Healthcare, Regulatory and Reimbursement Landscape - Australia

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1 Brochure More information from Healthcare, Regulatory and Reimbursement Landscape - Australia Description: Healthcare, Regulatory and Reimbursement Landscape - Australia Summary GlobalData, the industry analysis specialist, has released its new report, Healthcare, Regulatory and Reimbursement Landscape - Australia. The report is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in Australia. It identifies key trends, and most importantly, provides valuable insights into the trends and segmentation of the pharmaceutical and medical devices market. It is built using data and information sourced from proprietary databases, secondary research and in-house analysis by Our team of industry experts. In 2010, Australia s population was 22.4 million, largely due to a positive balance between the birth rate and mortality rate and net overseas immigration. The mortality rate is almost steady due to Australia s strong healthcare infrastructure and medical and diagnostic services. The pharmaceutical market was estimated at $14.9 billion in 2010 and is expected to reach $30.5 billion by 2020 at a projected CAGR of 7.4%. The medical device market size was worth approximately $6.5 billion in 2011 and is expected to reach $10 billion by 2020 at a projected CAGR of 4.8%. The positive trends in the healthcare market can be attributed primarily to - - Easy market access to pharmaceutical drugs - Increasing awareness of the need for the early detection of lifestyle and chronic diseases - Government-subsidized prescription medicines through the Pharmaceutical Benefit Scheme (PBS) for all eligible, general or concessional patients - Annual review and addition of expensive innovative drugs to the PBS drug list Scope The report provides information on the Australian healthcare, regulatory and reimbursement landscape, and includes - - Overview of the pharmaceutical and medical devices market, including size, segmentation, and key drivers and barriers. - Profiles and SWOT analyses of the major players in the pharmaceutical and medical devices market. The key players covered for the pharmaceutical market are Pfizer, AstraZeneca, Novartis, Sanofi and GlaxoSmithKline, and the key players covered for the medical devices market are Siemens Healthcare, GE Healthcare, DePuy Inc, F. Hoffmann-la Roche and Stryker Corporation. - Insightful review of the reimbursement and regulatory landscape, with details of the healthcare reimbursement process, regulatory agencies and market authorization processes for new drug and medical devices. - Detailed analysis of Australia s political and economic environment, including the economic indicators, demographics, healthcare infrastructure and healthcare expenditure. - An overview of the opportunities for and challenges to growth in the healthcare market. Reasons to buy This report comprehensively covers both the pharmaceutical and the medical devices market in Australia. It will enhance your decision-making capability and allow you to - - Develop business strategies by understanding the trends shaping and driving the healthcare market. - Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical and medical devices market segments and companies likely to impact the healthcare market in the future. - Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors. - Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment and strategic partnerships. - Identify, understand and capitalize on the opportunities and challenges in the healthcare market.

