COVID-19 is shaking up the diagnostics industry and will have both short- and long-term impact.
- In addition to the usual segmentation by application/ settings, this year we introduce the expected segmentation and market data/forecasts per type of test, spanning immunoassay, molecular diagnostics, clinical chemistry and more
- Detailed data for over 50 players, presented through charts: Installed base of instruments, instruments placed per year, tests per instrument per year, test ASP per type of test, consumable pullthrough per instrument
- More depth on market shares, per segment, and detailed list of players per segment
- Examples of success stories and failures, companies to watch in the coming years, and key considerations for commercial success
- New detailed sub-segmentation for the veterinary market and for the emergency testing market
- Overview of what microfluidic technology offers to point-of-need (PoN) testing
- New major trends and evolution at the market level and at the technology level including a focus on the high-plex molecular diagnostics space, and a focus on multi-modal platforms
- Updated market data and forecast 2018-2025, in value and units for microfluidic devices and tests, per segment and per type of test
- Supply chain description and analysis
- Market segmentation with technical and economical requirements per segment, product examples, key players, market share, and market and technology trends
Table of Contents
Table of contents, report scope and methodology 4
What we got right, what we got wrong 12
Executive summary 16
- Definitions – our vision of microfluidics
- Microfluidics – advantages and drawbacks
- Our vision of the microfluidic market
- Benefits of point-of-need and point-of-care testing
- Drivers fostering adoption of point-of-care
- Main requirements for point-of-need testing technologies
Market forecasts 76
- Market definitions and introduction to our market segmentation
- Market forecasts in units and dollars, for devices and for tests, per segment and per type of test
- Dynamics per segment
- Test and device ASP evolution, per segment and per type of test
- Comparison with the 2018 report
Market trends 104
- Increasing on-chip complexity for ever more integration and automation
- The problem of non-optimized cost structures
- There is no “one single microfluidic technology”
- Point-of-care testing roadmap
- Towards testing “anywhere, by anyone”
- Razor and razor-blade business model
- Charts: Installed base of instruments, instruments placed per year, tests per instrument per year, test ASP per type of test, consumable pullthrough per instrument
- In-house vs. outsourced production
- The lure of high-volume microfluidic device production
- Reaching commercial success is not an easy path
- Addressing other markets before human diagnostics
- Distribution networks are key for success – examples of distribution agreements
- Why are non-human testing applications struggling to take off?
- Rapid, high-multiplex molecular testing
- Examples of success stories, past, current and future, companies to watch in the coming years, recent failures, other companies examples and stories
- Chart: time from company inception to product launch, in function of funds raised
- Point-of-need instrument type roadmap
- Importance of multiplexing and wide assay menu, reimbursement problems
- The advent of multi-modal testing platforms
- Comparison with classic semiconductor markets’ dynamics
- Impact of the COVID-19 outbreak and companies active to develop SARS-CoV-2 tests
Market segment descriptions 167
- For each segment: description, technical requirements, economic requirements, market insights, type of tests, value of microfluidics, key players and products
Market shares and supply chain 227
- Market shares for the whole microfluidic-based point-of-need testing market
- Market shares for each market segment
- Microfluidic fabs: list of fabs per material type, geographical map, and analysis: why do companies choose to internalize or outsource production, where are the opportunities for fabs, what are the difficulties, why don’t large companies work (much) with the fabs, how do fabs climb into the supply chain?
- Other levels of the supply chain: design houses, surface modification companies, etc.
- Who’s working with whom?
