Disease Overview
Osteoporosis is the most common metabolic bone disorder, and is characterized by low bone mass accompanied by microarchitectural deterioration of bone tissue.
The consequent increase in bone fragility results in osteoporosis patients being prone to sustaining fractures.
Although the majority of osteoporosis patients are postmenopausal women, it is not a female-only disease. It is estimated that one in three women and one in five men aged over 50 years will sustain an osteoporosis-related fracture.
Market Snapshot
Osteoporosis is the most common metabolic bone disorder, and is characterized by low bone mass accompanied by microarchitectural deterioration of bone tissue.
The consequent increase in bone fragility results in osteoporosis patients being prone to sustaining fractures.
Although the majority of osteoporosis patients are postmenopausal women, it is not a female-only disease. It is estimated that one in three women and one in five men aged over 50 years will sustain an osteoporosis-related fracture.
Market Snapshot
- Prolia will drive growth of the US market, while Forteo losses will halt growth in Japan and the EU.
- The oral bisphosphonate alendronate dominates the treatment of all severities of low bone mass.
- Forecasted growth in the total prevalence of osteopenia and osteoporosis will be driven by aging populations.
- Biosimilar erosion and new anabolic entrants with superior efficacy are set to erode Forteo’s blockbuster sales.
- The arrival of Amgen’s Evenity will be delayed due to safety issues.
Table of Contents
FORECAST: OSTEOPOROSIS
Overview
Executive Summary
Market Overview And Trends
Market Definition And Methodology
Actonel
Boniva
Duavee
Edirol
Evenity
Evista
Forteo And Movymia
Fosamax
Prolia
Reclast
Tymlos
Primary Research Methodology
Executive Summary
Market Overview And Trends
Market Definition And Methodology
Actonel
Boniva
Duavee
Edirol
Evenity
Evista
Forteo And Movymia
Fosamax
Prolia
Reclast
Tymlos
Primary Research Methodology
TREATMENT: OSTEOPOROSIS
Overview
Executive Summary
Primary Research Methodology
Disease Definition And Diagnosis
Patient Segmentation
Current Treatment Options
Prescribing Trends
Treatment Trends In Osteopenia
Treatment Trends In Osteoporosis
Treatment Trends In Severe Osteoporosis
Compliance Rates
Unmet Needs In Osteoporosis
Executive Summary
Primary Research Methodology
Disease Definition And Diagnosis
Patient Segmentation
Current Treatment Options
Prescribing Trends
Treatment Trends In Osteopenia
Treatment Trends In Osteoporosis
Treatment Trends In Severe Osteoporosis
Compliance Rates
Unmet Needs In Osteoporosis
EPIDEMIOLOGY: OSTEOPOROSIS
Overview
Disease Background
Methodology
Forecast: Osteopenia
Forecast: Osteoporosis
Bibliography
Appendix: Additional Sources
Disease Background
Methodology
Forecast: Osteopenia
Forecast: Osteoporosis
Bibliography
Appendix: Additional Sources
MARKETED DRUGS: OSTEOPOROSIS
Overview
Product Overview
Bisphosphonates
Estrogens And Serms
Calcitonin
Anabolic Therapies
Other Drug Classes
Product Profile: Forteo
Product Profile: Prolia
Product Profile: Tymlos
Product Overview
Bisphosphonates
Estrogens And Serms
Calcitonin
Anabolic Therapies
Other Drug Classes
Product Profile: Forteo
Product Profile: Prolia
Product Profile: Tymlos
PIPELINE: OSTEOPOROSIS
Overview
Clinical Pipeline Overview
Comparator Therapy
Recently Discontinued Drugs
Additional Pharma Intelligence Pipeline Resources
Product Profile: Evenity
Clinical Pipeline Overview
Comparator Therapy
Recently Discontinued Drugs
Additional Pharma Intelligence Pipeline Resources
Product Profile: Evenity
LIST OF FIGURES
Figure 1: Osteoporosis drug sales across the US, Japan, and five major EU markets, by country, 2016–25
Figure 2: Osteoporosis sales in the US, by class, 2016–25
Figure 3: Osteoporosis sales for Edirol, generic eldecalcitol, Forteo, and Evenity in Japan, by product, 2016–25
Figure 4: Osteoporosis sales for Forteo, Movymia, biosimilar teriparatide, Evenity, and Tymlos across the US, Japan, and five major EU markets, 2016–25
Figure 5: Osteoporosis sales for branded and generic bisphosphonates across the US, Japan, and five major EU markets, 2016–25
Figure 6: Patient-based forecast methodology for osteoporosis
Figure 7: Price sources and calculations, by country
Figure 8: Actonel sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 9: Generic risedronate sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 10: Boniva sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 11: Generic ibandronate sales for osteoporosis across the US, Germany, Italy, Spain, and the UK, by country, 2016–25
