If there is one thing that the COVID-19 pandemic has highlighted to the global healthcare industry, it is that “a longer time from symptom onset to confirmed diagnosis yielded a worse COVID-19 prognosis”. While the pandemic is now reaching its final stages, it is vital to recognize the importance of early detection and treatment, especially neurodegenerative diseases. Alzheimer’s Disease (AD) is the most common neurodegenerative disease, which globally affects over 703 million people aged 65 years over (as of 2019). Moreover, this number is expected to double by 2050 according to the United Nations. Despite there being no known cure for AD, early diagnosis could improve the effectiveness of medication to cope with the symptoms of the disease. However, there is still no accepted method for AD detection and diagnosis!
Given the situation, the iGEM Team at NYUAD have developed ADx: an innovative product with the potential to revolutionize the diagnostics and testing industry worldwide. ADx consists of a small biochip which, with a small blood sample and a simple colorimetric analysis, will be capable of detecting Alzheimer’s Disease at early stages.
The ADx business model consists of two primary revenue streams. Firstly, we will charge an upfront fee for purchasing the colorimetric testing device and, secondly, we will have a recurring revenue stream from selling the biochips. We believe that we can maximize our revenues by making the hurdle to adoption of our testing devices as low as possible. Thus, we plan to sell the test analysis device below our cost or even give the device for free, thus adopting a “loss-leader” strategy. Costs will be recovered by charging a premium for the testing biochips, which are one-time use only. Given the biochips will be patented, customers will have to recurrently purchase chips from ADx, which will provide a healthy and continuous cash flow. Furthermore, ADx biochips will be exclusively compatible for analysis with our colorimetric testing device, to avoid any counterfeit or misleading results.
ADx target market includes hospitals, clinics, and laboratories. All these facilities normally possess the personnel to safely extract and process the blood samples required for this type of analysis. Furthermore, given the versatility, simplicity and reduced cost of the testing device, other target markets could include government agencies, nonprofit and charitable organizations.
ADx technology can be easily expanded to diagnostics of other types of diseases. Given ADx biochip analysis is based on a colorimetric technique, our testing device could be easily adapted to multiple biochips containing aptamers specific to biomarkers indicating different diseases. As a result, a single ADx testing device could be used for multiple diagnostic applications.
The simplicity of production and use will allow ADx devices to find broad use across a range of demographics. Targeting government healthcare programs, private testing centers, hospitals, and humanitarian missions.
| ADx | Computerized Tests | MRI/SPECT | CSF Immunoassay Analysis | |
|---|---|---|---|---|
| Indirect production cost per unit | $100 | $30,000 | $1,000,000 | $ 150,000 - 300,000 |
| Manufacturing cost per unit |
$15 | $700 | $1,000 | $1,000 |
| Portability |
High | High | Low | Low |
| Invasive |
No | No | No | Yes |
| Sensitivity |
Medium | Low | High | High |
It is natural that AD testing is amongst one of the most prioritized in global healthcare diagnostics. Therefore, studying the Alzheimer’s Disease Market is important to understand the potential impact of ADx.
Total Addressable Market – USD $3.59 bn
The estimations for the global Alzheimer’s Disease Diagnostic Market was valued at $3.59 bn in 2022, with projected growth up to $7.1 bn by 2027 at a CAGR of 8.90%.
Serviceable Available Market – USD $2.074 bn
At this stage, we isolated the testing methodology which is comparable to our offering. The key defining factor was the search for a biomarker specific to the neurodegenerative disorder. Target comparables included neurological biomarker testing for Alzheimer’s Disease, which is an emerging diagnostic method because of its high sensitivity and accuracy. Building on the data obtained from the “Neurological Biomarkers Market Size, Share Trend Analysis Report”, we estimated the target methods for AD as taking 57% of the market, accounting for $2.074 bn.
Serviceable Obtainable Market – USD $200 m
We finalized our estimations via adjusting for the target geographies (US and Europe) and possible demand “stickiness” stemming from the potential reluctance of large laboratories to revise their contracts with their suppliers. Nonetheless, given the strong competitive advantages of the product, we expect a high potential penetration of 10% of the serviceable addressable market, resulting in an obtainable market of $200m.
Due to the innovative and adaptable nature of the ADx technology, we expect that the ADx devices and cartridges will be able to detect other diseases by 2030. As such, we have estimated our long-term market reach in the following analysis.
Total Addressable Market – USD $207bn
We decided to divide the global testing market into several dominant categories: infectious, cancer, and neurodegenerative disease testing. Triangulating the data for the estimations of each category, we obtained an estimation of $207bn.
Serviceable Available Market – USD $51.18bn
Similar to COVID testing, we isolated the testing methodology which is comparable to our offering. Building on the data obtained from the “Biomarkers Market Size, Share & Trends Analysis Report”, we estimated the target methods as taking 25% of the total market, resulting in a serviceable market of $51.18bn.
Serviceable Obtainable Market – USD $2.6 bn
Similar to COVID testing, we finalized our estimations via adjusting for the target geographies (US and Europe) and possible demand “stickiness” stemming from the potential reluctance of large laboratories to revise their contracts with their suppliers. Nonetheless, given the strong competitive advantages of the product, we expect a high potential penetration of 5% of the serviceable addressable market, resulting in an obtainable market of $2.6bn.
As a value-driven pharmaceutical business, ADx prioritizes accessibility, inclusivity, and sustainable practices in its product offering. Low production costs as well as portability will allow ADx to be distributed in developing and impoverished communities, providing them with life-altering healthcare that they deserve. Our proposed partnerships with NGOs as well as government-sponsored healthcare programs will allow us to reach a wider, more diverse user population, bringing affordable and simple-to-use early-detection devices to those who need it most.
Sustainability and safety considerations form the core of our product development mindset – the disposable cartridges used by the ADx devices will be made out of biodegradable materials. After thorough sterilization of the contaminated materials, the customers will be able to dispose of the cartridges with regular biodegradable waste. This will be especially important for countries and regions that do not have widespread waste management capabilities.
Furthermore, the development of the ADx devices will be in line with the United Nation’s sustainable development goals, including #3 “Good Health and Well Being”, #4 ‘Quality Education’, #10 ‘Reduced Inequalities’, and #17 ‘Partnership for the Goals’. These goals at the forefront of the ADx value proposition and branding will create trust in the ADx products and ensure sustainable long-term growth.
ADx will leverage several funding streams to get the first steps off the ground, including direct fundraising from institutional investors and charitable donors, as well as private equity issuance. In the long term, the team behind ADx expects the company to issue an Initial Public Offering to attract a wider range of investors and fund further research, development, and growth in alternative disease detection.
At this stage, ADx requires USD $1.75m in direct funding. These funds will be used for the following needs: