IVD Market

Global IVD Market Size (2022 to 2027)

As per our analysis report, the global In-Vitro Diagnostics market size is estimated to be USD 73.93 billion in 2022. This figure is forecasted to grow to USD 97.08 billion by 2027 at a compound annual growth rate (CAGR) of 5.6%.

A recent survey by physicians in the U.S and Germany reported that 66% of clinical decisions would occur based on diagnostic tests. IVD shows beneficial effects on treatment outcomes, therapy choices, and others, and in-vitro diagnostics are performed under a specified condition in a test tube. These procedures will help to monitor the health problems of the people. The main aim of the research centers is to develop innovative methods using in-vitro diagnostics. These before have a prominent role in overcoming health-related issues globally.

The Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) has been established by the World Health Organization (WHO) to look over policies and strategies for IVD. It is to set new evidence-based guidance to scientists to promote in-vitro diagnostics tests. These policies are highly successful in reducing the prices of medicines.

COVID-19 impact on the global IVD Market:

Since January 2020, scientists have focused on developing various kits as the global COVID-19 pandemic outbreak is surging. The impact of this crisis is sharply affecting the demand of the IVD market. Prior diagnosing analysis to track the people affected by the diseases mainly propels the need for this market nowadays. The spread of COVID-19 has been slowed down in China due to their efforts in diagnostic testing. It has made pharmaceutical companies address these needs and development kits to test for COVID-19. South Korea also grabbed attention by testing a more significant number of people in a short period. As a result, IVD is a boom for this country, which played an essential role in the healthcare centers during the pandemic.

MARKET DRIVERS:

Y-O-Y growth in the aging population globally favors the global IVD industry growth.

According to the World Health Organization, the number of people over 65 is estimated to reach 1.5 billion by 2050. Diseases such as Cancer, Alzheimer'sritis, and others maintain a robust correlation with aging. In the treatment procedures, the laboratories use immunoassay-based tests aggressively, which is expected to drive the in-vitro diagnostics market. Increasing demand to provide appropriate treatment services is leveling up the need of this market.

The prevalence of automatic IVD systems in hospitals and laboratories will likely boost the global in-vitro diagnostics market growth.

IVD systems are very useful in diagnosing the disease as a patient can ensure proper treatment procedures. The emergence of advanced technologies in healthcare hit laboratories, where the demand for automatic systems is growing steadily. It is expected to fuel the growth rate of the market. In addition, the rising prevalence of user-friendly devices in laboratories is significantly influencing the market's demand.

The growing population suffering from chronic and infectious diseases is another major factor boosting the global IVD market.

The adoption of sedentary lifestyle changes leads to an increase in chronic diseases. As a result, growing incidences of chronic and infectious diseases are majorly fueling the market's growth rate. In addition, increasing awareness towards OTC (over-the-counter) devices will likely boost the market IVD industry demand.  

MARKET RESTRAINTS:

The shortage of skilled persons to perform these procedures effectively due to fewer training programs and the fluctuations in the prices of final products used in the laboratories slightly hamper the global in-vitro diagnostics market. Furthermore, the government's rules and regulations for approving newly launched products and the lack of standardization, other attributes declining the growth, are other challenging factors for the global IVD market.

REPORT COVERAGE:

This research report on the global in-vitro diagnostics market has been segmented and sub-segmented based on the product, technology, application, and region. 

IVD Market - By Product:

• Instruments
• Reagents and Kits
• Software

Based on the product, the Reagents and Kits segment was the leader in 2020 and is estimated to continue the same during the forecast period. Increasing the utilization of different devices in laboratories to ensure performance levels in the biotechnology field prompts the market. In addition, the growing usage of various tools in hospitals and laboratories is one factor propelling the in-vitro diagnostics market growth.

The instruments segment is another lucrative segment and is estimated to witness a healthy CAGR during the forecast period after the reagents and kits segment. Adopting advanced technologies and entering new players are some factors that boost the market growth.

IVD Market - By Technology:

• Clinical Chemistry
• Hematology
• Immunoassays
• Coagulation and Hemostasis
• Molecular Diagnostics
• Microbiology
• Other IVD technologies

Based on technology, the clinical chemistry segment held the most significant share of the global IVD market in 2020. Therefore, raising awareness is vital for the segment to grow enormously. In addition, increasing demand to develop quality products with the help of appropriate technology is leveraging the market's 

The molecular diagnostics and immunoassay segments are growing at healthy growth rates during the forecast period. Increasing incidences of infectious diseases and different genetic disorders are crucial factors for the segment to grow.

IVD Market - By Application:

• Diabetes
• Infectious Diseases
• Oncology/Cancer
• Cardiology
• Nephrology
• Autoimmune Diseases
• Drug Testing
• HIV

Based on application, the Oncology/Cancer segment is expected to have the fastest growth rate during the forecast period. The growing aging population is one of the most common factors gearing up the demand of the market. The infectious diseases segment is the second-largest segment that holds the market growth due to the common infectious diseases like multi-drug resistant infections.

