Decentralized testing for both human and non-human in-vitro diagnostics is increasingly taking advantage of innovative microfluidic technologies
PLENTY OF APPLICATIONS HAVE STARTED TO BENEFIT FROM MICROFLUIDICS FOR DECENTRALIZED TESTING, BUT HAVE NOT REALIZED THEIR FULL POTENTIAL – YET
Point-of-Care (PoC) testing is not a new concept - the first applications arose in the 1990s. Since then, microfluidic technologies have been increasingly used to solve technical problems and bring economic benefits to the healthcare industry. In the past few years, other applications have benefited from recent technological improvements: veterinary testing, environmental testing, agro-food and industrial testing are also part of the scope of the report. Decentralized testing brings significant operational benefits to various players across these applications. Microfluidics is part of the diagnostics revolution, with an explosion in the number of products on the market. However, with many applications but few solutions existing today, these markets have not yet reached their full potential.
In the report, Yole Développement (Yole)’s analysts explain why the human healthcare market still looks much more attractive to technology developers. However, in the near future the greatest opportunities will be in all the other markets. The report also explores which barriers still need to be taken down for decentralized/“point-of-need” (PoN), testing to flourish. Microfluidics-based point-of-need testing will grow from a $2.6B market in 2015 to $10.3B in 2021, which is a 26% compound annual growth rate (CAGR). This value represents more than 500 million tests in 2021, but only 61 million will be outside human diagnostics. In the report, Yole’s analysts detail the evolution of each application in terms of microfluidic technology’s use.
TECHNOLOGY BREAKTHROUGHS ARE TRANSFORMING POINT-OF-NEED TESTING
Since the emergence of PoC testing and despite technology improvements, diagnostics companies and technology developers have struggled to integrate and automate complex steps on microfluidic chips. These complex tests, typically involving molecular analysis, thus required manual intervention from the operator for sample preparation or bulky equipment. However, 2015 was a major turning point within the industry: the first ever DNA/RNA-based tests were Clinical Laboratory Improvement Amendments (CLIA)- waived by the US Food and Drug Administration (FDA). That means they are sufficiently fully-integrated, and easy enough to use and interpret to be run by totally untrained people, thus allowing decentralization of these tests to almost anywhere. In January 2015, the ALERE i Flu A&B Test was the first ever molecular test to be CLIA-waived, followed by Alere i Strep A, Roche’s Cobas LIAT Strep A, Flu A&B and Flu/RSV and Cepheid’s GeneXpert Flu/RSV Xpress. Yole’s analysts expect many more microfluidic-based tests to be granted a CLIA waiver in a near future, allowing molecular point-of-need testing to spread to locations where they have never been used before.
We have also entered a period during which there will be a transition towards point-of-care testing in hospitals, clinics and doctors’ offices for molecular diagnostics of seasonal diseases such as influenza. Polymerase chain reaction (PCR)-based tests are much more sensitive than immunoassays and are able to differentiate strains of the same disease. With a rapidly growing number of companies involved in molecular diagnostics and achieving milestones month after month, the future looks bright. In the report, we detail these recent technology improvements, including sample preparation and integration of PCR or of isothermal amplification technologies, which opens the door to increasingly complex microfluidic based decentralized assays.
POINT-OF-CARE TESTING HAS NOW FOUND ITS NICHE AND IS DRIVING HEALTHCARE TOWARDS PERSONALIZED MEDICINE
Faster, cheaper, easier to use: microfluidic technologies have transformed point-of-care. Today, the limits have been pushed beyond hospitals to reach doctors’ offices, patients’ homes and even remote areas in developing countries. This enables earlier diagnoses and clinical decisions and more accurate patient monitoring. This transformation of healthcare practices towards prevention and early detection, coupled with the explosion of companion diagnostics, will finally bring the major shift we have been hearing about for years, enabling personalized medicine.
This new generation of diagnostic tests will allow physicians to determine which treatment works best on which patient and at which dose, thus increasing overall therapeutic efficiency and reducing healthcare costs. Though the authorities have lagged behind in taking this paradigm shift in diagnostics into account, point-of-care is now clearly recognized and regulations are changing, with new directives recently agreed in Europe and China. Yole’s report takes an intense look into the regulatory, market access and reimbursement landscape across the USA, Europe and China in several Point-of-Need applications. It specifies the relevant legal texts, the regulatory and reimbursement players, and the main hurdles to market access for Point-of-Need testing players.
Objectives of the Report
This report’s objectives are to:
- Provides a complete update of market data and drivers, key technical and economic requirements and prospects of microfluidic technologies for PoN diagnostics in all applications
- Provide an analysis of the relationship between potential PoN applications, emerging technologies and the assets of microfluidics
- Recap all the principal strategic moves and fundraising that happened in the industry since 2014
- Focus on key market and technological aspects that have significantly changed since 2014
- Explain where, what and why the opportunities are all along the supply chain
- Provide in-depth understanding of the regulatory, market access and reimbursement landscape for Point-of-Need tests in several applications
- New market segmentation, better adapted to an evolving market
- Technology roadmap
- Focus on the characteristics of large assay panels and on multiplexing pros and cons
- Business model analysis
- Important chapter dedicated to regulations and reimbursement for IVD and PoN tests in human, veterinary and agro-food markets
- Who will be the next PoC giant?
- Focus on molecular diagnostics