Technology trends 270
- Materials, hybrid integration, manufacturing process comparison
- Detection methods overview, and focus on acoustic detection
- Matrix: type of test vs. type of detection, number of players, examples of players
- Roadmap: towards instrument-free consumables
- Achieving very rapid PCR diagnostics
- The advent of silicon-based platforms
- Integration and automation of complex sample preparation
- Toward standardized cartridge footprints
- Multiplexing: high-plex vs. low-plex
- Smartphone-based products
THE COVID-19 PANDEMIC HIGHLIGHTS THE IMPORTANCE OF RAPID, ACTIONABLE POINT-OF-CARE DIAGNOSTICS
The past few months have seen a new biological threat, the COVID-19 infection, also called new coronavirus, and caused by the SARS-CoV-2 virus, which has reshaped the entire diagnostics ecosystem. As the epidemic has slowed down in China, it is Europe’s and the USA’s turn to be suffering. As a direct consequence, there is a strong demand for diagnostics tests to rapidly identify infected people and numerous companies started developing such tests, including companies relying on microfluidic technologies. In a few weeks, tens of tests were ready. However, everything that has to deal with human health has to face very slow regulatory processes. In front of the sanitary emergency, the FDA and other regulatory bodies finally lowered their standards, granting “Emergency Use Authorizations” for some of these tests. Since mid-march, companies like Cepheid, GenMark, BioFire/bioMérieux, and Mesa Biotech got approval for microfluidicbased rapid molecular testing for SARS-CoV-2. Even more companies have released such tests for Research Use Only (RUO), waiting for approval. The mid-term goal for some of these companies will be to add SARS-CoV-2 to their syndromic respiratory panels. There is a race towards diminution of the time to result, from days to hours to minutes, but also towards increasing the throughput. Abbott announced a 13-minute test at the end of March, but its IDNOW platform deals with only one sample at the time. Other platforms take longer to deliver results but some of them can process multiple samples per run. The opportunity looks huge for diagnostics companies, but is the supply chain ready for mass-production of these tests in addition to their usual business or will it impact the production of other types of tests? The pandemic poses interesting questions regarding the length of development, approval and manufacturing of tests when we have no time to waste but that reliability cannot be compromised. It will be interesting to see how these issues will be addressed once the pandemic will be behind us.
DIFFERENT MARKET SEGMENTS ENJOY DIFFERENT DYNAMICS, BUT OVERALL MOLECULAR TESTING IS BOOMING LIKE NEVER BEFORE
The COVID-19 pandemic highlights the need for rapid and actionable results at the point-of-care, which is true for various, increasingly complex and comprehensive test panels. To achieve that, molecular diagnostics are key. This category of test is now making it to the next step, thanks to ever more complex integration and automation on-chip. For the first time in this report, Yole Développement (Yole) proposes market data and forecasts for 2018-2025 per type of test spanning clinical chemistry, immunoassays,
molecular diagnostics, cytometry, and more.
Molecular diagnostic tests represented more than half of the market value in 2019 and will represent about 70% by 2025. The overall microfluidicbased point-of-need testing market will grow at a compound annual growth rate (CAGR) from 2019-2025 of 13%, from $4.1B in 2019 to $10.1B in 2025, driven by human diagnostics segments. In the report, market data and forecasts are also split per market segment, spanning emergency testing, remote area testing, doctor’s office and pharmacies, veterinary, agro-food, industrial, and more.
Though most non-human testing areas are lagging behind, veterinary testing sees plenty of tests now reaching commercialization. New opportunities are emerging in industrial testing, for the quality control of pharmaceutical products. For each segment, market and technology trends are described in the report, along with main players, products and
market shares. Companies are racing towards everhigher- plex panels, meaning they want to enable detection of ever more pathogens in a single test.
They also aim to reduce time-to-result below 20 minutes to enable use of their technologies at the point-of-care, for example during classic medical appointments. Both are difficult to achieve at the same time, therefore companies have to make some choices. However, some companies are on track to deliver the promise of high-plex, rapid molecular diagnostics at the point-of-care in the coming years and are introduced in the report. In addition, for the first time Yole provides detailed data on about 50 point-of-need companies, presented through charts. The data includes the installed base of instruments, number of instruments placed per year, and number of tests per instrument per year. It also provides average selling price (ASP) per type of test, and consumable pullthrough per instrument.
THE ADVENT OF MULTI-MODAL PLATFORMS COULD INDUCE PROFOUND CHANGES IN MEDICAL PRACTICE, BUT ARE TECHNOLOGY DEVELOPERS READY TO OVERCOME THIS CHALLENGE?
The holy grail of diagnostics would be a small box able to perform any kind of test in minutes. Platforms that combine clinical chemistry and immunoassays have existed for a long time, but now some companies are addressing a much bigger challenge: combining clinical chemistry, immunoassays, cytometry and molecular diagnostics with the same instrument, at the point-of-care. By doing so, in theory a diagnostics facility could purchase only one instrument and run hundreds of different tests on that platform instead of having to purchase many different instruments, which is costly and requires lab space, and train personnel to use all these instruments. The difficulty is to be able to integrate all these different detection methods in a single, low-footprint and affordable instrument, while being able to design a cost-effective microfluidic cartridge able to run various types of
tests on the same footprint. It is difficult to say who will succeed in that area, but first-comers include companies like Bosch Healthcare with the Vivalytic platform, Qorvo Biotechnologies, Fluxergy and Truvian Sciences. Such multi-modal platforms are extremely promising but require a much heavier R&D effort than usual point-of-care platforms,
which are already difficult to bring to the market and to scale-up in a cost effective manner. More than ever, this poses the question of companies’ manufacturing strategy: is it better to manufacture chips and instruments in-house or to outsource to an experienced microfluidic device contract manufacturer? What are the advantages and the associated risks for both options? Which players have adopted which strategy for which products? In the report, Yole’s analysts provide in-depth insights on this topic.
