In Vitro Diagnostics (IVD) Market - Forecast(2022 - 2027)

Report Code: HCR 0577 Report Format: PDF + Excel

In Vitro Diagnostics (IVD) Market Overview

In Vitro Diagnostics (IVD) Market Size is estimated to reach $117.5 billion by 2027. Furthermore, it is poised to grow at a CAGR of 2.6% over the forecast period of 2022-2027. IVD techniques include various types of reagents, instruments, and software to analyze samples such as blood samples, urine, stool, tissue, and other types of body fluid obtained from the human body to diagnose disease, condition, and stage of infection. The various diseases can be detected using techniques such as Enzyme-Linked Immunosorbent Assay, immunoassays, isothermal nucleic acid amplification technology, radioimmunoassays, and polymerase chain reaction in medical diagnostic systems. In vitro diagnostic (IVD) investigations are indispensable for routine patient management. Patients are benefited by using appropriate testing, with an early diagnosis that reduces late-stage healthcare expenditure. Also, IVD is an essential part of the National Health System of England. As per the British 2019 In Vitro Diagnostics Association (BIVDA), In Vitro diagnostic influences 70% of clinical decisions. Such factors drive the In Vitro Diagnostics (IVD) market over the forecast period 2022-2027.

In Vitro Diagnostics (IVD) Market Report Coverage

The report: “In Vitro Diagnostics (IVD) Market Forecast (2022-2027)", by Industry ARC covers an in-depth analysis of the following segments of the In Vitro Diagnostics (IVD) Market.

By Test Type: Clinical Chemistry, Molecular Diagnostics, Immuno Diagnostics, Hematology, and Others. 
By Applications: Infectious Disease, Diabetes, Cancer/ Oncology, Cardiology, Autoimmune Disease, Nephrology, and Others.
By End User: Diagnostic Laboratories, Hospitals and Clinics, and Others.
By Usability: Disposable IVD Devices and Reusable IVD Devices.
By Products: Instruments, Reagents, and Others.
By Geography: North America (U.S., Canada, Mexico), Europe (Germany, United Kingdom (U.K.), France, Italy, Spain, Russia, and the Rest of Europe), Asia Pacific (China, Japan India, South Korea, Australia, and New Zealand, and Rest of Asia Pacific), South America (Brazil, Argentina, Chile, Colombia and Rest of South America), and Rest of the World (the Middle East, and Africa).

Key Takeaways

  • Geographically, North America held a dominant market share in the year 2021, Owing to advance healthcare infrastructure and the increasing prevalence of chronic diseases. 
  • An increasing number of uncurable life-threatening diseases across the world accelerates the growth of the In Vitro Diagnostics (IVD) Market over the forecast period 2022-2027.
  • However, the strict regulatory framework and high capital required for research and development may stymie the growth of the In Vitro Diagnostics (IVD) Market.
  • A detailed analysis of strengths, weaknesses, opportunities, and threats will be provided in the In Vitro Diagnostics (IVD) Market Report.
In Vitro Diagnostics (IVD) Market: Market Share (%) by region, 2021

In Vitro Diagnostics (IVD) Market

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In Vitro Diagnostics (IVD) Market Segmentation Analysis-By Application

In Vitro Diagnostics (IVD) Market based on the applications can be further segmented into Infectious Disease, Diabetes, Cancer/ Oncology, Cardiology, Autoimmune Disease, Nephrology, and Others. The infectious diseases segment held a dominant share in 2021, owing to the recent Covid-19 pandemic. Also, Malaria, Hepatitis C, Dengue, and Tuberculosis (TB) are the most common type of infectious diseases found across the world. TB is one of the deadliest infectious diseases word wide. As per the European Center for Disease Prevention and Control, in 2020 over 33000 TB cases were reported in the European region. Thus, the rising prevalence of communicable diseases contributes to the growth of the in vitro diagnostics market.

However, diabetes is estimated to be the fastest growing with a CAGR of 3.9% over the forecast period of 2022-2027. Owing to the increasing prevalence of diabetics and an increasing number of mortality related to diabetics create the need for IVD. IVD helps to determine glycaemic index which is beneficial for patients to take preventive measures against diabetics and to avoid any further complications. As per, the International Diabetic Federation report published in 2021, shows that 537 million adults between the ages of 20 to 79 years are living with diabetics and the total number of people living with diabetics is projected to rise to 643 million by 2030 and 783 million by 2045. Such an increasing prevalence of diabetics boosts the growth of the IVD market over the forecast period 2022-2027.

