The market for in vitro diagnostics was USD 83.4 billion by 2020. It is predicted to grow by a compound annual growth of (CAGR) in the range of 4.5 per cent from 2021 until 2027. This growth is due to the rising use of in vitro diagnostics (IVD) due to the increase in tests caused by the pandemic. The advancement of automated diagnostic systems for in vitro for hospitals and laboratories that provide accurate, efficient and reliable diagnoses is anticipated to drive the market’s growth. The growing number of diagnostic in vitro products launched by the major companies is also fueling the growth rate the sector is experiencing.
Globally, the population of the elderly is growing at a higher rate than younger. In many countries, the rise of the population of the older generation can be explained by the decline in fertility and the low birth rate. According to the United Nations, it was estimated that in 2017 there were 962 million people over 60 years across the globe. Furthermore, the amount of people who are aged 80 or more is expected to grow threefold by a third, from 137 million in 2017 up to 425 million by 2050. As we age, our immune system becomes compromised, which makes us more susceptible to developing various illnesses. Therefore, a large senior population needs better health care for chronic diseases.
The COVID-19 pandemic, which SARS-CoV-2 brought on, has been infecting millions worldwide. The pandemic outbreak has spurred the diagnostics industry to take action with the goal of developing new and fast diagnostics kits for identifying the coronavirus. Federal agencies accept most tests as part of an Emergency Use Authorization (EUA). The majority of the tests used to detect COVID-19 use the RT-PCR method. While the standard test can take about 5 to 6 hours for results, PoC assays significantly reduce the time required to produce results.
The incidence of various illnesses like cancer, autoimmune diseases and inflammatory disorders is growing globally and will stimulate the demand for diagnostic tests in vitro. According to the American Cancer Society, in the year 2018, around 1.7 million cancer cases were reported, and about 609,640 patients passed away from cancer.
The reagents segment was the most dominant market for in vitro diagnostics and was responsible for the highest revenue portion of 65.3 per cent in 2020. The growing demand for this segment is due to the need for quick, accurate and sensitive instruments. In addition, their extensive use in diagnostic testing in vitro, the rise in the demand for self-testing and point-of-care devices, and the increase in the number of R&D initiatives related to agents are likely to help the growth of this market.
Machines and equipment that aid in the automation of diagnosis and linking samples and reagents together are known as analytical instruments. Robots and commercially available kits are utilized within polymerase chain reaction (PCR) labs to determine and quantify the presence of blood antigens, infectious microorganisms and the viral load. Furthermore, the increased use of these devices to create new tests to detect infectious diseases is anticipated to drive the expansion of this market. For example, in February 2020, Sherlock Biosciences collaborated with Cepheid to create a brand new CRISPR-based molecular test compatible with GeneXpert. GeneXpert platform.
The services section includes software interfaces for operating diagnostic instruments, performing analysis and interpreting the results. The software used for diagnosing in vitro can be employed in various devices, including point-of-care analyzers, laboratory-based analyzers, handheld devices for in vitro diagnostics, and many more. Furthermore, the increasing use of in vitro diagnostics systems incorporating analyzer software in the diagnostic centre is expected to drive the market’s growth.
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The infectious diseases segment dominated the market and had the largest share of revenue of 41.8 per cent in 2020 due to the growing prevalence of diseases that cause infection, such as SARS-CoV-2 HIV, AIDS, tuberculosis and pneumonia. Additionally, growth in the production of diagnostic tests for infectious diseases by players in the market for tests in vitro is likely to boost the market. In December of this year, Siemens Healthineers received U.S. FDA premarket approval for 12 new assays for viral Hepatitis and various other illnesses. These tests are available on the Atellica Solution, which provides testing options to screen, diagnose, and monitor for Hepatitis C.
Cancer, a chronic illness, is among the leading causes of death worldwide. The most prevalent kinds of cancers include cancers of the prostate, colorectal, breast and lung. The rising incidence of cancer is predicted to increase the need for tests that can be used in vitro to diagnose cancer. Under the National Cancer Institute, in 2018, an estimated 1 735 350 new cancer cases were expected to be diagnosed; of these, 609,640 will die of this condition across the U.S.
Smoking, drinking cigarettes, a poor diet, less physical activity, and elevated blood pressure are risk factors for heart diseases. Additionally, diabetes mellitus can cause heart problems, leading to a rise in the demand for in vitro diagnostics for cardiology. Developing PoC devices that provide rapid and on-site diagnostics, specifically in urgent cases, is anticipated to propel the market.
The hospital segment led the market and had the highest revenue share at 44.2 per cent in 2020. This is due to the rise in hospitalizations because doctors must interpret diagnostic tests to determine the best course of treatment. Diagnostic centers typically collaborate with hospitals, and hospitals are equipped with their own diagnostic set-in place. Additionally, the continuous expansion of the healthcare infrastructure is expected to expand the existing facilities of hospitals. This is why the demand for tests for diagnostics in vitro is growing.
