In vitro diagnostics or IVD refers to medical tests performed on samples or specimens derived from the human body such as blood and tissues. These tests are usually carried out for diagnosing a disease or health condition. IVDs can also be used to monitor the health of people, which in turn can help treat or prevent diseases. Moreover, it can help monitor how patients are responding to a particular treatment regimen as well.
Apart from these, nowadays, IVD is used to find out whether a patient is likely to respond positively to a particular treatment regimen or therapy. This is known as precision medicine, which is basically an approach to patient care. In precision medicine, physicians select those treatment options that are most suitable to patients. This selection is done on the basis of a genetic understanding of their diseases.
In vitro diagnostics include instruments, systems, and reagents that are used for the purpose of diagnosing diseases and disorders. Procedures that are used for in vitro diagnostics can range from simple tests to DNA testing. Accordingly, the devices used for IVD can vary from the simple ones to complex and sophisticated laboratory instruments.
IVD plays a crucial role in the early detection and diagnosis of diseases and timely intervention. It ensures that patients get the right kind of treatments and thus, reduces the incidence of wrong treatment. All these help save lives, improve health outcomes, and reduce health expenditures.
In the coming years, the market for IVD is set to witness a high growth due to factors like an increasing aging population, rising rates of chronic diseases and obesity across the globe, and the growing demand for Point-of-Care devices. Advancements in IVD devices and technologies, especially those advancements that improve accuracy, reliability, cost-effectiveness, and portability of IVD devices are also expected to fuel market growth.
The global in vitro diagnostic market was valued at USD 64.02 billion in 2017 and is expected to reach a valuation of UDS 87.93 billion by 2023, growing at a CAGR of 5.2% during the forecast period from 2018 to 2023. Some of the major companies that are dominating the global IVD market are Abbot Diagnostics, Siemens Healthineers, Roche Diagnostic, and Danaher Corporation.
Devices can range from simple tests to sophisticated DNA technology including reagents, calibrators, control materials, kits, software, and related instruments.
IVD is an important segment in the global healthcare industry. The marketplace is witnessing rapid growth fuelled by technological advancements, better diagnostic tools, improved treatment monitoring, and increased availability of over-the-counter tests. IVDs add significant value to treatment processes and medical diagnoses, enhancing the well-being of the general public.
The In Vitro Diagnostics Directive (IVDD) 98/79/EC is a set of regulatory requirements that medical device manufacturers must comply with in order to place a CE Mark to their product. The aim of the IVDD is to protect the health and safety of patients and users – and serve the best interests of third parties – to ensure that manufacturers meet quality standards and demonstrate their products are safe, effective, and perform as intended.
Precision medicine is an approach to patient care that allows doctors to select treatments that are most likely to help patients based on a genetic understanding of their disease
What is in vitro diagnostics (IVD)? The FDA definition of IVD encompasses reagents, instruments, and systems intended for diagnosis of disease.
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.
In vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies. These in vitro diagnostics can include next generation sequencing tests, which scan a person’s DNA to detect genomic variations.
What is an In Vitro Diagnostic Device?
In Vitro Diagnostics (IVDs) are medical devices and accessories used to perform tests on samples, (e.g., blood, urine and tissue that has been taken from the human body) in order to: