Commercial Insight: Opioids in Australia

Introduction

The Australian opioid market grew from $63m in 2005 to $137m in 2009. Its growth will slow considerably and the market will be worth $182m in 2019. As many new drugs to come on the market will be reformulations, Datamonitor assumes that these will be priced at a similar level as currently available brands in order to receive reimbursement. This means that the value of the market will stabilize.

Scope

*Forecast to 2019 for marketed and late-stage pipeline opioid 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 studies examining the commercial potential of anti-abuse compounds and those in development for breakthrough cancer pain.

Highlights

The controlled-release class was the highest-selling class in 2009 with sales of $115m. The fast growth of this class in recent years, particularly between 2006 and 2008, can be almost completely attributed to the uptake of two transdermal patches and the oral drug OxyContin (oxycodone; Mundipharma).

As both OxyContin (oxycodone; Mundipharma) and Durogesic (fentanyl; Janssen-Cilag) will have to battle with the entry of generics and competing products in the oral controlled-release market, Norspan (buprenorphine; Mundipharma) will become the highest-selling drug in the Australian opioid market by 2019 with sales of $34m.

While peak sales of Actiq (fentanyl; Sigma Pharmaceuticals) were over $600m in the US, 2009 sales in Australia only reached $1m. Actiq's limited listing on the Palliative Care Schedule does not only greatly limit its patient population, it also makes it more cumbersome for physicians to apply for authorizations and repeat prescriptions.

Reasons to Purchase

*Identify key opportunities and threats that will impact the Australian opioid market as a whole and key brands and pipeline products in particular.

*Quantify the future size and scope of the Australian opioid market and predict the performance of its key compounds.

*Understand critical success factors in growing and defending opioid brand franchises from new entrants and generics.

