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11
January 2016
In Vitro Diagnostics (IVD) Market Size,
Growth, Competition and Trends (2012-
2018)
DeciBio Consulting, LLC
725 Arizona Ave. Suite 202
Santa Monica, CA 90401
Phone: 310-451-4510
Email: [email protected]
www.decibio.com
Information contained in this market report is believed to be reliable
at the time of publication. DeciBio Consulting, LLC is not soliciting
any action based on the information contained in this report. See
appendix section for complete disclosures.
22
Report Outline
• Introduction and Methodology
• Executive Summary
• IVD Market by Technology
• IVD Market by Therapeutic Areas
• Company Analysis
• Appendix
33
Table of contents
Introduction and Methodology 2
Report Outline 3
Introduction 4
Report Author Biographies 5
About DeciBio 6-7
DeciBio Definition of “In Vitro Diagnostics” 8
DeciBio Definitions: Technologies 9
DeciBio Definitions: TA (1 of 3) 10
DeciBio Definitions: TA (2 of 3) 11
DeciBio Definitions: TA (3 of 3) 12
Products Included / Excluded 13
Overview of Research 14
Segmentation Overview 15
Model Overview 16
Modeling Methodologies (1 of 3) 17
Modeling Methodologies (2 of 3) 18
Modeling Methodologies (3 of 3) 19
Executive Summary 20
Report Abstract 21
WW IVD Market by Technology 22
WW IVD Market by Therapeutic Area 23
WW IVD Market by Geography & Company 24
Geographic Growth & Segmentation 25
Key Trends: Market & Demographics 26
Key Trends: Regulatory & Reimbursement 27
Key Trends: Technology 28
Key Trends: Healthcare Delivery 28
IVD Market by Technology 30
Clinical Chemistry 31
Culture 32
Flow Cytometry 33
Glucose Strip Monitoring 34
Immunoassay 35
IVD Market by Technology (cont.) 30
Mass Spectrometry 36
Molecular Diagnostics 37
Tissue Diagnostics 38
IVD Market by Therapeutic Area 39
Autoimmune / Inflammatory 40
Blood Screening 41
Cardiovascular 42
Diabetes 43
Endocrine 44
General Chemistry 45
Hematology 46
Hemostasis 47
Infectious Disease 48
Metabolic 49
Microbiology 50
Oncology 51
Reproductive 52
Transplant 53
Other 54
Company Analysis 55
Roche 56
Abbott 57
Danaher 58
Siemens 59
Becton Dickinson 60
Thermo Fisher 61
Alere 62
OCD 63
Sysmex 64
BioMerieux 65
LifeScan 66
Bio-Rad 67
Company Analysis (cont.) 46
Werfen 68
Hologic 69
Qiagen 70
Bayer 71
Grifols 72
Arkray 73
Agilent 74
Cepheid 75
DiaSorin 76
Fujirebio 77
Luminex 78
Illumina 79
Nanostring 80
Appendix 81
Population Growth by Age 82
Healthcare Spend per Capita 83
About DeciBio 84
Other Relevant DeciBio Reports 85
Disclaimer 86
44
Report Author Biographies
David Cavanaugh ([email protected])
David Cavanaugh is a Partner at DeciBio with over 15 years of combined experience in life science business consulting and
life science research and development. David has extensive experience publishing on the clinical diagnostic and life sciene
research tools markets and advising leaders in these markets on various business issues.
David leads the clinical diagnostic practice at DeciBio where his roles include both the authorship of high quality market
intelligence content as well as leading tailored consulting engagements for a variety of client types. David earned his M.B.A
from the Kellogg School of Management at Northwestern University and his B.S. in Chemical Engineering from the University
of Virginia.
Melissa Campos ([email protected])
Melissa Campos is an Associate at DeciBio with ~5 years of combined experience in life science business consulting and
academic research. Melissa has conducted multiple engagements at DeciBio ranging from market opportunity assessments to
competitive intelligence landscapes for a large life science research tools and reagents company.
Prior to DeciBio, Melissa worked on a strategy consulting and market assessment project for a potential spin-out company as
a Graduate Student Consultant for the Beckman Research Institute at City of Hope. Melissa earned her Master of Bioscience
from the Keck Graduate Institute with a focus on Business of Bioscience, and her B.A. in Science and Management with a
biotechnology focus from Claremont McKenna College.
