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Page 1: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

© Feb 2018

From Technologies to Markets

Point-of-Need Testing: Applications of

Microfluidic Technologies

2018 Report

Sample

Page 2: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

2

Biography & contact

©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

ABOUT THE AUTHORS

Sébastien Clerc

Sébastien Clerc works as a Medical Technologies & Market Analyst at Yole Développement (Yole). As part of the Medical Technologies(MedTech) business unit, Sébastien authored a collection of market and technology reports dedicated to topics such as microfluidics,point-of-care, MEMS for healthcare applications and connected medical devices. In parallel, he is daily involved in custom projects such asstrategic marketing, technology scouting and technology evaluation to help academic and industrial players in their innovation processes.Thanks to its technology & market expertise, Sébastien has spoken in more than 10 industry conferences worldwide over the last 2years.

Sébastien Clerc is graduated from Grenoble Institute of Technology (Grenoble INP - Grenoble, France) with a Master degree inBiomedical Technologies. Then he completed his cursus with a Master degree in Innovation and Technology Management in the sameinstitute.

Email: [email protected] Phone: +33 472 83 01 87

Asma SIARI

As a Technology & Market Analyst in the Medical Technologies (MedTech) business unit at Yole Développement (Yole), Asma Siari is

involved in the development of technology & market reports as well as the production of custom consulting projects. After a Master’s

degree in Biotechnologies, Diagnostic Therapeutics & Management, Asma serves as Research Assistant at the Moores Cancer Center (San

Diego, CA). She is a coauthor in two scientific publications published in the Molecular Cancer Research Journal. Asma is graduated with

an Advanced Master’s degree in International Strategy & Marketing BtoB (EM Lyon Business School, France).

Email: [email protected] Phone: +33 472 83 01 84

Page 3: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

3

Abaxis, Abbott Point of Care, Accriva Diagnostics, Achira, AgPlus Diagnostics, Akonni Biosystems, Alere (Abbott), Ativa Medical, Atlas Genetics, Atonomics, BD Diagnostics, BioCartis, Blusense 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

LIST OF COMPANIES MENTIONED IN THIS REPORT

©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

290+ slides of market and technology analysis

Information gathered through direct discussions with players all along the supply chain

Page 4: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

4©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

OBJECTIVES OF THE REPORT

The report will provide:

• An introduction to Point-of-Need testing, our definitions and why it is used

• An overview of what microfluidic technology can bring to PoN testing

• A summary of what happened within the industry since 2016, the new trends and product launches.

• Market segmentation with technical and economical requirements per segment, examples of products, key players, market shares, market and technology trends.

• Market data 2017 and forecasts 2018-2023.

• A focus on some established and emerging applications (molecular diagnostics, handheld DNA sequencing…) along with some insights about the challenges of multiplexing.

• Supply and value chain analysis, COGS, ROI, materials…

• A detailed chapter dealing with regulations and reimbursement for several applications (human diagnostics, veterinary diagnostics, agro-food).

Page 5: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

5©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

OBJECTIVES OF THE REPORT

• This report provides a complete update of the market data and drivers, key technical,economic requirements and prospects of microfluidic technologies for Point of Needdiagnostics

• It provides an analysis of relation between the potential PON applications, the emergingtechnologies and the assets of microfluidics

Applications

•Market requirements

•Market drivers

•Health system drivers and constrains

Technologies, Systems

•System requirements

•Sample injection, preparation

•Volume of sample

•Systems requirements (economic, technical)

Microfluidics

•Microfluidic Device

•Detection technology

•Fluid handling, mixing

•Manufacturing and materials

Page 6: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

6

WHO SHOULD BE INTERESTED IN THIS REPORT?

• Diagnostics companies:o To have a broad overview of all Point-of-Need

testing applications and markets

o To identify new markets and the associatedrequirements

o To monitor and benchmark potentialcompetitors

o To understand behavior evolution

• Industrial & Services companies:o To understand what is the state of the art and

which solutions could bring operational benefits

• Financial & Strategic investors:o To understand the potential for Point-of-Need

testing

o To know the latest moves within the industry

o To get a list of PoN players and their activities

o To understand which are the sweet spots and thepromising applications

• R&D players:

o To understand new challenges in PoN testing andmicrofluidics

o To address the right market with the righttechnology

• Microfluidic foundries and device makers:

o To understand technical requirements depending onthe applications

o To identify business opportunities and prospects

• Healthcare & Governmental organizations:

o To evaluate benefits of using PoN testing

o To identify relevant companies

• Electronics, MEMS and optics companies:

o To understand the challenges and requirements inmicrofluidics, biology and healthcare

©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

Page 7: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

7

TABLE OF CONTENTS

1/2

• Introduction (p46)

• What happened since 2016? (p79)– Progression of PoN systems from 2012 to 2018 ( were we right

on our analysis of PoN market 2016)

– Mergers and acquisition analysis

– Collaborations

– Fundraising

– New products launched on the market

– Statistical analysis (application covered, type of sample used…)

• Market data and forecasts (p115)– Our definitions and Market segmentation

– Point of need tests market data and forecast in volume

– Point of need tests market data and forecast in value

– Related Microfluidic device market for point of need testing in

volume and value

– Microfluidics contribution in the final selling price of a test

– Microfluidic based PoN tests market growth per segments

• Market segmentation (p140)– Methodology

– Segments descriptionso S1: Emergency testing

o S2: Third-world infections: remote areas testing

o S3: Home tests

oS4: Doctor’s office screening

oS5: Decentralized hospital tests

o S6: Genetic testing, companion diagnostics, forensics

o S7: Veterinary testing

o S8: Environmental and Industrial testing

o S9:Agro-food testing

– Near time opportunity of PoN technologies: Project

the penetration of PoN systems in terms of Care

settings, time and disease)

• Focus on molecular diagnostics (p193)– Sample preparation challenges

– Who’s the next PoC giant?

©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

Page 8: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

8

TABLE OF CONTENTS

2/2

• Assay menus and multiplexing (p203)– Why High-plex and Multi samples

– High-plex vs. Low-plex

– Which company is providing which assay menu?

– Management of multiplexed PoC is complex

– IVD assay menus roadmap

– Targeted and syndromic point-of-need devices

– Comparison between point-of-need multiplexing solutions

– Focus on cardiac biomarkers

– Focus on Infectious diseases biomarkers

– Focus on Veterinary biomarkers

– Focus on agro-food industries biomarkers

• Regulatory & market access for Point-of-Care testing

(p224)– Regulatory requirement per countries (USA, Europe, China)

– Focus on the new IVD Directive arriving in Europe

• Reimbursement landscape for Point-of-Care testing (p243)– Reimbursement landscape in USA

– Reimbursement landscape in France, Germany, UK

• Regulations for veterinary diagnostics (p260)

• Regulations for agro-food industry (p263)

• Supply Chain (p269)

• Conclusions (p286)

©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

Page 9: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

9

DEFINITION OF PON TESTING

• We define as Point-of-Need testing any diagnostic test performed out of reference laboratories: at home, at the patient’s bed, inICUs (Intensive Care Units), at the physician’s office, near a production line, etc.

