Market Potential

Customers — Our initial marketing strategy targets mental health and general medicine healthcare providers: psychiatrists, clinical psychologists, and primary care physicians. Another significant target segment in the marketing plan consists of nationwide early intervention Coordinated Specialty Care (CSC) treatment centers for individuals with psychosis spectrum symptoms and first-episode psychosis (FEP). Our tests emphasize early detection in undiagnosed and misdiagnosed patients to reduce the diagnostic odyssey from Years to Days.

Potential Market Size — In the U.S., schizophrenia impacts 0.25% (677,500 patients) to 0.64% (1,734,400 patients), and Bipolar Disorder patient affects an estimated 2.8% (7,588,000 patients) of the U.S. population, respectively (NIMH). Our initial products diagnose and differentiate schizophrenia (SZ) and bipolar disorder (BD) from psychiatrically ordinary individuals, a critical unmet healthcare need. In the U.S., the annual healthcare cost (direct, indirect, plus non-healthcare) for schizophrenia is estimated to be $343 billion, and bipolar disorder is over $195 billion. The number of potential patients is estimated with the breakdown as follows: 114,000 first-episode psychosis per year; schizophrenia patients 31,455 per year; bipolar disorder patients 202,714 per year; and primary care patients 1,867,500 because of misdiagnosed patients with major depression disorder. Thus, the total potential for SZ and BD patients is over 2.2 million annually. The price per test is estimated to be between $1,500 and $3,000 per patient. We used $1,500 per test for our market size calculations, which projects the available market at over $3.3 billion annually

Differential Advantages — Our differential advantages drive demand for a reliable diagnostic tool, which is substantial:

• Current diagnostic methods rely heavily on patient-reported symptoms and clinical observations by psychiatrists, typically over 1 to 3 years. Our disruptive, rapid quantitative blood test results are returned to the ordering physician within 'Days, NOT Years™'.
• Research shows that ~40% of patients with severe psychiatric disorders were initially misdiagnosed, with SZ being misdiagnosed in ~50% of cases and BD in ~70%.
• There is a significant challenge in diagnosing youth and young adults who may exhibit unreported symptoms or early signs of psychosis months or even years before their FEP.
• Delay by incorrect diagnoses can lead to inappropriate treatment, thus not effectively managing the patient’s symptoms and causing disorders to worsen to a treatment-resistant state. Also, the lag in diagnoses and treatment is associated with an increase in suicide rate.

Future Potential Market Expansion — Additionally, our technology holds the potential for future expansion into 46 million patients with other mental health conditions to extend our reach to new patients with these disorders in the U.S. Other potential markets are the Juvenile Justice system (7 in 10 have a mental health condition), Jail (I in 4 have a serious mental health illness), prison (2 in 5 have a history of mental illness), screening military recruits, law enforcement personnel screening and U.S. border screening.

In Summary — Laguna Diagnostics is well-positioned to disrupt the psychiatric diagnostics market with our innovative, patent-protected technology. Our innovative rapid blood-based tests offer more accurate diagnosis, enabling earlier intervention, quicker treatment, and reduced costs, leading to improved quality of life for patients and their families. Invest or partner with Laguna Diagnostics.