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The global in-vitro diagnostics (IVD) market size was valued at USD 73.99 billion in 2024. The market is expected to grow from USD 77.73 billion in 2025 to USD 117.60 billion by 2032, exhibiting a CAGR of 6.1% during the forecast period.
In-vitro diagnostics (IVD) are medical devices that perform diagnostic tests on biological samples, such as blood, urine, and tissues. These tests help detect and monitor infectious diseases, autoimmune diseases, and several other medical conditions and are also used to analyze drug therapy modifications from time to time. Furthermore, according to the British In-Vitro Diagnostic Association, these tests influence approximately 70% of clinical decisions.
The rising demand for and adoption of in-vitro diagnostic solutions has driven the market growth. This growth is further augmented by increasing investments by key players in research & development to innovate their products and explore new applications of IVD techniques.
There is an increasing focus of prominent market players, including F. Hoffmann-La Roche Ltd., Abbott, and Siemens Healthineers AG, among others, on the R&D activities to develop and introduce technologically advanced products and novel systems. This is expected to support the growth of the market globally.
The IVD market is poised for significant growth, driven by technological advancements, increasing disease prevalence, and a shift toward personalized medicine. While challenges, such as regulatory complexities and market competition, persist, the industry's trajectory remains positive, with ongoing innovations and strategic collaborations paving the way for a more efficient and accessible healthcare landscape.
Increasing Prevalence of Chronic Diseases to Support Market Growth
The increasing prevalence of acute and chronic disorders, including cardiovascular, genetic, and neurological ailments, is resulting in the growing demand for in-vitro diagnostic products. The efficient use of IVD in the early diagnosis of such diseases allows doctors to work on appropriate treatments effectively.
Additionally, the growing geriatric population with increased susceptibility to health disorders, including liver, hypertension, cardiovascular disorders, and kidney diseases, among others, is expected to contribute to the market’s growth.
For instance, according to the 2023 statistics published by Time Magazine, about 297 million people are aged 60 and above in China. This is projected to boost the global in-vitro diagnostics (IVD) market growth in the coming years.
Increasing Funding and Government Support to Develop and Use IVD Devices Will Contribute to Market Growth
There is an increasing focus on raising awareness about government organizations, agencies, and associations encouraging the use of in-vitro diagnostic products by launching awareness initiatives, thereby driving the growth of the market. To clarify the priority of diseases based on burden and prevalence, the WHO released a model list of essential in-vitro diagnostics for primary healthcare and medical facilities with clinical laboratories. Both the categories are further sub-sectioned for general IVDs and specific diseases.
Additionally, growing R&D initiatives to support funding are expected to contribute to product development that will further boost the market’s growth.
Thus, all the aforementioned factors, along with the growing number of IVD product launches, are expected to drive the growth of the market.
High Cost of Instruments to Restrict Market Growth in Emerging Countries
There are numerous advantages associated with IVD products. However, the high cost of these in-vitro diagnostic instruments and their maintenance is likely to hinder their adoption. Additionally, these IVD products can be used only by skilled professionals, which also increases the maintenance cost of these products, subsequently limiting the market’s growth.
For instance, the cost of RT-PCR systems ranges from USD 15,000 to over USD 90,000. These cost factors have been responsible for the limited adoption of in-vitro diagnostic products in several emerging countries.
Gradual Shift of Preference Toward Adoption of Molecular Diagnostic Techniques
Molecular diagnostics is one of the most dynamic techniques in the in-vitro diagnostics industry, leading to advances in monitoring and revolutionizing healthcare across the world.
In the last decade, molecular diagnostics has become the most common practice for transplant and transfusion diagnostics and disease testing, and market players are currently focused on introducing new technologies.
Additionally, these techniques are comparatively more sensitive, allowing healthcare providers and laboratory physicians to detect infectious diseases even from a small number of samples. This has led to a shift of preference toward molecular diagnostic techniques in the global market.
