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Asia Pacific: Pharmahandbook - Product Image

Asia Pacific: Pharmahandbook

  • ID: 2618980
  • June 2013
  • Region: Asia
  • 214 Pages
  • VOI Consulting, Inc

Asia Pacific: Pharmahandbook: Australia, China, India, Indonesia, Japan, New Zealand, South Korea, Taiwan

Intellectual property in India. PBS access in Australia. Generics in Japan. And China. What about China? The pharmaceutical industry has questions. Our Asia-Pacific report has answers. It contains the information and analysis you need to expand or improve your drug development and business prospects in 8 countries with 55% of the world's population and $300 billion in combined pharmaceutical sales. The world's second and third-largest markets, Japan and China, are covered as are rapidly-developing India and Indonesia, newly-emerged South Korea and Taiwan, and mature but still-evolving Australia and New Zealand.

Why you need it

The 8 countries in this report account for one-third of global pharmaceutical sales but their operating environments are radically different. Asia-Pacific pharmahandbook gives you the information and analysis you need to develop and market pharmaceuticals in these vitally important Asia-Pacific markets.

An “essential resource”, "invaluable", "extremely useful", "a wonderful source of information"…that's what customers in the international pharmaceutical industry have been saying about pharmahandbook since 2003.

Note: Product cover images may vary from those shown

Notes

Overview

Calculation of GDP and National Healthcare Spending

Market Calculations

Time Considerations

Monetary Figures, Exchange Rates & Growth Calculations

Australia 2013

Healthcare System

Pharmaceutical Market
- Market Profile
- Market Structure
- The Pharmaceutical Benefits Scheme
- Section 100 Programs
- Memorandum of Understanding
- Forecasts

Regulatory

Approval Procedures
- TGA/Medsafe Merger (ANZTPA) Status

Pricing
- Cost Recovery
- Formulary Categories
- Managed Entry Scheme (MES)
- Mandatory Price Reductions
- Price Disclosure

Payment

Generics
- Generic Substitution
- The Generic Market

R&D / Clinical Trials
- Overview

Regulatory / Approval

Manufacturing

Distribution

Trade
- AUSFTA

Patent & Intellectual Property Issues
- Marketing
- Marketing Regulations
- List of Figures

China 2013

Healthcare System
- Health Reforms

Pharmaceutical Market
- Market Profile and Structure
- Product Segments
- Market Access
- Market Fragmentation
- Impact of 2009-2011 Health Reforms
- Market Performance and Forecasts

Regulatory

Approval Procedures
- Provisional vs. Final Standards

Pricing

Payment
- NRDL
- EDL
- Hospitals and Tendering Systems

Generics

R&D / Clinical Trials

Manufacturing

Distribution

Patent & Intellectual Property Issues
- The Monitoring Period
- Provisional vs. Final Standards
- Compulsory Licensing
- Marketing
- Marketing Regulations
- Marketing Practices

List of Figures

India 2013

Major Events

Healthcare System

Pharmaceutical Market
- Market Profile and Structure
- Market Performance and Forecasts

Regulatory

Approval Procedures
- Biosimilar Regulations
- Proposal to Restrict New Drug Approvals to Generic Names
- Reports of Lax Regulatory Oversight

Pricing
- Details of New Price Control System
- Proposals for Patented Medicine Price Controls

Payment

Generics

R&D / Clinical Trials
- Clinical Trial Regulations
- Clinical Trial Environment

Manufacturing

Distribution

Patent & Intellectual Property Issues
- Provisions of the Patent Law
- Lack of Data Exclusivity
- Recent Developments and Future Outlook
- Marketing
- Marketing Practices

List of Figures

Indonesia 2013

Major Events

Healthcare System
- Health Infrastructure
- Health Insurance
- Universal Health System Status

Pharmaceutical Market
- Market Profile
- Regulatory Barriers and Market Access
- Market Performance and Forecasts

Regulatory

Approval Procedures

Pricing

Payment
- PT Askes Formulary (DPHO)

Generics

R&D / Clinical Trials

Manufacturing

Distribution
- Patent & Intellectual Property Issues
- Compulsory Licensing
- Marketing

List of Figures

Japan 2013

Healthcare System
- Healthcare Infrastructure

Pharmaceutical Market
- Market Profile and Structure
- Market Performance and Forecasts
- Forecasts

Regulatory

Approval Procedures

Pricing
- General Procedures
- Adjustments to Calculated Price
- Additional Factors in New Drug Pricing
- Generic Pricing Procedures
- Biennial Price Cuts
- Price Maintenance System for Patented Drugs
- Health Technology Assessment (HTA) Board under Consideration

Payment

Generics
- Generic Companies
- Generic Market
- Generic Promotion Efforts
- Biosimilars

