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Opportunities and Challenges for Generic Drugs in Australia

Published by: Espicom Healthcare Intelligence

Published: Mar. 6, 2008 - 74 Pages


Table of Contents


FOREWORD

EXECUTIVE SUMMARY

BACKGROUND TO THE MARKET

Geography

Map of Australia

Political Overview

Economic Overview

Estimated/Projected GDP, 2007-2012

Demographics

Population

Population, June 1995-2006

Population by State/Territory, June 2006 (000s)

Principal Demographic Indicators

Principal Demographic Indicators, 1998-2005

The Australian Healthcare System

Organisation

Commonwealth level

State/Territory & Local Governments

Healthcare expenditure

Total Health Expenditure by Source of Funding, 1998/99 - 2004/05 (A$ millions)

Total Health Expenditure by Type, 2001/02 - 2004/05 (A$ millions)

Total Health Spending by Type & Source, 2004/05 (A$ millions)

Health Expenditure by State/Territory, 1998/99 - 2004/05

Hospitals

Public/Private Hospitals, 1998/99 - 2004/05

Private/Public Hospitals by State/Territory, 2004/05

Public/Private Hospital Beds, 1998/99 - 2004/05

Public/Private Beds by State/Territory, 2004/05

Ambulatory Care

Non-Admitted Patient Occasions of Service, Public Acute Hospitals, 1998/99-2004/05

Medical personnel

Medical Practitioners, 1998-2004

Medical Practitioners by State/Territory, 2001-04

Medical Specialists, 2002-04

THE AUSTRALIAN GENERIC PHARMACEUTICAL MARKET

In Context: the Australian Pharmaceutical Market

Summary of the Australian Pharmaceutical Market in 2007

Market Projections, 2007-2012

Pharmaceutical Expenditure by Source of Funds, 2003/04 - 2005/06 (A$ millions)

Percentage Change in Pharmaceutical Expenditure, 1999/00 - 2005/06

PBS prescription data

PBS Prescriptions, 2001-06 (000s)

Government Cost of PBS Prescriptions, 2001-06 (A$ millions)

PBS Prescriptions by ATC Category, 2001-06 (000s)

Total Cost of PBS Prescriptions by ATC Category, 2001-06 (A$ millions)

Top 20 PBS Drugs by Volume, 2004-06

Top 20 PBS Drugs by Cost, 2006 (A$ millions)

Top 20 Suppliers to the PBS by Value, 2005/06

Top 20 Suppliers to the PBS by Volume, 2005/06

Top 20 Suppliers to the PBS by Volume, 2005/06

Generic Market Size & Projections

Projected Generic Market, 2006-2012 (A$ millions)

Projected Generic Market, 2006-2012 (US$ millions)

Summary Outlook

Generics in the PBS Market

PBS Data for leading Generic Manufacturers, 2005/06

PBS Data for leading Generic Manufacturers, 2005/06 (% of Total)

Discounting, Mark-ups and Average Price, 2005/06

Discounting, Mark-ups and Average Price, 2005/06

Pharmaceutical Regulation

International harmonisation

Biosimilars in Australia

Omnitrope

EU regulations adopted, 2006

Mayne Pharma

Leading Manufacturers & Suppliers

Summary of Suppliers to the Australian Generic Market, 2007

Alphapharm Pty Limited

Financials

Alphapharm Sales, 2000-06 (million euros)

Alphapharm PBS Data, 2000-06

Products

Alphapharm Drugs Listed on the PBS, January 2008

US presence

Alphapharm US FDA ANDA Approvals 2002-07

Arrow Pharmaceuticals Pty Ltd

Financials

Arrow PBS Sales Data, 2005/06

Products

Arrow Prescription Drug Products (home developed), 2007

Arrow Drugs Listed on the PBS, January 2008

Aspen Australia

Financials

Aspen Pharmacare, Australian Sales Results, 2006-07 (million Rand)

Products

Aspen Prescription Drugs

Aspen signs distribution deal with Teva

Genepharm Pty Ltd

Financials

Genepharm Australasia Financial Results, 2006/07 (A$ millions)

Products

Genepharm Drugs Listed on the PBS, January 2008

Supply agreements

Generic Health Pty Ltd/Bellwether Pharma

Products

Bellwether Pharma Drugs Listed on the PBS, January 2008

GenRx Pty Ltd

GenRx PBS Sales Data, 2005/06

Products

GenRx Drugs Listed on the PBS, January 2008

Mayne Pharma (Hospira)

Financials

Mayne Financial Results, Fiscal 2005-06

Sales by Category, 2006

Mayne Pharma PBS Sales, 2003/04 - 2005/06

Products

Leading Mayne Pharma Products, August 2006

Mayne Pharma Drugs Listed on the PBS, January 2008

US presence

Mayne Pharma ANDA approvals, 2002-07

Faulding Pharmaceutical ANDA approvals, 2002-03

PharmAust

Ranbaxy Australia Pty Limited

Products

Ranbaxy Australia Drugs Listed on the PBS, January 2008

Sandoz Pty Ltd

Hexal Australia, PBS Sales 2005/06

Products

Sandoz Drugs Listed on the PBS, January 2008

Sigma Pharmaceuticals (Australia) Pty Ltd

Products

Sigma Drugs Listed on the PBS, January 2008

Orphan Pharmaceuticals

Winthrop Pharmaceuticals

Products

Winthrop Drugs Listed on the PBS, January 2008

Pricing & reimbursement: PBS

Selected Generic Medicine Price Comparisons, November 2004 (A$)

Rise in Co-payment rates, 2005

Therapeutic Group Premiums

US Free Trade Agreement

12.5% price reductions for new market entrants

Government announces further PBS reforms, 2006

Intellectual property

Data exclusivity

„Springboarding.

US Free Trade Agreement, Generic Amendments

Evergreening?

Ranbaxy fails to overturn patent on Lipitor

Pharmaceutical distribution

Wholesaling

Top Three Wholesalers, Pharmacy Revenues 2006-07 (A$ millions)

National Pharmaceutical Services Association

Australian Pharmaceutical Industries Ltd (API)

Sigma Pharmaceuticals

Symbion Health (formerly Mayne Group)

Retailing

Community Pharmacies by State/Territory, June 2007

People per Pharmacy, June 2007

New wholesaler/pharmacy margin deal agreed

APPENDIX 1: INTERNATIONAL COMPARISONS

Generic Pharmaceutical Expenditure

Generic Pharmaceutical Expenditure, 2007 (US$ billions)

Generic Pharmaceutical Expenditure per capita, 2007 (US$)

Generic Pharmaceutical Expenditure as % of Total, 2007

APPENDIX 2: SOURCES

Espicom Sources

Australian Government Sources

Industry Sources

APPENDIX 3: EXCHANGE RATES

Abstract

This report provides a complete assessment of the US$1.43 billion Australian generic pharmaceutical market.

Key areas addressed:
  • 5-year market forecast to 2012 for value and volume
  • The generics market in context of the whole pharmaceutical industry
  • Pricing/reimbursement issues
  • Extensive prescription data analysis for leading products and companies
  • Political, legal and economic assessment
  • Insightful review of 12 major domestic and foreign players who lead the generic market
  • Extensive background data on the Australian health system
The report answers key questions such as:
  • What is the estimated value of the Australian generic market now and in 2012?
  • How are price controls affecting generic drugs and how will this change in the future?
  • Will Alphapharm continue to dominate in the face of mounting domestic and international competition?


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