2 Contents: List of Tables 1.2 List of Figures 2 Introduction 2.1 Report Guidance 3 Overview of the Pharmaceutical and Medical Device Market 3.1 Pharmaceutical Market Supply Channels Market Segments Major Disease Areas Major Players 3.2 Medical Device Market Market Overview Overview of the Top Five Segments Major Players 3.3 Market Drivers and Barriers Drivers Barriers 4 Market Access 4.1 Reimbursement and Payers Landscape Reimbursement Process Overview of Insurance Providers Patient Share in Healthcare Spending Drug Price Trend Pricing Policies 4.2 Regulatory Landscape Overview of Regulatory Agencies New Drug Approval Process New Medical Device Approval Process Licensing Process for Pharmaceutical and Medical Device Manufacturing Licensing Process for Pharmaceutical Exports and Imports Intellectual Property Rights Clinical Trial Regulations Pharmaceutical and Medical Devices Advertising Regulations Pharmacy Regulations Labeling and Packaging Regulations 5 Country Analysis 5.1 Political Environment Political Structure Analysis of Current Political Environment Healthcare Policy Initiatives 5.2 Economic Landscape 5.3 Economic Indicators Gross Domestic Product Gross National Income Inflation Currency Exchange Rate Foreign Direct Investment Foreign Exchange Reserves Trade Balance Government Structural Balance Government Net Debt Major Industries 5.4 Demography Population Education and Literacy Employment Disease Burden Healthcare Facilities Healthcare Parameters Healthcare Personnel Environmental Health

3 5.5 Healthcare Expenditure Major Components of Healthcare Spending Share of Public and Private Sector in Healthcare Spending in Pharmaceutical R&D 5.6 Trade Associations Australian Pharmaceutical Marketing and Research Group Pharmacy Guild of Australia Generic Medicines Industry Association 5.7 Trade Fairs 6 Opportunities and Challenges 6.1 Opportunities 6.2 Challenges 7 Appendix 7.1 Abbreviations 7.2 Bibliography 7.3 Methodology Coverage Secondary Research Forecasting Primary Research Expert Panel Validation 7.4 Contact Us 7.5 Disclaimer 1.1 List of Tables Table 1: Pharmaceutical Market ($bn), Australia, Table 2: Pharmaceutical Market ($bn), Australia, Forecast, Table 3: Pharmaceutical Sales Under PBS ($bn), Australia, Table 4: Pharmacy and Wholesale Mark-up, Australia, 2011 Table 5: Biotechnology Companies, Market Capitalization ($m), Australian, 2011 Q4 Table 6: Over-the-counter Medicine Market ($bn), Australia, Table 7: Major Disease Areas, Australia, Pharmaceutical Expenditure under Pharmaceutical Benefits Scheme ($bn), 2010 Table 8: Top Five Suppliers to the Pharmaceutical Benefit Scheme, Australia, ($m), 2010 Table 9: Major Products, Pfizer, Global, Revenue ($m), 2011 Table 10: Late-stage Pipeline, Pfizer, 2012 Table 11: Major Products, AstraZeneca, Global, Revenue ($m), 2011 Table 12: Late-stage Pipeline, AstraZeneca, 2012 Table 13: Major Products, Novartis, Global, Revenue ($m), 2011 Table 14: Planned Filings, Novartis, 2012 to = 2016 Table 15: Major Products, Sanofi, Global, Revenue ($m), 2011 Table 16: Late-stage Pipeline, Sanofi, 2012 Table 17: Major Products, GlaxoSmithKline, Global, Revenue ($m), 2011 Table 18: Late-stage Pipeline, GlaxoSmithKline, 2012 Table 19: Medical Device Market ($bn), Australia, Table 20: Medical Device Market ($bn), Australia, Forecast, Table 21: Medical Device Market, Australia, Segments, Revenue ($m), 2011 Table 22: In Vitro Diagnostics Market ($m), Australia, Table 23: Sales Trends for Major Players-, In Vitro Diagnostics Devices, Australia, 2010 Table 24: Orthopedic Devices Market ($m), Australia, Table 25: Sales Trends for Major Players-, Orthopedic Devices, Australia, 2010 Table 26: Ophthalmic Devices Market ($m), Australia, Table 