The global in-vitro diagnostics market is expected to grow at a CAGR of around 3.2% from 2020 to 2027 and projected to reach the market value of around US$ 97.3 Bn by 2027.
In-vitro diagnostics (IVDs) are the tests performed on samples involving blood or tissues that are taken from the human body. In-vitro diagnostics detect diseases or other conditions, and can be used to monitor a person's overall health to treat, cure, and prevent diseases. Furthermore, IVDs are devices and defined under section 201(h) of the Federal Food, Drug, and Cosmetic Act and is also considered as the biological products subjected to section 351 of the Public Health Services Act. Like other medical devices, IVDs are subjected to premarket and post market controls. Moreover, IVDs are subjected to categorization under the "Clinical Laboratory Improvement Amendments (CLIA '88) of 1988.
COVID-19 accelerates demand for IVD
With high technological and regulatory barriers, in-vitro diagnostics (IVD) has grabbed significant attention coupled with relative high-margin industry with molecular diagnostics being one of the fastest growing segments. With spread of the pandemic the demand for in-vitro diagnostics has increased. Additionally, point-of-care (POC) testing has risen during the COVID-19 pandemic in response to demand for faster on-site screening. According to the Rockefeller Foundation, estimates show that around 70 million POC tests were conducted in the US with a strong peak reaching to 200 million a month in the forecast period. With growing numbers of patients in the pandemic it gives rise to development of new diagnostic technologies that involve next-generation sequencing (NGS) and CRISPR. NGS has benefited from the regulatory support. Authorities in China and US have approved some NGS based COVID-19 diagnostics for emergency use. Others are in pipeline with throughput as high as 100,000 samples per run.
Future of in-vitro diagnostics
As per the American Association for Clinical Chemistry, non-invasive prenatal testing (NIPT), next generation sequencing (NGS), liquid biopsy, and circulating tumor cells (CTC) test are the five strong pillars of the in-vitro diagnostics (IVD) industry. According to the statistics revealed by the Kalorama Information, publisher of the Worldwide Market for In Vitro Diagnostic Tests, estimates that over the next few years, sales using NGS will witness tremendous growth from US$ 250 Mn to US$ 800 Mn, with the number of CTC tests rising from US$ 100 Mn to US$ 300 Mn. Furthermore, molecular diagnostics is a fast growing segment in the global market coupled with some of the larger IVD companies involved in this area. Expansion of the lab-developed tests (LDTs) and more commercialization of reagents and test kits will grab significant turnover for the global market.
Development of automated in-vitro diagnostic will gain 100% results in the forecast period
A diagnostic test for COVID-19 designed for use in diagnostic system can process up to 1,000 tests in 24 hours. However, laboratory based tests typically take at least 24 hours to reveal the results once the samples reach the laboratory. Rapid, high-throughput tests are critical to offer quick results for the global population to aid worldwide public health response. Therefore, the molecular diagnostic test from Hologic, Inc. became the first COVID-19 product selected for development through ASPR's Biomedical Advanced Research and Development Authority. Additionally, Biomedical Advanced Research and Development Authority (BARDA) contributed US$ 699,000 to accelerate Hologic's development of a test that detects the genetic material of SARS-CoV-2. For product licensure and to reduce the spread of COVID-19, federal agencies are focusing on identifying products and technologies that will progress beyond non-clinical studies and establish domestic large-scale commercial Good Manufacturing Practices (cGMP) manufacturing capability and utilization of a platform to manufacture a product already approved by the FDA.
Rising number of in-vitro diagnostic products launched by the prominent players fuels the global IVD market
The manufacturers have expanded their manufacturing facilities across various regions involving Europe, North America, Latin America, and RoW. COVID-19 had a strong influence on the business. In September 2020, F. Hoffmann-La Roche Ltd, announced launching of new product namely SARS-CoV-2 Rapid Antigen Test in countries with CE mark that enhances fast triage decisions at point-of-care. Additionally, in November 2020, Sysmex Corporation, announced receiving of in vitro diagnostic approval for manufacturing and marketing of a SARS corona virus antigen kit HISCLTM SARS-CoV-2 Ag Reagent, which, in conjunction with its fully automated immunoassay systems HISCLTM-5000 / HISCLTM-800. The company launched the product in commercial market on November 18, 2020.
The in-vitro diagnostics market is segmented based on product, technology, application, and end-user. By product, the market is segmented as instruments, reagents, and services. Based on technology, the market is segmented into immunoassay, hematology, clinical chemistry, molecular diagnostics, coagulation, microbiology, and others. Furthermore, application segment is segmented as infectious diseases, diabetes, oncology, cardiology, nephrology, autoimmune diseases, drug testing, and among others. By end-user, the market is segmented as hospitals, laboratories, home care, and others.
Based on product, reagent segment dominated the overall IVD market and will continue its trend in the forthcoming years by recording significant revenue share for in-vitro diagnostics market. Furthermore, by application segment infectious diseases segment holds the dominating share and will account maximum market share contributing the growth of overall IVD market. Based on end-user, hospital segment is dominating the market and will continue its trend in the coming years. Such prominent factors contribute to the fullest for the ultimate growth of in-vitro diagnostic market globally.
Based on regions, North America holds the dominating market share in the in-vitro diagnostics market. Presence of prominent players involved in manufacturing of in-vitro diagnostics, high investments, and increasing focus on the POC and molecular diagnostics coupled with surge in R&D are the key factors that contribute to the fullest for the growth of North America regional market for in-vitro diagnostics. On the other hand, Asia-Pacific will record CAGR of all time high during the forecast period for in-vitro diagnostic market. Improvement in regulatory scenario and surging affordability rates are the prominent factors for the growth of in-vitro diagnostics market in APAC region.
The prominent players in the global in-vitro diagnostic market involves Abbott, Becton, Dickinson and Company, bioMérieux SA, Bio-Rad Laboratories, Inc., Danaher (Beckman Coulter, Inc.), F. Hoffmann-La Roche AG, Siemens, QIAGEN, Sysmex, Thermo Fisher Scientific, among others.
Market By Product
Market By Technology
Market By Application
Market By End-Use
Market By Geography
• Rest of Europe
• South Korea
• Rest of Asia-Pacific
• Rest of Latin America
Middle East & Africa
• South Africa
• Rest of Middle East & Africa
In-vitro diagnostics market is expected to reach a market value of around US$ 97.3 Bn by 2027.
The in-vitro diagnostics market is expected to grow at a CAGR of around 3.2% from 2020 to 2027.
Immunoassay is the leading segment in the technology segment.
High government involvement is one of the prominent factors that drive the demand for in-vitro diagnostics market.
Abbott, Becton, Dickinson and Company, bioMérieux SA, Bio-Rad Laboratories, Inc., Danaher (Beckman Coulter, Inc.), F. Hoffmann-La Roche AG, Siemens, QIAGEN, Sysmex, Thermo Fisher Scientific, and among others.
North America is anticipated to grab the highest market share in the regional market
Asia Pacific is expected to be the fastest growing market in the forthcoming years