Commercial Insight: Pain Market Overview - Non-traditional analgesics and opioid reformulations to sustain sector growth
Introduction
Scope
Highlights
Reasons to Purchase
Table of Contents
| ABOUT DATAMONITOR HEALTHCARE 2 About the Central Nervous System pharmaceutical analysis team 2 CHAPTER 1 EXECUTIVE SUMMARY 3 Strategic scoping and focus 3 Datamonitor insight into the disease market 3 Related reports 5 Upcoming related reports 6 CHAPTER 2 MARKET DEFINITION 8 Market definition for this report 8 Disease definition 9 Overview of pain-drug classes 10 M1A - Non-steroidal anti-inflammatory drugs (NSAIDs) 10 N1A - General anesthetics 11 N1B - Local anesthetics 11 N2A - Narcotic analgesics 11 N2B - Non-narcotic analgesics 12 Non-traditional analgesics 12 CHAPTER 3 MARKET OVERVIEW 13 Current market assessment 14 Sales by region 14 Pain market totaled $24.3 billion in 2007 14 5EU was the key growth market for pain in 2004-07 14 Pain market is a huge volume market 16 Despite recording negative sales value growth, the US pain market increased by volume 18 Sales by class 19 N2A Narcotic analgesic class accounts for the largest proportion of the pain market value 19 N2B Non-narcotic analgesic class accounts for over half of all pain market prescription volume 20 Sales by hospital or retail 22 France and Italy have the greatest proportion of sales originating from the hospital sector 22 General anesthetics sales originate predominantly from the hospital setting 23 Sales by branded and unbranded drugs 24 Unbranded drugs have accounted for the majority of the pain market value since 2005 24 Japan pain market is by far the least genericized 26 Unbranded products dominate the traditional analgesic classes 27 Sales by delivery method 28 Sales of solid oral products dominate pain-drug prescriptions 28 Higher priced parenteral and 'other' systemic formulations account for a greater proportion of the pain market sales value 29 Rest of World snapshot 31 Current market assessment 31 Rest of the world pain market is growing faster than the seven major markets 31 Rest of world is larger than the combined 5EU and Japan regions and accounts for one-third of total global pain market by value 32 Canada represents the largest of the small and emerging pain markets, Brazil is a close second 33 In South America, Brazil, Peru and Venezuela are all growing at over 20% a year 34 With retail sales only, China represents the strongest growing Pacific Rim pain market over 2004-07 35 Future market assessment 36 Sales by region 36 The US will be more susceptible to growth deviations as the 5EU market is expected to show steady yearly growth 36 Sales by class 38 Market to maintain recent positive turnaround in sales 38 Non-traditional analgesic class to claim a greater share of the pain market 40 CHAPTER 4 OPPORTUNITIES AND THREATS 42 Pain market opportunities 42 Underserved pain indications continue to provide significant opportunities 42 Fibromyalgia - FDA approvals further validate condition but misdiagnosis remains an issue 42 Neuropathic pain - improved efficacy rather than side-effect profile is key to driving commercial success 43 Cancer pain - variety of co-morbidities and types of pain experienced leave room for great treatment improvement 43 Breakthrough pain in non-malignant diseases 48 Back pain 51 Opportunities exist for reformulations in the mature opioids market 54 Requirement for anti-abuse technologies sees the US FDA designating two recently filed NDAs with priority reviews 54 Rapid-onset developments focus on fentanyl 55 Non-traditional analgesic classes 56 Physicians are now turning to alternative analgesics amid concerns over NSAID and opioid use 56 Pain market threats 56 Stigma attached to opioid abuse should not influence guidelines in such a way that restricts access 56 State pain policies must value opioid effectiveness 56 Pharmacovigilance requirements leads to more rigorous post-marketing regulations 57 Risk Evaluation and Mitigation Strategy (REMS) safety plan deemed essential for certain FDA approved fentanyl products 57 Cephalon asked to address Fentora risk management program before potential approval for non-cancer breakthrough pain 58 CHAPTER 5 BRAND DYNAMICS 59 Overview of competitive landscape 59 Leading 10 brands in the pain market 59 Celebrex and OxyContin - only pain brands to achieve blockbuster status in 2007 59 Duragesic and Actiq - two branded fentanyl formulations succumb to genericization 61 Lyrica and Cymbalta - non-traditional analgesic brands show strongest 4-year growth 62 Marketing strategies for the leading brands 63 Promotional spend 64 Sponsorship and public awareness campaigns 65 Direct-to-consumer advertising 66 M1A class leader: Celebrex (celecoxib, Pfizer) 66 Drug profile 66 Celebrex sales are largely derived from the US market 68 Increased promotional efforts in the US sees sales