分子品管的全球市场:2022年～2029年

本报告提供全球分子品管的市场调查，彙整市场定义和概要，市场成长的各种影响因素分析，法律制度，市场规模的转变·预测，各种区分·各地区/主要国家的明细，竞争环境，主要企业简介等资讯。

目录

第1章 全球分子品管市场:调查手法·调查范围

第2章 全球分子品管市场:市场定义·概要

第3章 全球分子品管市场:摘要整理

第4章 全球分子品管市场:市场动态

• 市场影响要素
  • 促进因素
  • 阻碍因素
  • 市场机会
  • 影响分析

第5章 全球分子品管市场:产业分析

• 波特的五力分析
• 供应链分析
• 价格分析
• 法规分析
• PEST分析

第6章 全球分子品管市场:COVID-19分析

• COVID-19:对市场的影响分析
• COVID-19旋涡之中的价格动态
• 供需频谱
• 政府在COVID-19疫情下的市场相关措施
• 製造商的策略性举措
• 总论

第7章 全球分子品管市场:各产品类型

• 独立控制
• 设备专用控制

第8章 全球分子品管市场:各用途

• 肿瘤
• 遗传基因检验
• 感染疾病
• 其他

第9章 全球分子品管市场:各终端用户

• 医院
• 临床实验室
• IVD製造商·CRO
• 其他

第10章 全球分子品管市场:各地区

• 北美
• 欧洲
• 南美
• 亚太地区
• 中东·非洲

第11章 全球分子品管市场:竞争情形

• 竞争模式
• 主要的展开·策略
• 企业占有率分析
• 产品基准
• 关注的主要企业
• 颠覆性技术的企业

第12章 全球分子品管市场:企业简介

• Bio-Rad Laboratories Inc
• F. Hoffmann-La Roche AG
• SeraCare Life Sciences Inc
• BioMerieux Inc
• ZeptoMetrix Corporation
• Abbott Laboratories
• Thermo Fisher Scientific
• Microbiologics Inc
• Quidel Corporation
• Qnostics Ltd

第13章 全球分子品管市场:DataM

• 附录
• 关于本公司·服务
• 联繫

Market Overview

The global molecular quality controls market size was worth US$ XX million in 2021 and is estimated to reach US$ XX million by 2029, growing at a CAGR of XX % during the forecast period (2022-2029).

Molecular quality controls are used to evaluate the performance of molecular tests such as in vitro nucleic acid testing procedures for viral load assays, pathogen detection, leukocyte reduced apheresis platelet (LRAP) units, healthcare-associated infections (HAIs) like pneumonia, urinary tract infections and more. These products majorly focus on the detection of defects, quality control, and validation panels to support in the implementation and monitoring assay-kit lot performance for clinical and research laboratories, blood diagnostic centers, and IVD manufacturers.

Market Dynamics

The global molecular quality controls market growth is driven by the increased demand for advanced diagnostics for sensitive reports and accurate diagnosis, rising incidence of infectious diseases, cancers and genetic disorders and rise in the volume of accredited clinical laboratories and adoption of third-party quality controls.

Increasing number of accredited clinical laboratories is expected to hold the largest share in this market segment

Globally, the number of laboratory tests being conducted has increased owing to the rising burden of various diseases worldwide. To meet this demand, the number of laboratories in public as well as the private sector is increasing. In most countries, it is mandatory for clinical laboratories to secure accreditation from regulatory bodies such as the International Organization for Standardization (ISO) 15189:2012 and other similar standards to perform diagnostic tests. During the accreditation process, the respective authorities evaluate the quality system and competence of a laboratory based on specific standards.

In 2020, the number of total laboratory entities registered for CLIA accreditation increased to 286,396 as compared to 259,967 in 2017. Also, in 2018, 15,353 laboratories received CLIA accreditation by several accreditation organizations.

Additional costs involved in quality control and budget constraints in hospitals and laboratories is expected hamper the market growth

Setting up a QC process in a clinical laboratory requires significant investments. Laboratories also need to maintain dedicated personnel to manage the QC system. Moreover, QC procedures incur similar costs, regardless of the volume of tests performed. Hence, the cost of adopting QC procedures is very high for clinical laboratories working with low volumes of diagnostic tests. This, coupled with budgetary constraints in many hospitals and laboratories in developed and developing economies, is expected to result in the lower adoption of QC practices.

COVID-19 Impact Analysis

COVID-19 is an infectious disease caused by the most recently discovered novel coronavirus. Largely unknown before the outbreak began in Wuhan (China) in December 2019, COVID-19 moved from a regional crisis to a global pandemic in just a few weeks. The World Health Organization (WHO) declared COVID-19 as a pandemic on March 11, 2020.

The COVID-19 pandemic negatively affected the sales of companies. Lockdowns resulting from the COVID-19 pandemic caused people to delay undergoing health check-ups, affecting the number of tests being performed and sales of reagents. However, a resurgence in testing numbers is seen as countries gradually ease restrictions on movement. With the COVID-19 pandemic, responding to infectious disease has become a pressing medical issue worldwide. In addition to developing vaccines and therapeutic drugs, there is a growing need for developing more precise and simple testing technologies and the expansion of testing structures. COVID-19 has also impacted the regulatory environment and practices, as governments and healthcare providers face unprecedented challenges. Regulatory authorities utilized methods to speed the approval of diagnostic products. Companies have also taken strategic developments to introduce COVID-19 rapid tests, sustain their revenues, and nullify the impact of COVID-19 on their operational capabilities.

