Pipeline and Commercial Insight: Osteoporosis - Novel agents to battle for payer acceptance

Published by: Datamonitor

Published: Jul. 13, 2009 - 375 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Urology and Gender specifc Health pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the osteoporosis market

Key metrics

Contributing experts

Related reports

CHAPTER 2 PATIENT POTENTIAL

Definition of osteoporosis

Etiology

Symptoms

Diagnosis and treatment rates

Underdiagnosis is a major problem in osteoporosis

World Health Organization fracture risk assessment tool

Treatment rates have been increasing but are still low

Patient segmentation

Disease severity

Gender

Epidemiology

Seven major markets

Female osteoporosis

Male osteoporosis

BRIC countries

Brazil - hip fracture prevalence is higher in men than women

Russia - over 85% of hip fractures occur in women over 60 years of age

India - Indian women experience osteoporotic fractures 10-20 years earlier than Caucasian women

China - over 61 million Chinese women will experience a hip fracture in 2009

Rest of the world

Current treatment options

Bisphosphonates

Selective estrogen receptor modulators

Parathyroid hormones

Calcitonins

Dual acting bone agents

Vitamin D and analogs

Calcium

Clinical unmet need in osteoporosis

Need for improved anabolic therapies

Efficacy at the hip

Increased compliance

Better side-effect profile and safety

Long-term safety of bisphosphonate use is questioned

Efficacy for spine fractures

Environmental unmet need in osteoporosis

Increased patient identification

Increased prevention of osteoporosis

Increase male osteoporosis awareness

Target product profile

CHAPTER 3 MARKET OVERVIEW

Market definition for this report

Seven major markets current and future market assessment

The osteoporosis market will continue to grow up to 2018 despite generic alendronate penetration

Regional dynamics - the US will remain by far the largest market region in 2018 although the fastest growing regions will be Italy and Spain

Drug class dynamics - bisphosphonates will remain the clear market leading class

Brand dynamics - Actonel (risedronic acid, Procter and Gamble Pharmaceuticals) becomes market leader in 2008

Rest of the world snapshot

The global osteoporosis market continues to display strong growth

The rest of the world accounted for 25.4% of the osteoporosis global market in 2008

The rest of the world outstrips the seven major markets in terms of volume

Other European countries form the largest region, but the BRIC countries are by far the fastest-growing

Calcium accounts for over 90% of the total volume sales in the rest of the world

Patient acquisition process

Introduction

Patient care path

Points of influence in the patient care path

Trigger point 1 - osteoporosis prevention

Trigger point 2 - disease severity influences osteoporosis treatment

Trigger point 3 - compliance issues and fractures

Drivers of drug choice

US formulary tier status for leading brands

EU osteoporosis reimbursement policies

Brand dynamics - bisphosphonates

Class overview

Fosamax/Fosamax Plus D (alendronate, Merck & Co.)

Drug profile

Product positioning

SWOT analysis

Brand forecast to 2018

Actonel/Actonel with Calcium (risedronic acid; Procter and Gamble/Sanofi-Aventis)

Drug profile

Product positioning

SWOT analysis

Brand forecast to 2018

Bonviva/Boniva (ibandronic acid, Roche/GlaxoSmithKline)

Drug profile

Product positioning

SWOT analysis

Brand forecast to 2018

Aclasta (zoledronic acid, Novartis)

Drug profile

Product positioning

SWOT analysis

Brand forecast to 2018

Bonoteo/Recalbon (minodronic acid, Astellas/Ono Pharmaceutical)

Drug profile

Product positioning

SWOT analysis

Brand forecast to 2018

Brand dynamics - selective estrogen receptor modulators

Evista (raloxifene, Eli Lilly)

Drug profile

Product positioning

SWOT analysis

Brand forecast to 2018

Brand dynamics - parathyroid hormones

Forteo (teriparatide, Eli Lilly)

Drug profile

Product positioning

SWOT analysis

Brand forecast to 2018

Preotact (full-length parathyroid hormone PTH 1-84, NPS/Nycomed)

Drug profile

Product positioning

SWOT analysis

Brand forecast to 2018

Brand dynamics - dual acting bone agents

Protelos (strontium ranelate, Servier)

Drug profile

Product positioning

SWOT analysis

Brand forecast to 2018

Brand dynamics - calcitonins

Miacalcic (calcitonin-salmon, Novartis)

Drug profile

Product positioning

SWOT analysis

Brand forecast to 2018

Fortical (calcitonin-salmon, Unigene)

