Point-of-Care Molecular Diagnostics Market Size to Exceed USD 12.61 Billion by 2034
The global point-of-care molecular diagnostics market size is evaluated at USD 8.95 billion in 2025 and is expected to hit approximately USD 12.61 billion by 2034, growing at a CAGR of 3.87% between 2025 and 2034.
According to Precedence Research, the worldwide point-of-care molecular diagnostics market revenue was valued at $8.65 billion in 2024. The rising incidence of infectious diseases, increasing demand for rapid diagnostic results, growing miniaturization of diagnostic devices, and rapid technological innovation are expected to propel the growth of the point-of-care molecular diagnostics market.
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Point-of-Care Molecular Diagnostics Market Key Takeaways
• North America has held the highest revenue share of 46% in 2024.
• Asia-Pacific region is expected to expand at the fastest CAGR during the forecast period.
• By application, the infectious disease segment has held a major market share of 31% in 2024.
• By application, the oncology segment is anticipated to grow at a CAGR of 4.8% during the projected period.
• By technology, the PCR-based segment has held the maximum market share of 59% in 2024.
• By technology, the genetic sequencing-based segment is estimated to grow at the fastest CAGR over the projected period.
• By location, the OTC segment had the largest market share of 57% in 2024.
• By location, the point of care test location segment is anticipated to expand at the fastest CAGR over the projected period.
• By end-use, the decentralized labs segment generated more than 45% of revenue share in 2024.
• By end-use, the home care segment is anticipated to grow at the fastest CAGR of 6.1% over the predicted period.
Market Overview and Industry Potential
The point-of-care molecular diagnostic market has been rapidly expanding over the years. Molecular diagnostics point of care (POC) allows for the quick detection and characterization of genetic material from pathogens, cancer cells, and other biological markers directly at the site of patient care rather than in centralized laboratories. These tests generate rapid results, allowing immediate clinical decision-making and assisting in improving overall patient management. In recent years, several technologies have been developed for DNA detection and amplification, majorly to detect pathogens. This market is experiencing an increasing demand for immediate and on-site diagnosis, especially in remote or resource-limited settings.
The rising development of miniaturization of diagnostic devices significantly fuels the market demand in the point-of-care molecular diagnostics industry. In addition, the rising number of new product introductions in point-of-care (POC) molecular diagnostics is projected to offer lucrative growth opportunities for the market’s expansion during the forecast period.
Increasing demand for rapid and on-site diagnostics
The surging demand for rapid and on-site diagnostics is expected to fuel the expansion of the point-of-care molecular diagnostics market during the forecast period. PoC testing is conducted at or near the site of patient care rather than in centralized laboratories. These tests are capable of generating rapid results, allowing for immediate clinical decision-making, particularly in emergencies and remote locations, and improving treatment outcomes.
These tests are generally performed using portable devices or simple test kits, which makes them ideal in various settings, including emergency rooms, clinics, and even in patients’ homes. Such factors are contributing to the overall growth of the point-of-care molecular diagnostics market in the coming years.
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Major Trends in the Point-of-care Molecular Diagnostics Market
Rising burden of chronic diseases
The increasing incidence of chronic diseases is anticipated to boost the growth of the point-of-care molecular diagnostics market during the forecast period. Point-of-care Molecular Diagnostics offers significant contributions to revolutionizing infectious disease management. Molecular diagnostics can identify certain strains and resistance genes, which guide appropriate antimicrobial therapy and reduce antibiotic misuse, crucial for combating antibiotic resistance. Traditional diagnostic methods, such as culture-based techniques, often take more time to yield results, which results in delayed treatment and poorer patient outcomes.
Molecular diagnostic tools, including PCR and isothermal amplification techniques, assist in detecting pathogens with high sensitivity and specificity within minutes. For instance, the use of rapid molecular tests allowed for the immediate isolation and treatment of infected individuals during the COVID-19 pandemic. This quick response aids in effectively controlling the spread of infectious diseases. In addition, the molecular diagnostics point-of-care molecular diagnostics is rapidly advancing the field of personalized medicine.
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Point-of-Care Molecular Diagnostics Market Report Coverage
|
Report Attribute |
Key Statistics |
|
Market Size by 2034 |
USD 10.14 Billion |
|
Market Size in 2025 |
USD 6.22 Billion |
|
Growth Rate from 2025 to 2034 |
CAGR of 5.58% |
|
Largest Market |
North America |
|
Base Year |
2024 |
|
Forecast Period |
2025 to 2034 |
|
Segments Covered |
Phase, Study Design, Indication, Study Design, Phase, and Regions |
|
Regions Covered |
North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa |
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Analysis U.S. Point-of-Care Molecular Diagnostics Market Size to
Surpass USD 3.38 Bn by 2034 The U.S. point-of-care molecular diagnostics market size reached
USD 2.36 billion in 2024 and is expected to expand around USD 3.38 billion by
2034, at a CAGR of 3.68% from 2025 to 2034. North America dominated the point-of-care Molecular diagnostics market in
2024. North
America held the dominating share in point-of-care molecular diagnostics market
in 2024. The growth of the region is attributed to the presence of prominent
market players, surging demand for faster and on-site diagnostics, rising focus
on improving patient outcomes, growing demand development of smaller and more
portable POC diagnostic devices, and advancement in the field of genetic
testing and personalized medicine. Asia
Pacific is expected to be the fastest-growing region owing to the rising
prevalence of chronic and infectious diseases, the rising aging
population, increasing demand rising demand for point-of-care diagnostics
particularly in remote and underserved areas, rising awareness about early disease
detection, and rapid technological innovation. Moreover, rising collaboration
and partnerships among healthcare providers and technology integration are
projected to accelerate the adoption of point-of-care molecular diagnostics in
the Asia Point-of-care Molecular Diagnostics Market Segmentation Analysis Location Analysis The
over-the-counter
(OTC) segment
held the largest share of the point-of-care molecular diagnostics market in
2024. The OTC
segment refers to the molecular diagnostic tests that patients can purchase and
use without the prescription or assistance of medical professionals. Several market
players are increasingly focused on developing and launching novel kits for the
diagnosis of a wide range of infectious diseases. In January 2024, 3EO Health,
a “Point of Life” diagnostics company focused on the development of
high-performing low-cost molecular diagnostics for both the point of care and
community settings, announced product availability of its COVID-19 test for
U.S. physicians and consumers. On
the other hand, the point-of-care test location segment is expected to grow significantly during the
forecast period. The point-of-care test location refers to the settings where molecular
diagnostic tests are conducted at or near the patient's location, generating
rapid and accurate results. PoC tests can be performed in various settings,
including emergency rooms, clinics, patients’ homes, and even non-traditional
locations like airports. The COVID-19 pandemic has increased the significance
of accessible and immediate molecular diagnostics in various test locations.
Several tests are performed outside of hospitals as they are portable, quick,
and affordable. Technology Analysis The
polymerase chain reaction (PCR) segment accounted for the highest revenue share
in 2024 and is anticipated to grow at a robust CAGR over the forecast period. PCR amplifies and analyzes
RNA or DNA sequences. PCR-based diagnostics include the development of
innovative rapid and portable PCR devices, lower test turnaround times and
improved sensitivity. The rising applications of POC molecular diagnostics in
cancer research, drug discovery and development, pharmacogenomics, and acquired
immunodeficiency syndrome are anticipated to drive the demand for polymerase chain reaction (PCR) technologies. These
factors are boosting the segment’s expansion during the forecast period. On the
other hand, the genetic sequencing-based segment is expected to grow at the fastest rate during the
forecast period of 2024 to 2034. On
the other hand, the genetic sequencing-based segment is projected to grow at
the fastest rate. In point-of-care molecular diagnostics, genetic sequencing
involves the analysis of DNA to identify specific genetic sequences, pathogens,
or mutations at the point of care. The adoption of genetic sequencing-based
technology facilitates real-time analysis of genetic material, assists in early
detection of disease, and enables personalized treatment decisions at the point
of care. Application Analysis: The
infectious disease segment held the largest share of the point-of-care
molecular diagnostics market in 2024. The rising prevalence of infectious
diseases has increased the demand for rapid and accurate diagnosis,
particularly during pandemics like COVID-19. In the point-of-care molecular
diagnostics market, infectious disease testing involves the quick and on-site
detection of pathogens, such as bacteria and viruses, directly from patient
samples. It provides results within minutes, allowing for quick response and
intervention. The availability of point-of-care molecular diagnostics emerges
as a transformative force for patient care, improving the impact on infectious
disease management. The oncology segment is expected to
grow significantly during the forecast period. The growth of the segment is
attributed to the increasing prevalence of cancer around the world. The most
prevalent types of cancer are breast, lung, colon & rectum, and prostate
cancers. Oncology involves the use of molecular diagnostic tests for the rapid
and accurate detection of cancer-related biomarkers, genetic mutations, and
oncogenic pathogens at the point of care. Molecular diagnostics at POC plays an
indispensable role in cancer detection and management. The adoption of advanced
techniques such as liquid biopsy allows for the non-invasive detection of
circulating tumour DNA (ctDNA) and other biomarkers from a simple blood sample.
