[Report] Osteoarthritis Market Research, Trends, Analysis TOC

ABOUT HEALTHCARE
- About the CNS, Arthritis and Pain pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
- Objective of the analysis
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
- Report methodology
- Contributing experts
  - About the CNS, Arthritis and Pain analysis team
  - Disclaimer
- List of Tables
  - Table 1:definition of OA market by ICD10 code
  - Table 2: Key players in the osteoarthritis market
  - Table 3: Incidence of OA by age group and by gender
  - Table 4: Prevalence of obesity in adults (age 15+) in the 7MM, 2005 and 2010
  - Table 5: Key late-stage pipeline products for OA, 2006
  - Table 6: Cost per standard unit for COX-2s in the UK
  - Table 7: Calculation of the $/SU of Celebrex and Arcoxia for Japan based on average historic sales in Pacific Rim from 2002 - 2005
  - Table 8: Calculation of the $/SU of Synvisc for Japan based on average historic sales in Pacific Rim from 2002 - 2005
  - Table 9: HA viscosupplements: key facts
  - Table 10: OA sufferers who present with the disease in specific parts of the body (%): US, Japan and 5EU markets, 2003
  - Table 11: Celebrex: key facts
  - Table 12: Arcoxia: key facts
  - Table 13: Mobic: key facts
  - Table 14: Voltaren: key facts
  - Table 15: Arthrotec: key facts
  - Table 16: Aleve: key facts
  - Table 17: Tramal: key facts
  - Table 18: Synvisc: key facts
  - Table 19: US OA drug sales ($, m) forecasts, 2005-15
  - Table 20: Japan OA drug sales ($, m) forecasts, 2005-15
  - Table 21: France OA drug sales ($, m) forecasts, 2005-15
  - Table 22: Germany OA drug sales ($, m) forecasts, 2005-15
  - Table 23: Italy OA drug sales ($, m) forecasts, 2005-15
  - Table 24: Spain OA drug sales ($, m) forecasts, 2005-15
  - Table 25: UK OA drug sales ($, m) forecast, 2005-15
- List of Figures
  - Figure 1: 7MM sales ($, m) of the OA drug classes, 2004-2005
  - Figure 2: Performance of the US, the five major EU and Japan OA markets, 2004-2005
  - Figure 3: OA-specific sales revenue ($, m) for key brands in the seven major markets, 2004-2005
  - Figure 4: Population growth of specific age groups: 2002-2050
  - Figure 5: The over 65 population in the seven major markets, 2005-2025
  - Figure 6: US top ten brand sales ($, m) for OA, 2005
  - Figure 7: The over 65 population (m), 1900-2030
  - Figure 8: Japan top ten brand sales ($, m) for OA, 2005
  - Figure 9: Sales ($, m) of Mobic (meloxicam) in Japan, 2002-2005
  - Figure 10: France top ten brand sales ($, m) for OA, 2005
  - Figure 11: Spain top ten brand sales ($, m) for OA, 2005
  - Figure 12: UK top ten brand sales ($, m) for OA, 2005
  - Figure 13: Italy top ten brand sales ($, m) for OA, 2005
  - Figure 14: Germany top ten brand sales ($, m) for OA, 2005
  - Figure 15: Summary of environmental factors affecting OA market size
  - Figure 16: Sales revenue ($, m) of Celebrex for OA in the 7MM, 2002-2015
  - Figure 17: Sales ($, m) of Arcoxia for OA in the five major EU markets, 2002-2015
  - Figure 18: Sales ($, m) of Synvisc and other HAs for OA in the 7MM, 2002-2015
  - Figure 19: The effect of patent expiry on the sales ($, m) of BI' s Mobic (meloxicam) for OA in the 7MM, 2002-2015
  - Figure 20: Sales ($, m) of Arthrotec (diclofenac + misoprostol) in the US and 5EU for OA, 2002-2015
  - Figure 21: Forecast sales ($, m) of Celebrex for OA in Japan, 2002-2015
  - Figure 22: Datamonitor forecasts of sales ($, m) of key HA viscosupplements for OA in Japan, 2002-2015
  - Figure 23: Methods of advertising and promoting drugs to patients and physicians
  - Figure 24: Most heavily DTC advertised drugs in 2000
  - Figure 25: Examples of DTC advertising for Vioxx
  - Figure 26: Vioxx (rofecoxib)
  - Figure 27: Examples of DTC advertising for Celebrex
  - Figure 28: Total promotional spend for Celebrex, Vioxx, Arcoxia and Mobic from 2003 to 2005
  - Figure 29: Merck ran preliminary ' taster' adverts for Arcoxia in anticipation of gaining FDA approval in October/November 2004
  - Figure 30: DTC advertising: advantages vs. disadvantages
  - Figure 31: HA viscosupplement market share (%) in the US, Japan and the five major EU (M5EU) markets, 2005
  - Figure 32: Difference in sales revenue ($, m) between 2004 and 2005 in the HA markets of the 7MM
  - Figure 33: Total OA-specific sales ($, m) for HA viscosupplements in US and Japan, 2002-2005
  - Figure 34: Total OA-specific sales ($, m) for HA viscosupplements in the five major EU markets, 2002-2005
  - Figure 35: HA viscosupplement market share (%) in Japan, 2005
  - Figure 36: HA viscosupplement market share (%) in the US, 2005
  - Figure 37: Promotional spend ($, m) for Synvisc and Hyalgan in the US, 2003-2005

Commercial Insight: Osteoarthritis - Market sees steady growth

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