Invitro Diagnostics Market

Invitro Diagnostics Market

Invitro Diagnostics Market Forecasts to 2030 - Global Analysis By Product and Service (Reagents & Kits, Instruments, Services and Data Management Software), Technology (Immunoassay/ Immunochemistry, Hematology, Microbiology, Urinalysis, Clinical Chemistry, Molecular Diagnostics, Coagulation and Hemostasis and Other Technologies), Application, End User and By Geography.

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Published: 2023 ID: SMRC24209

This report covers the impact of COVID-19 on this global market

Years Covered


Estimated Year Value (2023)

US $98.14 BN

Projected Year Value (2030)

US $148.54 BN

CAGR (2023 - 2030)


Regions Covered

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

Countries Covered

US, Canada, Mexico, Germany, UK, Italy, France, Spain, Japan, China, India, Australia, New Zealand, South Korea, Rest of Asia Pacific, South America, Argentina, Brazil, Chile, Middle East & Africa, Saudi Arabia, UAE, Qatar, and South Africa

Largest Market

Asia Pacific

Highest Growing Market

North America

According to Stratistics MRC, the Global In vitro Diagnostics Market is accounted for $98.14 billion in 2023 and is expected to reach $148.54 billion by 2030 growing at a CAGR of 6.1% during the forecast period. In vitro diagnostics (IVD) refers to a category of medical tests and diagnostic techniques on biological samples such as blood, urine, and tissues. These tests are used to monitor and identify autoimmune diseases, infectious diseases, and a variety of other medical conditions. They may also be used to analyse changes in drug therapy. Moreover, they enable precise and timely diagnoses, contributing to improved health outcomes, reduced healthcare costs, and the prevention of disease spread.

According to the International Diabetes Federation (IDF), in 2021, there were 537 million people across the globe suffering from diabetes, and the number is expected to increase to 643 million by 2030.

Market Dynamics: 


Increasing awareness of early disease diagnosis in emerging economies

The growing awareness of early disease diagnosis in emerging economies stands out as a significant driver of the in vitro diagnostics (IVD) market. As healthcare awareness and education improve in these regions, more people are seeking preventive healthcare measures and early disease detection. Early diagnosis often results in better treatment outcomes, reduced healthcare costs, and improved overall health. This awareness not only benefits individuals but also prompts healthcare systems and governments to invest in diagnostic infrastructure, thus boosting the demand for IVD products and services. Moreover, as emerging economies expand their healthcare access, there is a greater need for cost-effective and accessible diagnostic solutions, driving innovation and market growth in the IVD sector to meet these demands.


High cost

The expenses associated with developing, producing, and procuring IVD tests and equipment can be substantial. These costs are often passed on to healthcare providers and patients, leading to affordability challenges. Inadequate reimbursement and limited healthcare budgets further exacerbate the financial burden. This can result in reduced access to essential diagnostic services, particularly in resource-constrained settings, hindering early disease detection and management. Therefore, this will hamper market demand.


Technological advancements

Continuous innovation in diagnostic technologies is revolutionizing healthcare by enhancing accuracy, efficiency, and accessibility. Advanced techniques, such as molecular diagnostics, lab-on-a-chip platforms, and next-generation sequencing, allow for quicker and more precise test results. The development of portable and point-of-care testing devices makes diagnostics more convenient, especially in remote or resource-limited areas. Additionally, the integration of IVD with digital health platforms and artificial intelligence further enhances data analysis and interpretation. These advancements not only improve patient care but also reduce healthcare costs. IVD companies that invest in research and development to leverage these technologies can gain a competitive edge and tap into the expanding market for cutting-edge diagnostic solutions


Stringent regulations and legal standards

Stringent regulatory and legal guidelines pose a significant threat to the in vitro diagnostics (IVD) market. These guidelines often imposed to ensure the safety and efficacy of diagnostic tests, can lead to increased compliance costs, lengthy approval processes, and market entry barriers for IVD manufacturers. Non-compliance can result in fines and product recalls. Additionally, evolving regulations can make it challenging for companies to keep up with changing standards, impacting product development and innovation. 

