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In-Vitro Diagnostics Markets, 2022 -Market is Further Expected to Reach US$83.03 Billion
 
(August 10, 2017)

DUBLIN, August 10, 2017 /PRNewswire/ --

The "In Vitro Diagnostics - A Global Market Overview" report has been added to Research and Markets' offering.

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Global IVD market grew from $55.8 billion in 2014 to US$62.6 billion in 2017 and the market is further expected to reach US$83.03 billion by 2022. Molecular Diagnostics is projected to record the fastest growing IVD technology segment with a CAGR of around 8% during 2017-2022 analysis period and to touch US$10.5 billion by 2022.


The new report titled In Vitro Diagnostics - A Global Market Overview analyzes the global market of In Vitro Diagnostics (IVD) by geographic region, major country and prominent IVD technologies while special citation on end-use sectors in the United States and German markets. Clinical Chemistry is estimated to be the principal technology segment in the global IVD market cornering a market of $19.7 billion in 2017.

The In Vitro Diagnostics (IVD) industry is being positively impacted due to several factors that include rising global and regional trends of aging populations, growth in non-communicable diseases and greater affordability for treatment. Due to an increase in healthcare costs, greater weight is being given to evidence-based medicine with the aim of improving patient outcomes. The need for diagnostic devices in various conditions has been growing due to an aging population, growing epidemic of chronic diseases and (re)emergence of infectious diseases. A larger number of people are now gaining access to IVD due to growth in emerging countries and an impetus towards decentralized healthcare.

Nearly 68% of the global aged population resides in the developing economies and their population is increasing at a faster rate than that of developed regions. In fact, the population of aged individuals in developed economies has been exhibiting a declining trend, as can be seen from a fall of 38% in 2000 to 33% in 2015, which is likely to continue. This implies that the number of older people in the developing regions will grow over the coming decades.

Key Topics Covered: 

PART A: GLOBAL MARKET PERSPECTIVE

1. INTRODUCTION
1.1 Product Outline
1.1.1 In-Vitro Diagnostics Product Types
1.1.1.1 Reagents
1.1.1.1.1 General Purpose Reagents
1.1.1.1.2 Analyte Specific Reagents
1.1.1.1.3 Biochemical and Chemical Reagents
1.1.1.1.4 Opting for the Optimal Biochemical and Chemical Reagents for IVD Tests
1.1.1.2 Consumables
1.1.1.3 Instruments & Systems
1.1.2 In-Vitro Diagnostics Technologies Overview
1.1.2.1 Clinical Chemistry
1.1.2.1.1 Clinical Chemistry Analyzer/ Biochemistry Analyzer
1.1.2.2 Immunoassays
1.1.2.2.1 Objective of Immunoassays
1.1.2.2.2 Immunoassay Methodologies
1.1.2.2.3 Immunoassay Analyzer
1.1.2.2.3.1 Principles of Immunoassay analyzer operation
1.1.2.3 Diabetes Testing
1.1.2.3.1 Primary Types of Diabetes
1.1.2.3.2 Prediabetes
1.1.2.3.3 Diagnosis of Diabetes and Pre-Diabetes
1.1.2.3.4 Blood Glucose Monitoring Devices
1.1.2.4 Blood Testing
1.1.2.4.1 Categories of Blood Tests
1.1.2.4.2 Blood Chemistry Tests/Basic Metabolic Panel
1.1.2.4.3 Blood Enzyme Tests
1.1.2.4.4 Blood Tests to Assess Heart Disease Risk
1.1.2.4.5 Reference Ranges for Blood Tests
1.1.2.4.6 Analyzers
1.1.2.5 Molecular Diagnostics
1.1.2.5.1 Molecular Diagnostics Techniques
1.1.2.5.2 Molecular Diagnostics and Genome Research
1.1.2.5.3 Sample Collection and Preparation
1.1.2.5.4 Amplification and Detection Platforms and Assays
1.1.2.5.5 Software Tools
1.1.2.5.6 Complete Solutions
1.1.2.6 Pathology
1.1.2.6.1 Anatomical Pathology
1.1.2.6.2 Chemical Pathology
1.1.2.6.3 Clinical Pathology
1.1.2.6.4 Forensic Pathology
1.1.2.6.5 General Pathology
1.1.2.6.6 Genetic Pathology
1.1.2.6.7 Hematology Pathology
1.1.2.6.8 Immunopathology
1.1.2.7 Cellular Analysis
1.1.2.8 Microbiology