27: Sales Trends for Major Players-, Ophthalmic Devices, Australia, 2010 Table 28: Diagnostic Imaging Market ($m), Australia, Table 29: Sales Trends for Major Players-, Diagnostic Imaging, Australia, 2010 Table 30: Cardiovascular Devices Market ($m), Australia, Table 31: Sales Trends for Major Players-, Cardiovascular Devices, Australia, 2010 Table 32: Major Products, Siemens, Global, Revenue ($m), 2010 Table 33: Major Products, DePuy, 2012 Table 34: Major Products, Roche, Global, Revenue ($m), 2010 Table 35: Late-stage Pipeline, F. Hoffmann-La Roche Ltd., 2012 Table 36: Major Products, Stryker, Global, Revenue ($m), 2010 Table 37: Medicare Safety Net Original Threshold, Australia, 2012

4 Table 38: Extended Medicare Safety Net Medicare Safety Threshold, Australia, 2012 Table 39: Healthcare Spending, Australia, Patient's Share (%), Table 40: Change in Average Annual Price of Pharmaceutical Benefit Scheme Drugs (%), Australia, Table 41: Classification of Medical Devices, Australia, 2012 Table 42: Regulation of Advertising of Therapeutic Goods, Australia, 2012 Table 43: GDP Per Capita ($), Australia, Table 44: GDP Per Capita ($), Australia, Forecast, Table 45: GDP, Annual Growth (%), Australia, Table 46: GDP, Annual Growth (%), Australia, Forecast, Table 47: GNI Per Capita ($), Australia, Table 48: Average Consumer Price Index, Australia, Table 49: Average Consumer Price Index, Australia, Forecast, Table 50: Average Consumer Price, Australia, Annual Change (%), Table 51: Currency Exchange Rate (AUD$/$), Australia, Table 52: Foreign Direct Investment ($bn), Australia, Table 53: Foreign Exchange Reserves ($bn), Australia, Table 54: Imports of Goods and Services ($bn), Australia, Table 55: Exports of Goods and Services ($bn), Australia, Table 56: General Government Structural Balance ($bn), Australia, Table 57: General Government Net Debt ($bn), Australia, Table 58: General Government Net Debt ($bn), Australia, Forecast, Table 59: Major Industry Sectors-, GVA ($bn), Australia, 2008 Table 60: Population (m), Australia, Table 61: Population (m), Australia, Forecast, Table 62: Urban and Rural Population, Australia, Share (%), Table 63: Age Groups, Australia, Population Distribution (%), Table 64: Births (Per 1,000 Population), Australia, Table 65: Births (Per 1,000 Population), Australia, Forecast, Table 66: Mortality (Per 1,000 Population), Australia, Table 67: Mortality (Per 1,000 Population), Australia, Forecast, Table 68: Major Causes of Mortality ( 000), Australia, 2009 Table 69: Children <5 Years Age, Mortality (Per 1,000 Live Births), Australia, Table 70: Immunization Rate for DTP, Measles, Hepatitis B (%), Australia, Table 71: Major Causes of Male Mortality ( 000), Australia, 2009 Table 72: Major Causes of Female Mortality ( 000), Australia, 2009 Table 73: Gender Ratio (M/F), Australia, Table 74: Life Expectancy at Birth (Years), Australia, Table 75: Life Expectancy at Birth (Years), Australia, Forecast, Table 76: Schools, Australia, Table 77: School Students ( 000), Australia, Table 78: Education Participation (%), Year Olds, Australia, Table 79: Overseas Students (%), Australia, Table 80: Tertiary and Higher-education Students ( 000), Australia, Table 81: Unemployment Rate (%), Australia, Table 82: Most Frequently Diagnosed Diseases ( 000), Australia, Table 83: Major Diseases, Australia, DALY (Per 100,000 Population), 2004 Table 84: Public Hospitals, Australia, Table 85: Public Acute Care Hospitals, Australia, Table 86: Public Psychiatric Hospitals, Australia, Table 87: Private Hospitals, Australia, Table 88: Private Free-standing Day Hospital Facilities, Australia, Table 89: Other Private Hospitals, Australia, Table 90: Public Hospital Beds (Per 1,000 Population), Australia, Table 