Moreover, these techniques, which use nucleic acids and other cellular biomarkers, have facilitated medical advancements in diagnosing various diseases. They are also gaining huge popularity in the global market. The introduction of molecular biomarkers for cancer diagnosis has led to a substantial increase in diagnosed cases globally.
The advances in molecular diagnostic techniques, including next-gen sequencing, and the increasing prevalence of cancer and other chronic diseases, are anticipated to offer diverse opportunities to market players operating in the in-vitro diagnostics market.
The shift of preference from traditional diagnostic tools to advanced tools, including molecular diagnostics, is further anticipated to open new avenues for market players who can cater to these demands by introducing advanced tests.
Unfavorable Reimbursement Policies for In-Vitro Diagnostics
The lack of adequate reimbursement policies for these tests, especially in emerging countries, such as Brazil, Mexico, and others, is a major factor responsible for the limited adoption of testing solutions. The reimbursement scenario for in-vitro diagnostic products has been unfavorable in many countries worldwide. Various regions and their changing reimbursement policies have impacted the growth of the in-vitro diagnostics market globally.
Thus, economic factors, such as inadequate reimbursement policies and others, are expected to impact healthcare spending, further affecting the adoption of advanced diagnostic technologies.
Rising Penetration of Point-of-Care Testing Devices
The increasing prevalence of acute and chronic disorders is leading medical device companies to launch technologically advanced diagnostic devices. Due to the increasing prevalence of these diseases, medical device companies are focusing on the development of novel diagnostic devices. The benefits of point-of-care diagnostic tests, including lower costs, convenience & ease of testing, high efficiency, and others, are resulting in an increasing preference for these tests among the patient population. The increasing number of patients undergoing rapid diagnostics is leading to a growing demand for these tests and solutions.
Additionally, the increasing number of product launches by prominent market players and approvals by regulatory authorities will contribute to the growth of the market.
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The COVID-19 pandemic positively impacted the market in 2020. A few segments witnessed a decline in their revenues in this year, while the molecular diagnostics segment observed a significant increase in its revenue.
The rising prevalence of COVID-19 globally impacted the demand for diagnostics tests. There was a marked decline in routine tests for chronic diseases, especially in clinical chemistry, hematology, and immunodiagnostic lab-based tests. However, the molecular diagnostics segment witnessed a positive impact due to increasing focus on the introduction of advanced test kits among key players. This, and the growing demand for point-of-care COVID-19 tests among patients, supported the market’s growth during the pandemic.
Reagents & Consumables Widely Adopted due to Advent of Advanced Products
Based on product type, the market is divided into instruments and reagents & consumables. The reagents & consumables segment dominated the market in 2024 owing to an increase in the adoption of POC tests, self-testing kits, and several other products in in-vitro diagnosis. The growing number of R&D initiatives for diagnosing chronic conditions is one of the major factors supporting the demand for reagents & consumables. Moreover, the rising emphasis on early diagnosis globally further increases the number of patient admissions for routine tests, resulting in improved patient outcomes globally and supporting the segment’s growth.
On the other hand, the instruments segment is expected to record a considerable CAGR during the forecast period. The development and introduction of novel IVD instruments are expected to support the segment’s growth. For instance, in June 2023, BD launched a new instrument, the FACSDuet Premium Sample Preparation System, to strengthen its product portfolio for cellular diagnostics.
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Technological Advancements in Molecular Diagnostic Devices Drove their Demand
Based on technique, the market is divided into immunodiagnostics, clinical chemistry, molecular diagnostics, hematology, and others. The immunodiagnostics segment is further segmented into enzyme-linked immunosorbent assay (ELISA), fluorescence immunoassay (FIA), rapid test, and others. The clinical chemistry segment is further divided into electrolyte panels, basic and comprehensive metabolic panel, liver tests, renal tests, lipid panel, and others. Additionally, the molecular diagnostics segment is further divided into Polymerase Chain Reaction (PCR), in-situ hybridization, DNA sequencing & next-generation sequencing, and others.
