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

Report Code: HCR 0577 Report Format: PDF + Excel

In-Vitro Diagnostics Market Overview

The in-vitro diagnostics market held a share of $84.9 billion in the year 2020 and is expected to grow at a CAGR of 2.4% over the forecast period of 2021-2026. In-Vitro by lingual language means “in-glass”. The following signifies that the test is conducted chiefly in test tubes or equipment of similar types. The In-vitro medical diagnostic system is primarily used to understand a patient’s body physiology, which means detecting any kind of disease, underlying conditions, or infections. Enzyme-Linked Immunosorbent Assay or ELISA is a direct enzyme-linked immunoassay that is used to determine the antibodies present in one’s blood for a specific illness, and it is one of the applications for the market. Immunoassays Isothermal Nucleic Acid Amplification Technology is yet another type of assay or medical diagnostic technology primarily used in detecting infections related to COVID-19. Additionally, it has the capacity to detect both mild and acute infection and serosurveys are used to actualize the actual number of people affected by the virus. If the patient needs to get his hormonal levels or balance checked, they can opt for radioimmunoassay. Radioimmunoassay use sensitive molecules to detect the presence of concentrations related to anyone antigen, which in turn is targeted. Polymerase Chain Reaction or PCR tests are standard in-vitro diagnostic tests that use techniques to amplify the DNA sequences. The amplified DNA can help the scientists or other participants to study the DNA in greater detail. COVID-19 has uplifted the market in recent times, or to be precise, in the last year and a half. As a result, manufacturing companies specializing in the production of such tests have launched products that can be used by the person affected without the help of a third party.

Report Coverage

The report: In-Vitro Diagnostics Market Forecast (2021-2026)”, by Industry ARC covers an in-depth analysis of the following segments of the In-Vitro Diagnostics Market.
By Test Types- Clinical Chemistry, Molecular Diagnostics, Immuno Diagnostics, Hematology, and Others
By Application- 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 Rest of Europe), Asia Pacific (China, Japan India, South Korea, Australia, and New Zealand, and Rest of Asia Pacific), South America (Brazil, Argentina, and Rest of South America), and Rest of the World (the Middle East, and Africa).

Key Takeaways

  • North America held a dominant share in the following market for the year 2020 owing to the state-of-the-art medical infrastructure and increasing prevalence of cancer and other cardiovascular diseases.
  • Asia-Pacific shows optimistic signs for growth in the market due to rising spending by the government to make the medical industry robust, as the cases related to infectious diseases, diabetes and cancer are swarming forward. 
  • The in-depth analysis of Strengths, Weaknesses, Opportunities and Threats will be provided in our premium report.
  • Rise in the geriatric population, along with their ailing medical conditions; Spread of Sars-CoV-2 in all regions and the availability of POC testing will drive the market in the forecast period

Market Share: As per Geography for 2020

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In-Vitro Diagnostics Market Segment Analysis- By Application

The in-vitro diagnostic market can be segmented into six categories based on the application- infectious disease, diabetes, cancer/oncology, cardiology, auto-immune disorder and nephrology, amongst others.

Infectious Diseases held a dominant position in the market for the year 2020. Sars-CoV-19 accelerated in its spread in the year 2020 and followed an increasing trajectory up until now. For example, the cases of COVID in December were 75 million worldwide, which have now gone up to 208 million in August 2021. The deaths associated with the virus has gone up from 1.68 million to 4.3 million. The need to diagnose cases is an essential aspect for further treatment and hospitalization. Hence, the use of in-vitro diagnostic tests was predominantly made. Also, with cases of Covid-19, patients often develop other immune responses, which are fatal, and hence their diagnosis was also made using in-vitro diagnostics.

In the forecast period of 2021-2026, diabetes is said to grow at the fastest CAGR of 2.6%. It is owing to the rising prevalence of diabetes in the world. For example, 1.5 million deaths in 2019 were related to diabetes, and a 5% increase in premature deaths have been identified in the last sixteen years. In-Vitro Diagnostics methods can be used to determine the glycaemic index and take preventive measures to avoid complications arising from diabetes.

In-Vitro Diagnostics Market Segment Analysis- By-Products

The in-vitro diagnostic market can be segmented into two types based on products- Instruments and Reagents. The reagents segment dominated the market in the year 2020. It is owing to the product use across the industry. Reagents can be further bifurcated into GPR- General Purpose Reagents and the other Analyte Specific Reagents. Reagents are primarily responsible for inducing a chemical reaction. They are used to test the presence of various irregularities or substances. For example, one can use an ELISA or rapid HIV test to confirm their results at home. The kits have enzymes as reagents, and as soon as a person with HIV tests it, the reagent binds with one’s blood and give a positive or negative result. As per the data released by, an approximate number of 1.2 million people in the USA have HIV, and out of those, 13% are not yet diagnosed.

The reagents segment will continue to grow at the fastest CAGR of 2.9% over the forecast period of 2021-2026. It is due to the increase in the demand for rapid antigen tests/kits to diagnose the results at a faster rate by also spending less cost on them. Cases of HIV can range from 20.7 million in east and south African regions to 5.8 million in Asia-Pacific. Reagents used in these kits fill further fuel the demand for in-vitro diagnostic kits.