• Point-of-Care refers to human testing whereas we discuss a much larger scope:

• Human testing

• Veterinary testing

• Industrial testing (oil & gas, chemicals…)

• Agro-food testing (dairy, food, beverage, crops…)

• Environmental testing (water quality monitoring and bacteria detection…)

• Forensics

Clinical

diagnostics

Veterinary

diagnostics

Environmental

monitoring

Agro-food

testing

Industrial

testingForensics

And others!

©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

Page 10: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

10©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

SCOPE OF THE REPORT

This report will focus on tests to be performed at the point of need (= decentralized testing), already commercialized or indevelopment, based on microfluidic technology.

Microfluidic technology can be used both in the cartridge/chip and in the system reader.

Simple tests such as lateral flow analysis and tests done on strips (dedicated for Drugs of abuse tests, Fertility tests, Respiratorydisease tests...) are not included in the scope of this report.

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11

POINT-OF-NEED MARKET

Microfluidic-based tests are going to gain share representing $13.2B in 2023

The part held by the raw microfluidic devices will only reach

$1.8B in 2023 which means the value of chips is not

growing as fast as the global

market

In Vitro Diagnostics

market

PON testing market

Microfluidic-based PON

tests market

Microfluidic Devices

Market for PON

applications

20232017

$78B

$18B

$3.5B

$496M

$97B

$36B

$13.2B

$1.8B

©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

Page 12: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

12©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

DRIVERS FOSTERING ADOPTION

• Increase in home-

based POC usage

• Labs decentralization

and staff shortages

• Patient-centered care

• Simple tests can be

CLIA-waived by the

FDA, enabling use by

untrained users which

expands the potential

market

• Many PoC testing

programs, physician

offices and

laboratories limit their

menu to waived tests

• Platforms designed

for a rapid use in a

wide range of POC

tests

• Multiplexed tests

enable

comprehensive

diagnostic

• Multiple Assay

Platforms

• Cost-effectiveness

• Non-invasive

diagnostic tool testing

• Virulence increase

of chronic diseases

and infectious

disease

• Developing

countries

• Better patient

outcomes

• Simple to perform and

immediate results

• Minimal educational

requirements / trainings

• Digital

transformation of

healthcare

• Increase in the

number of

connected

solutions

• New business

models generated

by digital healthcare

Technology

improvement

Speed

New testing

opportunities

Care process

optimization

Testing

platforms

Regulatory

requirements

Connectivity

Page 13: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

13©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

M&A, COLLABORATIONS, FUNDRAISING AND RELEASED PRODUCTS SINCE 2016

Analysis of the strategic moves in the industry

• How is the market evolving, who are the main players and the promising new entrants?

• What strategic moves are driving the point-of-need market growth?

• Identification of new products

• New Regulatory Status of the main players

Page 14: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

14©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

MARKET DATA AND FORECASTS UPDATE

• Overview of the point-of-need market data and forecasts 2017-2023 for each segment

• Market share and dynamics per segment for 2017

Page 15: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

15©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

MARKET SEGMENTATION AND SEGMENTS DESCRIPTION

• Point-of-need market is split into segments depending on key technological and economical/behavioral

criteria

• Each segment has its whole chapter with detailed description, market data, key products examples, key

players, requirements and market insights.

Page 16: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

16©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

ANALYSIS OF PON TECHNOLOGY TRENDS

• Description of the technological challenges and technical requirements, focus on multiplexed testing

• Assay menus roadmap

• Analysis of price per test vs time to result for (cardiac, infectious diseases, Veterinary and agro-food

tests)

• What are the sweet spots for today and tomorrow

Page 17: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

17©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

SUPPLY CHAIN ANALYSIS

• Detailed supply chain and collaboration examples

• Who’s producing in-house, who is outsourcing, for which volumes?

• How can companies all along the supply chain make value with microfluidic-based point-of-need

solutions?

Page 18: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

18©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

REGULATORY, REIMBURSEMENT AND MARKET ACCESS LANDSCAPE

• Regulations, market access and reimbursement rules for several markets (medical, veterinary, agro-food) and

geographic areas (Europe, USA, China)

• Who pay? Who benefit?

• How health insurances deal with performance?

Page 19: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

19©2018 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies

RELATED REPORTS

Page 20: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

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.

POINT-OF-NEED TESTING: APPLICATION OF MICROFLUIDIC TECHNOLOGIESMarket & Technology report - February 2018

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

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

KEY FEATURES OF THE REPORT Get the sample of the report on www.i-Micronews.com•Yole’svisionofmicrofluidics-basedPoint-of-Need(PoN)

•AnalysisofmarketdynamicsandPoNdriversforhumandiagnostics,veterinarydiagnostics,environmental,industrial,andagro-foodapplications

•PoNtestrequirements•KeyPoNchallenges•Averagesellingprice(range)for

PoN tests•Marketsegmentationincludingmainplayersandproductexamplesforeachsegment,alongwithmarketshare

•Marketdataandforecastsovertheperiod2017-2023

•Regulatory,marketaccess,andreimbursementlandscapeinhuman,veterinary,andagro-foodmarketsintheUSA,Europe,andChina

WHAT’S NEW• Driversfosteringtheadoptionofpoint-of-need(PoN)systems,andplayers’ interest

• EvolutionofPoNtestingsystemsoverthepastfiveyears,anddescriptionofthemarket’smainplayers

• Newproductssince2016• AnalysisofM&A,fundraisings,andcollaborationssince2016

• Time-to-market for the main PoN testingsystems

• ListofnewregulationsforPoNsystems

• Updatedmarketsegmentationincluding:microfluidics’added-valueforeachapplication,keyplayers,requirements,andmarketinsights

• ChallengessurroundingmultiplexedtestsandIVDassaymenus

• TargetedandsyndromicPoNsystemsallowingdetectionofspecificanalytes or panels of analytes for a specificdisease,respectively

• Analysis of price per test vs. performance,overseveralapplications

•Updatedsupplychainanalysis

Since the beginning of 2016:

M&A

$11B+

Fundraisings

$671M+ 15+ new

systems reached the market

9+ have been CE-marked

8+ cleared bythe FDA

and 4+ CLIA-waived

(Yole Développement, February 2018)

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

Positive dynamics of microfluidic-based PoN

Page 21: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

POINT-OF-NEED TESTING: APPLICATION OF MICROFLUIDIC TECHNOLOGIES

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.

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.

