The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 9th Edition

Aug 13, 2014
1200 Pages - Pub ID: KLI5309370
Abstract Table of Contents Related Reports

The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 9th Edition

In nine best-selling editions, Shara Rosen (MBA, RT), has created authoritative market estimates and forecasted growth models for in vitro diagnostic (IVD) testing products throughout the world. This single volume covers the entirety of the clinical testing market and all of its segments, providing customers with a tremendous value.

Used by Top IVD Companies For Business Planning.

This year, Kalorama has published its ninth edition of this informative volume based on the market events of 2013 and early 2014. New entrants, new technologies have entered the stage and all important events are cataloged in this report. The idea behind Kalorama's unique report is that the entire market can be captured in one volume. Published every two years, this volume includes market estimates for 2013 base year and forecasts to 2018 for the most important aspects of all of the major segments of clinical lab testing, including:
  • Core Lab (General Chemistries, Workstations, Analyzers Blood Gases, Urinalysis, Critical Care)
  • Point of Care (POC), (Professional and Self-Testing, Glucose Testing, Pregnancy Tests, drugs of abuse, HIV, H. pylori, Other, OTC/Self Total, Professional POC, Cardiac Markers, Drugs of Abuse, HbA1c, Pregnancy, Other)
  • Histology and Cytology (Pap, ISH, IHC, HPV)
  • Lab-based Infectious Disease Immunoassays, by Test (Hepatitis, HIV, STDs, TORCH, Respiratory, Sepsis, Parasitology, Mycology, Others)
  • Molecular Assays (Infectious Disease, Blood Screening, Inherited Diseases, Oncology, Pharmacodiagnostics, Tissue Typing, Prenatal)
  • Hematology
  • Molecular Test Sales, Infectious Diseases (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Organism ID, Mycobacteria, TB, Others
  • Lab-based Immunoassay Sales by Analyte Type (Cardiac markers, Tumor markers, Diabetes/HbA1c, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic drugs, Tox/Drugs of abuse, Vitamin D)
  • Coagulation (Lab-Based, POC, Genetic Markers)
  • Microbiology and Virology by Test Type (Immunoassays, ID/AST, Infectious Diseases - DNA; ID/AST: Panels and Reagents, automated; Panels and Reagents, manual; Blood Culture; Chromogenic Media; Rapid Micro; Supplies)
  • Blood Banking (Grouping, Immunoassay Screens, NAT Screens)
The Worldwide Market for In Vitro Diagnostic Tests is a testament to the Kalorama methodology. It is the result of months of painstaking work by an IVD industry veteran, who has tracked hundreds of companies for developments, trends and financial results. This research is compiled along with the opinion, observations and insights of industry experts to produce an unparalleled vision of the industry as it is in 2014. The report includes data in a sizeable number of IVD segments and detailed discussion of the trends that are impacting the industry. The report also provides a realistic forecast five years into the future for companies already participating in or considering entry into this growing industry.

Independent Perspective. Authoritative Coverage.

At 1200 pages, this is the most comprehensive report on the in vitro diagnostic industry available. No surprise that it has been called the 'Bible of the IVD Industry' by past users of the report. Many of the top IVD companies use this product for business planning, which means that this volume can provide a uniform standard for in vitro diagnostic market numbers. This edition greatly expands coverage of the field and tracks the most important developments.

Understand areas of the market that might not be available in your company's internal resources. View the industry from an independent point of view. Learn about competitors in a way that may be invisible to internal personnel. Know the market players - your potential partners, your existing or potential competitors, in proper context. Save countless hours of staff time and other research expenses with the authoritative guide for IVD market estimates and forecasts.

Worldwide Coverage, Including Emerging Markets.

From the first edition, this report has been intended to create a global picture for readers. Clinical testing is a worldwide business. This has always been true, but today emerging markets are part of the growth strategy of companies large and small. Kalorama has adjusted to these industry trends with enhanced geographic segmentation. While the US is a large healthcare market, 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 the following regions:
  • North America
  • Europe (with total IVD market sizes for EU countries)
  • Asia (China, Japan, India)
  • Latin America
  • Rest of World
Not Just "What" Happened in the Industry, But "Why?"

The report does not merely report figures absent context. It describes the competitive workings of the diagnostics industry, combining a competitor, product, regulatory and payor decision analysis. In addition to providing authoritative market estimates for IVD market segments, this unique report seeks to explain why market events are occurring. The report delves into fast- breaking trends in in vitro diagnostics and distinguishes between company PR and actual market reality.

As part of its coverage, the following trends are detailed in the report:
  • Sample to Insight: IT Makes It Possible
  • The Lure of IVD – Companies Mix and Match
  • Distribution Agreements
  • Emerging Market Growth
  • Licenses and Collaboration Agreements
  • Test Services Commercialization
  • Top Suppliers and Niche Players
  • Selected Test Innovations from Non-Commercial Facilities
  • Sequencing Moves To The Clinic
  • LDTs
  • Personalized Precision Medicine Advances and Barriers
  • LOCs Enable Mobile Health (mHealth)
  • Digital PCR
  • Exomes
  • Omics and BIG Data
Superior Company Profiling - Understand How Companies Rank and Where They Compete.

The report contains detailed profiles of the top players in IVD. Profiling in this report describes the developments in each significant division of their business. A number of secondary players are also extensively profiled, as well as specialty companies with expertise in one testing area.
  • Abbott Diagnostics
  • Alere Inc.
  • Arkray
  • Beckman Coulter, Inc.
  • Becton, Dickinson and Company (BD)
  • bioMérieux Inc.
  • Bio-Rad Laboratories, Inc.
  • Danaher Corporation
  • Hologic, Inc.
  • Ortho Clinical Diagnostics (OCD)
  • Siemens Healthcare Diagnostics
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.
  • Affymetrix Inc.
  • Cepheid
  • Eiken Chemical Co., Ltd
  • ERBA Diagnostics, Inc.
  • DiaSorin S.p.A
  • Fujirebio Diagnostics, Inc.
  • Illumina
  • LabCorp
  • Luminex Corporation
  • Menarini Diagnostics
  • Myriad Genetics
  • PerkinElmer, Inc. (PE)
  • Quest Diagnostics
  • Quidel Corporation
  • Randox Laboratories Ltd.
  • TOSOH Corporation
  • Wako Pure Chemical Industries
  • And hundreds of other companies...
All market data are based on factory sales to the end user and not retail pricing or reimbursement payments. Data for the in vitro diagnostic market are presented in U.S. dollar market size for categories of tests, and for specific analytes where possible. The dollar value of a market segment is directly proportional to the number of tests performed, because the cost of the instrumentation is generally buried in the per test price.

The information presented in this report is derived on publicly available information sources such as company, government, and medical organization reports. The analysis is based on the author's industry knowledge combined with literature searches and interviews with industry professionals and experts in the IVD industry.

Additional Information

New Report Says In Vitro Diagnostic Market Reaches 54.6Billion 

NEW YORK, N.Y. - The world marketfor diagnostics is estimated at $54.6 billion in 2013, according to KaloramaInformation.  The market is expected to grow 4% annually and reach $65billion by 2018.  This includes all laboratory and hospital-basedproducts, and OTC product sales.  Kalorama revealed the market estimatesin its biennial survey of the IVD industry, The Worldwide Market for In Vitro DiagnosticTests, 9th Edition. 

 New technology is leading thecharge, according to Kalorama.  Diagnostic laboratory technology haschanged dramatically in the past few years, due to the publication of the humangenome project and advances in functional genomics, bioinformatics,miniaturization and microelectronics. 

“Not three years ago it would havebeen almost inconceivable to see research technologies such as genomesequencing and mass spectroscopy play a pivotal role in improving labmedicine,” said Shara Rosen, Kalorama’s lead diagnostic analyst and the authorof the report.  “Their influence is felt in personalized medicine,inherited diseases, pathogen detection, antibiotic resistance testing, bloodbanking and much more to come.”

 According to the report, thisphenomenon has seen the major vendors of these technologies enter the IVDmarket.  Life Technologies, Illumina, Affymetrix, Bruker Daltonics,PerkinElmer/Caliper and others have all launched clinical tests and testservices.

Commentary on LDT Regulatory changes

The 8th edition of this report published in 2012 discussed the possible regulation of lab developed tests (LDTs).  Well in 2014, the possible is a reality.  In the beginning …. September 2006, the FDA issued a draft guidance on analyte specific reagents (ASRs), which are commercially available reagents used in lab developed tests (LDTs).  The FDA decided to use enforcement discretion and excluded laboratory-developed tests from the ASR rule based on confidence in a high-complexity laboratory’s ability to use them.

LDTs are developed within the laboratory and do not currently require FDA clearance. They are currently regulated under CLIA as highly complex tests and thus are subject to in-house validation and cGMP quality documentation requirements.

August 1, 2014, the FDA announced plans to implement a risk-based regulation of laboratory-developed tests over the course of nine years.  The FDA also said it plans to release its draft guidance in 60 days.  The FDA’s announcement comes out at a time when the agency has come under increasing pressure from congressional and federal advisory committees, consumer groups and the industry to expand its oversight of in-house developed testing.  The FDA announcement stated that LDTs have become an intrinsic part of personalized medicine and that inaccurate test results could cause patients to seek unnecessary treatment, or delay and sometimes forgo treatment altogether.  Further the policy change “demonstrates the agency's commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.”

The statement also stated that the FDA would implement the regulations over a nine-year period and would focus on tests where a wrong result would pose the highest risk for patients.  It also said it would exempt tests for which there is no approved alternative and tests for rare diseases.

The FDA says it intends to require pre-market review for higher-risk LDTs, such as those that have the same intended use as FDA-approved or cleared companion diagnostics currently on the market.  The draft guidance also proposed that LDTs would be classified as Class I, II, or III depending on risk.  The agency will first focus on high-risk devices that have the same intended use as cleared or approved companion diagnostics. 

It is expected that the classification may take the form of a proposal submitted by the American College of Medical Genetics and Genomics.  In 3013, the American College of Medical Genetics and Genomics (ACMG, released a framework to standardize risk classification of laboratory developed tests (LDTs) for inherited conditions. The approach represents a regulatory context that the group hopes will be used to assist federal agencies and policymakers.  The ACMG presented risk-based classification that aligns risk with the medical decisions made based on the test results and how an incorrect result or interpretation might impact patients. 

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