Table of Contents
EXECUTIVE SUMMARY
- Strategic scoping and focus
- Datamonitor insight into the disease market
- Related reports
- Upcoming related reports
MARKET DEFINITION
- Market definition for this report
MARKET OVERVIEW
- Current and future market overview
- The total Australian antidiabetic market is expected to rise from $233m
in 2008 to $416m in 2018
- The current insulin market: Lantus leads both its class and the overall
insulin market in Australia
- The future insulin market: growth will eventually slow down
- The current non-insulin market: sales in thiazolidinedione class hit by
Avandia scare, but class still dominates
- The future non-insulin market: incretin mimetics will dominate
- Opportunities and threats
- Opportunities
- Diabetes prevalence in Australia will continue to rise
- The Aboriginal and Torres Strait Islander population has a higher risk
of developing diabetes
- Half of Australian diabetes patients do not reach HbA1c target of <7%
- HbA1c targets are loosened
- The Australian government subsidizes diabetes-related products
- Launch of novel compounds will replace generics and stimulate the
non-insulin market
- Dipeptidyl peptidase-IV inhibitors will move to second-line therapy
- Threats
- Health reforms aim to decrease the spending on antidiabetic drugs and
diabetes overall
- Australian government attempts to reduce overweight and obesity numbers
- High costs in the treatment of complications of diabetes further
incentivizes government to prevent increasing incidence
- Novel drugs may struggle to get on the Pharmaceutical Benefits Scheme,
as Byetta' s case shows
- Impact of biosimilars on insulins will become a threat in the future
- The Therapeutic Goods Administration may follow the US Food and Drug
Administration in its focus on cardiovascular risks
- Shift towards private insurance may translate into significant growth
opportunities for branded pharmaceuticals
BRAND DYNAMICS
- Overview of competitive landscape
- Patient acquisition process
- Patient care paths
- Points of influence in the patient care path
- Treatment guidelines
- Australian formulary status
- Actos (pioglitazone; Takeda/Eli Lilly)
- Drug profile
- Product positioning
- SWOT analysis
- Brand forecast to 2018
- Januvia (sitagliptin; Merck & Co)
- Drug profile
- Product positioning
- SWOT analysis
- Brand forecast to 2018
- Byetta (exenatide; Amylin/Eli Lilly)
- Drug profile
- Product positioning
- SWOT analysis
- Brand forecast to 2018
- Lantus (insulin glargine; Sanofi-Aventis)
- Drug profile
- Product positioning
- SWOT analysis
- Brand forecast to 2018
- NovoRapid (insulin aspart; Novo Nordisk)
- Drug profile
- Product positioning
- SWOT analysis
- Brand forecast to 2018
CASE STUDY - THE PROCESS FROM TGA APPROVAL TO PBS LISTING
- Role of the Therapeutic Goods Administration
- Reforms aim to make Therapeutic Goods Administration' s approval process
faster and more transparent
- Role of the Pharmaceutical Benefits Advisory Committee
- High level of evidence needed to show clinical and cost-effectiveness
points to a barrier of market entry
- Role of the Pharmaceutical Benefits Pricing Authority
- Reforms split the Pharmaceutical Benefits Scheme into two formularies
- Pricing methods used by the Pharmaceutical Benefits Pricing Authority
- Need for cost-effectiveness analysis slows down Pharmaceutical Benefits
Scheme listing considerably
- Byetta' s reimbursement is held up over pricing negotiations
- The difficulty lies in the number of units of insulin glargine that
Byetta should be compared with
- Possible outcomes and their impact
- Uptake Januvia is low due to limited approval and reimbursement
BIBLIOGRAPHY
- Articles
- Websites
- Press releases
APPENDIX A - THERAPEUTIC RELATIVITY SHEET FOR ANTIDIABETICS
- ATC A10 - Drugs used in diabetes (effective date: May 2009)
APPENDIX B - MARKET ASSUMPTIONS
- Data definitions, limitations and assumptions
- Standard units
- Derivation of sales forecasts and pricing trends
- Exchange rates used in this report
- Forecast methodology
APPENDIX C
- Contributing experts
- Conferences attended
- Report methodology
TABLES
- Table: Sales and growth of antidiabetics in Australia by class, 2008 and
2018
- Table: Prevalence estimates of diabetes mellitus (type 1 and 2) in
Australia and the seven major markets, 2007
- Table: Prevalence of known diabetes mellitus and newly diagnosed diabetes
mellitus by age and sex in Australia, 1999 - 2000
