The Strategic Imperative: Part 2 - Defining Your TPP Indication and Patient Population

Hi Ai Consulting
May 30
4 min read

Updated: Jun 5

Welcome to Part 2 of "The Strategic Imperative," where we'll focus on the core of your Target Product Profile (TPP): clearly defining your candidate's indication and precisely identifying your target patient population. This initial work ensures your development delivers a solution where it's most needed and valued, while also preparing you to mitigate unforeseen clinical trial risks and leverage key market information. In our previous post, we established that the TPP is a dynamic, crucial strategic roadmap, essential for driving internal clarity, fostering synergy, and significantly de-risking drug development.

Have You Selected the Specific Unmet Need You're Truly Solving for you TPP Indication and Patient Population?

You Indication is the Basket, your patient population is the purple strawberry — Target Patient Population Selection

Identifying the specific unmet need and patient subsets. The TPP must specify the intended patient population(s), including any subsets your candidate will treat. This means clearly articulating the unmet medical need or specific condition within that patient cohort, where current treatments are absent or inadequate. You can stratify the target population by factors like disease severity, previous treatment history, genetic markers, or other biomarkers, allowing for a more targeted development.

Nowadays, a broad "indication" is often not enough. Focusing on specific subsets of patients and detailed patient characteristics shows a shift towards precision medicine and highly targeted therapies. A broad indication might not be commercially viable. Identifying the patient population with the "highest unmet need" is key for market positioning and demonstrating true value. Thus, a strong TPP demands granular patient segmentation. This precision directly impacts your candidate's potential for favorable market access, reimbursement, and overall commercial success.

Mitigating Clinical Trial Risks: Will Unforeseen Population Shifts Force You to Restart or Halt Development?

Study population shifts can force you to restart or halt your development, or give it momentum. Which outcome do you prefer? Unanticipated changes can derail your clinical trial. Proactive TPP planning minimizes the risk of costly halts or re-starts.

Changes in Demographic Characteristics: The available population for study participation may shift due to underlying demographic trends, new medications or variations within clinics. Without a clear TPP that anticipates this, your trial recruitment and commercial viability could suffer.

Key Market Information: What Do You Need to Evaluate to Make Your TPP Resilient to Change?

Building a robust Target Product Profile requires deep market understanding, extending far beyond the lab. Building a strong patient profile within the TPP framework requires understanding the market landscape. This goes beyond clinical data, encompassing the real-world context of disease, patient needs, and commercial dynamics. The fundamental question is: who is this TPP for? Whose story are we telling? For that, we need to understand the patients.

Patient Demographics and Disease Burden: Do You Truly Know Your Patients Beyond Their Diagnosis?

A detailed analysis of incidence, prevalence, age, gender, health conditions, and disease severity is non-negotiable for targeting. Start by understanding the incidence (new cases) and prevalence (existing cases) of the condition within your target population. Analyze key demographic segments like age, gender, income, education, and location. Patient segmentation is vital for precision, stratifying the market by disease severity, treatment history, biomarkers, and other traits that differentiate patient cohorts and their likely response to therapy.

Patient Demographics and Disease Burden: Do You Truly Know Your Patients And Their Journey?

Patient Journey is a Must for TPP Indication Selection — A TPP Must Consider the Patient Journey

Indication selection demands an understanding of your patients, extending far beyond their diagnosis. Start by analyzing the incidence and prevalence of the condition within your target population, including key demographics like age, gender, and location. Patient segmentation is vital; stratify the market by disease severity, treatment history, and biomarkers to identify specific "patient subsegments" who will benefit most from your therapy. This shifts focus from "who has the disease" to "who will benefit most and why."

To truly grasp the real-world burden your patients face and where your candidate fits, you must understand its impact on their daily life and social functioning. This requires walking in their shoes and mapping their journey from first symptom to ongoing care.

Key stages typically include:

Awareness: Patients recognize a health issue and begin gathering information.
Consideration: They actively seek and evaluate treatment options.
Access: They navigate appointments, insurance, and the healthcare system.
Service Delivery: They directly receive treatment and care.
Ongoing Care: They engage in continuous support and follow-up.

A deep patient understanding, informed by analytics and real-world evidence, helps develop candidates and value propositions tailored to patient needs. This targeted approach leads to higher adoption, improved outcomes, and efficient resource allocation, i.e. potential revenue.

Need Help Getting Started?

You don't need to do it alone. Selecting Your TPP Indication and Patient Population has become easier thanks to TheraAIsight’s Target Product Profile Analysis + Benchmarking service uses AI to streamline and enhance your TPP process. Plus, our core offering, Custom Disease Landscape reports, provides the key market information, epidemiology, and patient journey insights you need to evaluate target patient needs and refine your TPP.

Here's how TheraAIsight helps you:

Get actionable insights for your target indication. AI replaces weeks of research, while our analysis reviews and enhances market landscapes for ANY disease in days, not weeks.
Use AI technology to extract data and deliver insights, including references to reputable sources.
AI generates 5 diverse product profiles based on critical market trends, giving you a comprehensive strategic overview.
AI reveals your TPP's quantitative market opportunities and challenges, equipping you with actionable insights for funding and strategic decisions.

Contact TheraAIsight today for a personalized consultation and discover how an AI-driven Disease Landscapes and TPP Analysis can transform your strategic outlook.