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IVD in China Market Outlook 2014-2024

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SKU: KLI5586455 Categories: Clinical Chemistry, Diagnostics Market Research, Immunoassays, Point-of-Care Diagnostics Pages: 264
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Description

IVD in China Market Outlook 2014-2024

With a population of more than 1 billion, China is the world’s largest country and therefore also its single largest potential market for goods and services. In the past ten years, China has led all major world economies in the average rate of growth in real GDP, total health expenditures, and government health expenditures. As an in vitro diagnostics (IVD) market, China trails only the populous, developed markets of the United States, western European countries, and Japan. China represents one of the largest clinical laboratory markets in the Asia-Pacific region, and the fastest growing among the top ten IVD country markets.

Kalorama Information’s report, IVD in China Market Outlook 2014-2024, places China and its in vitro diagnostics market in context with the developing world in terms of diseases, economic and healthcare system development, and other key metrics related to healthcare expenditures and diagnostics. China as an in vitro diagnostics market opportunity is defined by its standing next to other populous countries with demonstrated economic promise for over the past decade – Brazil, Russia and India; collectively with China referred to as “BRIC” nations. China and its healthcare system are confronted by challenges shared by less developed countries, but also burdens common among developed middle-income and affluent countries such as diabetes, cardiovascular disease, obesity and diseases of aging.

IVD in China presents current analysis of the Chinese in vitro diagnostics industry and provides forecasts to 2024. The report takes an in-depth look at the IVD market in China, providing data on the size and growth of the total Chinese in vitro diagnostics market as well as on the following IVD market segments:

  • Immunoassays
  • Clinical Chemistry
  • Hematology
  • Point of Care/OTC
  • Molecular
  • Urinalysis
  • Other IVD Tests

Issues & Trends in the IVD Market in China

  • The Future of Chinese Economic Growth
  • Chinese Healthcare Reform and Hospital Infrastructure
  • Market Barriers – Regulation, Policy and Distribution
  • Market Segment Opportunities
  • BRIC Metrics – Chinese IVD Market in Context
  • IVD Spending
  • Strengths – Conditions That Support Market Growth
  • Weaknesses – Factors That Pose Barriers to Market Success and Entry
  • Opportunities – Rural Healthcare and Technology Partnerships
  • Threats – Domestic Competition and Government Policy

IVD in China Market Outlook 2014-2024 provides detailed information regarding the IVD industry and company activity in China. Recent activity of international IVD Companies in China is presented.

International IVD Companies discussed include:

  • Abbott Laboratories
  • Affymetrix, Inc.
  • ALERE
  • Arkray
  • Axis-Shield, plc
  • Beckman Coulter, Inc./Danaher
  • Becton, Dickinson & Co.
  • Biohit Oy
  • bioMérieux, Inc.
  • Bio-RAD Laboratories, Inc.
  • Danaher Corp.
  • Gen-Probe, Inc.
  • Hologic, Inc.
  • Horiba Medical
  • Instrumentation Laboratory
  • IRIS International, Inc.
  • Laboratory Corporation of America
  • Life Technologies Corporation
  • Luminex Corporation
  • MedMira
  • Myriad Genetics
  • Novartis Diagnostics
  • Ortho Clinical Diagnostics
  • PerkinElmer
  • Phadia AB
  • Promega Corporation
  • QIAGEN N.V.
  • Radiometer A/S
  • Roche
  • Siemens
  • SuperNova Diagnostics, Inc.
  • Sysmex Corp.
  • Thermo Fisher Scientific

Chinese IVD Companies discussed include:

  • Autobio Group
  • BioSino Bio-Technology and Science, Inc.
  • CapitalBio Corporation
  • Caretium Medical Instruments
  • Chemtron Biotech Co., Ltd.
  • China Health Labs & Diagnostics, Ltd.
  • Daan Gene Co., Ltd.
  • Shanghai Fosun Pharmaceutical Co. Ltd.
  • Hai Kang Life Corporation
  • Shanghai Kehua Bio-engineering
  • Beijing Leadman Biochemistry Co., Ltd.
  • Mindray Medical International, Ltd.

Scope & Methodology

Information for this report was gathered from a wide variety of published sources including company reports, catalogs, materials and public filings; government documents; trade journals; newspapers and business press; analysts’ reports and other sources. Interviews with industry experts were conducted to capture the perspectives from market participants’ point of view and assess trends, and form the basis of the forecasting and competitive analysis. Sales estimates are provided for the historic 2009 to 2014 period and forecasts are provided through 2024. The size of each market segment refers to manufacturers’ revenues in U.S. dollars.

