Market Report Source

Overview

Introduction
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.

Scope

• 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

Highlights
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.

Reasons to Purchase

• 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

Table of Contents

TABLE OF 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