The global In Vitro Diagnostics (IVD) market size was USD 98.00 Billion in 2021 and is expected to register a revenue CAGR of 2.3% during the forecast period.
The global In Vitro Diagnostics (IVD) market size was USD 98.00 Billion in 2021 and is expected to register a revenue CAGR of 2.3% during the forecast period. Rising incidence of chronic diseases and increasing substantial investments for creation of automated IVD systems for use in labs and hospitals to produce accurate, timely, and reliable diagnoses are major factors driving revenue growth of the market.
IVDs are medical devices that use reagents and assays to determine medical conditions in a laboratory setting. These tools are also useful for examining patient tissue and bodily fluid samples. In addition, IVD equipment is also compatible with a wide range of procedures, including hematological diagnostics, immunodiagnostics, molecular diagnostics, and tissue diagnostics. It is also used to detect a wide range of medical conditions, including heart problems, cancer, and nephrological and infectious diseases.
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The IVD market is expanding at a nearly unstoppable rate. OEMs and contract manufacturers share the goal of making their next-generation diagnostic instruments more productive, user-friendly, and dependable in response to laboratory demands for increasingly complex and efficient IVD equipment, whether for immunoassay, clinical chemistry, hematology, molecular diagnostics, or infectious disease applications. OEMs are searching for solutions to validate and safeguard their income stream on proprietary consumables as reagents become more specialized. In addition, IVD equipment is frequently utilized by under-trained operators closer to the Point of Care (POC), therefore new equipment designs must incorporate ease of use, safety, and error prevention.
Advent of nano-biotechnology and biochips and miniaturization of microfluidic tools are other factors driving revenue growth of the market during the forecast period. Nanomaterials are being used as nanoprobes for diagnosis and bioanalysis. Nanotechnology-based systems have the potential to enable development of POC testing platforms with robust, portable, and affordable properties to detect infectious diseases, and can be cost-effectively deployed in markets in emerging economies. Furthermore, nanodiagnostics is also opening up lucrative opportunities for players in the market, as it enables rapid detection of infectious diseases.
Driver: Technological breakthroughs in IVD services, tools, and products
The Internet of Things (IoT) and Artificial Intelligence (AI) have both been readily integrated into in vitro diagnostics technology. IVD devices benefit from AI’s advanced data analytics and error minimization. In addition, AI-powered IoT technology helps with remote device monitoring, administration, and uptime efficiency, therefore, patients get access to medical information acquired by in vitro diagnostics testing through their smart devices.
Also, demand for Point-of-Care facilities growing, which is another factor driving revenue growth of the market. Majority of PoC testing equipment consists of handheld electronics or Lateral Flow Immunoassay (LFIA) platform-based molecular collecting techniques. LFIA platform, which is frequently produced as membrane-based test strips housed inside a plastic cassette, has a solid track record of accuracy and efficacy due to its use in at-home pregnancy tests, one of the first types of PoC testing. Moreover, PoC technology is more important as a result of rising demand for quick diagnosis of infectious and chronic diseases. Security, precision, and user-friendliness of PoC diagnostics have all improved with usage of smart devices. Furthermore, biosensors are another more recent PoC testing tool becoming more sensitive with time. A commercially accessible blood glucose monitor is an illustration of a biosensor that is frequently used in PoC diagnostics.
Restraint: Strict regulatory policies
The global In Vitro Diagnostics (IVD) market growth is hampered by several unfavorable factors. Diagnostic device and test regulatory approval processes are time-consuming. To verify safety of devices, regulatory approval includes a review of clinical data, calibration, manufacturing procedures, quality control, risk assessment, and other aspects. Despite this, complexity of molecular diagnostic equipment is a major factor restraining revenue growth of the market.
Product Type Outlook:
Based on product type, the global In Vitro Diagnostics (IVD) market has been segmented into instruments, reagents & kits, services, and others. The reagents & kits segment revenue is expected to account for largest share over the forecast period. This is due to rising demand for quick, precise, and sensitive equipment, in-vitro diagnostic testing usage, self-testing and point-of-care product usage, and reagent-related R&D initiatives. IVD procedures use IVD reagents for patient diagnosis, monitoring, and treatment, which are designed to be used for evaluation of human body specimen samples. It can also be utilized in a wide range of instruments, from simple lab equipment to compact, portable tests.
The instruments segment revenue is expected to register a rapid growth rate over the forecast period. Instruments used in in-vitro diagnostics (IVD) are medical tools that conduct tests on samples of body materials, such as tissues, blood, urine, and stool, to find diseases and infections. When examining specimens, such as donated blood and tissues from human body, instruments may contain control materials, kits, apparatuses, pieces of equipment, devices, or systems that are utilized alone or in combination.
Technology Outlook:
Based on technology, the global In Vitro Diagnostics (IVD) market has been segmented into immunochemistry, molecular diagnostics, hematology, microbiology, and others. The immunochemistry segment is expected to register a rapid growth rate over the forecast period. Use of antibodies for labeling and detection of biomolecules in techniques, such as ELISA, immunocytochemistry, and immunohistochemistry, is a key application of immunochemistry. Currently, immunochemistry is a recognized ancillary method for detection of lung cancer. In addition to aiding in morphological diagnosis of malignancy, it also plays a part in determining cell lineage, identifying primary site of tumor formation, and influencing prognosis and therapy choices.