Covid-19 Impact

During the COVID-19 pandemic, several segments witnessed both positive and negative effects. The market experienced a positive impact due to the increased use of molecular diagnostics, which counteracted the negative effects of other categories. Furthermore, among hospitalised COVID-19 patients, there was a rise in the need for test kits and consumables for monitoring blood glucose and troponin levels. Participants have experienced a significant increase in sales of molecular and point-of-care tests, which has resulted in a significant increase in their earnings. However, a significant drop in routine testing carried out in hospitals and laboratories globally caused some major firms to see a dip in their revenue margins. 

The Diabetes segment is expected to be the largest during the forecast period

The Diabetes segment is estimated to hold the largest share. Diabetes, a chronic metabolic disorder, represents a significant segment of the in vitro diagnostics (IVD) market. Diagnostic tests for diabetes are vital for the early detection, monitoring, and management of the condition. The IVD market for diabetes includes blood glucose monitoring devices, HbA1c tests, and various other assays for assessing blood sugar levels. As the global prevalence of diabetes continues to rise, this segment experiences consistent growth. Furthermore, IVD innovations play a crucial role in delivering precise and convenient tools for both patients and healthcare professionals to effectively control diabetes, reduce complications, and enhance the quality of life for millions of individuals affected by the disease. 

The Clinical Laboratories segment is expected to have the highest CAGR during the forecast period

The Clinical Laboratories segment is anticipated to have lucrative growth during the forecast period. Clinical laboratories are a fundamental segment of the in vitro diagnostics (IVD) market. These specialised facilities conduct various diagnostic tests on patient samples, such as blood, urine, and tissue, to aid in disease diagnosis, treatment, and monitoring. They play a crucial role in healthcare, providing essential information to healthcare providers for decision-making. Moreover, clinical laboratories offer a wide range of tests, including chemistry, microbiology, haematology, immunology, and molecular diagnostics. The clinical laboratory industry is growing due to the growing need for accurate and timely patient care as well as the need for healthcare services.

Region with largest share:

Asia Pacific commanded the largest market share during the extrapolated period. The Asia-Pacific region represents a rapidly growing and dynamic sector within the global in vitro diagnostics (IVD) market. With diverse and populous countries, such as China, India, and Japan, this region is witnessing significant expansion in healthcare infrastructure and increasing healthcare expenditures. Factors contributing to the growth include rising disease prevalence, increasing awareness of early disease detection, and growing access to healthcare services. Moreover, government initiatives and regulatory reforms are driving quality and accessibility in diagnostic testing. The COVID-19 pandemic has also emphasised the importance of IVD in the region, with a surge in demand for testing. 

Region with highest CAGR:

North America is expected to witness profitable growth over the projection period, owing to the well-established healthcare industry and the rising prevalence of chronic diseases. The region is characterized by a competitive landscape with prominent companies like Abbott Laboratories, Thermo Fisher Scientific, and Roche Diagnostics. Moreover, the market benefits from a strong focus on research and development, leading to the introduction of cutting-edge diagnostic tests and technologies. Regulatory bodies, such as the FDA in the United States, ensure quality and safety standards. Additionally, the COVID-19 pandemic has underscored the importance of IVD tests in the region for diagnosing, tracking, and managing infectious diseases.

Key players in the market

Some of the key players in the In vitro Diagnostics Market include Freenome Holdings, Inc., Agilent Technologies, Inc., Natera, Inc., Exact Sciences Corporation, F. Hoffmann-La Roche Ltd., Abbott Laboratories, Sysmex Corporation, Siemens Healthineers AG, BD (Becton, Dickinson, and Company), Quest Diagnostics Incorporated, Bio-Rad Laboratories, Inc., Alere, Inc., InterVenn Biosciences, Guardant Health, Thermo Fisher Scientific, Inc., NeoGenomics Laboratories, Invitae Corporation, Beckman Coulter, Danaher and Illumina, Inc.

Key Developments:

In May 2023, Freenome, a privately held biotech company, announced that it has acquired Oncimmune Ltd, a UK-based global immunodiagnostics developer with a commercialized CE-IVD marked EarlyCDT Lung blood test, autoantibody platform and research and development pipeline of 7+ cancer detection signatures.

In November 2022, Thermo Fisher Scientific (US) launched the rapid RT-PCR Accula Flu A/Flu B Test designed to enable healthcare providers to detect and differentiate influenza A and B in about 30 minutes.

