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Epidemiology Based Market Forecast Introduction Disease Overview Epidemiology Overview Forecasting Process Points To Remember Data Sources

Q&A

GlobalData uses epidemiology-based treatment flow model to forecast the market size. The forecasting model used at GlobalData makes use of epidemiology data gathered from research publications and primary interviews with physicians to represent the treatment flow patterns for individual diseases and therapies. The epidemiology-based forecasting model for a medical device is helpful in: Deriving the type of patient segment which is actually going for the procedures Frequency of usage of the device depending on the patient type which further helps to arrive at the absolute unit sale of a device in a year The market for any medical device is directly proportional to the volume of units sold and the price per unit. Market Size = Volumes of units sold X Average Selling Price

Epidemiology Based Market Forecast Introduction Disease Overview Epidemiology Overview Forecasting Process Points To Remember Data Sources Q&A

Disease overview plays most important role in your forecasting model. This section provides a context of the most important scientific and epidemiological aspects of the disease. Furthermore, in-depth understanding of the disease/indication will help you to narrow down and isolate the actual patient pool/procedure you need to consider for your concerned device/implant. Be well-versed with this section and study your disease strongly, as entire flow of the forecast model depends on the basic understanding of the disease. Clearly define the type of disease and patient segmentation while studying disease overview Type of disease (Chronic/Acute): This will be helpful in deciding whether you have to do prevalence based forecasting or incidence based forecasting. For Eg: As diabetes is a chronic disease we will follow prevalence based forecasting. For traumatic cases (Eg: traumatic arthritis)

we will follow incidence based forecasting. Type of patients (Male, female, infants, elderly): This will help you to understand among which patient population your indication is more common and will ultimately help you to select the major patient pool for the market model. For Eg: Rheumatoid arthritis (RA) is more common in women than in men. In fact, 70% of the patients with RA are women. So here your major patient pool will comprised of female population. Age Group: Thorough study of the disease will help in understanding among which age group the disease is more prevalent. In certain cases, the population of a specific age group is considered. Indications such as Osteoarthritis (Above 40 years of age), Myocardial infarction (Above 20 years of age) are examples of indications in which age specific population pool is considered.

Epidemiology Overview

The epidemiology-based forecasting model considers the data on prevalence, incidence, diseased population, diagnosed and treated population. This epidemiology data is gathered from association websites and population based studies and research articles published in journals or available on Pubmed and Medscape. This information is validated from interviews with physicians/ KOLs. The prevalence of a disease is the percentage of the total population who suffer from a disease/condition. Prevalence based forecasting is mostly done for chronic diseases. Incidence is the number of new cases of a condition, symptom, death, or injury that develop during a specific time period, such as a year. The incidence based forecasting is mostly done for acute conditions such as trauma, infections. The diagnosed population is the population diagnosed with a disease expressed as a percentage of the prevalent population. The treated population is calculated as a percentage of the population diagnosed with a disease.

Forecasting Process

The market forecast begins with the general population. This may vary depending upon the indication. In certain cases, the population of a specific age group is considered. Indications such as Osteoarthritis (Above 45 years of age), Myocardial infarction (Above 20 years of age) are examples of indications in which age specific population pool is considered. Depending upon the severity of the disease prevalence or incidence rate is applied to this population base to identify the prevalent/incident pool. This number needs to be validated through primary and secondary sources. The secondary sources used for applying these rates

should not be older than four to five years for the base year. For historic data you can anytime go to old sources for that year for which you are looking for historic data. Prevalence: Be careful while applying a prevalence rate on general population. Use at least two to three sources to finalize your prevalence rate. Prevalence of a disease is expressed either as a percentage or as a ratio. For example, if the prevalence of the disease is expressed as 1.2/10000, then the disease population can be calculated by cross-multiplication of the data with the total population in the geography. In some cases, the prevalence is expressed as a percentage of a particular age group/ Gender. For Eg: If the prevalence is expressed as a percentage of all men above 30 years of age, then the calculation would involve ONLY the male population above 30 years of age.

Forecasting Process (Contd)

For Eg: If your indication is prevalent in 45 years and above patient group then you have to apply that prevalence rate only in the 45 years and above age group of general population. For Eg: If you are getting a prevalence rate of diabetes as 0.26% in age group under 20 years of age, then you cannot apply this prevalence rate to overall population. You will have to be specific in applying this to age-wise population group with reference to mentioned prevalence. Prevalence of diseases might vary across geographies. Incidence data - Incidence rate is the number of new cases of a particular disease that occur in a year. Incidence data is expressed as a ratio or as real numbers. In case of genetic disorders, incidence data might be expressed as a ratio or percentage of the birth rate in the country. Use at least two to three sources to finalize your incidence rate. For Eg: If, over the course of one year, five women are diagnosed with breast cancer, out of a total female study population of 200 (who do not have breast cancer at the beginning of the study period), then we would say the incidence of breast cancer in this population was 0.025. (or 2,500 per 100,000 women-years of study) Diagnosis Rate - People who get diagnosed for the disease. Diagnosis rate/diagnosed population needs to be searched through secondary sources and then has to be validated with KOL interviews. Proper rationale or assumption should be used while applying diagnosis rate on to your diseased population.

