In vitro Diagnostics (IVD) Market Size, Share & COVID-19 Impact Analysis, By Product Type (Instruments and Reagents & Consumables), By Technique (Immunodiagnostics, Clinical Chemistry, Molecular Diagnostics, Hematology), By Setting (Laboratories and Point-of-care), By Application (Infectious Diseases, Cardiology, Oncology), By End-user (Clinical Laboratories, Hospitals) and Regional Forecasts, 2021-2028

The global In vitro Diagnostics (IVD) Market size was USD 80.43 billion in 2020. The global impact of COVID-19 has been unprecedented and staggering, with In vitro Diagnostics witnessing a positive impact on demand across all regions amid the pandemic. Based on our analysis, the global market exhibited a higher growth of 25.2 % in 2020 compared to the average year-on-year growth during 2017-2019. The market is projected to grow from USD 96.87 billion in 2021 to USD 149.03 billion in 2028 at a CAGR of 6.3% during the 2021-2028 period. The rise in CAGR is attributable to this market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.

In vitro Diagnostics are medical devices used to perform diagnostic tests on biological samples such as blood, urine, and tissues. The IVD tests help detect and monitor infectious diseases, autoimmune diseases, and several medical conditions and are being used to analyze drug therapies. Furthermore, according to the British In-vitro Diagnostic Association, in-vitro diagnostic tests influence approximately 70% of clinical decisions. However, less than 1% of the NHS’s budget is spent on the development of new and innovative IVD product portfolios each year.

The rising demand for point-of-care IVD devices and the increasing adoption of these devices have been instrumental in driving the growth of the market. This is further augmented by increasing investment by key players in research & development to innovate new products and explore new applications of IVD techniques.

• For instance, in March 2021, F. Hoffmann-La Roche Ltd launched Cobas 5800, a fully automated, low throughput PCR system.

This novel product will be used to detect novel viruses such as COVID-19. Such new launches are projected to contribute to the In vitro Diagnostics Market growth.

Market to Witness a Positive Impact Owing to Increasing Diagnostic Procedures amid COVID-19 Pandemic

The IVD market witnessed slower growth in terms of revenues in 2020, owing to the mixed impact of covid-19 on various segments. The COVID-19 pandemic has upsurged the demand for molecular diagnostics techniques as it is used to diagnose the SARS-CoV-2 virus. Additionally, there was increased demand for test kits, and consumables for monitoring blood glucose levels, troponin levels, and many others, among hospitalized patients suffering from covid-19.

This would significantly increase demand for point-of-care tests based on serology and molecular techniques globally. Market players witnessed a considerable increase in their revenues generated from sales of molecular tests and point-of-care tests.

However, other techniques such as immunodiagnostics, clinical chemistry, hematology, among others, experienced a decline in growth owing to lockdowns and a decline in routine testing performed in hospitals and laboratories worldwide. For instance, F. Hoffmann-La Roche Ltd, Abbott Laboratories, and bioMérieux SA witnessed a decline of -6.0%, -3.9%, and -7.0%, respectively in the revenues generated from the immunodiagnostics segment in 2020 as compared to 2019.

Additionally, the introduction of new techniques for rapid diagnosis of COVID-19 has surged the demand for in-vitro diagnostic (IVD) products and services worldwide.

• For instance, in March 2020, Abbott Laboratories launched a molecular test using polymerase chain reaction (PCR) methods on its m2000 RealTime lab-based platform to detect COVID-19 pursuant to an Emergency Use Authorization (EUA) in the U.S. and CE Mark.


• In March 2020, Abbott Laboratories launched a molecular test to detect COVID-19 on its ID NOW rapid point-of-care platform in the U.S., according to a EUA. Overall, the COVID-19 pandemic is expected to exert a positive impact on the IVD market growth.

LATEST TRENDS

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Increasing Adoption of Point-of-care Testing Devices to Fuel Demand for IVD Tests

Due to the increasing burden of diseases, medical devices companies are continuously involved in developing technologically advanced diagnostic devices. Furthermore, hospitals and laboratories have demonstrated a rising preference towards point-of-care testing devices to get accurate real-time data. This factor is likely to increase the demand for point-of-care testing devices, ultimately increasing the demand for In vitro Diagnostics devices.