Molecular diagnostics are increasingly used to assist patient management, from diagnosis to treatment in fields such as infectious disease, cancer, and congenital abnormalities. Furthermore, rapid development of molecular techniques in clinical laboratories is a result of rising demand for genomic and genetic information. In addition to screening and detection of viruses, molecular diagnostics are being used for treatment guidance and monitoring.
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Application Outlook:
Based on application, the global In Vitro Diagnostics (IVD) market has been segmented into infectious diseases, cancer, cardiac diseases, immune system disorders, HIV/AIDS, and others. The infectious disease segment is expected to register a rapid growth rate over the forecast period, owing to increase in infectious diseases such as HIV, Sex-Transmitted Diseases (STDs), and TB.
End-Use Outlook:
Based on end-use, the global In Vitro Diagnostics (IVD) market has been segmented into clinical laboratories, academic and medical schools, point-of-care testing centers, hospitals, and others. The hospitals segment revenue accounted for largest share in 2021. This is due to increasing number of patients visiting hospitals since doctors need to analyze diagnostic tests before starting therapy. Hospitals and diagnostic facilities typically work together, therefore hospitals frequently have their own diagnostic setup. Furthermore, revenue growth of this segment is driven by increased focus on development of healthcare infrastructure, which is likely to upgrade current hospital facilities.
Regional Outlook:
Based on regional analysis, the North America market is expected to register largest revenue share over the forecast period. This is attributed to region’s rising awareness regarding diagnostic devices, presence of established healthcare companies, rising incidence of chronic ailments, and presence of geriatric population in countries such as the U.S.
The Asia Pacific market is expected to register a significant revenue CAGR over the forecast period. This is due to increasing number of people in this region becoming aware of healthcare issues and are seeking early diagnoses. In addition, a huge patient population, uptick in chronic diseases requiring IVD testing, and enhanced healthcare facilities are expected to drive revenue growth of the market.
The Europe market is expected to register a steady revenue CAGR over the forecast period, owing to growing use of point-of-care diagnostics tests and e rising incidence of various chronic diseases in the country. Furthermore, increased susceptibility to infections and age-related diseases as a result of their low immunogenicity and growing geriatric population adds to burden of infectious diseases, which is another factor driving revenue growth of the in-vitro diagnostics market in this region.
Competitive Landscape:
The competitive landscape of the global In Vitro Diagnostics (IVD) market is moderately consolidated with few major companies operating on global and regional levels. Major companies are engaged in product development and strategic alliances to expand their respective product portfolios and gain a robust footprint in the global market. Some major companies in the market report include Abbott, Bio-Rad Laboratories, Inc., BIOMÉRIEUX, Thermo Fisher Scientific, Agilent Technologies, Inc., F. Hoffmann-La Roche Ltd., Ortho Clinical Diagnostics, Sysmex, Quidel Corporation, and Charles River Laboratories.
Some recent developments are as follows:
- On 21 September 2022, BioMérieux, a leader in the field of in vitro diagnostics and BrightInsight, Inc., a provider of the top global platform for biopharma and medtech regulated digital health solutions, announced a partnership to develop and market a Clinical Digital Solution for diagnostics that will enable clinical decision support for disease areas across their diagnostic tests.
- On 16 March 2022, Illumina, the DNA sequencing company, launched a new in vitro diagnostic test in Europe to characterize various cancer mutations and guide patients to tailored medicines
- On 16 February 2022, Invitae, a leading provider of in-vitro diagnostics (IVD), announced to launch FusionPlex Dx and LiquidPlex Dx in Europe. These products are a part of the company’s market-leading Anchored Multiplex PCR Chemistry IVD line. As a part of the fight against cancer, Invitae is providing crucial, high-quality innovation for precision oncology. With this announcement, Invitae offers best CE-IVD tools available so that European pathologists and oncologists may quickly and effectively provide patients with cancer therapy guidance.
Segments Covered in the report
This report offers historical data and forecasts revenue growth at a global, regional, and country-level, and provides analysis of the market trends in each of the sub-segments from 2019 to 2030. For the purpose of this report, Reports and Data has segmented the global In Vitro Diagnostics (IVD) market based on product type, technology, application, end-use, and region:
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In Vitro Diagnostics (IVD) Market Report Scope
Segments covered By Product Type Outlook, Technology Outlook, Application Outlook, End-Use Outlook, Regional Outlook
By Product Type Outlook
Instruments
Reagents & Kits
Services
Others
By Technology Outlook
Immunochemistry
Molecular Diagnostics
Hematology
Microbiology
Others
By Application Outlook
Infectious Diseases
Cancer
Cardiac Diseases
Immune System Disorders
HIV/AIDS
Others
By End-Use Outlook
Clinical Laboratories
Academic and Medical Schools
Point-of-Care Testing Centers
Hospitals
Others
Regional scope
North America
Europe
Asia Pacific
Latin America
Middle East & Africa
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