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The global in vitro diagnostics market size was USD 82.81 billion in 2020. The global impact of COVID-19 has been unprecedented and staggering, with in-vitro diagnostics witnessing a positive impact on demand across all regions amid the pandemic. Based on our analysis, the global market exhibited a higher growth of 28.8% in 2020 as compared to the average year-on-year growth during 2017-2019. The market is projected to grow from USD 96.13 billion in 2021 to USD 153.67 billion in 2028 at a CAGR of 6.9% during the 2021-2028 period. The rise in CAGR is attributable to this market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.
In vitro diagnostics are medical devices used to perform diagnostic tests on biological samples such as blood, urine, and tissues. The IVD tests help detect and monitor infectious diseases, autoimmune diseases, and several medical conditions and are being used to analyze drug therapies. Furthermore, according to the British In-vitro Diagnostic Association, in-vitro diagnostic tests influence approximately 70% of clinical decisions. However, less than 1% of the NHS’s budget is spent on the development of new and innovative IVD product portfolios each year.
The rising demand for point-of-care IVD devices and the increasing adoption of these devices have been instrumental in driving the growth of the market. This is further augmented by increasing investment by key players in research & development to innovate new products and explore new applications of IVD techniques.
This novel product will be used to detect novel viruses such as COVID-19. Such new launches are projected to contribute to the in vitro diagnostics market growth.
Market to Witness a Positive Impact Owing to Increasing Diagnostic Procedures amid COVID-19 Pandemic
The IVD market witnessed slower growth in terms of revenues in 2020, owing to the mixed impact of covid-19 on various segments. The COVID-19 pandemic has upsurged the demand for molecular diagnostics techniques as it is used to diagnose the SARS-CoV-2 virus. Additionally, there was increased demand for test kits, and consumables for monitoring of blood glucose levels, troponin levels, and many others, among hospitalized patients suffering from covid-19.
This would lead to a significant increase in demand for point-of-care tests based on serology and molecular techniques globally. Market players witnessed a considerable increase in their revenues generated from sales of molecular tests and point of care tests.
However, other techniques such as immunodiagnostics, clinical chemistry, hematology, among others, experienced a decline in growth owing to lockdowns and a decline in routine testing performed in hospitals and laboratories worldwide. For instance, F. Hoffmann-La Roche Ltd, Abbott Laboratories, and bioMérieux SA witnessed a decline of -6.0%, -3.9%, and -7.0%, respectively in the revenues generated from the immunodiagnostics segment in 2020 as compared to 2019.
Additionally, the introduction of new techniques for rapid diagnosis of COVID-19 has surged the demand for in-vitro diagnostic products and services worldwide.
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Increasing Adoption of Point-of-care Testing Devices to Fuel Demand for IVD Tests
Owing to the increasing burden of diseases, medical device companies are continuously involved in development of technologically advanced diagnostic devices. Furthermore, hospitals and laboratories have demonstrated a rising preference towards point-of-care testing devices to get accurate real-time data. This factor is likely to increase the demand for point-of-care testing devices, which would ultimately surge the demand for in-vitro diagnostics devices.
Additionally, the significant rise in new advanced product launches is contributing to the growth of the market.
Rising Incidence of Chronic Diseases to Augment Market Growth
The prevalence of several diseases such as genetic, cardiovascular, and neurological diseases is increasing significantly. According to the World Health Organization (WHO), cardiovascular diseases (CVDs) are the number 1 cause of death globally, causing an estimated 17.9 million deaths each year. This has led to a rise in awareness regarding early diagnosis among the population and an increase in routine diagnosis, which backs the overall growth of the market. Moreover, the introduction of novel advanced IVD products is also supporting the high growth of the market.
Additionally, the aging population is more susceptible to several diseases such as hypertension, diabetes, cardiovascular, liver, and kidney diseases are expected to increase significantly.