Stephane Budel ([email protected])
Stephane Budel is a Partner at DeciBio with over 15 years of combined experience in life science business consulting,
entrepreneurship, and academic research. Stephane has extensive experience analyzing private to mid-cap companies with
established to emerging technologies in the life science research tools and molecular diagnostics spaces.
Stephane is a market expert who specializes in the cutting edge of these markets, with a deep understanding of the technical
and business potential of innovative technologies such as qPCR, and NGS. Prior to DeciBio, Stephane earned his Ph.D. from
Yale University for his research on the molecular mechanisms of spinal cord injury and schizophrenia. A central part of his
research relied on genomics technologies, and included a collaboration with 454 Life Sciences.
55
DeciBio’s mission is to provide the market
intelligence and strategic insights that drive
disruption and innovation in the research tools,
clinical diagnostics, and medical device markets
66
Content Consulting
We are industry leaders in
market intelligence products
We serve companies through
tailored consulting engagements
Our proprietary content provides us with the most in-depth understanding of the
scientific and business challenges facing life science clients today
o Market Reports
o MarketBook
o Customer Surveys
o Business development
o Marketing strategy
o Opportunity assessments
77
In vitro diagnostics
Definition: In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other
conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae; such products
are intended for use in the collection, preparation, and examination of specimens taken from the human body
In this report, DeciBio limited its scope of what defines an in vitro diagnostic
(IVD) to include only those classified by the U.S. FDA (e.g., class I, II, or III)
Device
Classification
Note: * The FDA definition of effectiveness for class III devices is not the same as efficacy for pharmaceutical approvals
Source: FDA.gov, DeciBio analysis
• Examples of Class I IVDs include basic tests such as culture plates, they:
o Are not intended to help support or sustain life or be substantially important in preventing
impairment to human health
o Do not present an unreasonable risk of illness or injury devices
Class I
Class II
Class III
• Examples of Class II IVDs many typical tests such as a pregnancy test, cholesterol test, they:
o Are held to a higher level of assurance than Class I devices, and are designed to perform as
indicated without causing injury or harm to the patient or user
o Are sometimes exempt from premarket notification, but in general special controls may include
special labeling requirements, mandatory performance standards and post market surveillance
• Examples of Class III IVDs include tests such as companion diagnostics, they:
o Are devices that support or sustain life, are of substantial importance in preventing impairment or
disease and / or present the potential for an unreasonable risk of illness or injury
o Are products for which insufficient information exists to assure safety and effectiveness solely
through the general or special controls sufficient for Class I & II devices
Description
Typical
Pathway(s)
Premarket
Notification
510(k)
510(k) /
de novo
510(k)
De novo
510(k) /
Premarket
Approval
(PMA)
U.S. FDA Medical Devices Classification System
Revenues associated with laboratory developed tests (LDTs) are not included in our IVD market sizing
88
This report assesses the global market size, growth and trends of the IVD
marketplace; we define the technologies as the following:
Technology Definition ExamplesCommon External
Classifications*
Clinical
Chemistry
Demonstrating the presence of physiologically significant substances (e.g.,
proteins, metabolites) in the blood, urine, tissue, and body fluids with application
to the diagnosis of disease and therapy selection
Excludes: glucose strip monitoring
o General chemistry
analyzer (e.g., lipids,
electrolytes, enzymes)
o Urine analyzer
o Blood gas analyzer
o General chemistry
Culture
Detecting and quantifying bacteria related to microbial infections in urine, blood,
and other body fluids (e.g., CSF)
Excludes: N / A
o Solid culture
o Liquid cultureo Microbiology
Flow Cytometry
Making, processing, and displaying one or more measurements on individual cells
obtained from a cell suspension
Excludes: N / A
o Flow cytometerso Cellomics
o Single cell
Glucose Strip
Monitoring
Self-evaluating whole blood glucose levels outside the clinical laboratory using a
POC device
Excludes: N / A
o POC Glucometer o Diabetes
Immunoassay
Matching antibody-antigen response to indicate the presence or level of a protein,
frequently used in point-of-care (POC) testing and blood banking
Excludes: N / A
o ELISA
o Lateral flowo Immunochemistry
Mass
Spectrometry
Determining the identity of a chemical based on its mass using mass analyzers /
mass spectrometers
Excludes: N / A
o MALDI-TOF MS
o LC/MS
o GS/MS
o TOF LC/MS
o N / A
Molecular
Diagnostics
Examining nucleic genetic material (DNA / RNA) for sequences that may indicate
presence or susceptibility to disease
Excludes: N / A
o PCR / qPCR
o Sanger
o NGS
o Genomics
o Proteomics
Tissue
Diagnostics
Examining prepared and stained tissue or cells by a pathologist
Excludes: N / A
o IHC
o ISH
o Cytology
o Histology
Note: * External parties (e.g., IVD companies, market research firms) segment the market according to their unique views; this list includes other possible names and
categorizations of the same therapeutic areas
Source: DeciBio Analysis
99
This report assesses the global market size, growth and trends of the IVD
marketplace; we define the therapeutic areas as the following (1 of 3):Therapeutic
AreaDefinition Applications Examples
Common External
Classifications*
Autoimmune /
Inflammatory
Testing for autoimmune diseases and
monitoring inflammatory responses
Excludes: N / A
o Allergy testing
o Asthma testing
o Autoimmune diseases (e.g., celiac
disease, rheumatoid arthritis)
o IgA, IgG, IgE, IgM
o Rheumatoid factor
o Anti-CCP
o Allergy
o Inflammatory
Blood
Screening
Screening donated blood and plasma to
determine blood type and test for the
presence of infectious disease (e.g., HBV,
HCV, HIV, WNV)
Excludes: infectious disease testing on
patient samples
o Blood typing and grouping (e.g., ABO
group, Rh factor)
o Infectious disease screening
o ABO group
o RhD
o Infectious disease
screening
o Blood banking
o Subsegment of
hematology
Cardiovascular
Identifying conditions involving the
cardiovascular system
Excludes: N / A
o Routine testing (e.g. lipids)
o Acute cardiac conditions (e.g., acute
coronary syndrome, heart attack)
o Chronic cardiac conditions (e.g., heart
failure, coronary artery disease)
o Cholesterol
o Troponin
o CK-MB
o CPK
o BNP
o Cardiac markers
o Lipids
o Subsegment of
hematology or
general chemistry
Hemostasis
Evaluating the multiple enzymes and
proteins that regulate blood flow and clot
formation
Excludes: N / A
o Anticoagulation drug monitoring (e.g.,
PTT)
o Pre-operative screening
o Bleeding disorders (e.g., hemophilia,
Von Willebrand disease)
o PT/INR
o PTT
o ACT
o D-dimer
o Factor II, V, VIII, IX, X
o Coagulation
o Subsegment of
hematology or
general chemistry
Diabetes
Examining a heterogeneous group of
disorders characterized by hyperglycemia
and glucose intolerance
Excludes: N / A
o Diabetes screening
o Glucose monitoring
o HbA1c
o Insulin
o Glucose
o Subsegment of
metabolic
Endocrine
Testing related to the system of secretory
glands (i.e., thyroid, adrenal glands,
pituitary glands)
Excludes: pregnancy, fertility and prenatal
testing
o Hyper / hypothyroidism
o Hyperparathyroidism
o Endocrine disorders (e.g., Addison’s
disease, Conn’s disease, Graves’
disease)
o Thyroid uptake
o T3
o T4
o Thyroglobulin
o Cortisol
o Thyroid
o Fertility
o Hormones
o Subsegment of
general chemistry
Note: * External parties (e.g., IVD companies, market research firms) segment the market according to their unique views; this list includes other possible names and
categorizations of the same therapeutic areas
Source: DeciBio Analysis
1010
This report assesses the global market size, growth and trends of the IVD