Additionally, the significant rise in new advanced product launches is contributing to the growth of the market.

• In March 2021, F. Hoffmann-La Roche Ltd launched Cobas pulse point-of-care blood glucose testing instrument. This new product is anticipated to be the successor of the previous version Accu-Chek Inform II.


• In August 2019, Roche Diagnostics got FDA approval for the VENTANA PD-L1 (SP142) Assay for identifying triple-negative breast cancer (TNBC) patients

DRIVING FACTORS

Rising Incidence of Chronic Diseases to Augment Market Growth

The prevalence of several diseases such as genetic, cardiovascular, and neurological diseases is increasing significantly. According to the World Health Organization (WHO), cardiovascular diseases (CVDs) are the number 1 cause of death globally, causing an estimated 17.9 million deaths each year. This has led to a rise in awareness regarding early diagnosis among the population and an increase in routine diagnosis, which backs the market's overall growth. Moreover, the introduction of novel advanced IVD products is also supporting the high growth of the market.

Additionally, the aging population is more susceptible to several diseases such as hypertension, diabetes, cardiovascular, liver, and kidney diseases are expected to increase significantly.

• According to the United Nations, in 2019, 1 in 11 people in the world are over the age of 65 and anticipated to increase 1 in 6 people to be over the age of 65 by 2050. This issue is projected to further propel the global market during the forecast period.

RESTRAINING FACTORS

High Cost of IVD Instruments to Restrict Growth in Emerging Countries

In vitro Diagnostics products have witnessed significant advancement and developments in the past decade regarding new products being adopted and further design amendments, among others. However, the high cost of IVD instruments and the high cost associated with the maintenance of the instruments hindered the market growth up to a certain extent. Additionally, In vitro Diagnostics instruments require skilled professionals for operation. Thus, this increasing the maintenance cost of the device, which ultimately hamper the overall growth of the market,

The cost of RT-PCR systems ranges from USD 15,000 to over USD 90,000. The above cost factors have been responsible for the relatively limited adoption of In vitro Diagnostics products in several countries and regions.

SEGMENTATION

By Product Type Analysis

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Reagents & Consumables Segment to Dominate Backed by Advent of Advanced Products

Based on the product type, the market is segmented into instruments and reagents & consumables.

The reagents & consumables segment held the dominant share of the global market in 2020 due to the surge in usage of self-testing kits, POC tests, and several other advanced products in the in-vitro diagnosis. The increased number of research and development activities for diagnosing several chronic diseases is one of the major factors propelling the demand for reagents & consumables. Furthermore, the rising adoption of self-diagnosis tests and demand for point-of-care devices also contribute to the higher growth of the segment.

The instrument segment is anticipated to expand at a comparatively sluggish CAGR during the forecast period. The introduction of new advanced instruments offers an excellent avenue for segment growth. For instance, in March 2021, Sysmex Corporation launched two next-generation flagship models in the hematology business segment, the XR-Series Automated Hematology Analyzer, and a compact 3-part WBC differential model, i.e., the XQ-Series Automated Hematology Analyzer.

By Technique Analysis

Incessant Technological Advancements in Molecular Diagnostics Devices to Fuel This Segment   

On the basis of technique, the market is segmented into immunodiagnostics, clinical chemistry, molecular diagnostics, hematology, and other techniques.

The molecular diagnostics segment held the dominating share in 2020 due to the increasing demand for molecular diagnosis in infectious diseases. In 2020, the COIVID-19 pandemic hit worldwide. The SARS-CoV-2 virus that causes COVID-19 was diagnosed using Real-Time Quantitative Reverse Transcription PCR (qRT-PCR). Furthermore, in April 2021, Sysmex Corporation received approval from the Japanese medical regulatory authorities to manufacture and market the DetectAmp SARS-CoV-2 RT-PCR Kit. It is a SARS coronavirus nucleic acid kit used to detect the RNA of the novel coronavirus (SARS-CoV-2).

Furthermore, the segment is projected to grow at a substantial CAGR during the forecast period. The growth is attributed to the rapid increase in acute and chronic diseases around the globe. According to the World Health Organization (WHO), in 2019, an estimated 10 million people will be affected with tuberculosis (TB) worldwide. Such factors are contributing to the high growth of the segment.

