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Forecast Insight: Osteoarthritis - The COX-2 Pipeline Collapses

Published by: Datamonitor

Published: May. 23, 2008


Table of Contents


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Prexige's marketing authorization withdrawn in multiple regions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

Abstract

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


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