In Vitro Diagnostic (IVD) Market Research Report: By Offering (Reagents & Kits, Instruments, Software & Services), Technology (Clinical Chemistry, Immunochemistry, Molecular Diagnostics, Hematology, Microbiology), Application (Infectious Diseases, Diabetes, Oncology, Cardiology, Nephrology, Autoimmune Diseases), End User (Hospitals & Clinics, Point of Care, Laboratories, Research & Academic Institutes) - Global Industry Analysis and Growth Forecast to 2030

  • Published: October 2020
  • Report Code: LS10210
  • Available Format: PDF
  • Pages: 344

In Vitro Diagnostic Market Overview

The global in vitro diagnostic (IVD) market was valued at $63.5 billion in 2019, and it is expected to grow with a CAGR of 6.6% during the forecast period (2020–2030). This growth is primarily attributed to the stringent regulations regarding blood safety and sample contamination, surging burden of chronic diseases, increasing number of blood donors, advancements in the IVD technology, increasing healthcare expenditure, and surging number of hospitals and academic institutions.

COVID-19 has imposed a strong positive impact on the growth of the in vitro diagnostic market, primarily due to the increasing number of IVD tests, especially COVID tests, around the world. Patients hospitalized for the treatment of COVID-19 may require many other IVD tests for regular monitoring, or if they have a history of any other chronic disease. Moreover, the continued operations of private and reference laboratories during the lockdown have helped the market maintain its growth, globally.

In Vitro Diagnostic Market

Reagents & Kits Were Leading Category during Historical Period (2014–2019)

In 2019, the reagents & kits category led the global in vitro diagnostic market, based on offering. This was because of the rising number of laboratory tests on account of the increasing cases of chronic and infectious diseases. Further, the use of IVD testing in the ongoing research activities and the increasing IVD product launches are driving their adoption and boosting the growth of the industry.

Clinical Chemistry Held Largest Share in 2019

The clinical chemistry category dominated the in vitro diagnostic market in 2019, based on technology. The increasing prevalence of chronic diseases, availability of a broad range of clinical chemistry kits, and presence of a large number of players in this field are some of the major factors driving the growth of this category.

Infectious Diseases Is Fastest-Growing Category in Industry

Infectious diseases have emerged as the largest-revenue-generating category among all the application in the global market. Owing to the fact that infectious diseases are caused by pathogenic microorganisms, such as bacteria, viruses, parasites, or fungi, the diseases can be spread, directly or indirectly, from one person to another. The category is expected to witness highest growth during the forecast period. Moreover, the global prevalence of infectious diseases, such as influenza, HPV, hepatitis, HIV, and tuberculosis, is considerably high in spite of significant improvements in sanitation practices and medicine.

Laboratories Are Expected To Show Highest Growth Rate during Forecast Period

The laboratories category is predicted to witness the highest growth rate during the forecast period in the in vitro diagnostic market, based on end user. This is attributed to the increasing number of laboratories, including private laboratories, company, and industrial laboratories and laboratories in hospitals and clinics. Moreover, the rising patient population and growing accessibility of the advanced IVD technology are resulting in the growing usage of IVD tests in laboratories.

North America — Largest Revenue Contributor to Industry

North America is expected to lead the global in vitro diagnostic market throughout the forecast period. This can be attributed to the strong presence of market players, high healthcare spending, and increasing research and development (R&D) activities in the region. Furthermore, the extended support of the government and rapid adoption of advanced screening tests, such as nucleic acid testing (NAT), are propelling the market in the region. According to the Canadian Blood Services, NAT has been implemented in Canada for providing Canadians with a safer blood supply, by detecting viral genetic material in the donor blood, in case of infection.

Asia-Pacific (APAC) — Fastest-Growing Market for IVD Solutions

The in vitro diagnostic market in the APAC region is projected to grow with the highest CAGR during the forest period. One of the major factors driving the market growth in the region is the presence of key players and their engagement in strategic development activities to attain a significant market position. For instance, in October 2019, Abbott Laboratories announced that the Australian Red Cross Blood Service (Australian Blood Service) signed a multi-year agreement for the company’s blood and plasma screening technology, Alinity system. The agreement also included Abbott Laboratories’ total lab automation solution, as well as its informatics and professional services.

In Vitro Diagnostic Market

Product Launches and Approvals Are Key Market Trend

Several companies have recently gained approvals for their IVD products, thereby creating a significant impact on the in vitro diagnostic market. For instance, in January 2019, in the point-of-care (POC) segment, the U.S. Food and Drug Administration (FDA) approved the Sangia total prostate-specific antigen (PSA) test by OPKO Health Inc. It quantitatively measures the total PSA in capillary whole blood. It has been approved for use with the digital rectal exam (DRE), to screen for prostate cancer in men 50 years and older. The test can be administered with a finger prick, and results are generated within 12 minutes.

In Vitro Diagnostic Market

Surging Burden of Chronic Diseases

According to the International Diabetes Federation (IDF) Atlas 9th edition, in 2019, in the age group 20–64, 352 million people had diabetes, and this number is expected to rise to 486 million by 2045. Moreover, according to the WHO, the death count of cancer was 9.6 million in 2018. Moreover, according to the Joint United Nations Programme on HIV/AIDS (UNAIDS), the incidence of HIV/AIDS was 37.9 million people, worldwide, in 2018. Therefore, the increasing number of chronic disease patients is leading to the rising demand for IVD testing, which is resulting in the growth of the in vitro diagnostic market.

