nepidemiology and market size database ew microsoft office word document

7/30/2019 NEpidemiology and Market Size Database ew Microsoft Office Word Document

1/13

Epidemiology and Market Size Database

Functionality

o The Epidemiology and Market Size Database of GlobalDatas Pharma eTrackprovides an interactive, comprehensive, and analytical view of the pharmaceuticalmarket in key countries.

o The database has a user-friendly platform that provides flexible data outputoptions. For each indication, content can be browsed by individual countries or by

data type.

o Output data can be graphically displayed by clicking the "graph" button.Content

o The Epidemiology and Market Size Database covers over 200 indications in 17therapy areas across key markets including the US, Japan, France, Germany, Italy,

Spain, and the UK. Additional markets, such as Canada, Brazil, India, and China,are covered if their markets are highly relevant to an indication.

o For each indication, the database offers country-specific forecast for prevalent orincident cases, number of cases treated, average cost of therapy per case, market

size, and other data relevant to the indication .

Methodology Overview

o GlobalData uses a patient-based forecasting model to determine the market sizefor therapeutic indications. Estimates are based on a number of primary research

sources, including Key Opinion Leader (KOL) interviews and prescriber surveys,

as well as secondary research sources, such as company reports, press releases,published articles, proprietary databases, and general news media. Data for the

base year and forecast years of the model are grounded in the epidemiology and

market parameters, with top-down validation of the base-year market using

company-reported sales.


2/13

Patient Population Forecast Methodologyo The patient population is determined by GlobalData epidemiologists for each of

the markets under study. This population serves as the foundation of the forecast

and is approached from the perspective of disease prevalence and/or incidence.

o For a given indication, GlobalData epidemiologists obtain historical annualprevalence and/or incidence data in each market from reputable sources. These

sources include international databases, government publications, diseaseregistries, and country-specific epidemiology and statistical studies published in

peer-reviewed journals. The sources used are thoroughly reviewed by Masters and

PhD level epidemiologists to ensure data reliability.

o Click here for a list of sources used.o First, the vetted historical annual prevalence or incidence data are analyzed to

determine the disease population (prevalent and/or incident cases per year). The

exact methodology varies depending on the therapy area and indication.Generally, age- and gender-specific prevalence proportions and/or incidence rates

are combined with estimated population numbers to calculate the disease

population. Only the gender and age groups relevant to the indication will be

included in the analysis. In select therapy areas such as oncology, survival ratesare used to calculate prevalence.

o To identify the segments of the disease population that are eligible for specificpharmacological treatments, GlobalDatas analysts and epidemiologists furthersegment the population according to criteria relevant to the disease under study.

For example, many diseases are treated according to severity level; likewise,

existing comorbidities or risk factors may determine the treatment approach. Thissegmentation process ensures that the drug forecasts capture each drugs sales
http://__dopostback%28%27methodology1%24lnk_sourcelist%27%2C%27%27%29/http://__dopostback%28%27methodology1%24lnk_sourcelist%27%2C%27%27%29/http://__dopostback%28%27methodology1%24lnk_sourcelist%27%2C%27%27%29/


3/13

according to its targeted indication as precisely as possible. If applicable, detailed

disease population profiles are clearly stated at the bottom of the output table

generated from the database.

o Based on the disease nature and/or the amount of historical data available,epidemiologists also conduct trend analyses for disease population growth during

the forecast period.o Once the size of the total disease population has been determined, GlobalDatas

analysts determine the segment of the population that is eligible for drug

treatment by applying a symptomatic case percentage (if applicable), diagnosis

percentage, and a drug-treatment percentage. The symptomatic case percentagerepresent the proportion of cases that present with symptoms, the diagnosis

percentage represents the proportion of cases that have been clinically diagnosed

with a given disease, and the drug-treatment percentage represents the proportion

of diagnosed cases who go on to receive pharmacological therapy. GlobalDatasanalysts derive these percentages from primary and secondary data sources.