In-Vitro Diagnostics: zoom on the Point-of-Need market

(Yole Développement, February 2018)

In-Vitro Diagnostics market

PON testing market

Microfluidic-based PON tests market

Microfluidic devices market for PON

applications

2023 2017

$78B

$18B

$3.5B

$97B

$36B

$13.2B

$1.8B $496M

CAGR2017-2023: 24%

CAGR2017-2023: 23%

CAGR2017-2023: 5.35%

CAGR2017-2023: 9.8%

Point-of-Need applications roadmap

(Yole Développement, February 2018)

Other Point-of-Need segmentsare explored in this report

Page 22: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

Find more details about

this report here:

MARKET & TECHNOLOGY REPORT

COMPANIES CITED IN THE REPORT (non exhaustive list)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.

AUTHORSAs a Technology&MarketAnalyst in theMedical Technologies (MedTech) businessunitatYoleDéveloppement(Yole),Asma Siari is involved in the development oftechnology&marketreportsaswellastheproductionofcustomconsultingprojects.AfteraMaster’sdegreeinBiotechnologies,Diagnostic Therapeutics & Management,Asma served as Research Assistant atthe Moores Cancer Center (San Diego,CA). She is a coauthor in two scientificpublications published in the MolecularCancerResearchJournal.AsmaSiari isgraduatedwithanAdvancedMaster’sdegreeinInternationalStrategy&MarketingBtoB fromEMLyonBusinessSchool(France).

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> Reimbursement landscape in the USA> Reimbursement landscape in France, Germany, UK

Regulations for veterinary diagnostics 260

Regulations for the agro-food industry 263

Supply chain 269

Conclusions 286

TABLE OF CONTENTS (complete content on i-Micronews.com)

Sébastien Clerc works as a MedicalTechnologies & Market Analyst at YoleDéveloppement (Yole). As part of theMedicalTechnologies (MedTech)businessunit, Sébastien authored a collection ofmarketandtechnologyreportsdedicatedto topics such as microfluidics, point-of-care, MEMS for healthcare applicationsandconnectedmedicaldevices.Inparallel,he is daily involved in custom projectssuch as strategic marketing, technologyscouting and technology evaluation tohelp academic and industrial players intheir innovation processes. Thanks to its technology&marketexpertise,Sébastienhas spoken in more than 10 industryconferences worldwide over the last 2years.SébastienClercisgraduatedfromGrenobleInstitute of Technology (Grenoble INP -Grenoble, France) with a Master degreein Biomedical Technologies. Then hecompletedhiscursuswithaMasterdegreeinInnovationandTechnologyManagementinthesameinstitute.

RELATED REPORTBenef i tf romourBundle&AnnualSubscriptionoffersandaccessouranalysesatthebestavailablepriceandwithgreatadvantages

OBJECTIVES OF THE REPORT•Provideanoverviewofwhathashappenedwithintheindustrysince2016,includingstrategicmoves,newtrends,andproductlaunches

• Furnishacompleteupdatecomprisingmarketdataanddrivers,aswellaskeytechnicalandeconomicrequirementsformicrofluidictechnologies’prospectsinPoNtesting(allapplications)

• Offeramarketsegmentationwithtechnicalandeconomicrequirementspersegment,includingproductexamples,keyplayers,marketdata,andforecastsfor2017-2023,alongwithmarketsharesandmarket/technologytrends

• Highlightkeypointsthathavechangedsignificantlysince2016,bothonthemarketsideandthetechnologyside

• Explainwhereandwhytheopportunitiesareforvariousplayersacrossthesupplychain• Impartadeepunderstandingoftheregulatory,marketaccess,andreimbursementlandscape

for PoN tests in several applications

• MicrofluidicTechnologiesforDiagnosticApplicationsPatentLandscape

• BioMEMS:MicrosystemsforHealthcareApplications2016

• ConnectedMedicalDevicesMarketandBusinessModels2017

Findallourreportson www.i-micronews.com

Page 23: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

ORDER FORMPoint-of-Need Testing: Application of Microfluidic Technologies

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RETURN ORDER BY • FAX: +33 (0)472 83 01 83• MAIL: YOLE DÉVELOPPEMENT, Le Quartz,

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SALES CONTACTS • North America - Steve Laferriere: +13106 008 267

[email protected] • Europe & RoW - Lizzie Levenez: + 49 15 123 544 182

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[email protected]• Specific inquiries: +33 472 830 180 – [email protected]

(1) Our Terms and Conditions of Sale are available at www.yole.fr/Terms_and_Conditions_of_Sale.aspx The present document is valid 24 months after its publishing date: February 15th, 201

/

ABOUT YOLE DEVELOPPEMENT

BILL TO

Name (Mr/Ms/Dr/Pr):

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PRODUCT ORDER - Ref YD18007Please enter my order for above named report: One user license*: Euro 5,990 Multi user license: Euro 6,490- The report will be ready for delivery from February 26th, 2018- For price in dollars, please use the day’s exchange rate. All reports are

delivered electronically at payment reception. For French customers, add 20% for VAT

I hereby accept Yole Développement’s Terms and Conditions of Sale(1)

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Founded in 1998, Yole Développement has grown to become a group of companies providing marketing, technology and strategy consulting, media and corporate finance services, reverse engineering and reverse costing services and well as IP and patent analysis. With a strong focus on emerging applications using silicon and/or micro manufacturing, the Yole group of companies has expanded to include more than 80 collaborators worldwide covering MEMS and image sensors, Compound Semiconductors, RF Electronics, Solid-state lighting, Displays, software, Optoelectronics, Microfluidics & Medical, Advanced Packaging, Manufacturing, Nanomaterials, Power Electronics and Batteries & Energy Management.The “More than Moore” market research, technology and strategy consulting company Yole Développement, along with its partners System Plus Consulting, PISEO and KnowMade, support industrial companies, investors and R&D organizations worldwide to help them understand markets and follow technology trends to grow their business.

CONSULTING AND ANALYSIS• Market data & research, marketing analysis• Technology analysis• Strategy consulting• Reverse engineering & costing• Patent analysis• Design and characterization of innovative optical systems• Financial services (due diligence, M&A with our partner)More information on www.yole.fr

MEDIA & EVENTS• i-Micronews.com website & related @Micronews e-newsletter• Communication & webcast services• Events: TechDays, forums…More information on www.i-Micronews.com

REPORTS• Market & technology reports• Patent investigation and patent infringement risk analysis• Teardowns & reverse costing analysis• Cost simulation toolMore information on www.i-micronews.com/reports

CONTACTSFor more information about :• Consulting & Financial Services: Jean-Christophe Eloy ([email protected])• Reports: David Jourdan ([email protected]) Yole Group of Companies• Press Relations & Corporate Communication: Sandrine Leroy ([email protected])

Page 24: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

Definitions: “Acceptance”: Action by which the Buyer accepts the terms and conditions of sale in their entirety. It is done by signing the purchase order which mentions “I hereby accept Yole’s Terms and Conditions of Sale”.

“Buyer”: Any business user (i.e. any person acting in the course of its business activities, for its business needs) entering into the following general conditions to the exclusion of consumers acting in their personal interests.

“Contracting Parties” or “Parties”: The Seller on the one hand and the Buyer on the other hand.

“Intellectual Property Rights” (“IPR”) means any rights held by the Seller in its Products, including any patents, trademarks, registered models, designs, copyrights, inventions, commercial secrets and know-how, technical information, company or trading names and any other intellectual property rights or similar in any part of the world, notwithstanding the fact that they have been registered or not and including any pending registration of one of the above mentioned rights.

“License”: For the reports and databases, 3 different licenses are proposed. The buyer has to choose one license:• One user license: one person at the company can use the report.• Multi-user license: the report can be used by unlimited users

within the company. Subsidiaries and Joint-Ventures are not included.

• Corporate license: purchased under “Annual Subscription” program, the report can be used by unlimited users within the company. Joint-Ventures are not included.

“Products”: Depending on the purchase order, reports or database on MEMS, CSC, Optics/MOEMS, Nano, bio… to be bought either on a unit basis or as an annual subscription. (i.e. subscription for a period of 12 calendar months). The annual subscription to a package (i.e. a global discount based on the number of reports that the Buyer orders or accesses via the service, a global search service on line on I-micronews and a consulting approach), is defined in the order. Reports are established in PowerPoint and delivered on a PDF format and the database may include Excel files.

“Seller”: Based in Lyon (France headquarters), Yole Développement is a market research and business development consultancy company, facilitating market access for advanced technology industrial projects. With more than 20 market analysts, Yole works worldwide with the key industrial companies, R&D institutes and investors to help them understand the markets and technology trends.

1. SCOPE 1.1 The Contracting Parties undertake to observe the following

general conditions when agreed by the Buyer and the Seller. ANY ADDITIONAL, DIFFERENT, OR CONFLICTING TERMS AND CONDITIONS IN ANY OTHER DOCUMENTS ISSUED BY THE BUYER AT ANY TIME ARE HEREBY OBJECTED TO BY THE SELLER, SHALL BE WHOLLY INAPPLICABLE TO ANY SALE MADE HEREUNDER AND SHALL NOT BE BINDING IN ANY WAY ON THE SELLER.

1.2 This agreement becomes valid and enforceable between the Contracting Parties after clear and non-equivocal consent by any duly authorized person representing the Buyer. For these purposes, the Buyer accepts these conditions of sales when signing the purchase order which mentions “I hereby accept Yole’s Terms and Conditions of Sale”. This results in acceptance by the Buyer.

1.3 Orders are deemed to be accepted only upon written acceptance and confirmation by the Seller, within [7 days] from the date of order, to be sent either by email or to the Buyer’s address. In the absence of any confirmation in writing, orders shall be deemed to have been accepted.

2. MAILING OF THE PRODUCTS 2.1 Products are sent by email to the Buyer:

• within [1] month from the order for Products already released; or • within a reasonable time for Products ordered prior to their effective release. In this case, the Seller shall use its best endeavours to inform the Buyer of an indicative release date and the evolution of the work in progress.

2.2 Some weeks prior to the release date the Seller can propose a pre-release discount to the Buyer The Seller shall by no means be responsible for any delay in respect of article 2.2 above, and including incases where a new event or access to new contradictory information would require for the analyst extra time to compute or compare the data in order to enable the Seller to deliver a high quality Products.

2.3 The mailing of the Product will occur only upon payment by the Buyer, in accordance with the conditions contained in article 3.

2.4. The mailing is operated through electronic means either by email via the sales department or automatically online via an email/password. If the Product’s electronic delivery format is defective, the Seller undertakes to replace it at no charge to the Buyer provided that it is informed of the defective formatting within 90 days from the date of the original download or receipt of the Product.

2.5 The person receiving the Products on behalf of the Buyer shall immediately verify the quality of the Products and their conformity to the order. Any claim for apparent defects or for non-conformity shall be sent in writing to the Seller within 8 days of receipt of the Products. For this purpose, the Buyer agrees to produce sufficient evidence of such defects. .

2.6 No return of Products shall be accepted without prior information to the Seller, even in case of delayed delivery. Any Product returned to the Seller without providing prior information to the Seller as required under article 2.5 shall remain at the Buyer’s risk.

3. PRICE, INVOICING AND PAYMENT 3.1 Prices are given in the orders corresponding to each Product

sold on a unit basis or corresponding to annual subscriptions. They are expressed to be inclusive of all taxes. The prices may be reevaluated from time to time. The effective price is deemed to be the one applicable at the time of the order.

3.2 Yole may offer a pre release discount for the companies willing to acquire in the future the specific report and agreeing on the fact that the report may be release later than the anticipated release date. In exchange to this uncertainty, the company will get a discount that can vary from 15% to 10%.

3.3 Payments due by the Buyer shall be sent by cheque payable to Yole Développement, credit card or by electronic transfer to the following account: HSBC, 1 place de la Bourse 69002 Lyon France Bank code: 30056 Branch code: 00170 Account n°: 0170 200 1565 87BIC or SWIFT code: CCFRFRPP IBAN: FR76 3005 6001 7001 7020 0156 587

To ensure the payments, the Seller reserves the right to request down payments from the Buyer. In this case, the need of down payments will be mentioned on the order. 3.4 Payment is due by the Buyer to the Seller within 30 days

from invoice date, except in the case of a particular written agreement. If the Buyer fails to pay within this time and fails to contact the Seller, the latter shall be entitled to invoice interest in arrears based on the annual rate Refi of the «BCE» + 7 points, in accordance with article L. 441-6 of the French Commercial Code. Our publications (report, database, tool...) are delivered only after reception of the payment.

3.5 In the event of termination of the contract, or of misconduct, during the contract, the Seller will have the right to invoice at the stage in progress, and to take legal action for damages.

4. LIABILITIES 4.1 The Buyer or any other individual or legal person acting on

its behalf, being a business user buying the Products for its business activities, shall be solely responsible for choosing the Products and for the use and interpretations he makes of the documents it purchases, of the results he obtains, and of the advice and acts it deduces thereof.

4.2 The Seller shall only be liable for (i) direct and (ii) foreseeable pecuniary loss, caused by the Products or arising from a material breach of this agreement

4.3 In no event shall the Seller be liable for: a) damages of any kind, including without limitation, incidental or consequential damages (including, but not limited to, damages for loss of profits, business interruption and loss of programs or information) arising out of the use of or inability to use the Seller’s website or the Products, or any information provided on the website, or in the Products; b) any claim attributable to errors, omissions or other inaccuracies in the Product or interpretations thereof.

4.4 All the information contained in the Products has been obtained from sources believed to be reliable. The Seller does not warrant the accuracy, completeness adequacy or reliability of such information, which cannot be guaranteed to be free from errors.

4.5 All the Products that the Seller sells may, upon prior notice to the Buyer from time to time be modified by or substituted with similar Products meeting the needs of the Buyer. This modification shall not lead to the liability of the Seller, provided that the Seller ensures the substituted Product is similar to the Product initially ordered.

