UK In-Vitro Diagnostics (IVD) Market Size
| Study Period | 2019 - 2029 |
| Base Year For Estimation | 2023 |
| Market Size (2024) | USD 3.96 Billion |
| Market Size (2029) | USD 5.70 Billion |
| CAGR (2024 - 2029) | 7.59 % |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
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 Medical Diagnostic Testing becomes paramount in enhancing patient outcomes.
The demand for reliable Diagnostic Equipment 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 In-Vitro Diagnostics 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 Equipment but also bolster public trust in the safety and efficacy of IVD products, setting a robust foundation for market growth.
Amidst these changes, innovative Point of Care Diagnostics 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 Medical 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 Laboratory Testing.
UK In-Vitro Diagnostics (IVD) Market Trends
Infectious Diseases Segment is Expected to Witness Significant Growth Over the Forecast Period.
The infectious diseases segment within the In Vitro Diagnostics (IVD) market is projected to experience significant growth over the forecast period. This segment encompasses various diseases, including HIV/AIDS, hepatitis B, tuberculosis, and hepatitis C, all of which continue to pose substantial public health challenges in the UK. The increasing incidence of these infectious diseases, coupled with advancements in Diagnostic Tests and supportive government initiatives, underscores the potential for market expansion.
Data from the UK Health Security Agency underscores the ongoing challenge of infectious diseases in the UK. In 2023, the UKHSA reported 6,008 HIV diagnoses in England, a striking 51% surge from the 3,975 cases in 2022. Significantly, more than half of these cases were identified as having been diagnosed abroad, highlighting the critical need for robust screening and monitoring for both local and international cases. This uptick in diagnoses underscores an urgent demand for enhanced Diagnostic Equipment that deliver timely and precise results, fueling growth in the infectious diseases segment.
Innovations in diagnostic technology are pivotal to the growth of the infectious diseases segment. A recent example is the PA-100 AST, developed by Sysmex Astrego AB, which won a major UK science prize for its rapid antimicrobial susceptibility testing system for urinary tract infections (UTIs) in June 2024. This Point of Care Diagnostics system employs nanofluidic technology to swiftly determine the presence of bacteria and assess antimicrobial effectiveness. Such advancements in Diagnostic Assays not only enhance diagnostic accuracy but also facilitate timely treatment decisions, contributing to better patient outcomes and lower healthcare costs.
The UK government has demonstrated a commitment to fostering innovation in the IVD market. As of February 2024, the Innovative Devices Access Pathway (IDAP) pilot initiative is in its next phase, aimed at supporting the development of technologies that address unmet clinical needs. Eight innovative technologies have been selected to receive tailored regulatory and access support. Among these is an algorithm-based infection predictor developed by Presymptom Health Ltd., one of the innovative Molecular Diagnostics Companies UK, which utilizes a molecular test and a cloud-based algorithm to predict infection status days in advance. This could significantly reduce unnecessary antibiotic prescriptions and improve treatment timelines, addressing critical gaps in infectious disease management.
The infectious diseases segment of the UK In-Vitro Diagnostics market is poised for significant growth, contributed by the rising prevalence of infectious diseases, technological innovations, and proactive government initiatives.
Molecular Diagnostics Segment is Expected to Witness High Growth Over the Forecast Period.
The Molecular Diagnostics segment is poised for significant growth over the forecast period, contributed by technological advancements in the techniques, increasing accurate diagnostics needs, and strategic corporate activities.
Recent molecular diagnostics innovations have revolutionized how diseases are detected and monitored. Approaches such as polymerase chain reaction (PCR), next-generation sequencing (NGS), and CRISPR-based technologies enable rapid, accurate, and cost-effective Diagnostic Testing. These technologies not only enhance the precision of Diagnostic Tests but also facilitate the early detection of diseases, which is critical in conditions like cancer and infectious diseases.
Molecular diagnostics are increasingly being used in various applications beyond traditional clinical settings. For instance, in July 2024, Roche finalized its acquisition of LumiraRx's Point of Care Diagnostics technology, a strategic move aimed at enhancing access to Medical Testing in primary care. LumiraRx's innovative point-of-care solutions will augment Roche's existing diagnostics portfolio across multiple disease areas. This acquisition reflects a broader trend of integrating advanced diagnostic technologies into primary care settings, ensuring timely and accessible healthcare services for patients.
Similarly, in August 2023, Sherlock Biosciences reported the opening of a state-of-the-art 36,000 square foot biomanufacturing facility in the UK. This facility is designed to significantly expand the company's diagnostic capacity and enable rapid scaling of low-cost manufacturing of its Molecular Diagnostics products. This development is particularly noteworthy as it positions Sherlock to meet growing market demands while ensuring the affordability and accessibility of its diagnostic solutions.
Technological advancements, a pivot towards personalized medicine, and proactive measures by top companies are propelling the molecular diagnostics segment towards significant growth. With the industry's evolution, a commitment to improving diagnostic accuracy and accessibility is paramount, solidifying the integral role of molecular diagnostics in the future of healthcare.
