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In Vitro Diagnostics Market Size, Share & Industry Analysis, By Product Type (Instruments, Reagents & Consumables), By Technique (Immunodiagnostics, Clinical Chemistry, Molecular Diagnostics, Point of Care, Hematology and Others), By Application (Infectious Diseases, Cardiology, Oncology, Gastroenterology, Others), By End User (Clinical Laboratories, Hospitals, Physicians Offices, Others) and Regional Forecast, 2019-2026

Region : Global | Format: PDF | Report ID: FBI101443



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The global in vitro diagnostics market size was valued at USD 61.22 billion in 2018 is projected to reach USD 87.11 billion by 2026, exhibiting a CAGR of 4.5% during the forecast period.

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IVD are medical devices and accessories used to perform tests with the help of samples such as blood, urine, and tissue to help detect infection, prevent disease, monitor drug therapies and diagnose a medical condition.

In vitro diagnostics industry is consolidated in nature and demonstrates increasing adoption rates of diagnostic devices along with use of IVD instruments in clinical laboratories and hospitals. The industry has perceived significant developments over the recent years. Introduction of new techniques for rapid and fast disease diagnosis are anticipated to surge the demand for in vitro diagnostic services, subsequently, driving business growth during the forecast period.

The market is anticipated to witness the growth owing to technological advancements in healthcare, improved and efficient diagnostic tools, and increased availability of over the counter tests. Increasing demand for advanced, personalized and rapid diagnostic system is anticipated to propel the market.

Additionally, increased funding by government and other organizations in the healthcare sector is one of the factors likely to boost the global market during the forecast period. Various initiatives undertaken by the government to provide information and education on personalized medicine and IVD tools for effective patient management is anticipated to drive the in vitro diagnostics market growth.


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“Rising Prevalence of Chronic and Infectious Diseases to propel the Global Market.”

The rising prevalence of infectious diseases, leading to increasing demand for disease diagnosis is one of the factors anticipated to propel the market growth. According to the National Institute of Health (NIH), in 2017, around 23.5 million cases of autoimmune diseases were reported in America and this is expected to increase in the forthcoming years.

Additionally, increasing prevalence of cardiovascular diseases in developed and developing countries is one of the major factor driving the growth of the in vitro diagnosis. For instance, according to U.S. Department of Health & Human Services, around 735,000 Americans suffer from a heart attack every year. Additionally, as per the Heart Disease and Stroke Statistics, 2019 Update from the American Heart Association, around 116.4 million, or 46% of the US adults are estimated to have hypertension. The increasing number of patients suffering from cardiovascular diseases is likely to increase the demand for the in vitro diagnostics tools, subsequently propelling market growth.

The rising consumption of tobacco and alcohol, adoption of a sedentary lifestyle, unhealthy dietary habits, etc. are the major factors responsible for increasing prevalence of chronic diseases. The rising prevalence of the chronic disorders is likely to increase the demand of the in vitro testing.

“Increasing Use of Point-of-care (POC)  and Technological Advancements in IVD Tools to Drive the In Vitro Diagnostics Market.”

Increasing adoption and demand for point-of-care (POC) devices is expected to fuel market growth. Additionally, the introduction of advanced technologies, such as biochips and nano-biotechnology, and miniaturization of microfluidic tools is likely to boost the demand for point-of-care (POC) devices. These advanced techniques have facilitated easy access to point-of-care diagnostic tests and offer quick and valid test results, thereby fueling  the demand for in vitro diagnostic instruments . These factors are subsequently anticipated to drive the growth of the market during the forecast period.

For instance, In June 2019, Abbott launched, Afinion HbA1c Dx assay, its first rapid point-of-care test for diagnosis of diabetes among general population. The increased investment by key market players in the development of technologically advanced and rapid testing devices is likely to drive the growth of the market.

Recently, adoption of rapid and accurate tests for diagnosis of infectious diseases and other chronic diseases is driving the market. In March 2018, Sekisui Diagnostics announced the launch of Silaris point-of-care (POC) for the diagnosis of infectious diseases. Such product launches will shift the patient preference from traditional diagnostic tools towards advanced IVD services.


By Product Type Analysis

“Reagents & Consumables Segment to Generate the Highest Revenue”

As with the help of advanced technologies and rapid diagnosis, the in vitro diagnostics market is anticipated to grow at a faster rate. Increasing prevalence of chronic and infectious diseases, is projected to fuel the demand for diagnostics tools, that is projected to drive the growth of the market.

