Global In Vitro Diagnostics (IVD) Market Report – By Product and Services (Reagents, Instruments), By Technique (Immunodiagnostics, Haematology, Molecular Diagnostics), By Application (Infectious Diseases, Cancer, Cardiac Diseases), End-User (Hospitals, Standalone Laboratories, Academic and Medical Schools) By Region and Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2023-2032 

Report Overview

The Global in vitro diagnostics (IVD) market size is expected to be worth around USD 149.4 Bn by 2032 from USD 95.3 Bn in 2022, growing at a CAGR of 4.7% during the forecast period from 2022 to 2032.

Automated intravenous diagnostic (IVD) systems in hospitals and laboratories are anticipated to deliver accurate, fast, and error-free diagnoses. The market’s growth is also boosted by the increasing number of IVD (in vitro diagnostics) products introduced by significant players. Molecular diagnostic IVD products provide efficient and precise outcomes.

May 2021 marked the invention of an ultrasensitive molecular test by the University of California. Chip technology is the foundation of this test, which can distinguish between SARS-CoV-2 and influenza A antigens. More research is being done to make the test a Point-of-Care (POC) test. Therefore, the industry dynamics have changed. More players are focusing on home-based testing as a result. In addition, the FDA will prioritize home-based molecular diagnostic tests in 2021.

In March 2021, BATM Progressed Correspondences Ltd. reported the send-off of its sub-atomic diagnostics individual test pack for the location of Coronavirus.

In addition, these tests maintain a low risk of substitutes and enable the early detection of diseases. However, it is anticipated that the high cost of these tests will encourage patients to use external reserves. Additionally, the high rate of internal substitution for detecting newer infections like SARS-CoV-2 increases competition.

In areas like APAC, IVD products from established companies are not widely used; Local musicians selling instruments at lower prices dominate this area. The market is predicted to be driven primarily by technological portability, accuracy, and cost-effectiveness advances.

Increasing geriatric populations and awareness of early testing have increased regular checkups, as most infections and chronic conditions kill people over 75. The UK’s Office for Budget Responsibility says that healthcare costs have grown exponentially, which can put financial pressure on countries aging quickly. On the other hand, this expenditure is anticipated to impact the IVD industry, thereby propelling market expansion positively.

Key Takeaways

• Market Growth: The Global In Vitro Diagnostics (IVD) Market is exhibiting a CAGR of 4.7%.
• Technology Advancements: Automated IVD systems, including molecular diagnostic IVD products, are contributing to accurate and swift diagnoses, with notable innovations such as ultrasensitive molecular tests and point-of-care testing.
• Product and Services:
  • IVD encompasses testing of various bodily fluids and tissues using reagents, software, and instruments. It involves molecular diagnostics, hematological, tissue, and immunodiagnostics.
  • Laboratories, hospitals, and point-of-care testing facilities are the main users of IVD products.
• Applications:
  • Infectious diseases are the dominant application segment, with significant contributions to diagnosing contagious microorganisms such as pneumonia, hepatitis, and HIV/AIDS.
  • Chronic diseases like diabetes and cancer also drive market growth.
• End-User:
  • Laboratories hold the largest share of the market due to their volume of testing, while hospitals benefit from faster diagnostics.
  • Hospitalization demand for IVD tests remains high.
• Drivers:
  • Increasing incidence of chronic diseases, including cardiovascular, genetic, and neurological conditions.
  • The growing elderly population leads to more regular checkups.
• Restraints:
  • High cost of IVD instruments and the need for skilled professionals.
  • Unclear reimbursement scenarios and stringent regulatory policies.
• Trends:
  • Continuous technological advancements in diagnostic tools.
  • Preference for accurate real-time data from point-of-care testing devices.
• Opportunities: Emerging economies like South Korea, India, China, and Brazil present growth opportunities for major market players due to their adaptable regulations and increasing healthcare investments.
• COVID-19 Impact: The pandemic increased IVD usage significantly, especially for COVID-19 diagnostics. However, non-essential testing decreased, causing some setbacks.
• Regional Analysis: North America dominates the market, accounting for over 38% of total revenue in 2022, while Asia Pacific is expected to be the fastest-growing region during the forecast period.
• Key Players: Prominent players include Siemens Healthcare, Bio-Rad Laboratories, Abbott Diagnostics, ARKRAY Inc., Siemens Healthineers, Qiagen N.V., and others, with a focus on expanding product offerings and technological innovation.

