Point-Of-Care Molecular Diagnostics Market

Market Overview

The global point-of-care molecular diagnostics market size was valued at USD 2275.24 million in 2022. It is projected to reach USD 4487.93 million by 2031, growing at a CAGR of 7.84% during the forecast period (2023–2031).

Physicians can raise the quality of care they provide with the help of POC molecular diagnostic testing by quickly diagnosing and treating patients. The field of molecular diagnostics has been widely utilized by doctors in hospitals, clinics, and other medical facilities for quite some time. However, the limitations of molecular diagnostics have prompted them to seek out alternative methods of diagnosis due to issues like the tests' high costs, their time-consuming nature, and the delays in their results. Several factors, including increased consumer awareness of molecular mechanisms, rare disorders, and technological advances in DNA sequencing, are propelling the market for point-of-care molecular diagnostics. The detection of specific sequences of DNA or RNA in microorganisms is the basis of this molecular diagnostic. The healthcare industry relies on it for disease detection and urgent use authorization.

Market Dynamics

Global Point-Of-Care Molecular Diagnostics Market Drivers

Growing Incidence of Chronic and Infectious Diseases

There has been a worldwide rise in the prevalence of chronic diseases like cardiovascular disorders, diabetes, and various infectious diseases. One of the main factors driving demand for point-of-care diagnostics during the projected timeframe is the high prevalence rate of such conditions. Lower respiratory tract infections caused by the respiratory syncytial virus (RSV) affect between 4 and 5 million children annually, according to the Centers for Disease Control and Prevention (CDC). The rising incidence of diabetes and other chronic diseases worldwide is expected to boost the point-of-care diagnostics market as more people seek effective means of diagnosing and treating these conditions.

Proliferation of Decentralized Healthcare Systems

Point-of-Care testing has emerged as a vital component of patient-centered healthcare due to the urgent need for timely diagnosis results that underpin effective and convenient treatment planning. Decentralizing testing for chronic and infectious diseases has given patients more accessible access to diagnostics, which had previously only been available at a single point of care. A proliferation of companies catering to the rapid turnaround testing market has developed infectious disease tests for remote laboratories. Therefore, the need for a decentralized healthcare setting has been growing in response to the rising demand for quick and accurate diagnostics performed at home or in the doctor's office for patient convenience.

Global Point-Of-Care Molecular Diagnostics Market Restraints

Lack of Accuracy of POC Diagnostics

The high price tag of virus-clearing technologies has limited the worldwide lack of accuracy of rapid point-of-care diagnostic tests, lowering the number of FDA approvals for rapid tests and thereby slowing the expansion of the market. Pre-analytical errors plague the field of point-of-care testing. For instance, Siemens Healthcare issued a Class 2 Device Recall for the BGEM Test Card In-vitro diagnostic device in August 2020. This device is used to quantitatively test whole blood that has not been pre-treated with anticoagulants in the laboratory or at the point of care. It may lead to incorrect treatment of hypoglycaemia or a delay in diagnosing hyperglycaemia. As a result, during the predicted period, the global market is expected to grow slower than usual due to the lack of accuracy in POC testing.

Global Point-Of-Care Molecular Diagnostics Market Opportunities 

Technological Advancement

Major market players have shifted their attention to adopting cutting-edge technologies like artificial intelligence to create effective point-of-care diagnostics. Lab-on-a-chip platforms, wearable technology, and smartphone-based technology innovations have contributed significantly to the development of POCT devices in recent years. The groundwork for future revolutions has been laid by cloud-based deep learning systems. Innovations have facilitated the development of new techniques for these types of diagnostics in the miniaturization of chip technology, microfluidics, and biosensors. One of the main things pushing point-of-care testing forward, especially for infectious disease diagnosis, is lab-on-a-chip technology. In addition, many firms are concentrating on creating POC platforms that rely on nanoparticles. Healthcare providers can now take advantage of nanoparticles' unique characteristics in diagnosing and detecting a wide range of conditions thanks to advancements in nanotechnology. As a result, advances in manufacturing technology for point-of-care testing kits are anticipated to fuel the expansion of the global market over the forecast horizon.

