The global point-of-care molecular diagnostics market size is projected to reach USD 3.4 billion by 2028 from USD 2.0 billion in 2023, at a CAGR of 10.6% during the forecast period. The molecular diagnostics market is experiencing significant growth, primarily driven by several factors. These include the increasing incidence of infectious and chronic diseases, a growing emphasis on decentralized diagnostics, substantial research and development funding, and heightened awareness regarding early detection of infectious diseases. Additionally, the expanding applications of point-of-care diagnostic tests are contributing to market growth. However, there are certain challenges that may hinder the market’s progress. These challenges include the absence of a promising reimbursement scenario, technological advancements being slower in developing economies, and stringent regulatory hurdles related to point-of-care diagnostic test kits.
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The point-of-care molecular diagnostics market is categorized into different segments based on product & service, technology, application, end user, and region. Under the product & service segment, it is further divided into assays & kits, instruments & analyzers, and software & services. In 2022, the assays & kits segment held the largest market share. This significant share can be attributed to the widespread utilization of assays & kits in point-of-care molecular diagnostics, which is considerably higher in comparison to instruments or analyzers.
The point-of-care molecular diagnostics market is divided into various technology segments, including RT-PCR, INAAT, and other technologies. In 2022, the RT-PCR segment emerged as the dominant segment, capturing the largest share in the global market. The substantial market share can be attributed to the increasing utilization of RT-PCR applications in the fields of proteomics and genomics. Furthermore, the availability of portable and user-friendly devices has also contributed to the widespread adoption of RT-PCR technology in point-of-care molecular diagnostics.
Based on end-users, the point-of-care molecular diagnostics market is segmented into physicians’ offices, hospitals & ICUs, research institutes, and other end users. In 2022, The physicians’ offices segment held the largest market share in the point-of-care molecular diagnostics market. This segment’s significant revenue contribution can be attributed to its extensive utilization within physicians’ offices, where it enables rapid delivery of test results within 30 minutes. This quick turnaround time empowers physicians to make prompt treatment decisions without experiencing any delays.
The global market for point-of-care molecular diagnostics is divided into North America, Europe, Asia Pacific, and the Rest of the World. In 2022, North America emerged as the dominant region, capturing the largest market share in the point-of-care molecular diagnostics market. This can be attributed to several factors, including the presence of high healthcare expenditure levels in countries such as the US and Canada. Additionally, the region benefits from significant government support and funding initiatives, further contributing to its leading position among all the regions.
The major players operating in this market are Abbott Laboratories (US), F. Hoffmann-La Roche Ltd. (Switzerland), bioMérieux SA (France), Danaher Corporation (US), Quidel Corporation (US), QIAGEN N.V. (Netherlands), Co-Diagnostics, Inc. (US), Biocartis NV (Belgium), Meridian Bioscience, Inc. (US), Thermo Fisher Scientific, Inc. (US), Lucira Health, Inc. (US), Cue Health (US), OpGen, Inc. (US), Binx Health, Inc. (US), Molbio Diagnostics Pct. Ltd. (India), Genomadix (Canada), Visby Medical, Inc. (US), QuikPath PTE Ltd. (Singapore), MD-Bio (US), QuantuMDx Group Ltd. (UK), Aidian Oy (Finland), GeneSTAT Molecular Diagnostics, LLC (US), Labsystems Diagnostics Oy (Finland), Akonni Biosystems (US) and Curetis N.V. (Germany).
Recent Developments of Point of Care Molecular Diagnostics Industry:
In April 2023, QIAGEN N.V. (Netherlands) launched QIAstat-Dx in Japan with a respiratory panel for syndromic testing.
In June 2022, Biocartis NV (Belgium) launched the Rapid CE-marked IVD Idylla GeneFusion Panel for fast treatment decisions in lung cancer.
In May 2022, bioMérieux SA (France) received De Novo FDA Authorization for its BIOFIRE Joint Infection (JI) Panel.
In September 2021, F. Hoffmann-La Roche Ltd. (Switzerland) acquired TIB Molbiol (Germany) to expand its PCR test portfolio with a wide range of assays for infectious diseases.