Segment Analysis

The independent controls segment is expected to hold the largest share in this market segment

Independent controls are anticipated to hold the largest market share in the molecular quality controls market due to their highly precise, unbiased, and independent assessment of a testing system or method performance test results in a short time with the highest sensitivity rate as they are manufactured independently of the instrument, reagents, and calibrators. Furthermore, a steep rise in the adoption of these products among the third-party independent quality controls owing to their benefits such as a wide range of applications along with reduced operational costs is also expected to drive the use of independent controls fueling the market.

Geographical Analysis

North America region holds the largest market share of global molecular quality controls market

North America is expected to dominate the overall molecular quality control market, throughout the forecast period. The high adoption rate of advanced infrastructure, increased number of diagnostic centres and accredited clinical laboratories are factors estimated to fuel the market in the region. In North America, the United States holds the largest market share due to increased patient pool. For instance, as per U.S. Department of Health & Human Services report published in 2020, about 37,832 people in the U.S. were diagnosed with HIV in 2018 and 38,000 new HIV infections still occur in the United States and 6 dependent areas each year which results in rapid spread of various infectious diseases such as meningitis, urinary tract infections fueling the market contributing its outstanding share of the global market revenue during the forecast period.

Competitive Landscape

The global molecular quality controls market is moderately competitive with presence of local as well as global companies. Some of the key players which are contributing to the growth of the market include Bio-Rad Laboratories Inc F. Hoffmann-La Roche AG, SeraCare Life Sciences Inc, bioMerieux Inc, and ZeptoMetrix Corporation, Abbott Laboratories, Thermo Fisher Scientific, Microbiologics Inc, Quidel Corporation and Qnostics Ltd. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the Molecular Quality Controls globally. For instance, in April 2019, Bruker expanded its portfolio for microbial identification, infection control, and molecular diagnostics of infectious diseases by introducing new assays, software and library extensions for its MALDI Biotyper, IR Biotyper, and Fluorocycler XT product lines which are expected to have a positive impact on the market.

Global Molecular Quality Controls Market - Key Companies to Watch

Bio-Rad Laboratories, Inc

Overview: Bio-Rad Laboratories, Inc. is an American company that continued 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.

Product Portfolio: It includes products like Amplichek II, Level-1,2,3, Amplichek II, Negative MiniPak etc.

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Target Audience

Service Providers/ Buyers

Industry Investors/Investment Bankers

Education & Research Institutes

Research Professionals

Emerging Companies

Manufacturers

Table of Contents

1. Global Molecular Quality Controls Methodology and Scope

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

2. Global Molecular Quality Controls Market - Market Definition and Overview

3. Global Molecular Quality Controls Market - Executive Summary

• 3.1. Market Snippet by Product Type
• 3.2. Market Snippet by Age Group
• 3.3. Market Snippet by End-User
• 3.4. Market Snippet by Region

4. Global Molecular Quality Controls Market - Market Dynamics

• 4.1. Market Impacting Factors
  • 4.1.1. Drivers:
    • 4.1.1.1. Increasing number of accredited clinical laboratories
  • 4.1.2. Restraints:
    • 4.1.2.1. Additional costs involved in quality control and budget constraints in hospitals and laboratories
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Global Molecular Quality Controls Market - Industry Analysis

• 5.1. Porter's Five Forces Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. PEST Analysis

6. Global Molecular Quality Controls 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 Molecular Quality Controls Market - By Product Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
  • 7.1.2. Market Attractiveness Index, By Product Type
• 7.2. Independent Control*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
• 7.3. Instrument Specific-Control

8. Global Molecular Quality Controls 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
• 8.2. Oncology*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
• 8.3. Genetic Testing
• 8.4. Infectious Diseases
• 8.5. Others

9. Global Molecular Quality Controls 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
• 9.2. Hospitals*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
• 9.3. Clinical Laboratories
• 9.4. IVD Manufacturers & CROs
• 9.5. Others

10. Global Molecular Quality Controls Market - By Region

• 10.1. Introduction
  • 10.1.1. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029, 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 Type
  • 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 Type
  • 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 Type
  • 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 Type
  • 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 Type
  • 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 Molecular Quality Controls Market - Competitive Landscape

• 11.1. Competitive Scenario
• 11.2. Key Developments and Strategies
• 11.3. Company Share Analysis
• 11.4. Product Benchmarking
• 11.5. Key Companies to Watch
• 11.6. Company with disruptive technology

12. Global Molecular Quality Controls 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. F. Hoffmann-La Roche AG
• 12.3. SeraCare Life Sciences Inc
• 12.4. BioMerieux Inc
• 12.5. ZeptoMetrix Corporation
• 12.6. Abbott Laboratories
• 12.7. Thermo Fisher Scientific
• 12.8. Microbiologics Inc
• 12.9. Quidel Corporation
• 12.10. Qnostics Ltd

LIST NOT EXHAUSTIVE

13. Global Molecular Quality Controls Market - DataM

• 13.1. Appendix
• 13.2. About Us and Services
• 13.3. Contact Us