How DelveInsight Assisted a Client with NSCLC Epidemiology Forecasting segmented by Biomarker types

Client Overview

A leading biopharmaceutical company specializing in oncology approached DelveInsight for comprehensive epidemiology forecasting analysis of Non-Small Cell Lung Cancer (NSCLC) including various  genetic biomarkers datapoints. The client sought detailed insights to support their drug development strategy, identify target patient populations, and optimize market access planning.

Challenges Faced by the Client

1. Limited Biomarker-Specific Data – The client required precise segmentation and epidemiology forecast of NSCLC cases by genetic mutations/protein expressions such as PD-L1, KRAS, EGFR, BRAF, and NTRK.
2. Regional-Specific Epidemiology – The company needed country-wise epidemiological data across the United States, EU4 (Germany, France, Italy, Spain), the UK, and Japan (7MM) for assessing patient population trends and to understand country wise patient journey to further do their commercial planning.
3. Forecasting for Drug Development – The client required long-term epidemiological forecasts (2020–2034) to align with clinical trial timelines and market entry strategy.
4. Exploring opportunities in areas with unmet needs- Understanding the estimated number of patients affected with newer and emerging mutations, hard to treat gene fusions and cancer causing protein expressions, unexplored by pharma companies.

DelveInsight’s Approach

🔹 Data Collection & Analysis
DelveInsight leveraged a combination of real-world evidence, country-specific  sources, cancer registry data, peer-reviewed publications, meta-analysis clinical studies and primary research with key opinion leaders (KOLs) to create a robust epidemiology model.

🔹 Granular Disease Segmentation
The analysis included:

• Total NSCLC Incident Cases: ~204K cases in the US in 2024 (~115K in men and ~89K in women).
• Age-Specific Analysis: Patients ≥65 years accounted for ~140K cases in the US.
• Histological Subtype Breakdown:
  • Adenocarcinoma (~59%)
  • Squamous cell carcinoma (~25%)
  • Large cell carcinoma (~6%)
• Biomarker-Specific Incidence:
  • PD-L1 had the highest prevalence, followed by KRAS, EGFR, and BRAF (~5% of cases)
  • NTRK1/2/3 fusions were rare (~450 cases in the US).
  • MET expressions including  METex14 skipping,MET amplification, cMET overexpression
  • KRAS Mutation Subtypes: ~4,900 cases of KRAS G12C and ~13,300 cases of KRAS non-G12C in the US (2024).
  • Other NSCLC patient numbers with TIGIT expression, HER2 gene mutation, HER2 overexpression, HER2 amplification, ROS-1 alterations were also included.
• Stage-Specific Analysis- Stage I,Stage II,Stage IIIA,Stage IIIB and Stage IV data provided, wherein Stage IIIB and IV accounts for almost 50% of the overall NSCLC patients diagnosed, whereas the Stage I and Stage II accounts for roughly 35% of the cases. Considering most of the approved therapies have been approved for late stage patients, early stage NSCLC is a budding area with more commercial opportunity.

Custom Forecast Model (2020-2034)
DelveInsight developed a dynamic evergreen forecasting model to project NSCLC incidence trends, adjusting for factors such as:

• Demographic shifts (aging population, smoking rates)
• Advancements in genetic testing & screening programs
• Adoption and recommendation of each biomarker testing across countries
• Evolving treatment paradigms

 Actionable Insights for the Client

1. Strategic Clinical Trial Planning: The client identified the population of interest as an emerging biomarker target for drug development.
2. Market Expansion Strategy: The client prioritized countries of interest based on biomarker distribution trends.
3. Regulatory & Commercial Decision-Making: The data supported label expansion efforts and pricing strategy discussions with payers.

Impact & Results

• Enhanced Drug Development Strategy: The company optimized patient enrollment criteria for its NSCLC biomarker-driven clinical trials.
• Informed Market Access Plans: The forecast helped shape targeted commercialization strategies for different geographies.
• Competitive Positioning: The client gained a first-mover advantage in biomarker-driven NSCLC therapies.

Conclusion:
DelveInsight’s biomarker-specific epidemiology forecasting empowered the client with data-driven insights to refine their drug development and commercialization approach in NSCLC, ultimately driving better patient outcomes and strategic business growth.

Gain similar insights? Explore DelveInsight’s NSCLC Epidemiology-based Market Report for in-depth analysis of disease prevalence, incidence, and patient demographics.