Life science, the digital turnaround has begun, but acceleration is needed

Digital innovation is revolutionising the world of health, but life science companies are moving in a still uncertain context, where the speed of technological progress clashes with the slowness of regulation. This is the picture that emerges from the new report of the Life Science Innovation Observatory of the Politecnico di Milano, which turns the spotlight on the priorities, obstacles and prospects of the sector in 2025. Perhaps the most emblematic figure? 69% of companies in the ecosystem report the lack of a defined regulatory framework as the main obstacle to the development of digital therapies (DTx), solutions that 65% of companies consider strategic for supporting patients, and 58% for improving interaction with healthcare professionals. A snapshot that makes the news of a few days ago even more relevant: Italy has finally adopted a basic regulatory text to regulate digital therapies, the first step towards the structural integration of DTx in the NHS.

The report also identifies the main investment trends of Life Science companies, led by Ai(90%), Real-World Data (62%) and Health Apps and Clinical Sensors (48%). Digital Therapies rank in this hierarchy as a priority area for 38% of companies, but with a growing awareness of their clinical and strategic potential. However, only a minority of the sample (less than 50 per cent) declares itself ready to effectively implement these innovations: lack of resources, lack of digital skills and, above all, regulatory complexity, the first brake for 46 per cent of respondents, weigh heavily.

In this scenario of growing demand for regulated innovation, the text adopted on 3 July by the Social Affairs Commission of the Chamber of Deputies marks a historic change of step. The bill legally defines digital therapies as 'software-mediated therapeutic interventions', regulates the modalities of certification, prescription, and provision in the NHS, and establishes a National Evaluation Committee in charge of guiding their inclusion in the LEA. To be included in the Essential Levels of Care, DTx will have to be supported by at least two clinical studies with solid evidence.

The Politecnico also highlights corporate strategies for tackling this transformation. More than 50% of companies have set up functions dedicated to digital innovation, while a quarter have activated specific teams to follow individual technological areas. However, only 38% of companies have a centralised budget for digitalisation, a sign of governance that is still unstructured.

On the skills front, almost all companies have started internal training on Ai (78%) and Prompts (63%). About a third have already organised courses on DTx (33%) and health apps (30%). Health professionals are also showing increasing openness: 45% of specialists are ready to prescribe DTx, a percentage that rises to 60% among those who know the differences between these solutions and simple Apps. A figure that highlights how education is the real key to accessing new therapies. Meanwhile, the international DTx landscape continues to grow: by 2025 there will be 112 active digital therapies, with prevalence in mental health (35%), endocrinology (22%), and neurology (9%). There is growing interest in combination models (DTx + drug), now at 37% of the total, at the expense of stand-alone solutions. But patients' expectations are still not fully met: while progress monitoring is well covered (64%), other crucial functionalities, such as communication with the doctor (only in 46% of DTxs) or therapy reminders, remain partially unfulfilled.