Figure 12: Duavee sales for osteoporosis across the US and Italy, by country, 2016–25
Figure 13: Edirol sales for osteoporosis in Japan, 2016–25
Figure 14: Generic eldecalcitol sales for osteoporosis in Japan, 2016–25
Figure 15: Evenity sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 16: Evista sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 17: Forteo sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 18: Movymia sales for osteoporosis across the five major EU markets, by country, 2016–25
Figure 19: Biosimilar teriparatide sales for osteoporosis in the US, 2016–25
Figure 20: Fosamax sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 21: Generic alendronate sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 22: Prolia sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 23: Biosimilar denosumab sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 24: Reclast sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 25: Tymlos sales for osteoporosis across the US and five major EU markets, by country, 2016–25
Figure 26: Percentage of patients with low bone mass diagnosed at each disease subtype for the US, Japan, and five major EU markets
Figure 27: Segmentation of patients suffering from low bone mass in the US, Japan, and five major EU markets, by disease severity and country
Figure 28: Percentage of patients receiving each line of therapy, by severity
Figure 29: Percentage of diagnosed patients receiving each type of therapy for the treatment of osteopenia, by country
Figure 30: Percentage of diagnosed patients receiving each class of pharmacological therapy for the first-line treatment of osteopenia, by country
Figure 31: Top three first-line treatment regimens for osteopenia patients, by country
Figure 32: Percentage of diagnosed patients receiving each type of therapy for the treatment of osteoporosis, by country
Figure 33: Percentage of diagnosed patients receiving each class of pharmacological therapy for the first-line treatment of osteoporosis, by country
Figure 34: Top three first-line treatment regimens for osteoporosis patients, by country
Figure 35: Top three second-line treatment regimens for osteoporosis patients, by country
Figure 36: Top three third-line treatment regimens for osteoporosis patients, by country
Figure 37: Top three first-line treatment regimens for severe osteoporosis patients, by country
Figure 38: Top three second-line treatment regimens for severe osteoporosis patients, by country
Figure 39: Percentage of diagnosed patients receiving each class of pharmacological therapy for the third-line treatment of severe osteoporosis, by country
Figure 40: Compliance rates of patients suffering from low bone mass in the US, Japan, and five major EU markets, by country and disease subtype
Figure 41: Key unmet needs in osteoporosis treatment across the US, Japan, and five major EU markets
Figure 42: Trends in total prevalent cases of osteopenia in the US, Japan, and five major EU markets, by country, 2018–38
Figure 43: Trends in total prevalent cases of osteoporosis in the US, Japan, and five major EU markets, by country, 2018–38
Figure 44: Forteo for osteoporosis – SWOT analysis
Figure 45: The authors drug assessment summary of Forteo for osteoporosis
Figure 46: The authors drug assessment summary of Forteo for osteoporosis
Figure 47: Prolia for osteoporosis – SWOT analysis
Figure 48: The authors drug assessment summary of Prolia for osteoporosis
Figure 49: The authors drug assessment summary of Prolia for osteoporosis
Figure 50: Tymlos for osteoporosis – SWOT analysis
Figure 51: The authors drug assessment summary of Tymlos for osteoporosis
Figure 52: The authors drug assessment summary of Tymlos for osteoporosis
Figure 53: Evenity for osteoporosis – SWOT analysis
Figure 54: The authors drug assessment summary of Evenity for osteoporosis
Figure 55: The authors drug assessment summary of Evenity for osteoporosis
Figure 2: Osteoporosis sales in the US, by class, 2016–25
Figure 3: Osteoporosis sales for Edirol, generic eldecalcitol, Forteo, and Evenity in Japan, by product, 2016–25
Figure 4: Osteoporosis sales for Forteo, Movymia, biosimilar teriparatide, Evenity, and Tymlos across the US, Japan, and five major EU markets, 2016–25
Figure 5: Osteoporosis sales for branded and generic bisphosphonates across the US, Japan, and five major EU markets, 2016–25