In Vitro Diagnostics (IVD) Market Segmentation Analysis-By Products 

In Vitro Diagnostics (IVD) Market based on the products can be further segmented as Instruments, Reagents, and Others. The reagent segment held a dominant share in 2021 and is estimated to grow by 4.2% in the forecast period of 2022-2027. Owing to the increasing number of reagent kits available in the market to self-diagnose disease and infection at home. Such IVD kits consist of materials can be used to determine the outcome of a given test. There are various types of kits to diagnose diseases like Hepatitis C, and HIV self-testing kits which can give results in 20 minutes available online to easily purchase. Companies can now focus on specific profitable areas of the IVD sector owing to the emergence of kits that allow for rapid cancer detection. Invitae, has launched LiquidPlex Dx and FusionPlex Dx cancer diagnostic kits in February 2022 to allow effective management of cancer patients with medication and prompt transmission of essential information. Also, rapid demand for test kits for diagnosis and its attribute like the instant result and low in cost than other diagnostic methods and boosting the market growth. 

In Vitro Diagnostics (IVD) Market Segmentation Analysis by Geography

The In-Vitro Diagnostics (IVD) Market based on Geography can be further segmented into North America, Europe, Asia-Pacific, South America, and the Rest of the World. North America held the dominant share of 40% in 2021. This is owing to advance healthcare infrastructures and facilities available in this region. Also increasing prevalence of diabetics in the North American region and an increasing number of the elderly population in this region helps to drive the market. According to the department of economics and social welfare of the United Nations, 54 million people aged 65 and over lives in the U.S. in 2020, and it will reach up to 85.7 million by 2050. Such an increasing number of the elderly population and an increasing number of diabetes cases in the U.S helps to drive the IVD market in the North American region.

Furthermore, Asia-Pacific is estimated to be the fastest-growing over the forecast period 2022-2027. Owing to the growing prevalence of various chronic diseases, rapidly increasing population, rising investment in the R&B by governments and private organizations, supportive government regulation, and increasing preference for In Vitro Diagnosis by doctors and clinicians for accurate diagnosis of various diseases, the market is expected to expand over the forecast period.

In Vitro Diagnostics (IVD) Market Drivers

Increasing Number of Chronic Diseases Around the World Aids the Market Growth.

Chronic diseases like cancer, diabetes, and heart disease are the leading cause of mortality and disability around the world. In the U.S., six in ten adults suffer from chronic diseases and four in ten have more than two diseases. This impacted the national economy $4.1 trillion in 2021. The increasing consumption of tobacco, smoking habits, exposure to second-hand smoke, poor nutrition in diets, excessive alcohol consumption, and physical inactivity owing to a sluggish lifestyle are major issues. Every second, someone dies from CVD in the U.S as per American Heart Association. Such increasing prevalence of chronic diseases helps to drive the market over the forecast period 2022-2027.

Increasing Elderly Population and Genetic Disease Aids in Market Expansion.

The increasing number of elderly populations around the world creates a need for taking care of such people who frequently need medical help. With increasing, age number of health complications is raising in the body such as diabetes, blood pressure, cardiovascular diseases, and others. According to the department of economics and social welfare of the United Nations, 727 million people all over the world aged 65 and over in 2020, and it will reach up to 1.5 billion by 2050. Also, the incidence of rare genetic diseases is increasing over the past few years as a result of changes in lifestyle, changing climatic conditions, and others. As per National Human Genome Research Institute, about 350 million people around the world live with rare genetic diseases, and only 200000 of them get diagnosed. Such factors boost the market growth over the forecast period 2022-2027.

In Vitro Diagnostics (IVD) Market Challenges

Uncertain Regulatory Environment coupled with Shortage and Variance in cost of Raw Materials May Stymie Market Growth.

The regulatory guidelines for the manufacturing and commercialization of in-vitro diagnostic devices in Europe are regulated by Directive 98/79/EC of the European Commission. The time required to acquire regulatory approval for some IVD is uncertain and there is a risk of investment going in vain if the authority denies approval. Also, the marginality of IVD kits depends upon the cost and availability of raw materials. Both eventual shortages of raw materials and high prices generate blocks in the value chain which hampers production. In India, the basic customs duty on diagnostic instruments was 0% before February 2022, but as government charges, 7.5% to 15% charges on components and spare parts lead to an increased cost of finished products of the Indian IVD industry after the implementation of inverted duty structure correction.

In Vitro Diagnostics (IVD) Industry Outlook

Product launches, mergers and acquisitions, joint ventures, and geographical expansions are key strategies adopted by players in the In Vitro Diagnostics (IVD) Market. The top 10- In Vitro Diagnostics (IVD) Market companies include:
  1. F. Hoffmann-La Roche AG
  2. Abbott Laboratories
  3. Siemens Healthineers
  4. Danaher Corporation
  5. Thermo Fisher Scientific
  6. Sysmex Corporation
  7. bioMerieux SA
  8. Ortho Clinical Diagnostics
  9. Bio-Rad Laboratories Inc.
  10. Becton, Dickinson, and Company

Recent Developments

  • In May 2022, Roche announced a partnership with the Global Fund to support low and middle-income countries in strengthening critical diagnostic infrastructure to fight AIDS, TB, and malaria. This partnership includes the building of an effective process to collect, transport, test samples, and return results to patients for timely clinical intervention. 
  • In March 2022, Abbott laboratories with Local Initiative Support Corporation (LISC) announced to expand equity in the healthcare industry with a $37 million initiative amount, $25 million from Abbott and $12.5 million from LISC, to support diverse small businesses including growth capitals, loans and coaching to help business to expand and creates jobs in the healthcare industry.
  • In June 2021, Siemens healthcare announced a 10-year strategic partnership with Prisma Health, with the aim to create a better state of health for South Carolina. This joint venture creates the opportunity to enhance clinical care, development of latest technology, streaming process, and better disease prevention, early diagnosis, and treatment.

