Market and Technology Trends

Microfluidics Based Point-of-Need Testing 2023

By Yole Intelligence — May 2023

Point of Need testing revolution: How rapid microfluidic testing is changing the face of healthcare, driving a market expected to reach $16.2B in 2028.

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COVID-19 was an accelerator for the adoption of PoNT solutions

PoN microfluidic-based tests are used widely in hospitals, emergency rooms, and low-income countries. In 2022, 631 million modules were shipped, and we forecast this will reach 886 million in 2028 with a 5.8% CAGR22-28. In terms of revenue at the module level, this represented a global market of almost $10.8B in 2022, and the market is expected to grow to $16.2B, with a 7.0% CAGR22-28.

The COVID-19 pandemic accelerated access to accurate, rapid, and cost-effective testing for infectious diseases. During the pandemic, we observed a huge demand for tests: PCR and immunoassays are golden standards. Overall, the pandemic crisis greatly impacted microfluidic revenues, boosting the development of new technologies and panels and resulting in more instruments and production capacity. In early 2022, the same trends were observed. However, during the last two quarters of 2022, the diagnostic industry faced a massive slowdown as the situation has now stabilized thanks to the new vaccines and preventative measures (quarantine, masks).
To stabilize their business through annuity income based on consumables sales, players will be betting on their installed base and broadening their assay menus by targeting other diseases in coming years,
Human testing grew to the next level with very successful solutions: reliable, easy to use, fast, accurate, and comparable to clinical laboratories. Many instruments have been installed, and facilities can now increase their utilization as players develop their test menus.
Non-Human testing didn’t benefit from the pandemic. Indeed, the challenges are different, and they are less open to the rapid adoption of new solutions. Non-human testing generated $573M in revenue in 2022 at the module level, with veterinary testing representing almost 52%.
The development of research modules for drug discovery and screening, next-generation sequencing (genomics, proteomics), digital assays, and cell analysis has garnered significant interest. However, these solutions require several years before being adopted by a wide range of customers, as the underlying technology is complex and needs to be made more accessible. This can be achieved by developing comprehensible and comprehensive data analysis tools, which may involve artificial intelligence.

PoN microfluidics testing market: Opportunities and challenges for start-ups and established companies

Almost 91% of the PoN microfluidic testing market (in value) is held by ten players. This market is led by big diagnostics companies specializing in various tests, such as molecular, chemistry & electrolytes, and cytometry/hematology tests.

The leading players in PoNT microfluidic modules are almost the same as those leading the global PoC industry. The human testing market represents nearly 96% of the microfluidic modules market.

Danaher (Cepheid and HemoCue) is the leading company with a 35% market share by value. It is followed by Abbott, which represents 17% of the global module market value.

The component market represents 9% of the PoNT market. It is mainly driven by hospitals and emergency testing for molecular diagnostic applications for which components are more complex and bring more integrated functionalities, coming closer and closer to an “actual” lab-on-a-chip system.

In 2022, funds totaling $645M were raised, with several fundings related to the development of new products with high portability (Visby Medical, Biomensio), increased diversity in terms of the type of tests (Standard BioTools, Spindiag), and ease of use at the sample preparation and test process levels never reached before (Osler, Volta Labs).

A few M&As were identified in 2021-2023 linked to the acquisition of mid-sized diagnostics companies by competitors. These acquisitions were aimed at acquiring PoC technologies and increasing global commercial infrastructure and distribution footprint.

Some PoN microfluidic testing markets are open, while others are structured around big players. For example, many start-ups bring new technologies for human testing segments, attracting the bigger players (e.g., Scope Fluidics, acquired by Bio-Rad). However, the market for non-human testing is mainly driven by small to mid-sized companies, and big players are still waiting for good opportunities before entering these markets.

Innovations in PoNT to meet market demands for accuracy, speed, ease of use, and affordability.

The PoNT market's driving force is primarily the final product rather than technology development or innovation. Customers are generally more concerned with the end result than the testing process itself.

PoNT requires solving four main challenges:

Equivalent performance to clinical laboratories (accuracy, type of samples – such as blood, urine, saliva)
Time to results (for PoC, it is essential to have results in minutes, not in an hour, for example)
Ease of use (Intuitive as an electronic consumer product, suitable for various users and environments)
Cost-effective (example: molecular tests $45-$50)

The era following COVID-19 will witness advancements in technologies developed between 2017 and 2022. Numerous devices are already available in the market, and various detection and analysis methods have been established. In the healthcare sector, companies are concentrating on expanding their assay menus, including oncology, drug resistance (AMR), and companion diagnostics. Additionally, they are striving to build cost-effective products based on multiplexing solutions and enhance data analysis using artificial intelligence (AI).

Polymer remains the primary material for manufacturing single-use microfluidic components to meet these challenges. The main technology driver remains the increasing functionality of the cartridges with a high level of integration (pumps, reagents, …). This includes instrument-free cartridges that integrate detection in the cartridge itself. In addition, silicon-based microfluidic modules could offer new types of detection, such as electric or acoustic, to improve detection performance.

Key Features

Market segmentation data for 2022 and forecasts for 2023 - 2028 split into ten segments at the component and module level. Breakdowns by type of technologies in units and dollars.
Detailed explanation of current and future market trends, medical certifications of microfluidic technologies for PoNT applications.
Market share at the module level explaining the dynamics.
Fundraising and M&A analysis to help understand the ecosystem’s dynamics.
Description of the supply chain involving various players as a function of the materials used.
Materials, manufacturing, and other technology trends, along with roadmaps

What’s new?