In-Vitro Diagnostics Market Segment Analysis- By Geography

North America held a dominant share of 35% in the year 2020. It is due to the intensive health-related programs that motivate and educate the population for going for diagnostic tests. North America also constitutes a substantiating number of diabetic cases across the age groups. But, diabetes is often prevalent in those above 65+, and the senior population of the USA is set to overtake the younger by 2036. This creates a demand for the in-vitro diagnostic industry to provide rapid and susceptible products that can help in early detection and cure.

Asia- Pacific promises lucrative growth owing to the government's preference to invest heavily in the medical infrastructure, which focuses on detecting the disease way before it becomes critical. For example, India saw an exponential growth of 137% in budget allocation for medical infrastructure needs. All countries in this also see a rise in their senior population; for example, ten countries will be categorized as an "aging country" instead of eight countries. Similarly, 11 countries will be super-aged by 2050, which is just one in 2020. The following trends will help the companies maximize their revenues and the associated profits by, in turn, servicing the clients in the right spirit.

In-Vitro Diagnostics Market Drivers

Prevalence of chronic illness and infectious diseases such as Covid-19 to aid the market growth.

In- Vitro Diagnostics tests upliftment and technology up gradation has made it easy for doctors to diagnose and cure disease. The IVD testing denotes various benefits such as time, speed, location, and ease by which one can perform these tests at home. The rapid increase in the number of diabetic populations in the entire world has been worrying, and in-vitro diagnostic tools and instruments can widely help detect early signs of diabetes. For example, CDC reports that 88 million adults in the USA have pre-diabetes, and interestingly only 84% of them know they have it. Additionally, if all the population is considered, 34 million people have type 1/2 diabetes, and only 80% of them realize they have it; the rest, 20%, are not accounted for. Obesity and the rising geriatric population is a contributing factor, as of now, the numbers have grown multiple times than a decade ago. The following leaves an entire scope for the market.

Like this, In-Vitro diagnostic tests have been useful in the time of Sars-CoV-2. The government has been heavily relying on the usage of Serosurveys, which in turn communicates the number of people who have required antibodies to fight the virus. Surveillance has helped prioritize and implement strategies for vaccine coverage and medical aids, depending on the states or the most vulnerable population. For example, 36,277 samples were collected by the ICMR in India to understand the virus prevalence and protection level. With the help of ELISA or Enzyme-Linked Immunosorbent Assay, it was found that 67% of the entire respondents had covid antibodies, which is 2 in every three people accounted for. If the numbers show a broader picture of the virus prevalence, it can be said that only 400 million people in the following demographic are now vulnerable to the Covid virus. Like which, Tuberculosis is another disease that can be diagnosed using In-Vitro diagnostic tests.

Capacity of Disposable or Reusable IVD devices to produce results at the same time, without the presence of third party, can help the market to propel.

Another factor that shows potential for future market growth is the adaptability feature. For example, if a person has diabetes and needs to get it checked, they can now get instantaneous results by using disposable IVD devices or Reusable IVD devices. Earlier for which the patient had to travel certain kilometers, stand along in a line and then ultimately get the tests done. The cost for all such is tough to calculate, but the following offers a qualitative idea about its use. The second advantage the patient gets using the IVD devices is that the results can be produced within that same moment, which earlier at least needed a day. Thirdly, patients are no more dependent on the third party for conducting the test, and the instruction is straightforwardly mentioned in the booklet, which one can follow and perform the test on his own. To quote an example, In India, MyLab has recently come up with a self-diagnostic kit in order to know the presence of the covid-19 antigen. One must open the package, follow the instructions and get done with the tests. The tests result of which appear in 15 minutes. A person can significantly save his costs in terms of travel, time opportunity and others. The cost of such test is close to INR 250 or $4, while the primitive RT-PCR tests or Reverse Transcriptase- Polymerase Chain Reaction, which on average costs INR 900 or $12. Hence, a person can save costs up to three times, and the results can be delivered faster. Products launches such as these can help the market and various governments as well.

In-Vitro Diagnostics Market Challenges

Specificity from the real time in-vitro diagnostics is an issue the product developers have not yet addressed.

As per the study conducted by the US CDC, it was found that the specificity was low in the rapid antigen test as compared to the primitive way of using RT-PCR. As per the study conducted, the antigen test had a case sensitivity of only 80%, while the specificity was 98.9%, which means that out of 5 people infected with a disease, one will show negative test results despite being positive. Furthermore, the sensitivity decreased in asymptomatic cases to 41.2%, while the specificity was 98.4%. This indicates for asymptomatic careers, and two will show positive results while the rest three will show negative. Hence the government and hospitals often ask the symptomatic patient to get an RT-PCR test done, despite being negative on the rapid diagnosis.

The low specificity can act as a dampener for the market and slow down the overall progress.

