Description
In vitro diagnostics domain encompasses a variety of tests, which are categorized into four different classes based on their risk; such solutions serve a diverse set of therapeutic areas.
The global IVD market size is estimated to grow from $108 billion in 2024 to $190 billion by 2035, growing at a CAGR of 5.2% during the forecast period 2024 to 2035.
In vitro diagnostics (IVD) are the tests conducted on samples retrieved from human body, such as blood, saliva or tissue in order to detect diseases or conditions. Such tests help diagnose, monitor, and manage diseases, such as diabetes, infectious diseases, and cancer. The common types of IVD tests include immunoassays, molecular diagnostics, and clinical chemistry tests. Such tests play a crucial role in healthcare by providing timely and accurate information for medical decision-making. IVD solutions are essential tools for screening, diagnosing, and monitoring diseases, ultimately contributing to improved patient outcomes and public health.
In the following sections, we explore the various therapeutic areas targeted by In Vitro Diagnostic Solutions.
Infectious Disease – In vitro diagnostic solutions can be used to diagnose a variety of infectious diseases. For example, for HIV / AIDS, a variety of HIV antibody tests and viral load detection tests are available in the domain. On the other hand, for diseases, such as Hepatitis, a variety of surface antigen tests and Hepatitis C antibody tests are available in the market.
Cancer Diagnostics – In vitro diagnostic solutions serve as critical tools for early detection and management of oncological disorders. can be used to diagnose a variety of infectious diseases. Some of the examples include HER2/neu tests and estrogen receptor / progesterone receptor tests for breast cancer detection and fecal occult tests for colorectal cancer.
Cardiovascular Diseases – In vitro diagnostic solutions find their application in the diagnosis of various cardiovascular diseases. For example, cardiac biomarkers and troponin tests, lipid profile and cholesterol / triglyceride tests.
Autoimmune Disorders – In vitro diagnostic solutions are equally essential for the diagnosis of autoimmune diseases. For example, rheumatoid factor tests, anti-cyclic citrullinated peptide tests and antinuclear antibody tests for systemic lupus erythematosus.
Neurological Disorders – Many of the In vitro diagnostic solutions are pivotal in the diagnosis and management of neurological disorders. Some of the examples include amyloid beta (Aβ) protein tests and tau protein tests for Alzheimer's disease and oligoclonal banding tests in cerebrospinal fluid for multiple sclerosis.
Pregnancy and Fertility – In vitro diagnostic solutions find a variety of applications in the areas of pregnancy and fertility. For example, urine-based hCG tests for rapid pregnancy detection test, ovulation predictor kits and sperm analysis tests.
The In Vitro Diagnostic domain features a dynamic market landscape of players that utilize various type of advanced diagnostic technologies in order to offer a variety of diagnostic applications.
During our research, we observed that all the leading players employ the use of immunoassay and molecular diagnostic technologies, followed by hematological techniques and clinical chemistry technologies. Further, in terms of diagnostic applications, all the leading players offer diagnostic applications focused on infectious diseases. This is followed by players focusing on oncological applications (90%), gynecological (90%) and diabetic applications (80%).
Among the leading players considered in this analysis, the majority of this domain is constituted of very large players (80%). Examples of such companies include (arranged in alphabetical order) Abbott, Agilent Technologies, BD and bioMérieux. Further, in terms of location of headquarters, the majority of the leading players (50%) are based in North America. On the other hand, in terms of annual revenues, Roche emerged as the leading player which generated over USD 16.1 billion in revenue in the fiscal year 2023.
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