Forecast Insight: Osteoarthritis - The Cox-2 Pipeline Collapses

Provides Analysis of Recent Events in The Osteoarthritis Disease Area and Their Impact on The Market. Includes An Event-Based, Indication-Specific Ten Year Forecast of Both Pipeline and Marketed Products to 2017 in The Seven

Publication Date	May 2008
Publisher	Datamonitor
Product Type	Report
Pages	71
ISBN Number	not applicable
Product Code	DAT11829

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Summary

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.

Scope

This report gives a strategic analysis of the likely impact that recent events will have on the osteoarthritis market Includes osteoarthritis-specific and total brand sales forecasts for the key brands in the seven major markets to 2017 This report provides a global market snapshot by including osteoarthritis-specific sales analysis for leading brands outside the seven major markets This report includes updated forecasts of nearly 130 currently marketed products and reassesses pipeline product launch dates and sales forecasts

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.

Reasons to Purchase

Quantify the current size of the seven major markets and the trends in the rest of the world Understand when late-stage pipeline products will launch and what impact this will have on the market during the forecast period 2007 to 2017 Assess the impact of events, such as patent expiries, on the osteoarthritis-specific sales of key brand name products.

Content

about Datamonitor Healthcare
- about the Immunology and Inflammation (I&I) pharmaceutical analysis team
Chapter 1 Executive Summary
- Datamonitor insight into the osteoarthritis market
- Related reports
Chapter 2 Market Definition and Overview
- Market definition for this report
- Current seven major market assessment
- The osteoarthritis market totaled nearly $4 billion in 2007
- after three years of decline, osteoarthritis sales increased 0.8% from 2006 to 2007
- US remained the largest osteoarthritis market in 2007, despite the sharpest decline in sales compared to other major markets
- Rest of world snapshot
- Key brand comparison between the 7MM and rest of the world
- Expensive brands show strong sales in Canada, Australia and the EU, but Brazil and Mexico offer growth opportunity
- Future seven major market assessment
- Comparison with previous forecast
- The major change occurs in the COX-2 class
- Osteoarthritis market will grow to reach sales of $5.5 billion in 2017
- Osteoarthritis accounts for 15% on average of total branded values
- Forecast data tables
Chapter 3 Brand Dynamics
- Overview of Competitive Landscape
  - Pfizer's Celebrex was the leading drug for osteoarthritis in 2007
  - COX-2
  - Celebrex (celecoxib)
  - Celebrex's 7MM sales rise in the near-term but decline beginning in 2011 as pipeline agents followed by generic celecoxib enter the market
  - Patent covering Celebrex in the US enforceable until 2014
  - Generic versions of Celebrex will not be available until 2019 in Japan
  - Arcoxia (etoricoxib)
  - Arcoxia performed well in the EU markets from 2004 to 2007
  - Non-approvable in the US
  - EU patent covering Arcoxia expires in 2017
  - Prexige (lumiracoxib)
  - Prexige's marketing authorization withdrawn in multiple regions
  - Non-approvable in the US
  - Prexige will not be launched in Japan
  - GW-406381
  - GlaxoSmithKline's GW-406381 removed from Datamonitor's forecast
  - LAS-34475
  - Almirall's LAS-34475 removed from Datamonitor's forecast
  - Traditional NSAIDs
  - Mobic (meloxicam)
  - Impact of Mobic patent expiry in the US and five major EU markets
  - Generic meloxicam yet to enter Japan
  - Naproxcinod
  - Phase III program will conclude by the end of 2008