In-Vitro Diagnostics Market Landscape

The in-vitro diagnostic market excels by adopting strategies such as product launch and mergers and acquisitions. The top 10 companies operating in the In-Vitro Diagnostic Industry are- 

  • F. Hoffmann-La Roche AG,
  • Abbott Laboratories,
  • Siemens AG,
  • Thermo Fisher Scientific Inc.,
  • Danaher Corporation,
  • Bio-Rad Laboratories Inc.,
  • Sysmex Corporation,
  • Quest Diagnostics
  • Cepheid Inc.
Product Launch
  • In April 2021, MyLAB launched its rapid antigen self-test kit to detect the Sars-Cov-19 virus by providing results in 15 minutes. The test cost INR 250. 
  • In January 2021, BGI Genomics received a EUA from the FDA. The product to be launched is a real-time fluorescent RT-PCR kit, which relies heavily on nucleic acid present in the DNA structure of the Sars-CoV-19 virus. 
  • In January 2020, Spingo Tech GMBH launched a CE-IVD marked point of care test kit to ease a patient in the diagnosis of kidney function. It is a blood test.
  • In November 2019, Vidan Diagnostics launched Hydroxybutyrate 21 FS Reagent for Beckman Coulter to facilitate a clinical chemistry system. 

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1. In-Vitro Diagnostics Market- Overview
    1.1 Definitions and Scope
2. In-Vitro Diagnostics Market- Executive Summary
    2.1 Market Revenues and Key Trends by Company
    2.2 Key Trends by Test Type
    2.3 Key Trends by Application
    2.4 Key Trends by End Users
    2.5 Key Trends by Usability
    2.6 Key Trends by Product
    2.7 Key Trends by Geography
3. In-Vitro Diagnostics Market- Comparative Analysis
    3.1 Product Benchmarking- Key Companies
    3.2 Financial Analysis- Key Companies
    3.3 Market Share Analysis- Key Companies
    3.4 Patent Analysis
    3.5 Pricing Analysis
4. In-Vitro Diagnostics Market- Startup Companies Scenario
    4.1 Key Startup Company Analysis by
        4.1.1 Investment
        4.1.2 Revenue
        4.1.3 Application Analysis
        4.1.4 Venture Capital and Funding Scenario
5. In-Vitro Diagnostics Market- Industry Market Entry Scenario 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 Market- Market Forces
    6.1 Market Drivers
    6.2 Market Constraints
    6.3 Porter Five Forces Model
        6.3.1 Bargaining Power of Suppliers
        6.3.2 Bargaining Power 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 Market- Strategic Analysis
    7.1 Value- Chain Analysis
    7.2 Opportunities Analysis
    7.3 Market Life Cycle
8. In-Vitro Diagnostics Market-By Test Type (Market Size- $Million/$Billion)
    8.1 Clinical Chemistry 
    8.2 Molecular Diagnostics
    8.3 Immuno Diagnostics
    8.4 Haematology
    8.5 Others
9. In-Vitro Diagnostics Market- By Application (Market Size- $Million/$Billion)
    9.1 Infectious Diseases
    9.2 Diabetes
    9.3 Cancer/ Oncology
    9.4 Cardiology
    9.5 Autoimmune Disease
    9.6 Nephrology
    9.7 Other Applications
10. In-Vitro Diagnostics Market– By End Users (Market Size- $Million/$Billion)
    10.1 Diagnostic Laboratories
    10.2 Hospitals and Clinics
    10.3 Others 
11. In-Vitro Diagnostics Market– By Usability (Market Size- $Million/$Billion)
    11.1 Disposable IVD Devices
    11.2 Reusable IVD Devices
12. In-Vitro Diagnostics Market– By Product Type (Market Size- $Million/$Billion)
    12.1 Instruments
    12.2 Reagents
    12.3 Others
13. In-Vitro Diagnostics Market- By Geography (Market Size- $Million/$Billion)
    13.1 North America
        13.1.1 U.S.
        13.1.2 Mexico
        13.1.3 Canada
    13.2 Europe
        13.2.4 U.K.
        13.2.5 France
        13.2.6 Germany
        13.2.7 Italy
        13.2.8 Spain
        13.2.9 Russia
        13.2.10 Rest of Europe
    13.3 Asia Pacific
        13.3.11 China
        13.3.12 India
        13.3.13 Japan
        13.3.14 South Korea
        13.3.15 Australia & New Zealand
        13.3.16 Rest of Asia Pacific
    13.4 South America
        13.4.17 Brazil
        13.4.18 Argentina
        13.4.19 Rest of South America
    13.5 Rest of the World
        13.5.20 Middle East
        13.5.21 Africa 
14. In-Vitro Diagnostics Market Entropy
15. In-Vitro Diagnostics 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 Country- Key Companies
        15.1.4 Best Practices for Companies
16. In-Vitro Diagnostics Market- Key Company List by Country Premium (Premium)
17. In-Vitro Diagnostics Market-Company Analysis
    17.1 Company Revenue, Products, M&A, Developments
    17.2 Company 1
    17.3 Company 2
    17.4 Company 3
    17.5 Company 4
    17.6 Company 5
    17.7 Company 6
    17.8 Company 7
    17.9 Company 8
    17.10 Company 9
    17.10 Company 10 and more
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