Digital health AI technologies are transforming drug development and advances in healthcare delivery at unprecedented speed, with government support driving momentum to improve healthcare for a growing population. Sidley’s European life sciences lawyers Josephine Sommer, Eva von Muhlenen and Francesca Blyth share their timely insights on the top five trends in the life sciences industry that are being shaped by pioneering digital technologies. We’re excited to bring you a series of insightful interviews with leaders in the diverse digital health ecosystem, offering perspectives from Roche, Origen Genetics, FemTech Insights, Verge, Steto, and Clario.
trend one
Medtech and digital health markets grow despite tightening regulations
The European medical technology and digital health market continues to grow and expand despite increasing European regulatory requirements. The European medtech market is valued at approximately €160 billion in 2023,1 with an average annual growth rate of 5.4% from 2013 to 2023. Europe’s digital health sector revenue is also expected to show a high annual growth rate of 9.30% over the next five years, resulting in a market size of 53.59 billion by 2029 due to increasing adoption of digital treatments and care. It is predicted to reach 1 million euros. In recent years, the European market has passed several important regulations impacting the digital health and AI market, such as the Medical Devices and In Vitro Diagnostics Regulation, the AI Law, and the European Medical Data Space Regulation, but there are still some obstacles to the regulation. There doesn’t seem to be anything. Alternatively, growth in this segment may slow.
trend 2
Cybersecurity is paramount
Potential investors and buyers expect advanced cyber risk management and mitigation strategies from digital health and artificial intelligence companies. To succeed in this field, it is imperative that digital health innovators carefully monitor developments in the rapidly changing field of cybersecurity as it relates to healthcare technology. Because there is no “one-size-fits-all” way to think about these ever-evolving risks. . Companies are now starting to think creatively about how best to extend security measures in the startup space and how to manage potential external and internal threats to minimize business disruption and protect customers. Masu.
trend 3
Market access channels are expanding
Many European countries offer attractive market access routes for digital health applications, increasing patient access and creating clearer investment opportunities. for example:
Germany’s DiGA (Digitale Gesundheitsanwendungen) outlines medical laws and regulations that allow approved digital health applications to be prescribed by doctors and reimbursed by statutory health insurance, and provides a clear regulatory pathway for reimbursement of digital health apps. We provide. The UK’s NICE Digital Health Agency has developed the Digital Health Technologies Evidence Standards Framework and the Digital Health Technologies Evaluation Criteria. France provides full coverage for telemedicine (including doctors, nurses, speech pathologists, and midwives), which provides not only preventive care but also remote monitoring of cardiovascular diseases, pulmonary diseases, and other chronic diseases. , paving the way for important innovations in primary healthcare. Belgium has adopted a mobile app reimbursement scheme that meets mHealth Belgium’s Verification Pyramid Standards, ensuring that apps that meet stringent safety, quality and effectiveness standards are eligible for reimbursement.
These developments highlight our commitment to fostering an environment that provides broader access to various forms of digital healthcare.
trend 4
Femtech is on the rise
The femtech and women’s health market is in the spotlight as it is seen as a US$1 trillion economic opportunity by 2040. Women are responsible for 80% of household spending decisions and spend 30% more on health per capita than men. Currently, only 3% of digital health investments are going to femtech, leaving this market with significant growth potential. Recent investments have flowed into femtech areas such as HPV vaccines and pulmonary arterial hypertension, as well as a focus on cardiovascular and immunology research that addresses gender differences. We expect these trends to continue to grow and provide ample opportunities for developers and investors in the femtech space.
At the same time, the exploitation of data in personalized medicine is becoming increasingly popular among investors, who are particularly interested in the intellectual property rights and data usage rights secured by potential collaborators, as well as the quality of the data collected and analyzed. It is attracting attention. Investors recognize that such data, especially when combined with advanced analytics and AI, provides increased opportunities for personalized treatment plans. Industry recognition of the challenges posed by data standardization, quality and interoperability, data usage rights, data protection and privacy is driving interest in the burgeoning national data space. The European Health Data Space (EHDS) Regulation, which is likely to be enacted soon, aims to create a common framework across the EU to facilitate the secure and standardized exchange of health data. This initiative is expected to improve the ability of healthcare providers and researchers to access and utilize high-quality data for personalized medicine. Over the next few years, we expect that strategies to connect these data spaces will be developed and that EHDS will play a pivotal role in driving standardization and interoperability across Europe.
trend five
The rise of government-backed digital health hubs
Governments across Europe are actively supporting and funding MedTech startups through dedicated hubs. These government-supported initiatives, such as the UK National Institute for Health and Care Excellence, provide substantial research infrastructure. The Spanish Ministry of Health has developed the Spanish Digital Health Strategy, which includes the creation of innovation hubs in different regions to support the development and integration of digital health solutions into the national health system. These hubs provide resources such as funding, mentorship, and access to clinical trial networks.
