In-Vitro Diagnostics (IVD) global Market estimated to be worth $96,485.2 million by 2028
In-vitro diagnostics (IVD) is an integral part of the healthcare system enabling diagnosis, monitoring, screening and assessing predisposition of various diseases there by providing timely and targeted medical treatment, where, samples that have been taken from the human body which include blood, saliva, stool, urine and mucus, and others like sweat. In-vitro diagnostics tools have developed as more sophisticated, portable, easy to use next-generation devices giving precise reliable results in a wide range of applications.
IVD products include reagents, assay kits, instruments, systems, and software, which are used, either alone or in combination for the in-vitro examination of specimens for diagnosis, early screening monitoring, prognosis, or recurrence of diseases. Technologies used in in-vitro diagnostics are broadly classified into seven segments such as immunochemistry, clinical chemistry, molecular diagnostics, clinical microbiology, hematology, coagulation, hemostasis and others. These technologies have a broad range of applications such as oncology, diabetes, cardiology, nephrology, transplantation technology, genetic testing, autoimmune diseases, drug testing, infectious diseases and blood & related disorders tests.
According to IQ4I analysis, the In vitro diagnostic global market is expected to grow at low single digit CAGR from 2021 to 2028 to reach $96,485.2 million by 2028. The rising incidence of infectious diseases and non-infectious diseases is boosting the IVD market, for instance, According to WHO, in 2020, approximately 37.7 million people were living with AIDS across the world, and as of September 12, 2021, approximately 225.1 million cases and 4.6 million deaths related to COVID-19 were reported globally. According to the American Cancer Society, the total number of new cancer patients in 2021 was estimated to be 1.8 million with 0.6 million deaths. Growing awareness of companion diagnostics and personalized medicine, the emergence of minimally invasive and non-invasive in-vitro diagnostics, rising number of CLIA-waived IVD tests are driving the IVD market growth. However, some factors like the rising incidence of product recalls, lack of skilled laboratory technicians in developing nations, inadequate reimbursement, and stringent regulatory framework are expected to hamper the market growth.
The in-vitro diagnostics global market is segmented based on products, technology, applications, sample source, end-users and geography. The products market is segmented into instruments, reagents and software & services, where, reagents commanded the largest share of the market in 2021 and is expected to grow at low single digit CAGR from 2021 to 2028 an increase in the utilization of reagents and assay kits in clinical diagnosis.
The IVD global market based on technology is segmented into immunochemistry, clinical chemistry, molecular diagnostics, clinical microbiology, hematology, coagulation and hemostasis and others. Among these, the immunochemistry segment commanded the largest share in 2021 and the market is expected to grow at low single digit CAGR from 2021 to 2028 due to increase in demand for ELISA and other rapid antigen kits for detection of pathogen and disease conditions.
The IVD global market based on application is segmented into oncology, diabetes, infectious diseases, genetic testing, cardiology, autoimmune diseases, drug testing, nephrology, transplantation, Blood & related disorders, and others, among them, the infectious disease segment commanded the largest revenue in 2021, the transplantation segment is expected to grow at high teen CAGR from 2021 to 2028.
Among the sample sources segment, the blood-based tests commanded the largest revenue in 2021 and growing with a mid single digit CAGR from 2021 to 2028. Among the end-users segments, hospitals accounted for the largest revenue in 2021 due to an increase in the number of life-threatening chronic and infectious diseases requiring hospitalization and extensive testing. The home care segment is expected to grow at mid single digit CAGR from 2021 to 2028 due to the increasing utilization of point of care products for various applications.
Among the geography segments, North America accounted for the largest revenue in 2021. The factors such as increasing R&D and health care expenditure, increase in the incidence of infectious diseases particularly COVID-19 and non-infectious diseases with increased demand for early detection, diagnosis & treatment, increasing funding from the government for the disease research, development of diagnostic and therapeutic solutions, growing focus towards personalized medicine and a growing number of startup companies engaged in developing advanced solutions for use in diagnostics. The Asia-Pacific segment is expected to grow at mid single digit CAGR from 2021 to 2028.
Analysis by IQ4I indicated that close to $XX million was funded between January 2020 to August 2021 for various activities such as the development of new technology, and expansion of product manufacturing facilities. For instance, In August 2021, DNANudge received $60.0 million in funding from Ventura Capital and others to accelerate the global deployment of DnaNudge's menu of rapid tests, including CovidNudge, its lab-free real-time PCR test for SARS-CoV-2. Similarly, in February 2021, LightDeck Diagnostics (U.K.) received $5.65 Million from Biomedical Advanced Research and Development Authority (BARDA) to develop a rapid antigen test to detect SARS-CoV-2.