Product and Services Analysis

Blood, stool, urine, tissues, and other bodily fluids are tested for infections, illnesses, and conditions using reagents, software, and instruments for in vitro diagnostics (IVD) market. Additionally, various IVD devices employ molecular diagnostics, hematological, tissue, and immunodiagnostics. Expertise and technical proficiency are required for the IVD market’s application and management. As a result, specialist medical facilities employ diagnostic devices.

For instance, IVD products are utilized in standalone hospitals, laboratories, and point-of-care testing facilities. The in vitro testing method requires multiple reagents and software to ensure smooth operations. In addition, various HIV/AIDS-related diseases, including infectious diseases, oncology/cancer, diabetes, cardiac conditions, nephrology autoimmune diseases, and medical disorders, are diagnosed using in vitro diagnostics.

An increase in chronic and infectious diseases is primarily responsible for the in vitro diagnostics (IVD) market growth. Chronic diseases like diabetes, cancer, cardiovascular disease, and tuberculosis (TB) are rising in the current business climate. In addition, there is a significant rise in the number of patients with infectious diseases like respiratory, gastrointestinal, and STDs. The IVD market is driven by the expectation that the increase in these diseases will raise the demand for diagnostic tools.

In addition, technological advancements for the IVD industry, such as rapid test kits, have grown incredibly in recent years and are anticipated to continue. As a result, In-vitro diagnostics are utilized in various healthcare settings. In addition, the use of in vitro diagnostic tests has increased worldwide. It is because people are more aware of point-of-care testing. Some of the leading players are focusing on introducing new portable, transportable, handheld instruments that are easy to use outside laboratories. As a result, there will be an increase in demand from patients and healthcare professionals. Furthermore, in vitro diagnostic tests’ high sensitivity and specificity are significant reasons for their widespread use.

However, unclear reimbursement scenarios and stringent regulatory policies are anticipated to slow the market’s expansion. On the other hand, the in vitro diagnostics (IVD) market has lucrative opportunities due to the availability of products in development.

Technology Type Analysis

The molecular diagnostics application segment held the highest market share in 2021, with 37.95%, due to the introduction of novel products and ongoing technological development. Although complex equipment is typically required for PCR, innovations like postage-stamp-sized plasmofluidic chips have emerged from research efforts. Plasmofluidic chips, according to ACS Nano Journal in May 2021, are efficient and extremely fast. As a result of their ability to carry out a PCR test in just eight minutes, they are anticipated to expedite diagnosis in both the current and upcoming pandemics. Furthermore, in 2021, several new products were introduced in the immunoassay market.

Plating patient samples and selecting pure cultures from them serve as diagnostic tools. One of the microbiology testing applications that is expanding at the fastest rate is antibiotic susceptibility testing. The microbiology industry is expected to grow as the incidence of infectious diseases rises. It is anticipated that the FDA’s approval of advanced devices, like Colibri, approved in January 2022, will encourage the development of clinical microbiology analyzers by making it easier for AI-based automated workflows.

Applications Analysis

The infectious disease application segment dominated the market with a market share of 59.49% in 2021. The detection of contagious disease-causing microorganisms is made possible by IVDs. Pneumonia, hepatitis, tuberculosis, and HIV/AIDS are the most common infections that can cause death. In addition, major market players are working together to make it easier for patients and healthcare providers to access cutting-edge, high-quality laboratory services.

In January 2020, Quest Diagnostics and Memorial Hermann Health System collaborated to offer improved, high-quality, cost-effective, and novel diagnostic services to 21 hospital laboratories in the Huston region. Such efforts by market players to expand their presence are expected to boost the market growth.

End-User Analysis

The global market has been divided into end-user segments like hospitals, home care, laboratories, and others. In 2021, the laboratory end-use market was the most significant worldwide, with a revenue share of over 39%. The laboratory market is expected to expand due to several key factors, increased awareness of personalized medicine, increased demand for affordable services, and technological advancements. In addition, due to the large volume of laboratory testing, this is one of the market’s main revenue-generating segments.