Figure 6: Patient-based forecast methodology for osteoporosis
Figure 7: Price sources and calculations, by country
Figure 8: Actonel sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 9: Generic risedronate sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 10: Boniva sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 11: Generic ibandronate sales for osteoporosis across the US, Germany, Italy, Spain, and the UK, by country, 2016–25
Figure 12: Duavee sales for osteoporosis across the US and Italy, by country, 2016–25
Figure 13: Edirol sales for osteoporosis in Japan, 2016–25
Figure 14: Generic eldecalcitol sales for osteoporosis in Japan, 2016–25
Figure 15: Evenity sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 16: Evista sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 17: Forteo sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 18: Movymia sales for osteoporosis across the five major EU markets, by country, 2016–25
Figure 19: Biosimilar teriparatide sales for osteoporosis in the US, 2016–25
Figure 20: Fosamax sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 21: Generic alendronate sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 22: Prolia sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 23: Biosimilar denosumab sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 24: Reclast sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 25: Tymlos sales for osteoporosis across the US and five major EU markets, by country, 2016–25
Figure 26: Percentage of patients with low bone mass diagnosed at each disease subtype for the US, Japan, and five major EU markets
Figure 27: Segmentation of patients suffering from low bone mass in the US, Japan, and five major EU markets, by disease severity and country
Figure 28: Percentage of patients receiving each line of therapy, by severity
Figure 29: Percentage of diagnosed patients receiving each type of therapy for the treatment of osteopenia, by country
Figure 30: Percentage of diagnosed patients receiving each class of pharmacological therapy for the first-line treatment of osteopenia, by country
Figure 31: Top three first-line treatment regimens for osteopenia patients, by country
Figure 32: Percentage of diagnosed patients receiving each type of therapy for the treatment of osteoporosis, by country
Figure 33: Percentage of diagnosed patients receiving each class of pharmacological therapy for the first-line treatment of osteoporosis, by country
Figure 34: Top three first-line treatment regimens for osteoporosis patients, by country
Figure 35: Top three second-line treatment regimens for osteoporosis patients, by country
Figure 36: Top three third-line treatment regimens for osteoporosis patients, by country
Figure 37: Top three first-line treatment regimens for severe osteoporosis patients, by country
Figure 38: Top three second-line treatment regimens for severe osteoporosis patients, by country
Figure 39: Percentage of diagnosed patients receiving each class of pharmacological therapy for the third-line treatment of severe osteoporosis, by country
Figure 40: Compliance rates of patients suffering from low bone mass in the US, Japan, and five major EU markets, by country and disease subtype
Figure 41: Key unmet needs in osteoporosis treatment across the US, Japan, and five major EU markets
Figure 42: Trends in total prevalent cases of osteopenia in the US, Japan, and five major EU markets, by country, 2018–38
Figure 43: Trends in total prevalent cases of osteoporosis in the US, Japan, and five major EU markets, by country, 2018–38
Figure 44: Forteo for osteoporosis – SWOT analysis
Figure 45: The authors drug assessment summary of Forteo for osteoporosis
Figure 46: The authors drug assessment summary of Forteo for osteoporosis
Figure 47: Prolia for osteoporosis – SWOT analysis
Figure 48: The authors drug assessment summary of Prolia for osteoporosis
Figure 49: The authors drug assessment summary of Prolia for osteoporosis
Figure 50: Tymlos for osteoporosis – SWOT analysis
Figure 51: The authors drug assessment summary of Tymlos for osteoporosis
Figure 52: The authors drug assessment summary of Tymlos for osteoporosis
Figure 53: Evenity for osteoporosis – SWOT analysis
Figure 54: The authors drug assessment summary of Evenity for osteoporosis
Figure 55: The authors drug assessment summary of Evenity for osteoporosis
LIST OF TABLES
Table 1: Osteoporosis drug sales across the US, Japan, and five major EU markets, by country, 2016–25