Merger and acquisition activities were amounting close to $XX Bn, where, the acquisition deal between PerkinElmer and BioLegend for $5.25 Bn in June 2021 was the largest, Similarly, in April 2021, Hologic acquired Mobidiag for $785.0 million to develop Near-Patient, Acute Care Diagnostic Testing.
According to IQ4I analysis, clinical trials on IVD technologies such as circulating free DNA, circulating tumor cells, companion diagnostic, immunoassays, lipid profile, genetic disease, and microarrays. In circulation free DNA, there were a total of 76 clinical trials being conducted, in circulating free DNA (cfDNA) total of 123 clinical trials are being carried. In Immunoassays, 81 clinical trials are ongoing.
New technologies are being developed to increase the precision of pathogen and biomarker detection methods. The field is witnessing major advancements in recent years, owing to the development of highly advanced technology platforms. Technological advancements in gene sequencing have helped to determine multiple numbers of genes in a shorter period. Third-generation sequencing technologies produce substantially longer reads than second-
generation sequencing. In the past three decades, PCR has evolved from end-point PCR, through real-time PCR, to its current version, which is the absolute quantitative digital PCR (dPCR), which is the refinement of conventional PCR where it differentiates itself from conventional PCR from having the ability to measure and amplify a larger quantity of nucleic acids (RNA/DNA) by digitally displaying measurements rather than showing certain distinguishable patterns as in regular PCR. Engineers at MIT and Harvard University have designed a novel face mask that can diagnose the wearer with COVID-19 within about 90 minutes. According to IQ4I analysis, in the ongoing COVID-19 pandemic, close to XX million diagnostic tests will be performed, among which close to XX million PCR based diagnostic tests will be performed and is expected to generated close to XX million by end of 2021. The masks are embedded with tiny, disposable sensors that can be fitted into other face masks and could also be adapted to detect other viruses. Gold nanoparticles (AuNPs) were synthesized and conjugated to pAbs for the development of a dot-blot immunoassay. The developed dot-blot is evaluated with clinical serum and bronchoalveolar lavage samples.
The World Health Organization (WHO) declared the COVID-19 outbreak a Public Health Emergency of International Concern on 30 January 2020, and a pandemic on 11 March 2020, since then there have been close to 223.5 million cases (as of September 2021), resulting in 4.6 million deaths and about 218.9 million total recoveries. Like any other business, the in-vitro diagnostics market was impacted adversely, health concerns and significant changes in political or economic conditions caused by such outbreaks a significant reductions in demand for routine diagnostic testing and medical device procedures or increased difficulty in serving customers, disrupted manufacturing and supply chains, and negatively affected operations of suppliers, distributors and other third-party partners. On the other hand, due to the large demand for diagnosis and confirmatory testing, revenues in certain segments skyrocketed within the short period of the pandemic. During the COVID-19 public health emergency, many pandemic-related products (including diagnostic tests) were authorized by regulators for emergency use. In addition, many governments enacted policies to expedite or promote access to health care to slow or stop the spread of the virus. Examples include expansion of telehealth coverage and increased reimbursements for diagnostic testing.
IVD global market in 2021 is ruled top 8 key players namely Roche, Abbott Laboratories, Danaher, Siemens Healthineers, Hologic, Thermo Fisher, Biomereiux, Sysmex, these companies occupied a share of XX% in the In vitro diagnostic global market. Depending on the market penetration and capabilities in the In-vitro diagnostics global market, Roche diagnostics commanded the largest share of XX% in 2021, due to their developmental efforts of molecular diagnostic product range such as Cobas series of analyzers. The company is focusing more on innovation in products which has the potential to bring breakthroughs into the market.
The key players in the IVD global market include Abbott Laboratories, Inc. (U.S.), F.Hoffmann-La Roche AG (Switzerland), Siemens Healthineers(Germany), BioMereiux SA (France), Becton Dickinson and Company (U.S.), Bio-Rad Laboratories (U.S.), Danaher Corporation (U.S.), Sysmex (Japan), Dexcom (U.S), Hologic (U.S), Quidel (U.S) Qiagen N.V. (the Netherlands) and Thermo Fisher Scientific, Inc. (U.S.).