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Osteoporosis Drug Treatments: World Market Analysis & Disease Management Considerations

Published by: PJB Publications USA Inc.

Published: Jan. 1, 2003 - 170 Pages


Table of Contents


1 Executive Summary

       1.1 Scope and Objectives of Report

       1.2 Methodology

          1.2.1 Overview

          1.2.2 Prevalence Assumptions

          1.2.3 Sales Projections

          1.2.4 Compound Annual Growth Rate (CAGR)

       1.3 World Market Summary

          1.3.1 Current and Projected Global Market Sizes

          1.3.2 Pharmaceutical Market Leaders

          1.3.3 Compound Annual Growth Rate (CAGR)

          1.3.4 Market Growth Drivers


2 Overview of Osteoporosis

       2.1 Bone Physiology and Disease Pathophysiology

          2.1.1 Normal Bone Physiology

          2.1.2 Bone Resorption Process

          2.1.3 Bone Formation Process

          2.1.4 Pathophysiology of Bone Loss

       2.2 Classification

          2.2.1 Type I Osteoporosis

          2.2.2 Type II Osteoporosis

          2.2.3 Secondary Osteoporosis

       2.3 Prevalence

       2.4 Risk Factors

          2.4.1 General Risk Factors

          2.4.2 Risk Factors in Children and Adolescents

          2.4.3 Risk Factors in Women

          2.4.4 Risk Factors in Men

          2.4.5 Genetic Risk Factors

          2.4.6 Lifestyle Risk Factors

       2.5 Economic Impact of Osteoporosis

          2.5.1 Overview

          2.5.2 United States

          2.5.3 Europe


3 Osteoporosis Assessment and Non Pharmacologic Management

       3.1 Initial Assessment of Osteoporosis

          3.1.1 History and Physical Examination Parameters

          3.1.2 Evaluation of Osteoporosis Risk Stratification Tools

          3.1.3 Proactive Screening for Persons With Low BMD

       3.2 Osteoporosis Diagnostic Techniques

          3.2.1 Dual Energy X-Ray Absorptiometry (DXA)

          3.2.2 Quantitative Ultrasound (QUS)

          3.2.3 Single Energy X-Ray Absorptiometry (SEXA)

          3.2.4 Peripheral Dual Energy X-Ray Absorptiometry (PDEXA)

          3.2.5 Quantitative Computed Tomography (QCT)

       3.3 Osteoporosis Markers

          3.3.1 Osteocalcin

          3.3.2 Collagen (n-telopeptides)

       3.4 Dietary Considerations for Early Prevention

          3.4.1 Calcium Intake and Supplementation

          3.4.2 Vitamin A Intake

          3.4.3 Vitamin D Intake

          3.4.4 Magnesium

       3.5 Exercise and Lifestyle Factors


4 Pharmaceutical Therapies for Osteoporosis

       4.1 Bisphosphonates

          4.1.1 Fosamax (alendronate)

          4.1.2 Actonel (risedronate)

          4.1.3 Didronel (etidronate)

          4.1.4 Aredia (pamidronate)

       4.2 Selective Estrogen Receptor Modulators (SERMs)

          4.2.1 Evista (raloxifene)

       4.3 Calcitonin

          4.3.1 Miacalcin (salmon calcitonin)

       4.4 Hormone/Estrogen Replacement Therapy (HRT/ERT)

          4.4.1 Oral HRTs

          4.4.2 Transdermal HRTs

          4.4.3 Non-Estrogen-Based Therapy: Livial (tibolone)

          4.4.4 Efficacy Studies of HRT in Osteoporosis Prevention

          4.4.5 HRT Complications: Impact of Women’s Health Initiative (WHI)Trial

          4.4.6 Treatment Alternatives to HRT in Light of WHI Findings

       4.5 Parathyroid Hormone Therapy

          4.5.1 Forteo (teriparatide)

       4.6 Vitamin D

          4.6.1 Rocaltrol (calcitriol)

       4.7 Vitamin K2

       4.8 Sodium Fluoride

       4.9 Isoflavone Derivative (Ipriflavone)


