Point of Care Molecular Diagnostics Market

Industry Overview

Molecular diagnosis is detection of specific sequence of DNA or RNA that may be associated with the disease. Point of care molecular diagnostics help healthcare professionals in the detection of diseases through molecular technologies in point-of-care settings. The global point of care molecular diagnostics market is growing at a significant rate due to the intensifying occurrence of infectious diseases, and increasing focus on decentralized diagnostics. Different types of products and services contributed to the point of care molecular diagnostics market size. The market has witnessed a high demand for assays & kits over the last few years, due to the intensifying occurrence of infectious diseases.

Market Segmentation

Insight by Application

On the basis of application, the point of care molecular diagnostics market is subdivided into the hospital-acquired infection, hepatitis, oncology, respiratory diseases, sexually transmitted diseases, and others. Of all, respiratory diseases segment accounted for the major share in the global market, due to the increasing prevalence of tuberculosis and influenza, the growing inclination towards POC molecular diagnostics and technological developments in investigative tests.

Insight by Technology

On the basis of technology, the point of care molecular diagnostics market is subdivided into INAAT, R-PCR, and others. R-PCR segment is estimated to account the largest share in the market, due to easy to use devices and mounting usage of R-PCR in proteomics and genomics.

Insight by Product & Services

The global point of care molecular diagnostics market has also been segmented by product & services into instruments, assays & kits, and software and services. The assays & kits segment is estimated to account the largest share and is expected to grow at the fastest rate in the market due to the intensifying occurrence of infectious diseases.

Insight by End-User

The different end-users of point of care molecular diagnostics market are research institutes, hospital, decentralized laboratories, home care, and others. The decentralized laboratories are estimated to account the largest share in the market due to its ability to provide rapid and accurate molecular analysis.

Industry Dynamics

Growth Drivers

The increasing demand for CLIA-waived molecular POC tests, increasing public awareness levels pertaining to pre-disease detection and increasing focus on decentralized diagnostics are the primary growth drivers for point of care molecular diagnostics market. It has become feasible to detect numerous viral and bacterial organisms precisely from a patient specimen with the launch of amplification methods for other nucleic acid and polymerase chain reaction. The Clinical Laboratory Improvement Amendments (CLIA) is the regulation for all the U.S. facilities which test human specimens. In January 2015, the FDA approved the first disclaimer under CLIA for a nucleic acid-based test.

Intensifying occurrence of infectious diseases such as HIV, tuberculosis, influenza and others is boosting the growth of the point of care molecular diagnostics market. For instance, according to the World Health Organization (WHO), in 2016 approximately 10.4 million people fell ill with tuberculosis and approximately 1.7 million people die from the disease. Moreover, according to WHO in 2015 approximately 887,000 deaths occurred due to complications of hepatitis B and in 2016 approximately one million people died from HIV related causes.

Mounting penetration of POC molecular diagnostic tests in China, Brazil, and India shifting trend from hospital testing to point of care testing, and increasing R&D activities in molecular diagnostic testing are also fueling the growth of the point of care molecular diagnostics market. Government bodies and private entities provide fund for the development of cost-effective solutions, to satisfy the increasing customer demand. Moreover, increasing demand for fast and portable tests is also driving the growth of the market.

Challenges

The inadequate reimbursements, long product development time and stringent regulatory requirements for product launch are the major challenges for the growth of point of care molecular diagnostics market.

Geographic Overview

Geographically, North America is the largest point of care molecular diagnostics market due to the intensifying occurrence of infectious diseases, increasing demand for fast and portable tests, increasing government initiatives, increasing focus on preventive care to reduce the economic burden and increasing number of CLIA product approvals. For instance, according to the Centre for Disease Control and Prevention (CDC) in 2014 approximately 9,421 new cases were diagnosed with tuberculosis.

Asia-Pacific is observed to witness the fastest growth in the market as the region comprises of largest population. In addition, increasing demand for influenza A/B tests and growing initiatives by market players are also creating a positive impact on the point of care molecular diagnostics industry growth in the region.   

Competitive Insight

Major players in the industry are investing in the development of innovative and advanced products, which is strengthening their position in the market. For instance, in January 2017, Abbott received CE approval for Alinity System for blood and plasma screening. It is designed to screen blood and plasma faster and more efficiently within a smaller footprint. Abbott Laboratories, Danaher Corporation, Biomérieux Sa, Roche Diagnostics, Quidel, Meridian Bioscience, Mesa Biotech, Genepoc, DxNA, Atlas Genetics are some of the key players offering a point of care molecular diagnostics products.