Regional Analysis

The global point-of-care molecular diagnostics market is bifurcated into four regions, namely North America, Europe, Asia-Pacific, and LAMEA.

North America Dominates the Global Market

North America is the most significant shareholder in the global point-of-care molecular diagnostics market and is expected to grow during the forecast period. The regional market is also being pushed by governments' efforts to speed up the approval process for point-of-care molecular diagnostics. The highly advanced healthcare system in the United States and Canada is a significant factor fueling the expansion of North America's point-of-care molecular diagnostics market. Point-of-care diagnostics tests are in high demand in the United States and Mexico due to the high incidence of infectious diseases in both countries. However, the healthcare system in the United States is highly developed and organized. The system also supports R&D. These regulations pave the way for foreign companies to enter the North American market and the United States. The massive number of new product introductions has also aided the market expansion.

Asia-Pacific is expected to grow during the forecast period. Asia-Pacific is expected to grow significantly between 2023 and 2031 as a result of increased government initiatives to raise awareness, an increase in medical tourism, growing research activities in the region, the availability of massive untapped markets, a large population pool, the availability of well-established infrastructure, the improving rate of adoption of point of care molecular diagnostics in India and China, and the growing demand for quality healthcare. The rising prevalence of chronic diseases among the aging population, the expansion of key market players in the region, the lack of sophisticated central laboratory testing services, and the potential cost-effectiveness of POC molecular diagnosis are all factors fueling the growth of the Asia Pacific POC molecular diagnostics market.

The market expansion is anticipated to be aided by several clinical studies examining the efficacy and accuracy of novel molecular tests. The European region is primed to become a significant market space due to the rising demand for rapid diagnosis and the development of newer molecular diagnostic tests for DNA analysis. The government has also bolstered the diagnostics industry through R&D investments in cutting-edge point-of-care diagnostic tests. These factors contribute to the expansion of the regional market.

Segmental Analysis

The global point-of-care molecular diagnostics market is segmented by product type, technology, and end-user.

Based on product type, the global point-of-care molecular diagnostics market is bifurcated into analyzers, test kits, bacterial, fungal, and viral.

The test kit segment is the highest contributor to the market and is expected to grow during the forecast period. The high diagnostic accuracy and widespread application of test kits fuel the sector's expansion. Additionally, key market players have invested in technology to increase their product portfolio of disease-specific assays for early diagnosis in response to the rising incidence of chronic diseases. Such as, the first COVID-19 test kit, a nasal swab that delivers reliable results in 45 minutes, was approved by the FDA on March 21, 2020. Testing for bacteria, fungi, and viruses is each given its subheading within this section.

Based on technology, the global point-of-care molecular diagnostics market is bifurcated into PCR, genetic sequencing, hybridization, and micro-array.

The PCR segment is the highest contributor to the market and is expected to grow during the forecast period. The polymerase chain reaction (PCR) method has numerous applications in molecular biology, genetics, biotechnology, and drug discovery. It refers to a medical device that generates millions of copies of DNA. The expanding acceptance of personalized medicine and the increasing prevalence of infectious diseases are propelling this market. It is due to the growing demand for RT-PCR in fields such as proteomics, genomics, and COVID-19 testing, as well as the availability of portable, easy-to-use devices.

Based on end-user, the global point-of-care molecular diagnostics market is bifurcated into decentralized laboratories, hospitals, homecare, and assisted living healthcare facilities.

The decentralized laboratories segment is the highest contributor to the market and is expected to grow during the forecast period. The rapidity and precision with which these labs perform molecular analysis contribute to the expansion of this market. The prevalence of infectious diseases and growing interest in patient-centered care has contributed to the widespread adoption of regional testing facilities. Due to decentralized laboratories, core laboratories are undergoing a paradigm shift, with more complex tests moving to these facilities. In contrast, simpler ones are sent to outpatient and other clinics and even homes. Care for the expanding elderly population is improved by these innovations. Technological developments have also allowed even moderately trained staff to conduct tests.

Recent Developments

• November 2022- Roche's high-throughput test for the detection of the monkeypox virus has been granted EUA status by the U.S. Food and Drug Administration.

• October 2022- ABBOTT and the Home Edit have redesigned the medicine cabinet to prepare the public for the forthcoming flu season.