United Kingdom In-Vitro Diagnostics Market Size (2024 - 2029)

UK In-Vitro Diagnostics (IVD) Market Analysis

The United Kingdom In-Vitro Diagnostics Market size is estimated at USD 3.96 billion in 2024, and is expected to reach USD 5.70 billion by 2029, at a CAGR of 7.59% during the forecast period (2024-2029).

Factors such as the rising prevalence of chronic diseases, evolving regulatory landscapes, and technological advancements are driving the growth of the UK's IVD market.

Highlighting the urgent need for effective diagnostic solutions, the British Diabetic Association reported in April 2023 that over 5.6 million individuals in the UK are currently living with diabetes. As the healthcare system responds to this surge in chronic conditions, the significance of timely and accurate diagnostics becomes paramount in enhancing patient outcomes.

The demand for reliable diagnostic tools is intensifying due to the rising incidence of chronic diseases, especially diabetes and cardiovascular issues. Data from the British Diabetic Association indicates a peak in diabetes prevalence, underscoring the urgent need for regular monitoring. Concurrently, the British Heart Foundation noted that by September 2024, around 7.6 million individuals in England were grappling with cardiovascular challenges. These statistics not only underscore the escalating concern of chronic diseases but also pave the way for the expansion of the IVD market.

To strengthen the IVD market, the UK's regulatory environment is undergoing significant changes. For example, in January 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) appointed UL International UK Ltd as the primary assessor for most IVD devices, a strategic move to expedite the market entry of new diagnostics.

Furthermore, in August 2023, the MHRA's decision to onboard three additional UK Approved Bodies effectively doubled the nation's certification capacity for medical devices. Such regulatory strides not only expedite market access for groundbreaking diagnostic technologies but also bolster public trust in the safety and efficacy of IVD products, setting a robust foundation for market growth.

Amidst these changes, innovative diagnostic solutions are taking center stage. For instance, in February 2024, PulmoBioMed, a spin-out from Northumbria University, secured GBP 1.4 million (USD 1.8 million) for its handheld lung diagnostic device, PBM-Hale. This cutting-edge device, pivotal for early asthma diagnosis, captures breath samples. Clinical studies validate its prowess in swiftly detecting lung infections and inflammation, underscoring the transformative potential of such non-invasive diagnostics in patient care.

However, challenges persist. Stringent regulations surrounding IVD product approvals and pricing could pose hurdles to the market's growth.

Thus, the UK's in-vitro diagnostics market stands on the brink of substantial expansion. With chronic diseases on the rise and regulatory frameworks adapting, the fusion of innovative technologies and enhanced certification processes heralds a more resilient healthcare system, emphasizing the importance of timely and accurate diagnostics.

UK In-Vitro Diagnostics (IVD) Industry Segmentation

As per the scope of this report, in-vitro diagnostics as medical devices and consumables used to conduct tests on biological samples outside a living organism. These diagnostics play a crucial role in identifying medical conditions, including diabetes and cancer. The United Kingdom's in-vitro diagnostics market is categorized based on technique, product type, usability, application, and end-user. Techniques include clinical chemistry, molecular diagnostics, immunodiagnostics, and other methods such as hematology, microbiology, and urinalysis. Product segmentation encompasses instruments, reagents, and additional items. Usability divides the market into disposable and reusable IVD devices. Applications range from infectious diseases, diabetes, and cancer/oncology to cardiology, endocrinology, and genetic testing. End-users include diagnostics laboratories, hospitals, clinics, and others like clinic laboratories and academic institutions. The report provides market values (in USD) for each segment.