High Cost of IVD Instruments to Restrict Growth in Emerging Countries
In vitro diagnostics products have witnessed significant advancement and developments in the past decade regarding new products being adopted and further design amendments, among others. However, the high cost of IVD instruments and the high cost associated with the maintenance of the instruments hindered the market growth up to a certain extent. Additionally, in-vitro diagnostics instruments require skilled professionals for operation. Thus, this increasing the maintenance cost of the device, which ultimately hamper the overall growth of the market,
The cost of RT-PCR systems ranges from USD 15,000 to over USD 90,000. The above cost factors have been responsible for the relatively limited adoption of in vitro diagnostics products in several countries and regions.
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Reagents & Consumables Segment to Dominate Backed by Advent of Advanced Products
Based on the product type, the market is segmented into instruments and reagents & consumables.
The reagents & consumables segment held the dominant share of the global market in 2020 due to the surge in usage of self-testing kits, POC tests, and several other advanced products in the in-vitro diagnosis. The increased number of research and development activities for diagnosing several chronic diseases is one of the key factors propelling the demand for reagents & consumables. Furthermore, the rising adoption of self-diagnosis tests and demand for point-of-care devices also contribute to the higher growth of the segment.
The instrument segment is anticipated to expand at a comparatively sluggish CAGR during the forecast period. The introduction of new advanced instruments offers an excellent avenue for segment growth. For instance, in March 2021, Sysmex Corporation launched two next-generation flagship models in the hematology business segment, the XR-Series Automated Hematology Analyzer, and a compact 3-part WBC differential model, i.e., the XQ-Series Automated Hematology Analyzer.
Incessant Advancements in Molecular Diagnostics Devices to Fuel This Segment
On the basis of technique, the market is segmented into immunodiagnostics, clinical chemistry, molecular diagnostics, point-of-care, hematology, and other techniques.
The molecular diagnostics segment held the dominating share in 2020 due to the increasing demand for molecular diagnosis in infectious diseases. In 2020, the COIVID-19 pandemic hit worldwide. The SARS-CoV-2 virus that causes COVID-19 was diagnosed using Real-Time Quantitative Reverse Transcription PCR (qRT-PCR). Furthermore, in April 2021, Sysmex Corporation received approval from the Japanese medical regulatory authorities to manufacture and market the DetectAmp SARS-CoV-2 RT-PCR Kit. It is a SARS coronavirus nucleic acid kit that is used to detect the RNA of the novel coronavirus (SARS-CoV-2).
The point of care segment is projected to grow at a substantial CAGR during the forecast period. The growth is attributed to the rapid increase in acute and chronic diseases around the globe. According to the World Health Organization (WHO), in 2019, an estimated 10 million people will be affected with tuberculosis (TB) worldwide. Such factors are contributing to the high growth of the segment.
Increasing Prevalence of Infectious Diseases to Bolster Growth of This Segment
On the basis of application, the market can be segmented into infectious diseases, cardiology, oncology, gastroenterology, and other applications.
The infectious diseases segment held the dominating share in 2020 due to the increasing number of infectious diseases globally.
Furthermore, an increasing prevalence of several other infectious diseases such as hepatitis, diphtheria, Respiratory Syncytial Virus (RSV), and many others would contribute to the highest share of the segment.
The oncology application segment is expected to grow at a significant CAGR during the forecast period. The growth is attributed to the physician’s high preference for in-vitro diagnostic products to diagnose cancer. Furthermore, the rising number of cancer patients globally is expected to lead to this segment’s growth.
Higher Test Volume at Clinical Laboratories to Lead to Dominance of the Segment
Among end-users, the market includes clinical laboratories, hospitals, physician's offices, and others. The clinical laboratories segment dominated the market in 2020 owing to the higher number of diagnostics procedures taking place in clinical laboratories. Additionally, the availability of advanced technology and equipment in the clinical laboratories is fueling the diagnosis test volume, which ultimately contributes to the growth of the segment during the forecast period.
