA

GLOBAL SCOPE FOR CHINESE TCM

FORECASTS FOR THE FUTURE

STRATEGIES FOR THE FUTURE

STRATEGIC OPTIONS FOR CHINESE FIRMS

GENERICS

TRADITIONAL MEDICINE NCEs RESEARCH

SUPPORT FOR NEW ENTERPRISES GOVERNMENT POLICIES

LIST OF TABLES

Table 1: Leading Chinese Provinces By Pharmaceutical Sales

Table 2: Drugs With Largest Market Scope

Table 3: Fastest Growing Therapeutic Categories

Table 4: Registration Procedure For Pharmaceutical Imports

Table 5: Foreign Invested Pharmaceutical Firms

Table 6: Collaboration Between Chinese Firms And Foreign Mncs

Table 7: Government-Set Profit Margins For Drug Types In China

Table 8: Death Rate Of Major Diseases In Urban Areas

Table 9: Death Rate Of Major Diseases In Rural

Table 10: Percentage Of Children Vaccinated For Various Diseases

Table 11: Foreign Insurance Companies In China

Table 12: Leading Pharmaceutical Categories In China s Retail Market

Table 13: Leading Imported Pharmaceutical Categories In China s Retail Market Table

14: Leading Pharmaceutical Manufacturers In China s Retail Market Table

15: Leading Pharmaceutical Products In China s Retail Market By Sales Table

16: Leading Pharmaceutical Categories In China s Retail Market By Volume

TABLE OF FIGURES

Figure 1: Size Of Chinese Pharmaceutical & Biotechnology Industry

Figure 2: Break-Up Of Chinese Pharmaceutical Firms Based On Ownership Structure

Figure 3: Break-Up Of Chinese Pharmaceutical Firms Based On Output

Figure 4: Break-Up Of Chinese Pharmaceutical Firms Based On Output

Figure 5: Break-Up Of China  s Drug Market Profile

Figure 6: Projected Break-Up Of China  s Drug Market Profile In 2010

Figure 7: Size Of China  s Pharmaceutical Exports

Figure 8: Chinese Political System

Figure 9: Number Of Biotechnology Companies In China

Figure 10: Sales Of Biotechnology Products In China

Figure 11: Biotechnology Patents Granted In China

Figure 12: Mapping Of The Chinese Government Network In Healthcare

Figure 13: Chinese Healthcare Expenditure

Figure 14: Healthcare Expenditure As A % Of Gnp

Figure 15: Chinese Healthcare Network

Figure 16: Size Of China  s Medical Equipment Market

Figure 17: Insurance Premium Growth In China

Figure 18: Density Of Life Insurance In China

Figure 19: Penetration Of Life Insurance In China

Figure 20: OTC Pharmaceutical Sales In China

Figure 21: Retail Pharmaceutical Outlets In China

Figure 22: China  s Otc Drug Distribution Pattern

Figure 23: China  Drug Distribution Network