Market Size Forecast Methodology

o Market size is determined using a wide variety of sources that include patientpopulation, diagnosed and drug-treated population, dosing regimen, officialpatient treatment databases, company and product information, product pipeline

and clinical trial data, treatment pricing, macro-economic factors, and socio-

demographic factors. For each year during the forecastperiod, each drugsanticipated market share is based on projected uptake within its targeted

population segments.

o Primary research interviews are conducted with KOLs and prescribers to obtainhard-to-find data, determine the extent to which people in different markets are

open to trying new treatments, identify the prevailing healthcare infrastructure in

each country, and analyze healthcare structures effects on the availability of

treatment product distribution channels, product pricing and affordability,healthcare spending, and insurance coverage. Primary research also serves as a

quality control mechanism for the research process. GlobalData conducts more

than 5,000 primary interviews with experts in the life science industry per annum.

o Macroeconomic factors considered in market size forecasts include nationalincome, GDP growth, average income per individual, inflation, unemployment,

and pricing indices.

o Patent expiries and generic erosion that are expected to occur during the forecastperiod guide assumptions about the entry of generic drugs and resulting price

adjustments.

o Average Cost of Therapy (USD) - Each indications annual average cost oftherapy per case is calculated based on the following factors:

Price:GlobalData analysts calculate each marketed drugs price per day using country-specificdrug pricing publications with discount rates applied to reach ex-manufacturer prices, based on

the most frequently prescribed formulations as identified from our KOL interviews, prescribing

surveys, and secondary data sources. We forecast each pipeline drugs price per day relative tomarketed drugs based on its anticipated clinical positioning, taking into account all available


4/13

efficacy and safety findings, primary research, and secondary research sources. Drug price

assumptions include anticipated changes during the forecast period, including government-

mandated price adjustments, patent expiries, and the subsequent entry of generics; shifts intreatment patterns; and other anticipated events.

Number of treatment days:This number takes into account the drugs standard prescribedcourse of therapy and the resulting number of treatment days per year.

Compliance: This value describes the level of patient compliance with the drug. For example, adrug prescribed for daily administration will have a reduced compliance to account for missed

doses.

Average Cost of Therapy (USD) for all countriesThis value is calculated by a weighted

average as shown in the following equation.

Average cost of therapy for all countries

=Total therapy sales in US dollars of all countries considered in analysis

Total number of treated cases for all countries considered in analysis

Top-Down Validation of Base-Year Market:A top-down analysis is performed to determine

the expected patient population based on historical market size (pharmaceutical sales) for

reconciliation.

Reconciliation: GlobalData conducts a reconciliation process that compares and consolidates the

patient population derived from epidemiology forecasting with the expected patient populationbased on pharmaceutical sales. The reconciliation process establishes the market conditions and

assumptions used for the market size forecasting process.

Event-Driven Live Updates: As with all GlobalData databases, the Epidemiology and Market

Size Database ties in closely with GlobalDatas news and deals streams. Hundreds of

pharmaceutical-specific news sources are monitored on a daily basis for events that may affectmarket size, which may include changes in disease prevalence proportions, prescription trends,

and consumer attitudes toward drug usage, as well as the launch of new products . As these

events occur, the Epidemiology and Market Size Database will be updated to reflect expected

changes.


5/13

Definitions (Note, unless otherwise specified, the population refers to the total population of

each country, and the period of time is 1 calendar year.):

AGR (%)The percent change of a given parameter over a specified period of time.

Average Cost of Therapy (USD)The annual price of treatment for one patient for an

indication.

Booster Dose Coverage (%)The percentage of the population at risk that receives booster dosevaccination.

Compound Annual Growth Rate (CAGR) (%)The compounded year-over-year growth rate of

a given parameter over a specified period of time.

Cases Diagnosed (%)The percentage of the prevalent or incident population diagnosed with adisease.

Cases Diagnosed (N)The number of cases in a prevalent or incident population that arediagnosed with a disease.

Cases Eligible for Treatment (%)The percentage of diagnosed cases that is eligible for

treatment.


6/13

Cases Eligible for Treatment (N)The number of diagnosed cases that is eligible for treatment.

Cases Treated with Drug Therapy (%)The percentage of the diagnosed population that isprescribed drug therapy.

