In-Vitro Diagnostics Market

Market Overview

The global in vitro diagnostics (IVD) market size was valued at USD 73.00 billion in 2023 and is expected to reach USD 116.00 billion by 2032, growing at a compound annual growth rate (CAGR) of 5.20% during the forecast period.

In-vitro diagnostics (IVDs) are medical investigations conducted on samples taken from the human body, like blood, urine, or tissue, for disease, condition, or infection detection. These are tests done outside the human body, usually in a laboratory environment, using complex tools and techniques. IVD covers a wide range of techniques, from molecular diagnostics to immunoassays and clinical chemistry tests. These test plays significant role in early detection and diagnosis, monitoring, or treatment for most health disorders.

On the other hand, in-vitro diagnostics have of late seen phenomenal demand due to factors such as changing medical technology, a high burden of infectious and chronic diseases, and a growing need for an early accurate diagnostic test. Much of the growth in this industry can be attributed to new diagnostic technologies and platforms under development, making their way into the mainstream markets, such as molecular diagnostics, point-of-care diagnostics, and next-generation sequencing. These technologies have evolved to improve sensitivity, specificity, and speed, which enabled these to be more useful in clinical practice for the management of patients. For instance, Thermo Fisher Scientific, which offers a range of genetic analysis solutions, including next-generation sequencing (NGS) technologies. Thermo Fisher has been leveraging AI to enhance their sequencing platforms, making them more efficient in detecting genetic variations and predicting therapeutic responses based on genomic profiles.

Major shifts in the in-vitro diagnostics market, is being witnessed due to growing personalized medicine and an integration of artificial intelligence and machine learning into diagnostic tools. Personalized medicine relies on very accurate and highly detailed diagnosis, which the IVD test can provide, hence allowing for a customized treatment plan with improved health outcomes for the patients. Artificial intelligence and machine learning are being increasingly used to analyze extensive and complicated data sets produced by IVD tests that can turn out with much more accurate diagnoses and allow for predictive analytics. For instance, Guardant 360 TissueNext by Guardant Health, is the only tissue comprehensive genomic profiling with AI-powered PD-L1 detection. Guardant360 TissueNext tissue biopsy test finds actionable information when tissue testing is appropriate. The test leverages our AI-powered scoring algorithm to improve PD-L1 detection by >20% in Non-Small Cell Lung Cancer.

Another factor that influences the market is the growing awareness of preventive healthcare and regular health checkups. This trend resulted in an increased volume of diagnostic testing, as people are now more willing to undergo testing for early detection for any medical problems before it reaches a critical stage. With continuous innovations and a focus on improving diagnostic accuracy and efficiency, the IVD market will continue to grow for years to come.

Market Dynamics

Global In-Vitro Diagnostics Market Drivers

Increasing number of in-vitro diagnostic tests globally

The increasing number of in-vitro diagnostics (IVD) tests serves as a crucial driver for the global IVD market, driven by several interconnected factors shaping modern healthcare. As populations age and chronic diseases become more prevalent, there is a growing need for diagnostic tests that can detect diseases early, monitor treatment efficacy, and guide personalized healthcare interventions. The global burden of chronic diseases, such as cardiovascular diseases, diabetes, cancer, and respiratory diseases, is increasing. For instance, according to the World Health Organization (WHO), in 2024, chronic diseases account for approximately 60% of all deaths globally. So, with growing prevalence comes associated with the greater need for frequent diagnostic testing to initiate early detection, monitor disease progress, and guide treatment decisions. This will raise the demand for a wide range of IVD tests globally.

Moreover, advances in diagnostic technologies extend the capabilities of in-vitro diagnostics tests, such as molecular diagnostics, immunoassays, and digital pathology. Molecular diagnostics allows for exactly the same genetic and molecular profiling characterizing health or disease described in personalized medicine practices and targeted treatments. On the other hand, digital pathology significantly improves analysis of tissue samples for better diagnostic accuracy and can facilitate remote consultation and collaboration among healthcare professionals. For instance, Illumina demonstrates the strong transformation of NGS technologies in the IVD field. The NovaSeq or NextSeq series of Illumina sequencing platforms can enable full genomic profiling with the ability to sequence vast quantities of DNA quickly and accurately with exceptionally high levels of accuracy and throughput. These would allow for the identification of genetic mutations, variations, and biomarkers that may lead to cancer, inherited disorders, and infectious diseases. Illumina's technology supports personalized medicine by providing detailed genomic information to the clinician for accurate diagnosis, prognosis, and planning of treatment. This has increased the scope and complexity of diagnostic tests available in clinical practice.