Increasing Number of Blood Donors

According to the WHO, in 2018, 118.4 million units of blood were collected through donations, globally. Moreover, it was reported that there were about 13,300 blood centers in 169 countries, and about 106 million blood donations were reported. Additionally, more than 90% of the blood supply in 79 countries was from voluntary unpaid blood donations, and more than 50% of the blood supply in 56 countries was from paid blood donors. Thus, the rising number of blood donors would help in the in vitro diagnostic market growth.

In Vitro Diagnostic (IVD) Market Report Coverage
Report Attribute Details
Historical Years 2014-2019
Forecast Years 2020-2030
Base Year (2019) Market Size $63.5 Billion
Forecast Period (2020-2030) CAGR 6.6%
Report Coverage Market Trends, Revenue Estimation and Forecast, Segmentation Analysis, Regional and Country Breakdown, Impact of COVID-19, Companies’ Strategic Developments, Company Share Analysis, Company Profiling
Market Size by Segments By Offering, By Technology, By Application, By End User, By Region
Market Size of Geographies U.S., Canada, Germany, France, Italy, U.K., Spain, Japan, China, India, Brazil, Mexico, Saudi Arabia, South Africa
Secondary Sources and References (Partial List) African Medical and Research Foundation; American Cancer Society; American Heart Association; Centers for Disease Control and Prevention; Centers for Medicare and Medicaid Services; China Food and Drug Administration; European Heart Network; European Society of Cardiology; German Medical Association; International Diabetes Federation; International Trade Administration; National eHealth Authority; Organisation for Economic Cooperation and Development ; Saudi Association of Health Informatics; U.S. Food and Drug Administration; World Bank Group; World Health Organization


Market Players Are Introducing New Products to Gain Competitive Edge

The global in vitro diagnostic market is consolidated in nature, with the presence of players such as Thermo Fisher Scientific Inc., Danaher Corporation, F. Hoffmann-La Roche Ltd., and PerkinElmer Inc.

In recent years, players in the in vitro diagnostic industry have involved themselves in multiple product launches in order to stay ahead of their competitors. For instance:

  • In September 2020, Laboratory Corporation (LabCorp) launched a new single-panel test that can simultaneously identify COVID-19, influenza A/B, and respiratory syncytial virus (RSV). The company has filed an application with the U.S. Food and Drug Administration (FDA) to provide the combined test via Pixel, an at-home test collection kit developed by the company.
  • In June 2020, QuantuMDx Group announced that the SARS-CoV-2 detection assay has received the CE-IVD mark under the In-Vitro Diagnostics Directive (98/79/EC), which enables the use of the product within the European Union. The company registered the test with the U.K.’s Medicines & Healthcare Products Regulatory Agency (MHRA) and applied to the FDA for Emergency Use Authorization (EUA).
  • In April 2020, Ortho Clinical Diagnostics received the EUA approval for a total antibody assay for COVID-19, the VITROS immunodiagnostic products anti-SARS-CoV-2 total reagent pack and calibrators, from the USFDA.

Some of the Key Players in the Global In Vitro Diagnostic Market Are:

  • Thermo Fisher Scientific Inc.
  • Danaher Corporation
  • F. Hoffmann-La Roche Ltd.
  • PerkinElmer Inc.
  • Quidel Corporation
  • OraSure Technologies Inc.
  • Sysmex Corporation
  • Siemens AG
  • Abbott Laboratories
  • Becton, Dickinson and Company
  • Hologic Inc.
  • Sartorius Stedim Biotech S.A.
  • Bio-Rad Laboratories Inc.
  • bioMérieux S.A.
  • Trinity Biotech plc
  • Bio-Techne Corporation
  • DiaSorin S.p.A.
  • Ortho-Clinical Diagnostics Inc.
  • Grifols S.A.

In Vitro Diagnostic Market Size Breakdown by Segment

The In vitro diagnostic market report offers comprehensive market segmentation analysis along with market estimation for the period 2014–2030.

Based on Offering

  • Reagents & Kits
  • Instruments
  • Software & Services

Based on Technology

  • Clinical Chemistry
    • Basic metabolic panel
    • Lipid profile
    • Liver profile
    • Renal profile
    • Thyroid function panel
  • Immunochemistry
    • Enzyme-linked immunosorbent assay (ELISA)
    • Radioimmunoassay (RIA)
    • Fluoroimmunoassay (FIA)
    • Chemiluminescence immunoassay (CLIA)
    • Immunochromatographic Assay (ICA)
  • Molecular Diagnostics
    • Infectious diseases
    • Genomics
    • Blood donor screening
  • Hematology
    • Complete blood count (CBC)
    • Cholesterol testing
    • Blood glucose testing
    • Hemoglobin testing
    • Coagulation testing
  • Microbiology

Based on Application

  • Infectious Diseases
  • Diabetes
  • Oncology
  • Cardiology
  • Nephrology
  • Autoimmune Diseases

Based on End User

  • Hospitals & Clinics
  • Point of Care (POC)
  • Laboratories
  • Research & Academic Institutes

Geographical Analysis

  • North America IVD Market
    • U.S.
    • Canada
  • Europe
    • Germany
    • France
    •  U.K.
    • Spain
    • Italy
  • Asia-Pacific
    • China
    • Japan
    • India
  • Latin America (LATAM)
    • Mexico
    • Brazil
  • Middle East & Africa (MEA)
    • Saudi Arabia
    • South Africa
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