marketplace; we define the therapeutic areas as the following (2 of 3):Therapeutic
AreaDefinition Applications Examples
Common External
Classifications*
General
Chemistry
Examining general proteins and
metabolites that are applicable to overall
health or multiple therapeutic areas
Excludes: cardiovascular
o Routine testing (e.g., electrolytes,
nutritional assessment)
o Pre-operative screening
o Albumin
o Calcium
o Chloride
o Potassium
o Sodium
o Nutritional
assessment
o Electrolytes
o Metabolic
Hematology
Evaluating blood components (e.g.,
peripheral blood, bone marrow cells) in
order to diagnose various diseases of the
blood
Excludes: hemostasis, blood screening
o Routine testing (e.g., complete blood
count)
o Pre-operative screening
o Anemia testing
o RBCs
o WBCs
o Platelets
o Hematocrit
o Hemoglobin
o Coagulation
o Anemia
o Subsegment of
general chemistry
Infectious
Disease
Identify infectious diseases caused by
(predominantly) viral pathogens
Excludes: blood screening, HAIs, bacterial
infections
o Acute STDs (e.g., CT/NG, trichomonas,
MG)
o Chronic STDs (e.g., HBV, HCV, HIV)
o Respiratory tract infections (e.g.,
influenza, rhinitis, pneumonia)
o CT/NG
o HBV
o HCV
o HIV
o Influenza
o STDs
o Women’s health
o Respiratory
o Microbiology
o HAIs
Metabolic
Determining liver and kidney function,
electrolyte balance, and various other
metabolic aspects of patient health
Excludes: diabetes
o Newborn screening (e.g., SCID, PKU)
o Metabolic disorders (e.g., Gaucher’s
disease, Pompe disease, Barth
syndrome)
o BUN
o Creatinine
o Total protein
o ALT
o AST
o Urinalysis
o Renal
o Hepatic
o Subsegment of
general chemistry
Microbiology
Detecting disease-causing agents,
specifically hospital-acquired infections
(HAIs)
Excludes: viral infections (e.g., STDs,
respiratory infections)
o Hospital-acquired infection testing
(MRSA, C. diff, CMV)
o Bacterial infection testing (MTB,
Malaria, Chagas disease)
o MRSA
o C. diff
o CMV
o MTB
o Malaria
o HAIs
o Culture
o Subsegment of
infectious disease
Oncology
Testing for the presence of cancer and
monitoring patient response to therapy
Excludes: N / A
o Cancer diagnosis (e.g., breast, CRC,
lung, prostate, ovarian)
o Therapy monitoring
o PSA
o Her2-neu
o EGFR
o KRAS
o BRAF
o Cancer
o Tumor markers
Note: * External parties (e.g., IVD companies, market research firms) segment the market according to their unique views; this list includes other possible names and
categorizations of the same therapeutic areas
Source: DeciBio Analysis
1111
This report assesses the global market size, growth and trends of the IVD
marketplace; we define the therapeutic areas as the following (3 of 3):Therapeutic
AreaDefinition Applications Examples
Common External
Classifications*
Reproductive
Examining levels of hormones to
determine fertility, pregnancy and prenatal
status
Excludes: N / A
o Pregnancy test
o Fertility tests
o NIPT
o hCG
o Progesterone
o Testosterone
o FSH
o Fertility
o Prenatal
o Subsegment of
endocrine
Transplant
Monitoring transplant patients to remain in
a specific therapeutic range to prevent
rejection and reduce toxicity
Excludes: N / A
o Transplant screening tests (e.g., blood
typing, HLA typing, cross-matching)
o Patient / treatment response monitoring
o Toxicity
o HLA
o Cyclosporine
o Sirolimus
o Tacrolimus
o HLA typing
o Immunosuppressive
drugs
Other
Testing for broad applications related to
multiple therapeutic areas including drugs-
of-abuse and toxicity testing
Excludes: therapy monitoring for oncology
and transplant patients
o Drugs of abuse / toxicity tests
o Therapeutic drug monitoring (e.g.,
antiepileptics, antiarhythmics,
antibiotics)
o Acetaminophen
o Alcohol
o Cocaine
o Digoxin
o Lithium
o Drugs –of-abuse
o Toxicity
o Therapeutic drug
monitoring
Note: * External parties (e.g., IVD companies, market research firms) segment the market according to their unique views; this list includes other possible names and
categorizations of the same therapeutic areas
Source: DeciBio Analysis
1212
This report assesses the overall size, growth and trends of the global IVD
manufacturer market; it includes and excludes the following:
Instruments (Instruments, service