Additionally, laboratory-based tests outperform PoC and home tests regarding reliability, giving them an advantage over the other two categories. Due to an increase in hospitalizations requiring support from faster diagnostics, the hospital segment held a significant share of the market in 2021. In addition, the existing hospital facilities are anticipated to be enhanced due to the ongoing improvement of healthcare infrastructure. As a result, the need for IVD tests performed in hospitals is growing. Hospitals purchase the majority of IVD devices and use them frequently. Because IVD tests provide faster and more accurate results, over 6,093 hospitals in the United States will require constant IVD assistance for crucial decision-making in 2022.

Key Market Segments

Based on Product and Services

• Reagents
• Instruments
• Software and Services

Based on the Technique

• Immunodiagnostics
• Hematology
• Molecular Diagnostics
• Tissue Diagnostics
• Clinical Chemistry
• Other Techniques

Based on Application

• Infectious Diseases
• Cancer
• Cardiac Diseases
• Immune System Disorders
• Nephrological Diseases
• Gastrointestinal Diseases
• Other Applications

Based on End-User

• Hospitals
• Standalone Laboratories
• Academic and Medical Schools
• Point of Care
• Other End-Users

Drivers

Rising Incidence of Chronic Diseases to Augment Market Growth

Numerous diseases, including cardiovascular, genetic, and neurological ones, are becoming common. Cardiovascular diseases (CVDs), which account for 17.9 million deaths annually, are the leading cause of death worldwide, according to the World Health Organization (WHO). It has contributed to the overall market expansion by raising public awareness of early diagnosis and increasing routine diagnosis.

Additionally, the introduction of cutting-edge IVD products aided the rapid market development. Several diseases, including diabetes, hypertension, and liver, cardiovascular, and kidney diseases, which are anticipated to rise significantly, are also more likely to affect the elderly population.

In 2021, 9.5% of the world’s population will be over 65, according to the article published in Knoema. Therefore, it is expected to propel the global market during the forecast period.

Restraints

High Cost of IVD Instruments to Restrict Growth in Emerging Countries 

In the past ten years, in vitro diagnostics products have seen significant advancements in adopting new products and further design modifications. However, the high upkeep cost and IVD instruments somewhat hampered the market’s expansion. Additionally, skilled professionals are required to operate in-vitro diagnostics instruments. As a result, the cost of maintaining the device rises, ultimately slowing down the market’s growth. The price of an RT-PCR system can range anywhere from US$ 15,000 to more than US$ 90,000. In several nations and regions, the relatively limited adoption of in vitro diagnostics products is due to the cost above factors.

Trends

The constant development of Technology and advanced diagnostic tools

Medical device manufacturers are constantly developing technologically advanced diagnostic tools in response to the rising prevalence of diseases. In addition, hospitals and laboratories increasingly prefer accurate real-time data from point-of-care testing devices. Therefore, the demand for in vitro diagnostics instruments will likely rise with the need for point-of-care testing instruments.

The significant rise also aids the market’s expansion by introducing cutting-edge products.

• Hoffmann-La Roche Ltd. introduced the Cobas pulse blood glucose testing instrument in March 2021. The new product is anticipated to replace the previous version of AccuChek Inform II.
• According to the EUA, Abbott launched a molecular test to detect COVID-19 in the United States on its ID NOW rapid point-of-care platform in March 2020.

Opportunities

Growth opportunities from emerging economies

Major players in the in vitro diagnostics (IVD) market are anticipated to receive growth opportunities from emerging economies like South Korea, India, Mexico, China, Russia, Brazil, South Africa, and Turkey. Due to its relatively lenient regulations and data requirements, the Asia Pacific region has established itself as an adaptable and business-friendly hub.

China is currently one of the most significant investors in R&D. Additionally, as markets in the United States and Europe mature, numerous players are turning their attention to emerging markets. To meet the growing demand in China for advanced mass spectroscopy (MS), liquid chromatography (LC), and spectrometer systems that the company manufactures, Agilent Technologies (US) invested US$ 20 million in 2022 to expand its manufacturing center in Shanghai.

