The document discusses the current state and expected growth trends of the in vitro diagnostics (IVD) market. It notes that the global IVD market was estimated at $54.2 billion in 2013 and is expected to grow 4% annually to $64.3 billion by 2018. Technological advances in areas like genomics, bioinformatics, and miniaturization have transformed diagnostic laboratory technology in recent years. Personalized medicine, infectious disease testing, and other applications are driving growth in the IVD market. However, economic instability, rising healthcare costs, and reimbursement changes pose challenges for the industry.

1. The IVD Market: Current
Size and Expected Growth TrendDiagnostic laboratory technology has changed dramatically in the past few years, due to the publication
of the human genome project and advances in functional genomics, bioinformatics, miniaturization and
microelectronics. Not three years ago it would have been almost inconceivable to see research technologies
such as genome sequencing and mass spectroscopy play a pivotal role in improving lab medicine. Their
influence is felt in personalized medicine, inherited diseases, pathogen detection, antibiotic resistance testing,
blood banking and much more to come.
The world market for diagnostics is estimated at $54.2 billion in 2013 and is expected to grow 4% annually
to $64.3 billion by 2018. This includes all laboratory and hospital-based products, and OTC product sales.
Clinical lab medicine plays an integral role in healthcare and disease management. This phenomenon has seen
the major vendors of these technologies enter the IVD market. Life Technologies, Illumina, Affymetrix, Bruker
Daltonics, PerkinElmer/Caliper and others have all launched
clinical tests and test services.
Further the revolution in bioinformatics is allowing clinical and
traditional medical engineering to blend with components derived
from the telecommunications, information and computer sciences
industries. This opens new niche markets for POC test devices,
which will have a positive impact on diagnostic testing.
Health insurance giants Aetna, UnitedHealth and Kaiser in
collaboration with research organizations and IT companies are
working to make medicine really personalized. They are using Big
Data analytics engines that integrate the molecular information
(genomic, proteomic, metabolomic and others) from thousands of
patients that they insure with their demographic and disease
information to identify biomarkers linked to disease-driving
mechanisms. The long term goal is to develop markers that will
make personalized medicine very precise.
Lab-quality molecular tests and immunoassays at the point-of-care are on their way, but many of these tests
require some interpretation and consultation for appropriate disease management. To meet this demand
Smartphone apps have been launched just as fast as possible. The trend began with data analysis of blood
glucose monitoring to help people with diabetes improve management of their diabetes.
“…a time of global economic
instability and rising healthcare
costs.”

2. Now apps are available to help lab professionals consult with databases and experts worldwide. The
widespread availability of communication devices such as Apple’s iPAD and iPHONE and other android
phones and personal digital assistants are the most significant enablers of this phenomenon that will bring
quality diagnostics to people in remote areas of developing and developed countries.
However, these tests are being launched in Healthcare reform, the reformulation of reimbursement for the
newest and most valuable tests and the reorganization of the regulatory process for these tests in the U.S. have
created an environment of insecurity. The acute economic crisis in European countries has cut growth in the
IVD industry to 1% at best. Payers are cutting reimbursement schedules to the bare minimum to keep from
going broke. Japan has initiated its first pricing revision in ten years with an anticipated increase in payments.
On the supply side, labs are challenged to add new tests with little increase in financial and human
resources. For most labs it may even mean doing more with less.
There is also a lack of trained lab technologists, so there is a decreasing availability of human resources
needed to run the more complex new set of molecular and histological tests and immunoassays. Therefore there
has been a proliferation of test and lab automation tools launched that remove precious human resources from
mundane pre-analytical and sample tracking tasks to make time for more sophisticated ones. This phenomenon
was once thought to be the purview of core lab biochemistry and immunoassays but automation is becoming a
common feature hematology, blood banking, microbiology, and histology.
This emphasis on automation has created further
consolidation of laboratory testing to large core labs.
More and more assays in coagulation, infectious
diseases, proteins, diagetes and even HPV are
developed for automated clinical analyzers used in
the core lab. Systems for urinalysis, coagulation and
microbiology are ready to take their place along side
the hematology, chemistry and immunoassay
instruments – all located in a single core lab. In
larger labs they may be linked to a common track
line.
Getting information to care givers and patients is
now not an added plus, it is a prerequisite of all lab
operations. Thus the next 3-5 years will see an
intensification of the healthcare industry's emphasis
on informatics, wireless communications, data
networking and cost/effective healthcare delivery.
The reorganization of decentralized health care
delivery worldwide and patient-focused medicine are having an enormous impact on the role of medical devices
and diagnostic services in healthcare. Technological advancements, specifically those in device
Growth Rate by IVD Sector

3. miniaturization, data digitization, wireless communications and the Internet, form a technical synergy that will
permit IVD tests and devices to maintain a central role in disease management.
In the area of test economics, outcomes based disease management establishes guidelines and directives for
patient care. This is having a significant effect on the use of new tests, which have to prove their added value to
patient care. It also affects how many and which tests are
recommended and thus reimbursed for a specific disease
group. Health insurance companies such as Kaiser
Permanente, Aetna and UnitedHealth along with pharmacy
benefit organizations such as Medco are mining their
extensive databases to look for correlations between testing patterns and patient outcome. It is expected that
these would then be translated into test usage guideline.
For More Information, readers will want to consult Kalorama Information’s The Worldwide Market for
In Vitro Diagnostic Tests, 9th Edition. This updated report presents the trends, technologies, customer needs
and major suppliers with an eye on how they are shaping the IVD industry.
“…A number of world events
bode well for the future of
medical devices including IVDs.”