contracts and software)
Reagents
Services (excluded)
Market Revenue Component
• Instruments include systems used for sample preparation or analysis
o Example instruments include Hologic Panther, Cepheid GeneXpert, Roche cobas
• Service contracts include annual maintenance agreements between users and manufacturers to
“insure” the instrument and guarantee timely maintenance repair as needed
o Service contracts typically vary from 10-15% of instrument purchase price (per year)
• Software includes programs required to run the instruments analyzed in this report
o More advanced (e.g., Thermo Fisher lab automation software) and third party software are not
included in this analysis
• Reagents and kits are products that are used (in combination or not with an instrument) in order
to analyze a clinical sample
o Example reagents include diagnostic test kits and instrument controls
• Services include consulting solutions and outsourced services for anything outside of instrument
maintenance
o Example services include consumer testing facilities (e.g., Myriad Genetics, Foundation
Medicine, Pathway Genomics), OEM contracts (e.g., blood screening instruments manufactured
by Hologic sold by Grifols) and consulting or advisory services (e.g., Thermo Fisher laboratory
automation solutions, Siemens workflow management services)
Laboratory Developed
Tests (excluded)
• Laboratory developed tests include tests that laboratory develop on their own using non-IVD
assays and reagents (e.g., research use only)
o Example LDTs include: FoundationOne from Foundation Medicine; Oncotype DX from Genomic
Health; academic medical NGS panels for oncology (e.g., MSK-IMPACT)
1313
We used secondary research and our extensive knowledge of the industry to
compile data presented in this report
Note: * This is a high-level overview of secondary research sources used and is not comprehensive
Source: DeciBio analysis
We built a market model segmented by technology, therapeutic area (TA) and geography with growth rates
obtained from historic trends, analyst estimates, earnings call transcripts, company and investor presentations, and
other publications
• 10-K / 10-Q filings
• Company presentations
• Investor presentations
• Earnings call transcripts
• Analyst reports
• Press releases
• Company website
• Company publications
and posters
• Company technical
sheets
• Company product
catalogs
Data and analysis*
Company Financial Information Company Technical Information Other
• PubMed
• Peer-reviewed
publications and scientific
posters
• Government reports and
databases (e.g., NIH
reporter)
• Healthcare conferences
(e.g., JP Morgan, Cowen)
1414
For this report, DeciBio has segmented the WW IVD Market by company, and
for each company, by technology, therapeutic area and geography
Note: * For a complete list of companies covered, see the Company section of this report; ** Non-specific includes basic physiology like electrolytes, lipids and
enzymes
Source: DeciBio analysis
WW IVD Market (~$59B)
Abbott Grifols Thermo FisherBy
Company*
• Clinical Chemistry
• Culture
• Flow Cytometry
• Glucose Strip Monitoring
• Immunoassay
• Mass Spectrometry
• Molecular Diagnostics
• Tissue Diagnostics
• Autoimmune / Inflammatory
• Blood Screening
• Cardiovascular Disease
• Diabetes
• Endocrine
• General chemistry
• Hematology
• Hemostasis
• Infectious Disease
• Metabolic Disease
• Microbiology
• Oncology
• Reproductive
• Transplant
• Other
By Technology By Therapeutic Area By Geography
• North America
• Europe
• Latin America
• Asia Pacific
• China
• Japan
• RoW
… …
1515
• Clinical Chemistry
• Culture
• Flow Cytometry
• Glucose Strip Monitoring
• Immunoassay
• Mass Spectrometry
• Molecular Diagnostics
• Tissue Diagnostics
• Abbott
• Alere
• Arkray
• Bayer
• Becton Dickinson
• Bio-Rad
• Cepheid
• Etc…
• Abbott
• Agilent
• Alere
• Arkray
• Bayer
• BD
• BioMerieux
• Bio-Rad
• Cepheid
• Danaher
• DiaSorin
• Fujirebio
• Grifols
• Hologic
• Illumina
• LifeScan
• Luminex
• Nanostring
• OCD
• Qiagen
• Roche
• Siemens
• Sysmex
• Thermo Fisher
• Werfen
We estimated the Global IVD Market Size using a bottoms-up approach,
