Personalized care creates value when broad patient populations are divided into clinically meaningful groups and linked to appropriate diagnostics and treatments.
The opportunity is expanding in oncology, where decisions increasingly depend on molecular features.
Market size cannot be estimated from disease prevalence alone; it depends on how many patients are identified, tested, found to have actionable biomarkers, and ultimately treated. This distinction is critical as companion diagnostics grow.
In 2026, FDA‑authorized tests were tied to therapies targeting biomarkers such as BRAF, ESR1, PIK3CA, MET, HER2, and homologous‑repair genes.
The Addressable Population Is Smaller Than the Patient Population
A disease may affect millions, but only a fraction qualifies for personalized therapy.
The commercial funnel narrows from total patients to clinically eligible, biomarker‑positive, tested, treatment‑eligible, and finally treated patients.
Each step reduces the addressable market. For instance, a therapy targeting a mutation may start with a large patient pool but shrink sharply once biomarker prevalence and testing uptake are factored in. Patient stratification is therefore central to market sizing.
A useful assessment should establish:
- Disease prevalence and incidence
- Treatment eligibility
- Biomarker prevalence
- Testing rates
- Diagnostic accessibility
- Availability of matched therapies
- Treatment uptake
The resulting population is a more realistic basis for estimating demand than the total number of patients with the disease.
Diagnostics Determine How Much of the Market Can Actually Be Reached
Personalized treatment relies on identifying patients most likely to benefit. The FDA defines companion diagnostics as tests essential to the safe and effective use of a drug or biologic.
They can pinpoint patients who will respond, flag those at higher risk of adverse effects, or track treatment response.
The diagnostic pathway is therefore part of the commercial opportunity.
Markets with strong lab infrastructure and routine biomarker testing enable faster adoption, while limited access to molecular diagnostics slows uptake.
The assessment should consider:
- Testing availability: Are appropriate tests accessible in the target market?
- Laboratory capacity: Can laboratories process the expected testing volume?
- Turnaround time: Can results be delivered quickly enough to influence treatment decisions?
- Reimbursement: Who pays for testing, and under what conditions?
- Clinical integration: Are physicians routinely ordering and acting on the results?
These factors determine how much of the theoretical patient population can become commercially addressable.
Treatment Availability Completes the Opportunity
Identifying a patient does not automatically create treatment demand. The market must also have an available therapy, an appropriate treatment pathway and sufficient access to that treatment.
This is particularly relevant where several targeted therapies compete for overlapping patient segments. A company assessing market potential needs to understand not only the number of biomarker-positive patients but also:
- Approved therapies and indications
- Emerging treatments
- Competing mechanisms
- Treatment sequencing
- Reimbursement and access
- Physician prescribing patterns
In 2026, the FDA expanded companion‑diagnostic indications, including PIK3CA testing for inavolisib in breast cancer and MET exon 14 testing for tepotinib in advanced or metastatic NSCLC.
These developments create new patient segments and introduce fresh competitive dynamics for market participants.
The Adoption Gap Can Be Commercially Significant
The existence of a suitable diagnostic and treatment does not guarantee that patients will receive personalized care. ASCO data highlights the scale of the issue in metastatic NSCLC. Of 92,401 newly diagnosed US patients in 2024, 53% were positive for at least one of 10 guideline‑relevant targets.
Optimal panel testing could identify actionable targets in 76% of eligible cases, compared with 61% under suboptimal testing.
This shows that market opportunity lies not only in new therapies but also in broader adoption of existing testing and treatment pathways.
Where Nexdigm Identifies the Addressable Opportunity
Nexdigm’s personalized medicine opportunity analysis can connect these variables to determine the commercially addressable patient population within a disease or therapy area.
The assessment can examine:
- Patient segmentation: Clinical and demographic profiles of disease populations
- Biomarker opportunity: Prevalence of relevant biomarkers and treatment eligibility
- Diagnostic access: Availability of testing, lab networks, and reimbursement
- Treatment landscape: Approved and emerging targeted therapies
- Adoption: Physician testing, prescribing, and treatment behavior
- Market access: Pricing, reimbursement, and patient affordability
- Competitive environment: Current and pipeline therapies for the same segments
This provides a more detailed view of where patient stratification can translate into treatment demand.
From Patient Population to Commercial Opportunity
Nexdigm can assess personalized-care opportunities through five stages:
- 01 | Define the Patient Pool
Size the relevant population by disease, severity, treatment line and clinical characteristics. - 02 | Segment by Biomarker
Estimate the proportion of patients carrying relevant biomarkers or other characteristics associated with treatment selection. - 03 | Assess Diagnostic Reach
Evaluate testing availability, laboratory capacity, reimbursement and physician adoption. - 04 | Map Treatment Access
Assess matched therapies, competitive products, treatment sequencing and access conditions. - 05 | Quantify the Opportunity
Translate the addressable patient population, treatment uptake and competitive environment into market-level opportunity estimates.
This approach separates theoretical patient demand from commercially reachable treatment demand, providing a stronger basis for portfolio planning and market prioritization.
Nexdigm’s Case
A specialty-pharmaceutical company evaluated a targeted therapy opportunity across 4 markets. Nexdigm segmented the patient population by disease stage and biomarker prevalence, assessed diagnostic access and mapped competing therapies. The analysis identified 2 priority markets with the strongest combination of addressable patients, testing capacity and treatment access.
Personalized care creates its strongest commercial opportunities where patient identification, diagnostic access and targeted treatment are already connected through clinical practice. Nexdigm helps pharmaceutical, diagnostic and healthcare companies quantify those conditions, assess the addressable population and prioritize markets where personalized-care adoption can support sustainable growth.
To take the next step, simply visit our Request a Consultation page and share your requirements with us.
Harsh Mittal
+91-8422857704
[email protected]