Australia Pharmaceutical Market Overview - Reforms and Continued Price Cuts Will Change the Healthcare La

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Introduction

The prescription pharmaceutical market in Australia was valued at $9.1 billion in 2009. Key growth drivers include the growing use of chronic high-value innovative treatments driven by a rising elderly population and high public spending as a proportion of total healthcare expenditure.

Scope

* Overview of Australia's socioeconomics and demographics, healthcare system, regulation, pricing and reimbursement and intellectual property position.
* Assesses the size of Australia's pharmaceutical market by prescribing setting, therapy area, leading brands and by leading companies.
* Examines Australia's generics and biosimilars landscape in terms of regulatory issues, level of penetration, key players and degree of brand erosion.
* Quantifies Australia's R&D and manufacturing infrastructure for the leading pharmaceutical companies, including key metrics and domestic M&A analysis.

Highlights

Australia's health expenditure totaled $81.8 billion, representing 9.1% of gross domestic product (GDP) in the financial year of 200708, which is the same percentage of GDP as the previous year. Australia's health expenditure as a proportion of GDP has been comparable to that seen in Europe, with most of its spending coming from the government.

Lipitor (atorvastatin, Pfizer) generated significantly higher sales than any other brand on the Australian pharmaceutical market in 2009 ($550m). The second and third highest-selling brands, Crestor (rosuvastatin; AstraZeneca) and Nexium (esomeprazole; AstraZeneca), lag far behind Lipitor and did not even reach half of its sales.

Compared with Europe, where 17 biosimilars of five different molecules have been approved since 2006, Australia's biosimilar market is small, particularly in terms of sales at $45,000. Somatropin is the only biologic that has biosimilar versions available, although the market is still very much dominated by the original branded product.

Reasons to Purchase

* Evaluate the evolving regulatory landscape and the impact of pricing and reimbursement controls on market access.
* Quantify the size and growth of the prescription pharmaceutical market in Australia, analyzing key therapy areas, brands and companies.
* Assess drivers and resistors of generic and biosimilars uptake in Australia and the level of erosion brands can expect to face post patent expiry.

Table Of Contents

ABOUT DATAMONITOR HEALTHCARE
About the Healthcare Strategic Analysis Team
Geographic-specific reports:
Global issue reports:
About the Healthcare Asia-Pacific Team

1. Australia - Executive Summary
Strategic scoping and focus
Key findings - healthcare drivers and resistors in Australia
Australia - Socio-demographic and economic analysis
Socio-demographic trends
Socio-economic trends
Australia - Healthcare system and drug regulatory analysis
Healthcare expenditure
Healthcare system overview
Regulatory issues
Pricing and reimbursement issues
Australia - Prescription pharmaceutical sales analysis
Pharmaceutical market size
Leading therapy areas
Leading prescription pharmaceutical brands
Leading pharmaceutical companies
Australia - Drug expiry analysis
Generics market
Brand erosion post patent expiry
Biosimilars market
Australia - Pharmaceutical industry infrastructure analysis
Pharmaceutical industry infrastructure overview
R&D infrastructure trends
Manufacturing infrastructure trends
Related reports
Upcoming related reports
Table of Contents

2. Australia - Socio-demographic and economic Analysis
Key findings
Socio-demographic trends
Socio-economic trends
Demographic trends in Australia
High population growth is a hot topic in Australia
Australia's birth rate is expected to stabilize
Proportion of elderly individuals is set to rise
Australia's life expectancy is one of the highest compared with other markets
Australia is a culturally and ethnically diverse country
Ischemic heart disease tops disease burden in Australia
Political climate in Australia
Federal elections are set for August 21, 2010
The 2010-11 Budget shows that the government's priorities include reforms in health and hospitals
Memorandum of Understanding (MoU) is good for innovators, but not so good for generics companies
Fifth Community Pharmacy Agreement was received positively all around
Australia's economy performs relatively well despite global downturn
Australia is doing comparatively well in the face of the global financial crisis
Unemployment rate experienced a small setback
Business environment in Australia
Corporate tax rate is high compared with other medium-sized OECD countries, but likely to be lowered
Unexpected price cuts led to uncertainty in Australia's pharmaceutical business environment
Historically strong Australian biotechnology industry took a big hit from global downturn

