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Prolia® Demand Forecast- Osteoporosis Market (2010-2012)
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Methodology2010 Totals (Y1)2011 Totals (Y2)2012 Totals (Y3)Rationale/Assumption (with links to sources)
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General Osteoporosis Market:
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Total population with Osteoporosis in the U.S. 30,700,000Amgen prediction stated in the case (p.8)
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Diagnosed population with Osteoporosis in the U.S.15,500,000Stated in the case (p.8)
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Diagnosed-treated population with Osteoporosis in the U.S.5,600,000Stated in the case (p.5)
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Diagnosed-untreated population with Osteoporosis in the U.S.9,900,000Based on data above from case
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Diagnosed-treated population continuing to see declining BMD levels (intolerant)2,240,00040%- stated in case (p.8)
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Diagnosed-treated population with Osteoporosis in the U.S. with fractures (intolerant)280,0005%- stated in case (p.8)
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Diagnosed-treated population with Osteoporosis unsatisfied with existing treatment options1,960,00035% unsatisfied based on 65% satisfied/prefer Prolia based Study 141 satisfaction survey results (case p.6) * diagnosed treated population
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Diagnosed-treated population with Osteoporosis intolerant to existing treatment options2,520,000Sum of both intolerant groups listed above
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Market share assumption5%Assumption given there are 7 competitors and current market share of each stated in the case (p.15)
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Primary Target Segmentation:
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Indication/Demographics: Postmenopausal women aged 55+ in the U.S. with Osteoporosis
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Postmenopausal women aged 55+ in the U.S.40,230,000Based on 2010 U.S. Census data proving women usually have menopause by age 55
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Postmenopausal women diagnosed with Osteoporosis in the U.S.12,400,000Women comprise of 80% diagnosed with Osteoporosis
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Diagnosed-treated postmenopausal women in the U.S.6,885,72055.53% treatment rate based on study of postmenopausal women
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Diagnosed-untreated postmenopausal women in the U.S.5,514,280Difference between diagnosed and treated postmenopausal women in U.S.
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Insurance Coverage: Medicare & Private Insurance
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Postmenopausal women aged 55+ with private insurance13,541,41861.2% of people under age 65 had private health insurance in 2010; assume 55% are female based on Medicare data- 33.66% women applied to number of postmenopausal women in U.S.
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Postmenopausal women diagnosed with Osteoporosis with private insurance in the U.S.1,895,7992007-2008 14% prevalence rate of osteoporosis in women applied to number of postmenopausal women with private insurance
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Postmenopausal women aged 65+ with Medicare 25,743,000Medicare enrollment data from 2010
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Postmenopausal women diagnosed with Osteoporosis with Medicare in the U.S.3,604,0202007-2008 14% prevalence rate of osteoporosis in women applied to number of postmenopausal women with Medicare
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Diagnosed-insured postmenopausal women with Osteoporosis in the U.S.5,499,819Sum of Postmenopausal women with OP & Medicare, Postmenopausal women with OP, and private insurance
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Geographic/Healthcare Provider Type: Primary Care in Urban/Suburban Areas in the U.S.
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Number of primary care physicians in the U.S. 94,756Number of general primary care physicians in the U.S. in 2010
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Number of internal medicine physicians in the U.S. 113,591Number of internists in the U.S. in 2010
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Diagnosed postmenopausal women with Osteoporosis who saw their physician in the past year10,478,00084.5% of people saw their physician in the past year applied to number of women diagnosed with Osteoporosis in the U.S.
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Diagnosed-insured postmenopausal women with Osteoporosis in the U.S. who saw their physician in the past year4,647,34784.5% of people saw their physician in the past year applied to total number of insured postmenopausal women with Osteoporosis
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Number of diagnosed-insured postmenopausal women with Osteoporosis living in urban/suburban U.S.4,399,856Based on 80% of 2010 U.S. population living in urban/suburban areas (0.80*diagnosed insured women living in U.S.)
