Cambridge Design Partnership and CPI launch the UK’s In Vitro Diagnostics Roadmap

Cambridge Design Partnership and technology innovation catalyst CPI today launch A Strategic Technology Roadmap for the UK In Vitro Diagnostics Industry, a major new report for industry leaders, government, and the UK’s health tech companies.

The UK in vitro diagnostics (IVD) industry has the potential to help boost UK economic growth and make the UK a global leader in the industry while improving health in the UK and for people worldwide. A new strategy, applied over the next 10 years, can see the industry transformed. The Roadmap, researched and written by Cambridge Design Partnership, in partnership with CPI, the Association of British HealthTech Industries (ABHI), and funded by Innovate UK, defines the key technologies and strategies that can place the UK at the forefront of this industry.

In vitro diagnostics – analysing biological samples outside of the body to determine health status – shows huge promise, from earlier cancer detection to the prevention and management of infectious and chronic diseases. The UK is already a global leader for science and technology. Many of the technologies at the heart of this thriving industry were pioneered in the UK, from lateral flow tests to the genetic sequencing technology used in around 80% of the world’s genetic sequencing systems. But the UK is not at the top table of the growing IVD industry, with recent estimates suggesting it accounts for just 3% of a £90bn industry. While the UK excels at research, it is held back by the commercialisation process. As a result, many UK inventions are commercialised by overseas companies – start-ups and scale-ups are acquired by global leaders, and we are yet to see the emergence of major UK IVD companies or state-of-the-art R&D centres from the global industry.

A Strategic Technology Roadmap for the UK In Vitro Diagnostics Industry sets out a programme of change to help meet the clinical needs of the future and support the UK IVD industry, government, and Innovate UK to make informed investment and capability development decisions. This Roadmap is a resource for:

  • Companies planning their strategies over the medium to long term, particularly leaders in medical technology, the pharma industry, and the investment community that supports them
  • Policy makers and broader government stakeholders shaping future UK government strategy and funding decisions
  • All those interested in and charged with the success of UK PLC. 

Pari Datta, Principal Consultant in Strategy at Cambridge Design Partnership and the Roadmap’s lead author, says, “It’s hugely encouraging that the UK continues to lead the science behind all the major opportunities for the IVD industry – just as it did before for lateral flow testing and DNA sequencing. But we’ve yet to create global IVD industry leaders of our own or attract investment in UK R&D from global IVD leaders. Our strong position in research means we can change that. We can become one of the global IVD leaders of the future, boosting national economic growth and taking a global leadership role while improving patients’ lives worldwide.”

The Roadmap is part of the Health Technology Regulatory and Innovation Programme, an Innovate UK-sponsored initiative led by CPI in partnership with ABHI. This programme delivers a package of support to UK health tech companies to help them meet the regulatory requirements for developing, commercialising, and deploying their medical technology in the UK and globally.  

A second report – Challenges and Opportunities for the UK HealthTech Industry – was also published today. For this report, CPI and ABHI worked with over 350 small-to-medium-sized enterprises (SMEs), Innovate UK and health tech stakeholders to identify the key challenges faced by the UK health tech SME community. 

Dr Arun Harish, Strategy Director at CPI, said: “As a Catapult centre leading on HealthTech in the UK that works with many health SMEs in the sector, we understand how hard they find the navigation of the regulatory approvals process and the route to commercialisation. These two first-of-their-kind reports will help industry, policymakers, government, funding agencies and the wider HealthTech ecosystem immensely with shaping future interventions to grow the HealthTech industry in the UK. They also highlight the need for further intervention to support UK HealthTech businesses in developing and scaling-up innovative technologies, which will ultimately benefit UK populations.”

Selected Roadmap highlights

  • The Roadmap begins by defining a shared vision, acting as a focal point for stakeholders involved in the project and those going on to implement and follow the Roadmap. The vision statement is: “The UK will be the industry nucleus for world-leading businesses, with the resources, skills, and proven pathways for advancing pioneering technologies into successful data-enabled IVD solutions.”
  • Using oncology and infectious diseases as key disease states, input was collected from clinicians, publications, and patents to define nine key technology-enabled opportunities for the global IVD industry over the next 10 years. These are:
    1. Digital PCR
    2. Sequencing
    3. Cell-free nucleic acids
    4. Digital biomarkers
    5. Proteomics
    6. Combined biomarkers
    7. Single cell analytics
    8. Exosomes
    9. Metabolomics
  • The report recommends that the UK develops specific technologies in materials, enzymes, artificial intelligence (AI)/data, optics, microfluidics, and sensors. To advance in these opportunities, the IVD industry also needs to build collaborations with companies that have expertise in these areas.
  • Seven major challenges are identified that must be resolved, including lack of UK infrastructure and ecosystem for design and development, acquiring patient samples, clinical studies, commercialisation, adoption, clinical reimbursement, and financing and investment.
  • In conclusion, the report recommends that the UK needs to adopt the following strategies to overcome these challenges and realise its vision for the UK’s IVD industry:
    • Boost the IVD industry’s profile in the UK
    • Create a focused government-led strategy for the UK IVD industry
    • Support access to NHS resources during development and commercialisation
    • Assist IVD companies through a well-defined and harmonised regulatory pathway
    • Develop partnerships for high-risk IVD developments that have defined pathways to clinical use

Download the In Vitro Diagnostics Roadmap

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