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Point-of-Need Testing: Application of Microfluidic Technologies
Feb.2018

yole_ivd_zoom_on_pon_market
6 490 €

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Description

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Decentralized testing is now widespread, thanks to the endless possibilities enabled by microfluidic technologies

THERE IS STILL A PRONOUNCED INTEREST IN MICROFLUIDIC TECHNOLOGIES FOR PON TESTING, WITH COMPANIES INVOLVED IN THIS FIELD GREATLY BENEFITING FROM POSITIVE DYNAMICS

Microfluidic tests for Point-of-Need (PoN) testing consist of miniaturized diagnostic devices that perform analyses at or near the site where the biological sample is collected from a reference laboratory. The devices use micro-channels and are coupled to reagents in order to detect and measure specific biomarkers, all on a small chip. PoN market growth is driven mainly by point-of-care (PoC) and the promise of improving patient-centered care and overall healthcare changes, moving toward decentralization. PoC diagnostics allow patients to receive an appropriate treatment faster, and reduce costs by lowering the duration and frequency of a hospital stay.

In this context, Yole Développement’s (Yole) report analyzes how the $4B microfluidic market for PoN testing in 2017 will grow at a rate of 23% year-over-year, reaching around $13.2B by 2023. This growth will be driven by a high interest from in-vitro diagnostics (IVD) companies, and investors in decentralized testing technologies.

Since 2016, Yole’s analysts have identified more than $10B of investments in different acquisitions between large diagnostic companies: for example, Abbott, which acquired a large part of Alere (including diagnostic solutions for diabetes, lipid disorders, and molecular testing for infectious diseases) for an impressive amount of $5.3B. More recently, in January 2018 Qiagen acquired STAT Dx for $191M. This acquisition gives to Qiagen control of STAT Dx’s respiratory and gastrointestinal diseases pipeline.

Moreover, microfluidic companies developing PoN testing solutions have raised more than $650M since 2016, and the pace at which new products are being commercialized is accelerating. This report details these new product launches and describes what resides in the pipeline.

 

yole Positive dynamics of microfluidics based

 

NEAR-TERM PON OPPORTUNITY IS IN TRADITIONAL CARE SETTINGS, INCLUDING EMERGENCY TESTING AND DECENTRALIZED HOSPITAL TESTS. CONSUMER MARKETS WILL TAKE TIME TO BLOSSOM

The PoN market encompasses a wide range of products used by healthcare professionals and untrained consumers; such is the diversity for both user types in terms of applications and technologies. In this report, Yole’s analysts explore the technologies used across different market segments, highlight the reasons why such technologies are used, and discuss how they evolve. Based on conversations with industry experts, our analysts explain that in the long-term, advances in miniaturization, batteries, and molecular diagnostics will see POC tests proliferate beyond the traditional care settings of hospitals and doctor’s offices and into homes, representing a market value of $129M by 2023. Also, emergency testing and third-world testing will remain the largest segments in terms of volume of microfluidic-based consumables, reaching 211M units and 196.1M units by 2023, respectively.

We also expect to see abundant solutions from small startups and large diagnostic companies aimed at addressing veterinary, agro-food, environmental, and industrial testing segments. Furthermore, PoN assay menus are quickly expanding, with many companies releasing several new tests every year. Historically, assays with more complex procedural steps were reserved for central labs to carry out, but recently PoN diagnostic companies have developed microfluidic technologies to integrate all the required steps into a single cartridge that can perform multiple tests in parallel. For example, many companies (Alere, Biocartis, bioMérieux, Cepheid, GenePOC, Roche, among others) have brought to market molecular diagnostic tests including sample preparation, amplification, and detection.


Some key PoN players are developing targeted PoN systems allowing detection of a specific disease, while others are developing syndromic PoN tests for the detection of a wide number of analytes: for example, bioMérieux (BioFire), which is developing tests for groups of diseases (a gastrointestinal panel, a respiratory panel, etc.)

Further improvements in multiplexing, automation, and integration will drive the PoN market by enabling the development of increasingly complex tests on a simple microfluidic chip.

 

yole PON applications roadmap

ACROSS THE SUPPLY CHAIN, THERE IS A REAL FIGHT TO ACQUIRE VALUE

The overall market for PoN testing, no matter the technology, will swell to nearly $36B in 2023. In the meantime, microfluidic-based tests will gain share, representing $13.2B in 2023, while the portion tied to raw hardware (microfluidic devices) will only reach $1.8B in 2023. This means that the raw chips’ value is not growing as fast as the global market.


The current challenge for microfluidic foundries is to increase the value they are able to capture while facing tough competition from companies producing in-house, and also from large plastic molding companies (not specialized in microfluidics) that manage to manufacture microfluidic chips for customers. The chips are often made of polymer and sometimes integrate silicon or glass for enabling specific functions. Polymer is widely used (97% of all microfluidic tests for PoN applications) because injection molding technology is quite inexpensive at high volumes. In this report, Yole’s analysts present a detailed supply and value chain analysis, including cost of goods sold and offering concrete examples of well-known products.

