In April 2023, QIAGEN N.V. (Netherlands) launched QIAstat-Dx in Japan with a respiratory panel for syndromic testing.

Northbrook, IL 60062 -- (SBWire) -- 07/05/2023 --Point of Care Molecular Diagnostics Market in terms of revenue was estimated to be worth $2.0 billion in 2023 and is poised to reach $3.4 billion by 2028, growing at a CAGR of 10.6% from 2023 to 2028 according to a new report by MarketsandMarkets™. The growth of this market is majorly driven by increasing prevalence of infectious diseases and cancer, rising focus on decentralized diagnostics, increasing R&D funding, increasing awareness on the early detection of infectious diseases, and the increasing use of POC diagnostic tests.

The point of care molecular diagnostics industry is poised for significant growth and advancements in the near future. With the increasing demand for rapid and accurate diagnostic solutions, point of care molecular diagnostics offers several advantages. These include faster turnaround times, portability, and the ability to deliver results at the patient's bedside or in resource-limited settings. The industry is expected to witness the development of more compact and user-friendly devices that can detect a wide range of diseases, including infectious diseases, genetic disorders, and cancer, with high sensitivity and specificity. These advancements will enable healthcare providers to make timely and informed treatment decisions, leading to improved patient outcomes. Additionally, the integration of artificial intelligence and machine learning algorithms into point of care molecular diagnostics platforms may enhance diagnostic accuracy and interpretation of results. The industry's growth will also be fueled by the increasing prevalence of infectious diseases, the need for decentralized testing, and the rising focus on personalized medicine. Overall, the point of care molecular diagnostics industry holds immense potential to revolutionize healthcare delivery by providing rapid and precise diagnostic solutions at the point of care.

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Key Market Players:

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).

Driver: Growing incidence of infectious diseases and cancer

The rising occurrence of infectious diseases and cancer in both developed and developing regions is set to have a favourable impact on the expansion of the point-of-care molecular diagnostics market. The diagnosis and treatment of these diseases necessitate an increasing number of molecular diagnostic tests, leading to a surge in the demand for such tests. Moreover, the growing inclination towards preventive medicine further contributes to the anticipated rise in demand for point-of-care molecular diagnostics throughout the forecast period.

Restraint: Unfavourable reimbursement settings

The growth of the point-of-care molecular diagnostics market is hindered by inadequate reimbursements. One of the significant challenges faced by diagnostic companies is obtaining payment from Medicare and private health insurers for their tests. In the United States, Medicare revised its reimbursement mechanism for certain in vitro diagnostic (IVD) tests, including point-of-care molecular tests, in 2018. Some of these tests lack specific Healthcare Common Procedure Coding System (HCPCS) codes and are billed using unlisted codes instead. In such cases, payment amounts are established by Medicare Administrative Contractors (MACs) for their respective jurisdictions. Additionally, Medicare currently does not provide coverage for genetic testing in individuals without a personal history of cancer, as indicated by the American Society of Clinical Oncology. These factors are anticipated to have an adverse impact on the point-of-care molecular testing market.
The Assays & Kits segment is expected to account for the largest share of the Point of Care Molecular Diagnostics Market in 2022.

The products & services in the point-of-care molecular diagnostics market are categorized into assays & kits, instruments & analyzers, and software & services. Assays & kits specifically cater to various point-of-care settings such as hospital critical care units, physicians' offices, outpatient clinics, home care settings, and long-term care settings, among others. The continuous demand and recurring purchases of assays & kits are anticipated to fuel the growth of the point-of-care molecular diagnostics market.

The Respiratory Diseases segment accounted for the largest share of the point-of-care molecular diagnostics market in 2022.

The molecular diagnostics market is categorized into various applications, including respiratory diseases, sexually transmitted diseases, hospital-acquired infections, cancer, hepatitis, gastrointestinal disorders, and other applications. The growth of this market segment is primarily driven by the escalating prevalence of infectious diseases and the growing demand for early diagnosis and detection of these diseases. These factors are particularly significant in emerging countries, where there is a heightened need to address the challenges posed by infectious diseases through timely and accurate molecular diagnostics.
North America dominates the global point of care molecular diagnostics market.

The point-of-care molecular diagnostics market is divided into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. In 2022, North America emerged as the leading region, capturing the largest market share in the point-of-care molecular diagnostics market. The significant share of this region can be attributed to the highly advanced healthcare systems present in the United States and Canada. In recent years, there has been a notable increase in healthcare spending across North America. According to the Centers for Medicare & Medicaid Services, national health spending is projected to grow at an average annual rate of 5.4% from 2019 to 2028, reaching a staggering USD 6.2 trillion by 2028. This growing healthcare expenditure serves as a key driver for the biotechnology sector, including the point-of-care molecular diagnostics market.

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Point of Care Molecular Diagnostics Market Dynamics:

Drivers:

1. Increasing prevalence of infectious diseases and cancer
2. Rising focus on decentralized diagnostics and increasing R&D funding
3. Growing awareness of the early detection of infectious diseases
4. Increasing use of POC diagnostic tests

Restraints:

1. Unfavorable reimbursement scenario
2. High capital investments and low cost-benefit ratio

Opportunities:

1. Growing R&D activities in point-of-care molecular diagnostics testing
2. Growth opportunities in emerging economies

Challenges:

1. Stringent and time-consuming regulatory policies that significantly increase product launch cycle
2. Introduction of alternative technologies

Report Link: Point of Care Molecular Diagnostics Market

Recent Developments:

- 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.