91: Private Hospital Beds (Per 1000 Population), Australia, Table 92: Physicians (Per 1,000 Population), Australia, Table 93: Healthcare Personnel (Per 1,000 Population), Australia, Table 94: Nurses (Per 1000 Population), Australia, Table 95: PM10 (Micrograms Per Cubic Meter), Australia, Table 96: CO2 Emissions (000 s Tons), Australia, Table 97: NO2 Emissions (000 s Tons), Australia, Table 98: Healthcare Expenditure (% of GDP), Australia, Table 99: Healthcare Expenditure, Australia, Share of Major Components (%), Table 100: Healthcare Expenditure, Australia, Public-Private Share (%),

5 Table 101: Pharmaceutical R&D Expenditure ($m), Australia, Table 102: Major Healthcare Trade Fairs, Australia, List of Figures Figure 1: Pharmaceutical Market ($bn), Australia, Figure 2: Pharmaceutical Market ($bn), Australia, Forecast, Figure 3: Pharmaceutical Sales under PBS ($bn), Australia, Figure 4: Pharmaceutical Supply Chain, Australia, 2011 Figure 5: Over-the-counter Medicine Market ($bn), Australia, Figure 6: Major Disease Areas, Australia, Pharmaceutical Expenditure under Pharmaceutical Benefits Scheme ($bn), 2010 Figure 7: Top Five Suppliers to the Pharmaceutical Benefit Scheme, Australia, ($m), 2010 Figure 8: Medical Device Market ($bn), Australia, Figure 9: Medical Device Market ($bn), Australia, Forecast, Figure 10: Medical Device Market, Australia, Segments, Revenue ($m), 2011 Figure 11: In Vitro Diagnostics Market ($m), Australia, Figure 12: Sales Trends for Major Players-, In Vitro Diagnostics Devices, Australia, Figure 13: Orthopedic Devices Market ($m), Australia, Figure 14: Sales Trends for Major Players-, Orthopedic Devices, Australia, Figure 15: Ophthalmic Devices Market ($m), Australia, Figure 16: Sales Trends for Major Players-, Ophthalmic Devices, Australia, Figure 17: Diagnostic Imaging Market ($m), Australia, Figure 18: Sales Trends for Major Players-, Diagnostic Imaging, Australia, Figure 19: Cardiovascular Devices Market ($m), Australia, Figure 20: Sales Trends for Major Players-, Cardiovascular Devices, Australia, Figure 21: Drivers and Barriers, Healthcare Market, Australia, 2011 Figure 22: Pharmaceuticals and Devices Reimbursement Process, Australia Figure 23: Healthcare Spending, Australia, Patient's Share (%), Figure 24: Change in Average Annual Price of Pharmaceutical Benefit Scheme Drugs (%), Australia, Figure 25: Therapeutic Goods Administration Structure, 2012 Figure 26: New Drug Approval Process, Australia, 2012 Figure 27: Class I Non-sterile And Non-measuring Device Supply Process, Australia, 2012 Figure 28: Supply Process for Medical Device Manufactured in Australia, 2012 Figure 29: Supply Process for Medical Device Manufactured Overseas, Australia, 2012 Figure 30: Supply Process for Medical Device Containing Medicine or Materials of Animal, Microbial Recombinant or Human Origin, Australia, 2012 Figure 31: GDP Per Capita ($), Australia, Figure 32: GDP Per Capita ($), Australia, Forecast, Figure 33: GDP, Annual Growth (%), Australia, Figure 34: GDP, Annual Growth (%), Australia, Forecast, Figure 35: GNI Per Capita ($), Australia, Figure 36: Average Consumer Price Index, Australia, Figure 37: Average Consumer Price Index, Australia, Forecast, Figure 38: Average Consumer Price, Australia, Annual Change (%), Figure 39: Currency Exchange Rate (AUD$/$), Australia, Figure 40: Foreign Direct Investment ($bn), Australia, Figure 41: Foreign Exchange Reserves ($bn), Australia, Figure 42: Imports of Goods and Services ($bn), Australia, Figure 43: Exports of Goods and Services ($bn), Australia, Figure 44: General Government Structural Balance ($bn), Australia, Figure 45: General Government Net Debt ($bn), Australia, Figure 46: General Government Net Debt ($bn), Australia, Forecast, Figure 47: Major Industry Sectors-, GVA ($bn), Australia, 2008 Figure 48: Population (m), Australia, Figure 49: Population (m), Australia, Forecast, Figure 50: Urban and Rural Population, Australia, Share (%), Figure 51: Age Groups, Australia, Population Distribution (%), Figure 52: Births (Per 1,000 Population), Australia, Figure 53: Births (Per 1,000 Population), Australia, Forecast, Figure 54: Mortality (Per 1,000 Population), Australia, Figure 55: Mortality (Per 1,000 Population), Australia, Forecast, Figure 56: Major Causes of Mortality ( 000), Australia, 2009

6 Figure 57: Children <5 Years Age, Mortality (Per 1,000 Live Births), Australia, Figure 58: Immunization Rate for DTP, Measles, Hepatitis B (%), Australia, Figure 59: Major Causes of Male Mortality ( 000), Australia, 2009 Figure 60: Major Causes of Female Mortality ( 000), Australia, 2009 Figure 61: Gender Ratio (M/F), Australia, Figure 62: Life Expectancy at Birth (Years), Australia, Figure 63: Life Expectancy at Birth (Years), Australia, Forecast, Figure 64: Schools, Australia, Figure 65: School Students ( 000), Australia, Figure 66: Education Participation (%), Years Old, Australia, Figure 67: Overseas Students (%), Australia, Figure 68: Tertiary and Higher-education Students ( 000), Australia, Figure 69: Unemployment Rate (%), Australia, Figure 70: Most Frequently Diagnosed Diseases ( 000), Australia, Figure 71: Major Diseases, Australia, DALY (Per 100,000 Population), 2004 Figure 72: Public Hospitals, Australia, Figure 73: Public Acute Care Hospitals, Australia, Figure 74: Public Psychiatric Hospitals, Australia, Figure 75: Private Hospitals, Australia, Figure 76: Private Free-standing Day Hospital Facilities, Australia, Figure 77: Other Private Hospitals, Australia, Figure 78: Public Hospital Beds (Per 1,000 Population), Australia, Figure 79: Private Hospital Beds (Per 1,000 Population), Australia, Figure 80: Physicians (Per 1,000 Population), Australia, Figure 81: Healthcare Personnel (Per 1,000 Population), Australia, Figure 82: Nurses (Per 1,000 Population), Australia, Figure 83: PM10 (Micrograms Per Cubic Meter), Australia, Figure 84: CO2 Emissions (000 s Tons), Australia, Figure 85: NO2 Emissions (000 s Tons), Australia, Figure 86: Healthcare Expenditure (% of GDP), Australia, Figure 87: Healthcare Expenditure, Australia, Share of Major Components (%), Figure 88: Healthcare Expenditure, Australia, Public-Private Share (%), Figure 89: Pharmaceutical R&D Expenditure ($m), Australia, Figure 90: Opportunities and Challenges, Healthcare Market, Australia, 2011 Ordering: Order Online - Order by Fax - using the form below Order by Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland.

7 Page 1 of 2 Fax Order Form To place an order via fax simply print this form, fill in the information below and fax the completed form to (from USA) or (from Rest of World). If you have any questions please visit Order Information Please verify that the product information is correct and select the format(s) you require. Product Name: Web Address: Office Code: Healthcare, Regulatory and Reimbursement Landscape - Australia SC Product Formats Please select the product formats and quantity you require: Electronic (PDF) - Single User: Electronic (PDF) - Site License: Electronic (PDF) - Enterprisewide: Quantity USD 1995 USD 3990 USD 5985 Contact Information Please enter all the information below in BLOCK CAPITALS Title: Mr Mrs Dr Miss Ms Prof First Name: Last Name: Address: * Job Title: Organisation: Address: City: Postal / Zip Code: Country: Phone Number: Fax Number: * Please refrain from using free accounts when ordering (e.g. Yahoo, Hotmail, AOL)

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