According
to the data released by the World Health Organization (WHO)’s cancer agency,
the International Agency for Research on Cancer (IARC) in February 2024: there
were around 20 million new cases of cancer and approximately 9.7 million deaths
in 2022. It is reported that about one in five people will develop cancer
during 970,000 their lifetime. Lung cancer was the most commonly occurring
cancer worldwide with 2.5 million new cases accounting for 12.4% of the total
new cases. Female breast cancer ranked second (2.3 million cases, 11.6%),
followed by colorectal cancer (1.9 million cases, 9.6%), prostate cancer (1.5
million cases, 7.3%), and stomach cancer (970 000 cases, 4.9%). End-use Analysis The
decentralized labs segment accounted for the dominating share in 2024 owing to
the rising prevalence of breast cancer. Decentralized lab testing facilities are located closer to the site of
patient care, rather than in centralized laboratories. PoC testing has
significantly revolutionized the diagnostic landscape by enabling rapid,
accurate, timely, and on-site detection of the virus. Additionally, the
surge in the
adoption of miniaturized point-of-care devices along with the integration of
mHealth solutions are anticipated to drive the segment’s growth in the coming
years. The
home care segment is expected to witness a significant share during the
forecast period owing to the rising prevalence of chronic and infectious
diseases. In point-of-care molecular diagnostics, the home care segment
allows patients to effectively monitor chronic conditions, obtain rapid test
results, and access telehealth services in a home-based setting. The rapid
advancement in portable and user-friendly devices is making home-based
molecular diagnostics convenient and accessible for patients with chronic and infectious
diseases. Browse More Insights: 🔸Point-of-Care Infectious
Disease Diagnostics Market: https://www.precedenceresearch.com/point-of-care-infectious-disease-diagnostics-market 🔸Point of Care Testing (POCT)
Market: https://www.precedenceresearch.com/point-of-care-testing-market 🔸Infectious Disease
Molecular Diagnostics Market: https://www.precedenceresearch.com/infectious-disease-molecular-diagnostics-market 🔸Diagnostic Testing Market: https://www.precedenceresearch.com/diagnostic-testing-market 🔸Point-of-care Biosensors
Market: https://www.precedenceresearch.com/point-of-care-biosensors-market 🔸U.S. In Vitro Diagnostics
Market: https://www.precedenceresearch.com/us-in-vitro-diagnostics-market 🔸Infectious Disease
In-Vitro Diagnostics Market: https://www.precedenceresearch.com/infectious-disease-in-vitro-diagnostics-market 🔸Point-of-Care Glucose
Testing Market: https://www.precedenceresearch.com/point-of-care-glucose-testing-market 🔸Infectious Respiratory
Disease Diagnostics Market: https://www.precedenceresearch.com/infectious-respiratory-disease-diagnostics-market Point-of-care Molecular Diagnostics Marke Companies •
Abbott Laboratories, Inc. •
Roche Diagnostics •
bioMérieux SA •
Danaher Corporation (Beckman Coulter) •
Cepheid (a subsidiary of Danaher Corporation) •
QIAGEN N.V. •
Thermo Fisher Scientific, Inc. •
Hologic, Inc. •
Bio-Rad Laboratories, Inc. •
Becton, Dickinson and Company (BD) •
GenMark Diagnostics, Inc. •
Meridian Bioscience, Inc. •
Mesa Biotech, Inc. (a subsidiary of Thermo Fisher Scientific) •
Biocartis Group NV •
QuantuMDx Group Limited What is Going Around the Globe? • In
September 2024, Roche Diagnostics launched its first test using its new
high-throughput technology that enables users of Roche's Cobas analyzers to
simultaneously test for 12 respiratory viruses, including influenza A and B,
RSV, and the COVID-19 virus in a single patient sample. • In
January 2023, Molbio Diagnostics launched Truenat MTB-INH kit for testing the
presence of isoniazid resistance in Mycobacterium tuberculosis infection. The
test is validated by the Indian Council of Medical Research (ICMR) and approved
by the Central Drugs Standard Control Organization (CDSCO) and can provide
sample-to-test results in an hour. • In
March 2024, CureMatch and Spesana, two leading health-tech companies, announced
a new strategic partnership for the advancement of precision medicine and
transform the solutions available to clinicians & patients. The planned
integration & alignment of CureMatch’s innovative KRR (knowledge,
representation & reasoning) AI precision medicine platform with Spesana's
clinical workflow ecosystem aims to revolutionize patient care and outcomes in the
healthcare industry. • In
July 2024, Roche completed the acquisition of LumiraDx’s Point of Care
technology for up to USD 350m. The acquisition marks a significant expansion of
Roche’s diagnostics portfolio. The integration of LumiraDx's technology into
Roche's operations will introduce a multi-assay point-of-care platform. Segments Covered in the Report: By Technology •
PCR-based •
Genetic Sequencing-based •
Hybridization-based •
Microarray-based By Application •
Infectious Diseases •
Oncology •
Hematology •
Prenatal Testing •
Endocrinology •
Other By Location •
OTC •
POC By End Use •
Decentralized Labs •
Hospitals •
Homecare •
Assisted Living Healthcare Facilities •
Others By Geography •
North America •
Europe •
Asia Pacific •
Middle East & Africa •
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Moreover, technological advancements in the miniaturization of diagnostic
devices and the integration of mobile health (mHealth) solutions are
anticipated to enhance the efficiency and accessibility of POC molecular
diagnostics. In addition, the rising prevalence of chronic and infectious
diseases and genetic disorders, including Alzheimer’s disease, Parkinson’s
disease, and Turner syndrome, are anticipated to propel the market demand
during the forecast period. These factors, along with a well-established market
ecosystem, position North America as a major player in the point-of-care
molecular diagnostics market.