- Table: Summary of opportunities and threats in the antidiabetics market in
Australia, 2009
- Table: Sales forecasts of antidiabetics in Australia ($m), 2008 - 2018
- Table: Formulary status in Australia for leading antidiabetic therapies,
2009
- Table: Actos (pioglitazone) - Drug profile, 2009
- Table: Impacting factors on the revenues of Actos in Australia, 2008 - 2018
- Table: Januvia (sitagliptin) - Drug profile, 2009
- Table: Impacting factors on the revenues of Januvia in Australia, 2008 -
2018
- Table: Key clinical trial summary for Januvia (sitagliptin), 2009
- Table: Clinical profile of Januvia, Galvus and Onglyza
- Table: Byetta (exenatide) - Drug profile, 2009
- Table: Impacting factors on the revenues of Byetta in Australia, 2008 -
2018
- Table: Outcomes of the DURATION-1 and DURATION-2 trials compared with
pivotal trial outcomes of Byetta, Januvia and Actos
- Table: Lantus (insulin glargine) - Drug profile, 2009
- Table: Impacting factors on the revenues of Lantus in Australia, 2008 -
2018
- Table: Key clinical trial summary for Levemir (insulin detemir),
- Table: Key clinical trial summary for Lantus (insulin glargine), 2009
- Table: NovoRapid (insulin aspart) - Drug profile, 2009
- Table: Impacting factors on the revenues of NovoRapid in Australia, 2008 -
2018
- Table: Key clinical trial summary for NovoRapid (insulin aspart), 2009
- Table: Calculation of monthly price ($) of 25 and 75 units of insulin
glargine (Lantus)
- Table: Exchange rates from USD, 2008
FIGURES
- Figure: Sales of the Australian insulin and non-insulin diabetes market,
2004 - 2018
- Figure: Indexed total insulin sales by class in Australia, 2004 - 08
- Figure: Insulin sales by class in Australia, 2008 - 2018
- Figure: Insulin sales by company in Australia, 2008 - 2018
- Figure: Indexed total non-insulin sales by type in Australia, 2004 - 08
- Figure: Non-insulin sales by class in Australia, 2008 - 2018
- Figure: Prevalence of diabetes in Australia by body mass index category,
1981 and 1999 - 2000
- Figure: Population pyramids for Australia, 2009 and 2047
- Figure: Changing diabetes map, 2008
- Figure: Projected health and residential aged care expenditure for type 1
and 2 diabetes in Australia, 2002 - 03 to 2032 - 2033
- Figure: Type 2 diabetes patient care path
- Figure: Type 1 diabetes patient care path
- Figure: Common one and two insulin injection regimens
- Figure: Treatment tree as recommended by the 2008/09 edition of the
Australian Diabetes Management in General Practice guidelines
- Figure: Actos (pioglitazone) SWOT analysis, 2009
- Figure: Sales of Actos, Avandia and generics in Australia, 2008 - 2018
- Figure: Indexed volume (standard units) sold for Actos, Avandia and the
total thiazolidinedione class in Australia, 2007 - 08
- Figure: Sales of Actoplus Met, Avandamet and generics in Australia, 2008 -
2018
- Figure: Januvia (sitagliptin) SWOT analysis, 2009
- Figure: Sales of Januvia in Australia, 2008 - 2018
- Figure: Sales of Januvia and sitagliptin/pioglitazone in Australia, 2008 -
2018
- Figure: Sales of Januvia, Galvus, Onglyza and Ondero in Australia, 2008 -
2018
- Figure: Byetta (exenatide) SWOT analysis, 2009
- Figure: Sales of Byetta in Australia, 2008 - 2018
- Figure: Sales of Byetta and Victoza in Australia, 2008 - 2018
- Figure: Sales of Byetta, Victoza, Byetta LAR and taspoglutide in
Australia, 2008 - 2018
- Figure: Indexed sales of Lantus and Levemir and their price per standard
unit in Australia, 2004 - 08
- Figure: Lantus (insulin glargine) SWOT analysis, 2009
- Figure: Sales of Lantus and Levemir in Australia, 2008 - 2018
- Figure: NovoRapid (insulin aspart) SWOT analysis, 2009
- Figure: Sales of NovoRapid, Humalog, Actrapid, Apidra and Humulin in
Australia, 2008 - 2018
- Figure: Path of approval on the Australian Pharmaceutical Benefits Scheme
- Figure: Factors that the Australian Pharmaceutical Benefits Advisory
Committee has identified as informing its decision-making
- Figure: Factors that the Australian Pharmaceutical Benefits Pricing
Authority has identified as informing its decision-making
- Figure: The split between the Australian Formulary 1 (F1) and Formulary 2
(F2)
- Figure: Average time from ADEC recommendation to Australian PBS listing
for major submissions using a cost-effectiveness analysis approach
- Figure: Timeline of Januvia' s approvals by the FDA, EMEA and TGA
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