Reagents and consumables segment dominated the product type owing to their high usage in the in vitro diagnosis. Increased number of research and development activities for the diagnosis of chronic diseases is one of the major factor fueling the demand for reagents and consumables.

Rising demand and adoption of the self-test and point-of-care devices will subsequently increase the demand for these products.  An increasing number of IVD tests is one of the major factors driving the growth of the reagents and consumables segment.

The instruments segment is expected to grow at a slower pace. Technologically advanced instruments and introduction of rapid testing tools are some of the factors propelling the segment growth. For instance, in April 2018, Altona Diagnostics GmbH, launched a CE-IVD marked AltoStar Molecular Diagnostics Workflow. It is a flexible and efficient automatic system that automates the entire workflow from sample preparation up to analysis.

By Application Analysis

“Oncology to Exhibit a Significant CAGR During the Forecast Period.”

Infectious diseases dominated the application segment and is anticipated to exhibit lucrative growth over the forecast period. Rising prevalence of cardiovascular diseases such as coronary artery disease, arrhythmias, and stroke globally is likely to increase the demand for IVD tools. These factors are expected to drive the growth of the cardiology segment subsequently, which will boost the in vitro diagnostics market.

Oncology segment held a substantial share and is projected to witness significant CAGR during the forecast period. Availability of advanced home care kits such as fecal occult blood test (FOBT) for diagnosis of colon cancer in homecare settings is one of the major factors likely to drive this segment.

The increasing prevalence of infectious disease and cancer are major factors boosting the demand for in vitro diagnosis. Increasing investment by research institutes and key market players in the development of the rapid and easy in vitro testing tools in the oncology is one of the major factor propelling the growth of the oncology segment.

By Technique

“Immunodiagnostics to hold a Leading Position in the Market

The various techniques used in IVD are immunodiagnostics, clinical chemistry, molecular diagnostics, point-of-care, hematology, and others. The immunodiagnostics segment accounted for the largest share in the market.

Rising prevalence of chronic and infectious diseases and rising need for early diagnosis are some of the primary key factors attributed to the growth of the technique segment. Molecular diagnostics is expected to grow at a significant CAGR during the forecast period. This technology facilitates early detection of cancer, infectious diseases, and genetic disorders by using genetic technologies that helps in the detection of abnormalities in the prenatal stage.

Clinical chemistry segment accounted for the second-largest share in the technique segment. Attributing to various applications of clinical chemistry, including detection of hormone fluctuations and blood glucose levels is anticipated to propel the segment growth. Point of care segment is anticipated to grow at a significant CAGR during the forecast period owing to increased demand for the point of care testing diagnosis. The demand for rapid and accurate diagnosis globally is one of the major factor likely to accelerate the segment growth.

By End User Analysis


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“Clinical Laboratories to Hold the Highest Share.”

Followed by clinical laboratories, hospitals are anticipated to hold the second-highest global market share. High demand for IVD tests as a result of increased in hospitalization is one of the factors propelling their use in the hospital segment.

Increasing demand for biosensors, pregnancy kits, and glucose meters to ensure quick and accurate results are some of the major factors propelling the growth of the physician's offices segment at a faster rate.

Increasing incidence of cardiac diseases and diabetes and the rising prevalence of infectious diseases in developing countries are the major factors driving the demand for point-of-care tests. The growing use of point of care devices within hospitals and physician’s office, especially in remote and rural areas, is also fueling the demand for point of care tests and subsequently driving the growth of the hospitals and physicians office segments.


North America In-vitro Diagnostics Market Size, 2018

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North America generated a revenue of USD 23.09 billion in 2018 and is anticipated to emerge dominant in the global in vitro diagnostics market during the forecast period. Adequate and favorable government regulations, well-established diagnostic infrastructure, adoption of technologically advanced diagnostic techniques, and presence of prominent key market players in this region are some of the significant factors anticipated the drive the market in North America.  

Asia Pacific is expected to grow at a significant CAGR during the forecast period. Increasing prevalence of cardiovascular diseases and infectious diseases and rapid development in the healthcare infrastructure of developing countries such as India and China is anticipated to rise the demand for the IVD tools. These factors are expected to subsequently drive the market growth in the Asia Pacific at a faster pace.

On the other hand, Europe is projected to witness significant growth in the global market. The high-income countries, including Germany U.K., and Spain, are anticipated to contribute to the growth of this market in the region. Rising healthcare expenditure and increasing adoption of POC testing devices are some of the major factors driving the growth of the market in Europe.

