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In Vitro Diagnostics Quality Control Market Size, Share 2031
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In Vitro Diagnostics Quality Control Market Size, Share 2031

Segments - In Vitro Diagnostics Quality Control Market by Applications (Immunochemistry, Hematology, Clinical Chemistry, Molecular Diagnostics, Coagulation, Microbiology, and Others), Types (Quality Control and Quality Assurance Services), End-users (Laboratories, Home-care, and Hospitals), and Regions (Asia Pacific, North America, Latin America, Europe, and Middle East & Africa) - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast 2023 – 2031

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Author : Raksha Sharma
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Editor : Vishal Golekar

Upcoming | Report ID :HC-867 | 4.4 Rating | 61 Reviews | 134 Pages | Format : PDF Excel PPT

Report Description


The global in vitro diagnostics quality control market size was valued at USD 1.30 Billion in 2022 and is likely to reach USD 2.09 Billion by 2031, expanding at a CAGR of 5.4% during 2023 – 2031. The growth of the market is attributed to the existence of regulatory bodies and growing number of recognized clinical laboratories around the world.

In vitro diagnostics tests are done on samples of blood or tissue that are taken from human body. In vitro diagnostics are used for detection of diseases or other health conditions and for monitoring over health of person to treat, cure, or prevent diseases. It is also used in precision medicine to recognize those patients who are anticipated to get benefits from particular treatment or therapy. Diagnostic laboratories are rapidly developing due to rising prevalence of chronic diseases such as cardiovascular diseases (CVDs), diabetes, and infectious diseases. Several public and private laboratories are going through laboratory authorization procedures to fulfill the industry standards, expand procedural volume, and attract more patients. Laboratories accredited by Clinical Laboratory Improvement Amendments (CLIA) accredited are entitled for reimbursement through Medicaid and Medicare services.

There are some regulatory bodies present to monitor quality control and quality checking of IVD devices and service. Some of the key service providers are Therapeutic Goods Administration (TGA) for Australia, Health Canada for Canada; European Medicines Agency (EMEA) for Europe, Medicines and Healthcare Products Regulatory Agency (MHRA) for the U.K., Ministry of Health, Labor & Welfare (MHLW) for Japan, Ministry of Health for South Africa, Central Drug Standard Control Organization (CDSCO) for India, Ministry of Health, Labor & Welfare (MHLW) for Brazil, and Food and Drug Administration (FDA) for the U.S.

In Vitro Diagnostics Quality Control Market Outlook

Market Trends, Drivers, Restraints, and Opportunities

  • Rising number of clinical laboratories is anticipated to fuel the market growth in the coming years.

  • Increasing prevalence of obesity and chronic diseases and rising demand for third party quality assessments are key drivers of the in vitro diagnostics quality control market growth.

  • Increasing adoption of advanced diagnostic devices specifically in hospitals is projected to fuel the market expansion over the forecast period.

  • High cost of in vitro diagnostics is key factor responsible for hampering the market expansion.

  • Lack of skilled technicians handling the in vitro diagnostics quality control testing devices is anticipated to impede the market growth.

Scope of the Report

The report on the global in vitro diagnostics quality control market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Attributes

Details

Report Title

In Vitro Diagnostics Quality Control Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast

Base Year

2022

Historic Data

2016–2021

Forecast Period

2023–2031

Segmentation

Applications (Immunochemistry, Hematology, Clinical Chemistry, Molecular Diagnostics, Coagulation, Microbiology, and Others), Types (Quality Control and Quality Assurance Services), and End-users (Laboratories, Home-care, and Hospitals)

Regional Scope

Asia Pacific, North America, Latin America, Europe, and Middle East & Africa

Report Coverage

Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, and Trends, and Revenue Forecast

Key Players Covered in the Report

Siemens Healthcare GmbH; Roche Diagnostics; Alere, Inc.; Abbott Laboratories, Inc.; Bio-Techne; Hologic, Inc. (Gen-Probe); Qiagen N.V.; Bio-Rad Laboratories, Inc.; Quidel Corp.; Becton, Dickinson, and Company (BD); bioMerieux, Inc.; Sysmex Corp.; Sero AS; and Thermo Fisher Scientific, Inc.

