Contributed by Frédéric Breussin, Business Unit Manager Microfluidics & Medical Technologies, Yole Développement
Heavy recent investment by big players and significant new technologies now poised for introduction are accelerating the growth of the microfluidics market, pushing it towards $4 billion by 2016.
We estimate sales of microfluidic devices were up a healthy 19% in 2011, reaching roughly $1.3 billion, outpacing the 18% growth the sector saw from 2008 to 2010. We expect growth to pick up further over the next few years, with sales of fab-level microfluidics devices (not including chemistry) to average 23% annual compound growth through 2016, pushing the sector to almost $4 billion.
Some major manufacturers from other large volume polymer industrial markets are looking at turning their injection molding production skills to the microfluidics market. The small microfluidics volumes to date have made it diffi cult to get full industrial- volume controlled- process quality production –and such efficiencies are needed to spread the mold costs for injection molding over sufficient units to bring costs for disposable polymer microfluidics cartridges down to the necessary levels of $1-$2. But new players like Sony with its video disk experience and Konica with its microlens production skills will bring more sophisticated polymer volume manufacturing technology to the microfluidics sector.
Big muscle behind new technologies
New lower cost technologies for more useful point-of-care diagnostics are also about to hit the market. Growth in that potentially large market has been slower than expected, as suppliers have struggled to find compelling enough applications at low enough costs. But several elegant solutions for low cost tests for conditions where fast response really matters are poised for commercial introduction. We look for major players like Philips, BioCartis and Samsung to introduce new platforms for low cost polymer microfluidic diagnostic tests for cardiac states, bacterial infections and blood gases this year and next. Samsung Electronics will likely soon get international approvals for the bench- top automated blood analyzer it’s now selling to small clinics and hospitals in Korea. The system tests for 19 clinical analytes, including cholesterol, glucose, and indicators of heart, liver and kidney disease, all in about 12 minutes, thanks to a clever cassette design. The approach uses different spinning profiles of centrifugal force to move and mix the fluids for different steps, and laser heating to melt seals on various preloaded reagent wells as needed. Royal Philips Electronics and bioMérieux have integrated bioMérieux’s assay technology for heart attack markers on to Philips’ rapid diagnostics testing platform and are now engineering a commercial disposable cartridge and setting up manufacturing for product launch in 2013, aiming to match lab test accuracy with faster speed and lower cost.
Some of the technology acquisitions are also starting to show the results from the wider reach of their new big-company parents. BD Diagnostics aims to make the automated bench-top molecular test station technology it acquired with startup HandyLab into the laboratory equivalent of the smart phone, partnering with other infectious disease assay suppliers to port more tests to the platform. Beyond the current screening tests for MRSA infections and C.difficile diarrhea in hospital patients and B streptococcus in pregnant women, it’s working with Diagenode in Belgium to develop molecular diagnostic assays for respiratory and gastrointestional infections and meningitis, Biodiversity in Italy to port its molecular diagnostics for infections in immunocompromised and transplant patients, and Lab21 in the United Kingdom to add its Aspergillus fungus test to the automated test platform. Similarly,testing giant bioMérieux is porting assays for immunocompromised patients from its acquisition Argene to the automated test cartridges its developing with its part-owned partner Biocartis.
Strong growth for environmental testing and biomedical research
Such biologic diagnostic and medical screening tests, and environmental and industrial uses — worth some $910 million overall in 2010 — comprise the majority of the microfluidics market. The major applications are clinical and veterinary laboratory tests, to identify bacterial strains or to track response to cancer treatments. Typically these systems save time and money in the lab by using polymer microfluidics with relatively simple structures to automate testing, to reduce costs and speed turnaround time. Tests range across chemical detection for blood analysis; immunoassays for identifying bacteria and viruses; molecular detection for identifying and quantifying pathogens; and cytometry for blood counts and detection and analysis of cells.
Industrial and environmental testing applications will be the hot growth sector, with 38% CAGR through 2016, driven by the rollout of technology now available that can meet the increasing regulatory requirements and consumer demand for assuring food and water quality, with test for bacteria like e-coli as well as pesticides and other contaminants. Though sending the sample to the lab and inspecting what grows in the petri dish under a microscope a week later remains the standard reference for accuracy, companies are increasingly also using the faster microfluidics tests in house for more immediate feedback, and for ongoing monitoring and optimizing of their control and treatment processes.
Bringing these diagnostic and screening tests out of the lab and directly to the point of care, and expecting analysis in minutes instead of hours has proved rather more demanding, as the risk-adverse medical world still puts more trust in the accuracy of the traditional lab culture, and there are not so many applications where the faster results seem worth the still significantly higher cost— or worth revamping the whole established lab test system with its entrenched interests. But point of care diagnostics now appear to be poised for growth. We project 31% CAGR through 2011-2016. These diagnostics are starting to make inroads in emergency rooms, particularly for diagnosing cardiac events and identifying the bacteria causing severe infections, where saving time saves lives and cost is not an issue. Hospitals are also finding cases, such as kidney dialysis, where avoiding sending the sample to the lab and back streamlines operations enough to save cost, while allowing immediate adjustment of treatment. But the multiplicity of human diseases still means relatively small markets for most types of tests.
Demand for microfluidics devices for research in pharmaceuticals and life sciences is also poised for strong 34% compound average annual growth, to pass the $1 billion mark by 2016, as research moves to more complex biological analysis on more complex devices. Traditionally the pharmaceutical industry has used microfluidics for accurate dispensing of chemicals into well plates for high throughput robotic processing to screen many reactions at once. But it’s getting harder to develop major new medications that way. Instead the next generation of new drugs will increasingly require not just more automated screening of chemicals, but biologic testing to understand the underlying processes and the genomes and proteins involved, and the body response on the cellular level, to develop new molecules. That requires genomic and proteomic analyses to quickly screen for different populations or for effective responses. And that needs more complex high density chips with thousands of reaction chambers and high precision structures that have to be etched in glass or silicon, not on polymer. Genomics will continue to be the largest segment, but both proteomics and other miniaturized cell-based assays will see somewhat faster growth opportunities, though will remain relatively small in total unit sales.
Demand for microfluidics for drug delivery systems, primarily asthma inhalers and micropumps, will slow a bit to 20% CAGR for the period.
Frédéric Breussin is expert in Microfluidics for diagnostics and life sciences. He has supported many companies in their innovation and product development strategy in making the bridge between micro systems technologies and their applications in Life sciences, diagnostics and medical device industries. He holds an Engineering diploma from INSA Rouen and a DEA in fluid mechanics from University of Rouen.