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OVERVIEW 1
Catalyst 1
Summary 1
About Datamonitor healthcare 2
About the Asia-Pacific pharmaceutical analysis team 2
About the Central Nervous System pharmaceutical analysis team 2
EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the Australian opioid market 3
Related reports 4
Upcoming related reports 5
Table of Contents 6
1. MARKET DEFINITION 7
Market definition for this report 7
2. MARKET OVERVIEW 8
The prevalence of pain in Australia 8
Current and future market overview 11
Growth of the Australian opioids market will slow down considerably 12
Controlled-release formulations will continue to dominate the market 12
Norspan will take over from OxyContin as highest-selling brand in 2019 13
Opportunities 14
High unmet needs make the opioid market attractive 14
Need to reduce the abuse and overdosing potential of opioids 14
Need to improve opioid safety and side effects 15
Need to improve short-acting opioids 17
Need to improve the treatment of cancer pain 18
The nation focuses on pain with Australia's National Pain Strategy 18
Threats 19
Pain is often not managed optimally 19
Anti-nerve growth factor (NGF) therapies may impact future sales of currently leading brands 20
3. BRAND DYNAMICS 22
Overview of competitive landscape 22
Patient acquisition process 24
Trigger point 1: physician education 25
Trigger point 2: choice of molecule, method of administration and brand 25
The regulation of opioid prescriptions in Australia 28
Several initiatives aim to clamp down on opioid abuse 29
The National Drug Strategy 29
Medicare Australia's Prescription Shopping program 30
The Royal Australasian College of Physicians' prescription opioid policy 30
Mundipharma's Quality Use of Medicines program 31
Trends in marketing strategies 31
OxyContin (oxycodone; Mundipharma) 31
Drug profile 32
Product positioning 33
2008 safety notice regarding oxycodone highlights confusion between formulations 35
SWOT analysis 35
Brand forecast to 2019 36
Launch of follow-on product Targin 37
New controlled-release drugs Jurnista and tapentadol ER will target OxyContin's patient population 37
Entry of generic controlled-release oxycodone products 38
Other key oxycodone brands 38
Endone (oxycodone; Sigma Pharmaceuticals) 38
OxyNorm (oxycodone; Mundipharma) 40
Durogesic (fentanyl patch; Janssen-Cilag) 41
Drug profile 41
Product positioning 43
SWOT analysis 45
Brand forecast to 2019 45
Entry of generic fentanyl transdermal patches 46
Other key fentanyl brands 47
Actiq (fentanyl IR; Sigma Pharmaceuticals) 47
Norspan (buprenorphine; Mundipharma) 48
Drug profile 48
Product positioning 49
SWOT analysis 51
Brand forecast to 2019 51
MS Contin (morphine CR; Mundipharma) 52
Drug profile 52
Product positioning 53
SWOT analysis 53
Brand forecast to 2019 54
New controlled-release drugs Targin, Jurnista and tapentadol ER will take market share away from MS Contin 55
Entry of generic controlled-release oxycodone products 56
Other key morphine brands 56
Kapanol (morphine CR; GlaxoSmithKline) 56
Other key molecules 58
Methadone 58
Physeptone (methadone; GlaxoSmithKline) 58
Hydromorphone 59
Dilaudid (hydromorphone; Mundipharma) 59
Codeine 61
Pethidine 61
4. PIPELINE DYNAMICS - NEW CONTROLLED-RELEASE PRODUCTS 63
Jurnista (hydromorphone; Janssen-Cilag) 63
Drug profile 64
Development overview 64
Product positioning 66
SWOT analysis 67
Drug forecast to 2019 67
Targin (oxycodone CR/naloxone; Mundipharma) 68
Drug profile 68
Development overview 68
Product positioning 69
SWOT analysis 70
Drug forecast to 2019 71
Tapentadol ER (Johnson & Johnson/Grünenthal) 73
Drug profile 73
Development overview 74
Product positioning 75
SWOT analysis 76
Drug forecast to 2019 77
5. PIPELINE DYNAMICS - NEW IMMEDIATE-RELEASE PRODUCTS 78
Nucynta (tapentadol IR; Johnson & Johnson/Grünenthal) 80
Drug profile 80
Development overview 80
Product positioning 81
SWOT analysis 82
Drug forecast to 2019 82
MoxDuo IR (oxycodone/morphine; QRxPharma) 83
Drug profile 83
Development overview 83
Product positioning 85
SWOT analysis 86
Drug forecast to 2019 86
6. CASE STUDIES 88
Commercial potential of novel drugs for breakthrough cancer pain in Australia is low 88
Uncertainty in the development of anti-abuse formulations 91
7. BIBLIOGRAPHY 95
Journal papers 95
Websites 103
Datamonitor reports 104
Press releases 104
APPENDIX A - MARKET ASSUMPTIONS 105
Forecasting assumptions 105
New product launches 105
Patent expiries 105
Pricing assumptions 106
Data definitions, limitations and assumptions 106
Standard units 106
Derivation of sales forecasts and pricing trends 106
Forecast methodology 106
Exchange rates used in this report 107
APPENDIX B 108
Contributing experts 108
Report methodology 108
About Datamonitor 108
About Datamonitor Healthcare 108
About the Central Nervous System analysis team 109
Disclaimer 111
List of Tables
Table 1: Classification of pain by pathophysiology 8
Table 2: Mixed pain classification 9
Table 3: Australia: sales and growth of opioids by molecule ($000 and %), 2009 and 2019 11