segmenting revenues across technologies and therapeutic areas
Over 20 Leading Companies Were Included in Our Model
Individual Company IVD
Revenues% by Technology
Individual Company IVD
Revenues by Technologyx =
Individual Company IVD
Revenues by Technology =Σx
% by Therapeutic Area
=Individual Company IVD
Revenues by TA =Overall IVD Market by
Therapeutic Area
Overall IVD Market by
Technology
Σx
% by Geography
=Individual Company IVD
Revenues by Geography =Overall IVD Market by
GeographyΣ
1616
We used the following modeling methodology to determine the market size,
company revenues, segmentation, and growth (1 of 3)
Research Activity Methodology Example Sources
Determining IVD
Revenues by
Company*
• Cataloged overall company
revenues through SEC filings (e.g.,
10K, 10Q) and Annual Reports
from 2012-present**
• Determined IVD revenues (vs. non-
IVD revenues) through a mix of the
following sources:
o Financial reports (e.g., SEC filings,
Annual Reports)
o Investor presentations
o Industry publications
o Conference materials
o Company website
Segmentation by
Technology
• Determined technology splits
through relevant secondary
information using:
o Financial reports (e.g., SEC filings,
Annual Reports)
o Earnings call transcripts
o Sales data
o Analyst reports
o Industry publications
o Publicly available data on market
size and market share of
components of technology
DeciBio Model
DeciBio Model
Investor Presentation
Company SEC Filings
Available Sales Data
Note: * DeciBio determined revenues of non-major companies (“All Others”) through analysis of each individual technology including determining level of
fragmentation, layering in secondary data regarding market share, layering in secondary data regarding emerging company revenues, and estimating relative
size of “All Other” companies in each technology; ** Used financial data from 2011 for some companies to standardize the fiscal year to begin January 1st
Company SEC Filings
1717
We used the following modeling methodology to determine the market size,
company revenues, segmentation, and growth (2 of 3)
Research Activity Methodology Example Sources
Segmentation by
Therapeutic Area
& Geography
• Segmented each Technology by
Therapeutic Area (unique to each
technology) and Geography
• Determined Therapeutic Area splits
(for each technology) by using a
synthesis of the following:
o SEC filings
o Investor presentations
o Earnings call transcripts
o Company product catalogues
o Company website
o Publicly available data on market
size and market share of
components of therapeutic area
o Product prevalence in corporate
literature and company website
o Other DeciBio reports and
experience
• Determined Geography splits
using:
o Geography revenue breakdowns in
financial reports
o Analyst reports
o Earnings call transcripts
o Press releases
o Industry and government
publications
Company Websites Product Catalogs Investor Presentations
Other DeciBio Reports
Company Annual Report
Company SEC Filings
Earnings Press Release
Company Annual Report
1818
WIP
We used the following modeling methodology to determine the market size,
company revenues, segmentation, and growth (3 of 3)
Research Activity Methodology Example Sources
Building in
Growth
• Determined growth estimates by
using a synthesis of the following:
o Historical top-line growth rates
o Analyst estimates
o Analyst reports
o Earnings call transcripts
o Investor presentations
o Interviewee feedback
o Previous DeciBio reports and
experience
Triangulation
• Triangulated absolute and relative
company revenues, growth,
segment revenues against the
following:
o Internal data sets for individual
technologies, therapeutic areas
and geographies
o Previous DeciBio reports
o Industry / government publications
o Other available market data points
DeciBio Model
Analyst Estimates / Revenue Projections
Investor Presentations
Historical Top-Line Growth
DeciBio Triangulation Sheets
Triangulation
type unit input 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Secondary Sources
By Source
DeciBio MDx Market Report (2015) feed $B 4.0% 52$ 54$ 56$ 58$
Company Estimate feed $B 3.6% 55$ 56$ 59$ 61$ 63$ 65$