The Middle East and Africa is anticipated to register high growth in the market owing to the technological developments, rapidly expanding hospital infrastructure, and entry of global players in the region through direct and indirect presence. The region is significantly heading towards the modernization and technological developments. Latin America is also expected to grow at a significant CAGR during the forecast period.


“F. Hoffmann-La Roche Ltd, Abbott Laboratories, Thermo Fischer Scientific Inc., and Siemens Hold Dominant Shares by Providing IVD Tools ”

The top key market players focus on strategies, such as mergers and acquisitions, collaborations, and new product developments and launches to strengthen their market position globally and increase their market share. For instance, in August 2018, Sysmex Corp. and JVCKENWOOD Corp. jointly established a new manufacturing company “Creative Nanosystems Corp.” to develop and manufacture bio-devices. These strategic collaborations strengthened the company’s product portfolio and reinforced its market position.

Siemens Healthcare is one of the most significant market players in the healthcare industry and major player in laboratory diagnostics, medical information technology, and medical imaging. The diagnostics division of the company includes products for clinical chemistry, drug testing, hematology, coagulation, immunoassay, infectious diseases, molecular diagnosis, point of care testing and many others. Having a strong product portfolio and supply chain makes the company dominant in the market. Siemens Healthcare, Abbott Laboratories, F. Hoffmann-La Roche Ltd, and Thermo Fischer Scientific Inc., hold a dominant market share by providing a wide range of tools for the disease detection and analysis.


  • F. Hoffmann-La Roche Ltd

  • Abbott Laboratories

  • Siemens

  • Thermo Fisher Scientific Inc.

  • Danaher

  • Bio-Rad Laboratories, Inc.


  • Sysmex Corporation

  • Quest Diagnostics Incorporated

  • Other Prominent Players


A growing trend observed in the penetration of the in vitro diagnostics market across the industries. 

The report provides qualitative and quantitative insights on the global market and detailed analysis of market size & growth rate for all possible segments in the market. Along with this, the report provides an elaborative analysis of the global market dynamics and competitive landscape. Various key insights presented in the report are the price trend analysis, recent industry developments such as mergers & acquisitions, the reimbursement policies, SWOT analysis, and key retail industry trends, competitive landscape and company profiles.


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Report Scope & Segmentation



Study Period


Base Year


Forecast Period


Historical Period



  Value (USD Million)


By Product Type

  • Instruments

  • Reagents & Consumables

By Technique

  • Immunodiagnostics

  • Clinical Chemistry

  • Molecular Diagnostics

  • Point of Care

  • Hematology

  • Others

By Application

  • Infectious Diseases

  • Cardiology

  • Oncology

  • Gastroenterology

  • Others

By End User

  • Clinical Laboratories

  • Hospitals

  • Physician’s Offices

  • Others

By Geography

  • North America (U.S. and Canada)

  • Europe (U.K., Germany, France, Italy, Spain, Scandinavia, and Rest of Europe)

  • Asia Pacific (Japan, China, India, Australia, Southeast Asia, and Rest of Asia Pacific)

  • Latin America (Brazil, Mexico, and Rest of Latin America)

  • Middle East & Africa (South Africa, GCC and Rest of Middle East & Africa)

Frequently Asked Questions

Fortune Business Insights says that the in-vitro diagnostics market was valued at US$ 61.22 Bn in 2018 and is projected to reach US$ 87.11 Bn by 2026.

Growing at a CAGR of 4.5%, the in-vitro diagnostics market will exhibit steady growth in the forecast period (2019-2026)

Infectious disease in-vitro diagnostics segment is expected to be the leading segment in the in-vitro diagnostics market during the forecast period.

The rising prevalence of chronic and infectious diseases and the increasing use of point-of-care (POC) diagnostics and technological advancements in - vitro diagnostics tools are some of the factors anticipated to drive the growth of the in-vitro diagnostics market.

F. Hoffmann-La Roche Ltd, Abbott, Thermo Fischer Scientific Inc., and Siemens are the top players in the in-vitro diagnostics market.

North America is expected to hold the highest market share in the in-vitro diagnostics market.

The use of in-vitro diagnostics tools such as point of care testing tools at physicians’ offices and hospitals are some of the factors expected to drive the adoption of in-vitro diagnostics

Introduction technologically advanced, and rapid diagnostics kits and tools are one of the in-vitro diagnostics market trends.

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In-vitro Diagnostics (IVD) Market Size, Share and Global Industry Trend Forecast till 2026
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