Table of Contents

ONE: EXECUTIVE SUMMARY

Circulating Tumor Cells in Cancer

Current and Potential Clinical Applications of CTCs

CTCs Detection, Isolation and Analysis Technologies

Industry and Market Structure

TWO: CANCER OVERVIEW

Disease Overview

Risk Factors

Prevalence and Incidence of Cancer

THREE: CIRCULATING TUMOR CELLS OVERVIEW

Overview

CTCs Applications

Characteristics of CTCs

CTCs Isolation and Characterization Challenges

Current Markers for CTCs Identification and Analysis

Epithelial Cell Adhesion Molecule (EpCAM)

Ephrin Receptor B4 (EpB4)

Epidermal Growth Factor Receptor (EGFR)

Human Epidermal Growth Factor (HER2)

Mucin-1 (MUC-1)

Carcinoembryonic Antigen (CEA)

Cytokeratins

Other CTCs Markers Investigated for Clinical Applications

Cyclophilins

Plastin3 (PLS3)

Vimentin

Conclusions

Current and Potential Clinical Applications of CTCs

Prognostic Tool for Survival

Non-Invasive Early Diagnosis of Cancer

Predictors of Disease Evolution and Metastatic Potential

Therapy Guidance and Monitoring/ Predictor of Response to Therapy

Patient Stratification in Clinical Trials

Surrogate Endpoint in Clinical Trials

Drug Development – Selection of Drug Targets

FOUR: CTCs ISOLATION AND DETECTION TECHNOLOGIES

Overview

Enrichment Methods Based on Physical Properties

Size-based Methods

Density-based Methods

Electrophysiological-based Methods

Immuno-Mediated Capture Methods

Magnetic Platforms

Microfluidic Platforms

Conclusion

Optical Identification and Enumeration

Bioview’s Duet Cell Imaging System (Israel)

CytoTrack’s Optical Scanning Technology (Denmark)

Epic Sciences (San Diego, California, USA)

Ikonisys (New Haven, CT, USA)

Nucleic Acid-based CTC Detection Methods

RNAscope (Advanced Cell Diagnostics, USA)

Cytometric Detection and Enumeration Methods

FASTcell Cytometer (SRI Biosciences, USA)

On-chip Sort Cell Sorter (On-chip Biotechnologies, Japan)

Other CTCs Isolation and Detection Approaches

Virus Vectors Fluorescence

Selectin-Mediated Capture

Cell Adhesion Matrix

Other Combination Negative Depletion/ Positive Selection Methods

Rheology-based Methods

In Vivo Detection Methods

FIVE: INDUSTRY AND MARKET LANDSCAPE

Industry Structure

Competitive Factors

Products Analysis

CellSearch

AdnaTests

Significant Market Trends

Increasing Incorporation of CTCs Technologies in Clinical Trials to Accelerate

Market Growth

The Quest for Personalized Medicine to Spur the Use of CTCs in Research &

Development

Increasing Development of CTC-based Diagnostics Tests to Augment Market

Revenues

Increasing Global Incidence of Cancer and Life Expectancy to Increase Testing

Volumes

The Impact of Clinical Utility on Adoption of CTCs Tests in Clinical Practice

The Impact of New Technologies Approved by Regulatory Agencies on Market

Growth

The Impact of Insurance Coverage on Utilization and Market Revenues

Notable Industry Events

CTCs Enumeration by CellSearch Demonstrated Potential as Efficacy-Response

Surrogate

The Menarini Group Acquired Silicon Biosystems

Cynvenio Biosystems Launched ClearID Breast Cancer Monitoring Test

Vitatex Licenses Cell Adhesion Matrix Technology to Noble Life Sciences

SWOG S0500 Clinical Trial Results Presented in December 2013

Parsorter PS1 Launched to Market in Europe

Clearbridge Biomedics Launched the ClearCell FX System for Capturing CTCs in

Whole Blood Samples

Fluxion Biosciences Launched Next Generation Sequencing Assay Kits for IsoFlux

System

Janssen Diagnostics and Asuragen Introduce NGS technology for CellSearch

Biocept Collaborates with Rosetta Genomics to Evaluate CTCs’ microRNA

Biocept Launches Lung Cancer CTC Tests

Parsortix Collaborates with EKF Diagnostics and Undisclosed Pharmaceutical

Company to Develop “Liquid Biopsy” Applications

ThermoFisher Scientific Enters into Distribution Agreement with Cynvenio

Biosystems for LiquidBiopsy Platform

QIAGEN Acquired AdnaGen’s CTC’s Technology

Total Market Revenues and Forecast

Market Snapshot

Total Market Forecast

SIX: COMPANY PROFILES

Janssen Diagnostics

AdnaGen AG (currently QIAGEN Hannover GmbH)

Acousys Biodevices, Inc.

