By Aiden Hannah, Research Analyst, Deloitte

In November 2020 our report, ‘The future unmasked: Predicting the future of healthcare and life sciences in 2025’ included a prediction that technological breakthroughs would create new diagnostic pathways, enabling clinicians to deliver hyper-personalised evidence-based prevention and treatment interventions.¹ Over the past year the pandemic has continued to have a significant impact upon the healthcare industry, in particular the diagnostics industry. This week’s blog, by our new analyst Aiden Hannah, considers the lasting impact of some of these changes and what the diagnostics landscape may look like in the future.

A period of significant change

The COVID-19 pandemic has shone a spotlight on the diagnostics industry, exposing both its strengths and vulnerabilities. Many elective surgeries were cancelled, referrals for blood tests and cancer screenings were delayed, and the fragility of supply chains had significant implications for many MedTech companies. At the same time, the need for scans such as Magnetic Resonance Imaging (MRI) and Computerised Tomography (CT) scans for patients hospitalised with COVID-19 and the substantial increase in the use of both Polymerase Chain Reaction (PCR) and lateral flow tests saw many non-traditional diagnostic companies entering the diagnostics market. The continuing surge in demand for these tests, coupled with restarting clinical procedures has resulted in a sharp increase in the value of the UK In Vitro Diagnostics (IVDs) market in particular, rising to £1,811.8 million in 2021.²

The rapid transformations of the diagnostics industry have also changed patients’ experiences of diagnostics. Patient expectations around the availability of rapid diagnostics are likely to grow. Likewise, the pressures to combat the rising NHS backlog will increase demand for diagnostic tests. As predicted in our 2020 report, higher levels of investment, training and staffing are key to realising the full potential of this market.³

Improving diagnostic imaging power and efficiency with artificial intelligence

In the UK, the diagnostic imaging market is currently valued at approximately £498 million, and this is predicted to rise to £739 million by 2030.⁴ Including key diagnostic technologies such as CT, MRI and ultrasound systems, this is an area that was already seeing increasing demand for services prior to the pandemic. NHS England now predict rises of over 100 per cent in the next five years for some imaging services such as CT scanners.⁵

The development of Artificial Intelligence (AI) assisted imaging systems has also accelerated in recent years.⁶ AI can enhance imaging in a number of ways: from thyroid cancer screening to supporting radiologists in determining the impact of COVID-19 upon patient’s lungs, AI can improve accuracy and efficiency across a broad range of imaging applications.^{7 8}

Established during the pandemic, the NHS AI Lab Imaging Programme promotes the adoption of these technologies in the UK by creating ways for data to be collected and shared safely.⁹ The NHS plan to extend the scheme into a National AI Medical Imaging Platform (NMIP) to drive further innovation. This next generation of imaging technology includes AI-enhanced MRIs that decrease imaging times and deep-learning to boost image quality in CT scans, optimising patient diagnosis and treatment selection.^{10 11}

Embracing new diagnostic settings

Increased patient empowerment and the widespread adoption of at home self-testing for COVID-19 are further indications of the changes transforming healthcare.¹² The NHS’s drive to support healthy ageing and the need to reduce the unrelenting pressures on hospital resources will drive shifts in the mode of care delivery further still, including increasing demand for innovative, low-cost and portable diagnostics.

Our report ‘The future unmasked: Predicting the future of healthcare and life sciences in 2025’ predicted that advancements in technologies will empower clinicians to adopt new diagnostic pathways including the next generation of genomics and smart sensors (see Figure 1). These could revolutionise point-of-care (POC) diagnostics: lowering costs, improving accessibility, and supporting personalised treatments.

Figure 1. Summary of technological breakthroughs identified as having the potential to create new diagnostic pathways.

Source: Deloitte LLP

POC tests will augment the use of centralised laboratories and increase the efficiency of and access to diagnostics for many patients, including supporting patient triaging, remote monitoring of chronic conditions and acute patient management decisions inside and outside of traditional care settings. Devices will include advanced wearables for monitoring a variety of chronic conditions, predictive symptom tracking and rehabilitation monitoring.

A further crucial area where transformation is likely is in the use of rapid POC diagnostics to tackle antimicrobial resistance (AMR). Declared by the WHO as one of the top threats to global public health, the UK’s five-year action plan to tackle AMR includes incentivising the development and adoption of affordable, rapid tests that are accessible and promote antibiotic stewardship.^{13 14} With traditional hospital laboratory culture-based tests having typical turn-around times of at least 24 to 48 hours, POC devices that enable targeted prescribing within minutes would be transformational.¹⁵ Furthermore, low-cost technologies enabling  home screening of multiple biomarkers at once will likely become more common, such as tests differentiating between COVID-19, influenza and other viruses.