Definitions and wording are standardized to the microelectronic wording.
Market shares and analysis of the market at the instrument level.
Update of the new processes of medical certifications for PoNT solutions

Product objectives

Provide market metrics and forecasts for Point of Need Testing taking into account the trends for each application.
Presents an overview of the best future growth opportunities for Point of Need testing, along with the key drivers of the market.
Explores the ecosystem development product-wise and funding-wise and details the main stakeholders involved. A detailed analysis of the market shares at the module level is provided
A broad overview of the technology trends from components up to modules for point-of-need applications
Oversee the main players across the Point of Need Testing supply chain.
Analyze how the business models and supply chains are evolving.

Abbott, Accelix (LeukoDx), Achira Labs, AGC, Agilent Technologies, AgPlus Diagnostics, Akonni Biosystems, ALiA (Sanwa Biotech), Aline inc, Alveo – be.well, Ande Corporation, Antelope Dx, Arrayit Corporation, Ativa Medical, Atomica (IMT MEMS), Axxicon, Baebies, BD (Becton Dickinson), Berkeley Lights, BforCure, BGI, Bi.Flow Systems, Binx Health, Biocartis, Biomensio, bioMérieux, Bionano Genomics, Bio-Rad, BioSurfit, Bluesense Diagnostics, Boehringer Ingelheim, CapitalBiotech Corporation, Cardea, Carville, CDA, Charles River, ClexBio, CN Bio, Cubed Laboratories, Cue Health, Cytovale, Daktari Diagnostics, Danaher (Cepheid, HemoCue, Pall corporation, Beckman Coulter), Deepcell, Dermagnostix, DiaSorin Molecular, Dolomite Microfluidics, Elveflow (Elvesys), ENPLAS, Epicore Biosystems, Epigem, Evonetix, EVG (EV Group), Fast Radius, FEMTOprint, Finnadvance, Fluigent, FluimediX, Fluxergy, Genalyte, Gener8, GenSpeed Biotech, Helvoet, Heska (LightDeck), Hicomp, Hochuen Medical, Hologic (Mobidiag), IBM, IDEX Health & Science, iLine Microsystems, Illumina, imec, IMT, Inflammatix, InSilixa, Inventics Dx, InziGn, Isoplexis, Kloé, Kypha (Biosensa), LioniX, lumiraDx, LuminUltra, Lunaphore Technologies, Medimate (CE-Mate), MedSpray, Mekonos, MeMed, Menarini Silicon Biosystems, Meridian Biosciences, Mesa labs (Gyros protein), MGI (BGI), Micralyne (Teledyne Dalsa), Microfluidic ChipShop, Micron Biomedical, Micronit, Microculus, MicrofluidiX, microTEC, miDiagnostics, Mission Bio, MiTAS Chip, Molbio Diagnostics, MZP tech, Nabsys, NanoEntek, Nanomix, NanoPass, NanoScribe, NanoString Technologies, Natech Plastics, Nicoya, Nutcracker, Nypro (Jabil), Olink, Ondavia, Opgen Group (Curetis), OPKO Diagnostics, Optolane Technologies, Osler Diagnostics, Oxford Nanopore Technologies, Pacific Biosciences (+Omniome), Pattern Bioscience, Philips Innovation Services, Plan optik group (Little Things Factory), Plastic Design Corporation, Potomac, Precision Nanosystems, Qiagen, Qorvo Biotechnologies, Quanterix, QuantuMDx, Quantum-Si, QuidelOrtho, Qurin Diagnostics, Qvella Corporation, Rab-Microfluidics, Radisens Diagnostics, Randox Laboratories (Bosh Vivalytic), Rapid Fluidics, RedShift Bio, Rheonix, Roche Diagnostics (Genmark Diagnostics), Rogue Valley Microdevices, Roswell Biotechnologies, rqmicro, Sandstone Diagnostics, Sekisui (Veredus laboratories), Sartorius, Schott (MiniFAB), Schlumberger, SensoDx, Sherlock Biosciences (Sense Biodetection), Siemens Healthineers, Sight Diagnostics, Silex Microsystems, SiPhox, SkyWater Technology Foundry, Smiths Detection (Pathsensors), SpinChip Diagnostics, SpinDiag, Standard BioTools (Fluidigm), Stilla Technologies, STMicroelectronics, Stratec Consumables, Surfix Diagnostics, SynVivo, Syrris, Sysmex, T2 Biosystems, Takara bio, Talis Biomedical, Tangen Biosciences, TearLab, Tecnisco, TE Connectivity (microLIQUID, Wu, Toolbox Medical Innovations), Thermo Fisher Scientific, Thinkcyte, thinXXS (IDEX), Translume, Trilobite, TDK Tronics, Truvian Sciences, TSMC, uFluidix, Vantiva (Technicolor Precision Biodevices), Vela Diagnostics (Great basin scientific), Visby medical (Click diagnostics), Weidmann Plastics, Wenhao Chip, Werfen (Accriva Diagnostics), Xfab, Xona Microfluidics, z-microsystems, Zoetis, Zomedica Pharmaceuticals, and more.

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Microfluidics Based Point-of-Need Testing 2023

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Point of Need testing revolution: How rapid microfluidic testing is changing the face of healthcare, driving a market expected to reach $16.2B in 2028.

COVID-19 was an accelerator for the adoption of PoNT solutions

PoN microfluidics testing market: Opportunities and challenges for start-ups and established companies

Innovations in PoNT to meet market demands for accuracy, speed, ease of use, and affordability.