Introduction

On starting to pave the road for our diagnostic kit we needed to envision and design a complete roadmap guided by:-

●                   Extensive Analysis To The Market We are entering

●                   The Current State Of Our Nation

●                   Defining and Refining our customer segment,their market share,expected growth

●                   Understanding Our Competition

●                   Gaining more information from the people regarding the current situation

●                   Searching for the Stakeholders & Those who could contribute to our project

●                   Designing a Business Model Canvas & Sustainability

●                   Preparing a Market Plan for our diagnostic kit and platform.

Problem  Definition

Inborn errors of metabolism (IEM) are one of the biggest problems that face newborns & children especially if the child is not detected to have one of them.

Phenylketonuria is an autosomal recessive (AR) disease that causes a decrease in the metabolism of Phenylalanine(Phe). And if Phe accumulates undetectably a child can have dramatically negative sequelae that could end in very harmful complications such as mental retardation and neurological problems.

Unfortunately the current screening of phenylketonuria to newborns got a lot of drawbacks, One of the biggest is its high cost which isn’t affordable by a lot of people especially in developing countries, however, if phenylketonuria is detected early the patient could survive by sticking to a very strict diet which tremendously affects his  quality of life in a negative way. So we had to do something  to help them.

Product Overview

P-Kit: Point Of Care Home Screening Test Kit

In designing our kit we are working on, turning our screening tool into a home based tool that can be used by any person. We knew that our ultimate goal would be for our screening kit to reach every house and family here in the county so the kit needs to be available to be used at any time ,and making it as simple to use as possible is a top priority, that's why we went through making the kit be designed as a lateral flow assay, with the inclusion of a clear manual to help the user get proper and accurate results.

P-Pill: A Next Step Therapeutic Treatment for PKU Patients

As we come to acknowledge that diagnosed PKU patients have to stick to very strict diets for the sake of their survival making them deprived from many types of food as well as being forbidden from many drugs that contain phenylalanine and therefore have a generally lower quality of life so we needed to think and devise a solution for them.

Therefore In the future we envision that our therapeutic approach will be in the form of an enteric coated pill and this pill would need to be used life-long as the patient would be taking this pill every specified duration of time and this pill would help his body to provide the missing enzyme in his body therefore making him able to live a normal life and be able to enjoy their life normally .

SWOT analysis

Rest ASSURED: How we were inspired by WHO STD Diagnostics initiative (SDI)

Earlier on we knew that the WHO have developed and created a criteria for future diagnostics made in the field of Sexually Transmitted Diseases (STDs) and as they made these criteria specifically for people and countries with limited resources, Designing ASSURED:  affordability, sensitivity, specificity, user-friendly, rapid and robust, equipment-free and deliverable.

And we were inspired by them as we consider this to be a future benchmark and guideline for all point of care diagnostics and especially ours to help us in the creation more of a quality tested product and sustainable program for the prevention of further misdiagnosis of inborn errors of metabolism in general and more specifically phenylketonuria.

●    Affordability:

First point we have regarded in designing our product was to make our product as affordable as possible and to achieve that endeavor we have worked on always researching lesser value material without compromising the accuracy of our kit which was done by replacing the use of microfluidics with lateral flow assays and the replacement of the use of antibodies with aptamers.

●    Sensitivity & Specificity:

In all our work Accuracy was one of the essential pillars that we couldn’t compromise that’s why we have included the use of aptamers as they are generally more stable than antibodies can act like monoclonal antibodies and can even detect non-immunogenic substances in addition to the use of logic gates within the circuit that ensure specific binding to the target molecule and higher sensitivity.

●    User-Friendly:

Our kit was designed on the basis of being an easy to use device ,and in order to do that we picked a simple method for the patient to be able to self test himself/herself accompanied by a clear guide for the customer to easily understand the test result.

●    Rapid & Robust:

Our use of lateral flow assay accompanied by our robust design and usage of multiple controls and presence of a valid detection system ensures both rapid & accurate results.

●    Equipment-Free:

Our Device is labeled equipment-free needing nothing more than the actual kit and a drop of blood to get the results you need ensuring ease of use and avoiding complexity.

●    Deliverable:

Our plan is to provide our kit as a home device that would be easily present through either direct online ordering from our website or by mass distribution to pharmacies all across the country. We plan for this to begin by contacting owners and negotiating a long-term plan for the kit to be presented and featured at their places.