Table 4: Nerve growth factor (NGF) modulators pipeline, 2010 21
Table 5: Australia: summary of opportunities and threats in the opioid market, 2010 21
Table 6: Australia: sales forecasts of the key opioid brands($000), 2009-2019 23
Table 7: Australia: recommendations for the use of opioids in chronic nonmalignant pain in the community setting 26
Table 8: OxyContin (oxycodone) - drug profile in Australia, 2010 32
Table 9: Endone (oxycodone) - drug profile in Australia, 2010 39
Table 10: OxyNorm (oxycodone) - drug profile in Australia, 2010 40
Table 11: Durogesic (fentanyl) - drug profile in Australia, 2010 42
Table 12: Actiq (fentanyl) - drug profile in Australia, 2010 47
Table 13: Norspan (buprenorphine) - drug profile in Australia, 2010 48
Table 14: MS Contin (morphine; Mundipharma) - drug profile, in Australia 2010 53
Table 15: Kapanol (morphine) - drug profile in Australia, 2010 57
Table 16: Physeptone (methadone) - drug profile in Australia, 2010 59
Table 17: Dilaudid (hydromorphone) - drug profile in Australia, 2010 60
Table 18: Jurnista (hydromorphone; Janssen-Cilag) - drug profile in Australia, 2010 64
Table 19: Pivotal trial summary of active-controlled trials for Jurnista (hydromorphone; Janssen-Cilag) 65
Table 20: Targin (oxycodone/naloxone, Mundipharma) - drug profile in Australia, 2010 68
Table 21: Phase III trial summary of Targin (oxycodone/naloxone; Mundipharma) 69
Table 22: Tapentadol ER (Johnson & Johnson/Grünenthal) - drug profile in Australia, 2010 74
Table 23: Phase III trial summary of tapentadol ER (Johnson & Johnson/Grünenthal) 75
Table 24: Nucynta (tapentadol IR; Johnson & Johnson/Grünenthal) - drug profile in Australia, 2010 80
Table 25: Phase III trial summary of Nucynta (tapentadol IR; Johnson & Johnson/Grünenthal) 81
Table 26: MoxDuo IR (oxycodone/morphine; QRxPharma) - drug profile in Australia, 2010 83
Table 27: Phase III trial summary of MoxDuo IR (oxycodone/morphine; QRxPharma) 84
Table 28: Key fentanyl reformulations in late-stage R&D pipeline for breakthrough cancer pain, 2010 88
Table 29: Key anti-abuse products in late-stage R&D pipeline for pain, 2010 92
Table 30: New product launches in the opioid market in Australia, 2009-2019 105
Table 31: Patent expiry dates for key opioid brands in Australia, 2009-2019 105
Table 32: Pricing assumptions for key opioid pipeline products in Australia, 2009-2019 106
Table 33: Exchange rates from US dollars, 2009 107
List of Figures
Figure 1: Australia: prevalence of chronic pain by age and gender (%), 1997 10
Figure 2: Australia: total costs of chronic pain by type and bearer (%), 2007 11
Figure 3: Australia: indexed total value and volume of opioids, 2006-2019 12
Figure 4: Australia: indexed total sales of controlled-release brands, generics and novel brands, 2006-2019 13
Figure 5: Australia: performance of the top 5 opioid brands($m), 2009 versus 2019 14
Figure 6: Pain/opioid patient path, 2010 24
Figure 7: Australia: number of scripts claimed via the PBS for OxyContin by formulation and patient category, 2009 33
Figure 8: OxyContin (oxycodone; Mundipharma) - SWOT analysis in Australia, 2010 36
Figure 9: OxyContin (oxycodone; Mundipharma) sales in Australia, 2009-2019 37
Figure 10: Number of scripts claimed via the PBS for Durogesic by formulation and patient category in Australia, 2009 43
Figure 11: Standard units sold of Durogesic per quarter in Australia, 2005-2009 44
Figure 12: Durogesic (fentanyl; Janssen-Cilag) - SWOT analysis in Australia, 2010 45
Figure 13: Durogesic (fentanyl; Janssen-Cilag) sales in Australia, 2009-2019 46
Figure 14: Number of scripts claimed via the PBS for Norspan by formulation and patient category in Australia, 2009 49
Figure 15: Standard units sold and price per standard unit of Norspan and Durogesic per quarter in Australia, 2005-09 50
Figure 16: Norspan (buprenorphine; Mundipharma) - SWOT analysis in Australia, 2010 51
Figure 17: Norspan (buprenorphine; Mundipharma) sales in Australia ($m), 2009-2019 52
Figure 18: MS Contin (morphine; Mundipharma) - SWOT analysis in Australia, 2010 54
Figure 19: MS Contin (morphine; Mundipharma), Kapanol (morphine; GlaxoSmithKline) and generic controlled-release morphine sales in Australia ($m), 2009-2019 55
Figure 20: Sales of the controlled-release opioids market in Australia ($m), 2009-2019 63
Figure 21: Jurnista (hydromorphone; Janssen-Cilag) -SWOT analysis in Australia, 2010 67
Figure 22: Targin (oxycodone/naloxone; Mundipharma) - SWOT analysis in Australia, 2010 71
Figure 23: Targin (oxycodone; Mundipharma) sales in Australia, 2009-2019 73
Figure 24: Tapentadol ER (Johnson & Johnson) - SWOT analysis in Australia, 2010 77
Figure 25: Australia: sales of the immediate-release opioid market ($m), 2009-2019 79
Figure 26: Nucynta (tapentadol IR; Johnson & Johnson) - SWOT analysis in Australia, 2010 82
Figure 27: MoxDuo IR (oxycodone/morphine; QRxPharma) - SWOT analysis in Australia, 2010 86

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