The molecular diagnostics segment held a dominating market share in 2024; it is also expected to record a considerable CAGR over the forecast period. The segment’s growth is owing to increasing launches and approvals of innovative molecular diagnostics-based tests by market players. These factors have been instrumental in the higher adoption of these tests for the diagnosis of various conditions.
The clinical chemistry segment will also record a considerable CAGR during the forecast period. The increasing prevalence of lifestyle and chronic disorders and growing initiatives by regional and national healthcare agencies toward routine diagnosis are leading to an increase in the number of patients undergoing tests in clinical laboratories globally. This, along with the increasing number of clinical laboratories in developing countries and realignment of reimbursement policies of developed and emerging countries, is driving the segment's growth.
Increasing Number of Blood Tests for IVD Supported Segment’s Growth
On the basis of the sample, the market is segmented into blood, urine, saliva, tissue, and others.
The blood segment held a dominating market share in 2024. The benefits of blood tests, such as efficacy, improved diagnosis of the disease, and accurate monitoring of the condition, among others, are boosting the number of blood tests performed among patients.
The urine and saliva segments are also expected to record a considerable growth rate during the forecast period. The rising number of diagnostic tests performed with urine and saliva samples among the patient population is likely to support the segment’s growth in the market.
Increasing Adoption of Advanced Instruments in Laboratories Fueled Growth of the Segment
Based on setting, the market is bifurcated into laboratories and point-of-care. The laboratories segment dominated the market in 2024 due to the growing demand for advanced instruments in laboratories and increasing investments by private and public sectors in laboratory infrastructure in emerging countries. Also, most of the complex and sensitive diagnostic tests are carried out in laboratories, requiring skilled lab staff, specialized equipment, and more time to run.
The point-of-care segment is also expected to record a substantial CAGR during the forecast period. Increasing demand for COVID-19 point-of-care tests that provide rapid results is one of the major factors contributing to the growth of the segment. This, along with the increasing number of acquisitions and mergers among the major players, is supporting the growth of the segment.
Thus, growing product launches are expected to boost the growth of POC diagnostics. Additionally, point-of-care testing does not require highly skilled laboratory personnel or equipment. Therefore, it can be deployed in many different settings and at a large scale.
In-vitro Diagnostics Devices Found Robust Usage in Treatment of Infectious Diseases Due to Rising Prevalence
Based on application, the market is divided into infectious diseases, cardiology, oncology, gastroenterology, allergy, autoimmunity, prenatal screening, and others. The infectious disease segment dominated the market in 2024 owing to the growing prevalence of infectious illnesses among the patient population globally.
The oncology segment is also expected to record a considerable growth rate during the forecast period. The segment’s growth is due to the rising prevalence of cancer, resulting in a growing diagnosis rate among the patient population. This, along with the growing number of key players focusing on R&D activities to launch new products, is likely to support the growth of the segment in the market.
Higher Test Volume Boosted Adoption of IVDs at Clinical Laboratories
Based on end-user, the market is segmented into clinical laboratories, hospitals, physician's offices, and others. The clinical laboratories segment dominated the market in 2024 due to the increasing number of these laboratories, further supporting the growing number of diagnostic procedures among patients. Additionally, the outsourcing of clinical diagnostic services by public hospitals to independent clinical laboratories is a prime factor responsible for the high volume of tests being performed in these settings.
Additionally, the hospital segment is also expected to register a considerable CAGR during the forecast period. The segment’s growth is attributed to the increasing demand for monitoring processes for diseases, such as diabetes, hypertension, and pregnancy, which has diverted a huge patient pool toward hospitals. This, coupled with the growing number of hospitals across the world, is also supporting the increasing adoption of these in-vitro diagnostic products.
