Commercial Insight: Osteoarthritis

Summary

Introduction

The 2004 withdrawal of Vioxx from the global market had a negative effect on the COX-2 class, with a 44% fall in Celebrex sales for osteoarthritis in 2005. However, as patients sought an alternative to the COX-2s, there was positive growth in traditional NSAIDs, non-narcotic analgesics, narcotic analgesics, corticosteroids and HA viscosupplements, leading to a 1.1% increase in total market value.

Scope

• Sales and volume forecasts for the leading osteoarthritis therapies to 2015, calculated for the osteoarthritis indication alone
• Assessment of current and future opportunities and threats in the osteoarthritis market across the seven major pharmaceutical markets
• Key events that may affect revenues are applied and discussed for each of the seven major pharmaceutical markets.
• Case studies outline future strategies companies will use for advertising and marketing COX-2 inhibitors and the factors behind the success of Synvisc

Highlights

The osteoarthritis market is forecast to grow steadily, and will reach $7 billion by 2015. Growth comes from expanded use of hyaluronic acids and pipeline products launches. Despite competition from COX-2s such as Prexige and Arcoxia, Pfizer's Celebrex to remain the leading brand until patent expiry in 2014.

After the withdrawal of Vioxx over CV safety fears, Merck was criticized for its heavy marketing campaign. Companies should target their products to specific populations rather than the population as a whole, shift to eSampling and continue to conduct large-scale safety studies.

Synvisc sales will reach $300 million by 2015. Indication expansions in the US and EU, and launch in Japan, will drive sales. Future opportunities in the HA market will come from the development of single injection products. The EU markets show good opportunity for HAs with the highest growth.

Reasons to Purchase

• Assess the impact of events such as patent expiries and indication expansion on the osteoarthritis sales of key brand name products
• Quantify the future size of the market, in terms of volume and value, for the osteoarthritis indication in each of the seven major markets
• Understand strategies that pharmaceutical companies will use to market COX-2s in the future