Market Segment Insights

Immunochemistry segment to account for a key share

Based on applications, the global in vitro diagnostics quality control market is divided into immunochemistry, hematology, clinical chemistry, molecular diagnostics, coagulation, microbiology, and others. The immunology application segment dominated the global market in 2019 and is expected to account for a key market share during the forecast period. Immunology is a study of molecular mechanism to understand the functions of the immune system. It mainly includes the mechanism of action of antibodies, antigens, and their interactions. Detection of infectious microorganisms such as fungus, bacteria, and viruses by sensing the existence of their toxins and coat antigens is Strategic application of immunochemistry. Early diagnosis and growing outbreaks of chronic and communicable diseases are key factors for driving the demand of immunochemistry including various types of Enzyme-Linked Immunosorbent Assay (ELISA).

On the other hand, the molecular diagnostics segment is expected to expand at a substantial CAGR during the forecast period. Molecular diagnostics include a set of complex tests including major bacterial, viral, and parasitic infections. To overcome the traditional systems, advanced technologies are introduced such as Next-Generation Sequencing (NGS) and Polymerase Chain Reaction (PCR). The key pathogens regularly diagnosed using multiplex PCR which are H. influenza, S. pneumonia (respiratory tract infections), G. Lombardia, Leishmaniaspp, N. gonorrhea, C. trachoma (genital infections), and HIV, HSV (meningitis and encephalitis).

In Vitro Diagnostics Quality Control Market Application

Quality control segment is expected to grow at a rapid pace

On the basis of types, the market is bifurcated into quality control and quality assurance services. In 2019 the quality control segment held a high revenue share and it is projected to grow at a rapid pace during the forecast period. Quality control (QC) normally involves problems detection, monitoring work process, and doing correction in products or services before delivery. Statistical quality control is a process of monitoring analytical performance of clinical laboratory testing processes.

Quality control checks are performed at the time of installation of instrument, changing reagent lots, readings are not in range, and after servicing. There are many regulatory authorities such as American Association for Laboratory Accreditation (A2LA), Clinical Laboratory Improvement Amendments (CLIA) and European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) have increased demand of IVD quality control.

In Vitro Diagnostics Quality Control Market Types

Hospitals segment to hold a large market share

Based on end-users, the global in vitro diagnostics quality control market is divided into laboratories, home-care, and hospitals. The hospitals segment is projected to hold a large market share in the coming years owing to increasing number of admissions of healthcare professionals and improving reliability on clinical diagnosis to decide treatment alternatives in hospitals. For diagnostic services, hospitals are preferred as they conduct regular monitoring of tests and install a variety of advanced instruments. Moreover, growing demand for fast diagnostic tests as well as the wide availability of a large number of IVD instruments and reagent kits are some key factors responsible for the segment growth.

The home-care segment is projected to grow at rapid pace during the forecast period. Home-care settings comprise of different devices such as Point-of-Care (POC) instruments, IVD devices and self-testing kits. Self-testing kits helps patients to reduce hospital visits and ease for everyday testing. Home-care products includes a range of devices and kits such as hemoglobin sensors, pregnancy detection kits/devices, hormone home tests, urine analyzers, and blood glucose monitoring devices for diabetes patients.

North America to account for a key share

On the basis of regions, the global in vitro diagnostics quality control market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America dominated the market share in 2019, representing a revenue share of more than 44.7% of the global market. The presence of key global players and early adoption of advanced technology in the healthcare and medical sector especially in the US are key driving factors for the regional market growth. Furthermore, growing medical devices convergence of regulatory systems is boosted by Global Harmonization Task Force (GHTF) regulatory authorities such as the US FDA, which is projected to enhance the market growth.

The market in Asia Pacific, on the other hand, is anticipated to grow at a fast pace during the forecast period owing to growing awareness of the IVD quality control and several government agencies’ initiatives that encourage the development of advanced healthcare facilities in the region. For instance, the use of IVDs is widely encouraged by several bodies such as the Asia Pacific Federation of Clinical Biochemistry and Laboratory Medicine (APFCB), which play key roles in the regional market growth.