Thus, the increasing number of in-vitro diagnostics tests underscores their pivotal role in modern healthcare systems, supporting early disease detection, personalized treatment strategies, and improved patient management across a wide spectrum of health conditions. As healthcare continues to evolve, the demand for innovative and reliable diagnostic solutions is expected to remain robust, driving sustained growth and innovation in the global in-vitro diagnostics market.

Rising demand Point-of-Care Diagnosis

Point-of-care (POC) diagnosis has been a significant growth driver of the in vitro diagnostics market recently as health care is transformed by rapid diagnosis at or near the patient. This minimizes time to diagnosis, improves treatment decisions, and enhances patient outcomes across diverse healthcare settings, from emergency rooms to remote communities.

The demand for point-of-care diagnosis is increasing due to various factors. POC enables health providers to acquire results rapidly on-site and facilitates immediate clinical decisions. This becomes very critical in emergency departments, wherein the diagnosis can range from a life-threatening condition like myocardial infarction or sepsis to affecting the prognosis of a patient. For example, Siemens Healthineers offers bedside testing with RAPIDPoint systems for comprehensive blood gas, electrolyte, and metabolite results, ensuring timely intervention with changes in treatment modalities. Moreover, POC diagnosis has therefore played a very important role in chronic care through convenient and frequent monitoring. For instance, Abbott's FreeStyle Libre System provides continuous glucose monitoring for diabetic patients, under which they can check glucose levels as many times as they want during the day. This technology empowers patients in making informed decisions on diet, exercise, insulin dosing timely thereby improving their quality of life and health outcomes.

The rising demand for point-of-care (POC) diagnostics acts as a pivotal driver for the IVD market by addressing key healthcare challenges through rapid, on-site diagnostic capabilities. This significant growth was suddenly spiked during the COVID-19 Pandemic, due to the rising demand for rapid test to curb the rapid spread of the infectious diseases. Several companies introduced rapid testing equipment’s to full fill the rising demand. For instance, On July 6, 2020, BD (Becton, Dickinson and Company) announced that the FDA granted Emergency Use Authorization for a rapid, point-of-care SARS-CoV-2 diagnostic test using the BD Veritor Plus System. This new assay provides results in 15 minutes, enhancing access to COVID-19 diagnostics and enabling real-time decision-making while the patient is still onsite.

POC diagnostics enables immediate clinical decision-making in emergency settings, facilitates timely disease detection and monitoring in remote or underserved areas, streamlines patient care in outpatient settings, and enhances infectious disease management by enabling quick isolation and treatment initiation. Companies innovating in POC technologies, such as Abbott, Siemens Healthineers, and Cepheid, develop portable devices that deliver rapid results for critical biomarkers and infections, thus expanding access to diagnostics and improving patient outcomes, which collectively propel growth in the in-vitro diagnostics market.

Global In-Vitro Diagnostics Market Restraints

High development costs for in-vitro diagnostic tests

High development costs are associated with research and development, validation, and commercialization of new diagnostic tests, particularly where cutting edge technologies are involved, such as molecular diagnostics and artificial intelligence. These costs encompass various stages, including initial research, prototype development, clinical trials, regulatory approvals, and market launch. For instance, a new molecular diagnostic test requires huge expenses on special equipment, reagents, skilled personnel, and conformance to proper regulatory standards such as those from the FDA or CE Mark in Europe. For instance, as per an article published by the NIH, IVD costs account for 2.3% and 1.4% of total HCE in the US and Germany. Statistically, the average cost of bringing a new IVD test to market can range from 10 million to over a 100 million dollars, depending on the complexity and regulatory requirements involved. The costs arise from the need to conduct rigorous clinical validation studies aimed at originating test accuracy, reliability, and clinical utility. These are requirements or prerequisites for regulatory clearance and acceptance by healthcare providers, which in turn makes them major investment areas for molecular diagnostics companies.

