Personalised medicine is an emerging healthcare approach that tailors medical decisions about the prevention, diagnosis and treatment of disease by drawing on the individual patient's unique characteristics, including their genetic profile, biomarkers, lifestyle and environmental factors.
The combination of advanced personalised medicine with the adoption of MedTech promises to detect illness earlier and recommend the most effective prevention and treatment strategies for individual patients, whilst utilising specific technology to help monitor or treat conditions outside of a medical setting. This industry has exploded in recent years, with the UK personalised medicine market being estimated as being worth £20 billion in 2024, with predictions that it will grow to approximately £45 billion by 2035.
"The idea of personalised medicine, tailored to your DNA. The hope of treating diseases that we once feared incurable. The ability to predict and prevent illness long before it strikes. Think of the lives that will save" - Prime Minister Keir Starmer
The commercialisation of MedTech holds some challenges as there are higher entry barriers and longer incubation periods from the R&D stage to onward commercialisation. It relies upon patient data analysis, sufficient funding and regulatory approvals to bring a MedTech product to the market.
Alongside this growing market is the public's increased appetite for wellness products and gadgets to aid healthy living, which we have previously written on. This forms a blurry line with MedTech and a potential tension where one tranche of products possesses a higher regulatory threshold (MedTech), and the other (wellness) seeks to capitalise on strong brand messaging and marketing.
UK opportunities in the personalised medicine industry
The UK is a leading jurisdiction for personalised medicine companies to develop and commercialise technologies, with a range of government supports:
- The Government's Green paper on its new Invest 2035 industrial strategy emphasised the role of personalised healthcare and the broader life sciences sector as a key growth-driving sector which the government is prioritising.
- The UK is home to the 100,000 Genomes Project, a world-first initiative led by Genomics England to sequence and study patients affected by rare disease or cancer, and to make the data available for researchers to develop new treatments, diagnostics, devices and medicines. More recent initiatives by Genomics England include exploring the way that this genetic data can be brought together with pathology and radiology images to development more sensitive diagnostic approaches and sequencing the genomes of 100,000 newborn babies.
- The UK's Medicines and Healthcare products Regulatory Agency is open to ideas for innovative medicines, medical devices and manufacturing processes, providing advice on the regulatory framework for companies working in areas of regulatory uncertainty or fields undergoing rapid change.
Legal challenges for the development of the personalised medicine market
Advances in personalised medicine provide a range of patenting and licensing opportunities, including in relation to the discovery and delivery of new treatments. These new opportunities do however come with associated risks.
- The patentability of some aspects of innovative personalised medicines can be challenging across jurisdictions, with restrictions on methods of diagnosing diseases and difficulties in obtaining patent protection for DNA sequences. Innovators may need to consider relying on the full range of IP rights, including trade secret or database rights protection.
- Often the successful development of a personalised medicine will require the pooling of complementary technologies and expertise. This can include opportunities for data from existing wellness and wearable technologies to be repurposed and licensed for use within the personalised medicine industry. Other opportunities include the use of joint ventures as a vehicle for collaboration, allowing parties to combine IP assets and share research and development costs.
- Data protection and privacy concerns arise in relation to collecting information about patients' genetic profile, biomarkers and lifestyle. For example, this year's bankruptcy of DNA testing company 23andMe led to global regulatory interventions about the ongoing protection of its database of genetic and health information of its 15 million customers, including a warning issued by the UK Information Commissioner's Office.
The focus on MedTech and the growth of personalised medicine provides significant opportunities for innovators to collaborate across the industry, whilst maximising the value of their IP and supporting the UK;'s long term health goals.
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