4.6 In the case where, after inspection, it is acknowledged that the Products contain defects, the Seller undertakes to replace the defective products as far as the supplies allow and without indemnities or compensation of any kind for labor costs, delays, loss caused or any other reason. The replacement is guaranteed for a maximum of two months starting from the delivery date. Any replacement is excluded for any event as set out in article 5 below.

4.7 The deadlines that the Seller is asked to state for the mailing of the Products are given for information only and are not guaranteed. If such deadlines are not met, it shall not lead to any damages or cancellation of the orders, except for non acceptable delays exceeding [4] months from the stated deadline, without information from the Seller. In such case only, the Buyer shall be entitled to ask for a reimbursement of its first down payment to the exclusion of any further damages.

4.8 The Seller does not make any warranties, express or implied, including, without limitation, those of sale ability and fitness for a particular purpose, with respect to the Products. Although the Seller shall take reasonable steps to screen Products for infection of viruses, worms, Trojan horses or other codes containing contaminating or destructive properties before making the Products available, the Seller cannot guarantee that any Product will be free from infection.

5. FORCE MAJEURE The Seller shall not be liable for any delay in performance directly or indirectly caused by or resulting from acts of nature, fire, flood, accident, riot, war, government intervention, embargoes, strikes, labor difficulties, equipment failure, late deliveries by suppliers or other difficulties which are beyond the control, and not the fault of the Seller.

6. PROTECTION OF THE SELLER’S IPR 6.1 All the IPR attached to the Products are and remain the

property of the Seller and are protected under French and international copyright law and conventions.

6.2 The Buyer agreed not to disclose, copy, reproduce, redistribute, resell or publish the Product, or any part of it to any other party other than employees of its company. The Buyer shall have the right to use the Products solely for its own internal information purposes. In particular, the Buyer shall therefore not use the Product for purposes such as: • Information storage and retrieval systems; • Recordings and re-transmittals over any network (including

any local area network); • Use in any timesharing, service bureau, bulletin board or

similar arrangement or public display; • Posting any Product to any other online service (including

bulletin boards or the Internet);• Licensing, leasing, selling, offering for sale or assigning the

Product. 6.3 The Buyer shall be solely responsible towards the Seller of

all infringements of this obligation, whether this infringement comes from its employees or any person to whom the Buyer has sent the Products and shall personally take care of any related proceedings, and the Buyer shall bear related financial consequences in their entirety.

6.4 The Buyer shall define within its company point of contact for the needs of the contract. This person will be the recipient of each new report in PDF format. This person shall also be responsible for respect of the copyrights and will guaranty that the Products are not disseminated out of the company.

6.5 In the context of annual subscriptions, the person of contact shall decide who within the Buyer, shall be entitled to access on line the reports on I-micronews.com. In this respect, the Seller will give the Buyer a maximum of 10 password, unless the multiple sites organization of the Buyer requires more passwords. The Seller reserves the right to check from time to time the correct use of this password.

6.6 In the case of a multisite, multi license, only the employee of the buyer can access the report or the employee of the companies in which the buyer have 100% shares. As a matter of fact the investor of a company, the joint venture done with a third party etc..cannot access the report and should pay a full license price.

7. TERMINATION 7.1 If the Buyer cancels the order in whole or in part or postpones

the date of mailing, the Buyer shall indemnify the Seller for the entire costs that have been incurred as at the date of notification by the Buyer of such delay or cancellation. This may also apply for any other direct or indirect consequential loss that may be borne by the Seller, following this decision.

7.2 In the event of breach by one Party under these conditions or the order, the non-breaching Party may send a notification to the other by recorded delivery letter upon which, after a period of thirty (30) days without solving the problem, the non-breaching Party shall be entitled to terminate all the pending orders, without being liable for any compensation.

8. MISCELLANEOUS All the provisions of these Terms and Conditions are for the benefit of the Seller itself, but also for its licensors, employees and agents. Each of them is entitled to assert and enforce those provisions against the Buyer. Any notices under these Terms and Conditions shall be given in writing. They shall be effective upon receipt by the other Party. The Seller may, from time to time, update these Terms and Conditions and the Buyer, is deemed to have accepted the latest version of these terms and conditions, provided they have been communicated to him in due time.

9. GOVERNING LAW AND JURISDICTION 9.1 Any dispute arising out or linked to these Terms and

Conditions or to any contract (orders) entered into in application of these Terms and Conditions shall be settled by the French Commercial Courts of Lyon, which shall have exclusive jurisdiction upon such issues.

9.2 French law shall govern the relation between the Buyer and the Seller, in accordance with these Terms and Conditions.

TERMS AND CONDITIONS OF SALES

Page 25: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

© 2018

Yole Développement

FromTechnologies to Market

Source: Wikimedia Commons

Page 26: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

21©2018 | www.yole.fr | About Yole Développement

FIELDS OF EXPERTISE COVERED BY OUR 40+ ANALYSTS

MEMS & Sensors

Solid State Lighting(LED, OLED, …)

Compound Semi.

Imaging

Photonics

MedTech

Manufacturing

Advanced

Packaging

Batteries / Energy Management

Power Electronics

Displays

RF

Devices &

Techno.

Advanced

Substrates

Software

Page 27: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

22©2018 | www.yole.fr | About Yole Développement

3 BUSINESS MODELS

o Consulting and Analysis

• Market data & research,

marketing analysis

• Technology analysis

• Strategy consulting

• Reverse engineering & costing

• Patent analysis

• Design and characterization of

innovative optical systems

• Financial services (due diligence,

M&A with our partner)

www.yole.fr

o Syndicated reports

• Market & technology reports

• Patent investigation and patent

infringement risk analysis

• Teardowns & reverse costing

analysis

• Cost simulation tool

www.i-Micronews.com/reports

o Media

• i-Micronews.com website

• @Micronews e-newsletter

• Communication & webcast

services

• Events: TechDays, forums,…

www.i-Micronews.com

Page 28: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

23©2018 | www.yole.fr | About Yole Développement

6 COMPANIES TO SERVE YOUR BUSINESS

Due diligence

www.yole.fr

Manufacturing costs analysis

Teardown and reverse engineering

Cost simulation tools

www.systemplus.fr

Market, technology and strategy

consulting

www.yole.fr

IP analysis

Patent assessment

www.knowmade.fr

Innovation and business maker

www.bmorpho.com

Design and characterization of

innovative optical systems

www.piseo.fr

Yole Group of Companies

Page 29: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

24©2018 | www.yole.fr | About Yole Développement

OUR GLOBAL ACTIVITY

30%of our business

40%of our business 30%

of our business

Greater

China office

Yole Japan

HQ in Lyon

Nantes

Paris

Nice

Vénissieux

Europe office

Frankfurt

Hsinchu

Tokyo

Yole Inc.

