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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.

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)

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