IVD Market - By Region:

• North America
• Europe
• Asia-Pacific
• Latin America
• The Middle East and Africa

Geographically, North American IVD Market was the largest market for In-Vitro diagnostics, accounting for around 37% in 2020, owing to the growing prevalence of chronic diseases such as cancer and respiratory diseases in the region. In comparison, the U.S. IVD market has a positive growth rate. However, introducing new diagnostic procedures that are simple and convenient for system technicians is leveling up the market. Conversely, the Canadian IVD market is forecasted to grow at a significant CAGR of 6.1% between 2020 to 2025.

The Asia-Pacific IVD market is the fastest-growing segment, with a CAGR of 6.4%. The Asia Pacific is following North America in accounting for the leading share in the global in-vitro diagnostics market with the rise in the number of health disorders due to changes in lifestyles and food habits. IVD market in India has prominent shares in the APAC IVD market by changes in the governments. Also, the launch of reimbursement schemes favoring ordinary people is leveraging market demand. As a result, the Indian IVD market is growing more aggressively among different Asia-Pacific nations and is expected to witness a CAGR of 6.9% during the forecast period.

The European IVD Market has grown tremendously and will hit the highest CAGR shortly. Increasing demand for point-of-care testing devices is gearing up the market's need. In 2019, the UK IVD market was the most dominant regional market in the European IVD market and was predicted to grow at a CAGR of 6.5% from 2021 to 2026 and worth USD 2980 million in 2020. The German IVD market is another lucrative regional market in Europe and was considered one of the largest in Europe in 2019. The IVD market in Germany is projected to register a CAGR of 5.1% between 2020 to 2025.

The IVD market in the Latin American region is predicted to showcase a CAGR of 5.9% from 2021 to 2026. In Latin America, the IVD market in Brazil was growing consistently and is forecasted to witness a CAGR of 4.98% during the forecast period. Followed by Brazil, the Mexican IVD market is estimated to register a healthy growth rate during the forecast period.

The Middle East and Africa IVD Market to have a slight inclination in the growth rate in the coming years. UAE led this regional market in the recent past, and the UAE market was worth USD 321 million in 2020 and is estimated to grow at a CAGR of 5.12% during the forecast period.

KEY MARKET LEADERS IN THE IVD MARKET:

Abbott Laboratories, Johnson and Johnson, Siemens Healthcare, Becton Dickinson, Roche Diagnostics, and Beckman Coulter Inc. are a few of the dominating companies in the global IVD market.

Other companies that account for a significant share of the IVD market are Biomérieux, Ortho Clinical Diagnostics, Inc., Bio-Rad Laboratories, Inc., Danaher Corporation, Sysmex Corporation, and Thermo Fisher Scientific, Inc.

RECENT MARKET DEVELOPMENTS:

Product Launches:

• On April 11, 2019, to fight against cancer, Sophia genetics took a step forward in announcing the CE-IVD marking of its Solid Tumor Solution (STS). This application can detect solid tumors like lung, colorectal, skin, and brain cancers.
• On April 19, 2019, Altona diagnostics GmbH announced the launch of the Altostar Molecular Diagnostic workflow. It is a CE-marked device with several benefits, such as flexibility and efficiency in testing infectious diseases.
• On November 27, 2018, the first automated in vitro diagnostic (IVD) named Roche launched VENTANA pan-TRK (EPR17341) Assay. This launch is beneficial in laboratories to detect tropomyosin receptor kinase (TRK) proteins in cancer.
• On July 11, 2018, Namsa announced the Launch of IVD development services through integrated laboratory testing. This company is to put complete efforts into manufacturing capable devices in favor of the end-users.
• On December 28, 2018, Genesig Real-Time PCR Epstein-Barr Virus (EBV) Kit and Genesig Real-Time PCR BK virus (BKV) Kit were launched by Novacyt. These two kits are under the name CE-IVD mark molecular diagnostic kits. These kits accurately diagnose the disease and are easily handled in real-time applications.
• On July 31, 2018, Surmodics, Inc. introduced Matrix Guard Diluent; this move helped their shares eventually propel. The kit is to reduce false-positive results while performing tests using IVD.

Product Approvals:

• On July 12, 2019, the Abbott IVD system had clearance from the FDA for screening blood and plasma donations. This system has additional automatic features that can run up to 3 hours without human effort. In addition, it can do 600 tests per hour.
• On March 06, 2019, Instrumentation Laboratory (IL) received approval from U.S Food and drug administration for the innovative product GEM Premier ChemSTAT in vitro diagnostic (IVD) analyzer. It is developed with intelligent quality management and is broadly used in point-of-care testing, primarily in hospital Emergency Departments and clinical laboratories.

Collaborations/Partnerships:

• On August 03, 2019, Sysmex, a leading company supporting IVD instruments, agreed with JVCKENWOOD Corporation to manufacture IVD biodevices. As a result, these companies will better use micro and nanofabrication technology in developing useful IVD devices.
• On November 09, 2019, Lexent Bio partnered with Illumina, Inc. to develop a next-generation sequencing IVD kit to diagnose cancer. This product is to promote companies' portfolios to the next level.