Phoenix

Yole Korea

Seoul

Palo Alto

Page 30: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

25©2018 | www.yole.fr | About Yole Développement

ANALYSIS SERVICES - CONTENT COMPARISON

Technology

and Market

Report

Leadership

Meeting

Q&A

Service

Depth of the analysis

Bre

adth

of th

e a

nal

ysis

Meet the

Analyst

Custom

Analysis

High

High

Low

Page 31: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

26©2018 | www.yole.fr | About Yole Développement

SERVING THE ENTIRE SUPPLY CHAIN

Our analysts provide market analysis,

technology evaluation,

and business plans along the entire

supply chain

Integrators, end-

users and software

developpers

Device manufacturers

Suppliers: material, equipment,

OSAT, foundries…

Financial investors, R&D centers

Page 32: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

27©2018 | www.yole.fr | About Yole Développement

SERVING MULTIPLE INDUSTRIAL FIELDS

We workacross

multiples industries to understand

the impact of More-than-

Moore technologies from deviceto system

From A to Z…

Transportation

makers

Mobile phone

and

consumer

electronics

Automotive

Medical

systems

Industrial

and defense

Energy

management

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28©2018 | www.yole.fr | About Yole Développement

o Yole Développement, System Plus Consulting, KnowMade and PISEO, all part of Yole Group of Companies, keep on increasing their collaboration to offer, in 2018, a

collection of 150+ reports. Combining respective expertise and methodologies from the 4 companies, the reports aim to provide market & technology analysis, patent

investigation and patent infringement risk analysis, teardowns & reverse costing analysis.They cover:

o You are looking for:

• An analysis of your product market

• A review of your competitors evolution

• An understanding of your manufacturing and production costs

• An understanding of your industry technology roadmap and related IPs

• A clear view on the evolution of the supply chain…

Our reports are for you!

The combined team of 60+ experts (PhDs, MBAs, industry veterans…) from Yole Développement, System Plus Consulting, KnowMade and PISEO, collect information,identify the trends, the challenges, the emerging markets, the competitive environments and turn it into results to give you a complete picture of your industrylandscape.

In the past 20 years, we worked on more than 1 700 projects, interacting with technology professionals and high level opinion makers from the main players of theindustry.

o In 2018, Yole Group of Companies plan to publish +150 reports. Gain full benefit from our Annual Subscription offers and receive at least a 36% discount.

REPORTS COLLECTION

www.i-Micronews.com

• MEMS & Sensors

• RF devices & technologies

• Imaging

• Medical technologies (MedTech)

• Photonics

• Advanced packaging

• Manufacturing

• Advanced substrates

• Power electronics

• Batteries and energy management

• Compound semiconductors

• Solid state lighting

• Displays

• Software

Page 34: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

29©2018 | www.yole.fr | About Yole Développement

OUR 2018 REPORTS COLLECTION (1/3)

MEMS & SENSORS

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Status of the MEMS Industry 2018 - Update

− Silicon Photonics 2018 - Update

− Consumer Biometrics: Sensors & Software 2018 - Update

− MEMS Pressure Sensors 2018

− Air Quality Sensors 2018

− Sensors for AR/VR 2018

o REVERSE ENGINEERING & COSTING REVIEW – by System Plus Consulting

− Gas & Particles Sensors

− MEMS Pressure Sensors

− Piezo MEMS 2018 *

o PATENT ANALYSES – by KnowMade

− MEMS Microphone – Patent Landscape Analysis

RF DEVICES AND TECHNOLOGIES

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− RF Front End Module and Connectivity for Cellphones 2018 – Update

− 5G Impact on RF Industry: From Wireless Infrastructure to Cellphone Terminals

2018 - Update

− RF GaN 2018 – Update

− Advanced RF System-in-Package for Cellphones 2018 – Update *

− Radar Technologies for Emerging Applications 2018 *

− Radar Technologies for Automotive 2018

− RF & Photonic Technologies for 5G Infrastructure 2018

o REVERSE ENGINEERING & COSTING REVIEW – by System Plus Consulting

− RF Front-End Modules in Smartphones

− RF GaN *

o PATENT ANALYSES – by KnowMade

− RF Front End Module – Patent Landscape Analysis

− RF GaN – Patent Landscape Analysis

IMAGING & OPTOELECTRONICS

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Status of the CMOS Image Sensor Industry 2018 – Update

− Status of the Compact Camera Module Industry 2018 - Update

− 3D Imaging and Sensing 2018 - Update

− Imaging for Industry and Automation 2018

− Sensors for Robotic Vehicles 2018

− Imagers and Detectors for Security and Smart Buildings 2018

− LiDARs 2018

o QUARTERLY UPDATE – by Yole Développement

− CMOS Image Sensors 2018 *

o REVERSE ENGINEERING & COSTING REVIEW – by System Plus Consulting

− CMOS Image Sensors

− Compact Camera Modules

o PATENT ANALYSES – by KnowMade

− LiDAR – Patent Landscape Analysis

− Time-of-Flight IR Sensor in the Apple iPhone 7 Plus - Patent-to-Product Mapping

SOFTWARE

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Consumer Biometrics: Sensors & Software 2018 - Update

− Processing Hardware and Software for AI: Integration Challenges 2018

Update : 2017 version still available / *To be confirmed

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30©2018 | www.yole.fr | About Yole Développement

OUR 2018 REPORTS COLLECTION (2/3)ADVANCED PACKAGING

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Status of Advanced Packaging Industry 2018 - Update

− Status of Advanced Substrates 2018: Embedded Die and Interconnects, Substrates

Like PCB Trends

− Fan-Out Packaging 2018 – Update

− 3D TSV and Monolithic Business Update 2018 – Update

− Advanced RF System-in-Package for Cellphones 2018 – Update *

− Power Packaging Modules 2018 - Update

− Discrete Power Packaging 2018 – Update

− MEMS Packaging and Testing 2018 – Update

− Memory Packaging Market and Technology Report 2018 – Update

− Status of Panel Level Packaging 2018

− Trends in Automotive for Advanced Packaging 2018

− Processing Hardware and Software for AI: Integration Challenges 2018

− Integrated Passive Devices (IPD) 2018

o REVERSE ENGINEERING & COSTING REVIEW – by System Plus Consulting

− RF Front-End SiP

− Fan-Out Packaging *

o PATENT ANALYSES – by KnowMade

− Hybrid Bonding for 3D Stack – Patent Landscape Analysis

MANUFACTURING

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Manufacturing Wafer Starts for More than Moore 2018

− Equipment for More than Moore: Technology & Market Trends for Lithography &

Bonding/Debonding 2018

− Equipment for More than Moore: Technology & Market Trends for Thin Film

Deposition & Etching 2018

o REVERSE ENGINEERING & COSTING REVIEW – by System Plus Consulting

− Wafer Bonding Technology Overview 2018

MEMORY

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Emerging Non Volatile Memory 2018 – Update

