Entrepreneurship
1. Issue
Borrelia Burgdorferi, the causative agent for Lyme disease (LD), is responsible for an estimated 476,000 cases in the United States alone each year (CDC, 2024). However, one of the key issues with Lyme disease stems from the large number of people who are not diagnosed in a timely manner, which leads to treatment failure. This can eventually lead to Post-Treatment Lyme Disease (PTLD), which accounts for 34% of LD cases, and over 1.9 million people across the United States. These individuals can suffer from long-term symptoms such as fatigue, pain, and cognitive dysfunction. In addition to the detrimental health impacts, there is also a considerable economic impact caused by LD. Current estimates for the economic burden that stems from LD range from $345 to $968 million each year, and cost roughly $1,200 for every person that gets infected. For those that suffer from PTLD, the cost is doubled to $2,400 per infection. (DeLong et al., 2019).
1.2 Current Diagnostic Methods
There are currently two primary methods that are utilized to test for Lyme Disease. The first method of blood sampling PCR, which is not recommended by the CDC, tests for DNA left behind by the B.burgdorferi bacteria, but has been shown to have low specificity, and not be a reliable method for testing as the B. burgdorferi bacteria rapidly migrates from the bloodstream into tissue and joints.. The second method, currently recommended by the CDC, is a serological test. This test detects antibodies produced as a response to the bacteria B. burgdorferi. However, this method of testing does not work until 3-4 weeks post-infection, due to antibodies not being found in the bloodstream until that time period has passed.
2. Solution
Due to current diagnostic testing methods not being timely and/or effective, it is necessary for a diagnostic test to be produced that allows for the rapid detection of Lyme within a few days of infection. To fill this gap, we developed LANCET, a rapid diagnostic and novel therapeutic for Lyme disease (see Diagnostic Overview and Theraputic Overview). This test differs from other commercially available tests because it tests for surface proteins; LANCET does not have to wait for the production of antibodies. This allows our test to return a positive result after infection in as little as two days. Additionally, surface proteins are shed into the bloodstream, which allows our test to remain effective for up to 250 days after infection, while PCR tests can become ineffective after hours.
3. Market Analysis (Nova, 2025)
3.1 TAM-SAM-SOM (see Fig. 1)
Total Available Market (TAM) - The TAM in our case, defines the global market for LD testing, which in our case is approximately 13.20 billion dollars * in 2026. Due to this being across the globe, LANCET would instead focus on a smaller, more attainable market. Serviceable Addressable Market (SAM) - The SAM for LANCET would be the total possible market that our project could service. In our case, this would be the whole of the United States, with a LD testing market in 2026 of approximately 1.80 billion dollars **. But the United States as a whole would not be a customer base that LANCET could realistically service, so LANCET would instead center on an even more focused market. Serviceable Obtainable Market (SOM) - The SOM, is how much LANCET could realistically capture, given current resources, competition, and marketing. The SOM is the most realistic target for any business, and for LANCET this would be the Southern region of the United States. The LD testing market for the Southern/Eastern region of the United States is worth approximately 188.64 million dollars***
3.2 Market Competition
As stated in 1.2, Blood PCR tests are not recommended by the CDC due to low sensitivity and the dissemination of bacteria into joints. Serological tests remain the current recommended method for testing for Lyme disease, but they rely on the body’s production of antibodies, which slows testing to 3-4 weeks after infection. Even though there is such a large number of available diagnostics, LANCET remains a superior product to all of these alternatives due to testing for shed proteins in the bloodstream, which allows for incredible specificity, and opens up the testing timeline to 2-100 days after initial infection (see Fig. 2).
4. Financial Analysis
4.1 Cost Analysis
For a full LANCET test kit, we researched material costs, but on top of this, there are also other costs including R&D, marketing, administrative, manufacturing and distribution costs (see Implementation). To calculate total costs and revenue, we set our end goal to produce one million tests a year by 2032. We would plan to begin production in 2028, and scale by 200 thousand units every year. LANCET would cost $20 per test kit, which includes the LFA and the one-pot reaction with all required lyophilized reagents.
4.1.1 Revenue
LANCET’s revenue is based on the number of units sold at a cost of $20 per test kit, coming out to an increase of $4,000,000 per year for the first 5, and then peaking at $20,000,000 after reaching our ideal production of 1,000,000 tests a year (see Table 1).
| Year of Production | Tests Sold | Revenue |
|---|---|---|
| Year 1 | 200,000 | $4,000,000 |
| Year 2 | 400,000 | $8,000,000 |
| Year 3 | 600,000 | $12,000,000 |
| Year 4 | 800,000 | $16,000,000 |
| Year 5+ | 1,000,000 | $20,000,000 |
4.1.2 Production Costs
Pure materials costs for our product come out to $12.68 (Implementation). Full material costs are $13.28, but due to bulk orders, we estimate a 60 cent discount. We estimate manufacturing costs to come out to roughly 2 million dollars per year, which accounts for factory space, utilities, packaging and labor costs associated with production at our peak production of 1 million tests a year.
4.1.3 Miscellaneous Costs
In addition to costs of manufacturing, there are other costs that must be paid either on an annual or one-time basis. In order to get the lab equipment necessary to produce our product, we estimate a necessary initial investment of five million dollars, which accounts for every necessary piece of equipment, including but not limited to fume hoods, micropipettes, centrifuges, lyophilizers, etc. To remain as a competitive company and grow our market share, we also need to invest in marketing, distribution, general administrative support, and legal fees. This is estimated to cost one million dollars a year, and will help us eventually grow to produce our end goal of increasing production by 200 thousand units a year, until we can produce a million tests every year.