4. The Worldwide Market for In
Vitro Diagnostic Tests 9TH EDITION
The biennial edition of Kalorama’s comprehensive look at
the in vitro diagnostic market is coming soon.
Total Market Coverage
In nine best-selling editions, Shara Rosen has detailed the
market for in vitro diagnostic (IVD) testing, throughout the
world, in one complete volume.
Market numbers for business planning matched with a
discovery of the trends that are impacting the industry in
every IVD segment: Clinical Chemistry – Core Lab,
Molecular Diagnostics, Point of Care, Histology and
Cytology, Testing Services, IT in IVD, Test Services, CTCs,
Blood Banking Diagnostics, Microbiology and Virology,
Hematology and Immunoassays.
The report, The Worldwide Market for In Vitro Diagnostic
Tests, combines real industry knowledge with an
exhaustive review of the medical, business, and company
literature. Market sizes, forecasts and shares are provided,
as well as a geographic breakdown of the segments, where
possible.
Superior Trend Coverage
There are many sources for what happened in a market last year.
Kalorama Information’s unique report provides the reasons ‘why’
events happened. Changes in technology development,
regulatory and reimbursement issues, clinical care, and business
environments are discussed. Current market numbers are
presented for 2011, with projections given through 2016.
A Truly Global Resource
From the first edition, this report was designed as a global
resource in order to give market-watchers a true picture of the
industry. IVD is a worldwide business. While the US is a large
healthcare market, much of the dynamism, the growth, and also
competition is occurring in other areas.
Many of the most interesting opportunities for companies are occurring in
emerging markets. As part of its coverage, the report breaks down the entire
IVD market for North America, Europe (EU countries, incl. IVD market sizes
by country), Eastern Europe, South America, Asia (Japan, China and India) and Rest of World

5. IVD changes constantly.
This report keeps up with those
changes.
The need to know is what’s driving diagnostics. 6 Billion
Tests are performed each year. There are over 4,000 test
products. Just 2% of the costs of healthcare are spent on
testing, but 70% of clinical decisions are made using a
diagnostic test product. For infectious disease and cancer,
test makers with innovative products can expect
opportunities for new business.
Personalized medicine is finally on its way and not just for cancer patients. Why? Because pharma
companies are getting it – you can’t have a targeted therapeutic without an assay to select a potential
user. There has been a significant increase in pharma/Dx collaborations in the areas of neurological
disorders, autoimmune diseases and others.
For many years, we have heard about investment in emerging markets, the BRIC and others. In some
ways it was a lot of rhetoric – it is now a reality and all of the companies involved in emerging markets
have reported at least a 15%-20% increase in revenues there and in some cases more.
Mobile phones help us all find each other in big box stores, send Instagrams and generally keep in touch.
For healthcare providers – laboratory professionals, physicians and nurse practitioners – mobile phone
Apps are proving to be an invaluable tool to keep up to date, to
research disease guidelines and more.
Big data is all the buzz – let us not forget that data mining finds
correlations – many of which may have absolutely no significance
for the problem to be solved. It is only a beginning to finding real
answers that can improve patient care.
Is the liquid biopsy using either CTCs or cfDNA coming to routine
lab medicine? A sure sign of increased interest and uptake is
when test controls and standards are commercialized. In the past
few years several companies that market molecular test controls have increased their offerings in this
way.
The reimbursement conundrum continues – governments want better outcomes but also lower costs,
and developed countries are developing new reimbursement methods to counter these forms.
“the core lab of biochemistry,
immunoassays and hematology
still account for most IVD sales
but the last few years have
seen quite a bit of movement in
some areas.”
–Author, Shara Rosen