Moreover, these high development costs can deter smaller companies and startups with limited financial resources from entering the IVD market, thus potentially limiting innovation. Moreover, budget pressures on healthcare systems and reimbursement policies may reduce the adoption of costly diagnostic technologies. Cost-effectiveness and return on investment considerations often drive purchasing decisions, impacting the market expansion of novel and potentially life-saving diagnostic innovations.

Thus, high development costs in the in-vitro diagnostics market act as a restraint by creating significant barriers to entry for smaller companies and startups, limiting their ability to innovate and compete with established players. The substantial financial investment required for research, development, clinical trials, and regulatory approvals deters new entrants from entering the market. As a result, the adoption rates of expensive or novel diagnostic technologies could be slower, impacting market expansion and the accessibility of advanced diagnostic solutions for patient care.

Global In-Vitro Diagnostics Market Opportunities

Rapid Growth in Personalized Medicine

Personalized medicine has been growing rapidly, this significantly changes the in-vitro diagnostics market by changing its focus toward targeted treatment strategies for individual patient characteristics, genetic profiling, and biomarker identification. Next-generation sequencing tools in genomics have advanced to the stage at which full analysis of genes of any given person can now be done to point to those mutations, variants, or biomarkers associated with susceptibility, progression, or response to treatment.

For example, Foundation Medicine now part of Roche, is one of the companies focused on molecular diagnostics analyzing tumor genomes to guide personalized decisions in cancer treatment. Their tests, such as FoundationOne CDx, offer genomic profiling of solid tumors to identify potential targeted therapies and immunotherapy options for genetic alterations in the tumor.

Additionally, the development of companion diagnostics plays a crucial role in personalized medicine by correlating specific biomarkers or genetic signatures with drug responses. For example, Myriad Genetics offers companion diagnostic tests like BRACAnalysis CDx for identifying mutations in BRCA1 and BRCA2 genes in order to administer appropriate and effective treatment against breast and ovarian cancers, including selecting PARP inhibitor therapies.

These advancements enable clinicians to tailor treatment plans to individual patients, optimizing therapeutic efficacy while minimizing adverse effects. Other than improving the final results for patients, personalized medicine provides an opportunity for healthcare cost efficiency that is made through avoiding a trial-and-error approach in treatment. Thus, companies that invest in innovation-prone genetic and molecular diagnostic tests would make themselves likely to take advantage of the increasing demand for personalized health care solutions, hence driving the market's growth and differentiation in in-vitro diagnostics.

Regional Analysis

The global in-vitro diagnostics market has been studied across North America, Europe, Asia-Pacific, and LAMEA.

North America is the most significant global in-vitro diagnostics market shareholder and is expected to expand substantially during the forecast period. The infrastructure in terms of health is very developed in North America, and there is a huge prevalence of chronic diseases, including cancer, cardiovascular disorders, and diabetes that require frequent diagnosis testing. For instance, in the United States, cancer incidence rates remain high with around 1.9 million people living with cancer in 2022, driving demand for advanced molecular diagnostics and screening tests like those offered by companies such as Quest Diagnostics and LabCorp, which dominate the clinical laboratory services market.

Asia-Pacific region is a pivotal market for the in-vitro diagnostics industry, due to rapid urbanization, economic development, and improvements in healthcare infrastructure across countries like China, India, Japan, and South Korea have significantly expanded access to healthcare services, driving demand for diagnostic tests. Countries such as China and India are witnessing an increasing trend of chronic diseases like diabetes and cardiovascular disorders, which generates demand for advanced diagnostic solutions. Companies, such as Mindray, based in China, have capitalized on this growth by developing a wide range of diagnostic instruments and reagents tailored to local healthcare needs.

Segmental Analysis

The global in-vitro diagnostics market has been divided into product, technique, application, and end-user.

Based on the Product, the global in-vitro diagnostics market has been categorized into reagents, instruments, and services & software.

