Forecast Insight: Osteoarthritis -

Introduction

With several recent non-approvable decisions in the osteoarthritis market since 2006, Datamonitor has updated its forecast to account for the effect on the market. We have revised the market outlook over the next 10 years using the latest IMS data. We expect the market to grow steadily, with a CAGR from 2007 to 2017 of 3.2%, to reach sales of nearly $5.5 billion in 2017.

Report Highlights
Highlights

After three years of decline, market sales grew by 0.8% (2006-07) to reach $4 billion in the 7MM in 2007. Driving growth was an increase in sales of COX-2, non-narcotic analgesic and corticosteroid classes. Market sales will reach $5.5 billion by 2017 (3.2% CAGR) boosted by pipeline product launches, particularly NicOx's naproxcinod. Lessened side effect concern and clever marketing contributed to the rebound in Celebrex sales. Also contributing to Celebrex's reprise was the Japanese launch in June 2007. Celebrex will remain the market leading brand for osteoarthritis treatment until patent expiry in 2014, when more than 70% first year generic erosion is forecast. Arcoxia (etoricoxib) and Prexige (lumiracoxib) will not launch in the US as previously predicted. The COX-2 pipeline has collapsed with little sign of future promise. This counters the rise in Celebrex and Arcoxia sales, which show that opportunities exist, but at present regulatory requirement generates a large barrier to entry.
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TABLE OF CONTENTS
ABOUT DATAMONITOR HEALTHCARE 2
About the Immunology and Inflammation (I&I) pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Datamonitor insight into the osteoarthritis market 3
Related reports 4
CHAPTER 2 MARKET DEFINITION AND OVERVIEW 6
Market definition for this report 6
Current seven major market assessment 9
The osteoarthritis market totaled nearly $4 billion in 2007 9
After three years of decline, osteoarthritis sales increased 0.8% from 2006 to 2007 10
US remained the largest osteoarthritis market in 2007, despite the sharpest decline in sales compared to other major markets 12
Rest of world snapshot 13
Key brand comparison between the 7MM and rest of the world 13
Expensive brands show strong sales in Canada, Australia and the EU, but Brazil and Mexico offer growth opportunity 14
Future seven major market assessment 16
Comparison with previous forecast 16
The major change occurs in the COX-2 class 16
Osteoarthritis market will grow to reach sales of $5.5 billion in 2017 17
Osteoarthritis accounts for 15% on average of total branded values 20
Forecast data tables 21
CHAPTER 3 BRAND DYNAMICS 26
Overview of competitive landscape 26
Pfizer's Celebrex was the leading drug for osteoarthritis in 2007 26
COX-2 28
Celebrex (celecoxib) 28
Celebrex's 7MM sales rise in the near-term but decline beginning in 2011 as pipeline agents followed by generic celecoxib enter the market 28
Patent covering Celebrex in the US enforceable until 2014 31
Generic versions of Celebrex will not be available until 2019 in Japan 32
Arcoxia (etoricoxib) 32
Arcoxia performed well in the EU markets from 2004 to 2007 32
Non-approvable in the US 34
EU patent covering Arcoxia expires in 2017 35
Prexige (lumiracoxib) 35
Prexige's marketing authorization withdrawn in multiple regions 36
Non-approvable in the US 36
Prexige will not be launched in Japan 36
GW-406381 37
GlaxoSmithKline's GW-406381 removed from Datamonitor's forecast 37
LAS-34475 37
Almirall's LAS-34475 removed from Datamonitor's forecast 37
Traditional NSAIDs 38
Mobic (meloxicam) 38
Impact of Mobic patent expiry in the US and five major EU markets 38
Generic meloxicam yet to enter Japan 40
Naproxcinod 41
Phase III program will conclude by the end of 2008 41
Datamonitor has pushed back Naproxcinod's launch date in the US and EU to Q3 2010 43