Contents

• Chapter 1 Executive Summary
  • Objective of the analysis
  • Datamonitor insight into the osteoarthritis market
• Chapter 2 Market Definition And Overview
  • Market definition for this report
  • The Japanese market
  • The market value is calculated using IMS diagnosis value
  • Current market situation
  • Despite the withdrawal of Merck's Vioxx from the global market, the OA market rose by 1.1% from 2004 to 2005
  • The US saw negative growth between 2004 and 2005, but remains the largest overall market for OA
  • Mobic showed the greatest increase in sales revenue in the seven major markets between 2004 and 2005
  • Strategic scoping and focus
• Chapter 3 Country Market Assessments
  • Global opportunities and threats
  • Global Opportunities
  • The overall aging global population will increase the OA patient population
  • Increasing levels of obesity across the seven major markets will lead to a rise in the number of cases of symptomatic OA
  • DMOADs provide the biggest opportunity to OA sufferers and to pharmaceutical companies, but currently elude the market
  • Global Threats
  • Pharmacovigilance is leading to more stringent post-marketing regulations
  • US: opportunities and threats
  • US Market overview
  • US Opportunities
  • The number of over 65 year olds is forecast to increase as the 'baby boom' generation reaches retirement
  • Medicare Part D reforms will provide a short-term boost, but in the longer term the impact is less certain
  • US Threats
  • The Medicare 'doughnut hole' could result in a surge of parallel imports
  • Disclosure of clinical trial results could become mandatory
  • Increased scrutiny of DTC advertising due to COX-2 withdrawals
  • Japan: opportunities and threats
  • Japan Market overview
  • Japan Opportunities
  • Is there an opportunity for COX-2 inhibitors in the Japanese market?
  • Separation of manufacturing and marketing entities benefits both Japanese and foreign companies
  • Fewer outsourcing restrictions enhances manufacturing efficiency
  • Japan Threats
  • The Japanese market is expected to experience a significant increase in generic usage
  • Flat-sum reimbursement discourages physicians from prescribing highly priced medicines
  • 5EU: opportunities and threats
  • EU Market overview
  • EU Opportunities
  • Review of OA treatment by NICE in the UK
  • In France and Italy, innovative drug development is encouraged by price premium and high-level reimbursement
  • In Germany, the free pricing system and culture of innovation encourages novel drug development
  • New fast track drug assessment process speeds up time between licensing and NICE recommendations in the UK
  • Planned electronic prescribing in Spain will improve access to treatments and promote the rational use of drugs
  • EU Threats
  • The NHS is unreceptive to new treatments compared to the rest of Europe
  • Government awareness campaign promotes generic use in Spain
  • New EU states may lead to a flood of cheaper drug exports
  • Pharmaceutical price cuts continue in Spain and are planned for Italy
  • national Health insurer allowed greater powers to decrease expensive prescribing in Germany
  • Summary of environmental issues affecting OA market size
• Chapter 4 Forecast Analysis
  • Key events
  • New Product Launches
  • The launch of a number of COX-2 inhibitors will see an increase in the competition against market leader Celebrex
  • Could naproxcinod and licofelone prove to be viable alternatives to COX-2s?
• Idea-033
  • Side effects and competition from other capsaicin creams will limit the commercial opportunities of zucapsaicin as a treatment for OA
  • Impact of COX-2 and NSAID product launches on market leader Celebrex
  • CRx-102 is a good treatment concept but this may not be reflected in market uptake
  • Major Clinical Trials
  • Does the MEDAL program go far enough to secure approval for Merck's Arcoxia in the US?
  • Additional Indications
  • Label expansion for Synvisc will help drive future sales
  • Patent Expiries
  • Mobic
  • Arthrotec
  • Celebrex
  • Synvisc
  • Product launches in Japan
  • Celebrex will be the first COX-2 launched in Japan for OA
  • Synvisc will have to compete with Artz and Suvenyl when it is launched in Japan
  • Data definitions, limitations and assumptions
  • Standard Units
  • Japanese Market Data
  • Derivation of Sales Forecasts and Pricing Trends
  • Drug pricing and genericization assumptions
  • Forecast methodology
• Chapter 5 Commercial Impact And Lifecycle Management: Case Studies
  • Introduction
  • Case Study 1: Marketing and advertising strategy. How should companies advertise and promote COX-2s post-Vioxx?
  • Analysis of DTC advertising
  • Pharmaceutical companies use many methods to promote their products to patients and to physicians
  • Spending on DTC advertising surged in 1997 after the FDA relaxed its regulatory guidelines
  • Vioxx was the most heavily DTC advertised drug in 2000
  • Merck and Pfizer ran aggressive advertising campaigns for Vioxx and Celebrex, respectively
  • DTC advertising underwent considerable review in 2005
  • The future of DTC advertising
  • The US will soon be the only country in the world where DTC advertising is legal
  • It would be very inadvisable for Merck to go to the same lengths for Arcoxia as it did for Vioxx
  • Pfizer has cut almost 20% of its sales force but will maintain strong support for Celebrex
  • What will be the future strategies used by pharmaceutical companies to market COX-2s?
  • Case Study 2: Product differentiation. Synvisc and Hyaluronic acids
  • Intra-articular HA viscosupplements
  • HA viscosupplements are designed to replace synovial fluid in joints affected by OA
  • Despite variability in reported efficacy, HA viscosupplements have a definite place in the treatment of OA
  • The US and Japan are the largest markets for HA viscosupplements
  • Growth in the HA market has been higher in the EU than in the US and Japan
  • There are many brands of HA viscosupplement available throughout the seven major markets
  • The Japanese HA market is dominated by Artz
  • Synvisc is the most popular HA viscosupplement in the US, which is reflected by high sales revenues
  • Further indication expansion of HA viscosupplements may be limited by the size and accessibility of the affected joint
  • Future direction for HA viscosupplements
  • Companies should focus on developing single injection HA viscosupplements
  • Strong growth in the EU markets indicates good potential for future HA products
• Appendix A – Major Brand Key Facts
  • Major brand key facts
  • COX-2 market data
  • Celebrex (celecoxib)
  • Arcoxia (etoricoxib)
  • NSAID market data
  • Mobic (meloxicam)
  • Voltaren (diclofenac)
  • Arthrotec (diclofenac + misoprostol)
  • Aleve (naproxen)
  • Analgesic market data
  • Tramal (tramadol)
  • Hyaluronic acid market data
  • Synvisc (hylan G-F 20)
• Appendix B – Market Forecast Data Tables
  • US
  • Japan
  • France
  • Germany
  • Italy
  • Spain
  • UK
• Appendix C
  • Bibliography
  • References
  • Websites
  • Datamonitor reports
  • Report methodology
  • Contributing experts
  • About Datamonitor
  • About Datamonitor Healthcare
  • About the CNS, Arthritis and Pain analysis team
  • Disclaimer