市場調査報告書：ジェネリック医薬品：オーストラリア

Abstract

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

Valued at US$1.43 billion, the Australian generics market accounts for 14.9% of the total pharma market value but only 30% by volume. With the government keen to keep drug costs down, and with a number of major branded products losing patent protection the market is one of the safer opportunities in the region. But how will the market grow and in what way?

The central challenge to the Australian drug industry is the government' s continued pressure to keep prices low in an effort to rein in PBS expenditure. The change of regime is unlikely to help and the new Labor government will, if anything, be even stricter.

Generics are not exempt from this; price reforms will place heavy downward pressure on the value of the market for generics. These began with the 12.5% cuts in 2005, and will go on until at least 2012. The most significant cut is likely to be the 25% reduction mooted for August 2008. These should have the effect of boosting volumes while depressing revenues.

However, generics are widely used and well accepted among patients and prescribers. Generic expenditure per capita is on a rough par with the Netherlands or Switzerland. Patent expiries will continue to be the main driver of value growth in the market.

Opportunities?

More importantly, generic dispensing is, as a % of the whole, relatively low at 30% of total prescriptions. With price a big issue, and with the prospect of generic competition on leading products (such as atorvastatin, Australia' s leading product) then the opportunity for generic volumes is good - but will values follow?

The generic industry is highly concentrated. Until recently, the only significant player was Alphapharm, although its position at the top has come under increasing threat from the new Sigma/Arrow partnership. The market is becoming more open to overseas players, although they are as yet to take significant market share. Sandoz, Ranbaxy and Teva all have established an interest in the market.

Now you can easily evaluate the Australian generic drugs market

But who are the leading players and what are their strengths/weaknesses? What barriers to market entry exist? Where are the best opportunities? What is the operating and regulatory environment for companies? The answers to these and many other questions can be found in this 74-page report

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

オーストラリアにおけるジェネリック医薬品の機会と課題

Opportunities and Challenges for Generic Drugs in Australia

Abstract

Opportunities?

Now you can easily evaluate the Australian generic drugs market

Table of Contents

FOREWORD

EXECUTIVE SUMMARY

BACKGROUND TO THE MARKET

THE AUSTRALIAN GENERIC PHARMACEUTICAL MARKET

APPENDIX 1: INTERNATIONAL COMPARISONS

APPENDIX 2: SOURCES

APPENDIX 3: EXCHANGE RATES