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Number of primary care physicians per 100,000 people in the U.S. in urban/suburban areas8484/100,000 pcp in urban areas
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Psychographic/Behavioral: Newly diagnosed/looking for low-effort treatment
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Postmenopausal women diagnosed with Osteoporosis each year201,1500.5% increase in prevalence each year applied to the total postmenopausal women each year
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Percentage of postmenopausal women diagnosed with Osteoporosis who were recommended medication by their physician59.30%59.3% prescriber rate in postmenopausal women with osteoporosis
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Diagnosed-insured postmenopausal women with Osteoporosis who received Rx from provider2,609,11559% Rx prescriber rate applied to the number of insured urban/suburban postmenopausal women with osteoporosis who see their internists
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Percentage of postmenopausal women diagnosed with Osteoporosis who received Rx from provider and initiated treatment21.70%Based on 37.60% non-initiation rate
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Diagnosed-insured postmenopausal women with Osteoporosis who received Rx from provider and initiated treatment566,17821.7% initiation rate applied to number of women who received Rx
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Percentage of postmenopausal women diagnosed with Osteoporosis who were recommended medication by their physician but did not initiate treatment 37.60%37.6% non-initiation rate of 59.3% prescribed rate
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Diagnosed-insured postmenopausal women with Osteoporosis who received Rx from a provider and did not initiate treatment981,02737.60% non-initiation rate applied to the number of diagnosed women who received Rx from provider
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Percentage of postmenopausal women diagnosed with Osteoporosis did not receive Rx by their physician40.70%Based on 59% prescriber rate
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Diagnosed-insured postmenopausal women with Osteoporosis who did not receive Rx from provider1,790,74140.7 non-prescription rate applied to diagnosed-insured women
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Prolia Annual Demand Forecast:
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Market Capture: Untreated, Unsatisfied, & Intolerant
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Untreated:
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Diagnosed-untreated population with Osteoporosis in the U.S.9,900,000
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Diagnosed-untreated population with Osteopenia in the U.S. not given Rx from provider4,029,300Based on 40.7% non-prescription rate
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Diagnosed-untreated population with Osteopenia in the U.S. given Rx from provider and did not initiate treatment3,722,400Based on 37.60% non-initiation rate
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Total diagnosed-untreated population with Osteoporosis in the U.S.7,751,700Sum of Diagnosed-untreated population with Osteopenia in the U.S. not given Rx from provider + Diagnosed-untreated population with Osteopenia in the U.S. given Rx from provider and did not initiate treatment
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Diagnosed-untreated for Osteoporosis population with market share assumption387,5855% market share applied to total diagnosed-untreated population
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Unsatisfied:
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Diagnosed-treated population with Osteoporosis unsatisfied with existing treatment options1,960,00035% unsatisfied based on 65% satisfied/prefer Prolia based Study 141 satisfaction survey results (case p.6) applied to diagnosed treated population
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Unsatisfied diagnosed-treated population with Osteoporosis in the U.S. given Rx from provider1,162,280Applied 59% prescriber rate to diagnosed unsatisfied population
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Unsatisfied diagnosed-treated population with Osteoporosis in the U.S. given Rx from provider and initiated treatment252,215Applied 21.70% initiation rate to unsatisfied diagnosed population with Rx
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Unsatisfied population with diagnosed-treated Osteoporosis with market share assumption12,6115% market share applied to total diagnosed-unsatisfied population
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Intolerant:
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Diagnosed-treated population with Osteoporosis intolerant to existing treatment options2,520,000
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Intolerant diagnosed-treated population with Osteoporosis given Rx from provider 1,494,360Applied 59% prescriber rate to diagnosed intolerant population
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Intolerant diagnosed-treated population with Osteoporosis given Rx from provider and initiated treatment324,276Applied 21.70% initiation rate to intolerant diagnosed population with Rx
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Intolerant diagnosed-treated population with Osteoporosis with market share assumption16,2145% market share applied to total diagnosed-intolerant population
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Annual increase in new patient pool-420,574424,779Conservative 1% growth rate based on high efficacy but higher pricing and competitive landscape based on information provided in the case
