Point of Care (PoC) Molecular Diagnostics Market Report

Point of Care (PoC) Molecular Diagnostics Market Analysis By Application, (Infectious Diseases, Oncology, Hematology, Prenatal Testing, Endocrinology), By Technology (PCR-based, Microarray-based, Hybridization-based, Genetic Sequencing-based), By Test Location, (Over-the-counter, Point-of-care), By End-use (Decentralized Labs, Hospitals, Home-care, Assisted Living Facilities) And Segment Forecasts To 2024

Published: June 2016  |  162 Pages  |  Format: PDF  |  Report ID: 978-1-68038-886-2

Industry Insights

Global point of care molecular diagnostics market was valued at USD 1.2 billion in 2015. Ongoing R&D to miniaturize extraction, purification, amplification and detection in molecular tests is expected to be a positive influence on growth in demand for POC devices in this market.

Furthermore, growth in the achieved level of understanding about the molecular mechanisms underlying common as well as rare disorders coupled with the advancement in methods of DNA sequencing & analysis, are factors expected to enhance molecular genomic and genetic testing portfolios, including POC molecular diagnostic capabilities.

For instance, development of diagnostic methods for ‘single gene’ ailments through mutation-specific targeted analysis using comparatively more portable sequence analysis platforms is a type of development expected to evolve the current way of molecular diagnosis into a much more robust and mobile methodology. Extremely parallel next-gen sequencing enables simultaneous multi-gene examination which can be used to sequence exomes for direct clinical testing.

U.S. Point of Care Molecular Diagnostics Market, By Application, 2015 - 2024 (USD Million)

U.S. Point of Care Molecular Diagnostics Market

Application Insights

Point of care testing in molecular diagnostics has a wide application base that includes near patient testing in infectious disease management, oncology, hematology, prenatal testing, endocrinology and some other minor applications. Most significant developments on an application basis have taken place in the fields of infectious diseases and oncology POC molecular tests.

Consequently, infectious diseases segment accounted for the largest share of revenue in 2015.

It has been observed that rapid molecular diagnostic tests for infectious diseases have witnessed higher penetration in the medical systems of developed and developing countries because they provide and facilitate more suitable antimicrobial treatment, quicker disease management, improved distribution of healthcare laboratory assets and reduce mortality and costs.

Technology Insights

Technology wise, point of care molecular diagnostics market has been categorized into PCR-based, genetic sequencing based, hybridization-based and microarray-based tests and devices. PCR-based molecular diagnostics are the gold standard when it comes to POC testing and consequently accounted for the largest share of revenue in 2015. Furthermore, complete commercialization of POC tests that provide rapid real time PCR analysis with a high level of accuracy for infectious diseases such as H1N1 or influenza.NGS based molecular testing near the patient is anticipated to witness considerable growth over the forecast period due to a number of innovative developments that have taken place in the market over the last decade.

Availability of platforms that enable genetic sequencing and analysis of DNA data at the point of care with high accuracy and provide rapid diagnosis is attributive towards anticipated progress in this segment. Rapid DNA analysis is expected to register considerable growth in the coming years owing to presence of advancements incorporated by prominent players in this segment.

Test Location Insights

POC testing includes two types of test in the scope that can be broadly classified into Point of care tests and over-the-counter tests (OTC). OTC tests are even more portable in nature relative to POC tests and have a higher degree of usage at homes, and assisted living facilities.

A major user of OTC constitute non-skilled personnel and in most cases the patients themselves. Furthermore, a number of these devices are CLIA waived as well which also increases their usage rate in non-laboratory near patient settings. Owing to the associated ease of usage, higher availability and greater adoption rate, OTC tests are expected to generate relatively higher revenue than POC tests over the forecast period.

End-use Insights

Point of care molecular devices are used at a number of testing settings that include decentralized laboratories, hospitals, home-care, assisted living healthcare facilities and other minor end-user segments. Usage of molecular tests at Point of care settings in decentralized laboratories accounted for the largest share of revenue for the year 2015.

Ability of these tests to provide rapid and accurate molecular analysis while having a significantly smaller physical footprint as compared to their central laboratory-based counterparts is a major factor that supports the segment’s larger revenue base.

Regional Insights

North America led this industry with revenue share of over 40%. Ongoing focused efforts by major market participants to strengthen their positions is an important factor accounting for the region’s major share. Furthermore, a number of clinical studies investigating the efficiency and accuracy of novel molecular POC tests are also expected to contribute towards the regions market potential over the forecast period.

Growing demand for near patient testing in Europe and development of newer molecular diagnostic tests for DNA analysis have poised the region as a major market space second only to the U.S. However, Asia Pacific is expected to witness a considerably faster growth in demand over the forecast period due to a relatively lower availability of sophisticated central laboratory testing services, a larger population base in need for clinical testing and the potential cost effective implementation of Point of care molecular tests.

Competitive Insights

Key market participants operating in the point of care molecular diagnostics market are Abbott Laboratories, Alere Inc. (Abbott), Bayer Healthcare, Roche Diagnostics, Becton Dickinson, bioMerieux, Bio-Rad Laboratories, Cepheid, Danaher Corporation, Johnson and Johnson among others.

Owing to ongoing developments and commercialization of novel miniaturized molecular diagnostic tests by relatively smaller market entities, the market is also witnessing a phase of consolidation, amalgamation and acquisitions wherein, larger market participants are involved in attempts to strengthen their market positions in the rapidly growing POC molecular diagnostic space.

Analyst Perspective

The study is a derivative from the point of care diagnostics, and molecular diagnostics market. Under the broad umbrella of In-vitro diagnostic capabilities that have been introduced and commercialized over the last decade, it has been observed that the healthcare industry has focused its attention and development effort in the enhancement of two key aspects, viz; a) move towards prevention and early detection rather cure later, b) enhance portable testing capabilities and decentralize healthcare testing.

As a consequence, to this concentrated effort in the direction, it has been observed that a sizeable revenue flow is progressively being directed towards areas focused on diagnostic capabilities and Point of care testing enhancement. The current market report specifically focuses on the relatively less aged segment of POC market. During the course of the next decade, a significant number of product commercialization and new product development cycles are expected to take place that will reinforce the molecular diagnostics expected high rate of growth.

Owing to the expected development and growth of the Point of care molecular diagnostics, the report aims to provide insights associated with the ongoing R&D, future product commercialization, POC MDx application and usage, market adoption, penetration rates, and revenue flow for these products across key regions and countries.

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