Regional Analysis

North America dominates the Global In Vitro Diagnostics (IVD) Market.

The global market has been subdivided into North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa based on geography. In 2022, North America dominated the global market and contributed more than 38% of the total revenue. The region is anticipated to maintain its leading market position over the forecast period. The market in this region is driven by several factors, including the rising prevalence of chronic diseases, the rapidly expanding senior population, the high cost of healthcare, and government support.

It is anticipated that the demand for genetic testing for personalized health care, such as for diabetes and cancer, will continue to propel market expansion in North America. However, Asia Pacific is anticipated to be the region’s fastest-growing market during the forecast period, with a significant revenue share in 2022.

Infectious diseases, cardiovascular conditions, and cancer are just a few conditions that can be diagnosed using in vitro diagnostics tests. Stabilizing economies, a rapidly expanding middle-class population, favorable government policies, and rapid urbanization are expected to drive the Asia-Pacific regional market. Some of the prominent Key players in the market are Siemens Healthcare GmbH, Bio-Rad Laboratories, Abbott Diagnostics, ARKRAY Inc., Siemens Healthineers AG, Qiagen N.V., Becton, Dickinson and Company, Immuno Diagnostics, Inova Diagnostics, Beckman Coulter/Danaher and others.

Key Regions

• North America
  • The US
  • Canada
  • Mexico

• Western Europe
  • Germany
  • France
  • The UK
  • Spain
  • Italy
  • Portugal
  • Ireland
  • Austria
  • Switzerland
  • Benelux
  • Nordic
  • Rest of Western Europe

• Eastern Europe
  • Russia
  • Poland
  • The Czech Republic
  • Greece
  • Rest of Eastern Europe

• APAC
  • China
  • Japan
  • South Korea
  • India
  • Australia & New Zealand
  • Indonesia
  • Malaysia
  • Philippines
  • Singapore
  • Thailand
  • Vietnam
  • Rest of APAC

• Latin America
  • Brazil
  • Colombia
  • Chile
  • Argentina
  • Costa Rica
  • Rest of Latin America

• Middle East & Africa
  • Algeria
  • Egypt
  • Israel
  • Kuwait
  • Nigeria
  • Saudi Arabia
  • South Africa
  • Turkey
  • United Arab Emirates
  • Rest of MEA

Key Players Analysis

Market players use this strategy to broaden their product offerings and provide customers with cutting-edge, innovative technological goods. For example, Abbott received FDA approval for its rapid handheld blood test for traumatic brain injury (TBI) in January 2021.

Patients are evaluated for mild TBIs and concussions using the first-ever test. In addition, Abbott introduced the RealTime SARS-CoV-2 assay, a PCR-based COVID-19 diagnostic test, in March 2020. A COVID-19 test developed by BioMedomics can detect antibodies in the blood in as little as 15 minutes.

Market Key Players

• Abbott Laboratories
• Hoffmann-La Roche Ltd
• Sysmex Corporation
• BioMerieux SA
• Quidel Corporation
• Seegene Inc.
• Bio-Rad Laboratories, Inc.
• Quest Diagnostics Incorporated
• Agilent Technologies, Inc.
• Other Key players.

Key Industry Developments

• In November 2022, the rapid RT-PCR Accula Flu A/Flu B test was launched by Thermo Fisher Scientific (US); it is designed to enable healthcare providers to differentiate and detect influenza A and B in about 30 minutes.
• In October 2022, to acquire The Binding Site Group (a global leader in specialty diagnostics), Thermo Fisher Scientific (US) entered a definitive agreement. The Binding Site provides specialty instruments and diagnostic assays to improve the management and diagnosis of immune system disorders and blood cancers.
• In September 2022, the UF-1500 Fully Automated Urine Particle Analyser (UF-1500) was launched by Sysmex Corporation (Japan) for urine sediment testing.
• In August 2022, Abbott Laboratories (US) and AL-Futtaim Health (Dubai) entered a strategic partnership to improve the standards of advanced laboratory diagnostics in Dubai.
• In February 2022, Sysmex LLC, a new subsidiary, was opened by Sysmex Corporation (Japan) in Saudi Arabia.

Report Scope