In Vitro Diagnostics Quality Control Market Region

Segments

Applications

  • Immunochemistry
  • Hematology
  • Clinical Chemistry
  • Molecular Diagnostics
  • Coagulation
  • Microbiology
  • Others

Types

  • Quality Control
  • Quality Assurance Services

Products

  • Hospitals
  • Laboratories
  • Home-care

Regions

  • Asia Pacific
  • North America
  • Latin America
  • Europe
  • Middle East & Africa

Key Players

  • Siemens Healthcare GmbH
  • Roche Diagnostics
  • Alere, Inc.
  • Abbott Laboratories, Inc.
  • Bio-Techne
  • Hologic, Inc. (Gen-Probe)
  • Qiagen N.V.
  • Bio-Rad Laboratories, Inc.
  • Quidel Corp.
  • Becton, Dickinson, and Company (BD)
  • bioMerieux, Inc.
  • Sysmex Corp.
  • Sero AS
  • Thermo Fisher Scientific, Inc.

Competitive Landscape

Some of the key market players competing in the global in vitro diagnostics quality control market are Siemens Healthcare GmbH; Roche Diagnostics; Alere, Inc.; Abbott Laboratories, Inc.; Bio-Techne; Hologic, Inc. (Gen-Probe); Qiagen N.V.; Bio-Rad Laboratories, Inc.; Quidel Corp.; Becton, Dickinson, and Company (BD); bioMerieux, Inc.; Sysmex Corp.; Sero AS; and Thermo Fisher Scientific, Inc.

Major market players are constantly focusing on application development and customized products as the market is increasingly competitive. Moreover, several companies are spending a huge amount on marketing and advertisement especially in developing countries for the expansion of their business operations and market share.

