The global in-vitro diagnostics market was valued at US$81.284 billion in 2020 and is expected to grow at a CAGR of 6.29% over the forecast period to reach a total market size of US$124.581 billion by 2027.
In-vitro diagnostics are tests performed on samples obtained from the human body, such as blood or tissue, to diagnose illnesses or other conditions. They can also be used to track a person's general health status to assist in curing, treating, or preventing diseases. These tests can be carried out at labs, healthcare institutions, or even at home. The tests themselves may be carried out on a wide range of equipment, from simple portable devices to sophisticated laboratory gear. They enable clinicians to accurately diagnose patients and work to provide suitable treatments.
The global IVD market has benefited from increased demand for point-of-care IVD equipment. The newly released IVD instruments and devices are simple to use and extremely efficient, which has increased their appeal among healthcare practitioners. There are also numerous over-the-counter diagnostic kits on the market, such as glucose monitoring kits. The elderly prefers these kits since they minimise hospital visits. People prefer simple diagnostic kits that can be used in in-home care settings, which has enhanced the relevance of these products during the COVID-19 pandemic.
However, the market is expected to be hampered by tight government restrictions and poor reimbursement policies. During the projection period, however, the high growth rate of emerging economies presents attractive possibilities for major participants in the in-vitro diagnostics market.
North America is projected to be the largest regional market for in vitro diagnostics during the forecast period, and it is likely to continue to do so due to its well-developed healthcare system and growing healthcare awareness among patients. According to the American Cancer Society, in 2020, roughly 1.8 million new cancer cases and 606,520 cancer deaths are expected to be detected in the United States. Furthermore, in the United States, individuals with chronic diseases are the most frequent users of healthcare facilities. The majority of hospital admissions and prescriptions are filled by them. Other factors that contribute to the market's growth include the accessibility of devices, increased knowledge about their usage, and the existence of a significant number of populations suffering from different chronic conditions. Another factor driving the in vitro diagnostics market expansion is the presence of a large number of prominent companies in North America. Furthermore, due to an increase in healthcare expenditure and the incidence of diabetes in the area, Asia-Pacific is anticipated to expand at the highest rate throughout the projection period. Possible factors, such as the large population of patients with other chronic illnesses that necessitate IVD testing, also contribute to the Asia-Pacific market's growth.
The growing elderly population in both developed and developing regions would have a positive impact on the IVD market. The prevalence of age-related disorders is projected to rise dramatically as the world's ageing population grows rapidly. According to the OECD, there were 54 million elderly people in the United States in 2019. Geriatric populations are likewise substantial and rising in other industrialised economies across the world. Japan, for example, has the highest ratio of the elderly population to the productive population, followed by Germany. According to the American Medical Association, by 2030, it is expected that 60% of people aged 65 and over will have more than one chronic disease. Therefore, the global prevalence of different disorders is anticipated to rise as the geriatric population grows. This is regarded as a major driver for IVD market expansion.
Inadequate reimbursement is a significant roadblock to the IVD market expansion. A few years ago, Medicare in the United States changed the way it reimbursed several IVD tests, , including molecular diagnostics. Some molecular pathology tests don't have their own Healthcare Common Procedure Coding System (HCPCS) codes, so they're charged using unlisted codes instead. Medicare Administrative Contractors (MACs) set a payment amount for their local jurisdictions in such instances. These changes are likely to have a negative impact on the molecular and genetic testing industry in the United States, thus limiting the IVD market’s growth.
The COVID-19 outbreak had a significant impact on the in-vitro diagnostics market. For example, the sector was confronted with new challenges such as disrupted supply chains, fluctuating product demand, and so on. Furthermore, raw materials and human resource availability were also hampered. However, the in vitro diagnostics market also experienced a surge in demand for new COVID-19 test kits, which presented an opportunity for the industry players. For example, in March 2020, Qiagen released the QIAstat-Dx test kit in Europe for the detection of SARS-CoV-2 coronavirus, and in February 2020, the US Food and Drug Administration (FDA) established a new strategy to speed up the availability of diagnostics. The authorization for emergency use of in vitro diagnostics (IVDs) for the diagnosis of COVID-19 was given on the basis of a public health emergency. Thus, the overall impact of the COVID-19 pandemic on major participants in the in vitro diagnostics sector remained positive.