Increase or decrease of the diagnosis rate may depend on the following factors: Accessibility to Primary Care Physicians (PCPs)/ specialized doctors Availability of diagnostic centers (Advancements in the technology) Availability of better health care services Awareness about the disease Severity of the symptoms Government initiatives The treated patient pool is derived by applying the treatment rate to the diagnosed patient pool.

Treatment rate is sourced from secondary sources and verified through primary interviews. Remember not all the treated population will go for the procedures. The treated population going for the device usage depends upon the severity of the disease, access to health care and affordability. For E.g.: Patients with Vertebral Compression Fractures (VCF) who undergoes treatment is around 20% of the diagnosed pool. But out of this treated patient pool nearly 18% goes for treatment with VCF repair devices, whereas remaining patients goes for alternative treatments such as drugs and braces. Another E.g.: Patients with Renal Artery Stenosis (RAS) who undergoes treatment, not all the treated patient pool goes for renal artery stenting. Some patients also goes for alternative treatments such as drugs and life style modification.

The device uptake percentage is allocated based on the primary responses and the information available in secondary sources (Such as user site). Increase or decrease of the treatment rate may depend on the following factors: Affordability/Willingness Technological advances Accessibility to specialized doctors Average selling price (ASP) of the device is mostly gathered from primary and secondary source. ASP is the price at which a device is available in a target country to an end user (End user is defined in different ways for different nodes. Eg: Typically for capital equipment and implantable consumables, end user is considered to be the healthcare setting. For consumables purchased by patient, the end user is a patient). Factors such as company share, reimbursement, company type (local/domestic or multinational) are taken into consideration during analysis of average selling prices. Following sources are used for ASP analysis: Company websites Annual reports/industry reports Press releases Product monologue

Following factors may influence the price dynamics : Government regulations Competition Disease burden/Unmet need For countries wherein adequate data is not available, analogue/benchmarking based forecasting technique is used. For E.g.: If you are getting specific data point (prevalence, incidence, diagnosis rate, treatment rate or similar index) for a particular country, then with the help of supporting sources you can consider this as benchmark and can apply it on other countries as well depending upon the similarity in the demographics of both the countries (Kindly note that you can benchmark the

data only on the basis of similar demographics). Classic E.g.: Brazil and Mexico, Chile and Argentina.

The model considers the impact of price inflation of the devices.

Following factors may influence the price dynamics : Government regulations Competition Disease burden/Unmet need For countries wherein adequate data is not available, analogue/benchmarking based forecasting technique is used. For E.g.: If you are getting specific data point (prevalence, incidence, diagnosis rate, treatment rate or similar index) for a particular country, then with the help of supporting sources you can consider this as benchmark and can apply it on other countries as well depending upon the similarity in the demographics of both the countries (Kindly note that you can benchmark the data only on the basis of similar demographics). Classic E.g.: Brazil and Mexico, Chile and Argentina.

The model considers the impact of price inflation of the devices.

Following factors may influence the price dynamics : Government regulations Competition Disease burden/Unmet need For countries wherein adequate data is not available, analogue/benchmarking based forecasting technique is used. For E.g.: If you are getting specific data point (prevalence, incidence, diagnosis rate, treatment rate or similar index) for a particular country, then with the help of supporting sources you can consider this as benchmark and can apply it on other countries as well depending upon the similarity in the demographics of both the countries (Kindly note that you can benchmark the data only on the basis of similar demographics). Classic E.g.: Brazil and Mexico, Chile and Argentina.

The model considers the impact of price inflation of the devices.

Points To Remember :

Understand your disease thoroughly Understand your patient pool Do proper patient segmentation Add the inclusion and exclusion of taxonomy Prevalence/ Incidence data should be taken from major Government websites and associations. Validate this data point from at least four to five sources The sources used for prevalence and incidence data for the base year should not be older than four to five years Take expert insights on the diagnosis, treatment and usage of the device from the respective Country participant supported by secondary sources. Give the other name for the device if at all it was referred Do the primaries from the user end Benchmarking/Analogue based forecasting can be done only if the countries have similar demographics Maintain source sheet It should contain the last access date Screen shots of the data Web source of the data

Key Data Sources : World Health Organization Harrisons Principles of Internal Medicine (For complete understanding of the disease) Annual reports

Federal Institute for Drugs and Medical Devices Pharmaceuticals and Medical Devices Agency National Institute for Health and Clinical Excellence, the UK Country Specific Medical Agencies such as Italian Medical Agency The New England Journal of Medicine Healthcare Cost and Utilization Project (HCUP) European Hospital and Healthcare Federation (HOPE) Medicines and Health Products Agency National Institutes of Health, the US Centers for Disease Control and Prevention, the US Medscape Pubmed