In Vitro Diagnostics Quality Control Market Keyplayers

Table Of Content

1. Executive Summary
2. Assumptions and Acronyms Used
3. Research Methodology
4. In Vitro Diagnostics Quality Control Market Overview
  4.1. Introduction
     4.1.1. Market Taxonomy
     4.1.2. Market Definition
  4.2. Macro-Economic Factors
     4.2.1. Industry Outlook
  4.3. In Vitro Diagnostics Quality Control Market Dynamics
     4.3.1. Market Drivers
     4.3.2. Market Restraints
     4.3.3. Opportunity
     4.3.4. Market Trends
  4.4. In Vitro Diagnostics Quality Control Market - Supply Chain
  4.5. Global In Vitro Diagnostics Quality Control Market Forecast
     4.5.1. In Vitro Diagnostics Quality Control Market Size (US$ Mn) and Y-o-Y Growth
     4.5.2. In Vitro Diagnostics Quality Control Market Size (000’ Units) and Y-o-Y Growth
     4.5.3. In Vitro Diagnostics Quality Control Market Absolute $ Opportunity
5. Global In Vitro Diagnostics Quality Control Market Analysis and Forecast by Types
  5.1. Market Trends
  5.2. Introduction
     5.2.1. Basis Point Share (BPS) Analysis by Types
     5.2.2. Y-o-Y Growth Projections by Types
  5.3. In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Types
     5.3.1. Quality Control
     5.3.2. Quality Assurance Services
  5.4. Absolute $ Opportunity Assessment by Types
  5.5. Market Attractiveness/Growth Potential Analysis by Types
6. Global In Vitro Diagnostics Quality Control Market Analysis and Forecast by Applications
  6.1. Market Trends
  6.2. Introduction
     6.2.1. Basis Point Share (BPS) Analysis by Applications
     6.2.2. Y-o-Y Growth Projections by Applications
  6.3. In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Applications
     6.3.1. Immunochemistry
     6.3.2. Hematology
     6.3.3. Clinical Chemistry
     6.3.4. Molecular Diagnostics
     6.3.5. Coagulation
     6.3.6. Microbiology
  6.4. Absolute $ Opportunity Assessment by Applications
  6.5. Market Attractiveness/Growth Potential Analysis by Applications
7. Global In Vitro Diagnostics Quality Control Market Analysis and Forecast by Region
  7.1. Market Trends
  7.2. Introduction
     7.2.1. Basis Point Share (BPS) Analysis by Region
     7.2.2. Y-o-Y Growth Projections by Region
  7.3. In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Region
     7.3.1. North America
     7.3.2. Latin America
     7.3.3. Europe
     7.3.4. Asia Pacific
     7.3.5. Middle East and Africa (MEA)
  7.4. Absolute $ Opportunity Assessment by Region
  7.5. Market Attractiveness/Growth Potential Analysis by Region
  7.6. Global In Vitro Diagnostics Quality Control Demand Share Forecast, 2019-2026
8. North America In Vitro Diagnostics Quality Control Market Analysis and Forecast
  8.1. Introduction
     8.1.1. Basis Point Share (BPS) Analysis by Country
     8.1.2. Y-o-Y Growth Projections by Country
  8.2. North America In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Country
     8.2.1. U.S.
     8.2.2. Canada
  8.3. Absolute $ Opportunity Assessment by Country
  8.4. North America In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Types
     8.4.1. Quality Control
     8.4.2. Quality Assurance Services
  8.5. Basis Point Share (BPS) Analysis by Types
  8.6. Y-o-Y Growth Projections by Types
  8.7. North America In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Applications
     8.7.1. Immunochemistry
     8.7.2. Hematology
     8.7.3. Clinical Chemistry
     8.7.4. Molecular Diagnostics
     8.7.5. Coagulation
     8.7.6. Microbiology
  8.8. Basis Point Share (BPS) Analysis by Applications
  8.9. Y-o-Y Growth Projections by Applications
  8.10. Market Attractiveness/Growth Potential Analysis
     8.10.1. By Country
     8.10.2. By Product Type
     8.10.3. By Application
  8.11. North America In Vitro Diagnostics Quality Control Demand Share Forecast, 2019-2026
9. Latin America In Vitro Diagnostics Quality Control Market Analysis and Forecast
  9.1. Introduction
     9.1.1. Basis Point Share (BPS) Analysis by Country
     9.1.2. Y-o-Y Growth Projections by Country
     9.1.3. Latin America Average Pricing Analysis
  9.2. Latin America In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Country
      9.2.1. Brazil
      9.2.2. Mexico
      9.2.3. Rest of Latin America
   9.3. Absolute $ Opportunity Assessment by Country
  9.4. Latin America In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Types
     9.4.1. Quality Control
     9.4.2. Quality Assurance Services
  9.5. Basis Point Share (BPS) Analysis by Types
  9.6. Y-o-Y Growth Projections by Types
  9.7. Latin America In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Applications
     9.7.1. Immunochemistry
     9.7.2. Hematology
     9.7.3. Clinical Chemistry
     9.7.4. Molecular Diagnostics
     9.7.5. Coagulation
     9.7.6. Microbiology
  9.8. Basis Point Share (BPS) Analysis by Applications
  9.9. Y-o-Y Growth Projections by Applications
  9.10. Market Attractiveness/Growth Potential Analysis
     9.10.1. By Country
