Point-of-Need Testing: Application of Microfluidic Technologies
- 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
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
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
Table of Contents
What has happened since 2016? 79
- Progression of PoN , from 2012 – 2018+
- M&A analysis
- 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
- 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
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.
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.
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.
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