Cases Treated with Drug Therapy (N)The number of cases of the diagnosed population that isprescribed drug therapy.

Incidence (Cases per 100,000 Population)Also known as incidence rate. A measure of the

frequency at which new cases of illness occur within a given population in one year.

Incident CasesThe number of new cases of illness that occur within a given population in one

year.

Market Size (USD Million)The total value of the pharmaceutical market for one year for agiven indication.

Mortality (%)The percentage of a specified population that is expected to die from the disease.

Number of Doses (N)The number of doses of a drug given in a specified time period.

Prevalence (%)Also known as prevalence proportion. The percentage of a given populationassumed to have a particular disease or attribute in one year.

Prevalent Cases (N)The number of persons with a disease within a given population in oneyear.

Primary and Booster Doses Coverage (%)The percentage of the population at risk thatreceives both primary and booster dose vaccinations.

Primary Dose Coverage (%)The percentage of the population at risk that receives primarydose vaccination.

Population Covered by Booster Dose (N)The number of persons in the population at risk that

receive booster vaccination.

Population Covered by Primary Dose (N)The number of persons in the population at risk thatreceive primary dose vaccination.

Population Covered by Primary and Booster Doses (N) - The number of persons of the

population at risk that receives both primary and booster dose vaccinations.

Prophylaxis (%)The percentage of cases that receives preventative treatment.

Prophylaxis (N)The number of cases that receives preventative treatment.


7/13

Recurrence (%)The percentage of prevalent and/or incident cases that experience a second

episode of a disease occurring after a first episode was considered cured. For infectious diseases,

recurrence is due to reinfection by a different strain. However a relapse is due to infection withthe same strain that caused the first episode.

Recurrent Cases (N)The number of prevalent and/or incident cases that experience a secondepisode of a disease occurring after a first episode was considered cured.

Refractory Cases (%)The percentage of treated patients who are refractory to treatment (alsoknown as do not respond to treatment).

Refractory Cases (N)The number of patients who are refractory to treatment (also known as do

not respond to treatment).

Relapse (%)The percentage of treated cases whose condition returns after remission orapparent cure.

Relapsed Cases (N)The number of treated cases whose condition returns after remission orapparent cure.

Stockpiled Vaccines (%)The percentage of manufactured vaccines that are scheduled for

stockpile.

Stockpiled Vaccine Doses (N)The number of doses of manufactured vaccines that are

scheduled for stockpile.

Symptomatic Cases (%)The percentage of prevalent/incident cases that present with

symptoms.

Symptomatic Cases (N)The number of prevalent/incident cases that present with symptoms.

Vaccination Coverage (%)The percentage of the population at risk that receives vaccination.

Vaccinated Population (N)The number of people in the population at risk that receivevaccination.

Drug Sales Forecasting Methodology

GlobalData uses a Patient-Based Forecasting Technique to forecast sales of a drug for atherapeutic indication.

GlobalData reports cover seven major geographies, namely the US, the UK, Germany, France,

Spain, Italy and Japan. The forecasting model used at GlobalData gathers data from research

publications and primary interviews with physicians. The drug sales are calculated as the productof annual prescription volume and the price per prescription


8/13

Annual Drug Sales = Annual Prescription Volume * Price per Prescription (1)

The number of patients to whom the drug may be prescribed can be calculated as below Number of Patients who are prescribed the Drug = Drug Market Penetration * Number of

Patients approved to take the Drug

. (2)

Number of Patients Approved to take the Drug For finding the number of patients approved to take the drug, patient groups are formed

based on following parameters.

a) Disease Type (e.g. invasive or non-invasive etc.) b) Disease Stage (e.g. locally advanced, metastatic etc.) c) Risk category of patients (e.g. high risk, intermediate risk or low risk etc.) d) Line of treatment (e.g. first line or second line) e) Phase of treatment (e.g. induction phase or a maintenance phase etc.) Based on above parameters, the overall patients with a disease can be categorized into

multiple patient groups as depicted in the figure below.

he patient groups, who are not approved to take the drug, are excluded to get the numberof patients approved to take drug as depicted in the figure below.


