In-Vitro Diagnostics Instruments Market By Product Type (Immunochemistry, Clinical microbiology, POCT, SMBG, Tissue Diagnostics, Molecular Diagnostics, Hemostasis) By End-User and Region - Global Forecast to 2026

Global In-vitro Diagnostic Instruments Market Overview

"The In-vitro Diagnostic Instruments Market size is expected to be worth around US$ xx Billion by 2021 from US$ X.xx million in 2031, growing at a CAGR of X.x% during the forecast period 2021 to 2031."

Request Covid - 19 Impact

An in-vitro diagnostic (IVD) device is defined as a device that is intended for the in-vitro examination of specimens derived from the human body principally to provide information for diagnostic, monitoring, or compatibility purposes. These in-vitro diagnostic instruments can be used alone or in combination.

In-vitro diagnostics involves tests performed on samples such as blood or tissue that have been collected from the human body. It helps monitor a person’s overall health check-up to help treat or prevent diseases. Devices can range from simple tests to sophisticated DNA technology, including reagents, control materials, calibrators, and related instruments.

The Food and Drug Administration (FDA) has been involved in regulating IVD since the Medical Device Amendments of 1976. FDA classifies in-vitro diagnostic instruments into Class I, II, or III according to the level of regulatory control necessary to assure safety and effectiveness. The classification of an IVD determines the appropriate premarket process. The Code of Federal Regulations lists existing in-vitro diagnostic instruments in 21 CFR 862, 21 CFR 864, and 21 CFR 866.

Global In-vitro Diagnostic Instruments Market Dynamics:

Increasing personalized healthcare approach and the ease offered by in-vitro diagnostic techniques and devices, such as faster detection of asymptomatic infections and diseases and easy patient management when the clinical presentation is non-specific, are driving the growth of the global market.  In addition, the rising adoption of point-of-care testing among healthcare professionals and homecare settings is another factor fueling the growth of the target market.

Furthermore, the growth of the global market is fueled by technological advancements, improved patient monitoring and diagnostic tools, and increased availability of over-the-counter tests. In-vitro diagnostic instruments help to add noteworthy value to the diagnosis and prognosis of diseases, thus enhancing the well-being of the general population.

Report Coverage and Deliverables

PDF report and online dashboard will help you understand:

• Competitive benchmarking
• Market forecasts
• Company market shares
• Market opportunities
• Latest trends & dynamics

Request a Free Sample Copy

View Infographic

In-vitro diagnostics are different from other medical technologies available in the market. Still, the most significant difference is that it never comes in direct contact with the patient as they provide information based on the analysis of samples.

However, stringent government regulations and a lack of reimbursement policies in developing economies is a major factor expected to hamper the global market growth.

Market Analysis by In-vitro Diagnostic Instruments Product Type:

Based on product type, the immunochemistry segment is expected to account for a major share in terms of revenue in the global market. It is projected to register a CAGR of over 7% over the forecast period, owing to the launch of new biomarkers by manufacturers and growth in small-scale laboratories performing routine tests. In addition, extensive usage of ELISA and semi-quantitative diagnostic tests is another factor supporting the growth of the immunochemistry segment in the global market.

Moreover, the immunochemistry segment is projected to maintain its dominant revenue contribution in the global market over the forecast period. Furthermore, the introduction of new technologies such as immunofluorescence assay and chemiluminescence immunoassay by players in the market also impels the growth of the immunochemistry segment.

Increasing healthcare awareness among individuals and rising demand for quality healthcare equipment in medical facilities supports the development and launch of innovative products by manufacturers in the global market.

Global In-vitro Diagnostic Instruments Market Analysis by End User:

Based on end-user, the hospitals and diagnostic laboratories segment is expected to account for a major share in terms of revenue in the global market and is projected to register a CAGR of over 7% over the forecast period, owing to the increasing geriatric population, rising number of patients admitting in hospitals suffering from chronic diseases, and increasing government support for the development of hospital infrastructure are major supporting growth of this segment. In addition, rising government funds to facilitate diagnostic laboratories with the latest diagnostic equipment and tools is another factor supporting the growth of the global market, especially in developing countries.

Global Market Analysis by Region:

The Americas market is expected to dominate the global in-vitro diagnostic instruments market in revenue terms. It is estimated to account for the largest market revenue share of over 30% in 2017 compared to markets in other regions. It is expected to maintain its dominant revenue contribution in the global in-vitro diagnostic instruments market over the forecast period. This can be attributed to increasing healthcare awareness among individuals, rising chronic cases, availability of technologically advanced diagnostic tests, and adoption of point-of-care testing techniques by healthcare professionals. The availability of technologically advanced healthcare infrastructure and novel diagnostic options that help cure and treat infections are other factors contributing to the highest market share.

The market in the Asia Pacific is projected to register a significant growth of around 7%, which is relatively higher than that of markets in other regions. Increasing patient pool and rising government support for the treatment of chronic diseases in countries such as India and China are major expected to support the growth of the global market in Asia Pacific market over the forecast period. Product expansion by the key players in the emerging economies is another major factor boosting growth in the Asia Pacific region.

Moreover, markets in Latin America and Middle East & Africa are also projected to witness moderate growth over the forecast period owing to recent advancements in technology, increasing healthcare expenditures, rising initiatives by regulatory bodies, and augmented healthcare facilities are expected to boost the target market.

Global In-Vitro Diagnostics Instruments Market Segmentation:

Global in-vitro diagnostic instruments market segmentation by product type:

• Immunochemistry
• Clinical Microbiology
• POCT
• SMBG
• Tissue Diagnostics
• Molecular Diagnostics
• Hematology
• Hemostasis

Global in-vitro diagnostic instruments market segmentation by end-user:

• Hospitals and Diagnostic Laboratories
• Homecare
• Academic and Research Institutes

 Global in-vitro diagnostic instruments segmentation by region:

• The Americas
• Europe
• Asia Pacific
• Rest of the World (ROW)