− Memory Packaging Market and Technology Report 2018 – Update

o QUARTERLY UPDATE – by Yole Développement

− Memory Market 2018 (NAND & DRAM)

o MONTHLY UPDATE – by Yole Développement

− Memory Pricing 2018 (NAND & DRAM)

o REVERSE ENGINEERING & COSTING REVIEW – by System Plus Consulting

− DRAM Technology & Cost Review 2018

− NAND Memory Technology & Cost Review 2018

COMPOUND SEMICONDUCTORS

MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Status of Compound Semiconductor Industry 2018 *

− Power SiC 2018: Materials, Devices, and Applications - Update

− Power GaN 2018: Materials, Devices, and Applications – Update

− RF GaN 2018 – Update

− GaAs Materials, Devices and Applications 2018

− InP Materials, Devices and Applications 2018

o REVERSE ENGINEERING & COSTING REVIEW – by System Plus Consulting

− Power SiC Devices

− Power GaN Devices

o PATENT ANALYSES – by KnowMade

− Power SiC – Patent Landscape Analysis

− Status of the GaN IP – Patent Landscape Analysis

Update : 2017 version still available / *To be confirmed

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31©2018 | www.yole.fr | About Yole Développement

OUR 2018 REPORTS COLLECTION (3/3)

POWER ELECTRONICS

MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Status of Power Electronics Industry 2018 - Update

− Power Packaging Modules 2018 - Update

− Discrete Power Packaging 2018 - Update

− EV/HEV Market Expectations and Technology Trends - Update

− Wireless Charging Market Expectations and Technology Trends 2018

− Integrated Passive Devices (IPD) 2018

o QUARTERLY UPDATE – by Yole Développement

− Power ICs Market 2018 – Update

o REVERSE ENGINEERING & COSTING REVIEW – by System Plus Consulting

− Power ICs Market 2018 *

− Power Modules *

BATTERY AND ENERGY MANAGEMENT

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Status of Battery Industry Update with Focus on Manufacturing 2018 *

− Battery Pack Technology and Business Opportunities 2018 - Update

o PATENT ANALYSES – by KnowMade

− Solid-State Batteries – Patent Landscape Analysis

SOLID STATE LIGHTING

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− IR LEDs and Lasers 2018 - Update

− Automotive Lighting 2018 – Update

− UV LEDs 2018 - Update

− VCSELs 2018

− Lasers 2018

− Light Shaping Technologies 2018

− LiFi 2018

o REVERSE ENGINEERING & COSTING REVIEW – by System Plus Consulting

− VCSELs 2018

− UV LEDs 2018 *

DISPLAYS

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− MicroLED Displays 2018 – Update

− Quantum Dots and Wide Color Gamut Display Technologies 2018 - Update

− Organic Thin Film Transistor 2018: Flexible Displays and Other Applications -

Update *

− Displays for AR / VR / MR 2018

− Non Display Applications of MicroLEDs 2018 *

o PATENT ANALYSES – by KnowMade

− MicroLED Display – Patent Landscape Analysis

MEDTECH

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Status of the BioMEMS Industry 2018 - Update

− Point-of-Need Testing: Application of Microfluidic Technologies 2018 - Update

− Neuro-Technologies for Healthcare and Consumer Applications 2018

− CRISPR Technology: From Lab to Industries 2018

− Portable Medical Imaging 2018

− Inkjet for Additive Manufacturing in the Micro-Electronics Industry 2018

− Liquid Biopsy 2018: From Isolation to Downstream Applications

− Chinese Microfluidics Industry 2018

o PATENT ANALYSES – by KnowMade

− Microfluidic IC Cooling – Patent Landscape Analysis

− Circulating Tumor Cell Isolation – Patent Landscape Analysis

− Organ-on-a-Chip – Patent Landscape Analysis

Update : 2017 version still available / *To be confirmed

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32©2018 | www.yole.fr | About Yole Développement

OUR 2017 PUBLISHED REPORTS (1/3)MEMS & SENSORS

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Status of the MEMS Industry 2017

− High End Inertial Systems Market and Technology 2017

− Magnetic Sensors Market and Technologies 2017

− MEMS and Sensors for Automotive - Market and Technology Trends 2017

− Acoustic MEMS and Audio Solutions 2017

− Sensors and Sensing Modules for Smart Homes and Buildings 2017

− Fingerprint Sensor Applications and Technologies – Consumer Market Focus 2017

o REVERSE COSTING REPORT – by System Plus Consulting

− Continental SRL1: State-of-the-art LiDAR for Advanced Driver Assistance Systems –

Reverse Costing Report

− Bosch Mobility Ultrasonic Sensor – Reverse Costing Report

− MEMS Packaging 2017 - Reverse Costing Review

− Bosch BMP380 Pressure Sensor – Reverse Costing Report

IMAGING & PHOTONICS

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Status of the CMOS Image Sensor Industry 2017

− 3D Imaging and Sensing 2017

− Uncooled Infrared Imaging Technology & Market Trends 2017

− Camera Module Industry Market and Technology Trends 2017

o REVERSE COSTING REPORT – by System Plus Consulting

− FLIR Boson – a small, innovative, low power, smart thermal camera core – Reverse

Costing Report

− Camera Module Physical Analyses Overview 2017

RF DEVICES AND TECHNOLOGIES

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− RF Front End Modules and Components for Cellphones 2017

− Advanced RF System-in-Package for Cell Phones 2017

− 5G Impact on RF Front-End Industry 2017

ADVANCED PACKAGING

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Status of the Advanced Packaging Industry 2017

− Embedded Die Packaging: Technology and Market Trends 2017

− Fan-Out: Technologies and Market trends 2017

− Advanced Substrates Overview: From IC Package to Board 2017

− 3D TSV and 2.5D Business Update - Market and Technology Trends 2017

− Advanced RF System-in-Package for Cellphones 2017

− Memory Packaging Market and Technology Report 2017

− MEMS Packaging 2017

− Emerging Non-Volatile Memory 2017

o REVERSE COSTING REPORT – by System Plus Consulting

− NVIDIA Tesla P100 - Reverse Costing Report

− MEMS Packaging - Reverse Technology Review

− Advanced RF SiP for Cellphones 2017 - Reverse Costing Review

SOFTWARE

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Embedded Software in Vision Systems

MEDTECH

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Status of the Microfluidics Industry 2017

− Solid-State Medical Imaging 2017

− Organs-On-Chips 2017

− Connected Medical Devices Market and Business Models 2017

− Artificial Organ Technology and Market analysis 2017

− Medical Robotics Technology & Market Analysis 2017

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33©2018 | www.yole.fr | About Yole Développement

OUR 2017 PUBLISHED REPORTS (2/3)

MANUFACTURING

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Laser Technologies for Semiconductor Manufacturing 2017

− Equipment and Materials for 3D TSV Applications 2017

− Equipment and Materials for Fan-Out Packaging 2017

− Glass Substrate Manufacturing in the Semiconductor Field 2017

BATTERIES & ENERGY MANAGEMENT

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Status of the Rechargeable Li-ion Battery Industry

