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Australia Pharmaceutical Market Overview – Reforms and continued price cuts will change the healthcare landscape now available at ReportsandReports

The prescription pharmaceutical market in Australia was valued at .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 .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 (0m). 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 ,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 (.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