Osteoarthritis - Market sees steady growth
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the CNS, Arthritis and Pain pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Objective of the analysis - page 3
- Datamonitor insight into the osteoarthritis market - page 3
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 13
- Market definition for this report - page 13
- The Japanese market - page 16
- The market value is calculated using IMS diagnosis value - page 17
- Current market situation - page 19
- Despite the withdrawal of Merck's Vioxx from the global market, the OA market rose by 1.1% from 2004 to 2005 - page 19
- The US saw negative growth between 2004 and 2005, but remains the largest overall market for OA - page 19
- Mobic showed the greatest increase in sales revenue in the seven major markets between 2004 and 2005 - page 22
- Strategic scoping and focus - page 23
- Market definition for this report - page 13
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 24
- Global opportunities and threats - page 24
- Global Opportunities - page 24
- The overall aging global population will increase the OA patient population - page 24
- Increasing levels of obesity across the seven major markets will lead to a rise in the number of cases of symptomatic OA - page 27
- DMOADs provide the biggest opportunity to OA sufferers and to pharmaceutical companies, but currently elude the market - page 28
- Global Threats - page 29
- Pharmacovigilance is leading to more stringent post-marketing regulations - page 29
- Global Opportunities - page 24
- US: opportunities and threats - page 30
- US Market overview - page 30
- US Opportunities - page 31
- The number of over 65 year olds is forecast to increase as the 'baby boom' generation reaches retirement - page 31
- Medicare Part D reforms will provide a short-term boost, but in the longer term the impact is less certain - page 32
- US Threats - page 33
- The Medicare 'doughnut hole' could result in a surge of parallel imports - page 33
- Disclosure of clinical trial results could become mandatory - page 33
- Increased scrutiny of DTC advertising due to COX-2 withdrawals - page 34
- Japan: opportunities and threats - page 35
- Japan Market overview - page 35
- Japan Opportunities - page 36
- Is there an opportunity for COX-2 inhibitors in the Japanese market? - page 36
- Separation of manufacturing and marketing entities benefits both Japanese and foreign companies - page 36
- Fewer outsourcing restrictions enhances manufacturing efficiency - page 37
- Japan Threats - page 37
- The Japanese market is expected to experience a significant increase in generic usage - page 37
- Flat-sum reimbursement discourages physicians from prescribing highly priced medicines - page 38
- 5EU: opportunities and threats - page 39
- EU Market overview - page 39
- EU Opportunities - page 44
- Review of OA treatment by NICE in the UK - page 44
- In France and Italy, innovative drug development is encouraged by price premium and high-level reimbursement - page 45
- In Germany, the free pricing system and culture of innovation encourages novel drug development - page 46
- New fast track drug assessment process speeds up time between licensing and NICE recommendations in the UK - page 46
- Planned electronic prescribing in Spain will improve access to treatments and promote the rational use of drugs - page 47
- EU Threats - page 47
- The NHS is unreceptive to new treatments compared to the rest of Europe - page 47
- Government awareness campaign promotes generic use in Spain - page 48
- New EU states may lead to a flood of cheaper drug exports - page 48
- Pharmaceutical price cuts continue in Spain and are planned for Italy - page 49
- National Health insurer allowed greater powers to decrease expensive prescribing in Germany - page 50
- Summary of environmental issues affecting OA market size - page 51
- Global opportunities and threats - page 24
- CHAPTER 4 FORECAST ANALYSIS - page 52
- Key events - page 52
- New Product Launches - page 52
- The launch of a number of COX-2 inhibitors will see an increase in the competition against market leader Celebrex - page 53
- Could naproxcinod and licofelone prove to be viable alternatives to COX-2s? - page 56
- IDEA-033 - page 57
- Side effects and competition from other capsaicin creams will limit the commercial opportunities of zucapsaicin as a treatment for OA - page 57
- Impact of COX-2 and NSAID product launches on market leader Celebrex - page 58
- CRx-102 is a good treatment concept but this may not be reflected in market uptake - page 58
- Major Clinical Trials - page 59