Market Analysis

Current National situation

To analyze our market properly we needed to understand the current situation here in our country first, so we tried to find out how much were our people interested about the topic of phenylketonuria & Screening tests ,and after thorough analysis of the results it became clear that there were a fundamental problem as the interest level about the topic have been decreasing through the years, as we have witnessed the levels of interest and searches having a share of 1.0k of the volume of searches out of 89.3K searches about the disease. All of which might indicate lack of knowledge about the disease.

Figure (1). Generated Data Using Google Trends tool regarding search interest about phenylketonuria keyword between 2004-present in Egypt.

Figure (2). Data Generated Using SemRush tool regarding search volumes worldwide of phenylketonuria keyword

Further search and analysis also demonstrated that Egypt’s interest compared to other countries worldwide was disappointing being in the 26th Position ,and with the knowledge that Egypt is one of the highest countries with Inborn errors of metabolism & Phenylketonuria as according to data & research 1 out of every 5000 live births here turns out to be affected with phenylketonuria and even this data might be presenting an underestimation of the data.

We can combine the meaning of all that we now know to conclude that our people need much more information about the topic than they already know ,and that the current awareness regarding the situation is low, also we can conclude that our screening kit for diseases such as phenylketonuria will have a large section of users that will need both information and the facilities to access Medical care that they didn’t know they need.

Figure (3). Data showing worldwide search interest about phenylketonuria keyword categorized by region between 2004-present

In addition, our country’s current policies endorsed by the president now goes in line with working on finding a solution for inborn errors of metabolism as the government is trying to find new initiatives to help with the current problem. Therfore we expect a substantial rise of the public’s interest in the topic which would increase the market’s size and change their buying habits.

Pharmaceuticals Market analysis: A Broad View of the Market

Figure (4). Market overview for pharmaceuticals industry using Open Trends tool

After Further analysis of our market we found that it's a relatively easy market to compete in here in Egypt as it had an estimated difficulty of competition of 5%. On the other hand We have found out that although the market have an average high traffic of 8.2 million with peaks in the market that reached up to 50 million, that growth has dramatically decreased from the previous year with a negative Year-over-year (YOY) growth of - 143.07%, However we believe the lack of competition and market traffic would compensate for the decline in yearly growth.

Figure (5). Market overview for pharmaceuticals industry using SEMRush tool

Furthermore  we have found that the pharmaceuticals market had such a large market size here in egypt with a substantial 199.3M of Revenue as a total addressable market however only 14.3M was the serviceable available market. This indicates that the market has a great potential for expansion allowing new competitors the chance to gain much more revenue.

Competitor & Niche Market Analysis

Revealing a gap in the market

In Egypt, We have one of the highest prevalences of phenylketonuria in the whole world which was measured to be around 1 for every 5000 child. And it would be expected for our country to have a greater number of facilities and tests for these children and their screening to prevent a little child from getting long-term brain damage.

However the actual situation is remarkably different from what is expected as here in the country there are only very few providers of screening services and diagnostics, until very recently with the government's initiative to counter Inborn errors of metabolism, and practically, there is complete absence of any point of care diagnostic in the market for any inborn error of metabolism.

We designed the heat map below to demonstrate the prevalence of PKU Worldwide according to literature, and as it can be seen Egypt is one of the few countries in the map to have the darkest color concentration, all of which indicates a huge gap between what is happening and what needs to be done.

Competitors in the current scene:

Diagnostic Approach Competitor Analysis

After thorough investigation of the market and the demand we have found out that in the country there is only two tests available that can diagnose the disease which are:

●       National Gene sequencing: in which they analyze the DNA sequence for patients in order to find out the presence of changes in areas of the genome that would represent the person acquiring the disease.

●       Tandem mass spectrometry

However we’ve found out that our competitors lack many things:

●       First of all, our competitor tests in the country are very costly as a single test for phenylketonuria done through the national gene sequencing program is estimated to cost around 150$ and the tandem mass spectrometry would cost around 25$ knowing that here in Egypt we have an average salary of 500$ per month. So these tests would be very expensive for the average user especially knowing that we are targeting more of the lower income parts of the society as they are more likely to be unaware of that illness and have much higher rates of home deliveries for children.

●       The Second issue regarding these method is their extensive need for human resources and computing which is required to interpret and analyze the data with the current workflow

●       The Third issue regarding a method such as the gene sequencing is the need for a very large disk and computer storage space with it being a hurdle to both long-term data presence and the use of very high disk space.