Abaxis (Zoetis), Abbott, Abionic, Accelix (LeukoDx), Accriva Diagnostics (Instrumentation Laboratory, Werfen), Achira Labs, Agilent Technologies, AgPlus Diagnostics, Akonni Biosystems, Alere (Abbott, Quidel, Siemens), ALine, ANDE, Aprimeo Diagnostics (R-Biopharm), Applied Microarrays, Ativa Medical, Atonomics, Avalun, Axxicon, Balda AG (Stevanato Group), Bayer, BD (Becton Dickinson), Biko, binx health (formerly Atlas Genetics), Biocartis, Biodetection Instruments, BioFire Diagnostics (bioMérieux), BioMensio, bioMérieux, Bionuclear, Bio-Rad, BioSensia, Biosurfit, Blusense Diagnostics, Boehringer Ingelheim Mobinostics, Bosch Healthcare, Boule Diagnostics, Caliper Life Sciences (PerkinElmer), Carbo Analytics, Cepheid (Danaher), Charles River Laboratories, Click Diagnostics, Coris Bioconcept, Covance (LabCorp), Cubed Laboratories (formerly FCubed), Cue Health, Curetis, Curiosity Diagnostics (Scope Fluidics), Daktari Diagnostics, Denz BIO-Medical, DiaSorin Molecular, DNAe (DNA Electronics), DxNA, Enigma Diagnostics, ENPLAS, Etta Healthcare (Ovagene Oncology), ExcitePCR (PositiveID Corporation), Flow Alliance, Fluid-Screen, FluimediX, Fluxergy, Focus Diagnostics (DiaSorin Molecular), Future Horizon Scientific, Genalyte, GeneFluidics, GenePOC (Meridian Bioscience), GenMark Diagnostics, GenSpeed Biotech, Great Basin Scientific (Vela Diagnostics), Gulf Bio Analytical, GSK, Hahn-Schickard, Helvoet, HemoCue (Radiometer, Danaher), IDEX Health&Science, IQuum (Roche), iLine Microsystems, imec, Inflammatix, InSilixa, Instant Labs (Luminultra), IntegenX (Thermo Fisher Scientific), Klearia, LacriScience, LeukoDx, LexaGene, Luminex Corporation, LumiraDx, Maccura, MBio Diagnostics, Medimate (CE-Mate), MeMed, Menarini, Meridian Bioscience, Mesa Biotech, Microfluidic ChipShop, MicroLiquid, Micronics (Sony), Micronit, Minicare (Siemens), MiniFAB (Schott), Mobidiag, MolBio Diagnostics, NanoEntek, Nanomix, Nanosphere (Luminex), Nichirei Biosciences, Nypro (Jabil), Ondavia, Ontera (formerly Two Pore Guys), OPKO Diagnostics, Optolane Technologies, Osler Diagnostics, Oxford Nanopore Technologies, Pall Corporation (Danaher), PathSensors, Phase Three Product Development, Philips, POC Medical Systems, Qiagen, Qorvo Biotechnologies, Quanterix, QuantuMDx, Quidel, Quimica Valaner, Qvella, RAB-Microfluidics, Radisens Diagnostics, Randox Biosciences, Rapid Diagnostics, R-Biopharm, RedBud Labs, Rheonix, Righton, Roche, rqmicro, Samsung, Sandstone Diagnostics, Sanwa Biotech, Sekisui Diagnostics, SensoDx, Siemens Healthineers, Sight Diagnostics, SMB (Zoetis), SpinChip Diagnostics, Spindiag, Stat-Dx (Qiagen), STMicroelectronics, Stratec Consumables, Surfix, Symbient Product Development, TearLab, Technicolor Precision Biodevices, Theranos, thinXXS (IDEX), Truvian Sciences, T2 Biosystems, Vela Diagnostics, Veredus Laboratories, Wako Diagnostics, Wi inc, Wondfo, Yield Engineering Systems (YES), Zenosense, z-microsystems, Zoetis, Zomedica Pharmaceuticals, and more.
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