How big is the IVD market?

At an estimated value of over USD 72.02 billion in 2019, the Global In Vitro Diagnostics (IVD) Market is predicted to thrive at a CAGR of 4.1% and valued at over USD 112.05 billion over the forecast year 2020-2030.

What is IVD industry?

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.

What is diagnostic industry?

Diagnostics refers to the investigation and identification of disease states in medicine. The modern diagnostic industry generally falls into two broad categories, that is in vitro diagnostics and in vivo diagnostics.

What is vitro diagnostic?

Subscribe to Email Updates. In vitro diagnostics are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases.

What is an IVD device?

in vitro diagnostic device (IVD) A medical device is an in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use.

What is the meaning of IVD?

in vitro diagnostic product
IVD means any in vitro diagnostic product and those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae, including the collection, preparation and …

What is for in vitro diagnostic use only?

In Vitro: ‘In Vitro’ means In an Artificial Environment, rather than inside a living organism, e.g. in a test tube. In Vitro Diagnostic Use Only: To be used only for the purpose of identifying the use of a drug(s) or alcohol from a specimen gathered from a human body outside of a living organism i.e. a test tube.”

What does IVD stand for?

in vitro diagnostic device
in vitro diagnostic device (IVD) A medical device is an in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use.

Is my device an IVD?

An IVD Medical Device is defined in the IVDR as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of …

What class are IVD devices?

The FDA classifies medical devices, including IVD products, into Class I, II, or III according to the level of regulatory control that is necessary to reasonably assure safety and effectiveness.

What is in vitro medical device?

According to the IVDD, in vitro diagnostic medical devices include: reagents, reagent products, calibration materials, control materials, kits, instruments, apparatus, equipment, and systems that are intended for use in the examination of specimens taken from the human body (tissue, blood, urine, etc.) to diagnose …

Is an LDT and IVD?

The key distinction between FDA-reviewed IVDs and LDTs is where they are made: LDTs are designed and used in a single laboratory, and are sometimes referred to as “in-house” tests. Though LDTs may contain the same or similar components as FDA-reviewed tests, they must be developed and used within the same facility.

How big is the IVD market in Asia?

The Asia-Pacific IVD Market accounted for $13,680 million in 2016, and is estimated to reach at $19,888 million by 2023, growing at a CAGR of 5.4% from 2017 to 2023.

Why is the in vitro diagnostics market growing so fast?

The growth can be attributed to the increasing adoption of in vitro diagnostics (IVD) owing to a rise in testing due to the pandemic. The development of automated in vitro diagnostic systems for laboratories and hospitals to provide efficient, accurate, and error-free diagnosis is expected to fuel market growth.

Who are the companies in the IVD market?

Companies profiled in this market include, Thermo Fisher Scientific Inc., Alere Inc., Biomerieux, Danaher Corporation, F. Hoffmann-La Roche AG, Becton Dickinson and Company, Bio-Rad Laboratories, Bayer AG, Sysmex Corporation, and Johnson & Johnson among others.

How much does the EU spend on IVD per capita?

In the newer EU member states, IVD expenditure averaged 1.3% of total healthcare expenditure (THE), significantly higher than the 0.63% seen in older member states (EU-15), but in absolute terms, the new member states spend only €11 per capita compared to €22.8 in the EU-15. Growth in the newer states are at +5.8 compared to 0.8% in EU-15 states.