Market Report Source

Overview

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.

Table of 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

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