Datamonitor has upgraded its forecast for naproxcinod 44
Diractin (IDEA-033) 46
Updated launch date in the EU for 2008 46
Diractin outlicensed to Alpharma and US launch updated for 2011 46
Potential for Diractin in Japan 48
Licofelone 48
Licofelone pulled from Datamonitor's forecast 48
PN-400 (naproxen + esomeprazole) 49
PN-400 added to forecast update 49
Non-narcotic analgesics 51
Zucapsaicin 51
Zucapsaicin was removed from the forecast update 51
Narcotic analgesics 52
Fentora (fentanyl) 52
FDA advisory panel votes against use of Fentora in non-cancer breakthrough pain 52
Corticosteroids 53
CRx-102 (prednisolone + dipyridamole) 53
Long-term safety concerns an issue with CRx-102 53
Hyaluronic acids 54
Synvisc (Hylan GF-20) 54
Filed in Japan and launch expected in 2009 54
Synvisc-One (Hylan GF-20) 54
Single injection Synvisc-One granted EU approval 54
US approval of Synvisc-One expected late in 2008 56
BIBLIOGRAPHY 57
References 57
Websites 57
Datamonitor reports 59
APPENDIX 60
Contributing experts 60
Methodology 61
Indication split calculations 61
Assumptions and caveats for diagnosis value estimates 62
Generic erosion and pricing assumptions 63
About Datamonitor 63
About Datamonitor Healthcare 64
Datamonitor Healthcare's research and analysis methodologies 65
Datamonitor Healthcare's therapy area capabilities 65
Disclaimer 67
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LIST OF TABLES
Table 1: Datamonitor's definition of osteoarthritis by ICD-10 code 8
Table 2: Leading branded drug sales ($m) for osteoarthritis in the 7MM, and the Rest of World (ROW), 2007 14
Table 3: Osteoarthritis-specific sales forecasts for the 7MM ($m), 2007-2017 22
Table 4: Leading branded drug sales ($m) for osteoarthritis in the 7MM, 2007-2017 27
Table 5: Key products in the late-stage R&D pipeline for osteoarthritis, 2007 28
Table 6: Osteoarthritis-specific sales ($m) of Celebrex (celecoxib) in each of the 7MM, 2004-07 30
Table 7: Osteoarthritis-specific sales ($m) of Arcoxia (etoricoxib) in Germany, Italy, Spain and the UK, 2004-07 33
Table 8: Brand erosion of Mobic (meloxicam) following first generic entrant, by quarter, in US, France, Germany, Italy, Spain and the UK 39
Table 9: Naproxcinod: Phase III program for osteoarthritis 42
Table 10: Datamonitor's definition of osteoarthritis by ICD-10 code 62
LIST OF FIGURES
Figure 1: Osteoarthritis sales in the US, 5EU and Japan, 2004-07 9
Figure 2: Key events impacting the osteoarthritis market, 2004-08 10
Figure 3: Osteoarthritis market sales by class in the 7MM, 2004-07 12
Figure 4: Sales performance of the US, 5EU and Japan osteoarthritis markets, 2006-07 13
Figure 5: Comparison of COX-2 class forecasts in the 7MM, 2005-2017 17
Figure 6: Osteoarthritis sales by class in the 7MM, 2007-2017 18
Figure 7: Impact of key events on the osteoarthritis market, 2007-2017 19
Figure 8: Market share of drug classes for osteoarthritis, 2007 vs. 2017 20
Figure 9: Total market forecast for osteoarthritis and all other indication sales, split by indication in the 7MM, 2007-2017 21
Figure 10: Osteoarthritis-specific sales ($m) forecast for Celebrex in the seven major markets, 2007-2017 31
Figure 11: Osteoarthritis-specific sales ($m) forecast for Arcoxia in the EU markets, 2007-2017 34
Figure 12: Brand erosion of Mobic (meloxicam) in US, France, Germany, Italy, Spain and the UK 40
Figure 13: Datamonitor's 2006 and updated sales ($m) forecast for NicOx's naproxcinod in the 7MM, 2007-2017 45
Figure 14: Datamonitor's 2006 and updated sales ($m) forecast for Idea's Diractin (IDEA-033) in the 7MM, 2007-2017 47
Figure 15: Datamonitor's sales ($m) forecast for Pozen's PN-400 in the 7MM, 2007-2017 50
Figure 16: Datamonitor's osteoarthritis-specific sales ($m) forecast for Genzyme's Synvisc in the 7MM, 2007-17 55
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