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

Datamonitor
July 13, 2009
375 Pages - SKU: DFMN2391585

Abstract Table of Contents Related Reports

Introduction

Osteoporosis continues to be an attractive therapy area for large pharmaceutical companies due to its high prevalence rate and unmet need. Globally, sales for osteoporosis drugs grew 7.0% year-on-year from 2004 to $9.6 billion in 2008 driven by strong performance of the bisphosphonate class.

Scope

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.

Highlights

The osteoporosis seven major market value was $7.1 billion in 2008, 76.4% of the global market. Although between 2007 and 2008 the market declined due to generic penetration of the market leading brand Fosamax (alendronate, Merck & Co), the launch of new pipeline drugs will result in a significant market growth.

The launch of four pipeline selective estrogen receptor modulators (SERMs) between 2009 and 2012 will boost class sales across the seven major markets. However, the challenge for marketing companies is to convince prescribers in the EU, where uptake has historically been low, of the effect of SERMs in the wider patient group.

The largest growth driver of the osteoporosis market over the forecast period is expected to be Amgen's denosumab, potentially the first monoclonal antibody to market. However, success will rely on a good long-term safety profile and price competitiveness, which are relative unknowns at this stage.

Reasons to Purchase

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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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

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

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