An evolving regulatory landscape

Alongside these innovations, the medical devices and IVD sectors are in a period of significant regulatory change. Specifically, new European Union Medical Devices and IVD Regulations and a UK regulatory transition towards a new Conformity Assessment (CA) mark. There are currently only three organisations in the UK able to perform regulatory conformity assessments for IVDs (notified bodies), raising concerns around capacity and approval delays.¹⁶ At the same time, the pandemic has pushed the boundaries of medical device regulation. Many disruptive new technologies have been developed and greater collaboration between businesses, regulators and government bodies has been shown to have had a positive impact on the industry. For the breakthrough technologies discussed in this blog, there can be significant regulatory hurdles. By creating a forward thinking, collaborative and responsive regulatory framework, regulation can support healthcare’s digital transformation.¹⁷

Harnessing digital innovation

The accelerated advancement of digital technologies over the past decade has helped drive process automation and efficiency in diagnostics, moreover the power of AI for decision support and predictions is becoming clear. Taking data from multiple interconnected diagnostic devices, AI in combination with the data integrity offered by blockchain have the power to revolutionise data-driven healthcare delivery in future. The use of Virtual Reality (VR) and Augmented Reality (AR) are further changing the diagnostics landscape,¹⁸ enhancing diagnostic imaging by creating interactive patient image overlays with depth perception.¹⁹ Further applications include supporting the diagnosis of neurological diseases and biomechanics analysis.^{20 21}Gamification has also emerged as a potentially powerful tool for both the diagnosis and treatment of mental health conditions, integrated with existing diagnostic devices such as EEG.²² Harnessing these digital technologies will require cross-sector collaborations to unlock their full potential.

Aiden Hannah, Research Analyst

Aiden has a background in physics and biomedical engineering, and a strong technical knowledge of diagnostics and digital healthcare. Most recently working as an academic researcher, he undertook a range of multidisciplinary projects involving close collaborations between MedTech companies and clinicians; supporting the development of novel biosensors and low-cost diagnostics, including clinical trial design and conduct. Aiden has focused on the health technology investment pipeline and the medical device regulatory processes as part of his doctorate industry placements.

Email | LinkedIn

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¹ Clinicians are empowered by diagnostic and treatment paradigms (deloitte.com)

² ‘Market size and growth, In Vitro Diagnostics Market, United Kingdom, 2015-2030’, Global Data.

³ Clinicians are empowered by diagnostic and treatment paradigms (deloitte.com)

⁴ ‘Market Size and Growth’, Global data.

⁵ ‘Diagnostics: Recovery and Renewal’, NHS England, October 2020. See also: BM2025Pu-item-5-diagnostics-recovery-and-renewal.pdf (england.nhs.uk)

⁶ The future of diagnostic imaging | Independent Imaging

⁷ ‘Using AI in Medical Imaging to Improve Accuracy and Efficiency’, Intel. See also: using-ai-in-medical-imaging-to-improve-accuracy-and-efficiency.pdf (intel.com)

⁸ Shaping the future of European healthcare | Deloitte UK

⁹ AI in imaging - NHSX

¹⁰ Philips debuts AI-equipped MRI machines plus spectral angio-CT combination scanners | FierceBiotech

¹¹ The Technology | AI | Canon Medical Systems

¹² Shaping the future of European healthcare | Deloitte UK

¹³ Antimicrobial resistance (who.int)

¹⁴ ‘Tackling antimicrobial resistance 2019–2024’, HM Government, January 2019. See also: UK_AMR_5_year_national_action_plan.pdf (publishing.service.gov.uk)

¹⁵ Test Frequencies and Turnaround Times (royalwolverhampton.nhs.uk)

¹⁶ Medical devices: UK approved bodies - GOV.UK (www.gov.uk)

¹⁷ ‘Taskforce on Innovation, Growth and Regulatory Reform independent report’, Rt Hon Sir Iain Duncan Smith MP, Rt Hon Theresa Villiers MP, George Freeman MP, 2021

¹⁸ ‘Virtual/Augmented Reality in Healthcare’, Global Data, January 2020.

¹⁹ ‘Virtual/Augmented Reality in Healthcare’, Global Data, January 2020.

²⁰ Słyk S, Zarzycki MZ, Kocwa-Karnaś A, Domitrz I. Virtual reality in the diagnostics and therapy of neurological diseases. Expert Rev Med Devices. 2019 Dec;16(12):1035-1040. doi: 10.1080/17434440.2019.1693892.

²¹ Kiper P, Baba A, Alhelou M, Pregnolato G, Maistrello L, Agostini M, Turolla A. Assessment of the cervical spine mobility by immersive and non-immersive virtual reality. J Electromyogr Kinesiol. 2020 Apr; 51:102397. doi: 10.1016/j.jelekin.2020.102397.

²² Sinha N. (2021) Introducing Gamification for Advancing Current Mental Healthcare and Treatment Practices. In: Marques G., Bhoi A.K., Albuquerque V.H.C.., K.S. H. (eds) IoT in Healthcare and Ambient Assisted Living. Studies in Computational Intelligence, vol 933. Springer, Singapore