The segment of reagents usually dominates the products in the global in-vitro diagnostics (IVD) market, and this is propelled by a number of factors. Reagents are consumables used in diagnosis testing, including biochemical assays, immunoassays, and molecular diagnostics. They are utilized in huge volumes for routine testing in laboratories and point-of-care settings. Companies specializing in reagents, such as Roche Diagnostics and Abbott Laboratories, have invested years in building robust portfolios that help meet the requirements of many diagnostic applications: infectious diseases, oncology, genetic testing, and more. Moreover, the reagents segment benefits from continuous demand due to the recurrent need for diagnostic testing in healthcare settings, supporting disease screening, diagnosis, and monitoring. This sustained demand, coupled with ongoing technological advancements in reagent formulations and applications, reinforces its dominant position within the IVD market segments.

Based on the technique, the global in-vitro diagnostics market has been categorized into immunoassays, clinical chemistry, molecular diagnostics, hematology, microbiology, coagulation & hemostasis, urinalysis, chromatography & mass spectrometry.

In in-vitro diagnostics (IVD) market, immunoassays emerge as a dominant segment due to its versatile applications and widespread use across various healthcare settings. Immunoassays are rapidly growing in the IVD market due to their increasing application in diagnosing chronic and infectious diseases. For instance, Abbott's Architect and Alinity platforms experienced substantial growth, particularly in COVID-19 antibody testing. Siemens Healthineers reported a significant rise in demand for their Atellica immunoassay analyzers, driven by their efficiency and accuracy in various diagnostic tests. These advancements, along with the shift towards point-of-care testing and technological innovations such as high-throughput immunoassays, are propelling the market forward. Hence, the aforementioned factors are supporting the lion’s share of the segment.

Based on the technique, the global in-vitro diagnostics market has been categorized into infectious diseases, oncology, endocrinology, cardiology, blood screening, genetic testing, autoimmune diseases, allergy diagnostics, drug monitoring & testing, bone & mineral disorders, coagulation testing, blood group typing, and other applications

Based on application categories, infectious diseases dominate the global in-vitro diagnostics (IVD) market due to several key factors. Infectious disease diagnostics encompass a full range of tests carried out to detect the pathogen, which includes bacteria, viruses, fungi, and parasites in patient samples. Because infectious diseases are quite prevalent in general all over the world, coupled with public health concerns in the form of the emergence of infections and antimicrobial resistance, huge demand is created for diagnostic solutions. The top companies in this space are Abbott Laboratories, BD, and bioMérieux, each having large portfolios of products linked to rapid diagnostic tests, molecular assays, and automated systems that target infectious agents. Moreover, the COVID-19 pandemic has almost effortlessly pointed out the fact that infectious disease diagnostics plays a central role in the management of outbreaks and public health surveillance, hence increasing the pace of adoption and innovation in this space. These factors collectively underscore infectious diseases as a dominant and growing application area within the global IVD market.

Based on the End-user type, the global in-vitro diagnostics market has been categorized into standalone laboratories, hospitals, academics & medical schools, point-of-care and others.

The global in-vitro diagnostics market, by end-user type, is dominated by hospitals because it forms a central location for the provision of complete care to patients, coupled with extensive diagnostic testing requirements. Hospitals require a wide range of diagnostic tests for disease screening, diagnosis, monitoring, and management in several departments such as the emergency room, intensive care unit, and specially designated clinics. fully equipped with advanced laboratory infrastructure and maintain large volumes of patients require continuous and large-scale usage of in-vitro diagnostic tests.

Recent Developments

• In January 2024, ELITechGroup introduced the PLUS ELITe MGB kit, which is certified by the Conformite Europeenne-In Vitro Diagnostic Regulation (CE-IVDR) and can target bacterial pathogens linked to gastrointestinal infections, as part of an expansion of its line of in-vitro diagnostics products. The purpose of this product range expansion is to boost the use of these kits for identifying bacterial pathogens linked to gastrointestinal diseases.
• In January 2023, Cipla Inc. introduced a point-of-care diagnostic tool for treating a range of non-communicable diseases as well as other chronic diseases.