 

 

yole IVD zoom on PON market

Objectives of the Report

  • Provide an overview of what has happened within the industry since 2016, including strategic moves, new trends, and product launches
  • Furnish a complete update comprising market data and drivers, as well as key technical and economic requirements for microfluidic technologies’ prospects in PoN testing (all applications)
  • Offer a market segmentation with technical and economic requirements per segment, including product examples, key players, market data, and forecasts for 2017 - 2023, along with market shares and market/technology trends
  • Highlight key points that have changed significantly since 2016, both on the market side and the technology side
  • Explain where and why the opportunities are for various players across the supply chain
  • Impart a deep understanding of the regulatory, market access, and reimbursement landscape for PoN tests in several applications

WHAT'S NEW

  • Drivers fostering the adoption of point-of-need (PoN) systems, and players’ interest
  • Evolution of PoN testing systems over the past five years, and description of the market’s main players
  • New products since 2016
  • Analysis of M&A, fundraisings, and collaborations since 2016
  • Time-to-market for the main PoN testing systems
  • List of new regulations for PoN systems
  • Updated market segmentation including: microfluidics’ added-value for each application, key players, requirements, and market insights
  • Challenges surrounding multiplexed tests and IVD assay menus
  • Targeted and syndromic PoN systems allowing detection of specific analytes or panels of analytes for a specific disease, respectively
  • Analysis of price per test vs. performance, over several applications
  • Updated supply chain analysis

 

Table of contents

Introduction  46



What has happened since 2016?  79


> Progression of PoN , from 2012 - 2018+
> M&A analysis
> Collaborations
> Fundraising
> New product launches on the market
> Statistical analysis (application covered, type of sample used, etc.)


Market Data and Forecasts  115


> Our definitions and market segmentation
> PoN tests - market data and forecasts, in volume
> PoN tests - market data and forecasts, in value
> Related microfluidic device market for PoN testing, in volume and value
> Microfluidic’s contribution to a test’s final sales price
> Microfluidic-based PoN tests - market growth, per segments

 

Market Segmentation  140


> Methodology
> Segment descriptions
- S1: Emergency testing
- S2: Third-world infections - remote-area testing
- S3: Home tests
- S4: Doctor’s office screening
- S5: Decentralized hospital tests
- S6: Genetic testing, companion diagnostics, forensics
- S7: Veterinary testing
- S8: Environmental and industrial testing
- S9: Agro-food testing
> PoN technologies’ near-term opportunity is in DNA sequencing


Focus on Molecular Diagnostics  193


> Sample preparation challenges
> Who is the next PoC giant?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Assay Menus and Multiplexing  203


> Why high-plex and multi-samples?
> High-plex vs. low-plex
> Which company provides which assay menu?
> The complex management of multiplexed PoC
> IVD assay menus - roadmap
> Targeted and syndromic PoN devices
> Comparing different PoN multiplexing solutions
> Focus on cardiac biomarkers
> Focus on infectious disease biomarkers
> Focus on veterinary biomarkers
> Focus on agro-food industry biomarkers

   

Regulatory and Market Access for PoC Testing  224


> Regulatory requirements, per country (USA, Europe, China)
> Focus on the new IVD Directive arriving in Europe

 

Reimbursement Landscape for PoC Testing  243


 

Regulations for Veterinary Diagnostics  260


 

Regulations for the Agro-Food Industry  263


 

Supply Chain  269


 

Conclusions  286


 

 

 

 

 

 

 

 

 

 

 

 

Companies cited

Abaxis
Abbott Point of Care
Accriva Diagnostics
Achira
AgPlus Diagnostics
Akonni Biosystems
Alere (Abbott)
Ativa Medical
Atlas Genetics
Atonomics
BD Diagnostics
BioCartis
Blusens Diagnostics
Biodetection Instruments
Biofire (BioMérieux)
BioSensia
Biosurfit
Carbo Analytics
Carclo Diagnostic Solutions
Cepheid
Coris BioConcept
Daktari Diagnostics
DNA Electronics
Dolomite Microfluidics
Dianax
Enigma Diagnostics
ExcitePCR
Etta Healthcare (OvaGene Oncology)
Fast-Track Diagnostics
F Cubed
FluimediX
Focus Diagnostics (DiaSorin Group)
Genalyte
GeneFluidics
GenePOC
Great Basin
HemoCue (Radiometer
Danaher)
Ikerlan
INO
Instant Labs
Iquum (Roche)


 

Lacrisciences
LeukoDx
Luminex
Medimate
Mesa Biotech
Micronics (Sony)
Molbio Diagnostics Pvt. Ltd
Nanomix
Nanosphere
NetBio
OndaVia
OPKO Diagnostics
Oxford Nanopore
Pall Corporation
PathSensors
Patterson
Philips
POC Medical Systems
PositiveID
QuantuMDx
Radiometer (Danaher)
Radisens Diagnostics
Rheonix
Roche
Samsung
Sandstone Diagnostics
Sanwa Biotech
Schlumberger
SMB (Zoetis)
Sony DADC (Stratec)
Spartan Bioscience
Sphere Medical
SpinChip Diagnostics AS
StableLab
STMicroelectronics
TearLab
Tecil
Ubiquitome
Vista Therapeutics
Wako Diagnostics
and more.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

KEY FEATURES OF THE REPORT

  • Yole’s vision of microfluidics-based Point-of-Need (PoN)
  • Analysis of market dynamics and PoN drivers for human diagnostics, veterinary diagnostics, environmental, industrial, and agro-food applications
  • PoN test requirements
  • Key PoN challenges
  • Average selling price (range) for PoN tests
  • Market segmentation including main players and product examples for each segment, along with market share
  • Market data and forecasts over the period 2017 - 2023
  • Regulatory, market access, and reimbursement landscape in human, veterinary, and agro-food markets in the USA, Europe, and China