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體外診斷

市場調查報告書

商品編碼

1063203

體外診斷(IVD)品管的全球市場(2021年～2028年)

Global IVD quality control Market - 2021-2028

出版日期: 2022年03月03日 | 出版商:

DataM Intelligence | 英文 190 Pages | 商品交期: 約2個工作天內

價格

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簡介目錄

本報告提供全球體外診斷(IVD)品管市場相關調查分析，市場動態，產業分析，市場分析，競爭情形等系統性資訊。

簡介
- 市場規模分析，及與前一年同期比較成長分析(%):各產品及服務
- 市場魅力指數:各產品及服務
品管產品*
- 全血為基礎的品管
- 血清及血漿為基礎的品管
- 尿為基礎的品管
- 其他
- 簡介
- 市場規模分析，100萬美元(2019年～2028年)，及與前一年同期比較成長分析(%)(2020年～2028年)
資料管理解決方案
品質保證服務

第8章全球體外診斷(IVD)品管市場:各應用領域

簡介
- 市場規模分析，及與前一年同期比較成長分析(%):各應用領域
- 市場魅力指數:各應用領域
免疫化學*
- 簡介
- 市場規模分析，100萬美元(2019年～2028年)，及與前一年同期比較成長分析(%)(2020年～2028年)
血液
分子診斷
凝固/止血
其他

第9章全球體外診斷(IVD)品管市場:各終端用戶

簡介
- 市場規模分析，及與前一年同期比較成長分析(%):各終端用戶
- 市場魅力指數:各終端用戶
醫院*
- 簡介
- 市場規模分析，100萬美元(2019年～2028年)，及與前一年同期比較成長分析(%)(2020年～2028年)
臨床實驗室
研究機關、學術機構
其他

第10章全球體外診斷(IVD)品管市場:各地區

簡介
- 市場規模分析，100萬美元(2019年～2028年)，及與前一年同期比較成長分析(%)(2020年～2028年):各地區
- 市場魅力指數:各地區
北美
歐洲
南美
亞太地區
中東和非洲

第11章全球體外診斷(IVD)品管市場-競爭情形

主要的開發與策略
企業佔有率分析
產品的基準
值得注意的主要企業的清單

第12章全球體外診斷(IVD)品管市場-企業簡介概要

Bio-Rad Laboratories Inc.*
- 企業概要
- 產品系列及說明
- 主要亮點
- 財務概要
bioMerieux Inc
F. Hoffmann-La Roche AG
SeraCare Life Sciences Inc
ZeptoMetrix Corporation
Thermo Fisher Scientific, Inc.
Quidel Corporation
Grifols, S.A.
Bio-Techne Corporation
Streck, Inc.

第13章全球體外診斷(IVD)品管市場-DataM

附錄
關於本公司、應用
諮詢方式

簡介目錄

Product Code: DMMD4825

Market Overview

Various infectious and non-communicable disorders are detected using in-vitro diagnostic tests performed on obtained blood tissue samples. They are used to track a patient's health, cure diseases, and assist medical experts in determining the most appropriate treatment technique or therapy for them. IVQ Quality Controls are items used to assess the test's quality and precision.

The global IVD quality control market size was valued US$ XX million in 2020 and is estimated to reach US$ XX million by 2028, growing at a CAGR of XX % during the forecast period (2021-2028).

Market Dynamics

Clinical laboratories are becoming more and more accredited to drive market growth.

Laboratory tests have increased globally as the global burden of various diseases has increased. To accommodate this need, the public and commercial sectors have built more laboratories. With the development of the COVID-19 pandemic in December 2019, the demand for diagnostic testing has skyrocketed. Many government agencies have opened additional facilities and expanded laboratory testing capabilities in response to the epidemic.

Moreover, clinical laboratories must obtain regulatory approval before performing diagnostic tests in most countries. Furthermore, ISO 15189:2012 and comparable standards are becoming required in many nations. Authorities analyze the quality system and competency-based on specified standards during the accreditation procedure. Thus, the market is expected to drive in the forecast period from the above statements.