     9.10.2. By Product Type
     9.10.3. By Application
  9.11. Latin America In Vitro Diagnostics Quality Control Demand Share Forecast, 2019-2026
10. Europe In Vitro Diagnostics Quality Control Market Analysis and Forecast
  10.1. Introduction
     10.1.1. Basis Point Share (BPS) Analysis by Country
     10.1.2. Y-o-Y Growth Projections by Country
     10.1.3. Europe Average Pricing Analysis
  10.2. Europe In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Country
     10.2.1. Germany
     10.2.2. France
     10.2.3. Italy
     10.2.4. U.K.
     10.2.5. Spain
     10.2.6. Russia
     10.2.7. Rest of Europe
  10.3. Absolute $ Opportunity Assessment by Country
  10.4. Europe In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Types
     10.4.1. Quality Control
     10.4.2. Quality Assurance Services
  10.5. Basis Point Share (BPS) Analysis by Types
  10.6. Y-o-Y Growth Projections by Types
  10.7. Europe In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Applications
     10.7.1. Immunochemistry
     10.7.2. Hematology
     10.7.3. Clinical Chemistry
     10.7.4. Molecular Diagnostics
     10.7.5. Coagulation
     10.7.6. Microbiology
  10.8. Basis Point Share (BPS) Analysis by Applications
  10.9. Y-o-Y Growth Projections by Applications
  10.10. Market Attractiveness/Growth Potential Analysis
     10.10.1. By Country
     10.10.2. By Product Type
     10.10.3. By Application
  10.11. Europe In Vitro Diagnostics Quality Control Demand Share Forecast, 2019-2026
11. Asia Pacific In Vitro Diagnostics Quality Control Market Analysis and Forecast
  11.1. Introduction
     11.1.1. Basis Point Share (BPS) Analysis by Country
     11.1.2. Y-o-Y Growth Projections by Country
     11.1.3. Asia Pacific Average Pricing Analysis
  11.2. Asia Pacific In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Country
     11.2.1. China
     11.2.2. Japan
     11.2.3. South Korea
     11.2.4. India
     11.2.5. Australia
     11.2.6. Rest of Asia Pacific (APAC)
  11.3. Absolute $ Opportunity Assessment by Country
  11.4. Asia Pacific In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Types
     11.4.1. Quality Control
     11.4.2. Quality Assurance Services
  11.5. Basis Point Share (BPS) Analysis by Types
  11.6. Y-o-Y Growth Projections by Types
  11.7. Asia Pacific In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Applications
     11.7.1. Immunochemistry
     11.7.2. Hematology
     11.7.3. Clinical Chemistry
     11.7.4. Molecular Diagnostics
     11.7.5. Coagulation
     11.7.6. Microbiology
  11.8. Basis Point Share (BPS) Analysis by Applications
  11.9. Y-o-Y Growth Projections by Applications
  11.10. Market Attractiveness/Growth Potential Analysis
     11.10.1. By Country
     11.10.2. By Product Type
     11.10.3. By Application
  11.11. Asia Pacific In Vitro Diagnostics Quality Control Demand Share Forecast, 2019-2026
12. Middle East & Africa In Vitro Diagnostics Quality Control Market Analysis and Forecast
  12.1. Introduction
     12.1.1. Basis Point Share (BPS) Analysis by Country
     12.1.2. Y-o-Y Growth Projections by Country
     12.1.3. Middle East & Africa Average Pricing Analysis
  12.2. Middle East & Africa In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Country
     12.2.1. Saudi Arabia
     12.2.2. South Africa
     12.2.3. UAE
     12.2.4. Rest of Middle East & Africa (MEA)
  12.3. Absolute $ Opportunity Assessment by Country
  12.4. Middle East & Africa In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Types
     12.4.1. Quality Control
     12.4.2. Quality Assurance Services
  12.5. Basis Point Share (BPS) Analysis by Types
  12.6. Y-o-Y Growth Projections by Types
  12.7. Middle East & Africa In Vitro Diagnostics Quality Control Market Size and Volume Forecast by Applications
     12.7.1. Immunochemistry
     12.7.2. Hematology
     12.7.3. Clinical Chemistry
     12.7.4. Molecular Diagnostics
     12.7.5. Coagulation
     12.7.6. Microbiology
  12.8. Basis Point Share (BPS) Analysis by Applications
  12.9. Y-o-Y Growth Projections by Applications
  12.10. Market Attractiveness/Growth Potential Analysis
     12.10.1. By Country
     12.10.2. By Product Type
     12.10.3. By Application
  12.11. Middle East & Africa In Vitro Diagnostics Quality Control Demand Share Forecast, 2019-2026
13. Competition Landscape
  13.1. Global In Vitro Diagnostics Quality Control Market: Market Share Analysis
  13.2. In Vitro Diagnostics Quality Control Distributors and Customers
  13.3. In Vitro Diagnostics Quality Control Market: Competitive Dashboard
  13.4. Company Profiles (Details: Overview, Financials, Developments, Strategy)
     13.4.1. Siemens Healthcare GmbH
     13.4.2. Roche Diagnostics
     13.4.3. Alere, Inc.
     13.4.4. Abbott Laboratories, Inc.
     13.4.5. Bio-Techne
     13.4.6. Hologic, Inc. (Gen-Probe)
     13.4.7. Qiagen N.V.
     13.4.8. Bio-Rad Laboratories, Inc.&l

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