4.2 Cash Projections
By adding all of our variable and fixed costs, we utilize all of our costs in Figure 2. Overall, our costs are 3 million dollars annually, $12.68 per unit, and an initial investment of 5 million dollars a year. Our revenue is the number of units sold, at a cost of $20 per unit.
4.3 Break-even Analysis
Using our calculations of each year’s cumulative earnings , we aim to break even in July of 2032, less than 5 years after beginning production (see Figs. 3-4).
5. Distribution
Our primary distribution strategy will be to partner with current medical distributors to directly sell LANCET kits to hospitals and other medical facilities such as private clinics, infectious disease specialists, rheumatologists, where medical professionals can use this test to diagnose LD in their patients. Additionally, we will also target governmental agencies such as national parks which will allow for on-site Lyme testing in areas without direct access to medical facilities.
6. SWOT Analysis
Strengths :
- Novel Approach: Due to our diagnostics unique market position, we can quickly capitalize on the LD testing market and gain market share
- Large market: The United States’ Lyme testing market is valued at hundreds of millions of dollars, allowing for us to be able to start to sell tests immediately after production, and quickly scale to a larger market.
- Growing Issue: With Lyme cases increasing each year, this is going to continue to be an increasing market, with an estimated US’ CAGR of 7.72%
Weaknesses:
- High chance of failure: Due to the project still being in early stages of development, there is a chance that some unforeseen issues arise, quickly hindering production
- Regulatory challenges: Gaining approval from the FDA can be a resource-intensive process, and resources required can scale past what they are currently estimated to be
- Initial investment: Requires large investment in order for production to begin
Opportunities:
- Growing Demand: LD is massively underreported, showing a necessity for more diagnostics, and heightens the need for a more time-efficient test
- Research Grants/Contract Awards: Due to a lack of effective testing, NGOs and the government has issued grants to allow for increased funding, which can help subsidize R&D as well as manufacturing
- Public Awareness: As LD cases increase, we can utilize social media, and other methods of marketing to increase the average person’s awareness of Lyme, which will also increase our market share
Threats:
- Market Competition: With the LD testing space being valued at billions of dollars, there are dozens of companies that are already established that sell millions of tests yearly, and competing against them will require lots of resources
- Regulatory Delays (FDA): We currently estimate 2 years to market, but FDA delays can slow down our run to production, which would cost us in possible earnings
- Scientific Advancement: With biotech research expanding so fast, more effective methods of Lyme testing may be quickly developed
7 5-Year Plan
7.1 Year 1 (2026) - R&D and Regulatory Approvals
7.1.1 R&D
We aim to have LANCET fully completed by March 2026. This would include completely integrating each portion of our wetlab, and developing commercially viable LFAs. From April-December, we would work on mapping out our full production process
7.1.2 Regulatory Approval
LANCET would begin to seek FDA approval in April 2026 in order to be able to sell to the general public and hospitals. The full details regarding Regulations are in Implementation (see Implementation).
7.2 Year 2 (2027) Completing Regulatory Approvals and Production Setup
7.2.1 Continuing Regulatory Approvals
After beginning regulatory approvals in April 2026, we aim to have completed all regulatory requirements and gain FDA approval by June 2027.
7.2.2 Beginning Production Setup
From January-June 2027, we will work on mapping out our full production process, and having each step fully planned. This gives us the remaining 6-7 months to focus on production. In July after gaining FDA approval, we will begin setting up production. This includes using our initial 5 million dollar investment that will fully cover any equipment needed, as well as any other costs before moving to production.
7.3 Year 3 (2028) - Launching Production
From January-March 2028, we will work on onboarding employees. This will give us the remaining 9 months of the year (April-December) to begin production. 2028 will require 200 thousand units to be produced, which will be at a rate of approximately 22.22 thousand units per month.
7.4 Year 4 (2029) - Scaling Production
After using 2028 to begin production and train employees, we begin to scale production. In 2029 we aim to produce 400 thousand units over 12 months at a production rate of approximately 33.33 thousand units per month.
7.5 Year 5 and Beyond (2030-2032+) - Continuing to Scale Production
Continuing our increase of 200 thousand units a year, we aim to produce 600 thousand units in 2030, which gives us a production rate of 50 thousand units a month. As we continue on from 2030, we aim to produce 800 thousand units in 2031 at a production rate of approximately 66.67 thousand units a month. In 2032, we aim to produce 1 million units at a production rate of roughly 83.33 thousand units a month. From 2033 and onwards, we aim to continue at our rate of production in 2032, and eventually scale our production outside of the South/East region of the US, and eventually outside of the US.
8. Conclusion
Despite being such a pressing public health threat, Lyme disease lacks an accurate and timely diagnostic method. This causes hundreds of thousands to go without a diagnosis, and suffer from the effects of Lyme and PTLD. Our rapid diagnostic kit will be critical to mitigate the effects of Lyme disease as cases continue to grow across the country, and the world. With our clear and achievable market strategy, we aim to be producing 1 million test kits per year by 2032, which will allow us to break even by July of 2032, and begin making a profit of over 4.3 million dollars a year. LANCET is well positioned to become the leading diagnostic in the multi-billion dollar industry of Lyme disease testing, and seeks to become a successful business venture that also improves the lives of millions across the globe.