Restraint:

In low- and middle-income countries, there are stringent quality-control regulations. Implementing QC procedures for clinical laboratories that do limited volumes of diagnostic tests is very expensive. It is projected that, when combined with funding constraints in many hospitals and laboratories in both developed and developing economies, QC procedures adoption will decrease. Thus, the market is expected to get hampered in the forecast period from the above statements.

COVID-19 Impact Analysis

The COVID-19 pandemic has positively impacted healthcare systems and the market. The extremely contagious nature of this respiratory disease puts current viral detection technology to the test in terms of speed, scalability, affordability, and accuracy. Immunoassays have been utilized to surveillance individuals by detecting antibodies against SARS-CoV-2, whereas molecular tests have been the gold standard for direct detection of viral RNA in suspected individuals. Immunoassays, unlike molecular testing, are non-invasive tests of viral infection. As of this date, more than 140 diagnostic assays have been created and have been granted emergency use authorization by the Food and Drug Administration (FDA) (EUA).

Moreover, Government regulators have also expressed their support for these tests in the fight against the pandemic. As a result, the IVD business has seen both positive and bad consequences, and important participants have made strategic decisions to deal with the situation. As the number of fast diagnostic tests, point-of-care tests, and IVD devices grow, the demand for control and calibrator kits to ensure that patients' sample findings are accurate and precise. Therefore, Companies and laboratories emphasize the quality of their test results, which has aided market growth.

Segment Analysis

Molecular Diagnostics segment is expected to hold the largest market share in IVD quality control market

The molecular diagnostics segment is expected to dominate in 2020. The segment benefits because of the rising global frequency of cancer, greater research on cancer biomarkers, enhanced diagnosis infrastructure, and additional applications in detecting multiplex PCR, HIV, respiratory tract infections, and genital infections. Moreover, molecular diagnostic testing plays an increasingly important role in clinical laboratory evaluation. Nucleic acid isolation, gel electrophoresis, various forms of PCR, RT-PCR and real-time PCR, microarray, sequencing, and restriction enzyme analysis are all common molecular procedures utilized in a molecular diagnostic lab. NGS has recently become a necessary component in a molecular lab.

Additionally, due to the increasing technical complexity of molecular diagnostic testing and the need for quality evaluation to ensure standards, and the U.S. Food & Drug Administration (FDA) has written regulations citing quality control material as medical devices. For instance, 21 CFR 862.1660, Mulit-Analyte Controls Unassayed under Clinical Chemistry, and more recently 21 CFR 866.3920, classify Class II controls requiring FDA 510(k) review under microbiology. These are some factors that the market is expected to hold the largest market share in the forecast period.

Geographical Analysis

North America region holds the largest market share in the global IVD quality control market

In 2020, North America accounted for the highest revenue share. The rising number of diagnostic facilities and accredited clinical laboratories, as well as the high rate of adoption of technological infrastructure, well-developed healthcare infrastructure, as well as an increase in lifestyle diseases in the region and expansion of the product approval by the key players, are some of the factors due to which the market is expected to boost in the forecast period. For instance, During the five years between 2017 and 2022, the number of enterprises in the Diagnostic & Medical Laboratories industry in the United States increased by 2.3 percent per year on average. There are 29,151 Diagnostic & Medical Laboratories businesses in the US as of 2022, an increase of 2.3% from 2021.

Moreover, Abbott Laboratories (US) gained CE approval for their Panbio Rapid Antigen self-test in June 2021. It aided the company in expanding its reach throughout Europe for COVID-19 testing that was quick and accurate. Therefore, it has increased the demand for IVD quality control products, due to which the North American region is expected to hold the largest market share in the forecast period.

Competitive Landscape

Major key players in the IVD quality control market are Bio-Rad Laboratories Inc ., bioMerieux Inc., F. Hoffmann-La Roche AG, SeraCare Life Sciences Inc ., ZeptoMetrix Corporation, Thermo Fisher Scientific, Inc., Quidel Corporation, Grifols, S.A., Bio-Techne Corporation and Streck, Inc.

