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Published by: Datamonitor
Published: Oct. 20, 2009 - 154 Pages
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Cardiovascular and Metabolic pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Strategic scoping and focus
- Datamonitor insight into the disease market
- Related reports
- Upcoming related reports
- CHAPTER 2 MARKET DEFINITION
- Market definition for this report
- CHAPTER 3 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
- There are over 1 million people with diabetes in Australia
- The increase of obesity in Australia is linked to a surge in type 2 diabetes
- Physical inactivity as a risk factor for type 2 diabetes
- The impact of Australia's aging population on the prevalence of type 2 diabetes
- 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
- CHAPTER 4 BRAND DYNAMICS
- Overview of competitive landscape
- Patient acquisition process
- Patient care paths
- Points of influence in the patient care path
- Trigger point 1: ensure high-risk individuals are screened
- Trigger point 2: promote use of metformin straight after diagnosis
- Trigger point 3: influence initial choice of oral hypoglycemic agent
- Trigger point 4: impact switching decisions
- Trigger point 5: influence choice of insulin treatment
- Treatment guidelines
- Australian formulary status
- Actos (pioglitazone; Takeda/Eli Lilly)
- Drug profile
- Product positioning
- SWOT analysis
- Brand forecast to 2018
- Scare around Avandia will continue to contribute to Actos's sales
- Positive results from the PPAR trial would add further support to Actos's competitive profile
- The launch of Actoplus Met will boost Actos's franchise
- The launch of generics will greatly impact Actos's revenues from 2011 onwards
- The launch of novel drug classes will significantly slow down growth in sales over the next decade
- Januvia (sitagliptin; Merck & Co)
- Drug profile
- Product positioning
- SWOT analysis
- Brand forecast to 2018
- Approval and reimbursement of further indications would give revenues a boost
- Positive clinical trial outcomes would help to build Januvia's profile
- The launch of a sitagliptin/pioglitazone fixed-dose combination in Australia will strengthen the sitagliptin franchise
- Avandia safety scare led some physicians to switch to Januvia
- Novel dipeptidyl peptidase-IV inhibitors coming to market will significantly slow down growth in Januvia sales over the next decade
- Launch of saxagliptin/metformin fixed-dose combination will impact Janumet's sales
- Byetta (exenatide; Amylin/Eli Lilly)
- Drug profile
- Product positioning
- SWOT analysis
- Brand forecast to 2018
- Positive outcome of pricing negotiations will be essential for improved uptake of Byetta
- The launch of once-daily glucagon-like peptide-1 agonists will significantly slow Byetta's growth in sales over the next decade
- Once-weekly glucagon-like peptide-1 agonists will dominate their class
- Lantus (insulin glargine; Sanofi-Aventis)
- Drug profile
- Product positioning
- SWOT analysis
- Brand forecast to 2018
- Brand loyalty will protect Lantus from main competitor Levemir, despite a number of new clinical trials
- Cancer safety scare predicted to have minimal impact
- NovoRapid (insulin aspart; Novo Nordisk)
- Drug profile
- Product positioning
- SWOT analysis
- Brand forecast to 2018
- Number of clinical trials aim to shift even more patients to NovoRapid
- CHAPTER 5 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
- Reference pricing method is mainly used for products in Formulary 1
- Cost Plus method is mainly used for products in Formulary 2
- 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
- About Datamonitor
- About Datamonitor Healthcare
- About the Cardiovascular and Metabolic pharmaceutical analysis team
- Disclaimer
- List of Tables
- Table 1: Sales and growth of antidiabetics in Australia by class, 2008 and 2018
- Table 2: Prevalence estimates of diabetes mellitus (type 1 and 2) in Australia and the seven major markets, 2007
- Table 3: Prevalence of known diabetes mellitus and newly diagnosed diabetes mellitus by age and sex in Australia, 1999-2000
- Table 4: Summary of opportunities and threats in the antidiabetics market in Australia, 2009
- Table 5: Sales forecasts of antidiabetics in Australia ($m), 2008-2018
- Table 6: Formulary status in Australia for leading antidiabetic therapies, 2009
- Table 7: Actos (pioglitazone) - Drug profile, 2009
- Table 8: Impacting factors on the revenues of Actos in Australia, 2008-2018
- Table 9: Januvia (sitagliptin) - Drug profile, 2009
- Table 10: Impacting factors on the revenues of Januvia in Australia, 2008-2018
- Table 11: Key clinical trial summary for Januvia (sitagliptin), 2009
- Table 12: Clinical profile of Januvia, Galvus and Onglyza
- Table 13: Byetta (exenatide) - Drug profile, 2009
- Table 14: Impacting factors on the revenues of Byetta in Australia, 2008-2018
- Table 15: Outcomes of the DURATION-1 and DURATION-2 trials compared with pivotal trial outcomes of Byetta, Januvia and Actos
- Table 16: Lantus (insulin glargine) - Drug profile, 2009
- Table 17: Impacting factors on the revenues of Lantus in Australia, 2008-2018
- Table 18: Key clinical trial summary for Levemir (insulin detemir),
- Table 19: Key clinical trial summary for Lantus (insulin glargine), 2009
- Table 20: NovoRapid (insulin aspart) - Drug profile, 2009
- Table 21: Impacting factors on the revenues of NovoRapid in Australia, 2008-2018
- Table 22: Key clinical trial summary for NovoRapid (insulin aspart), 2009
- Table 23: Calculation of monthly price ($) of 25 and 75 units of insulin glargine (Lantus)
- Table 24: Exchange rates from USD, 2008
- List of Figures
- Figure 1: Sales of the Australian insulin and non-insulin diabetes market, 2004-2018
- Figure 2: Indexed total insulin sales by class in Australia, 2004-08
- Figure 3: Insulin sales by class in Australia, 2008-2018
- Figure 4: Insulin sales by company in Australia, 2008-2018
- Figure 5: Indexed total non-insulin sales by type in Australia, 2004-08
- Figure 6: Non-insulin sales by class in Australia, 2008-2018
- Figure 7: Prevalence of diabetes in Australia by body mass index category, 1981 and 1999-2000
- Figure 8: Population pyramids for Australia, 2009 and 2047
- Figure 9: Changing diabetes map, 2008
- Figure 10: Projected health and residential aged care expenditure for type 1 and 2 diabetes in Australia, 2002-03 to 2032-2033
- Figure 11: Type 2 diabetes patient care path
- Figure 12: Type 1 diabetes patient care path
- Figure 13: Common one and two insulin injection regimens
- Figure 14: Treatment tree as recommended by the 2008/09 edition of the Australian Diabetes Management in General Practice guidelines
- Figure 15: Actos (pioglitazone) SWOT analysis, 2009
- Figure 16: Sales of Actos, Avandia and generics in Australia, 2008-2018
- Figure 17: Indexed volume (standard units) sold for Actos, Avandia and the total thiazolidinedione class in Australia, 2007-08
- Figure 18: Sales of Actoplus Met, Avandamet and generics in Australia, 2008-2018
- Figure 19: Januvia (sitagliptin) SWOT analysis, 2009
- Figure 20: Sales of Januvia in Australia, 2008-2018
- Figure 21: Sales of Januvia and sitagliptin/pioglitazone in Australia, 2008-2018
- Figure 22: Sales of Januvia, Galvus, Onglyza and Ondero in Australia, 2008-2018
- Figure 23: Byetta (exenatide) SWOT analysis, 2009
- Figure 24: Sales of Byetta in Australia, 2008-2018
- Figure 25: Sales of Byetta and Victoza in Australia, 2008-2018
- Figure 26: Sales of Byetta, Victoza, Byetta LAR and taspoglutide in Australia, 2008-2018
- Figure 27: Indexed sales of Lantus and Levemir and their price per standard unit in Australia, 2004-08
- Figure 28: Lantus (insulin glargine) SWOT analysis, 2009
- Figure 29: Sales of Lantus and Levemir in Australia, 2008-2018
- Figure 30: NovoRapid (insulin aspart) SWOT analysis, 2009
- Figure 31: Sales of NovoRapid, Humalog, Actrapid, Apidra and Humulin in Australia, 2008-2018
- Figure 32: Path of approval on the Australian Pharmaceutical Benefits Scheme
- Figure 33: Factors that the Australian Pharmaceutical Benefits Advisory Committee has identified as informing its decision-making
- Figure 34: Factors that the Australian Pharmaceutical Benefits Pricing Authority has identified as informing its decision-making
- Figure 35: The split between the Australian Formulary 1 (F1) and Formulary 2 (F2)
- Figure 36: Average time from ADEC recommendation to Australian PBS listing for major submissions using a cost-effectiveness analysis approach
- Figure 37: Timeline of Januvia's approvals by the FDA, EMEA and TGA
AbstractIntroduction
Datamonitor expects the Australian antidiabetics market to reach $416m by 2018. The growth will be driven by the launch of new drug classes, notably the incretin mimetics, and large growth in patient numbers. Although strongest growth is expected in the non-insulin market, the insulin market will continue to dominate, generating revenues of $224m 10 years from now.
Scope- Forecast for marketed and late-stage pipeline antidiabetic products in Australia
- Assessment of Australia-specific drivers and resistors likely to impact the market
- Future market outlook for individual products taking into account key market events, in particular patent expiry and competitor launch dates
- Case study examining the approval and reimbursement process in Australia in general and for several antidiabetics in specific
Highlights
The Australian antidiabetics market is expected to grow from $233m in 2008 to $416m in 2018 at a rate of 6% CAGR. Significant unmet needs in diabetes fuel a large pipeline. The epidemiological growth of the market, impacted by the obesity epidemic and improved diagnosis rates, is further driving the market.
In 2008, the long- and fast-acting insulin classes dominated the insulin market. This situation is not expected to change throughout the forecast period as there is very limited activity within the insulin antidiabetic pipeline and no serious challenges to the market leading therapies.
The strong market position of Avandia in 2007 has all but been destroyed by a meta-analysis published in mid-2007. Despite positive outcomes from GlaxoSmithKline's RECORD trial in 2009, the product will not regain market share before its patent expiry.
Reasons to Purchase- Identify key opportunities and threats that will impact the use and uptake of new and existing products
- Quantify the future size and scope of the Australian antidiabetics market and predict the performance of key compounds
- Understand critical success factors in growing and defending antidiabetic brand franchises from new entrants and generics
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