During the period between 2024 and 2032, the global market for point-of-care molecular diagnostics is predicted to expand at a CAGR of 8.5%. The growth of the point-of-care molecular diagnostics market is primarily driven by the increasing prevalence of infectious diseases and cancer, as well as the growing demand among end users for point-of-care molecular testing due to its appealing characteristics. Medical professionals have utilized molecular diagnostics in laboratories and other healthcare settings for quite some time. However, the high cost of testing, the time-consuming nature, and the delayed results of molecular diagnostics has prompted them to seek alternate diagnostic techniques. This has thrown the point-of-care market for molecular diagnostics into the spotlight. Point-of-care molecular diagnostics has gained substantial traction across end-use verticals, including hospitals and research institutes, as a result of its ability to reduce turnaround time and promptly provide accurate results. Point-of-care molecular testing provides the rapid and early identification of diseases in non-laboratory settings. These tests are typically done at the locations of nearby patients.
The increasing adoption of point-of-care molecular diagnostic solutions for the early detection of a wide range of diseases, from respiratory diseases and cancer to sexually transmitted diseases and gastrointestinal disorders, is a major factor driving the growth of the point-of-care molecular diagnostics market. The rapid rise of the molecular diagnostics and molecular imaging sectors, fuelled by increased health awareness in emerging nations, will create opportunities for point-of-care molecular diagnostics manufacturers in the coming years. Moreover, recent advancements in microfluidics and genetic sequencing, as well as the development of low-cost and rapid point-of-care molecular diagnostic platforms, will enhance sales of POC molecular diagnostics equipment, consequently expanding the market for molecular POC tests.
The increasing prevalence of infectious diseases and cancer in both developed and developing nations will have a positive impact on the expansion of the point-of-care molecular diagnostics industry. The rising frequency of prescriptions for molecular diagnostic tests can be attributed to the diagnosis and treatment of certain conditions. Over the forecast period, demand for point-of-care molecular diagnostics is estimated to be driven by the aforementioned factors and the growing trend toward preventive medicine.
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Emerging economies such as India, South Korea, Brazil, and Mexico present market participants in the point-of-care molecular diagnostics sector with tremendous development potential. This is a result of low regulatory barriers, advances in healthcare infrastructure, a growing patient population, an increase in the prevalence of infectious diseases, and rising healthcare costs. Moreover, the regulatory systems of a number of these countries are more adaptive and business-friendly than those of developed nations.
Inadequate reimbursements are a major barrier impeding the expansion of the point-of-care molecular diagnostics sector. Medicare and private health insurers' unwillingness to pay for diagnostic testing is a key barrier to the commercialization of the majority of diagnostic tests. In 2018, Medicare in the United States revised its payment mechanism for a number of IVD tests, including molecular diagnostics at the point-of-care. Multiple of these tests are invoiced using Healthcare Common Procedure Coding System (HCPCS) codes that are not listed. In such situations, Medicare Administrative Contractors (MACs) determine the payment amount for their respective local governments. CMS reduced the Medicare payment rate for COVID-19 tests utilizing high throughput technology to USD 75 unless laboratories can process the results in less than two days. Medicare does not currently cover genetic testing for those without a family history of cancer (Source: American Society of Clinical Oncology).
POC testing has several applications in molecular diagnostics, including testing close to the patient in infectious disease management, cancer, hematology, prenatal screening, and endocrinology. In infectious diseases and oncology, point-of-care (PoC) molecular testing has undergone the most significant application-based developments. In 2023, the infectious illnesses segment generated the most revenue. Contributing to the revenue share of infectious diseases for rapid molecular diagnostic tests are the provision and facilitation of appropriate antibiotic therapy, faster disease management, improved distribution of healthcare laboratory assets, and decreases in mortality and healthcare costs.
The market for point-of-care molecular diagnostics has been segmented on the basis of technology into PCR-based, genetic sequencing-based, hybridization-based, and microarray-based tests and devices. PCR-based testing generated the largest revenue share in 2023. The commercialization of point-of-care diagnostics that provide accurate, rapid real-time PCR analysis for infectious diseases such as H1N1 and influenza will drive the market. Due to a number of industry advancements, NGS-based molecular testing near the patient is anticipated to have a significant increase throughout the forecast period. Innovative platform improvements that enable high-precision genetic sequencing and DNA data processing at the point of care and rapid diagnosis contribute to the anticipated growth of this market segment. Rapid DNA analysis is predicted to have tremendous growth in the next years as a result of industry players' ongoing innovation and R&D activities.
Based on the location of the tests, the market is segmented into Proof-of-Concept (PoC) and Over-the-Counter (OTC) tests. For use in homes and assisted living institutions, OTC tests are superior to POC tests in terms of versatility and portability. The majority of users of over-the-counter medicines are unskilled professionals and, in the vast majority of cases, the patients themselves. A few of these testing tools are also free from CLIA regulations, which encourages their use outside of laboratories. Due to their usability, accessibility, and greater acceptance rate, over-the-counter (OTC) tests are likely to generate more revenue over the forecast period.
The market is categorized by end-use into, among others, decentralized laboratories, hospitals, home care facilities, and assisted living facilities. Decentralized laboratories generated the largest revenue share in 2023. The ability of these tests to give rapid and accurate molecular analysis with a far smaller physical footprint than their central laboratory-based equivalents is a significant factor in the segment's larger revenue share.
Continuous efforts by market leaders to strengthen their market position are a major contribution to the majority share. In addition, a number of clinical studies evaluating the efficacy and accuracy of novel molecular tests are expected to contribute to the growth of the market over the forecast period. Europe has become an important market niche due to the increasing demand for rapid diagnosis and the advent of novel molecular diagnostic technologies for DNA analysis. Due to a lack of modern central laboratory testing services, a larger population base requiring clinical testing, and the potential cost-effective implementation of Point-of-Care molecular assays, Asia Pacific is anticipated to enjoy the fastest growth rate throughout the projected period.
Abbott Laboratories (United States), F. Hoffmann-La Roche Ltd. (Switzerland), bioMérieux S.A. (France), Danaher Corporation (United States), Quidel Corporation (United States), QIAGEN N.V. (Netherlands), Co-Diagnostics, Inc. (U.S.). Innovative point-of-care molecular diagnostic platforms, such as the point-of-care molecular COVID test and paper-based nucleic acid amplification assays, can be used to diagnose diseases with relative ease. In addition, they have employed strategies such as mergers, acquisitions, and partnerships, among others, to expand its global reach.