Table 2: Osteoporosis sales in the US, by brand and class, 2016–25
Table 3: Osteoporosis sales in Japan, by brand and class, 2016–25
Table 4: Osteoporosis sales in the five major EU markets, by brand and class, 2016–25
Table 5: Summary of drug classes and molecules in The authors osteoporosis patient-based forecast
Table 6: Exchange rates used for calculating prices
Table 7: Patent expiry dates for key marketed brands in osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 8: Estimated launch dates for key late-stage osteoporosis pipeline candidates in the US, Japan, and five major EU markets, by country, 2016–25
Table 9: Actonel sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 10: Generic risedronate sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 11: Boniva sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 12: Generic ibandronate sales for osteoporosis across the US, Germany, Italy, Spain, and the UK, by country, 2016–25
Table 13: Duavee sales for osteoporosis across the US and Italy, by country, 2016–25
Table 14: Edirol sales for osteoporosis in Japan, 2016–25
Table 15: Generic eldecalcitol sales for osteoporosis in Japan, 2016–25
Table 16: Evenity sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 17: Evista sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 18: Forteo sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 19: Movymia sales for osteoporosis across the five major EU markets, by country, 2016–25
Table 20: Biosimilar teriparatide sales for osteoporosis in the US, 2016–25
Table 21: Fosamax sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 22: Generic alendronate sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 23: Prolia sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 24: Biosimilar denosumab sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 25: Reclast sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 26: Tymlos sales for osteoporosis across the US and five major EU markets, by country, 2016–25
Table 27: Physicians surveyed for the osteoporosis primary research study, 2016
Table 28: Physicians surveyed for the osteoporosis primary research study, 2016
Table 29: World Health Organization definitions of bone mass based on BMD
Table 30: Clinical risk factors included in FRAX scoring
Table 31: Selected bisphosphonates products for the treatment of osteoporosis across the US, Japan, and five major EU markets
Table 32: Selected SERMs and estrogen products for the treatment of osteoporosis across the US, Japan, and five major EU markets
Table 33: Calcitonin products for the treatment of osteoporosis across the US, Japan, and five major EU markets
Table 34: Other drugs available for the treatment of osteoporosis across the US, Japan, and five major EU markets
Table 35: Low bone mass patients treated with pharmacological therapy in the US, Japan, and five major EU markets, by country
Table 36: Top three third-line treatment regimens for osteopenia patients, by country
Table 37: Sources used for the epidemiological analysis of osteopenia and osteoporosis in the US, Japan, and five major EU markets, by country
Table 38: Total prevalent cases of osteopenia in the US, Japan, and five major EU markets, by country, 2018–38
Table 39: Total prevalent cases of osteoporosis in the US, Japan, and five major EU markets, by country, 2018–38
Table 40: Key marketed drugs for osteoporosis
Table 41: Bisphosphonate class overview
Table 42: Estrogens/SERMs class overview
Table 43: Salmon calcitonin class overview
Table 44: Anabolic class overview
Table 45: Other drug classes overview
Table 46: Forteo drug profile
Table 47: Forteo pivotal trial data in osteoporosis
Table 48: Forteo late-phase trial data in osteoporosis
Table 49: Prolia drug profile
Table 50: Prolia pivotal trial data in osteoporosis
Table 51: Prolia late-phase trial data in osteoporosis
Table 52: Tymlos drug profile
Table 53: Tymlos Phase III trial data in osteoporosis
Table 54: Tymlos planned Phase III trials in osteoporosis
Table 55: Phase III pipeline products in development for osteoporosis
Table 56: Forteo drug profile
Table 57: Forteo trial data in osteoporosis
Table 58: Late-stage compounds that were recently discontinued for osteoporosis
Table 59: Odanacatib drug profile
Table 60: Odanacatib trial data in osteoporosis
Table 61: Evenity drug profile
Table 62: Evenity pivotal trial data in osteoporosis
Table 63: Evenity other late-phase trials in osteoporosis