6. Extensive Coverage
TABLE OF CONTENTS
1 EXECUTIVE SUMMARY
Introduction – Doing more with less
Scope and Methodology
Size and Growth of the Market
Market Trends
2 INTRODUCTION
Background
Report Design
Lab Medicine Disciplines And Applications
Market Analysis of IVD Market Segments
The lure of IVD – new majors and entrants
Licenses and distribution agreements
Test Services
Top Suppliers and Niche players
Point of View
3 OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC
MARKETS
Background
Population and Disease Demographics, Worldwide
Chronic Diseases as a Market Driver
Cancer
Diabetes
Allergy
The BRIC Effect
World Segments of the IVD Market and IVD Market
Evolution
Specific Country Information
The United States of America – a world in flux
RUO/IUO Issues
The Patient Protection and Affordable Care Act
Accountable Care Organizations
LDT Oversight
Accent on Preventative Care
In Patient Bundling
Molecular test reimbursement
Japan
Europe – effects of austerity
IVD Directive Update
China
India
Brazil
Russia
4 TRENDS AND INNOVATION
Background
Looking to the East
Looking Past the Hospital ER
Telemedicine and Home Care Trends
Commercialization of Novel Tests
EMR Update
Wireless Connectivity and Healthcare Efficiencies
IVD Apps
5 POINT-OF-CARE TEST PLATFORMS
Overview of POC Tests
The Major POC Test Players
Market Analysis
Blood Glucose Monitoring
Blood Glucose Self Testing
Continuous Self Testing
Blood Glucose Testing by Professionals
Diabetes Testing – Glycated Hemoglobin
The Genetics of Diabetes
The Commercial Outlook for POC Tests
6 THE CORE LAB:
Core Lab Overview
Overview of Chemistry Tests
Market Analysis : Leading Suppliers and
Growth Potential
Lab-based Chemistries
Critical Care Analysis
Urinalysis
The Commercial Outlook for the Core Lab
7 IMMUNOASSAYS
Overview of Immunoassays
Market Analysis
Immunoassay Test Segments - Mature and
Emerging
Point-of-care OTC and Professional Use
The Commercial Outlook for Immunoassays
8MOLECULAR ASSAY PLATFORMS
Overview of Molecular Assays
Worldwide Opportunities for Molecular Tests
Molecular Test User Markets
Next generation Sequencing
Mass Spectroscopy
Molecular Technologies And Players
Market Analysis
Oncology
Inherited Diseases
Pharmacodiagnostics
Prenatal Chromosome Analysis
Tissue Typing
The Commercial Outlook for Molecular Tests
9 HEMATOLOGY
Overview of Hematology
Automation and IT
Digital Evolution
Decentralized Hematology Testing
Market Analysis : Leading Suppliers
The Commercial Outlook for Hematology Tests

7. 10 COAGULATION
Overview of Coagulation / Immunohematology
Tests
Special Topic
Genetics and Personalized Medicine
Warfarin
Plavix
Market Analysis
Lab-based Testing
Genetic markers of hypercoagulopathies
Decentralized Coagulation testing – Professional
Use
Decentralized Coagulation testing – OTC
Platelet Testing
Leading Suppliers
The Commercial Outlook for Coagulation Tests
11 MICROBIOLOGY AND VIROLOGY
Overview of Microbiology / Virology Tests
Special Topics
Antimicrobial Drug Resistance
Genome Sequencing and Mass Spectrometry
Sepsis Serology
Market Analysis
Supplies
Chromogenic Media
Microbial Identification and Antimicrobial
Sensitivity Tests
Liquid Microbiology
Blood Culture
Immunoassays – lab based
Immunoassays – rapid
Molecular Tests
The Commercial Outlook for Microbiology / Virology
Tests
12 BLOOD BANKING SERVICES
Overview of Blood Banking
Blood Management – are all these transfusions good
medicine
Blood Tracking
Chagas Disease
Platelet Safety
Market Analysis
Blood Grouping
Immunoassay Screens
Nucleic Acid Testing Continues to Grow
Leading Suppliers
The Commercial Outlook for Blood Banking
13 HISTOLOGY AND CYTOLOGY
Overview of Histology / Cytology
Special Topics
Companies expand with test services
Market Analysis
Histology/Cytology
Traditional Stains
Pap and HPV Tests
Immunochemistry and In Situ Hybridization
Pharmacodiagnostic Histology
Digital Imaging
Tissue Microarrays
Circulating Tumor Cells
Chromosome Analysis
Flow Cytometry
The Commercial Outlook for Histology and Cytology
Tests
14 COMPANY PROFILES – THE TOP TIER
15 COMPANY PROFILES – THE SECOND TIER
16 COMPANY PROFILES – NICHE PLAYERS
17 COMPANY PROFILES – BLOOD BANK
SPECIALISTS
18 COMPANY PROFILES – COAGULATION
SPECIALISTS
19 COMPANY PROFILES – DIABETES SPECIALISTS
20 COMPANY PROFILES – HEMATOLOGY
SPECIALISTS
20B – COMPANIES SPECIALIZING IN CIRCULATING
TUMOR CELLS
21 COMPANY PROFILES – HISTOLOGY SPECIALISTS
22 COMPANY PROFILES – IMMUNOASSAY
SPECIALISTS
23 COMPANY PROFILES – MICROBIOLOGY
SPECIALISTS MICRO.DOC
24 COMPANY PROFILES – MOLECULAR ASSAY
SPECIALISTS
25 COMPANY PROFILES – POINT-OF-CARE
SPECIALISTS
26 COMPANY PROFILES – TEST SERVICE PROVIDERS
27 COMPANY PROFILES – INFORMATION
TECHNOLOGY SPECIALISTS
28 COMPANY PROFILES – CORE LAB AND OTHER
COMPANIES