2. IVD REGULATIONS & STANDARDS
2.1 International Medical Device Regulators Forum and Global Harmonization Task Force (GHTF)
2.1.1 General Classification System for IVD Medical Devices
2.2 The United States
2.2.1 IVD Classification
2.2.2 Clinical Laboratory Improvement Amendments of 1988 (CLIA '88)
2.2.3 Premarket Notification 510(k)
2.2.4 De Novo Classification for IVD Devices
2.2.5 Premarket Approval (PMA)
2.2.6 Requirements for IVD Labeling
2.2.7 FDA Draft Guidances Designed to Consolidate Regulatory Oversight for Next-Generation Sequencing Tests
2.3 Europe
2.3.1 Directive 98/79/EC (IVDD)
2.3.2 Essential Requirements for IVD Medical Devices
2.3.3 Requirements that Apply to the Design and Manufacture of the Devices
2.3.4 Product Groups
2.4 China
2.4.1 Provisions for In-vitro Diagnostic Reagent Registration
2.4.2 Registration Procedure for Imported IVD Products
2.4.3 IVD Type Testing Process for Imported IVDs
2.4.4 Clinical Trials
2.5 Japan
2.5.1 Classification of IVDs
2.5.2 Registration Requirements for IVDs
2.5.3 Pre-market Approval (Shonin)
2.5.4 Technical Specifications Required for Approval of Class III IVDs
2.5.5 Pre-market Certification (Ninsho)
2.5.6 Pre-market Submission (Todokede)
2.5.7 Marketing Authorization Holder (Seihan)

3. KEY MARKET TRENDS
3.1 Ageing Population and Burden of Disease Contribute to Growth in Demand for IVD
3.2 Clinical Diagnostics Evolve to Prognostics and Predictive
3.3 Next-Generation Sequencing Revolutionizes Clinical Applications
3.3.1 Cancer Diagnostics and Treatment
3.3.2 HLA/MHC Complex
3.3.3 Neonatal and Prenatal Testing
3.3.4 Pathogen Detection and Subtyping
3.4 Pace of PCR Accelerated with Portable Diagnostic System
3.5 Rapid DNA Test Offers Scope for Replacing PCR

4. KEY GLOBAL PLAYERS
Abbott Laboratories, Inc. (United States)
Becton, Dickinson and Company (United States)
Biomerieux SA (France)
Bio-Rad Laboratories, Inc. (United States)
Danaher Corporation (United States)
ELITech Group (France)
ERBA Diagnostics Mannheim GmbH (Germany)
Hologic Inc. (United States)
Ortho Clinical Diagnostics (United States)
Roche Diagnostics Corporation (United States)
Siemens Healthineers, Inc. (United States)
Sysmex Corporation (Japan)
Wefen Group (Spain)

