As the New Year is fast approaching, we asked members of our Life Sciences team to share their predictions of what will be the key issues facing the industry in 2025. Please find our summary below, including the latest market trends and compliance challenges that could impact your business. We hope you will find it an insightful read over the holiday season. 

MARKET TRENDS: 

Life Sciences Story – the Deal Era
The 2023/2024 trend of divesting to focus on core assets isn't quite over yet as large corporations continue to look for ways to optimise their P&L. Tech adoption and AI continue to provide deal opportunities in the sector and after a year of political uncertainty, the promise of an era of relative political stability has given the market a renewed optimism. We anticipate that there will continue to be smaller, strategic and focused acquisitions being made in biotech and technology alongside more valuable strategic plays for new assets. 

Is AI in Drug Discovery Patentable?
As AI and machine learning become more advanced in 2025, we could see an increase in patent applications (and oppositions) in which AI has made an inventive contribution to the claimed invention, is referred to in the patent application, or even where AI itself has 'discovered' a new drug.  This will likely require courts and patent offices around the world to reassess many key questions of patent law, including the scope of patent protection afforded to such inventions. Please find further reading here and on algorithmic biases here. 

The Continuing Rise of Genomics
Genome editing is an immensely powerful tool which has the potential to revolutionise life sciences. In recent years, the technology has moved on quickly heralding myriad scientific opportunities and we expect genomic-related advances to continue to come thick and fast through 2025 and beyond, in particular, building on CRISPR technology.  This raises the question of whether the law can keep pace with the science, particularly now that attention has been turned to AI and what it might be able to do to improve, augment and enhance the use of CRISPR.  DLA Piper's Genomics Series gives a deeper insight into the genomics revolution. 

The New Age of Healthcare: Telemedicine 2.0
Telemedicine is entering a new age – one that involves patients being treated in virtual hospitals, the use of virtual reality (VR) and augmented reality (AR) in patient care and the development of the Internet of Medical Things (IoMT). Virtual hospitals with health professionals monitoring and treating patients using videoconferencing technology and wearable devices are broadening their treatment capabilities to more complex health issues including telemonitoring for patients with diabetes and for stroke rehabilitation. Virtual and physical hospitals are also increasingly adopting VR and AR to help doctors assess risks, carry out remote consultations and even perform surgeries. With the proliferation of health technologies, the IoMT will strengthen and evolve in 2025, creating new opportunities for collaborations between health professionals, hospitals and technology providers.

Globalisation of Mass Claims to Continue
Collective litigation, especially around product liability and anti-trust, remains a growing risk. In 2025, life sciences companies should monitor the UK Civil Justice Council's proposals for third party litigation funding reform.  It is anticipated there will be proposals to reform and potentially expand litigation funding arrangements in England. As the UK is the global centre for litigation funding, these reforms will have global implications, especially in Europe as avenues for collective litigation continue to mature.

Life Sciences in the UPC 
The Unified Patent Court is now 18 months old.  It has been embraced by life sciences companies in a way that many commentators did not predict at the outset.  Concerns that the new system would be developed based primarily on technology cases have been allayed, with around 25% of current cases before the Court being in the life sciences (second to technology, with 38%, and ahead of industrials, with 22%).  This seems set to continue, with more unitary patent applications filed in the first year in relation to medical technology than any other technological field.  And with the third section of the Central Division opening its doors in Milan in June this year, it remains to be seen whether the move from France to Italy of Central Division cases involving pharmaceuticals, medical devices and agriculture will result in a noticeable influence of Italian patent law and procedure within the UPC. 

Collaboration is Key
Collaboration will increase in 2025, driven by the pace of scientific development (in particular, digital transformation) and increased market confidence.  In a sector moving as fast as ours, few organisations have all the skills needed to go it alone, and many are confident enough to plug the gaps by teaming up.  Whether via formal joint ventures, shared R&D, bought-in skills or looser associations, 2025 will see the announcement of some exciting collaborations.

ESG is a Top Pick for Boards  
Life sciences businesses are high impact across the ESG spectrum, with complex supply chains,  extensive use of natural resources, and systemic product impact on societies and individuals: a huge challenge from a sustainability perspective. The potential for generative AI to enable LS companies to address that challenge profitably is revolutionary. A potential which is equalled only by the urgent need for the senior leadership of those businesses to develop governance protocols and procedures to keep their use of AI safe, transparent, and virtuous.  That is a top agenda item for boards in 2025 - a competitive and commercial imperative.

COMPLIANCE CHALLENGES: 

Overhaul of EU Life Sciences Regulatory Landscape
The EU LS regulatory landscape is experiencing a significant overhaul.  In addition to the highly publicised upcoming sector legislation such as the EU Pharma Package and the SoHo Regulation, a new EU Biotech Act is already in the making.  Also noteworthy is the imminent EU HTA Regulation, beginning in January 2025, especially now that Member States are increasingly looking to evolve their approaches to pricing and reimbursement.  AI and data have become indispensable for the sector, which is why the enforcement of the EU AI and Data Act and the upcoming European Health Data Space Regulation should also not be overlooked. Finally, continuing supply issues caused by the Medical Device Regulation and the In Vitro Diagnostic Regulation appear to have prompted the EU legislator to take action and contemplate updating the regulations in 2025.  

Cybersecurity takes Centre Stage
After many years of grappling with the ever-increasing threat of cyber-attacks, 2025 will be the year in which the regulation of cybersecurity finally steps up a gear.  In the EU alone, life sciences companies will, for the first time, find themselves part of 'critical national infrastructure' under the bloc's NIS 2 cybersecurity rules, which will continue to be transposed by Member States throughout the year.  Key obligations include minimum cybersecurity risk framework measures, incident reporting, and accountability for the 'management body'.  Meanwhile, European companies will also begin preparing for the product-orientated Cyber Resilience Act, which applies from 2027, although medical device manufacturers are exempt,  they are not exempt from the Data Act, which applies from September 2025 and which, amongst other things, raises cybersecurity concerns through the requirement to provide all data generated by the device to the user, or to nominated third parties. However, it is not just in Europe that new cyber rules are either being introduced or bedding in – changes are also taking effect in Australia, the UK and India, amongst others.

Competition Enforcement Target Wider Array of Practices
We anticipate that in 2025 competition authorities across the globe will continue to actively enforce in the life sciences sector, both in pharma and medtech.  Focus areas will include abuse of dominance in the form of foreclosure of competitors through practices such as disparagement and actions relating to patents. In relation to the latter, we believe that lifecycle management in its entirety will be looked at critically.

Healthcare Anticorruption Maintains Momentum in China
China’s increased anticorruption enforcement actions and higher penalties for bribery under the recently amended Criminal Code indicate a continued push to eradicate corruption in 2025. The anticorruption momentum in the life sciences sector is expected to continue as regulators emphasise proactive reporting of misconduct and effective compliance programs in recent regulations and compliance guidelines.
 

If you would like any further information regarding any of the topics listed in this article, please reach out to your usual DLA Piper contact or lifesciences@dlapiper.com 

Thank you to our contributors: Marco de Morpurgo, Victoria Rhodes, Tom Heylen, Nicholas Tyacke, Rebecca Lawrence, Greg Bodulovic, Jeremy Sher, Siona Spillett, Richard Taylor, Alex Tamlyn, Moritz von Hesberg, Jean-Christophe Top, James Clark, Joost Haans, Christine Liu, Adam Vause, Lyndsey Hudson and Guy Burrows.