Home care refers to the treatment at home provided by licensed healthcare professionals or self-care provided by patients. Self-care devices comprise the most significant portion of the home-based care segment. It’s more convenient and helps reduce hospital visits. The home care sector is predicted to see the highest growth rate, with an annual growth rate of 6.6 per cent during the forecast timeframe, because of the increasing number of geriatric patients and the increasing demand for in vitro diagnostic tools.
Other users for in vitro diagnostics include different healthcare settings such as laboratories, ambulatory healthcare services, and educational institutions, specifically for emergencies and research institutions. Healthcare institutions typically perform POC tests to monitor or detect disease. The high acceptance of POC tests in the mentioned organizations due to the lower cost and rapid results is expected to drive the development of this market.
The immunoassay sector dominated the market and had the highest revenue share of 29.8 per cent in 2020. It is predicted to expand rapidly over the next few years due to its role in detecting infective microbes such as bacteria, fungus and viruses through the screening for their toxic substances. The growing rate of chronic diseases, including HIV and the development of instruments with higher precision could be the reason for the most significant market percentage.
Clinical Chemistry is the actual application of biochemistry. It is used to study body fluids to determine the purposes of diagnosis and therapy. Plasma, serum and urine are among pathology’s most frequently examined samples. The increased utilization of approved blood gas analyzers to detect respiratory ailments is expected to boost the expansion of markets for in vitro diagnostics. For example, in March 2020, Siemens Healthineers AG received U.S. FDA approval for its Rapidpoint 500e Blood Gas Analyzer, awarded the CE-IVD seal in August 2019.
The microbiology sector includes tests and assays used for the detection of microorganisms that are infected. To fight the resistance to antibiotics, initiatives from organizations to improve the outcomes of patients with cost-effective and speedy diagnostic methods are anticipated to drive the market’s expansion. For example, in April of 2019, The University of Antwerp, Welcome Trust, and bioMerieux joined forces to launch Value-Dx, Innovative Medicines Initiative (IMI) project created by six companies that offer in-vitro diagnostics to combat resistance to antimicrobials.
North America accounted for the highest revenue share of 41.1 per cent of the IVD market in 2020 and is predicted to remain dominant throughout the forecast. This is due to the presence in the region of the major market players. Additionally, the rising incidence of illness rates and increased awareness of consumers are driving the need for better diagnostic tools.
The market in the Asia Pacific is predicted to see the highest growth rate over the forecast timeframe at 6.2 per cent. The Asia Pacific consists of developing and developed economies. Growing awareness of healthcare, the number of patients seeking an early diagnosis in the Asia Pacific, and high chronic illness prevalence are expected to boost the market.
Key Companies & Market Share Insights
The IVD market is highly price-sensitive, and companies compete in manufacturing adequate and cost-effective products. Companies are making mergers, acquisitions, and partnerships to improve their manufacturing capabilities and product offerings and create competitive advantages. Additionally, they are working to obtain approval for new devices to detect different types of infections. For instance, in 2019, Abbott received the WHOs prequalification approval for the m-PIMA HIV-1/2 VL POC HIV-1/2 VL test for diagnosing viral infections. The product was granted CE approval in December of 2018.
The presence of significant players in this market dramatically reduces opportunities for new companies to get into the market because it’s challenging to meet the high capital requirements. Some of the most well-known players in the market for in vitro diagnostics include:
- Bio-Rad Laboratories, Inc.
- Becton, Dickinson and Company
- Shanghai Kehua Bio-engineering Co.
- Siemens Healthineers AG
- Myriad Genetics
- Ortho Clinical Diagnostics
- Quidel Corporation
- F. Hoffmann-La Roche AG
- Sysmex Corporation
- Charles River Laboratories International, Inc.
- Quest Diagnostics
- Agilent Technologies
|In Vitro Diagnostics Market Report Scope and Segmentation|
|UNIT||Value (USD Million/Billion)|
|BY REGION||North America, Europe, Asia Pacific, Latin America, Middle East and Africa|
Segments Covered in the Report
The report predicts revenue growth at the global, regional and country levels. It analyses the most recent trends within each sub-segment between 2016 and 2027. To conduct this report, Grand View Research has divided the global in-vitro diagnostic market report based on technology, product application, end-user and location:
- Product Outlook
- Technology Outlook
- Clinical Chemistry
- Molecular Diagnostics
- Application Outlook
- Infectious Disease
- Autoimmune Disease
- Testing for drugs
- End-use Outlook
- Home Care
- North America
- The Netherlands
- Czech Republic
- Rest of Europe
- Asia Pacific
- South Korea
- Australia & New Zealand
- Rest of Asia Pacific
- South America
- Rest of South America
- The Middle East & Africa
- Saudi Arabia
- South Africa
- Northern Africa
- Rest of MEA