- Does the MEDAL program go far enough to secure approval for Merck's Arcoxia in the US? - page 59
- Additional Indications - page 61
- Label expansion for Synvisc will help drive future sales - page 61
- Patent Expiries - page 63
- Mobic - page 63
- Arthrotec - page 65
- Celebrex - page 67
- Synvisc - page 67
- Product launches in Japan - page 68
- Celebrex will be the first COX-2 launched in Japan for OA - page 68
- Synvisc will have to compete with Artz and Suvenyl when it is launched in Japan - page 69
- New Product Launches - page 52
- Data definitions, limitations and assumptions - page 70
- Standard Units - page 70
- Japanese Market Data - page 70
- Derivation of Sales Forecasts and Pricing Trends - page 71
- Drug pricing and genericization assumptions - page 71
- Forecast methodology - page 73
- Key events - page 52
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 74
- Introduction - page 74
- Case Study 1: Marketing and advertising strategy. How should companies advertise and promote COX-2s post-Vioxx? - page 74
- Analysis of DTC advertising - page 74
- Pharmaceutical companies use many methods to promote their products to patients and to physicians - page 74
- Spending on DTC advertising surged in 1997 after the FDA relaxed its regulatory guidelines - page 75
- Vioxx was the most heavily DTC advertised drug in 2000 - page 76
- Merck and Pfizer ran aggressive advertising campaigns for Vioxx and Celebrex, respectively - page 77
- DTC advertising underwent considerable review in 2005 - page 82
- The future of DTC advertising - page 85
- The US will soon be the only country in the world where DTC advertising is legal - page 85
- It would be very inadvisable for Merck to go to the same lengths for Arcoxia as it did for Vioxx - page 86
- Pfizer has cut almost 20% of its sales force but will maintain strong support for Celebrex - page 86
- What will be the future strategies used by pharmaceutical companies to market COX-2s? - page 87
- Analysis of DTC advertising - page 74
- Case Study 2: Product differentiation. Synvisc and Hyaluronic acids - page 90
- Intra-articular HA viscosupplements - page 90
- HA viscosupplements are designed to replace synovial fluid in joints affected by OA - page 90
- Despite variability in reported efficacy, HA viscosupplements have a definite place in the treatment of OA - page 90
- The US and Japan are the largest markets for HA viscosupplements - page 91
- Growth in the HA market has been higher in the EU than in the US and Japan - page 92
- There are many brands of HA viscosupplement available throughout the seven major markets - page 95
- The Japanese HA market is dominated by Artz - page 98
- Synvisc is the most popular HA viscosupplement in the US, which is reflected by high sales revenues - page 98
- Further indication expansion of HA viscosupplements may be limited by the size and accessibility of the affected joint - page 101
- Future direction for HA viscosupplements - page 104
- Companies should focus on developing single injection HA viscosupplements - page 104
- Strong growth in the EU markets indicates good potential for future HA products - page 104
- Intra-articular HA viscosupplements - page 90
- APPENDIX A - MAJOR BRAND KEY FACTS - page 105
- Major brand key facts - page 105
- COX-2 market data - page 105
- Celebrex (celecoxib) - page 105
- Arcoxia (etoricoxib) - page 106
- NSAID market data - page 107
- Mobic (meloxicam) - page 107
- Voltaren (diclofenac) - page 108
- Arthrotec (diclofenac + misoprostol) - page 109
- Aleve (naproxen) - page 110
- Analgesic market data - page 111
- Tramal (tramadol) - page 111
- Hyaluronic acid market data - page 112
- Synvisc (hylan G-F 20) - page 112
- COX-2 market data - page 105
- Major brand key facts - page 105
- APPENDIX B - MARKET FORECAST DATA TABLES - page 113
- US - page 113
- Japan - page 121
- France - page 126
- Germany - page 132
- Italy - page 136
- Spain - page 139
- UK - page 141
- APPENDIX C - page 146
- Bibliography - page 146
- References - page 146
- Websites - page 148
- Datamonitor reports - page 151
- Report methodology - page 151
- Contributing experts - page 152
- About Datamonitor - page 152
- About Datamonitor Healthcare - page 152
- About the CNS, Arthritis and Pain analysis team - page 153
- Disclaimer - page 155
- Bibliography - page 146
- List of Tables
- Table 1: Datamonitor's definition of OA market by ICD10 code - page 17
- Table 2: Key players in the osteoarthritis market - page 21
- Table 3: Incidence of OA by age group and by gender - page 24
- Table 4: Prevalence of obesity in adults (age 15+) in the 7MM, 2005 and 2010 - page 27