In October 2022, Thermo Fisher Scientific (US) entered a definitive agreement to acquire The Binding Site Group, a global leader in specialty diagnostics. The Binding Site provides specialty diagnostic assays and instruments to improve the diagnosis and management of blood cancers and immune system disorders.

In September 2022, Sysmex Corporation (Japan) launched the UF-1500 Fully Automated Urine Particle Analyzer (UF-1500) for urine sediment testing. The UF-1500 inherits the high levels of functionality and usability of the UF-5000 Fully Automated Urine Particle Analyzer (UF-5000).

In August 2022, Al-Futtaim Health (Dubai) and Abbott Laboratories (US) entered into a strategic partnership to improve the standards of advanced laboratory diagnostics in Dubai.

Product and Services Covered:
• Reagents & Kits 
• Instruments 
• Services 
• Data Management Software 

Technologies Covered:
• Immunoassay/ Immunochemistry 
• Hematology 
• Microbiology 
• Urinalysis 
• Clinical Chemistry 
• Molecular Diagnostics 
• Coagulation and Hemostasis 
• Other Technologies 

Applications Covered:
• Infectious Diseases
• Drug Testing/ Pharmacogenomics 
• Oncology 
• Diabetes 
• Autoimmune Diseases 
• Cardiology 
• Nephrology 
• Other Applications 

End Users Covered:
• Hospital Laboratories
• Academic Institutes 
• Patients 
• Point-of-Care Testing Centers 
• Clinical Laboratories 
• Other End Users 

Regions Covered:
• North America
o US
o Canada
o Mexico
• Europe
o Germany
o UK
o Italy
o France
o Spain
o Rest of Europe
• Asia Pacific
o Japan        
o China        
o India        
o Australia  
o New Zealand
o South Korea
o Rest of Asia Pacific    
• South America
o Argentina
o Brazil
o Chile
o Rest of South America
• Middle East & Africa 
o Saudi Arabia
o Qatar
o South Africa
o Rest of Middle East & Africa