UK In-Vitro Diagnostics (IVD) Industry Overview
The In-Vitro Diagnostics market in the United Kingdom is characterized as semi-consolidated. It features a mix of several major players, both global and regional. Key players in this domain include Abbott Laboratories, Becton, Dickinson and Company, BioMerieux SA, Bio-Rad Laboratories, Inc., Danaher Corporation, F. Hoffmann-La Roche AG, Qiagen N.V., Siemens Healthineers AG, Sysmex Corporation, Thermo Fischer Scientific Inc., and Fujifilm Holdings Corporation.
UK In-Vitro Diagnostics (IVD) Market Leaders
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Abbott
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Thermo Fisher Scientific Inc.
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Siemens Healthineers AG
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QIAGEN
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F. Hoffmann-La Roche Ltd
*Disclaimer: Major Players sorted in no particular order
UK In-Vitro Diagnostics (IVD) Market News
- August 2024: Eurobio Scientific, a prominent player in in-vitro specialty medical diagnostics and life sciences, has finalized its agreement with Myriad Genetics to acquire the EndoPredict genomic test. The company boasts a strong foothold in the UK.
- May 2024: Prolight Diagnostics' CTO expressed excitement over securing a grant from the UK government. The NIHR i4i Product Development Award, part of the UK's National Institute for Health and Care Research (NIHR) Invention for Innovation (i4i) Programme, offers funding opportunities. This programme champions translational research, emphasizing medical devices, in-vitro diagnostics, and digital health tools, all aimed at addressing challenges in health and social care.
UK In-Vitro Diagnostics (IVD) Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rising Prevalence of Chronic Diseases
4.2.2 Increasing Awareness and Acceptance of Personalized Medicine and Companion Diagnostics
4.2.3 Increasing Use of Point-of-care (POC) Diagnostics
4.3 Market Restraints
4.3.1 Stringent Regulations
4.4 Porter's Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value- USD)
5.1 By Technique
5.1.1 Clinical Chemistry
5.1.2 Molecular Diagnostics
5.1.3 Immuno Diagnostics
5.1.4 Other Techniques
5.2 By Product
5.2.1 Instrument
5.2.2 Reagent
5.2.3 Other Products
5.3 By Usability
5.3.1 Disposable IVD Devices
5.3.2 Reusable IVD Devices
5.4 By Application
5.4.1 Infectious Disease
5.4.2 Diabetes
5.4.3 Cancer/Oncology
5.4.4 Cardiology
5.4.5 Other Applications
5.5 By End-Users
5.5.1 Diagnostic Laboratories
5.5.2 Hospitals and Clinics
5.5.3 Other End-Users
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Abbott
6.1.2 Becton, Dickinson and Company
6.1.3 BioMerieux SA
6.1.4 Bio-Rad Laboratories, Inc.
6.1.5 Danaher Corporation
6.1.6 F. Hoffmann-La Roche Ltd
6.1.7 QIAGEN
6.1.8 Siemens Healthineers AG
6.1.9 Sysmex Corporation
6.1.10 Thermo Fisher Scientific Inc.
6.1.11 Fujifilm Holdings Corporation
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
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.
| By Technique | |
| Clinical Chemistry | |
| Molecular Diagnostics | |
| Immuno Diagnostics | |
| Other Techniques |
| By Product | |
| Instrument | |
| Reagent | |
| Other Products |
| By Usability | |
| Disposable IVD Devices | |
| Reusable IVD Devices |
| By Application | |
| Infectious Disease | |
| Diabetes | |
| Cancer/Oncology | |
| Cardiology | |
| Other Applications |
| By End-Users | |
| Diagnostic Laboratories | |
| Hospitals and Clinics | |
| Other End-Users |
UK In-Vitro Diagnostics (IVD) Market Research FAQs
How big is the United Kingdom In-Vitro Diagnostics Market?
The United Kingdom In-Vitro Diagnostics Market size is expected to reach USD 3.96 billion in 2024 and grow at a CAGR of 7.59% to reach USD 5.70 billion by 2029.
What is the current United Kingdom In-Vitro Diagnostics Market size?
In 2024, the United Kingdom In-Vitro Diagnostics Market size is expected to reach USD 3.96 billion.
Who are the key players in United Kingdom In-Vitro Diagnostics Market?
Abbott, Thermo Fisher Scientific Inc., Siemens Healthineers AG, QIAGEN and F. Hoffmann-La Roche Ltd are the major companies operating in the United Kingdom In-Vitro Diagnostics Market.
What years does this United Kingdom In-Vitro Diagnostics Market cover, and what was the market size in 2023?
In 2023, the United Kingdom In-Vitro Diagnostics Market size was estimated at USD 3.66 billion. The report covers the United Kingdom In-Vitro Diagnostics Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the United Kingdom In-Vitro Diagnostics Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
UK In-Vitro Diagnostics Industry Report
Statistics for the 2024 UK In-Vitro Diagnostics market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. UK In-Vitro Diagnostics analysis includes a market forecast outlook to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
UK In-Vitro Diagnostics Market Report Snapshots
