In Vitro Diagnostics Ivd Market is estimated to be valued at USD 118.98 Bn in 2024 and with CAGR of 6.3% over the forecast period 2024-2031. The market is expected to witness growth, owing to continuous advancements in molecular diagnostics and point-of-care testing devices.
Market Dynamics:
Technological advancements in the field of IVD is expected to fuel the market growth over the forecast period. Assay automation, computer-aided integration, and miniaturization of testing systems have revolutionized diagnostics procedures. This has led to enhanced efficiency and quick turnaround time. Moreover, increasing prevalence of chronic and infectious diseases worldwide is another key factor boosting demand for IVD tests. According to the WHO September 2023 press release, chronic diseases accounted for over 74% of global deaths in 2020. Early detection of chronic conditions through IVD tests can facilitate timely clinical interventions and management of diseases.
Rising Prevalence of Chronic and Infectious Diseases
One of the major drivers for the growth of global in-vitro diagnostics market is rising prevalence of chronic and infectious diseases globally. Conditions like cancer, diabetes, cardiovascular diseases and respiratory diseases pose a huge burden and their diagnosis is largely dependent on in- vitro diagnostic methods. The spread of infectious diseases like HIV/AIDS, hepatitis, tuberculosis and others have pushed the need for advanced IVD technologies for screening, diagnosis and management of infected patients. As the number of people suffering from chronic and infectious diseases rises, demand for IVD devices, reagents and services is projected to increase significantly in the coming years.
Advances in Molecular Diagnostics and Point-Of-Care Testing
Another key driver for the market is the ongoing advances in molecular diagnostic technologies and point-of-care testing solutions. Molecular diagnostics allow for detection of genes and mutations associated with diseases at the DNA/RNA level. Their high sensitivity and accuracy are invaluable in diagnosing conditions like cancer and genetic disorders. POC testing devices have enabled faster diagnosis and monitoring of patients outside of conventional laboratory settings. Technologies like microfluidics, microarrays and cloud connectivity in POC devices are improving their ease of use. The ability to deliver quick diagnoses without the need for specialized infrastructure or personnel is boosting the uptake of molecular diagnostics and POC testing globally. Automation of lab processes using robots is also supporting the growth of high-throughput and precise testing.
Low Awareness in Developing Regions
One of the key challenges restraining the growth of the market is the generally low level of awareness about the clinical benefits of diagnostic testing, especially in developing parts of the world. In many African and Asian countries, people frequently does not undergo routine health check-ups or laboratory screenings due to a lack of information as well as financial constraints. Even awareness programs by governments and NGOs had limited success in changing attitudes. As a result, conditions continue to remain undiagnosed until advanced stages in such regions. This adversely impacts the sales potential for IVD companies targeting emerging markets. Overcoming awareness barriers through sustained education and promotion is crucial for tapping the potential of developing country markets fully.
High Costs of New Technologies
Another major challenge is the prohibitively high costs associated with many new molecular diagnostic tests and automated IVD systems. Next-generation sequencing platforms, mass spectrometry solutions, flow cytometry instruments and other high-end technologies carry huge price tags of millions of dollars. While useful in research and reference laboratories, these are generally beyond the budgets of small to medium clinical labs and hospitals in both developed and developing countries. Even the consumables and reagents for new tests are priced high initially to recover heavy R&D investments by companies. This restraints wider adoption, especially in cost-sensitive developing world markets. Continuous efforts to drive down costs through economies of scale and newer low-cost technologies will be vital to overcoming this restraint.
Remote Diagnostics and Home Healthcare
With the rise of telemedicine, remote patient monitoring and home healthcare, there is a huge opportunity for portable, easy-to-use IVD devices suitable for decentralized healthcare delivery outside of clinics and hospitals. Technologies like Bluetooth-enabled glucose meters, blood pressure cuffs, pregnancy test kits, COVID-19 antigen self-test kits and others have demonstrated the viability of self-testing and diagnosis with real-time data transmission. This allows carers to track health status round the clock without physical visits. As patients preference for convenient self-monitoring increases, especially among the elderly and those with chronic conditions, the market potential for remote diagnostics is enormous. Companies need to actively develop products optimised for this use case leveraging latest mobile and remote monitoring technologies.
Digitalization and Ai-Enabled IVD Solutions
IVD firms can leverage AI and machine learning algorithms to automate tests, improve diagnostics, maintain equipment and drive predictive and presymptomatic screening. AI also enables development of virtual diagnostic assistants for patients.
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Key Development
- On March 06, 2024, CleanNA, a leading Netherlands-based manufacturer specializing in magnetic bead-based nucleic acid extraction kits and systems, launched its second CE-IVD-certified product. The Clean Quick Viral DNA/RNA (CE-IVD) kit is designed to efficiently extract viral DNA and RNA from nasopharyngeal or oropharyngeal swabs preserved in an inactivating viral transport medium.
- On February 12, 2024, Roche, a global healthcare conglomerate, launched three novel coagulation tests tailored for the oral Factor Xa inhibitors: apixaban, edoxaban, and rivaroxaban. These tests are now available in countries recognizing the CE mark. Notably, these anticoagulants were included in the World Health Organization's Model List of Essential Medicines in 2019, highlighting their potential benefits for patients.
- On January 04, 2024, HORIBA Medical, a prominent manufacturer of in-vitro diagnostic equipment, introduced the latest HELO 2.0 high throughput automated hematology platform. This cutting-edge system had received CE-IVDR approval and is currently awaiting certification from the U.S. FDA. Building upon the success of its predecessor, the new HELO 2.0 was developed in close collaboration with customers to enhance and fulfill all requirements for high throughput fully automated hematology analysis.
- In July 2022, DiaCarta Inc., a molecular diagnostics company, announced the attainment of the CE-IVD Mark for its newly developed QuantiVirus SARS-CoV-2 & Flu A/B test. The QuantiVirus SARS-CoV-2 & Flu A/B Detection Test is a real-time PCR assay designed for the qualitative detection of nucleic acids from SARS-CoV-2 and influenza viruses. This test is intended for use with nasopharyngeal swabs or saliva samples from individuals suspected of having COVID-19 and/or influenza. The CE-IVD Mark signifies compliance with European Directive requirements for in vitro diagnostic devices.
- In June 2022, Agilent Technologies Inc., a renowned American company specializing in the development and manufacturing of analytical instrumentation, disclosed that its previously CE-IVD marked instruments, kits, and reagents had obtained clearance as IVDR Class A under the new EU IVDR regulation, effective May 26, 2022. This transition to Class A IVDR-compliant products ensures continuity for EU laboratories utilizing Agilent IVDR instruments, kits, and reagents in their diagnostic processes, allowing seamless continuation of their workflows without interruption.
Key Players: Siemens Healthineers, Sysmex Corporation, Bio-Rad Laboratories, bioMérieux S.A., Becton Dickinson and Company, Danaher Corporation, Abbott Laboratories, F. Hoffmann-la Roche Ltd, QIAGEN N.V., Arkray Inc., Nittobo Medical Co. Ltd., Medical & Biological Laboratories Co. Ltd., Miraca Holdings Inc., Mizuho Medy Co. Ltd., Thermo Fischer Scientific Inc, Diasorin, Agilent Technologies, Inc, and Grifols SA