●       The Final issue would be the time factor as these tests take a long time

Figure(7). Showing a double axis competitor analysis showing likely testing competitors categorized according to perceived quality & Price

Therapeutic Approach Competitor Analysis

After thorough investigation of the market and the demand we have found out that there is two general management and treatment modalities  available that can help treat the disease which are:

●Dietary Restriction: By Generally eliminating and forbidding foods and drugs that contain phenylalanine

● Sapropterin (Kuvan) : Which is a drug that can activate residual PAH enzyme to improve metabolism of phenylalanine

But on the other hand we’ve found out that other modalities have major drawbacks such as :-

● Sapropterin (Kuvan) isn’t effective in all patients with pku and have varying effects in these patients according to the amount of residual PAH enzyme in the patients

●Sapropterin (Kuvan) drug have various side effects such as esophagitis, gastritis, headache, vomiting, runny nose and nasal congestion, sore throat, diarrhea, and cough

●       It’s easy to recognize how much severe dietary restrictions would affect a child or a later on adult with PKU and the drawbacks of the restriction of so many types of food and drugs and how it would affect his quality of life

StakeHolder analysis : Identify, Prioritize & Understand

Identify

The first thing that we need to do when conducting a stakeholder analysis is the identification of all those that currently & could possibly in the future influence your project so as to achieve that endeavor.

-        World Health Organization (WHO)

-        National PKU Alliance

-        Egyptian Health Ministry & Government Officials

-        Egyptian PKU Association

-        Public & Private Hospitals

-        UK’s National Society For PKU Charity

-        Private Clinics & Doctors

Prioritize

Next on we needed to Prioritize our stakeholders and their rules and prepare proper management for each stakeholder either on an individual or organizational level and in order to do that we designed a Power/Interest grid to establish each role and prepare a project management plan in advance.

Understand

And In order to do this we needed to answer 3 questions:-

What motivates our stakeholders?

Our stakeholders are motivated primarily by the very fact that by helping our project and our cause they are acting out and being proactive towards a societal and a devastating national problem that have been lurking around for so long. Our stakeholders see the potential of such a project and its long term impact both locally and internationally.They are motivated because they can help in the formulation of a solution to help ease the suffering of others and hopefully to one day prevent any future pain of a misdiagnosed child.

How does our project align with their priorities?

Those who already influence our project or could potentially support our cause & product are those that have their main priorities set as being:-

●       Achieving Universal & National Health Coverage

●       Promoting Health & Well being of humans

●       Working Towards solving the problem of IEMs & PKU

And Our Projects main goals align with their same priorities as we aim towards providing a national and maybe an international solution for an unsolved and ongoing problem and possibly provide them with a long term

How can we change any negative views about our project?

When we are approached by negative view we need to:

●       Meet them one on one and establish early contact and try to explain misunderstood points

●       Listen to what they say non judgmentally and try to seek information and opinions from them so we can further enhance our project

●       Learn from what they think and see a middle solution that would work to solve both their problem and ours.

Investments in PKU & Probable Sources of Funding

We found after search that there have been minimal investments in the field of finding a treatment for PKU, However we found out that the main two investments in the field was done by:-

-        Pfizer pharmaceutical company which invested 60 million $ in supporting gene therapies for PKU, More specifically for a company called Homology Medicines which work on genetic medicines

-        The National PKU alliance has also, according to their page, worked on investing in targeted research in PKU.

So we have tried to learn from them and as we see we can think that Pfizer company & National PKU alliance could be potential sources for funding but on the other hand other key players that was identified in the stakeholder analysis could also be suggested as potential sources of funding for our project such as the Egyptian PKU alliance & The health ministry.

Long Term Plan: Business Model Canvas, Cost analysis, Marketing plan & Timeline

Our Business Model Canvas

Diagnostic Kit Business Model Canvas

Therapeutic approach Business Model Canvas

Cost analysis

To try and make an estimate of what the cost of our product and one test would be we went on to estimate the expected product using literature, similarly made products, and lateral flow assays as well as the prices which we paid for our lab work, and to make estimates of how much each of them would be needed to hypothetically manufacture one piece of our product

Figure(8). This figure illustrates the cost share of each of our lateral flow assay diagnostic

So after investigation it is estimated that the total cost of our product would be around 49 EGP per test which is the equivalent of 2.5$.

This indicates that our product would be much cheaper than its competitors with the tandem mass spectrometry being priced at 25$ and the national gene sequencing program which is priced at 150$.