Advanced Cell Diagnostics, Inc.

ApoCell, Inc.

BioCEP Ltd.

Biocept, Inc.

Biofluidica

BioView Ltd.

Clearbridge Biomedics Pte Ltd

Creatv MicroTech, Inc.

Cynvenio Biosystems

CytoTrack ApS

DeNovo Sciences Inc.

Epic Sciences

Fluidigm Corporation

Fluxion Biosciences

GILUPI GmbH

iCellate Medical AB

Ikonisys, Inc.

IVDiagnostics, LLC

Miltenyi Biotec GmbH

On-chip Biotechnologies

Oncolys Biopharma Inc.

Parsortix/ANGLE plc

QIAGEN N.V.

RareCells Diagnostics

RareCyte, Inc.

ScreenCell

Silicon Biosystems

SRI Biosciences

Vitatex Inc.

Vortex Biosciences

LIST OF EXHIBITS

TWO: CANCER OVERVIEW

Table 2-1: Top Ten Causes of Death in the World by Geographic Region, 2012

Table 2-2: Top Ten Causes of Death in the World, 2012

Table 2-3: Projected Top Ten Causes of Death in the World, 2015

Table 2-4: Projected Top Ten Causes of Death in the World in High Income Countries, 2015

Table 2-5: Projected Top Ten Causes of Death in the World in Upper Middle Income Countries, 2015

Table 2-6: Global Incidence of Cancer by Geographic Region, 2012

Table 2-7: Global Incidence of the Five Most Common Types of Cancer in Men,2012

Table 2-8: Global Incidence of the Five Most Common Types of Cancer in Women, 2012

Table 2-9: Global Incidence of Most Common Types of Cancer in Both Genders,2012

Table 2-10: Projected Growth in Global Incidence of Cancer by Geographic Region, 2012-2030

THREE: CIRCULATING TUMOR CELLS OVERVIEW

Table 3-1: Typical Human Blood Cellular Composition

Table 3-2: Challenges in the Detection and Isolation of CTCs, 2015

Table 3-3: Selected Markers for CTCs Identification and Analysis

Table 3-4: Selected EpCAM-based Methods

Table 3-5: Current and Potential Clinical Uses of CTCs, 2015

FOUR: CTCs ISOLATION AND DETECTION TECHNOLOGIES

Table 4-1: Selected Size-Based CTCs Enrichment Methods

Table 4-2: Selected Density-Based CTCs Enrichment Methods

Table 4-3: Selected CTCs Detection and Isolation Methods Based on

Electrophysiological Properties

Table 4-4: Selected CTCs Magnetic Platforms Based on Cell Surface Markers

Table 4-5: Selected CTCs Immunomagnetic Microfluidics Platforms

Table 4-6: Selected CTCs Optical Identification Methods

Table 4-7: Selected Nucleic Acid-based CTCs Detection Methods

Table 4-8: Comparison of Selected Cytometric CTCs Detection Methods

Table 4-9: Selected CTCs In Vivo Detection Platforms

FIVE: INDUSTRY AND MARKET LANDSCAPE

Table 5-1: Industry Structure – Selected Competitors and Marketed Products, 2014

Table 5-2: CellSearch System (IVD Use) Analysis, 2015

Table 5-3: AdnaTest (IVD Use) Analysis, 2015

Table 5-4: Significant Trends in the CTCs Market, 2015

Figure 5-1: Estimated Market Breakdown, 2014 (Research Segment, Diagnostics Segment)

Figure 5-2: Estimated Market Breakdown by Type of Cancer, 2014 (Breast,

Prostate, Colorectal, Lung, Others)

Figure 5-3: Estimated Market Breakdown by Geographic Region, 2014 (US, EU, ROW)

Table 5-5: Global Revenues and Forecast for the CTCs Market by Application, 2013-2015 and 2019 (Diagnostics Segment, Research Segment, Total Market)

Figure 5-4: Global Revenues and Forecast for the CTCs Market, 2013-2015 and 2019 (Diagnostics Segment, Research Segment, Total Market)

Table 5-6: Global Revenues for the CTCs Market by Geographic Region, 2013-2015 and 2019 (US Market, EU Market, ROW Market, Total Market)

Figure 5-5: Global Revenues for the CTCs Market by Geographic Region, 2013- 2015 and 2019 (US Market, EU Market, ROW Market, Total Market)

 

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