By Setting Analysis

Continuous Innovations in Point-of-Care Systems to Upsurge Demand of This Segment

On the basis of setting, the market is segmented into laboratories and points of care.

The laboratories segment held the dominating share in 2020. This is majorly due to the rising adoption of advanced instruments by this setting, along with rapid investments by public and private sectors in laboratory infrastructure in developing countries. Additionally, most complex and sensitive diagnostic tests are carried out in laboratories and require skilled lab staff, specialized equipment, and slightly more time to run.

The point-of-care segment is projected to grow at a substantial CAGR during the forecast period. Due to the increased burden of patient populations suffering from various diseases (diabetes, infectious disease, HIV, etc.), medical device giants are focusing on introducing innovative and accurate testing kits. Furthermore, the launch of COVID-19 POC diagnostics kits by companies has elevated the revenue growth in the year 2020. For example, in October 2020, Siemens Healthineers announced the launch of the Rapid Antigen Test for the Detection of SARS-CoV-2. Therefore, such novel product launches will significantly augment POC diagnostics business growth. Additionally, point-of-care testing does not require highly skilled laboratory personnel or equipment to be carried out. It can therefore be deployed in lots of different settings and at a significant scale.

By Application Analysis

Increasing Prevalence of Infectious Diseases to Bolster Growth of This Segment

On the basis of application, the market can be segmented into infectious diseases, cardiology, oncology, gastroenterology, and other applications.

The infectious diseases segment held the dominating share in 2020 due to the increasing number of infectious diseases globally.

• According to the statistics from the Joint United Nations Programme on HIV/AIDS, 38.0 million people globally were living with HIV in 2019. Furthermore, 1.7 million people became newly infected with HIV in 2019.

Furthermore, an increasing prevalence of several other infectious diseases such as hepatitis, diphtheria, Respiratory Syncytial Virus (RSV), and many others would contribute to the highest share of the segment.

The oncology application segment is expected to grow at a significant CAGR during the forecast period. The growth is attributed to the physician’s high preference for in-vitro diagnostic products to diagnose cancer. Furthermore, the rising number of cancer patients globally is expected to lead to this segment’s growth.

• According to the statistics from the National Cancer Institute, in 2020, an estimated 1,806,590 new cancer cases were diagnosed in the United States. Additionally, the rate of new cases of cancer (cancer incidence) is 442.4 per 100,000 men and women per year.

By End-user Analysis

Higher Test Volume at Clinical Laboratories to Lead to Dominance of the Segment

Among end-users, the market includes clinical laboratories, hospitals, physician's offices, and others. The clinical laboratories segment dominated the market in 2020 owing to the higher number of diagnostics procedures taking place in clinical laboratories. Additionally, the availability of advanced technology and equipment in the clinical laboratories is fueling the diagnosis test volume, which ultimately contributes to the growth of the segment during the forecast period.

Furthermore, the physician's offices segment is expected to grow at a higher CAGR owing to the rising shift of patients preferring physician offices for point-of-care tests. Additionally, with an increasing number of hospitals and clinics in developed economies and emerging countries, the increasing usage of point-of-care devices such as pregnancy kits and glucose meters within hospitals and physician’s offices is also driving the demand for In vitro Diagnostics products and subsequently driving the growth of the segment.

REGIONAL INSIGHTS

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On the basis of region, the market can be segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.

The market in North America was valued at USD 31.95 billion in 2020 and is anticipated to continue to dominate the global market during the forecast period. Some of the prominent factors contributing to the region’s highest share include the presence of major companies in the region, such as Abbott, Thermo Fisher Scientific Inc., Becton, Dickinson and Company, and Danaher Corporation, along with the rising R&D investments by these key players to develop new advanced products. Other contributing factors include the well-established diagnostic infrastructure and the strong adoption of technologically advanced products by diagnosis service providers in the region. These are expected to drive market growth in the region.

Europe is anticipated to be the second-most dominant region in terms of IVD market share. The market in Europe holds a significant share due to rising healthcare expenditure, well-established infrastructure, and the presence of a large pool of patients suffering from infectious diseases and cancer.