Drug profile

Product positioning

SWOT analysis

Brand forecast to 2018

CHAPTER 4 PIPELINE OVERVIEW AND R&D DYNAMICS

Pipeline overview

Comparative forecasts

Datamonitor pipeline assessment summary

Key companies involved in the disease osteoporosis pipeline

Companies currently involved in the market are seeking novel drug developments to maintain their market share

Amgen - a future key market player

Amgen faces challenges to entry into the musculoskeletal market

Amgen's osteoporosis pipeline

Amgen geographic outlook

Clinical trial design in osteoporosis

Preclinical trials

Two different animal species testing is required by the FDA and EMEA

Preclinical trial design should reflect the clinical indication

Clinical trial design

The FDA and EMEA have different patient inclusion requirements for osteoporosis trials

Clinical endpoints

CHAPTER 5 LATE-STAGE DRUG ANALYSIS AND FORECASTS

Definition of current comparator therapies

Overall market comparator - Fosamax (alendronate, Merck & Co)

Clinical trial data for Fosamax

Individual class comparators

Bisphosphonates - key late-stage pipeline

Pipeline summary

Comparative forecasts

EX101 (alendronate; EffRx)

Drug overview

SWOT analysis

Clinical attractiveness

Commercial attractiveness

Datamonitor drug assessment score card for EX101

Satisfaction of unmet needs

Forecasts to 2018

Almerol (MER-103, alendronate; Merrion)

Drug overview

SWOT analysis

Clinical trial data

Clinical attractiveness

Commercial attractiveness

Datamonitor drug assessment score card for Almerol

Satisfaction of unmet needs

Forecasts to 2018

Late-stage development compounds recently discontinued

Selective estrogen receptor modulators - key late-stage pipeline

Pipeline summary

Comparative forecasts

Fablyn (lasofoxifene; Pfizer/Ligand)

Drug overview

SWOT analysis

Clinical trial data

Clinical attractiveness

Commercial attractiveness

Datamonitor drug assessment score card for Fablyn

Satisfaction of unmet needs

Forecasts to 2018

Conbriza/Viviant (bazedoxifene; Wyeth)

Drug overview

SWOT analysis

Clinical trial data

Clinical attractiveness

Commercial attractiveness

Datamonitor drug assessment score card for Conbriza

Satisfaction of unmet needs

Forecasts to 2018

Aprela (bazedoxifene with conjugated estrogens; Wyeth)

Drug overview

SWOT analysis

Clinical trial data

Clinical attractiveness

Commercial attractiveness

Datamonitor drug assessment score card for Aprela

Satisfaction of unmet needs

Forecasts to 2018

Arzoxifene (LY353381, Eli Lilly)

Drug overview

SWOT analysis

Clinical trial data

Clinical attractiveness

Commercial attractiveness

Datamonitor drug assessment score card for arzoxifene

Satisfaction of unmet needs

Forecasts to 2018

Parathyroid hormones and analogs - key late-stage pipeline

Pipeline summary

Comparative forecasts

ZT-031 (previously Ostabolin-C, Zelos Therapeutics)

Drug overview

SWOT analysis

Clinical trial data

Clinical attractiveness

Commercial attractiveness

Datamonitor drug assessment score card for ZT-031

Satisfaction of unmet needs

Forecasts to 2018

ZP-PTH (hPTH1-34, Zosano Pharma)

Drug overview

SWOT analysis

Clinical trial data

Clinical attractiveness

Commercial attractiveness

Datamonitor drug assessment score card for ZP-PTH

Satisfaction of unmet needs

Forecasts to 2018

Calcitonins - key late-stage pipeline

Pipeline summary

Capsitonin (BN-002, Bone medical)

Drug overview

SWOT analysis

Clinical trial data

Clinical attractiveness

Commercial attractiveness

Datamonitor drug assessment score card for capsitonin

Satisfaction of unmet needs

Forecasts to 2018

Other drugs - key late-stage pipeline

Pipeline summary

Comparative forecasts

Denosumab (AMG-162, Amgen)

Drug overview

SWOT analysis

Clinical trial data

Clinical attractiveness

Commercial attractiveness

Datamonitor drug assessment score card for denosumab

Satisfaction of unmet needs

Forecasts to 2018

Odanacatib (MK0822, Merck & Co)