rebound 69 Celebrex reserved for second-line osteoarthritis therapy after acetaminophen or a topical NSAID 69 SWOT analysis 70 Strengths - broad indication coverage and US patent protection to drive mid-term sales growth 70 Weaknesses - cardiovascular warnings on label document potential risks with Celebrex use 71 Opportunities - Japanese launch opens up new market opportunities 71 Threats - pipeline drugs to provide major market threat 71 N1A class leader: Sevorane (sevoflurane, Abbott) 71 Drug profile 71 Availability of Baxter's generic sevoflurane versions results in declining yearly sales 72 SWOT analysis 73 Strengths - remains inhaled general anesthetic gold standard after more than 15 years on the market 73 Weaknesses - level of genericization will increase with major patents expired 74 N1B class leader: Lidoderm (lidocaine 5% patch, Endo) 74 Drug profile 74 2007 European roll-out comes 8 years after US launch 74 SWOT analysis 76 Strengths - remains first and only of its kind resulting in strong brand loyalty 76 Weaknesses - although rare and mild in nature Lidoderm can cause local allergic reactions 76 Opportunities - EU launch as Versatis should maintain strong historical sales growth 77 Threats - uncertainty over strength of US patents could see challengers emerge 77 N2A class leader: OxyContin (oxycodone HCl controlled-release, Purdue) 77 Drug profile 77 Extensive genericization has hit sales over the last 4 years 79 SWOT analysis 80 Strengths - Purdue has successfully reinstated OxyContin's key patents 80 Weaknesses - abuse potential limits OxyContin's patient potential 80 Opportunities - launch of new dosages provides more options for abuse-prone patients 81 Threats - imminent launch of abuse deterrent oxycodone formulations will pressurize OxyContin 81 N2B class leader: Efferalgan (acetaminophen, Bristol-Myers Squibb) 82 Drug profile 82 Non-traditional analgesic class leader: Lyrica (pregabalin, Pfizer) 82 Drug profile 82 Sales from pain indications accounted for over 60% of Lyrica's 2007 total 83 SWOT analysis 84 Strengths - broad neuropathic pain indications and most recent fibromyalgia approval to drive future growth 84 Weaknesses - Schedule V classification increases complexity of prescribing 85 Opportunities - Lyrica has yet to be launched in Japan 85 Threats - approval of additional drugs for fibromyalgia will provide stiff competition in this young and growing market 86 CHAPTER 6 KEY DEVELOPERS 87 Strategic overview 87 Despite a significant decline in its franchise, Pfizer continues be the driving force in the pain market 87 Generics companies have prospered in the pain market 88 Trends in corporate strategy 89 Only half of the leading 10 pain market companies are actively looking to further enhance their pain franchise offerings 90 Big Pharma seeks out novel developments while specialist companies focus on reformulations 91 Recent strategic partnerships/deals 91 Licensing deals will remain an important strategy to companies of all sizes in the pain market 91 Big Pharma market leader - Pfizer 93 Unearthing unchartered pain indications continues to reap rewards 93 Increased Celebrex investment set to drive future growth 94 Pfizer - the pioneer in neuropathic pain and now fibromyalgia 95 Pfizer identifies pain to be a 'high-potential disease area' 96 Late-stage developments show desire to maintain investment in well-established pain franchise 97 Specialist pain company - Endo 97 Endo prospers on Lidoderm's success 97 Recently established Opana franchise set for steady growth 99 Research and development review sees Endo discontinue development of two late-stage pain products 100 In-licensing remains key in Endo's refocused pipeline 100 Leading generics company presence - Teva 101 The exploitation of major pain brands proves a lucrative strategy for Teva 101 Reinstated OxyContin patent to hurt Teva from 2008 102 Challenges to Celebrex's patents appear to be unsuccessful 103 Key emerging companies - King Pharmaceuticals and Pain Therapeutics 104 Strategic alliance plays a significant part in King Pharmaceuticals and Pain Therapeutics emergence as key players in the pain market 104 Partnership marries drug development capabilities with commercial expertise 104 Remoxy's anti-abuse potential to fulfill a significant market opportunity 104 Potential Alpharma takeover shows King Pharmaceuticals's intention to further shift focus to the pain market 105 Oxytrex shows Pain Therapeutics' development strength and provides another strong out-licensing opportunity 106 BIBLIOGRAPHY 107 Journal papers 107 Websites 110 Datamonitor reports 114 APPENDIX A - MARKET ASSUMPTIONS 115 Data definitions, limitations and assumptions 115 Standard units 115 Japanese market data 115 Rest of World 115 Forecast methodology 116 Important information specifically for this report 116 APPENDIX B 117 Report methodology 