Across all the medical technologies and disease areas I’ve analyzed, I’ve found that true market opportunity size rarely is well understood. When we meet with clients to kick off a new strategic market assessment, we’re provided with an overview of the new technology or potential acquisition. Most times, the client leadership team cites a hefty figure for the anticipated market opportunity.

Unfortunately, there are many reasons your market may be smaller — perhaps much smaller — than you think. From the hundreds of technologies and therapeutic areas our team has worked on, here are the five most common reasons:

1. Incidence, Not Prevalence: It’s almost never enough to simply look at how many people exist with a given condition. A host of critical questions must be addressed to drill down to the true market potential of a given technology, including the distinction between prevalence and incidence. 
2. Gross Vs. Net: Every technology experiences a translation from its technical Indications for Use to the practical group of patients who will actually be considered by physicians for a therapy or procedure. These factors range from clinical considerations — such as limited life expectancy or inability to comply with required behavior/medicine changes — to economic considerations, such as patients without insurance or those unable to afford the out-of-pocket costs.
3. Diagnosed Vs. Undiagnosed Patients: One of the most difficult barriers to overcome is a low diagnosis rate for the target disease area. The patients are out there, but cannot be identified as good candidates for treatment.
4. Patient Bother: Even if a patient has been diagnosed, their condition may not bother them enough to make them a realistic candidate for your technology.
5. Unmet Need: It seems like a no-brainer, but it’s often a brain puzzler: genius medical technologies fail to gain adoption, because literally there is not enough market need.

Thinking through all the real-world reasons why a clinician wouldn’t or couldn’t treat someone with your technology is critical to an accurate understanding of the market opportunity. Sadly, some organizations don’t prioritize rigorous opportunity analysis until they start to feel the stress of early commercialization not meeting expectations.

But, true market potential is knowable long before you’re in the red. We’ve uncovered cases in which the disease comprised a tiny fraction of a large, well-known condition, making it nearly impossible to show clinical significance — in which drug therapies rendered surgical options fruitless; in which the industry itself lacked a standardized definition of the condition or how to best treat it; and many other “preventable” scenarios.

In each of these cases, with advance knowledge of their product’s true potential, the companies could have shifted course to invest and plan strategically, nurturing the technology’s market development in parallel with product development to harness a higher return on investment.

Based on the results of the hundreds of strategic market assessments our team has performed collectively, it’s best to be sure you understand the defensible, fact-based market need for your great idea before investing significantly in an intuitive belief of its potential.

Any of these five reasons, among others, could derail your business. The key is knowing the realities of the market ahead of time, and carefully planning out your pathway to becoming a new standard of care. As we like to say, knowing is everything.