  - Datamonitor has pushed back Naproxcinod's launch date in the US and EU to Q3 2010
  - Datamonitor has upgraded its forecast for naproxcinod
  - Diractin (IDEA-033)
  - Updated launch date in the EU for 2008
  - Diractin outlicensed to Alpharma and US launch updated for 2011
  - Potential for Diractin in Japan
  - Licofelone
  - Licofelone pulled from Datamonitor's forecast
  - PN-400 (naproxen + esomeprazole)
  - PN-400 added to forecast update
  - Non-narcotic analgesics
  - Zucapsaicin
  - Zucapsaicin was removed from the forecast update
  - Narcotic analgesics
  - Fentora (fentanyl)
  - FDA advisory panel votes against use of Fentora in non-cancer breakthrough pain
  - Corticosteroids
  - CRx-102 (prednisolone + dipyridamole)
  - Long-term safety concerns an issue with CRx-102
  - Hyaluronic acids
  - Synvisc (Hylan GF-20)
  - Filed in Japan and launch expected in 2009
  - Synvisc-One (Hylan GF-20)
  - Single injection Synvisc-One granted EU approval
  - US approval of Synvisc-One expected late in 2008
- Bibliography
  - References
  - Websites
  - Datamonitor reports
Appendix
- Contributing experts
- Methodology
- Indication split calculations
- Assumptions and caveats for diagnosis value estimates
- Generic erosion and pricing assumptions
- about Datamonitor
- about Datamonitor Healthcare
- Datamonitor Healthcare's research and analysis methodologies
- Datamonitor Healthcare's therapy area capabilities
- Disclaimer
List of Tables
- Table 1: Datamonitor's definition of osteoarthritis by ICD-10 code
- Table 2: Leading branded drug sales ($m) for osteoarthritis in the 7MM, and the Rest of World (ROW), 2007
- Table 3: Osteoarthritis-specific sales forecasts for the 7MM ($m), 2007-2017
- Table 4: Leading branded drug sales ($m) for osteoarthritis in the 7MM, 2007-2017
- Table 5: Key products in the late-stage R&D pipeline for osteoarthritis, 2007
- Table 6: Osteoarthritis-specific sales ($m) of Celebrex (celecoxib) in each of the 7MM, 2004-07
- Table 7: Osteoarthritis-specific sales ($m) of Arcoxia (etoricoxib) in Germany, Italy, Spain and the UK, 2004-07
- Table 8: Brand erosion of Mobic (meloxicam) following first generic entrant, by quarter, in US, France, Germany, Italy, Spain and the UK
- Table 9: Naproxcinod: Phase III program for osteoarthritis
- Table 10: Datamonitor's definition of osteoarthritis by ICD-10 code
List of Figures
- Figure 1: Osteoarthritis sales in the US, 5EU and Japan, 2004-07
- Figure 2: Key events impacting the osteoarthritis market, 2004-08
- Figure 3: Osteoarthritis market sales by class in the 7MM, 2004-07
- Figure 4: Sales performance of the US, 5EU and Japan osteoarthritis markets, 2006-07
- Figure 5: Comparison of COX-2 class forecasts in the 7MM, 2005-2017
- Figure 6: Osteoarthritis sales by class in the 7MM, 2007-2017
- Figure 7: Impact of key events on the osteoarthritis market, 2007-2017
- Figure 8: Market share of drug classes for osteoarthritis, 2007 vs. 2017
- Figure 9: Total market forecast for osteoarthritis and all other indication sales, split by indication in the 7MM, 2007-2017
- Figure 10: Osteoarthritis-specific sales ($m) forecast for Celebrex in the seven major markets, 2007-2017
- Figure 11: Osteoarthritis-specific sales ($m) forecast for Arcoxia in the EU markets, 2007-2017
- Figure 12: Brand erosion of Mobic (meloxicam) in US, France, Germany, Italy, Spain and the UK
- Figure 13: Datamonitor's 2006 and updated sales ($m) forecast for NicOx's naproxcinod in the 7MM, 2007-2017
- Figure 14: Datamonitor's 2006 and updated sales ($m) forecast for Idea's Diractin (IDEA-033) in the 7MM, 2007-2017
- Figure 15: Datamonitor's sales ($m) forecast for Pozen's PN-400 in the 7MM, 2007-2017
- Figure 16: Datamonitor's osteoarthritis-specific sales ($m) forecast for Genzyme's Synvisc in the 7MM, 2007-17