The market in Asia Pacific is estimated to grow at the highest CAGR, especially in developing countries such as India, South Korea, Australia, and China. For instance, in April 2021, Seegene Inc. announced that it had secured an export permit from South Korea’s Ministry of Food and Drug Safety to begin exporting its COVID-19 variant tests to countries around the world. This permit will fortify the company's sales and market position globally.

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Latin America and the Middle East & Africa are anticipated to account for a limited market revenue share during the forecast period. However, improvement in healthcare expenditure and increasing adoption of point-of-care devices in Latin America and the Middle East & Africa is expected to lead to future growth prospects.

KEY INDUSTRY PLAYERS

F. Hoffmann-La Roche Ltd, Abbott, Thermo Fisher Scientific Inc., and Sysmex Corporation are Key Players of the Market

The global In vitro Diagnostics Market is fragmented, with players such as F. Hoffmann-La Roche Ltd, Abbott, Thermo Fisher Scientific Inc., and Sysmex Corporation accounting for a significant share in 2020. The top market players focus on strategies such as mergers and acquisitions, collaborations, and new product developments and launches to strengthen their market position globally.

• For instance, in March 2021, F. Hoffmann-La Roche Ltd. signed a definitive merger agreement with GenMark Diagnostics, Inc. This acquisition will help Roche gain access to GenMark’s novel technology to test for a broad range of pathogens with one patient sample.


• In March 2021, F. Hoffmann-La Roche Ltd announced the launch of Cobas pure integrated solutions in countries accepting the CE mark. This new compact analyzer combines three technologies on a single platform helping to simplify operations in small to medium-sized labs.

Other market players with a significant presence in the global market include Siemens Healthineers AG, BD (Becton, Dickinson, and Company), Seegene Inc., DiaSorin S.p.A., and Quest Diagnostics Incorporated. These companies are expected to focus on new products launched to increase their share in the market during the forecast period.

LIST OF KEY COMPANIES PROFILED:

• F. Hoffmann-La Roche Ltd (Basel, Switzerland)


• Abbott Laboratories (Illinois, U.S.)


• Thermo Fisher Scientific Inc. (Massachusetts, U.S.)


• Sysmex Corporation (Hyogo, Japan)


• Siemens Healthineers AG (Munich, Germany)


• BD (Becton, Dickinson, and Company) (Franklin Lakes, U.S.)


• Seegene Inc. (Seoul, Republic of Korea)


• DiaSorin S.p.A. (Saluggia, Italy)


• Quest Diagnostics Incorporated (New Jersey, U.S.)


• Bio-Rad Laboratories, Inc. (Hercules, California, U.S.)

KEY INDUSTRY DEVELOPMENTS:

• December 2020 – Abbott launched its multiplex molecular test on its Alinity m system to detect COVID-19, flu A, flu B, and respiratory syncytial virus (RSV) pursuant to a CE Mark.


• December 2020 - Abbott received CE Mark and launched its SARS-CoV-2-IgG II quantitative lab-based serology blood test for use on its ARCHITECT and Alinity i platforms.


• March 2020 - Thermo Fisher Scientific Inc. received a CE mark for its diagnostic test to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19.


• March 2021 - BD announced that the U.S. FDA granted emergency use authorization (EUA) for a new, rapid antigen test to detect SARS-CoV-2, influenza A, and influenza B in a single test.


• February 2021 - BD and Scanwell Health announced a collaboration to create an at-home rapid test for SARS-CoV-2 using a BD antigen test and the Scanwell Health mobile app.

REPORT COVERAGE

An Infographic Representation of In-vitro Diagnostics (IVD) Market

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The global In vitro Diagnostics Market report provides detailed market analysis and focuses on key aspects such as an overview of the advanced product, the prevalence of several diseases and disorders and key countries, pricing analysis. Additionally, it includes an overview of reimbursement scenarios for diagnostic procedures, key industry developments such as mergers, partnerships, & acquisitions, the impact of COVID-19 on the market, and brand analysis. Besides these, the report offers insights into the market trends and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the market over recent years. The report also covers regional analysis of different segments.

Report Scope & Segmentation