The in vitro diagnostics market was valued at approximately USD 76,281.75 million in 2021, and it is expected to witness a revenue of USD 1,01,542.35 million in 2027, with a CAGR of 4.90% over the forecast period.
The COVID-19 pandemic turned the spotlight on in vitro diagnostics since there is an increasing demand for IVD kits and reagents for the rapid and accurate diagnosis of SARS-CoV2 virus infection among the global population. The outbreak of COVID-19 is expected to positively impact the market, as in vitro diagnostics involves the testing of various biological samples. This is expected to aid the diagnosis of infectious diseases, such as COVID-19. Testing remains a crucial step in controlling the COVID-19 pandemic. As the number of COVID-19 cases is increasing across the world, governments of various countries are exploring the possibility of allowing private laboratories to ramp up testing.
Also, the rapid launch of diagnostic kits for the diagnosis of COVID-19 by key players is driving the market during the pandemic. For instance, in March 2020, Qiagen launched QIAstat-Dx test kit for the detection of SARS-CoV-2 coronavirus in Europe, and in April 2020, Altona Diagnostics launched CE-IVD marked RealStar SARS-CoV-2 RT-PCR Kit 1.0, an in vitro diagnostic test based on real-time PCR technology, for the qualitative detection of lineage B-beta coronavirus (lineage B-?CoV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Additionally, in February 2020, the US FDA issued a new policy to expedite the availability of diagnostics. A public health emergency was determined, justifying the authorization of emergency use of in vitro diagnostics (IVDs) for the diagnosis of COVID-19. Thus, the global COVID-19 pandemic is expected to have a positive impact on the growth of the studied market.
The growth of the global IVD market can be attributed to the high prevalence of chronic and infectious diseases. According to the Centers for Disease Control and Prevention (CDC), in 2021, around 18.2 million adults aged 20 and older had coronary artery disease (CAD) in the United States. Heart disease is the leading cause of death among people in the US. The high incidence of chronic diseases increases the demand for huge diagnostic procedures, which, in turn, drives the market.
Additionally, the current market is also growing due to the use of advanced technologies in the IVD market. There has been a paradigm shift from traditional diagnostics to a new generation of diagnostics that work at the gene level. This was made possible by the inclusion of advanced technologies, such as genetic testing, molecular diagnostics, polymerase chain reaction (PCR), and next-generation sequencing (NGS) in the IVD platform. Also, the increasing product launches with advanced features are expected to drive the market. For instance, in January 2020, SphingoTec GmbH launched its IB10 sphingotest penKid, a CE-IVD-marked point-of-care test for Proenkephalin, the biomarker that allows real-time assessment of kidney function with a simple blood test. Thus, given the aforementioned factors, the in vitro diagnostic market is anticipated to propel over the forecast period.
Key Market Trends
Reagents are Expected to Hold the Largest Market Share in the Product Segment
In the product segment of the in vitro diagnostic market, the reagent segment is expected to witness the largest CAGR over the forecast period.
The reagent segment of the market includes chemical, biological, or immunological components, solutions, or preparations intended by the manufacturer to be used during the in vitro diagnosis process. Given the high cost of many diagnostic platforms, it is common for manufacturers to lease equipment instead of selling technology outright to end users. In these arrangements, the lease is tied to contracts to purchase associated reagents or assays for the equipment over the life of the contract.
The COVID-19 pandemic is expected to significantly aid in the growth of the segment, owing to the high requirement of reagents to meet the increasing diagnostics demand globally for the diagnosis of the COVID-19 infection.
Additionally, with the increasing burden of chronic diseases worldwide, the demand for in vitro diagnostics increases, which, in turn, surges the demand for reagents used in the various testing platforms. Also, the growing product launches in the market are expected to drive the market. For instance, in November 2019, Vidan Diagnostics launched ?-Hydroxybutyrate 21FS Reagent for Beckman Coulter AU clinical chemistry systems. Thus, owing to the aforementioned factors, the reagent segment is expected to grow tremendously over the forecast period.
North America Dominates the Market and is Expected to Continue its Dominance in the Forecast Period
North America currently dominates the market for in vitro diagnostics, and it is expected to continue its stronghold for a few more years. This region is expected to increase its market share in the future, owing to the well-established healthcare industry and rising prevalence of chronic diseases in the region. The United States holds the majority of the market in the North American region, due to the rising healthcare expenditure, along with the rapid adoption of point-of-care testing.
According to the American Cancer Society, in 2020, about 1.8 million new cancer cases were diagnosed, and approximately 606,520 cancer deaths occurred in the United States. Moreover, people with chronic conditions are the most frequent users of healthcare facilities in the United States. They account for the majority of hospital admissions and prescription filling, and thus, they drive the growth of the market.
Moreover, in February 2020, the FDA issued its first Emergency Use Authorization to the Centers for Disease Control and Prevention (CDC), authorizing the use of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel for the presumptive qualitative detection of nucleic acid from COVID-19 samples, in response to the COVID-19 pandemic. Hence, following this, many in vitro diagnostics received the FDA’s EUA, which is expected to impact the market growth in the region.
Additionally, the growing number of product launches in the region and the high concentration of key players in North America act as major factors in driving the market. For instance, in May 2020, Bio-Rad Laboratories Inc.’s SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit was granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA). The SARS-CoV-2 Droplet Digital PCR (ddPCR) test runs on Bio-Rad’s QX200 and QXDx ddPCR systems. Thus, given the aforementioned factors, the in vitro diagnostic market is anticipated to grow significantly in North America over the forecast period.
The in vitro diagnostic market is highly competitive and consists of several major players. In terms of market share, a few of the major players currently dominate the market. However, with technological advancements and product innovations, mid-size to smaller companies are increasing their market presence by introducing new products at lower prices. Companies like Thermo Fischer Scientific Inc., Abbott Laboratories, Siemens Healthcare GmbH, and F. Hoffmann-La Roche AG hold a substantial market share in the in vitro diagnostic market. Additionally, the key players are involved in strategic alliances, such as acquisitions, collaborations, and partnerships, with companies that complement their product portfolio. For instance, in May 2020, Becton Dickinson and Company completed the acquisition of NAT Diagnostics to expand its point-of-care testing for infectious disease portfolio.
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In Vitro Diagnostics
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