5 Osteoporosis Therapeutics in Development

       5.1 Number of Drugs in Development

       5.2 Bisphosphonates

          5.2.1 Ibandronate (Roche)

          5.2.2 Zoledronate (Novartis)

       5.3 Selective Estrogen Receptor Modulators (SERMs)

          5.3.1 Lasofoxifene (Pfizer)

       5.4 Parathyroid Hormone Drugs

       5.5 Hormone/Estrogen Replacement Therapies (HRT/ERT)

       5.6 Protein- and Gene-based Drugs

       5.7 Calcitonin Agents

       5.8 Other Agents: Vitamin D, Calcium Receptor Antagonist, Strontium

       5.9 Statin Use and Osteoporosis Prevention


6 Market Analysis

       6.1 Past Performance of Global Osteoporosis Drug Market

          6.1.1 Total Worldwide Sales 1999-2001

          6.1.2 Worldwide Sales by Drug Category 1999-2001

          6.1.3 Market Leaders by Drug 1999-2001

          6.1.4 Hormone Replacement Therapy Market

       6.2 Global Market Projections for Osteoporosis Drugs

          6.2.1 Total Worldwide Sales and Growth Projections 2002-2006

          6.2.2 United States Market

          6.2.3 European Market

          6.2.4 Japanese Market

          6.2.5 Rest of World Market

          6.2.6 Key Market Drivers

       6.3 Competitive Analysis

          6.3.1 Bisphosphonates

          6.3.2 Selective Estrogen Receptor Modulators (SERMs)

          6.3.3 Calcitonin Agents

          6.3.4 Hormone Replacement Therapy

          6.3.5 Climara (estradiol transdermal)

          6.3.6 Vivelle/Vivelle-Dot (estradiol transdermal) and CombiPatch                                (estrogen/progestin)


7 Disease Management Implications and Market Strategies

       7.1 Provider Awareness of Osteoporosis

       7.2 Consumer Awareness of Osteoporosis

          7.2.1 Consumer Advertising Considerations

       7.3 Pharmaceutical Marketing Opportunities

          7.3.1 Increasing Consumer Awareness

          7.3.2 Increasing Healthcare Provider Awareness

       7.4 Disease Management (DM) Strategies

          7.4.1 DM and Quality Management

          7.4.2 DM Program Components

       7.5 Pharma-Sponsored DM Initiatives

          7.5.1 DM Opportunities for the Pharma Industry

       7.6 Future Healthcare Economic Trends

       7.7 DM Objectives in the Pharma Industry


8 Company Profiles

       8.1 Aventis Pharmaceuticals Inc.

       8.2 Eisai Co. Ltd.

       8.3 Eli Lilly & Co.

       8.4 Ligand Pharmaceuticals

       8.5 Merck & Co., Inc.

       8.6 Novartis Pharmaceuticals Corp.

       8.7 Pfizer Inc.

       8.8 Procter & Gamble Co.

       8.9 Roche

       8.10 Wyeth


9 References




List of Tables



    Table 2-1 Osteoporosis Risk Factors

    Table 3-1 Patient History Parameters Pertaining to Osteoporosis

    Table 3-2 Simple Calculated Osteoporosis Risk Estimation (SCORE) Model

    Table 3-3 FORE Indications for BMD Testing

    Table 3-4 NOF Indications for BMD Testing

    Table 4-1 Oral Hormone/Estrogen Replacement Therapies

    Table 4-2 Transdermal Hormone/Estrogen Replacement Therapies

    Table 5-1 Bisphosphonates in Development for Osteoporosis

    Table 5-2 SERMs in Development for Osteoporosis

    Table 5-3 Parathyroid Hormone Drugs in Development for Osteoporosis

    Table 5-4 Hormone Replacement Therapies in Development for Osteoporosis

    Table 5-5 Protein- and Gene-based Drugs in Development for Osteoporosis

    Table 5-6 Calcitonin Drugs in Development for Osteoporosis

    Table 5-7 Other Drugs in Development for Osteoporosis

    Table 6-1 Total Worldwide Osteoporosis Drug Market Size Excluding HRT 1999-2001