3. Australia - Healthcare system and drug regulatory analysis
Key findings
Healthcare expenditure
Healthcare system overview
Regulatory issues
Pricing and reimbursement issues
Healthcare expenditure - Australia's growth in pharmaceutical spending is under debate
Australia's healthcare system
The structure of the Australian healthcare system is complex
Reforms aim to decrease complexity and inequalities by changing the funding and governance of health and hospitals
Government focuses on early intervention and the integration of care in the community
Medicare provides Australians with a range of free services
Medicare Australia funds and provides public healthcare services
Pharmaceutical Benefits Scheme (PBS) funds the use of prescription drugs
The Australian government promotes the uptake of private health insurance
GP Super Clinics will be established in order to improve access to primary care
Australia's hospital system is split between a public and private market
Rural and Indigenous health are key focal points
National Medicines Policy aims to improve health outcomes through appropriate access to medicines
The Pharmaceutical Health and Rational Use of Medicines Committee and National Prescribing Service focus on quality use of medicines
Regulatory issues in Australia
Therapeutic Goods Administration (TGA) largely adopts EU standards
The Advisory Committee on Prescription Medicines (ACPM) has taken over from the Australian Drug Evaluation Committee (ADEC)
New organizational structure was put in place in mid-2010
New fees for the evaluation of prescription medicines
Therapeutic Goods Administration (TGA) reforms aim to reduce regulatory burden
Accelerated application entry and improved application coordination (streamlined submission process)
Increased transparency of prescription medicine regulatory process (the AusPAR project)
Improved access to prescription medicine information (the PI/CMI project)
The 'biologicals framework' refreshes regulations for biologicals
Intellectual property environment
Standard 20-year patent can be extended by up to 5 years
Data exclusivity is 5 years, during which 'springboarding' is allowed
Pricing reforms may encourage 'evergreening'
Drug counterfeiting is less of a problem in Australia than in other developed markets
Drug importation is controlled by the government and patent holders
Drug reimbursement in Australia
Reimbursement is decided by the Pharmaceutical Benefits Advisory Committee (PBAC)
High level of evidence is needed for a drug to be added to reimbursement list
Transparency in PBAC decisions has improved
Probability of a positive PBAC outcome was 75% in 2009, but lower for major applications
Parallel applications to the TGA and PBAC will become possible from 2011
AUD10m ($7.9m) threshold for cabinet approval remains
Section 100 programs provide drugs under special arrangements
Drug pricing in Australia
Prices are negotiated by the Pharmaceutical Benefits Pricing Authority (PBPA)
Latest Pharmaceutical Benefits Scheme (PBS) reforms led to considerable drug price reductions
The price disclosure program singles out generics for further price cuts
Criticized 'therapeutic groups' have been put to a halt by the Memorandum of Understanding (MoU)
The PBPA uses different types of pricing models
Reference pricing method is mainly used for products in Formulary 1
Cost Plus method is mainly used for products in Formulary 2
Weighted Average Monthly Treatment Cost (WAMTC) is a key feature in therapeutic groups
Risk sharing agreements lack transparency
Special patient contributions apply in some cases
The Access to Medicines Working Group (AMWG) facilitates discussion between the government and pharmaceutical industry on PBS reforms
PBAC evaluates bDMARDs in cost-effectiveness review
Australian Government Productivity Commission highlights specific concerns about the regulation of medicines in Australia
Requirement for multiple ethics approvals
Timeliness and cost of manufacturing audits/GMP assessments
TGA transparency and communication
Concerns about PBS listing and pricing processes
Delays in achieving PBS listing due to overlapping processes
Concerns about marketing and advertising rules
Australia's healthcare reforms

