Point of Care Molecular Diagnostics Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global point of care molecular diagnostics market growth forecasted to transform from USD 2.0 billion in 2023 to USD 3.4 billion by 2028, driven by a CAGR of 10.6%. Market growth is mainly driven by rising incidence of infectious diseases and acute and chronic conditions and increased focus on improving the state of healthcare facilities and infrastructure. However, the market entry of several firms has been resisted by uncertain reimbursement circumstances. The market's expansion is further constrained by a shortage of high-complexity testing facilities that can perform POC molecular diagnostics testing.

Point Of Care Molecular Diagnostics Market Trends

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Point of Care Molecular Diagnostics Market Dynamics

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 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: Unfavorable reimbursement settings

The growth of the 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.

Opportunity: Growth prospects in emerging countries

Players in the market have substantial growth prospects in emerging economies like India, South Korea, Brazil, and Mexico. These opportunities stem from several factors, including relatively low regulatory barriers, advancements in healthcare infrastructure, expanding patient populations, increasing incidence of infectious diseases, and a rise in healthcare expenditure. Additionally, the regulatory policies in some of these countries are more flexible and conducive to business compared to those in developed nations.

Challenge: Establishment of alternative technologies

The emergence of alternative technologies, including those employed in COVID-19 testing, presents a potential obstacle to the growth of the market . Most diagnostic tests can be divided into serological and antigen tests and these tests result is usually available in 15 minutes, and thus they are commonly referred to as rapid tests. Antigen tests are also cheaper to manufacture than molecular tests owing to their simpler design. Thus, the introduction of alternative technologies might be challenging to the growth of the market.

Point of Care Molecular Diagnostics Market Ecosystem

Prominent companies in this market include well-established, financially stable manufacturers of point of care molecular assay and kits. These companies have been operating in the market for several years and possess state-of-the-art technologies, diversified product portfolio, strong global sales, and marketing networks. Prominent companies in this market include Abbott Laboratories (US), F. Hoffmann-La Roche Ltd. (Switzerland), bioMérieux SA (France), Danaher Corporation (US), and QIAGEN N.V. (Netherlands).

In 2022, assays & kits segment accounted for the largest share of the point of care molecular diagnostics industry, by product & service

Based on product, the point of care molecular diagnostics market is segmented into instruments & analyzers, and software & services. In 2022, the assays & kits segment accounted for the largest share of this market. The frequent purchase of these products due to their recurrent usage drives the market growth of this segment.

In 2022, RT-PCR segment accounted for the largest share in the point of care molecular diagnostics industry, by technology

The point of care molecular diagnostics market is segmented into RT-PCR, INAAT and other technologies based on technology. In 2022, the RT-PCR segment accounted for the largest share. RT-PCR is one of the most widely used technologies in diagnostics due to its ease of use, cost-effectiveness, and prompt turnaround time (4 to 6 hours).

In 2022, Physicians’ offices segment accounted for the largest share in the point of care molecular diagnostics industry, by end user

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 accounted for the largest share of the market. Point-of-care molecular assay & kits and systems are extensively used in physicians’ offices as they provide quick results within 30 minutes. This helps in instant diagnosis which allows to diagnose or monitor a patient’s condition immediately.

North America is the largest region of the point of care molecular diagnostics industry

The global point of care molecular diagnostics market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. In 2022, North America accounted for the largest share of the global market. The high burden of infectious diseases and cancers on regional healthcare systems is one of the major drivers for market growth. Furthermore, the presence of a well-developed healthcare infrastructure and the growing adoption of advanced technologies infectious disease testing are other factors anticipated to support the growth of the market in the region.

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The major players in this market are Abbott Laboratories (US), F. Hoffmann-La Roche Ltd. (Switzerland), bioMérieux SA (France), Danaher Corporation (US), and QIAGEN N.V. (Netherlands). These players lead the market because of their extensive product portfolios and wide geographic presence. These dominant market players also have numerous advantages, such as more robust marketing and distribution networks, larger budgets for R&D, and better brand recognition.

Point of Care Molecular Diagnostics Market Report Scope

This report categorizes the point of care molecular diagnostics market to forecast revenue and analyze trends in each of the following submarkets:

By Product & Service

• Assays & kits
• Instruments & Analyzers
• Software & Services

By Technology

• RT-PCR
• INAAT
• Other technologies

By Application

• Respiratory Diseases
• Sexually Transmitted Diseases
• Hospital-acquired Infections
• Cancer
• Hepatitis
• Gastrointestinal Disorders
• Other Applications

By End User

• Physicians’ Offices
• Hospitals & ICUs
• Research Institutes
• Other End Users

By Region

• North America
  • US
  • Canada
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Rest of Europe (RoE)
• Asia Pacific
  • China
  • Japan
  • India
  • Rest of Asia Pacific (RoAPAC)
• Rest of the World (RoW)

Recent Developments of Point of Care Molecular Diagnostics Market

• 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.

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