The global market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
North America In-vitro Diagnostics (IVD) Market Size, 2024 (USD Billion)
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Increasing Product Launches and Approvals by Key Players to Support the Region’s Growth
The market in North America was valued at USD 27.90 billion in 2024 and may continue to dominate the global market during the forecast period. Some of the prominent factors contributing to the region’s rapid growth include the presence of major companies, such as Abbott, Thermo Fisher Scientific Inc., BD, and Danaher Corporation, especially in the U.S., favorable government regulations, well-established diagnostic infrastructure, and adoption of technologically advanced diagnostic techniques.
The increasing prevalence of infectious and chronic diseases in the U.S. is one of the factors driving the growth of the market. This, along with the growing presence of a well-established healthcare infrastructure, favorable reimbursement scenario for in-vitro diagnostics tests, and higher awareness among the patient population about early diagnosis, is leading to the higher adoption of advanced tests and instruments by healthcare settings in the country.
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Europe is anticipated to be the second-most dominant region in terms of market share. The growth is owing to certain factors, including well-established infrastructure, healthcare expenditure, and an increasing prevalence of infectious diseases, cancer, and other disorders. This, coupled with the growing number of POC device launches, is likely to support the adoption of these instruments.
Germany dominated the European market in 2024. The increasing prevalence of chronic diseases, such as diabetes and cancer, coupled with a well-established healthcare infrastructure, higher diagnosis rates, and increasing adoption of novel tests & instruments based on innovative techniques by healthcare settings are some of the factors fueling the growth of the in-vitro diagnostics market in the country.
However, the regulatory challenges experienced in the region, especially in emerging countries, such as Poland, Romania, and Bulgaria, among others, also present a lucrative opportunity for the manufacturers to launch innovative devices to cater to the growing demand for IVD devices.
Key trends and innovations in the region
The rising preference for molecular diagnostics for transplant & transfusion diagnostics and disease testing, among others, is augmenting the demand for novel products. This, along with technological advancements in these devices, among other factors, is likely to support the use of these devices.
The Asia Pacific market is estimated to record the highest CAGR over the forecast period, especially in developing countries, such as India, South Korea, Australia, and China. Increasing disease prevalence, improving approval & reimbursement policies, and rising per capita healthcare expenditure in this region are projected to drive the market’s growth in Asia Pacific during 2025-2032.
Moreover, the growing prevalence of chronic diseases, such as diabetes, cancer, gastrointestinal disorders, and others and increasing focus on the expansion of healthcare infrastructure among governmental and non-governmental organizations are likely to support the adoption of these devices.
The Latin America market is anticipated to account for a limited market share during the forecast period. However, the growing geriatric population, increasing prevalence of infectious diseases, improvements in healthcare expenditure, and increasing adoption of point-of-care devices in the region are expected to create strong growth prospects for the market in the future.
The Middle East & Africa is growing due to a rising focus on the development of healthcare infrastructure, increasing acquisitions & mergers among key players, and an increasing number of players expanding their presence in emerging countries, among others.
The regulatory landscape of in-vitro diagnostics (IVD) is rapidly evolving owing to the rising development, approval, and distribution of diagnostic tests used in the detection of various diseases. The U.S. FDA and Europe’s IVDR are prominent organizations that play a major role in shaping these regulations.
In-vitro diagnostic devices are regulated by the Center for Devices and Radiological Health (CDRH). For a subset of medical devices, the Center for Biologics Evaluation and Research (CBER) is responsible for ensuring the safety and effectiveness of IVDs. Increasing focus on stringent regulatory guidelines for IVD devices ensures their safety and effectiveness and expands the scope of these devices in the market. However, overly stringent regulations can also deter innovation by imposing hurdles for smaller firms to compete, further slowing the pace of the development of new products.