Drug overview

SWOT analysis

Clinical trial data

Clinical attractiveness

Commercial attractiveness

Datamonitor drug assessment score card for odanacatib

Satisfaction of unmet needs

Forecasts to 2018

Eldecalcitol (ED-71, Chugai/Taisho)

Drug overview

SWOT analysis

Clinical trial data

Clinical attractiveness

Commercial attractiveness

Datamonitor drug assessment score card for eldecalcitol

Satisfaction of unmet needs

Forecasts to 2018

Key early-stage compounds in osteoporosis

BIBLIOGRAPHY

Journal papers, books, and conference abstracts

Websites

Datamonitor reports

APPENDIX A

Data definitions, limitations and assumptions

Standard units

Derivation of sales forecasts and pricing trends

Methodology

Indication-specific sales calculations

Forecast assumptions

APPENDIX B

Contributing experts

About Datamonitor

About Datamonitor Healthcare

About the Urology and Gender specifc Health analysis team

Disclaimer

List of Tables

Table 1: Sales forecast for key marketed brands in osteoporosis across the seven major markets, 2008-2018

Table 2: Sales forecast for pipeline products in osteoporosis in the seven major markets ($m), 2009-2018

Table 3: Risk factors (-) and protective factors (+) for axial and appendicular bone mineral density in women aged 65 years and over

Table 4: Fracture risk assessment tool (FRAX) questionnaire, 2009

Table 5: 10-year probability of osteoporotic fractures (%), according to BMD T-score at the femoral neck in women aged 65 years from the UK n

Table 6: Causes of male osteoporosis

Table 7: Summary of osteoporosis prevalence studies in the seven major markets, 2009

Table 8: Osteopenia epidemiology across the seven major markets, 2009

Table 9: Osteoporosis epidemiology across the seven major markets, 2009

Table 10: Severe osteoporosis epidemiology across the seven major markets, 2009

Table 11: Summary of osteoporosis epidemiology of women over 50 years of age across the seven major markets, 2009

Table 12: Estimated osteoporosis epidemiology of women over 50 years of age across the seven major markets, 2020

Table 13: Prevalence of osteopenia in men over 50 across the seven major markets, 2009

Table 14: Prevalence of osteoporosis in men over 50 across the seven major markets, 2009

Table 15: Estimated female hip fracture prevalence in Brazil, 2009, 2015 and 2020

Table 16: Estimated male hip fracture prevalence in Brazil, 2009, 2015 and 2020

Table 17: Estimated number of female hip fractures in Russia, North America and Europe, 1990, 2025, and 2050

Table 18: Estimated number of male hip fractures in Russia, North America, Europe, 1990, 2025 and 2050

Table 19: Female prevalence of osteopenia in India, 2009, 2015 and 2020

Table 20: Female prevalence of osteoporosis in India, 2009, 2015 and 2020

Table 21: Estimated number of hip fractures in Chinese women, 2009, 2015 and 2020

Table 22: Estimated female osteoporosis prevalence in China, 2009, 2015, 2020

Table 23: Estimated male osteoporosis prevalence in China, 2009, 2015, 2020

Table 24: Estimated number of osteoporotic fractures by site, in men and women aged 50 years and over by region, in 2000

Table 25: Key medications currently approved for osteoporosis treatment across the seven major markets, 2009

Table 26: Key marketed bisphosphonates in osteoporosis across the seven major markets, 2009

Table 27: Marketed selective estrogen receptor modulators in osteoporosis across the seven major markets, 2009

Table 28: Marketed parathyroid hormones in osteoporosis, 2009

Table 29: Key marketed calcitonins in osteoporosis across the seven major markets, 2009

Table 30: Key dual acting bone agents marketed across the seven major markets, 2009

Table 31: Summary of key drugs in osteoporosis side effects and safety profiles, 2009

Table 32: Osteoporosis target product profile, 2009

Table 33: Summary of therapeutic classes in osteoporosis by ATC code, 2009

Table 34: Summary of the ICD-10 codes used to derive osteoporosis-specific sales from each brand

Table 35: Regional osteoporosis market sales ($m) dynamics across the seven major markets, 2004-2018

Table 36: ATC class sales ($m) in osteoporosis across the seven major markets, 2004-2018

Table 37: Key marketed brand sales ($m) in osteoporosis across the seven major markets, 2004-08

Table 38: Sales forecast for key marketed brands in osteoporosis across the seven major markets, 2008-2018