Comper Healthcare:

Overview:

Bio-Rad Laboratories, Inc. is an American company that continues to produce innovative and useful products in the healthcare industry that assist life science researchers in accelerating the discovery process, and medical diagnostic labs obtain faster, better results. Bio-Rad's life science products essentially include instruments, software, consumables, reagents, and content for the areas of cell biology, gene expression, protein purification, protein quantitation, drug discovery and manufacture, food safety, and science education. These products are based on technologies to separate, purify, identify, analyze, and amplify biological materials such as antibodies, proteins, nucleic acids, cells, and bacteria. Moreover, Bio-Rad's diagnostic products and systems use various technologies and provide clinical information in the blood transfusion, diabetes monitoring, autoimmune, and infectious disease testing markets. These products support the diagnosis, monitoring, and treatment of diseases and other medical conditions. The company has over 8,000 employees and a global network of operations that serves customers' life science research and clinical diagnostics, helping people live longer, healthier lives.

Product Portfolio:

InteliQ Immunology Control: Liquid control available in barcoded, load-and-go tube configuration, designed to monitor the precision of immunology assays. Comprehensive menu of serum proteins, including Rheumatoid Factor.

Why Purchase the Report?

Visualize the composition of the IVD quality control market segmentation by product and Services, application, end user and region highlighting the key commercial assets and players.

Identify commercial opportunities in IVD quality control market by analyzing trends and co-development deals.

Excel data sheet with thousands of data points of IVD quality control market- level 4/5 segmentation.

PDF report with the most relevant analysis cogently put together after exhaustive qualitative interviews and in-depth market study.

Product mapping in excel for the key product of all major market players

The global IVD quality control market report would provide an access to an approx. 45+market data table, 40+figures and 190 pages.

Target Audience

Service Providers/ Buyers

Industry Investors/Investment Bankers

Education & Research Institutes

Research Professionals

Emerging Companies

Manufacturers

Market Segmentation

Global IVD quality control Market - By Product and Services

Quality Control Products

Whole blood based quality controls

Serum & Plasma based quality controls

Urine based quality controls

Others

Data Management Solutions

Quality Assurance Services

Global IVD quality control Market - By Application

Immunochemistry

Hematology

Molecular Diagnostics

Coagulation/Hemostasis

Others

Global IVD quality control Market - By End user

Hospitals

Clinical Laboratories

Research and Academic Institutes

Others

Global IVD quality control Market - By Region

North America

South America

Europe

Asia

Middle East & Africa

1. Global IVD quality control Market Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Global IVD quality control Market - Market Definition and Overview

3. Global IVD quality control Market - Executive Summary

3.1. Market Snippet by Product and Services
3.2. Market Snippet by Application
3.3. Market Snippet by End User
3.4. Market Snippet by Region

4. Global IVD quality control Market - Market Dynamics

4.1. Market Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Clinical laboratories are becoming more and more accredited to drive market growth.
- 4.1.2. Restraints:
  - 4.1.2.1. Stringent quality-control regulations are expected to hamper market growth.
- 4.1.3. Opportunity
- 4.1.4. Impact Analysis

5. Global IVD quality control Market - Industry Analysis

5.1. Supply Chain Analysis
5.2. Pricing Analysis
5.3. Regulatory Analysis
5.4. Unmet Needs

6. Global IVD quality control Market - COVID-19 Analysis

6.1. Analysis of Covid-19 on the Market
- 6.1.1. Before COVID-19 Market Scenario
- 6.1.2. Present COVID-19 Market Scenario
- 6.1.3. After COVID-19 or Future Scenario
6.2. Pricing Dynamics Amid Covid-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion

7. Global IVD quality control Market - By Product and Services

7.1. Introduction
- 7.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product and Services
- 7.1.2. Market Attractiveness Index, By Product and Services Segment
7.2. Quality Control Products*
- 7.2.1. Whole blood based quality controls
- 7.2.2. Serum & Plasma based quality controls
- 7.2.3. Urine based quality controls
- 7.2.4. Others
- 7.2.5. Introduction
- 7.2.6. Market Size Analysis, US$ Million, 2019-2028 and Y-o-Y Growth Analysis (%), 2020-2028
7.3. Data Management Solutions
7.4. Quality Assurance Services

8. Global IVD quality control Market - By Application

8.1. Introduction
- 8.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 8.1.2. Market Attractiveness Index, By Application Segment
8.2. Immunochemistry*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis, US$ Million, 2019-2028 and Y-o-Y Growth Analysis (%), 2020-2028
8.3. Hematology
8.4. Molecular Diagnostics
8.5. Coagulation/Hemostasis
8.6. Others

9. Global IVD quality control Market - By End user

9.1. Introduction
- 9.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End user
- 9.1.2. Market Attractiveness Index, By End user Segment
9.2. Hospitals*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis, US$ Million, 2019-2028 and Y-o-Y Growth Analysis (%), 2020-2028
9.3. Clinical Laboratories
9.4. Research and Academic Institutes
9.5. Others

10. Global IVD quality control Market - By Region

10.1. Introduction
- 10.1.1. Market Size Analysis, US$ Million, 2019-2028 and Y-o-Y Growth Analysis (%), 2020-2028, By Region
- 10.1.2. Market Attractiveness Index, By Region
10.2. North America
- 10.2.1. Introduction
- 10.2.2. Key Region-Specific Dynamics
- 10.2.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product and Services
- 10.2.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 10.2.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End user
- 10.2.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 10.2.6.1. U.S.
  - 10.2.6.2. Canada
  - 10.2.6.3. Mexico
10.3. Europe
- 10.3.1. Introduction
- 10.3.2. Key Region-Specific Dynamics
- 10.3.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product and Services
- 10.3.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 10.3.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End user
- 10.3.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 10.3.6.1. Germany
  - 10.3.6.2. U.K.
  - 10.3.6.3. France
  - 10.3.6.4. Italy
  - 10.3.6.5. Spain
  - 10.3.6.6. Rest of Europe
10.4. South America
- 10.4.1. Introduction
- 10.4.2. Key Region-Specific Dynamics
- 10.4.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product and Services
- 10.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 10.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End user
- 10.4.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 10.4.6.1. Brazil
  - 10.4.6.2. Argentina
  - 10.4.6.3. Rest of South America
10.5. Asia Pacific
- 10.5.1. Introduction
- 10.5.2. Key Region-Specific Dynamics
- 10.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product and Services
- 10.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 10.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End user
- 10.5.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 10.5.6.1. China
  - 10.5.6.2. India
  - 10.5.6.3. Japan
  - 10.5.6.4. Australia
  - 10.5.6.5. Rest of Asia Pacific
10.6. Middle East and Africa
- 10.6.1. Introduction
- 10.6.2. Key Region-Specific Dynamics
- 10.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product and Services
- 10.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 10.6.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End User

11. Global IVD quality control Market - Competitive Landscape

11.1. Key Developments and Strategies
11.2. Company Share Analysis
11.3. Product Benchmarking
11.4. List of Key Companies to Watch

12. Global IVD quality control Market- Company Profiles

12.1. Bio-Rad Laboratories Inc.*
- 12.1.1. Company Overview
- 12.1.2. Product Portfolio and Description
- 12.1.3. Key Highlights
- 12.1.4. Financial Overview
12.2. bioMerieux Inc
12.3. F. Hoffmann-La Roche AG
12.4. SeraCare Life Sciences Inc
12.5. ZeptoMetrix Corporation
12.6. Thermo Fisher Scientific, Inc.
12.7. Quidel Corporation
12.8. Grifols, S.A.
12.9. Bio-Techne Corporation
12.10. Streck, Inc.

LIST NOT EXHAUSTIVE