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Market Capture Patients initiating Prolia Rx each year416,410420,574424,779Sum of untreated, unsatisfied, and intolerant populations
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Market Capture patients completing Prolia Rx first time in year416,410420,574424,779Based on 100% completion rate assumption
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Market Capture patients completing Prolia Rx second time in year270,667273,373276,106Estimated at 65% higher than 50% adherence rate cited due to HCP administration and efficacy/safety profile of Prolia (stated in the case on p.3 based on bisphosphonate adherence rate)
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Continuing patient fills from previous years0175,933177,693Estimated at 65% higher than 50% adherence rate cited due to HCP administration and efficacy/safety profile of Prolia (stated in the case on p.3 based on bisphosphonate adherence rate)
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Total Market Capture Demand (in units):687,077869,880878,578Sum of 1st dose, 2nd dose, and continuing patients for market capture patients
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Market Growth: Primary Target & Off-Label Use
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Primary Target:
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Diagnosed-insured urban/suburban postmenopausal women with Osteoporosis who received Rx from provider and initiated treatment566,17821.7% initiation rate applied to number of women who received Rx
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Annual increase in new patient pool-28,59228,878Conservative 1% growth rate based on high efficacy but higher pricing and competitive landscape based on information provided in the case
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Patients initiating Prolia Rx each year28,30928,59228,878Based on the assumption of 5% market share applied to the diagnosed-insured number of women with osteoporosis who received Rx and initiated treatment
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Patients completing Prolia Rx first time in year 28,30928,59228,878Based on 100% completion rate assumption
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Patients completing Prolia Rx second time in year 18,40118,58518,771Estimated at 65% higher than 50% adherence rate cited due to HCP administration and efficacy/safety profile of Prolia (stated in the case on p.3 based on bisphosphonate adherence rate)
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Continuing patient fills from previous years011,96112,080Estimated at 65% higher than 50% adherence rate cited due to HCP administration and efficacy/safety profile of Prolia (stated in the case on p.3 based on bisphosphonate adherence rate)
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Total Primary Target Demand (in units):46,71059,13759,729Sum of 1st dose, 2nd dose, and continuing patients for primary target patients
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Off-label Use:
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Population with Osteopenia in the U.S.43,400,00043.9% osteopenia prevalence in 2010
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Diagnosed-treated population with Osteopenia in the U.S.15,624,00036% of population treated-assumption based on treatment rate for osteoporosis above
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Diagnosed-treated population with Osteopenia in the U.S. given Rx from provider9,265,032Assumption- same rate of Rx provided as osteoporosis population (above)
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Diagnosed-treated population with Osteopenia in the U.S. given Rx from provider and initiated treatment2,010,512Assumption- same rate of Rx provided as osteoporosis population (above)
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Off-Label Use with market share assumption100,5265% market share applied to diagnosed-treated population with Osteopenia
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Annual increase in new patient pool-101,531102,547Conservative 1% growth rate based on high efficacy but higher pricing and competitive landscape based on information provided in the case
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Patients initiating Prolia Rx each year100,526101,531102,5475% market share applied to diagnosed-treated population with Osteopenia
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Patients completing Prolia Rx first time in year 100,526101,531102,547Based on 100% completion rate assumption
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Patients completing Prolia Rx second time in year 65,34265,99566,656Estimated at 65% higher than 50% adherence rate cited due to HCP administration and efficacy/safety profile of Prolia (stated in the case on p.3 based on bisphosphonate adherence rate)
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Continuing patient fills from previous years042,47242,897Estimated at 65% higher than 50% adherence rate cited due to HCP administration and efficacy/safety profile of Prolia (stated in the case on p.3 based on bisphosphonate adherence rate)
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Total Off-label demand (in units):165,868209,998212,099Sum of 1st dose, 2nd dose, and continuing patients for off-label use patients
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Total Market Growth Demand (in units):212,578269,136271,828Sum of primary target & off-label use
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Total expected annual Prolia demand (units)899,6541,139,0161,150,406Sum Market Capture Patients + Market Growth Patients
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Total expected gross revenue$742,214,756 $939,688,252 $949,085,018 Based on sale price of $825/injection
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