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- Discuss your Total Available Market and Total Addressable Market. List all your assumptions and hypotheses.
The long term objective of our venture is to screen all newborns for Sickle Disease and Sickle Cell Trait shortly after birth. We aim to do this with a low cost, point of care diagnostic test strip. The point-of-care testing market has been developing rapidly over recent years. This market includes all detection devices that are able to rapidly diagnose patients. The global point-of-care testing (POCT) market is expected to grow up to $36.96 billion in 2021. This expansion of the market is validated by the importance of POCT in global health. These devices are intended to simplify the diagnosis of many diseases and are especially useful in low-resource areas. Hence, our Total Available Market would be the children under 5 years old and their families that would benefit from early Sickle Cell Disease testing. Therefore, our venture has a diverse range of clients that would make up the Total Addressable Market.
Several non-profit organizations, such as the World Health Organization, also distribute these diagnostic devices to low-resource areas as a step towards reducing world health care issues. This point-of-care device will likely be distributed by a non-profit organization to be utilized by health care professionals and patients in low and middle resource countries. The patients and medical professionals who come in contact directly with the device are the product’s end users. The product’s targeted customers are non-governmental organizations (NGOs) and other healthcare organizations that will be investing in the device. In Sierra Leone, there is a Free Healthcare Initiative (FHCI) funded by other governments (especially the UK Department of International Development), the UN, and financial NGOs. This initiative provides free, basic healthcare services to pregnant women, lactating mothers, and children under 5. Once the utility of the product in Sierra Leone is proven this device could become a part of this initiative as a free, commonplace screening device among all newborns.
Currently, a pilot study of the Sickle SCAN device conducted by Dr. Cheedy Jaja has been put into place in an effort to create change in SCD diagnostic processes through introducing their product. However, this diagnosis is not significantly accessible in countries of low resources due to the requirement of performing a 200-fold blood dilution step and a costly charge of $4.50 per test. Other programs include collecting dried blood spot (DBS) samples from newborns in high-risk areas, and sending them to centralized laboratories for isoelectric focusing analysis. Two such programs were initiated in Angola and Uganda; however, these initiatives were time-consuming and expensive (with costs estimated to be $15.36 and $9.94 per test, respectively).
To address these problems, our current understanding of the healthcare system and distribution of diagnostic devices in low and middle-income countries leads to the belief that this test strip must be considered inexpensive. The intended novel device configuration, the “E-Junction”, allows the device to run using a whole drop of blood, eliminating a dilution step. The device takes approximately 15 minutes to run. The estimated lateral flow diagnostic device prototype and production bills of materials is currently $2.98 however, further optimization of the device will reduce the cost ideally less than $1.00 (US). Therefore, if our research is supported by the FHCI, the device’s direct customers would be the groups behind the funding of the FHCI. This kind of screening device will be of value to customers as it will reduce other medical costs by improving initial diagnosis of individuals with sickle cell anemia. Until this device proves it’s utility, other NGOs will be purchasing the product.
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