Table 2: Osteoporosis sales in the US, by brand and class, 2016–25
Table 3: Osteoporosis sales in Japan, by brand and class, 2016–25
Table 4: Osteoporosis sales in the five major EU markets, by brand and class, 2016–25
Table 5: Summary of drug classes and molecules in The authors osteoporosis patient-based forecast
Table 6: Exchange rates used for calculating prices
Table 7: Patent expiry dates for key marketed brands in osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 8: Estimated launch dates for key late-stage osteoporosis pipeline candidates in the US, Japan, and five major EU markets, by country, 2016–25
Table 9: Actonel sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 10: Generic risedronate sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 11: Boniva sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 12: Generic ibandronate sales for osteoporosis across the US, Germany, Italy, Spain, and the UK, by country, 2016–25
Table 13: Duavee sales for osteoporosis across the US and Italy, by country, 2016–25
Table 14: Edirol sales for osteoporosis in Japan, 2016–25
Table 15: Generic eldecalcitol sales for osteoporosis in Japan, 2016–25
Table 16: Evenity sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 17: Evista sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 18: Forteo sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 19: Movymia sales for osteoporosis across the five major EU markets, by country, 2016–25
Table 20: Biosimilar teriparatide sales for osteoporosis in the US, 2016–25
Table 21: Fosamax sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 22: Generic alendronate sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 23: Prolia sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 24: Biosimilar denosumab sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 25: Reclast sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
Table 26: Tymlos sales for osteoporosis across the US and five major EU markets, by country, 2016–25
Table 27: Physicians surveyed for the osteoporosis primary research study, 2016
Table 28: Physicians surveyed for the osteoporosis primary research study, 2016
Table 29: World Health Organization definitions of bone mass based on BMD
Table 30: Clinical risk factors included in FRAX scoring
Table 31: Selected bisphosphonates products for the treatment of osteoporosis across the US, Japan, and five major EU markets
Table 32: Selected SERMs and estrogen products for the treatment of osteoporosis across the US, Japan, and five major EU markets
Table 33: Calcitonin products for the treatment of osteoporosis across the US, Japan, and five major EU markets
Table 34: Other drugs available for the treatment of osteoporosis across the US, Japan, and five major EU markets
Table 35: Low bone mass patients treated with pharmacological therapy in the US, Japan, and five major EU markets, by country
Table 36: Top three third-line treatment regimens for osteopenia patients, by country
Table 37: Sources used for the epidemiological analysis of osteopenia and osteoporosis in the US, Japan, and five major EU markets, by country
Table 38: Total prevalent cases of osteopenia in the US, Japan, and five major EU markets, by country, 2018–38
Table 39: Total prevalent cases of osteoporosis in the US, Japan, and five major EU markets, by country, 2018–38
Table 40: Key marketed drugs for osteoporosis
Table 41: Bisphosphonate class overview
Table 42: Estrogens/SERMs class overview
Table 43: Salmon calcitonin class overview
Table 44: Anabolic class overview
Table 45: Other drug classes overview
Table 46: Forteo drug profile
Table 47: Forteo pivotal trial data in osteoporosis
Table 48: Forteo late-phase trial data in osteoporosis
Table 49: Prolia drug profile
Table 50: Prolia pivotal trial data in osteoporosis
Table 51: Prolia late-phase trial data in osteoporosis
Table 52: Tymlos drug profile
Table 53: Tymlos Phase III trial data in osteoporosis
Table 54: Tymlos planned Phase III trials in osteoporosis
Table 55: Phase III pipeline products in development for osteoporosis
Table 56: Forteo drug profile
Table 57: Forteo trial data in osteoporosis
Table 58: Late-stage compounds that were recently discontinued for osteoporosis
Table 59: Odanacatib drug profile
Table 60: Odanacatib trial data in osteoporosis
Table 61: Evenity drug profile
Table 62: Evenity pivotal trial data in osteoporosis
Table 63: Evenity other late-phase trials in osteoporosis