R&D / Clinical Trials
- Clinical Trial Environment
- Clinical Trial Regulations

Manufacturing

Distribution
- Patent & Intellectual Property Issues

Marketing

List of Figures

Korea 2013

Healthcare System

Pharmaceutical Market
- Market Profile and Structure
- Innovation Incentives
- Incrementally Modified Drugs
- Market Performance and Forecasts

Regulatory

Approval Procedures

Pricing
- Patented Drugs
- April 2012 Pricing System for Non-patented Drugs
- Original Drugs Losing Exclusivity
- Generic Drugs
- Ongoing Price Cutting Measures
- Proposed Future Price Reforms

Payment
- Hospital Purchasing and Payment

Generics
- Biosimilars

R&D / Clinical Trials

Manufacturing

Distribution
- Trade
- Patent & Intellectual Property Issues
- Korea-US Free Trade Agreement

Marketing

List of Figures

New Zealand 2013

Healthcare System

Pharmaceutical Market
- Market Profile and Structure
- PHARMAC
- Market Performance and Forecasts

Regulatory

Approval Procedures
- TGA/Medsafe Merger (ANZTPA) Status

Pricing
- PHARMAC's Role in Hospital Purchases

Payment
- Changes to the Exceptional Circumstances Scheme

Generics

R&D / Clinical Trials
- Distribution
- Trade
- Patent & Intellectual Property Issues

Marketing

List of Figures

Taiwan 2013

Healthcare System

Pharmaceutical Market
- Market Profile and Structure
- Market Performance and Forecasts

Regulatory
- TFDA

Approval Procedures
- Bridging Study Policies

Pricing
- Patented Products
- Health Technology Assessments (HTA) & Innovation Categories
- Multi-Source Products
- Price Volume Surveys
- Impact of 2G NHI on Drug Pricing
- Drug Expenditure Target (DET)
- Actual Transaction Pricing (ATP)

Payment

Generics
- Biosimilars

R&D / Clinical Trials
- Clinical Trials
- IND Review Process
- Manufacturing
- Patent & Intellectual Property Issues

Marketing

List of Figures

Value of Insight

About VOI Consulting, Inc.

About the Author

Australia

List of Figures

Figure 1 - Population and Economic Statistics
Figure 2 - General Healthcare Statistics
Figure 3 - Destination of Health Expenditures, FY 2009/10
Figure 4 - Employed Medical Practitioners by Type and Practice Location
Figure 5 - Population Statistics
Figure 6A - Pharmaceutical Market Snapshot
Figure 6B - Pharmaceutical Market Snapshot
Figure 7 - Structure of the Australian Prescription Drug Market
Figure 8 - FY 2010/11 PBS Activity by Category
Figure 9 - FY 2010/11 PBS Activity by ATC Level 2 Categories (Figures in 000; A$)
Figure 10 - Top 20 Pharma Companies by PBS Sales FY 2010/11 (A$ and Rx Volume shown in thousands)
Figure 11 - Pharmacy Reimbursement Rates - Standard PBS Drugs
Figure 12 - Pharmacy Reimbursement Rates - Highly Specialized Drugs
Figure 13 - Top 50 PBS Drugs by Cost to Government (A$ and Rx Volume in thousands)

China

List of Figures

Figure 1 - Population and Economic Statistics
Figure 2 - General Healthcare Statistics
Figure 3 - Health Insurance Coverage in China 2011
Figure 4 - Demographic Profile
Figure 5A - Pharmaceutical Market Snapshot
Figure 5B - Pharmaceutical Market Snapshot
Figure 6 - Chinese Cities by Tier
Figure 7 - Top 10 Pharmaceutical Companies (Q1 2012)
Figure 8 - Share of Market Value by Drug Type (Western Drugs: 2009-2011) 49)
Figure 9 - Procedures and Timeframe for Market Access in China
Figure 10 - Drug Approval Procedures & Timing
Figure 11 - Generics Share of Market Value and Volume Forecasts (2010-2015)
Figure 12 - Clinical Trial Regulatory Approval Process
Figure 13 - Top 10 Pharmacy Chains 2011
Figure 14 - Promotional Spending by Type 2011
Figure 15 - Promotional Spending by Company 2011

India

List of Figures

Figure 1 - Population and Economic Statistics
Figure 2 - General Healthcare Statistics
Figure 3 - Health Insurance Coverage by Scheme (Millions of People)
Figure 4 - Demographic Profile
Figure 5A - Pharmaceutical Market Snapshot
Figure 5B - Pharmaceutical Market Snapshot
Figure 6 - Pharmaceutical Markets by Location Type
Figure 7 - Sources of Pharmaceutical Market Growth 2007 to 2011
Figure 8 - Retail and Hospital Sales and Share 2006-2011
Figure 9 - Therapeutic Category Share of Market and Value Growth (Year-Ending Jun 2012 vs. Jun 2011)
Figure 10 - Indian Regulatory System
Figure 11 - Responsibilities of Central and State Drug Regulators
Figure 12 - DPCO History
Figure 13 - Indian Clinical Trial Starts by Phase (Number and Share: 2006-2011)
Figure 14 - Top 50 Companies by sales in Indian Outpatient Market (MAT Mar 2012)
Figure 15 - Structure of Distribution Network
Figure 16 - Price Build-up in Distribution Channel
Figure 17 - Promotional Spending by Type 2011
Figure 18 - Top 10 Companies and Brands by Promotional Spending 2011