- Table 5: Key late-stage pipeline products for OA, 2006 - page 52
- Table 6: Cost per standard unit for COX-2s in the UK - page 71
- Table 7: Calculation of the $/SU of Celebrex and Arcoxia for Japan based on average historic sales in Pacific Rim from 2002 - 2005 - page 72
- Table 8: Calculation of the $/SU of Synvisc for Japan based on average historic sales in Pacific Rim from 2002 - 2005 - page 73
- Table 9: HA viscosupplements: key facts - page 96
- Table 10: OA sufferers who present with the disease in specific parts of the body (%): US, Japan and 5EU markets, 2003 - page 102
- Table 11: Celebrex: key facts - page 105
- Table 12: Arcoxia: key facts - page 106
- Table 13: Mobic: key facts - page 107
- Table 14: Voltaren: key facts - page 108
- Table 15: Arthrotec: key facts - page 109
- Table 16: Aleve: key facts - page 110
- Table 17: Tramal: key facts - page 111
- Table 18: Synvisc: key facts - page 112
- Table 19: US OA drug sales ($, m) forecasts, 2005-15 - page 113
- Table 20: Japan OA drug sales ($, m) forecasts, 2005-15 - page 121
- Table 21: France OA drug sales ($, m) forecasts, 2005-15 - page 126
- Table 22: Germany OA drug sales ($, m) forecasts, 2005-15 - page 132
- Table 23: Italy OA drug sales ($, m) forecasts, 2005-15 - page 136
- Table 24: Spain OA drug sales ($, m) forecasts, 2005-15 - page 139
- Table 25: UK OA drug sales ($, m) forecast, 2005-15 - page 141
- List of Figures
- Figure 1: 7MM sales ($, m) of the OA drug classes, 2004-2005 - page 19
- Figure 2: Performance of the US, the five major EU and Japan OA markets, 2004-2005 - page 20
- Figure 3: OA-specific sales revenue ($, m) for key brands in the seven major markets, 2004-2005 - page 23
- Figure 4: Population growth of specific age groups: 2002-2050 - page 25
- Figure 5: The over 65 population in the seven major markets, 2005-2025 - page 26
- Figure 6: US top ten brand sales ($, m) for OA, 2005 - page 31
- Figure 7: The over 65 population (m), 1900-2030 - page 32
- Figure 8: Japan top ten brand sales ($, m) for OA, 2005 - page 35
- Figure 9: Sales ($, m) of Mobic (meloxicam) in Japan, 2002-2005 - page 36
- Figure 10: France top ten brand sales ($, m) for OA, 2005 - page 40
- Figure 11: Spain top ten brand sales ($, m) for OA, 2005 - page 41
- Figure 12: UK top ten brand sales ($, m) for OA, 2005 - page 42
- Figure 13: Italy top ten brand sales ($, m) for OA, 2005 - page 43
- Figure 14: Germany top ten brand sales ($, m) for OA, 2005 - page 44
- Figure 15: Summary of environmental factors affecting OA market size - page 51
- Figure 16: Sales revenue ($, m) of Celebrex for OA in the 7MM, 2002-2015 - page 58
- Figure 17: Sales ($, m) of Arcoxia for OA in the five major EU markets, 2002-2015 - page 61
- Figure 18: Sales ($, m) of Synvisc and other HAs for OA in the 7MM, 2002-2015 - page 63
- Figure 19: The effect of patent expiry on the sales ($, m) of BI's Mobic (meloxicam) for OA in the 7MM, 2002-2015 - page 65
- Figure 20: Sales ($, m) of Arthrotec (diclofenac + misoprostol) in the US and 5EU for OA, 2002-2015 - page 66
- Figure 21: Forecast sales ($, m) of Celebrex for OA in Japan, 2002-2015 - page 69
- Figure 22: Datamonitor forecasts of sales ($, m) of key HA viscosupplements for OA in Japan, 2002-2015 - page 70
- Figure 23: Methods of advertising and promoting drugs to patients and physicians - page 75
- Figure 24: Most heavily DTC advertised drugs in 2000 - page 77
- Figure 25: Examples of DTC advertising for Vioxx - page 78
- Figure 26: Vioxx (rofecoxib) - page 79
- Figure 27: Examples of DTC advertising for Celebrex - page 80
- Figure 28: Total promotional spend for Celebrex, Vioxx, Arcoxia and Mobic from 2003 to 2005 - page 81
- Figure 29: Merck ran preliminary 'taster' adverts for Arcoxia in anticipation of gaining FDA approval in October/November 2004 - page 82
- Figure 30: DTC advertising: advantages vs. disadvantages - page 83
- Figure 31: HA viscosupplement market share (%) in the US, Japan and the five major EU (M5EU) markets, 2005 - page 92
- Figure 32: Difference in sales revenue ($, m) between 2004 and 2005 in the HA markets of the 7MM - page 93
- Figure 33: Total OA-specific sales ($, m) for HA viscosupplements in US and Japan, 2002-2005 - page 94
- Figure 34: Total OA-specific sales ($, m) for HA viscosupplements in the five major EU markets, 2002-2005 - page 95
- Figure 35: HA viscosupplement market share (%) in Japan, 2005 - page 98
- Figure 36: HA viscosupplement market share (%) in the US, 2005 - page 99
- Figure 37: Promotional spend ($, m) for Synvisc and Hyalgan in the US, 2003-2005 - page 101
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