What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements

Free Customization Offerings: 
All the customers of this report will be entitled to receive one of the following free customization options:
• Company Profiling
o Comprehensive profiling of additional market players (up to 3)
o SWOT Analysis of key players (up to 3)
• Regional Segmentation
o Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary    
2 Preface     
 2.1 Abstract    
 2.2 Stake Holders   
 2.3 Research Scope   
 2.4 Research Methodology  
  2.4.1 Data Mining  
  2.4.2 Data Analysis  
  2.4.3 Data Validation  
  2.4.4 Research Approach  
 2.5 Research Sources   
  2.5.1 Primary Research Sources 
  2.5.2 Secondary Research Sources 
  2.5.3 Assumptions  
3 Market Trend Analysis   
 3.1 Introduction   
 3.2 Drivers    
 3.3 Restraints   
 3.4 Opportunities   
 3.5 Threats    
 3.6 Product Analysis   
 3.7 Technology Analysis  
 3.8 Application Analysis  
 3.9 End User Analysis   
 3.10 Emerging Markets   
 3.11 Impact of Covid-19   
4 Porters Five Force Analysis   
 4.1 Bargaining power of suppliers  
 4.2 Bargaining power of buyers  
 4.3 Threat of substitutes  
 4.4 Threat of new entrants  
 4.5 Competitive rivalry   
5 Global Invitro Diagnostics Market, By Product and Service
 5.1 Introduction   
 5.2 Reagents & Kits   
 5.3 Instruments   
 5.4 Services    
 5.5 Data Management Software  
6 Global Invitro Diagnostics Market, By Technology 
 6.1 Introduction   
 6.2 Immunoassay/ Immunochemistry 
 6.3 Hematology   
 6.4 Microbiology   
 6.5 Urinalysis   
 6.6 Clinical Chemistry   
 6.7 Molecular Diagnostics  
 6.8 Coagulation and Hemostasis  
 6.9 Other Technologies   
7 Global Invitro Diagnostics Market, By Application 
 7.1 Introduction   
 7.2 Infectious Diseases   
 7.3 Drug Testing/ Pharmacogenomics 
 7.4 Oncology    
 7.5 HIV/AIDS    
 7.6 Diabetes    
 7.7 Autoimmune Diseases  
 7.8 Cardiology   
 7.9 Nephrology   
 7.10 Other Applications   
8 Global Invitro Diagnostics Market, By End User 
 8.1 Introduction   
 8.2 Hospital Laboratories  
 8.3 Academic Institutes   
 8.4 Patients    
 8.5 Point-of-Care Testing Centers  
 8.6 Clinical Laboratories  
 8.7 Other End Users   
9 Global Invitro Diagnostics Market, By Geography 
 9.1 Introduction   
 9.2 North America   
  9.2.1 US   
  9.2.2 Canada   
  9.2.3 Mexico   
 9.3 Europe    
  9.3.1 Germany   
  9.3.2 UK   
  9.3.3 Italy   
  9.3.4 France   
  9.3.5 Spain   
  9.3.6 Rest of Europe  
 9.4 Asia Pacific   
  9.4.1 Japan   
  9.4.2 China   
  9.4.3 India   
  9.4.4 Australia   
  9.4.5 New Zealand  
  9.4.6 South Korea  
  9.4.7 Rest of Asia Pacific  
 9.5 South America   
  9.5.1 Argentina  
  9.5.2 Brazil   
  9.5.3 Chile   
  9.5.4 Rest of South America 
 9.6 Middle East & Africa  
  9.6.1 Saudi Arabia  
  9.6.2 UAE   
  9.6.3 Qatar   
  9.6.4 South Africa  
  9.6.5 Rest of Middle East & Africa 
10 Key Developments    
 10.1 Agreements, Partnerships, Collaborations and Joint Ventures
 10.2 Acquisitions & Mergers  
 10.3 New Product Launch  
 10.4 Expansions   
 10.5 Other Key Strategies  
11 Company Profiling    
 11.1 Freenome Holdings, Inc.  
 11.2 Agilent Technologies, Inc.  
 11.3 Natera, Inc.   
 11.4 Exact Sciences Corporation  
 11.5 F. Hoffmann-La Roche Ltd.  
 11.6 Abbott Laboratories   
 11.7 Sysmex Corporation  
 11.8 Siemens Healthineers AG 
 11.9 BD (Becton, Dickinson, and Company) 
 11.10 Quest Diagnostics Incorporated 
 11.11 Bio-Rad Laboratories, Inc.
 11.12 Alere, Inc.   
 11.13 InterVenn Biosciences  
 11.14 Guardant Health   
 11.15 Thermo Fisher Scientific, Inc.  
 11.16 NeoGenomics Laboratories  
 11.17 Invitae Corporation   
 11.18 Beckman Coulter   
 11.19 Danaher    
 11.20 Illumina, Inc.   
List of Tables     
1 Global Invitro Diagnostics Market Outlook, By Region (2021-2030) ($MN)
2 Global Invitro Diagnostics Market Outlook, By Product and Service (2021-2030) ($MN)
3 Global Invitro Diagnostics Market Outlook, By Reagents & Kits (2021-2030) ($MN)
4 Global Invitro Diagnostics Market Outlook, By Instruments (2021-2030) ($MN)
5 Global Invitro Diagnostics Market Outlook, By Services (2021-2030) ($MN)
6 Global Invitro Diagnostics Market Outlook, By Data Management Software (2021-2030) ($MN)
7 Global Invitro Diagnostics Market Outlook, By Technology (2021-2030) ($MN)
8 Global Invitro Diagnostics Market Outlook, By Immunoassay/ Immunochemistry (2021-2030) ($MN)
9 Global Invitro Diagnostics Market Outlook, By Hematology (2021-2030) ($MN)
10 Global Invitro Diagnostics Market Outlook, By Microbiology (2021-2030) ($MN)
11 Global Invitro Diagnostics Market Outlook, By Urinalysis (2021-2030) ($MN)
12 Global Invitro Diagnostics Market Outlook, By Clinical Chemistry (2021-2030) ($MN)
13 Global Invitro Diagnostics Market Outlook, By Molecular Diagnostics (2021-2030) ($MN)
14 Global Invitro Diagnostics Market Outlook, By Coagulation and Hemostasis (2021-2030) ($MN)
15 Global Invitro Diagnostics Market Outlook, By Other Technologies (2021-2030) ($MN)
16 Global Invitro Diagnostics Market Outlook, By Application (2021-2030) ($MN)
17 Global Invitro Diagnostics Market Outlook, By Infectious Diseases (2021-2030) ($MN)
18 Global Invitro Diagnostics Market Outlook, By Drug Testing/ Pharmacogenomics (2021-2030) ($MN)
19 Global Invitro Diagnostics Market Outlook, By Oncology (2021-2030) ($MN)
20 Global Invitro Diagnostics Market Outlook, By HIV/AIDS (2021-2030) ($MN)
21 Global Invitro Diagnostics Market Outlook, By Diabetes (2021-2030) ($MN)
22 Global Invitro Diagnostics Market Outlook, By Autoimmune Diseases (2021-2030) ($MN)
23 Global Invitro Diagnostics Market Outlook, By Cardiology (2021-2030) ($MN)
24 Global Invitro Diagnostics Market Outlook, By Nephrology (2021-2030) ($MN)
25 Global Invitro Diagnostics Market Outlook, By Other Applications (2021-2030) ($MN)
26 Global Invitro Diagnostics Market Outlook, By End User (2021-2030) ($MN)
27 Global Invitro Diagnostics Market Outlook, By Hospital Laboratories (2021-2030) ($MN)
28 Global Invitro Diagnostics Market Outlook, By Academic Institutes (2021-2030) ($MN)
29 Global Invitro Diagnostics Market Outlook, By Patients (2021-2030) ($MN)
30 Global Invitro Diagnostics Market Outlook, By Point-of-Care Testing Centers (2021-2030) ($MN)
31 Global Invitro Diagnostics Market Outlook, By Clinical Laboratories (2021-2030) ($MN)
32 Global Invitro Diagnostics Market Outlook, By Other End Users (2021-2030) ($MN)
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.