Table 39: Key events impacting the osteoporosis market, 2009-2018

Table 40: Global sales ($m) dynamics of the osteoporosis market, 2004-08

Table 41: Regional split of the global osteoporosis market sales, 2004-08

Table 42: Global osteoporosis market volume (IMS standard unit) sales by ATC class, 2008

Table 43: Representative formulary tier status in the US for leading brands in osteoporosis, 2009

Table 44: EU osteoporosis treatment reimbursement policies, 2008

Table 45: Fosamax: key facts, 2009

Table 46: Impacting factors on the revenues of Fosamax brand franchise, 2009-2018

Table 47: Actonel: key facts, 2009

Table 48: Impacting factors on the revenues of the Actonel brand franchise, 2009-2018

Table 49: Bonviva: key facts, 2009

Table 50: Impacting factors on the revenues of Bonviva brand franchise, 2009-2018

Table 51: Aclasta: key facts, 2009

Table 52: Impacting factors on the revenues of Aclasta, 2009-2018

Table 53: Bonoteo: key facts, 2009

Table 54: Impacting factors on the revenues of Bonoteo, 2009-2018

Table 55: Evista: key facts, 2009

Table 56: Impacting factors on the revenues of Evista, 2009-2018

Table 57: Forteo: key facts, 2009

Table 58: Impacting factors on the revenues of Forteo, 2009-2018

Table 59: Preotact: key facts, 2009

Table 60: Impacting factors on the revenues of Preotact, 2009-2018

Table 61: Protelos: key facts, 2009

Table 62: Impacting factors on the revenues of Protelos, 2009-2018

Table 63: Miacalcic: key facts, 2009

Table 64: Impacting factors on the revenues of Miacalcic, 2009-2018

Table 65: Fortical: key facts, 2009

Table 66: Impacting factors on the revenues of Fortical, 2009-2018

Table 67: R&D drug pipeline for osteoporosis, 2009

Table 68: Sales forecast for pipeline products in osteoporosis in the seven major markets ($m), 2009-2018

Table 69: Amgen's osteoporosis pipeline, 2009

Table 70: FDA and EMEA preclinical study requirements for osteoporosis drug approval, 2009

Table 71: Summary of the key FDA and EMEA Phase III clinical trial requirements in osteoporosis, 2009

Table 72: FDA recommended primary efficacy points for prevention and treatment studies

Table 73: Biomarkers for bone formation and bone resorption, 2009

Table 74: Defining the gold standard for osteoporosis: key clinical trial results for Fosamax

Table 75: Key efficacy data for Fosamax (alendronate), Evista (raloxifene) Forteo (teriparatide) and Miacalcic (calcitonin-salmon) in the treatment of osteoporosis

Table 76: Key products in the late-stage bisphosphonate pipeline for osteoporosis, 2009

Table 77: EX101: key facts, 2009

Table 78: Sales forecasts ($m) for EX101 in the seven major markets, 2011-18

Table 79: Impacting factors on the revenues of EX101, 2011-18

Table 80: Almerol: key facts, 2009

Table 81: Sales ($m) forecasts for Almerol in the seven major markets, 2014-18

Table 82: Impacting factors on the revenues of Almerol, 2014-18

Table 83: Recently discontinued late-stage bisphosphonates, 2009

Table 84: Key products in the late-stage selective estrogen receptor modulator (SERM) pipeline for osteoporosis, 2009

Table 85: Fablyn: key facts, 2009

Table 86: Summary of key Phase III clinical trials for Fablyn (lasofoxifene)

Table 87: Cumulative outcomes of 3 years treatment with Fablyn (lasofoxifene) versus placebo (rate per 1,000 subjects over 3 years)

Table 88: Sales ($m) forecasts for Fablyn in the seven major markets, 2010-18

Table 89: Impacting factors on the revenues of Fablyn, 2010-18

Table 90: Conbriza: key facts, 2009

Table 91: Summary of key Phase III clinical trials for Conbriza (bazedoxifene)

Table 92: Summary of fracture data from Conbriza (bazedoxifene) Phase III clinical trial

Table 93: Sales forecasts for Conbriza in the seven major markets, 2009-2018 ($m)

Table 94: Impacting factors on the revenues of Conbriza, 2009-2018

Table 95: Aprela: key facts, 2009

Table 96: Aprela forecast osteoporosis sales ($m) across the seven major markets, 2011-2018

