In Vitro Diagnostics (IVD) Market Analysis | 2022-2028

“The In Vitro Diagnostics Market was estimated at USD 100.49 billion in 2021 and is expected to grow at a CAGR of 2.7% during 2022-2028 to reach USD 121.09 billion in 2028”.

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Market Dynamics

Introduction

In Vitro Diagnostics (IVD) refers to medical tests and devices used to diagnose diseases, conditions, or infections by analyzing samples taken from the human body, such as blood, urine, or tissue. These tests are performed outside the human body, typically in laboratories, using various techniques like molecular diagnostics, immunoassays, and clinical chemistry.

IVD plays a crucial role in healthcare by providing essential information for disease detection, monitoring, and management, thereby enabling informed clinical decisions and personalized treatment plans. It encompasses a wide range of applications, from routine blood tests to complex genetic testing.

Market Drivers

The growth of the In Vitro Diagnostics (IVD) Market is primarily driven by -

• Major factors such as the high prevalence of chronic and infectious diseases.
• The rapid development of diagnostic kits for the diagnosis of COVID-19 by key companies.
• The growing demand for IVD kits and reagents.

Recent News and Developments

• Allogene Therapeutics and Foresight Diagnostics have announced a strategic partnership to develop a minimal residual disease (MRD) in-vitro diagnostic (IVD) for use in Allogene's ALPHA3 trial, the first pivotal trial for first-line consolidation treatment of large B-cell lymphoma (LBCL). The IVD will utilize Foresight's ultra-sensitive PhasED-Seq ctDNA-MRD platform to identify patients with MRD after initial treatment, who may benefit from consolidation with Allogene's "off-the-shelf" allogeneic CAR T therapy, cema-cel.
• Pillar Biosciences, in collaboration with Illumina, has achieved FDA approval for its oncoReveal™ CDx pan-cancer solid tumor in vitro diagnostic (IVD) for general tumor profiling. This innovative IVD, validated for use on the Illumina MiSeq™ Dx System, offers a comprehensive panel covering 22 genes, enabling accurate and actionable testing for various solid cancer types. The approval signifies a significant advancement in precision medicine and improved healthcare outcomes globally.
• Veracyte, a global diagnostics company, has entered into a multi-year agreement with Illumina to develop and offer some of its high-performing molecular tests as decentralized in vitro diagnostic (IVD) tests on Illumina's NextSeq 550Dx next-generation sequencing (NGS) instrument. This agreement is part of Veracyte's expanded, multi-platform IVD approach, which will also include qPCR, and is designed to accelerate the company's ability to make its tests available to more patients globally.
• In January 2024, NeuMoDx CT/NG Assay by QIAGEN received FDA clearance for detecting Chlamydia trachomatis and Neisseria gonorrhoeae infections on its NeuMoDx 96 and 288 PCR systems. This assay improves the accessibility, affordability, and timeliness of STI testing in the U.S., complementing QIAGEN's broad menu of 16 CE-IVD tests available globally on these fully automated molecular diagnostics systems.
• QIAGEN's NeuMoDx HIV-1, HBV, and HCV quantitative assays received approval from India's CDSCO for blood-borne virus testing, marking the first BBV monitoring assays registered in the country. These assays, designed for the NeuMoDx PCR platform offer reliable viral load monitoring for clinical management of patients with HIV-1, HBV, and HCV infections. 

Segments Analysis

“The Molecular Diagnostics sector held the largest share of the market and is anticipated to experience robust growth throughout the forecast period”.

The market is segmented into clinical chemistry, molecular diagnostics, immuno diagnostics, hematology, and others. The Molecular Diagnostics segment accounted for the largest IVD market share of >35% in 2021 and is projected to grow at a healthy CAGR during the forecast period.

By Product Type

“The Reagents segment led the global market and is expected to grow steadily during the forecast period”.

The market is segmented into instruments, reagents, and others. There is an increasing need for reagents to meet the growing demand for diagnostics worldwide, for the diagnosis of COVID-19 infection. The Reagents segment accounted for the largest market share of >60% in 2021 and is projected to grow at a healthy CAGR during the forecast period.

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By End-User Type

“Diagnostic Laboratories hold the largest share of the In Vitro Diagnostics (IVD) market and are set to grow steadily”.

The market is segmented into diagnostic laboratories, hospitals and clinics, and others. The Diagnostic Laboratories segment accounted for the largest IVD market share of >35% in 2021 and is projected to grow at a healthy CAGR during the forecast period.

Major growth factors of the laboratory segment are the growing demand for affordable services, technological advancements, and a rapid increase in awareness about personalized medicines.

By Application Type

“The Infectious Disease segment dominates the market and is projected to grow steadily during the forecast period”.

The market is segmented into infectious disease, diabetes, cancer/oncology, cardiology, autoimmune disease, nephrology, and others. The Infectious Disease segment accounted for the largest market share of >55% in 2021 and is projected to grow at a healthy CAGR during the forecast period.

The IVDs facilitate the detection of microorganisms or disease-causing bacteria. HIV/AIDS, TB, hepatitis, and pneumonia are the most frequently occurring life-threatening illnesses.

Regional Analysis

“North America leads the market, expected to grow steadily. Europe and Asia-Pacific also promise significant growth opportunities in the forecast period”.

The market is broken down geographically into North America, Europe, Asia-Pacific, and the Rest of the World (RoW). In terms of regions, North America accounted for the largest market share of >40% in 2021 and is projected to grow at a healthy CAGR during the forecast period.

It is estimated to be the dominating region in the market over the forecast period on account of its well-established healthcare industry, rising prevalence of chronic diseases in the region, presence of some of the market's major players, and an increasing number of product launches. Europe and Asia-Pacific are also expected to offer substantial growth opportunities during the forecast period.

Key Players

The following are the key players in the Global In Vitro Diagnostics (IVD) Market (arranged alphabetically)

• Abbott Laboratories
• Arkray Inc.
• Becton, Dickinson, and Company
• Bio-Rad Laboratories, Inc.
• Biomerieux SA
• Danaher Corporation
• F. Hoffmann-La Roche Ltd.
• Siemens Healthcare GmbH
• Sysmex Corporation
• Thermo Fischer Scientific Inc.

Note: The above list does not necessarily include all the top players in the market.

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Report Features

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This report offers high-quality insights and is the outcome of a detailed research methodology comprising extensive secondary research, rigorous primary interviews with industry stakeholders, and validation and triangulation with Stratview Research’s internal database and statistical tools.

More than 1,000 authenticated secondary sources, such as company annual reports, fact books, press releases, journals, investor presentations, white papers, patents, and articles have been leveraged to gather the data.

We conducted more than 15 detailed primary interviews with the market players across the value chain in all four regions and with industry experts to obtain both qualitative and quantitative insights.

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