List of Figures


Research Methodology

We at Stratistics opt for an extensive research approach which involves data mining, data validation, and data analysis. The various research sources include in-house repository, secondary research, competitor’s sources, social media research, client internal data, and primary research.

Our team of analysts prefers the most reliable and authenticated data sources in order to perform the comprehensive literature search. With access to most of the authenticated data bases our team highly considers the best mix of information through various sources to obtain extensive and accurate analysis.

Each report takes an average time of a month and a team of 4 industry analysts. The time may vary depending on the scope and data availability of the desired market report. The various parameters used in the market assessment are standardized in order to enhance the data accuracy.

Data Mining

The data is collected from several authenticated, reliable, paid and unpaid sources and is filtered depending on the scope & objective of the research. Our reports repository acts as an added advantage in this procedure. Data gathering from the raw material suppliers, distributors and the manufacturers is performed on a regular basis, this helps in the comprehensive understanding of the products value chain. Apart from the above mentioned sources the data is also collected from the industry consultants to ensure the objective of the study is in the right direction.

Market trends such as technological advancements, regulatory affairs, market dynamics (Drivers, Restraints, Opportunities and Challenges) are obtained from scientific journals, market related national & international associations and organizations.

Data Analysis

From the data that is collected depending on the scope & objective of the research the data is subjected for the analysis. The critical steps that we follow for the data analysis include:

  • Product Lifecycle Analysis
  • Competitor analysis
  • Risk analysis
  • Porters Analysis
  • PESTEL Analysis
  • SWOT Analysis

The data engineering is performed by the core industry experts considering both the Marketing Mix Modeling and the Demand Forecasting. The marketing mix modeling makes use of multiple-regression techniques to predict the optimal mix of marketing variables. Regression factor is based on a number of variables and how they relate to an outcome such as sales or profits.

Data Validation

The data validation is performed by the exhaustive primary research from the expert interviews. This includes telephonic interviews, focus groups, face to face interviews, and questionnaires to validate our research from all aspects. The industry experts we approach come from the leading firms, involved in the supply chain ranging from the suppliers, distributors to the manufacturers and consumers so as to ensure an unbiased analysis.

We are in touch with more than 15,000 industry experts with the right mix of consultants, CEO's, presidents, vice presidents, managers, experts from both supply side and demand side, executives and so on.

The data validation involves the primary research from the industry experts belonging to:

  • Leading Companies
  • Suppliers & Distributors
  • Manufacturers
  • Consumers
  • Industry/Strategic Consultants

Apart from the data validation the primary research also helps in performing the fill gap research, i.e. providing solutions for the unmet needs of the research which helps in enhancing the reports quality.

For more details about research methodology, kindly write to us at

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