− Market Opportunities for Thermal Management Components in Smartphones

DISPLAYS

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− MicroLED Displays

− Quantum Dots and Wide Color Gamut Display Technologies

− Phosphors & Quantum Dots 2017 - LED Downconverters for Lighting & Displays

SOLID STATE LIGHTING

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− LED Packaging 2017: Market, Technology and Industry Landscape

− CSP LED Lighting Modules

− IR LEDS and VCSELs - Technology, Applications and Industry Trends

− LED Lighting Module Technology, Industry and Market Trends 2017

− Automotive Lighting: Technology, Industry and Market Trends 2017

− Horticultural LED Lighting: Market, Industry, and Technology Trends

POWER ELECTRONICS

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Status of the Power Electronics Industry 2017

− Thermal Management Technology and Market Perspectives in Power Electronics and

LEDs 2017

− Gate Driver Market and Technology Trends 2017

− Power MOSFET 2017: Market and Technology Trends

− Power Module Packaging: Material Market and Technology Trends 2017

− IGBT Market and Technology Trends 2017

o QUARTERLY UPDATE – by Yole Développement

− Power Management ICs Market 2017

o REVERSE COSTING REPORT – by System Plus Consulting

− EPC2045 100V GaN-on-Silicon Transistor – Reverse Costing Report

− Silicon Capacitor - Technology and Cost Review

− Industrial 100V MOSFET - Technology and Cost Review

− InvenSense ICM-20789: High Performance 6-Axis Motion Sensor and Pressure Sensor

Combo – Reverse Costing Report

COMPOUND SEMICONDUCTORS

o MARKET AND TECHNOLOGY REPORT – by Yole Développement

− Bulk GaN Substrate Market 2017

− RF Power Market and Technologies 2017: GaN, GaAs and LDMOS

− Power SiC 2017: Materials, Devices, Modules, and Applications

− Power GaN 2017: Epitaxy, Devices, Applications, and Technology Trends

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34©2018 | www.yole.fr | About Yole Développement

OUR 2017 PUBLISHED REPORTS LIST (3/3)

OUR PARTNERS’ REPORTS

PATENT ANALYSES – by KnowMade

− Wireless Charging Patent Landscape Analysis

− RF Acoustic Wave Filters Patent Landscape Analysis

− NMC Lithium-Ion Batteries Patent Landscape Analysis

− Pumps for Microfluidic Devices Patent Landscape

− III-N Patent Watch

− FLUIDIGM Patent Portfolio Analysis

− Knowles MEMS Microphones in Apple iPhone 7 Plus Patent-to-Product Mapping 2017

− Consumer Physics SCiO Molecular Sensor Patent-to-Product Mapping

− Patent Licensing Companies in the Semiconductor Market - Patent Litigation Risk and Potential Targets

− Microfluidic Technologies for Diagnostic Applications Patent Landscape

TEARDOWN & REVERSE COSTING – by System Plus Consulting

More than 60 teardowns and reverse costing analysis and cost simulation tools published in 2017

MORE INFORMATION

o All the published reports from theYole Group of Companies are available on our website www.i-Micronews.com.

o Ask for our Annual Subscription offers: With our bundle offer, you choose the number of reports you are interested in and select the related offer. You then have up

to 12 months to select the required reports from the Yole Développement, System Plus Consulting and KnowMade offering. Pay once and receive the reports

automatically (multi-user format). Contact your sales team according to your location (see the last slide).

Page 40: Point-of-Need 2018 -Sample - US 3DS OUTSCALE€¦ · OBJECTIVES OF THE REPORT The report will provide: • An introduction to Point-of-Need testing, our definitions and why it is

35©2018 | www.yole.fr | About Yole Développement

MICRONEWS MEDIA

o About Micronews Media

To meet the growing demand for market,

technological and business information,

Micronews Media integrates several tools able

to reach each individual contact within its

network.We will ensure you benefit from this.

ONLINE ONSITE INPERSON

@Micronews e-newsletter

i-Micronews.com

i-Micronewsjp.com

FreeFullPDF.com

Events Webcasts

Unique, cost-effective ways

to reach global audiences.

Online display advertising

campaigns are great strategies

for improving your

product/brand visibility. They

are also an efficient way to

adapt with the demands of the

times and to evolve an effective

marketing plan and strategy.

Brand visibility, networking

opportunities

Today's technology makes it

easy for us to communicate

regularly, quickly, and

inexpensively – but when

understanding each other is

critical, there is no substitute

for meeting in-person. Events

are the best way to exchange

ideas with your customers,

partners, prospects while

increasing your brand/product

visibility.

Targeted audience

involvement equals clear,

concise perception of your

company’s message.

Webcasts are a smart,

innovative way of

communicating to a wider

targeted audience. Webcasts

create very useful, dynamic

reference material for

attendees and also for

absentees, thanks to the

recording technology.

Benefit from the i-Micronews.com

traffic generated by the 11,200+

monthly unique visitors, the

10,500+ weekly readers of

@Micronew se-newsletter

Several key events planned for

2018 on different topics to

attract 120 attendees on average

Gain new leads for your business

from an average of 340

registrants per webcast

Contact: Camille Veyrier ([email protected]), Marketing & Communication Project Manager

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36©2018 | www.yole.fr | About Yole Développement

CONTACT INFORMATION

o CONSULTING AND SPECIFIC ANALYSIS

• North America: Steve LaFerriere, Director of Northern America Business DevelopmentEmail: [email protected] – +1 31 06 008 267

• Japan & Rest of Asia: Takashi Onozawa, General Manager, Asia Business DevelopmentEmail: [email protected] - +81 3 4405 9204

• Greater China: Mavis Wang, Director of Greater China Business DevelopmentEmail: [email protected] - +886 979 336 809

• RoW: Jean-Christophe Eloy, CEO & President, Yole DéveloppementEmail [email protected] - +33 4 72 83 01 80

o REPORT BUSINESS

• North America: Steve LaFerriere, Director of Northern America Business DevelopmentEmail: [email protected] – +1 31 06 008 267

• Europe: Lizzie Levenez, EMEA Business Development ManagerEmail: [email protected] - +49 15 123 544 182

• Rest of Asia: Takashi Onozawa, General Manager, Asia Business DevelopmentEmail: [email protected] - +81 3 4405 9204

• Japan:

• Miho Othake, Account ManagerEmail: [email protected] - +81 3 4405 9204

• Itsuyo Oshiba, Account ManagerEmail: [email protected] - +81-80-3577-3042

• Greater China: Mavis Wang, Director of Greater China Business DevelopmentEmail: [email protected] - +886 979 336 809

o FINANCIAL SERVICES (in partnership with Woodside Capital Partners)

• Jean-Christophe Eloy, CEO & PresidentEmail: [email protected] - +33 4 72 83 01 80

o GENERAL

• Public Relations: [email protected] - +33 4 72 83 01 89

• Email: [email protected] - +33 4 72 83 01 80

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