Company Estimate feed $B 5.3% 53$ 56$ 59$ 62$ 66$ 69$ 73$ 75$
Analyst Report feed $B 5.0% 50$ 53$ 55$ 58$ 61$ 63$
Market Research Website feed $B 7.0% 46$ 49$ 52$ 56$ 60$ 65$
Market Research Website feed $B 7.8% 44$ 47$ 51$ 55$ 59$ 64$
Publication feed $B 5.0% 41$ 43$ 45$ 47$
feed $B
feed $B
Total diagnostics revenue calc $B 41$ 43$ 48$ 52$ 55$ 58$ 61$ 64$ 67$ 73$ 75$
1919
Report Outline
• Introduction and Methodology
• Executive Summary
• IVD Market by Technology
• IVD Market by Therapeutic Areas
• Company Analysis
• Appendix
2020
Abstract: DeciBio forecasts that the WW IVD market will grow at ~5% p.a. over
the next 3 years, driven by high-growth segments
This inaugural edition of DeciBio’s IVD report provides an overview of the In Vitro Diagnostics (IVD) market from 2012 to
2018. IVD companies offer diagnostic instruments, reagents and services to clinical laboratories. These tests are marketed
and sold specifically for the purpose of patient diagnosis and treatment decision making, and as such must be approved for
this purpose by governing regulatory bodies (e.g. FDA or CE Mark approval). This market report excludes laboratory
developed tests (LDTs) since they do not use IVD kits / assays.
The ~$60B worldwide IVD market is expected to grow at ~5% through 2018. This market is currently moderately
consolidated, with top 15 manufacturers (including Roche, Abbott, Danaher, Siemens, Becton Dickenson, Thermo Fisher,
Alere, OCD, Sysmex, BioMerieux, LifeScan (J&J), Bio-Rad, Werfen, Hologic and Phillips) representing over 75% of sales.
However, many mid-size (e.g., Cepheid, Luminex) and smaller emerging (e.g., Illumina, NanoString) players are highlighted
and included in this report as well.
The analysis conducted for this report includes careful triangulation of market growth with past and forecasted organic growth
from key players. Our market model provides robust segmentation and growth segmented by:
• Technology: clinical chemistry, culture, flow cytometry, glucose strip monitoring, immunoassay, mass spectrometry, molecular
diagnostics and tissue diagnostics
• Therapeutic area: autoimmune, blood screening, cardiovascular, diabetes, endocrine, general chemistry, hemostasis, hematology,
infectious disease, metabolic disease, microbiology, oncology, reproductive, transplant, and other
• Geography: North America, Europe, LATAM, Asia-Pac, China, Japan and ROW
• Competitor: Roche, Abbott, Danaher, Siemens, Becton Dickinson, Thermo Fisher, Alere, OCD, Sysmex, BioMérieux, LifeScan
(J&J), Bio-Rad, Werfen, Hologic, Phillips and many others
In addition to the quantitative market model, we detail market trends (e.g., clinical adoption of next generation sequencing
(NGS), changing trends in lab throughput needs), drivers (e.g., infectious disease testing switching from low priced culture to
higher priced MDx) and moderators (e.g., pricing and reimbursement pressures), and a high level technology and revenue
breakdown for key competitors.
All data are based on manufacturer sales as publically reported, other public data and over 1,000 customer interviews with
customers and industry participants conducted over the last year.
Online abstract
2121
Report Outline
• Introduction and Methodology
• Executive Summary
• IVD Market by Technology
• IVD Market by Therapeutic Areas
• Company Analysis
• Appendix
2222
If interested in this report, consider the following DeciBio reports
• Find related DeciBio reports on our website: www.decibio.com:
o Molecular Diagnostics: Market Size, Segmentation, Growth and Opportunities
(http://www.decibio.com/MDx)
o Next Generation Sequencing: Market Size, Segmentation, Growth and Trends by
Provider (http://www.decibio.com/NGS)
o Single Cell Genomics (SCG): Market Size, Segmentation, Growth, Competition and
Trends (http://www.decibio.com/SCG)
o Companion Diagnostics: Market Size, Segmentation, Growth, Competition and Trends
(http://www.decibio.com/CDx)
o Life Sciences Research Tools Market (http://decibio.com/Rx_tools)
• Contact us at [email protected] in order to receive information on our
DeciBio Marketbook, which provides additional granularity on these markets