In-vitro diagnostics are defined as devices in section 201(h) of the Federal Food, Drug, and Cosmetic Act, and may also be biological products subject to section 351 of the Public Health Service Act. IVD devices are further subjected to premarket and post-market controls. According to the FDA Act, the devices are classified into Class I, II, or III according to the level of regulatory control that is necessary to ensure safety and effectiveness.
Manufacturers experience certain challenges while navigating regulatory requirements, such as the high cost of conformity assessment, difficulty in transitioning to new regulations, and meeting the complex documentation requirements for IVDs, among others.
Regulatory compliance ensures the safety and efficacy of the in-vitro diagnostic devices, further reducing the risks in in-vitro diagnostic techniques. However, overly stringent regulatory norms can slow the pace of the launch of IVD devices in the market.
The increasing prevalence of chronic diseases, such as gastrointestinal disorders, the rapidly increasing geriatric population, and rising technological advancements in IVD devices, among others, are some of the factors contributing to the market’s growth.
There is a rising focus on government initiatives to raise awareness about the safety and efficacy of IVD procedures among the patient population. This, along with the rising number of key players focusing on research and development activities to launch novel products, is likely to support the adoption of these products.
Companies to Focus on Inorganic Growth Strategies to Strengthen Their Market Positions
The global in-vitro diagnostics market is semi-consolidated. A few prominent players, such as F. Hoffmann-La Roche Ltd., Abbott, and Siemens Healthineers AG, hold a majority share of the global market. F. Hoffmann-La Roche Ltd. is one of the major players operating in the global market. The rising focus of the company on R&D activities to develop and introduce technologically advanced products and novel systems is one of the significant factors contributing to the growing share of the company.
Abbott is another leading player in the global market due to its diversified product portfolio and direct and indirect global presence. Additionally, partnerships with various key market players have further strengthened the company's market position. In September 2023, Abbott collaborated with LifeLabs, a company focused on health diagnostic services, to support the growing patient population.
Other market players include BD, QuidelOrtho Corporation, and several small-scale companies. These players are focusing on R&D to introduce new products, expand their geographic presence, and establish a strong brand presence, further supporting the global in-vitro diagnostics (IVD) market share.
The report provides a detailed analysis and in-vitro diagnostics market forecast. It focuses on key aspects, such as an overview of the product, the prevalence of several diseases, key countries, and pricing analysis. Additionally, it includes an overview of reimbursement scenarios for diagnostic procedures, key industry developments, such as mergers, partnerships & acquisitions, the impact of COVID-19 on the market, and brand analysis. Besides these, the report offers insights into the latest market trends and highlights key industry developments. In addition to the abovementioned factors, the report encompasses several factors that have contributed to the market's growth in recent years. The report also covers the regional analysis of different segments.
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ATTRIBUTE | DETAILS |
Study Period | 2019-2032 |
Base Year | 2024 |
Estimated Year | 2025 |
Forecast Period | 2025-2032 |
Historical Period | 2019-2023 |
Growth Rate | CAGR of 6.1% from 2025-2032 |
Unit | Value (USD Billion) |
Segmentation | By Product Type
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By Technique
| |
By Sample
| |
By Setting
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By Application
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By End-user
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By Region
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Fortune Business Insights says that the global market size was valued at USD 73.99 billion in 2024 and is projected to reach USD 117.60 billion by 2032.
In 2024, North America was valued at USD 27.90 billion.
Registering a CAGR of 6.1%, the market will exhibit healthy growth during the forecast period of 2025-2032.
The reagents & consumables segment is expected to lead this market during the forecast period.
The increasing adoption of point-of-care testing devices and rising prevalence of chronic and infectious diseases are major factors driving the market growth.
F. Hoffmann-La Roche Ltd, Abbott, Danaher, Siemens Healthineers AG, Thermo Fisher Scientific Inc., and Sysmex Corporation are the major players in the global market.
North America held a dominant market share in 2024.
The rising use of advanced products in in-vitro diagnosis and increasing cases of chronic diseases around the globe are expected to drive the adoption of these products.
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