117 About Datamonitor 118 About Datamonitor Healthcare 118 About the central nervous system analysis team 119 Disclaimer 120 List of Tables Table 1: Pain market sales value by region ($m) across the seven major markets (7MM), 2004-07 14 Table 2: Pain market sales volume by region ($m) across the seven major markets, 2004-07 17 Table 3: Pain market sales value by class across the seven major markets ($m), 2004-07 19 Table 4: Pain market sales volume by class across the seven major markets ($m), 2004-07 21 Table 5: Summary of opportunities and threats in the seven major market pain market, 2008 42 Table 6: Epidemiology surveys of cancer pain 45 Table 7: Epidemiology surveys of breakthrough pain in cancer patients 49 Table 8: Epidemiology surveys of low back pain 52 Table 9: Top 10 pain brands by seven major market revenues ($m), 2004-07 61 Table 10: Marketing strategies employed by the companies behind the top three pain market brands, 2008 64 Table 11: Celebrex - Drug profile, 2008 67 Table 12: Sevorane - Drug profile, 2008 72 Table 13: Lidoderm - Drug profile, 2008 75 Table 14: OxyContin - Drug profile, 2008 78 Table 15: Lyrica - Drug profile, 2008 83 Table 16: Top 10 pain market companies by seven major market revenues ($m), 2004-07 87 Table 17: Strategic importance of pain market drugs to the leading pain market companies, 2008 90 Table 18: Key strategic deals and events in the pain market, 2008 92 Table 19: Pfizer's pain market portfolio overview, 2004-07 94 Table 20: Pfizer's late-stage (Phase II onwards) pain pipeline, 2008 96 Table 21: Endo's pain market portfolio overview, 2004-07 98 Table 22: Endo's pain pipeline, 2008 101 Table 23: Teva's pain drug portfolio overview, 2004-07 102 List of Figures Figure 1: Pain market sales value in the US, 5EU and Japan ($ billion), 2004-07 15 Figure 2: Sales value performance of the US, 5EU and Japan pain markets ($m), 2004-07 16 Figure 3: Pain market sales volume in the US, 5EU and Japan (IMS standard units [SUs] sold), 2004-07 17 Figure 4: Sales volume performance of the US, 5EU and Japan pain markets (IMS standard units [SUs] sold), 2004-07 18 Figure 5: Sales value performance of the seven major market pain market by class ($m), 2004-07 20 Figure 6: Sales volume (SUs m) performance of the seven major market pain market by class, 2004-07 21 Figure 7: Pain market volume and value sales by retail and hospital distribution channel in the US and 5EU countries, 2007 23 Figure 8: Pain market volume and value sales in terms of retail and hospital origin in the US and 5EU by class, 2007 24 Figure 9: Branded and unbranded sales value of the pain market across the seven major markets ($m), 2004-07 25 Figure 10: Branded and unbranded pain market volume and value sales in the US, 5EU and Japan, 2007 26 Figure 11: Branded and unbranded pain market volume and value sales in the seven major markets by class, 2007 27 Figure 12: Seven major market pain market sales volume (IMS standard units sold) by delivery method, 2007 29 Figure 13: Seven major market pain market sales value dynamics by delivery method, 2007 30 Figure 14: Pain market sales value ($ billion) and volume (IMS standard units [SUs]) in the rest of the world, 2004-07 31 Figure 15: Rest of World versus seven major market sales split in the pain market ($m), 2007 32 Figure 16: Sales value of the largest 10 small and emerging pain markets, 2004-07 33 Figure 17: Pain market sales value in South America ($m), 2004-07 34 Figure 18: Pain market sales value dynamics in the Pacific Rim ($m), 2004-07 35 Figure 19: Pain market historic (2004-07) and Datamonitor forecast (2008-2017) sales by region across the seven major markets 37 Figure 20: Pain market historic (2004-07) and Datamonitor forecast (2008-2017) sales by class across the seven major market 39 Figure 21: Market value share of pain market drug classes in the seven major markets ($ billion), 2007 versus 2017 40 Figure 22: Top 10 pain brands by seven major market revenues ($m), 2007 60 Figure 23: Sales value dynamics of the top 10 pain brands by seven major market revenues ($m), 2004-07 63 Figure 24: US and 5EU promotional spend for the top 10 pain market brands, 2007 65 Figure 25: Seven major market sales revenues for 2007's leading M1A - NSAID class brands, 2004-07 68 Figure 26: Celebrex seven major market revenues ($m), 2007 69 Figure 27: Sevorane seven major market sales revenue versus generics ($m), 2004-07 73 Figure 28: Seven major market Oxycodone HCl extended-release sales value ($m) by brand (OxyContin) and generics versus total molecule sales volume (SUs), 2004-07 79 Figure 29: Seven major market Lyrica sales split by sector - pain market versus total other sales, 2004-07 84 Figure 30: Sales value dynamics of the top 10 pain market companies by seven major market revenues ($m), 2004-07 88 |
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