Indonesia

List of Figures

Figure 1 - Population and Economic Statistics
Figure 2 - General Healthcare Statistics
Figure 3 - Trends in Public Health Centers (Puskesmas)
Figure 4 - Distribution of Public and Private Hospitals (Aug 2012)
Figure 5 - Demographic Profile
Figure 6A - Pharmaceutical Market Snapshot
Figure 6B - Pharmaceutical Market Snapshot
Figure 7 - Sales and Share by Product Type 2007-2012 (Ex-manufacturer)
Figure 8 - Leading Prescription and OTC Companies (2011)
Figure 9 - Leading Companies: Overall, Pharmacy, and Hospital Markets (2011)
Figure 10 - Prescription and OTC Sales Forecasts (2012 to 2016)
Figure 11 - Structure and Responsibilities within BPOM's Directorate of Drug & Biological Product Evaluation
Figure 12 - Characteristics of the DPHO Formulary 2007 to 2012
Figure 13 - Indonesian Clinical Trial Starts by Phase (Number and Share: 2006-2012)
Figure 14 - Structure of Distribution Network
Figure 15 - Products covered by compulsory license decree (September 3, 2012)

Japan

List of Figures

Figure 1 - Population and Economic Statistics
Figure 2 - General Healthcare Statistics
Figure 3 - Types of Health Insurance Organizations
Figure 4 - Japanese Physicians by Specialty
Figure 5 - Demographic Structure
Figure 6A - Pharmaceutical Market Snapshot
Figure 6B - Pharmaceutical Market Snapshot
Figure 7 - Prescription Drug Sales by Channel 2011
Figure 8 - Sales of Ethical (Prescription) Drugs in Japan 2004-11; Local and US$ Values
Figure 9 - 2011 Sales by Therapeutic Category
Figure 10 - Sales of Top 10 Products 2011
Figure 11 - PMDA Drug Review Offices and Responsibilities
Figure 12 - Drug Pricing Process (Non-generics)
Figure 13 - Leading Generic Companies 2010
Figure 14 -Generic Penetration Rates 2005-11
Figure 15 - Japanese Clinical Trial Starts by Phase (Number and Global Share: 2006-2011)
Figure 16 - Sales of Top 20 Companies 2011 (Distributor Level)
Figure 17 - Sales-Force Size (Number of MRs): Top 20 Companies 2010

Korea

List of Figures

Figure 1 - Population and Economic Statistics
Figure 2 - General Healthcare Statistics
Figure 3 - NHI Copayment Schedule 2012
Figure 4 - Number of Health Facilities by Type
Figure 5 - Demographic Profile
Figure 6A - Pharmaceutical Market Snapshot
Figure 6B - Pharmaceutical Market Snapshot
Figure 7 - Summary of Pharmaceutical Market Reforms (2000 to 2012)
Figure 8 - Sales of Prescription and OTC Drugs 2008-2011 (US Dollars)
Figure 9 - 2011 Outpatient Prescription Drug Sales and Share by Therapeutic Category
Figure 10 - Korea Clinical Trial Starts by Phase (Number and Global Share: 2006-2011)
Figure 11 - Leading Domestic Companies by Share of Value in the Outpatient Segment 2010-2011

New Zealand

List of Figures

Figure 1 - Population and Economic Statistics
Figure 2 - General Healthcare Statistics
Figure 3 - Sources of Health Funds 2010
Figure 4 - Destinations of Funds FY 2010
Figure 5 - Demographic Profile
Figure 6A - Pharmaceutical Market Snapshot
Figure 6B - Pharmaceutical Market Snapshot
Figure 7 - PHARMAC Spending at Ex-Mfr Level by Category 2010 and 2011 Fiscal Years
Figure 8 - Top 20 Subsidized Products by Value and Prescription Volume FY 2011

Taiwan

List of Figures

Figure 1 - Population and Economic Statistics
Figure 2 - General Healthcare Statistics
Figure 3 - Funding Flows for Personal Healthcare 2010
Figure 4 - Health Spending by Destination 2010
Figure 5 - Taiwan's Health Infrastructure 2012
Figure 6A - Pharmaceutical Market Snapshot
Figure 6B - Pharmaceutical Market Snapshot
Figure 7 - Pharmaceutical Copayment Rates 2012
Figure 8 - Number of Approved Clinical Trial Protocols and Sites by Phase (2004-2010)
Figure 9 - Taiwan Clinical Trial Starts by Phase (Number and Global Share: 2006-2011)

Note: Product cover images may vary from those shown
Note: Product cover images may vary from those shown

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