Commercial Insight: Osteoporosis

Summary

The osteoporosis market is due a major upheaval when market leader Fosamax (alendronate) loses its US patent. The resultant heightened competition will force market players to implement radical lifecycle management strategies to safeguard their franchise revenue. New market entrants provide further complexity to the competitive landscape but will also drive market growth over the next ten years.

• This report focuses on the leading therapies used in osteoporosis, with sales and volume country- and indication-specific forecasts to 2016
• Assessment of current and future opportunities and threats in the osteoporosis market across the seven major pharmaceutical markets
• Future market events that are expected to affect drug revenues are discussed and quantified for each of the seven major markets
• Lifecycle management case studies show how previously successful strategies should be applied in today's market

Reformulations of marketed products have helped rejuvenate the calcitonin and bisphosphonate markets amid genericization. Arguably the most exciting is the Roche's Boniva (ibandronate) reformulation which will generate substantial revenue as both an oral monthly and injectable quarterly product.

Following a number of recent reports that have concluded that vitamin D and calcium supplementation decreases the risk of cancer there is further support for the strategy to include a popular supplementary medication as either a combination pill or separately within the prescription brand packaging.

Eli Lilly has successfully launched two very different therapies to treat osteoporosis. Evista (raloxifene) and Forteo (teriparatide) The two products have been successful, being the third and fourth highest selling products on the osteoporosis market. In 2006, Evista generated sales of $739m and Forteo returned revenue of $574m.

• Assess the impact of events such as patent expiries and new product launches on the osteoporosis sales of key marketed products
• Quantify the future size of the osteoporosis market, in terms of volume and value, in each of the seven major markets
• Identify key lifecycle management strategies that can ensure long term growth in the competitive osteoporosis market

Contents

• Chapter 1 Executive Summary
  • Scope and objective of the analysis
  • Datamonitor insight into the osteoporosis market
  • Contributing experts
• Chapter 2 Market Definition And Overview
  • Market definition for this report
  • Current market situation
  • Market continues trend of steady growth
  • US market share dominates but in Europe, Italy shows strongest growth
  • Top five brands contribute to 73% of total market
  • Merck's market dominance threatened by rival brands and generics
  • Reformulation is a key brand lifecycle strategy for osteoporosis players
  • Further European roll-out will boost Boniva sales
  • Strategic scoping and focus
• Chapter 3 Country Market Assessments
  • Summary of environmental issues affecting osteoporosis market size
  • Seven major markets opportunities and threats
  • Opportunities
  • Ageing population expands osteoporosis patient potential
  • Global organizations support initiatives for improved patient identification, increasing the number of patients available for treatment
  • Increasing recognition of the male osteoporosis market
  • EMEA suggests reduction in length of pivotal trials
  • Threats
  • Growing genericization of the market introduces strong cost competition
  • EMEA to revise guidelines for evaluation of primary osteoporosis drugs creating the potential for new drugs to usurp establish products
  • Parallel trade from new EU states threatens to introduce cheap alternatives
  • US: opportunities and threats
  • Opportunities
  • Manufacturers can tap into the large untreated patient population
  • HEDIS criteria, supported by industry, has potential to increase diagnostic and treatment rates
  • Threats
  • Many elderly patients fall into the Medicare Part D 'donut hole' and are denied reimbursement
  • Genericization of Fosamax exacerbated by generic reimbursement
  • Direct to consumer advertising curbed limits patient visibility of new products in US
  • Osteoporosis given a low priority by US government
  • Japan: opportunities and threats
  • Opportunities
  • Underdeveloped Japan market is becoming more accepting of US and 5EU products
  • Japanese government supports osteoporosis awareness initiatives
  • Increasing incidence of hip fractures
  • Governmental funding for clinical trials
  • Cash injection for elderly healthcare
  • Threats
  • Grades for osteoporosis drugs create more bureaucracy before launch onto Japanese market
  • Lagging approval times have yet to quicken
  • France: opportunities and threats
  • Opportunities
  • French identify those at risk of fracture increasing potential treatable population
  • Threats
  • Generic incursion on the osteoporosis market will be most rapid in France
  • Germany: opportunities and threats
  • Opportunities
  • Large untreated patient population indicates sizeable scope for market growth
  • Current consumer information needs to be updated presenting an opportunity for manufacturers to promote brand image
  • Threats
  • Limitations on DXA scanning reimbursement impacts diagnosis rates
  • Italy: opportunities and threats
  • Opportunities
  • Italian government makes osteoporosis a high priority
  • Threats
  • Extensive cost containment measures in place
  • Spain: opportunities and threats
  • Opportunities
  • Pharma tax reduction to create savings in region of $5.8m
  • Threats
  • Severe lack of scanning equipment limits market
  • UK: opportunities and threats
  • Opportunities
  • Creation of the 'Musculoskeletal Services Framework' improves accessibility of the health services to patients
  • NOS input to NICE methodologies appraisals strives to widen potential market
  • Investment in DXA scanning will increase opportunities for diagnosis
  • Reduced clinical trial times will accelerate pipeline products to the market
  • Threats
  • Generic alendronate is a barrier to UK market entry
• Chapter 4 Forecast Analysis
  • Key events
  • New product launches in the US and EU
  • Preos in Europe
  • Aclasta
  • Bazedoxifene
  • Denosumab
  • BN-002
  • Ostabolin-C
  • MER-103
  • New product launches in Japan
  • Bisponal
  • ED-71
  • hPTH
  • Denosumab
  • Patent expiries
  • Fosamax
  • Actonel
  • Evista
  • Miacalcin (intranasal formulation)
  • Reformulations
  • Boniva brand
  • Miacalcin
  • Fortical
  • Actonel in Japan
  • Data definitions, limitations and assumptions
  • Standard units
  • Japanese market data
  • Derivation of sales forecasts and pricing trends
  • Market definition
  • Generic erosion and pricing assumptions
  • Forecasts
  • Forecast methodology
• Chapter 5 Commercial Impact And Lifecycle Management: Case Studies
  • Introduction
  • Strategies to optimize administration are well suited to the osteoporosis market
  • Intermittent dosing is the key market driving strategy
  • SWOT analysis of intermittent dosing
  • Daily to weekly dosing switch was a key strategy for market leader
  • Geographic expansion now necessary to optimize switch to weekly dosing
  • From daily to yearly - opportunity still exists for more intermittently dosed products
  • Innovative modes of delivery
  • Intranasal delivery rejuvenates brands in the calcitonin class
  • Tolerable oral solution is permissible with Servier's new mechanism of action
  • Addition of vitamin D and calcium supplements
  • Merck's combination product Fosamax Plus D was most successful strategy
  • P&G's co-packaging strategy 'Actonel with Calcium' has drawbacks
  • Differing patient segmentation and product positioning of multiple brands minimizes franchise risk
  • Eli Lilly: same indication, different mechanisms of action with Evista and Forteo
  • Alternating brand strategies help to maintain revenue growth
  • Roche: two differently administered intermittent doses of Boniva target separate patient groups
• Bibliography
  • Journal papers
  • Websites
• Appendix A - Market Data And Major Brand Key Facts
  • Summary osteoporosis market data
  • Key marketed products
• Appendix B - Market Forecast Data
  • Global
  • M5EU
  • US
  • Japan
  • France
  • Germany
  • Italy
  • Spain
  • UK
• Appendix C
  • Contributing experts
  • Report methodology
  • About Datamonitor
  • About Datamonitor Healthcare
  • About the Women's Health and Urology analysis team
  • Disclaimer