In-vitro diagnostics are tests performed on samples obtained from the human body, such as blood or tissue, to diagnose illnesses or other conditions. They can also be used to track a person's general health status to assist in curing, treating, or preventing diseases. These tests can be carried out at labs, healthcare institutions, or even at home. The tests themselves may be carried out on a wide range of equipment, from simple portable devices to sophisticated laboratory gear. They enable clinicians to accurately diagnose patients and work to provide suitable treatments.
The global IVD market has benefited from increased demand for point-of-care IVD equipment. The newly released IVD instruments and devices are simple to use and extremely efficient, which has increased their appeal among healthcare practitioners. There are also numerous over-the-counter diagnostic kits on the market, such as glucose monitoring kits. The elderly prefers these kits since they minimise hospital visits. People prefer simple diagnostic kits that can be used in in-home care settings, which has enhanced the relevance of these products during the COVID-19 pandemic.
However, the market is expected to be hampered by tight government restrictions and poor reimbursement policies. During the projection period, however, the high growth rate of emerging economies presents attractive possibilities for major participants in the in-vitro diagnostics market.
North America is projected to be the largest regional market for in vitro diagnostics during the forecast period, and it is likely to continue to do so due to its well-developed healthcare system and growing healthcare awareness among patients. According to the American Cancer Society, in 2020, roughly 1.8 million new cancer cases and 606,520 cancer deaths are expected to be detected in the United States. Furthermore, in the United States, individuals with chronic diseases are the most frequent users of healthcare facilities. The majority of hospital admissions and prescriptions are filled by them. Other factors that contribute to the market's growth include the accessibility of devices, increased knowledge about their usage, and the existence of a significant number of populations suffering from different chronic conditions. Another factor driving the in vitro diagnostics market expansion is the presence of a large number of prominent companies in North America. Furthermore, due to an increase in healthcare expenditure and the incidence of diabetes in the area, Asia-Pacific is anticipated to expand at the highest rate throughout the projection period. Possible factors, such as the large population of patients with other chronic illnesses that necessitate IVD testing, also contribute to the Asia-Pacific market's growth.
Growth Factors
Increased prevalence of chronic and infectious diseases, as well as an ageing population:
The growing elderly population in both developed and developing regions would have a positive impact on the IVD market. The prevalence of age-related disorders is projected to rise dramatically as the world's ageing population grows rapidly. According to the OECD, there were 54 million elderly people in the United States in 2019. Geriatric populations are likewise substantial and rising in other industrialised economies across the world. Japan, for example, has the highest ratio of the elderly population to the productive population, followed by Germany. According to the American Medical Association, by 2030, it is expected that 60% of people aged 65 and over will have more than one chronic disease. Therefore, the global prevalence of different disorders is anticipated to rise as the geriatric population grows. This is regarded as a major driver for IVD market expansion.
Restraints:
Unfavourable reimbursement:
Inadequate reimbursement is a significant roadblock to the IVD market expansion. A few years ago, Medicare in the United States changed the way it reimbursed several IVD tests, , including molecular diagnostics. Some molecular pathology tests don't have their own Healthcare Common Procedure Coding System (HCPCS) codes, so they're charged using unlisted codes instead. Medicare Administrative Contractors (MACs) set a payment amount for their local jurisdictions in such instances. These changes are likely to have a negative impact on the molecular and genetic testing industry in the United States, thus limiting the IVD market’s growth.
COVID-19's Impact on the In Vitro Diagnostics Market:
The COVID-19 outbreak had a significant impact on the in-vitro diagnostics market. For example, the sector was confronted with new challenges such as disrupted supply chains, fluctuating product demand, and so on. Furthermore, raw materials and human resource availability were also hampered. However, the in vitro diagnostics market also experienced a surge in demand for new COVID-19 test kits, which presented an opportunity for the industry players. For example, in March 2020, Qiagen released the QIAstat-Dx test kit in Europe for the detection of SARS-CoV-2 coronavirus, and in February 2020, the US Food and Drug Administration (FDA) established a new strategy to speed up the availability of diagnostics. The authorization for emergency use of in vitro diagnostics (IVDs) for the diagnosis of COVID-19 was given on the basis of a public health emergency. Thus, the overall impact of the COVID-19 pandemic on major participants in the in vitro diagnostics sector remained positive.
Key Development:
- The recent launch of the Production Linked Incentive Scheme (PLI 2.0) by the Indian government aims to improve India's manufacturing capabilities by increasing investment and production in the IVD sector, with the goal of creating global champions who can grow and scale using cutting-edge technology and thus penetrate global value chains.
- Roche Diagnostics released a SARS-CoV-2 antibody test in September 2020.