Relevant Titles


Report Code: HCR 0248


Report Code: HCR 0063


Report Code: HCR 0169

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1. In Vitro Diagnostics (IVD) Market– Overview
    1.1 Definitions and Scope
2. In Vitro Diagnostics (IVD) Market- Executive Summary
3. In Vitro Diagnostics (IVD) Market- Comparative Analysis
    3.1 Company Benchmarking - Key Companies
    3.2 Global Financial Analysis - Key Companies
    3.3 Market Share Analysis - Key Companies
    3.4 Patent Analysis
    3.5 Pricing Analysis
4. In Vitro Diagnostics (IVD) Market- Startup Companies Scenario Premium
    4.1 Key Start-up Company Analysis by
    4.2 Investment
    4.3 Revenue
    4.4 Venture Capital and Funding Scenario
5. In Vitro Diagnostics (IVD) Market– Industry Market Entry Scenario Premium Premium
    5.1 Regulatory Framework Overview
    5.2 New Business and Ease of Doing Business Index
    5.3 Case Studies of Successful Ventures
6. In Vitro Diagnostics (IVD) Market- Forces
    6.1 Market Drivers
    6.2 Market Constraints/Challenges
    6.3 Porter Five Force Model
        6.3.1 Bargaining power of suppliers
        6.3.2 Bargaining powers of customers
        6.3.3 Threat of new entrants
        6.3.4 Rivalry among existing players
        6.3.5 Threat of substitutes
7. In Vitro Diagnostics (IVD) Market– Strategic Analysis
    7.1 Value Chain Analysis
    7.2 Opportunities Analysis
    7.3 Market Life Cycle
8. In Vitro Diagnostics (IVD) Market– By Products
    8.1 Instruments
    8.2 Reagents
    8.3 Others.
9. In Vitro Diagnostics (IVD) Market– By Test Type
    9.1 Clinical Chemistry
    9.2 Molecular Diagnostics
    9.3 Immuno Diagnostics
    9.4 Hematology
10. In Vitro Diagnostics (IVD) Market– By End-User
    10.1 Diagnostic Laboratories
    10.2 Hospitals and Clinics
    10.3 Others
11. In Vitro Diagnostics (IVD) Market– By Applications
    11.1 Infectious Disease
    11.2 Diabetes
    11.3 Cancer/ Oncology
    11.4 Cardiology
    11.5 Autoimmune Disease
    11.6 Nephrology
    11.7 Others
12. In Vitro Diagnostics (IVD) Market– By Usability
    12.1 Disposable IVD Devices
    12.2 Reusable IVD Devices.
13. In Vitro Diagnostics (IVD) Market- By Geography
    13.1 North America
        13.1.1 U.S.
        13.1.2 Canada
        13.1.3 Mexico
    13.2 Europe
        13.2.1 U.K.
        13.2.2 Germany
        13.2.3 France
        13.2.4 Italy
        13.2.5 Spain
        13.2.6 Russia
        13.2.7 Rest of Europe
    13.3 Asia-Pacific
        13.3.1 China
        13.3.2 India
        13.3.3 Japan
        13.3.4 South Korea
        13.3.5 Australia & New Zealand
        13.3.6 Rest of Asia-Pacific
    13.4 South America
        13.4.1 Brazil
        13.4.2 Argentina
        13.4.3 Chile
        13.4.4 Colombia
        13.4.5 Rest of South America
    13.5 Rest of the World
        13.5.1 Middle East
        13.5.2 Africa
14. In Vitro Diagnostics (IVD) Market- Entropy
15. In Vitro Diagnostics (IVD) Market– Industry/Segment Competition Landscape Premium 
    15.1 Market Share Analysis
        15.1.1 Global Market Share – Key Companies
        15.1.2 Market Share by Region – Key companies
        15.1.3 Market Share by Countries – Key Companies
    15.2 Competition Matrix
    15.3 Best Practices for Companies
16. In Vitro Diagnostics (IVD) Market– Key Company List by Country Premium Premium
17. In Vitro Diagnostics (IVD) Market- Company Analysis
    17.1 Company 1
    17.2 Company 2
    17.3 Company 3
    17.4 Company 4
    17.5 Company 5
    17.6 Company 6
    17.7 Company 7
    17.8 Company 8
    17.9 Company 9
    17.10 Company 10
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