9/13

Net Penetration of Drug

After calculating the number of patients approved to take drug, different treatmentoptions available for patients in each patient group are evaluated. The market penetration

of the drug will be driven by the potency of the drug, along with its side effect profile

and, suitability of alternative treatment options. Drug risk benefit score quantifiesefficacy, side effect profile, dosing convenience. The market penetration of drug in a

particular patient group is also determined by the competition from alternative treatmentoptions. Global captures this aspect of the market into Competition Intensity which isdetermined by presence of generics, affordability, premium pricing and relative efficacy

Drug Risk Benefit Score

Drug risk benefit score quantifies efficacy, side effect profile, dosing convenience. Aweight is assigned on each of the factors and factor scores are calculated. Individual

scores are then aggregated to calculate a drug risk benefit score as shown in the figure

below:

Each of the factors in DRB includes sub factors as depicted in the table below. Maximumvalues are considered on basis of as reported so far or as expected/estimated as per

various primary/secondary sources.


10/13

Competition Intensity

Intensity of competition is one of the key parameters that determines the marketpenetration is based on the following factors

The market penetration of Drug in a particular patient group in the forecasting period isdetermined by the following factors.

a)All the available drugs in the patient group.

b)The launch and expiration of drugs during the forecasting period. c)The potency of the drug along with its side effect profile and suitability of alternative

treatment options.

d)Patients ability to afford drugs across various geographies. d)An analogous forecasting methodology is used to account for the introduction of new

products, the patent expiries of branded products and the subsequent introduction of

generics. Historic data for new product launches and generics penetration are used to

arrive at robust forecasts. Therapy uptake and compliance data are fitted into the


11/13

forecasting model to account for patient switching and compliance behavior. To account

for differences in patients ability to afford drugs across various geographies,

macroeconomic data such as inflation, GDP and healthcare indicators such as healthcarespending, insurance coverage and average income per individual are used.

The following matrix is suggestive indicator of a drugs market penetration:

The overall market penetration of the Drug is calculated by taking weighted averagepenetration of drug in each patient group.

Once the penetration data is available for the drugs under coverage, it is validated tocheck that it does not exceed the maximum possible penetration for the particular therapy

area, leaving enough margin for other drugs which have not been covered under thestudy.

Net Annual Dosing

Annual dosing of the drug in a patient group is calculated by multiplying the number ofinstillations per cycle by number of cycles of the drug given annually. The net annual

dosing of the drug is calculated by weighted average addition of annual dosing of the

drug in the approved patient groups

Annual Cost of Therapy The annual cost of therapy is the product of net annual dosing and the price per unit of

the drug.

Annual Cost of Therapy = Net Annual Dosing * Price per Unit of Drug (7)

Primary Research


12/13

GlobalData conducts hundreds of primary interviews a year, with industry participantsand commentators, in order to validate its data and analysis. A typical research interview

fulfills the following functions:

o It provides first-hand information on the market size, market trends, growthtrends, competitive landscape and future outlook.

oIt helps in validating and strengthening the secondary research findings.

Primary research involves e-mail interactions, telephone interviews as well as face-to-face interviews for each market, category, segment and sub-segment across geographies.

The participants who typically take part in such a process include, but are not limited to:o Industry participants: CEOs, VPs, marketing/product managers, market

intelligence managers and national sales managers.

o Hospital stores, laboratories, pharmacies, distributors and para-medics.o Outside experts: investment bankers, valuation experts, research analysts.o Key opinion leaders: physicians and surgeons specializing in the different

therapeutic areas.

Expert Panels

GlobalData uses a panel of experts to cross verify its databases and forecasts.GlobalDatas expert panel comprises of marketing managers, product specialists,international sales managers from pharmaceuticals companies; academics from research

universities, KOLs from hospitals. Historic data and forecasts are relayed to GlobalDatas

Expert Panel for feedback and adjusted in accordance with their feedback.

Process Flow Diagram


13/13

nepidemiology and market size database ew microsoft office word document

Documents