    Table 6-2 Total Worldwide Osteoporosis Drug Market Size Including HRT 1999-2001

    Table 6-3 Worldwide Sales by Osteoporosis Drug Category 1999-2001

    Table 6-4 Worldwide Sales Leaders by Osteoporosis Drug 1999-2001

    Table 6-5 Worldwide Sales Leaders by HRT Drugs for Osteoporosis 1999-2001

    Table 6-6 World Osteoporosis Drug Market Size and Growth Projections 2002-2006

    Table 6-7 World Osteoporosis Drug Market Size Projections by Geographic Region 2002-2006

    Table 6-8 World Osteoporosis Drug Market Growth Projections (CAGRs) by Geographic Region 2000-2001, 2001-2005, 2000-2006

    Table 6-9 U.S.: Osteoporosis Drug Market Size and Growth Projections 2002-2006

    Table 6-10 Europe: Osteoporosis Drug Market Size and Growth Projections 2002-2006

    Table 6-11 Japan: Osteoporosis Drug Market Size and Growth Projections 2002-2006

    Table 6-12 Rest of World: Osteoporosis Drug Market Size and Growth Projections 2002-2006

    Table 7-1 Disease Management Program Components  in an Osteoporosis Prevention and Treatment Model






List of Figures



    Figure 6-1 Total Worldwide Osteoporosis Drug Market Size Excluding HRT 1999-2001

    Figure 6-2 Total Worldwide Osteoporosis Drug Market Size Including HRT 1999-2001

    Figure 6-3 Worldwide Sales by Osteoporosis Drug Category 1999-2001

    Figure 6-4 Worldwide Sales Leaders by Osteoporosis Drug 1999-2001

    Figure 6-5 Worldwide Sales Leaders by HRT Drugs for Osteoporosis 1999-2001

    Figure 6-6 World Osteoporosis Drug Market Size Projections 2002-2006

    Figure 6-7 World Osteoporosis Drug Market Size Projections by Geographic Region 2002-2006

    Figure 6-8 World Osteoporosis Drug Market Growth Projections (CAGRs)by Geographic Region 2000-2001, 2001-2005, 2000-2006

    Figure 6-9 U.S.: Osteoporosis Drug Market Size Projections 2002-2006

    Figure 6-10 Europe: Osteoporosis Drug Market Size Projections 2002-2006

    Figure 6-11 Japan: Osteoporosis Drug Market Size Projections 2002-2006

    Figure 6-12 Rest of World: Osteoporosis Drug Market Size Projections 2002-2006


Abstract

Osteoporosis is defined as metabolic bone disease characterized by deterioration of bone tissue and low bone mass density leading to enhanced bone fragility and a consequent increase in fracture risk. General risk factors for osteoporosis include female gender, increased age, early menopause, low body weight, positive family history, and sedentary lifestyle. Besides adequate nutrient (calcium, vitamin D) intake and weight-bearing exercise to prevent osteoporosis, pharmaceutical therapies are often used to treat osteoporotic conditions. The total world market for osteoporosis drugs surpassed an estimated $5 billion in 2002 and is projected to exceed $11.5 billion by 2006.

This report analyzes the global osteoporosis drug market, as well as geographic markets in the U.S., Europe, Japan, and the rest of the world. The report covers drugs currently available on the market and in development for the prevention and treatment of osteoporosis. World and geographic market sizes and projections through 2006 are provided, as well as projected CAGRs and competitive analysis of key products and their manufacturers. Also covered is an analysis of how disease management companies are impacted by the osteoporosis drug market and where market strategies lie. Company profiles for 10 major players in the global osteoporosis drug market are also included.



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