Furthermore, the physician's offices segment is expected to grow at a higher CAGR owing to the rising shift of patients preferring physician offices for point of care tests. Additionally, with an increasing number of hospitals and clinics in developed economies and emerging countries and the increasing usage of point-of-care devices such as pregnancy kits and glucose meters within hospitals and physician’s offices is also driving the demand for in vitro diagnostics products and subsequently driving the growth of the segment.
North America In vitro Diagnostics Market Size, 2020 (USD Billion)
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On the basis of region, the market for in vitro diagnostics can be segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.
The market in North America was valued at USD 32.77 billion in 2020 and is anticipated to continue to dominate the global market during the forecast period. Some of the prominent factors contributing to the region’s highest share include the presence of major companies in the region, such as Abbott, Thermo Fisher Scientific Inc., Becton, Dickinson and Company, and Danaher Corporation, along with the rising R&D investments by these key players to develop new advanced products. Other contributing factors include the well-established diagnostic infrastructure and the strong adoption of technologically advanced products by diseases diagnosis service providers in the region. These are expected to drive market growth in the region.
Europe is anticipated to be the second-most dominant region in terms of market share. The European market holds a significant share due to rising healthcare expenditure, well-established infrastructure, and the presence of a large pool of patients suffering from infectious diseases and cancer.
The Asia Pacific in vitro diagnostics market is estimated to grow at the highest CAGR, especially in developing countries such as India, South Korea, Australia, and China. For instance, in April 2021, Seegene Inc. announced that it had secured an export permit from South Korea’s Ministry of Food and Drug Safety to begin exporting its COVID-19 variant tests to countries around the world. This permit will fortify the company's sales and market position globally.
Latin America and the Middle East & Africa are anticipated to account for a limited market revenue share during the forecast period. However, improvement in healthcare expenditure and increasing adoption of point-of-care devices in Latin America and the Middle East & Africa is expected to lead to future growth prospects.
F. Hoffmann-La Roche Ltd, Abbott, Thermo Fisher Scientific Inc., and Sysmex Corporation are Key Players of the Market
The global market is fragmented, with players such as F. Hoffmann-La Roche Ltd, Abbott, Thermo Fisher Scientific Inc., and Sysmex Corporation accounting for a significant share in 2020. The top market players focus on strategies such as acquisitions, collaborations, and new product developments and launches to strengthen their market position globally.
Other market players with a significant presence in the global market include Siemens Healthineers AG, BD (Becton, Dickinson, and Company), Seegene Inc., DiaSorin S.p.A., and Quest Diagnostics Incorporated. These companies are expected to focus on new products launched to increase their share in the market for in-vitro diagnostics during the forecast period.
An Infographic Representation of In-vitro Diagnostics (IVD) Market
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The global in vitro diagnostics market report provides detailed market analysis and focuses on key aspects such as an overview of the advanced product, the prevalence of several diseases and disorders and key countries, pricing analysis. Additionally, it includes an overview of reimbursement scenarios for diagnostic procedures, key industry developments such as mergers and acquisitions as well as partnerships, the impact of COVID-19 on the market, and brand analysis. Besides these, the report offers insights into the market trends and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the market over recent years. The report also covers regional analysis of different segments.
Value (USD Billion)
By Product Type
Fortune Business Insights says that the global market size was USD 82.81 billion in 2020 and is projected to reach USD 153.67 billion by 2028.
In 2020, North America stood at USD 32.77 billion.
Registering a CAGR of 6.9%, the market will exhibit steady growth in the forecast period (2021-2028).
The reagents & consumables segment is expected to lead this market during the forecast period.
The increasing adoption of point-of-care testing devices and the rising prevalence of chronic and infectious diseases are major factors driving the markets growth.
F. Hoffmann-La Roche Ltd, Abbott, Thermo Fisher Scientific Inc., and Sysmex Corporation are major players in the global market.
North America dominated the market in terms of share in 2020.
The rising use of advanced products in in-vitro diagnosis and the increasing cases of acute and chronic diseases around the globe are expected to drive the adoption of these products.
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