A Target Product Profile (TPP) serves as the primary strategic framework that aligns commercial and clinical workstreams. When properly defined, the TPP enables drug developers to manage the development equation of risk x cost x time = success, and it starts by keeping the end in mind. Defining the needs of patients, physicians, and payers early in the process ensures a commercially viable product with a potentially higher valuation.

Below, we have outlined some key findings underlining the importance of utilizing a TPP.

1. Use of TPPs – An overwhelming number of BLA, novel product NDAs and 505b2 NDA submissions do not reference a TPP in their negotiations.
2. Launch success is becoming elusive – The average first year sales for the 51 products launched in 2022 was only $65 million. Excluding COVID products, first year sales have been steadily declining over the past 5 years.
3. Market access and competition are creating a challenging environment – Based on Rx access and dispensing rates only 44% of all prescriptions were filled. The number of products blocked by payers is increasing annually.
4. FDA complete response letters (CRLs) are on the rise – Since 2018 the number of CRLs issued by FDA has almost tripled. While CRLs are increasing FDA Advisory Committee Meetings (ADCOM) are decreasing.
5. TPPs are more important than ever – The TPP framework provides a strategic iterative document that defines and aligns commercial, clinical, medical, manufacturing, and regulatory requirements. It articulates the unmet medical needs of patients, physicians, and payers. It is a core document that positions and differentiates a product.

For help with building a strong TPP, read our Checklist, Target Product Profile Checklist: Laying the Foundation for Early-Stage Assets.