Table 97: Impacting factors on the revenues of Aprela, 2011-18

Table 98: Arzoxifene: key facts, 2009

Table 99: Summary of key clinical trials for arzoxifene

Table 100: Arzoxifene Phase III study results, 2009

Table 101: Phase III trial in postmenopausal women to determine the efficacy of arzoxifene on fracture risk and breast cancer, 2009

Table 102: Arzoxifene forecast osteoporosis sales ($m) across the seven major markets, 2012-2018

Table 103: Impacting factors on the revenues of arzoxifene, 2012-18

Table 104: Key products in the late-stage parathyroid hormone (PTH) pipeline for osteoporosis, 2009

Table 105: ZT-031: key facts, 2009

Table 106: ZT-031 forecast osteoporosis sales ($m) across the seven major markets, 2014-18

Table 107: Impacting factors on the revenues of ZT-031, 2014-18

Table 108: ZP-PTH: key facts, 2009

Table 109: ZP-PTH forecast osteoporosis sales ($m) across the seven major markets, 2015-18

Table 110: Impacting factors on the revenues of ZP-PTH, 2015-18

Table 111: Key products in the late-stage calcitonin pipeline for osteoporosis, 2009

Table 112: Capsitonin: key facts, 2009

Table 113: Capsitonin forecast osteoporosis sales ($m) across the seven major markets, 2013-18

Table 114: Impacting factors on the revenues of capsitonin, 2013-18

Table 115: Key products in the late-stage 'other treatments' pipeline for osteoporosis, 2009

Table 116: Denosumab: key facts, 2009

Table 117: Summary of key denosumab studies, 2009

Table 118: Denosumab Phase III DECIDE clinical trial results

Table 119: Japanese Phase III trial in postmenopausal women to determine the efficacy of denosumab in reducing fracture risk, 2009

Table 120: Denosumab forecast osteoporosis sales ($m) across the seven major markets, 2010-18

Table 121: Impacting factors on the revenues of denosumab, 2010-18

Table 122: Odanacatib: key facts, 2009

Table 123: Phase III trial in postmenopausal women to determine the efficacy of odanacatib in reducing fracture risk, 2009

Table 124: Phase III trial in postmenopausal women to determine the efficacy of odanacatib on bone mineral density (BMD), 2009

Table 125: Phase III trial in postmenopausal women to determine the safety and efficacy of odanacatib on bone mineral density (BMD), 2009

Table 126: Odanacatib forecast osteoporosis sales ($m) across the seven major markets, 2014-18

Table 127: Impacting factors on the revenues of odanacatib, 2014-18

Table 128: Eldecalcitol: key facts, 2009

Table 129: Summary of key clinical trials for eldecalcitol

Table 130: Eldecalcitol forecast osteoporosis sales ($m) across the seven major markets, 2011-18

Table 131: Impacting factors on the revenues of eldecalcitol, 2011-18

Table 132: Summary of products in preclinical trials for the treatment of osteoporosis, 2009

Table 133: Patent expiry dates for key marketed brands in osteoporosis in the US and Japan, 2009

Table 134: Patent expiry dates for key marketed brands in osteoporosis in the five major European market regions, 2009

Table 135: Estimated launch dates for key late stage pipeline products and marketed brands in the seven major market regions, 2009-2018

Table 136: Datamonitor drug assessment parameters for pipeline bisphosphonate products, 2009

Table 137: Datamonitor drug assessment parameters for pipeline selective estrogen receptor modulators (SERMs) products, 2009

Table 138: Datamonitor drug assessment parameters for pipeline parathyroid hormone (PTH) products, 2009

Table 139: Datamonitor drug assessment parameters for pipeline calcitonins products, 2009

Table 140: Datamonitor drug assessment parameters for pipeline other products, 2009

Abstract

• Patient potential analysis across the seven major markets and BRIC nations (Brazil, Russia, India, and China).
• Analysis of global osteoporosis prescriptions from 20042008, split by geographical region, drug class, molecule, and brand.
• In depth profiles of key current osteoporosis brands including SWOT analyses and country-specific sales forecasts to 2018.
• R&D pipeline analysis with detailed profiles and forecasts of key agents, including Amgen's denosumab and new selective estrogen receptor modulators.

• Understand current and future osteoporosis drug market dynamics
• Gain insight into the unmet needs of current osteoporosis treatment and to what extent pipeline drugs will address these issues
• Evaluate the sales forecasts of marketed, generic, and key pipeline drugs to 2018 in the US, Japan, France, Germany, Italy, Spain, and the UK

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