5. KEY BUSINESS & PRODUCT TRENDS
cobas MRSA/SA test Launched by Roche
ClearLLab Reagents Cleared by FDA for Specific Leukemia and Lymphoma Detection
FDA Approves Hologics Aptima HSV 1 & 2 Molecular Assay
CE Mark Allotted to Thermo Fishers Innovative Buprenorphine-Detecting Immunoassay
Oxford Gene Technology Taken Over by Sysmex Corp
Diagnostic Solutions for Combating Antimicrobial Resistance from BD
Abbott and Alere Agree at a Lower-Priced Deal
Roches CINtec Histology Test Granted FDA Approval
Beckman Coulters DxC 700 AU Chemistry Analyzer Cleared by FDA
Agilent Technologies Unveiled Postnatal Assay for Identifying Genetic Anomalies
Cepheids Xpert Xpress Flu and Xpert Xpress Flu/RSV Cleared by FDA
TruQuick Rapid Tests from Meridian Bioscience Introduced in Asia-Pacific
Accriva Diagnostics Acquired by WerfenLife
Abbott Acquires St. Jude Medical, Inc
PerkinElmer to Acquire Tulip Diagnostics Private Limited in India
Merck Launches New Calibration Kit for In-Vitro Diagnostic Use
Sekisui Diagnostics Unveils OSOM. BVBLUE. Rapid Test Service for Bacterial Vaginosis
bioMirieux and Banyan Biomarkers Collaborated to Develop Blood-Based Biomarkers for Traumatic Brain Injury
QIAGEN Unveils Novel CALR Mutation Assay for MPN Diagnosis
FDA CLIA Waiver for Sekisui Diagnostics OSOM. Ultra Flu A&B Test Solution
BD MAX Vaginal Panel Obtains FDA Market Authorization to Identify Common Causes of Vaginal Infections
Celgene and Agios collaborated with Abbott
ARKRAY, Inc. Launched New Blood Glucose Test Meter
BD Vacutainer. Barricor Tube Receives FDA 510(k) Approval for Innovative Blood Collection and Separation Technology
Becton, Dickinson Launches Next Generation Mobile Point-Of-Care Diagnostic Device
Bioline Unveils New SensiFAST Lyo-Ready No-ROX Mix
Abbott Launches ALINITY, Novel Next Generation Diagnostic Systems
Thermo Fisher Scientific featured expanded Offerings for Clinical Applications at AACC 2016
Alere started Diagnostics manufacturing factory in India
Roche Unveils Innovative Accu-Chek Guide Blood Glucose Monitoring System
Siemens Healthcare Diagnostics Obtains FDAs Emergency Use Authorization for VERSANT. Zika RNA 1.0 Assay
WHO Prequalification for Alere HIV Combo Test
bioMirieux expanded its pathogen identification capability on VITEK. MS
ARKRAY, Inc. Unveiled Blood Glucose Meter for Dogs and cats
Hologic's Aptima. Zika Virus Assay obtained FDA Emergency Use Authorization
Ortho Clinical Diagnostics Obtained CE Mark Approval for VITROS. Immunodiagnostic HIV Combo Test
Beckman Coulter and Ortho Clinical Diagnostics Collaborated To Offer Infectious Disease Testing Menu to High-Volume Labs
Bio-Rad Launches Amplichek II Quality Control for the Molecular Diagnostics Testing Market
Quest Diagnostics Sold Focus Diagnostics Molecular and Immunoassay Business to DiaSorin S.p.A.
Siemens Healthcare and Thermo Fisher Formed Strategic Relationship in Molecular Testing
Ortho Clinical Diagnostics Announces Availability of ORTHO Sera Extended Phenotype Testing on ORTHO VISION. Analyzer for BioVue. Cassettes
Thermo Fisher Scientific Inc Acquired Affymetrix, Inc.
Bio-Rad received CE IVD Marking for its QX200 Droplet Digital PCR System
Quest Diagnostics Enlarge Dako's PD-L1 IHC 28-8 Complementary Test Solution to Constitute Melanoma
ARKRAY, Inc expanded its operations by constructing integrated manufacturing system in Philippines
KHB Shanghai Kehua Bio-Engineering Acquires the Italian Technogenetics
Meridian Bioscience Invests in Oasis Diagnostics.
Biocartis Unveils Influenza-Respiratory Virus Panel on the Idylla platform
Focus Diagnostics Simplexa Flu A/B & RSV Direct Test Obtains FDA Approval to Include 53 New Virus Strains for the 2015-2016 Flu Season
Cepheid Obtains FDA Market Approval for Xpert TV, Test for Detecting Trichomonas Vaginalis Infection
QIAGENs RespiFast RG Improves Diagnosis of Respiratory Infections
Roche Acquires GeneWEAVE to bolster Offerings in Microbiology Diagnostics
Cepheid and FIND Launches World's Most Portable Molecular Diagnostics System, GeneXpert Omni
Roche Unveils point-of-care (POC) Troponin Test Solution to help Diagnose Heart Attack Patients at High Mortality Risk
Siemens HIV Combo Assay Obtained FDA Clearance
Ortho Clinical Diagnostics Obtains FDA 510(k) Approval for VITROS. Chemistry Products HbA1c Reagent Kit
QIAGEN and Biotype Diagnostics Enter into Joint Venture Agreement
QIAGEN and Hitachi High-Technologies Enters into Collaboration for Molecular Testing
Alere and FIND Collaborated to Develop New Rapid Diagnostic Tests for Simultaneous Detection of Malaria and Sleeping Sickness
Abbott's Unveiled Pioneering Blood Test solution to aid in detecting Early Pregnancy
Abbott Laboratories Inc and Sekisui Medical join forces
ARKRAY Launches Urine Analyzer thinka RT-4010 for Dogs and Cats
ARKRAY unveils new compact line-up of the existing reagent kit CinQ HbA1c
Cepheid Obtains FDAs Emergency Use Authorization for Xpert Ebola Diagnostic Test
Biocartis and Microbiome Collaborated to Develop Rapid and Sensitive Sepsis Test Solution
bioMirieux and Astute Medical associated to develop and market NephroCheck. Test for VIDAS., an assay to assess the risk of developing acute kidney injury

6. GLOBAL MARKET OVERVIEW
6.1 Global In-Vitro Diagnostics Market Overview by Product Type
6.1.1 Global In-Vitro Diagnostics Product Market Overview by Geographic Region
6.1.1.1 Reagents & Consumables
6.1.1.2 Instruments & Systems
6.2 Global In-Vitro Diagnostics Market Overview by Technology Area
6.2.1 Global In-Vitro Diagnostics Technology Market Overview by Geographic Region
6.2.1.1 Clinical Chemistry
6.2.1.2 Immunoassay
6.2.1.3 Diabetes Testing
6.2.1.4 Blood Testing
6.2.1.5 Molecular Diagnostics
6.2.1.6 Pathology
6.2.1.7 Cellular Analysis
6.2.1.8 Microbiology

For more information about this report visit https://www.researchandmarkets.com/research/86sn7w/in_vitro


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