- The Oncoguide panel system, which facilitates cancer genome profiling, was introduced by Sysmex in July 2020.
- In January 2020, SphingoTec GmbH launched the IB10 sphingotest penKid, a CE-IVD-marked point-of-care test for Proenkephalin, a biomarker that allows for real-time evaluation of kidney function with a simple blood test.
Market Segmentation
By Technique
- Immunoassay
- Molecular Diagnostics
- Hematology
- Others
By Application
- Infectious diseases
- Autoimmune diseases
- Drug Testing
- Oncology
- Others
By End-User
- Diagnostic Laboratories
- Hospitals and Clinics
- Research Laboratories and Institutes
By Geography
- North America
- United States
- Canada
- Mexico
- South America
- Brazil
- Argentina
- Others
- Europe
- Germany
- France
- UK
- Italy
- Others
- Middle East and Africa
- Saudi Arabia
- UAE
- Israel
- Others
- Asia Pacific
- China
- Japan
- India
- Australia
- Taiwan
- Thailand
- Indonesia
- Others
Frequently Asked Questions about the Global In Vitro Diagnostics Market
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Report Attribute | Details |
---|---|
No. of Pages | 124 |
Published | March 2022 |
Forecast Period | 2020 - 2027 |
Estimated Market Value ( USD | $ 81.28 billion |
Forecasted Market Value ( USD | $ 124.58 billion |
Compound Annual Growth Rate | 6.2% |
Regions Covered | Global |
No. of Companies Mentioned | 10 |
Table of Contents
1. Introduction1.1. Market Definition1.2. Market Segmentation
2. Research Methodology2.1. Research Data
2.2. Assumptions
3. Executive Summary3.1. Research Highlights
4. Market Dynamics4.1. Market Drivers
4.2. Market Restraints
4.3. Porters Five Forces Analysis
4.3.1. Bargaining Power of Suppliers
4.3.2. Bargaining Power of Buyers
4.3.3. The threat of New Entrants
4.3.4. Threat of Substitutes
4.3.5. Competitive Rivalry in the Function
4.4. Function Value Chain Analysis
5. Global In Vitro Diagnostics Market Forecast by Technique 5.1. Introduction
5.2. Immunoassay
5.3. Molecular Diagnostics
5.4. Hematology
5.5. Others
6. Global In Vitro Diagnostics Market Forecast by Application 6.1. Introduction
6.2. Infectious diseases
6.3. Autoimmune diseases
6.4. Drug Testing
6.5. Oncology
6.6. Others
7. Global In Vitro Diagnostics Market Forecast by End-User7.1. Introduction
7.2. Diagnostic Laboratories
7.3. Hospitals and Clinicals
7.4. Research Laboratories and Institutes
8. Global In Vitro Diagnostics Market, By Geography 8.1. Introduction
8.2. North America
8.2.1. United States
8.2.2. Canada
8.2.3. Mexico
8.3. South America
8.3.1. Brazil
8.3.2. Argentina
8.3.3. Others
8.4. Europe
8.4.1. Germany
8.4.2. France
8.4.3. UK
8.4.4. Italy
8.4.5. Others
8.5. Middle East and Africa
8.5.1. Saudi Arabia
8.5.2. UAE
8.5.3. Israel
8.5.4. Others
8.6. Asia Pacific
8.6.1. China
8.6.2. Japan
8.6.3. India
8.6.4. Australia
8.6.5. Taiwan
8.6.6. Thailand
8.6.7. Indonesia
8.6.8. Others
9. Competitive Environment and Analysis9.1. Major Players and Strategy Analysis
9.2. Emerging Players and Market Lucrativeness
9.3. Mergers, Acquisitions, Agreements, and Collaborations
9.4. Vendor Competitiveness Matrix
10. Company Profiles.10.1. Roche Diagnostics
10.2. Plasmatec
10.3. Vitro Bio
10.4. Omega Diagnostics Group PLC & Technologien GmbH
10.5. DST Diagnostische Systeme
10.6. SD Biosensor
10.7. Abbott Diagnostics
10.8. Meril Diagnostics
10.9. NIPPON GENE CO., LTD.
10.10. Rapid Diagnostics Group of Companies
Companies Mentioned
- Roche Diagnostics
- Plasmatec
- Vitro Bio
- Omega Diagnostics Group PLC & Technologien GmbH
- DST Diagnostische Systeme
- SD Biosensor
- Abbott Diagnostics
- Meril Diagnostics
- NIPPON GENE CO., LTD.
- Rapid Diagnostics Group of Companies