‘Winning’ target product profiles for CAR-T cell therapies in oncology: critical success factors for commercially viable therapies

The global CAR-T cell therapy market is predicted to reach US$29.0 billion in revenues by 2029, growing at a CAGR rate of 39.6% from 2024–2029. Despite the attractiveness of the potential market, CAR-T cell therapies have high costs of goods (COGs) due to their complex manufacturing process and a high price, making it crucial for CAR-T cell developers to develop a target product profile (TPP) at an early stage to determine if a commercially attractive product is achievable and hence viable. This article emphasizes the importance of developing a TPP for CAR-T cell therapies and offers best practice guidance on its development. It highlights the strategic role of a TPP in clinical development and the value of adopting an evidence-based approach to developing a TPP, as led by a cross-functional multi-disciplinary team. A CAR-T-specific template is proposed, combining various TPP templates. Finally, we provide clarity on what a ‘good’ TPP looks like, optimal timing for development, governance processes, data and insights needed, and key ‘watch outs’.

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