In Vitro Diagnostics Market Size, Share & Trends Analysis Report By Product, By Technology (Molecular Diagnostics, Clinical Chemistry), By Application, By End Use, And Segment Forecast, 2020 - 2027

Report Overview

The global in-vitro diagnostics market size was valued at USD 60.8 billion in 2019 and is expected to expand at a CAGR of 4.4% over the forecast period. Development of automatic in vitro diagnostics (IVD) systems for laboratories and hospitals to provide efficient, accurate, and error-free diagnosis is expected to fuel the growth. For instance, in March 2019, Becton, Dickinson and Company received CE-IVD certification for BD FACSDuet automated flow cytometry system that enables clinical laboratories to increase their efficacy and throughput as compared to manual processes.

Rising geriatric population is expected to be one of the high impact rendering market drivers. According to the United Nations (UN), it was estimated that, in 2017, there were around 962 million people with age above 60 years worldwide. Furthermore, according to the World Health Organization (WHO), by 2020, the number of populations above 60 years will be more than that of the children younger than 5 years.

Presence of research organizations that provide consulting services, clinical research, and laboratory testing to combat the increasing demand for rapid diagnosis and treatment plans is expected to drive the IVD market. For instance, in July 2018, NAMSA started IVD development business to provide resources such as in-vitro diagnostics regulatory, and clinical research for global manufacturers.

In addition, the presence of Medicare and Medicaid facilities due to rising demand for diagnosis of diseases using in vitro diagnosis is expected to fuel the market growth over the forecast period. For instance, in December 2017, the Centers for Medicare & Medicaid Services covered FoundationOne CDx (F1CDx) after it was approved by the U.S. Food and Drug Administration (FDA).

Product Insights

Reagents held the dominant market share in 2019. Factors, such as rise in the number of R&D initiatives related to reagents and increase in the demand for self-test and Point-of-Care (POC) products are expected to accelerate the growth of the segment over the forecast period. In addition, key market players are launching new systems using reagents with advanced technology. For instance, in January 2019, Beckman Coulter, Inc. launched ClearLLab 10C System for clinical flow cytometry lab. The new system includes CE-IVD panels of immunophenotyping regents for lymphoid and myeloid lineages. The tubes in the panel utilize DURA Innovations dry reagent technology, which requires no refrigerator to deliver high-quality results.

On the other hand, instruments are expected to expand at a lucrative CAGR during the forecast period. Technological advancements and innovations are expected to create growth opportunities for the segment in the forthcoming years. 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 till analysis.

Technology Insights

On the basis of technology, the in vitro diagnostics market is segmented into coagulation, microbiology, molecular diagnostics, clinical chemistry, immunoassay, hematology, and others. Immunoassay dominated the global IVD market in 2019, attributed to increasing adoption of immunoassay based POC testing and rapid testing. Molecular diagnostics is expected to witness the fastest growth over the forecast period. Rising approvals by regulatory authorities can be attributed to this growth. For instance, in April 2019, SOPHiA GENETICS received CE-IVD marking for Solid Tumor Solution (STS). It detects and characterizes altered genes in lung, colorectal, brain, and skin cancer.

Application Insights

The infectious disease segment held the leading market share in 2019 due to increasing incidence of infectious diseases such as pneumonia, tuberculosis, AIDS, and HIV. Manufacturers are developing new in vitro diagnostic systems to combat the rising incidence of infectious diseases. For instance, in May 2019, Roche Diagnostics launched Cobas MTB-RIF/INH test that detect resistance in antibiotics in tuberculosis DNA. Development and launch of such tests is another factor contributing to this dominance.

Oncology is expected to register the fastest CAGR during the forecast period, owing to the presence of automated in vitro diagnostics assay and rising prevalence of cancer. In November 2018, Roche Diagnostics launched VENTANA pan-TRK (EPR17341) Assay for global distribution. It is the first automated IVD immunohistochemistry assay used for the detection of tropomyosin receptor kinase in cancer patients.

End-use Insights

In-vitro diagnostics services are used by hospitals and laboratories as well as directly by patients. Homecare segment is expected to be the fastest-growing over the forecast period. Hospital segment accounted for the largest market share in 2019, owing to high demand for in vitro diagnostic tests as a result of increase in hospitalization. For instance, in March 2019, Instrumentation Laboratory received clearance forGEM Premier ChemSTAT IVD analyzer. This system was majorly developed for point of care diagnosis for emergency departments in hospitals.

Regional Insights

North America held the largest market share in 2019. Favorable government regulations, well-established diagnostic infrastructure, technological advancements in the field of in-vitro diagnostics, and presence of key market players are the factors responsible for the largest regional share.

In addition, development of in vitro diagnostics kits for laboratories in hospitals in the U.S. is expected to drive the market growth in North America. For instance, in November 2019, Lexent Bio, Inc. and Illumina, Inc. entered into a partnership to develop IVD kits for Lexent portfolio of Next-Generation Sequencing (NGS) based cancer diagnostics. These kits are focused on improving clinical practice in hospitals with laboratories.

On the other hand, Asia Pacific is expected to witness the fastest CAGR over the forecast period. Presence of a large number of target population along with improving healthcare infrastructure is anticipated to provide high growth potential to key manufacturers in the region.

In-Vitro Diagnostics Market Share Insights

Some of the key market players are Siemens Healthineers; Qiagen; Becton, Dickinson and Company; F. Hoffmann-La Roche Ltd.; bioMerieux SA; Hologic, Inc. (Gen-Probe); Abbott Laboratories; Danaher; Sysmex Corporation; and Cepheid.

The companies focus on strategies, such as mergers and acquisitions, collaborations, and new product developments. In addition, they are aiming to expand their businesses in developing regions to increase their market share. For instance, in August 2018, Sysmex Corporation and JVCKENWOOD Corporation agreed to jointly establish a new company Creative Nanosystems Corporation to develop and manufacture biodevices.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest market trends in each of the sub-markets from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global in-vitro diagnostics market report on the basis of product, technology, application, end-use, and region:

• Product Outlook (Revenue, USD Million, 2016 - 2027)

  • Instruments

  • Reagents

  • Services

• Technology Outlook (Revenue, USD Million, 2016 - 2027)

  • Immunology

    • Instruments

    • Reagents

    • Services

  • Hematology

    • Instruments

    • Reagents

    • Services

  • Clinical chemistry

    • Instruments

    • Reagents

    • Services

  • Molecular Diagnostics

    • Instruments

    • Reagents

    • Services

  • Coagulation

    • Instruments

    • Reagents

    • Services

  • Microbiology

    • Instruments

    • Reagents

    • Services

  • Others

    • Instruments

    • Reagents

    • Services

• Application Outlook (Revenue, USD Million; 2016 - 2027)

  • Infectious Disease

  • Diabetes

  • Oncology

  • Cardiology

  • Nephrology

  • Autoimmune Diseases

  • Drug Testing

  • Others

• End-Use Outlook (Revenue, USD Million; 2016 - 2027)

  • Hospital

  • Laboratory

  • Home Care

  • Others

• Regional Outlook (Revenue, USD Million; 2016 - 2027)

  • North America

    • The U.S.

    • Canada

  • Europe

    • The U.K.

    • Germany

    • Spain

    • France

    • Italy

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Singapore

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • MEA

    • South Africa

    • United Arab Emirates

    • Saudi Arabia