4. Australia - Prescription pharmaceutical sales analysis
Key findings
Pharmaceutical market size
Leading therapy areas
Leading prescription pharmaceutical brands
Leading pharmaceutical companies
Pharmaceutical market size in Australia
Leading therapy areas in Australia
Cardiovascular drugs hold the largest share of the Australian market value
Central nervous system products hold the second-largest share of the Australian market value
Musculoskeletal drugs exhibited the strongest growth in sales in 2005-09 and 2008-09
The hematology class experienced the most rapid decline in growth
Leading pharmaceutical brands in Australia
Lipitor achieved by far the highest sales in Australia in 2009, but generics are expected in 2012
Crestor experiences a huge uptake in sales but may face price cuts and uncertain patent protection
Nexium's sales are going strong despite its price being linked to generic omeprazole
Leading companies in the Australian pharmaceutical market
Leading international companies active in Australia account for 63% of the pharmaceutical market
Leading Australian companies only make up 7% of the Australian pharmaceutical market
Sigma Pharmaceuticals
CSL
iNova Pharmaceuticals

5. Australia - Drug expiry analysis
Key findings
Generics market
Brand erosion post patent expiry
Biosimilars market
Australia generics market dynamics
Australia generics volume uptake
Australia generics value uptake
Drivers and resistors in the Australian generics market
Brand substitution is allowed if equivalence has been shown
Prevention of brand substitution by physicians is possible, but uncommon
Competing on price is difficult for generics manufacturers in Australia
High generics prices are targeted in continued price cuts
Pharmacists receive AUD1.50 for each script of a premium-free PBS drug they dispense
The Generic Medicines Industry Association (GMiA) unites key generics players
The National Prescribing Service (NPS) promotes generics education
Key generics players in Australia
Generic simvastatin is main single source of income for key generics players in Australia
Opportunities for the generics industry
Small molecule brand erosion in Australia
Overview of drugs analyzed
Mean level of brand erosion in Australia
Brand erosion in the Australian retail and hospital setting
Brand erosion by therapy area in Australia
Brand erosion by drug formulation in Australia
Biosimilars market dynamics in Australia
Drivers of biosimilar uptake - Australia bases its biosimilar approval pathway on that of the EU
Resistors of biosimilar uptake - limitations around reimbursement may cast a shadow over the commercial attractiveness of biosimilars in Australia
Somatropin is the only biosimilar available in Australia
Key players in the Australian biosimilars market
Monoclonal antibodies represent a major opportunity for the biosimilars industry
Over $400m in monoclonal antibody sales to go off-patent before 2015
However, branded monoclonal antibody uptake is currently hampered by reimbursement issues
International drivers and resistors to biosimilar monoclonal antibody uptake
Monoclonal antibody biosimilars in development internationally

6. Australia - Pharmaceutical industry infrastructure analysis
Key findings
Pharmaceutical industry infrastructure overview
R&D infrastructure trends
Manufacturing infrastructure trends
Overview of the pharmaceutical infrastructure in Australia
R&D and manufacturing strategies in Australia
Australia misses out as clinical trials are moved to Asia
Key company infrastructure in Australia
Pfizer
AstraZeneca
Sanofi-Aventis
GlaxoSmithKline
Novartis
Merck & Co.
Johnson & Johnson
Sigma Pharmaceuticals
Roche
Mylan

7. Bibliography
Australia - Executive Summary
Publications and online articles
Datamonitor reports and products
Australia - Socio-demographic and economic analysis
Publications and online articles
Australia - Healthcare system and drug regulatory analysis
Publications and online articles
Datamonitor reports and products
Australia - Prescription pharmaceutical sales analysis
Publications and online articles
Australia - Drug expiry analysis
Publications and online articles
Datamonitor reports and products
Australia - Pharmaceutical industry infrastructure analysis
Publications and online articles

APPENDIX
Exchange rate used in this report
Australia brand erosion - additional data
Australia brand erosion - methodology
Datamonitor prescription pharmaceutical definition and therapy area classification
About Datamonitor
About Datamonitor Healthcare
Datamonitor consulting
Disclaimer
Disclaimer

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