In-vitro Diagnostics Market Size By Product Type (Reagents & Kits, Instruments), By Test Type (Clinical Chemistry, Immunoassay/Immunochemistry, Molecular Diagnostics, Hematology, Urinalysis), By Application (Oncology, Infectious Diseases, Diabetes, Cardiology, Nephrology, Autoimmune Diseases, Drug Testing/Pharmacogenomics), By End-user (Hospitals, Diagnostic Laboratories, Academic & Research Institutes), Industry Analysis Report, Regional Outlook, Growth Potential, Competitive Market Share & Forecast, 2022 - 2030

Industry Overview

In-vitro Diagnostics Market size surpassed USD 91.6 billion in 2021 and is expected to witness 3.1% CAGR from 2022 to 2030. In-vitro diagnostics are tests done on blood sample or tissue sample taken from the human body. This type of diagnostics is mainly performed for detecting infections, diseases & conditions. Nowadays, in-vitro diagnostics are applicable in precise medicine to identify patients with specific treatments or therapies. In-vitro diagnostics tests are mainly done in laboratories and healthcare facilities with the availability of skilled professionals and infrastructural development.
 

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Surging number of pathology labs & services equipped with advanced diagnostics machines is expected to drive market growth over the forthcoming years. The impact of COVID-19 on the in-vitro diagnostics market is observed to be positive. As COVID-19 pandemic increased, the demand for quick and accurate testing options like RT-PCR also increased drastically. Thus, new diagnostic technologies such as next-generation sequencing and CRISPR are introduced in the market. For instance, in November 2020, U.S. Food and Drug Administration (FDA) granted emergency approval for two CRISPR-based diagnostic tests from Mammoth Biosciences and Sherlock Biosciences for COVID-19 testing.
 

In-vitro diagnostics are mainly used to detect and analyze human samples such as saliva and blood by measuring concentration of specific substances or by detecting presence or absence of set of markers such as an immune response to infection or genetic mutation. Therefore, to monitor a person’s overall health in-vitro diagnostics tests are preferred to help cure and treat diseases.
 

Rising prevalence of infectious and chronic diseases across the globe is expected to accelerate the overall market statistics

Increase in-vitro diagnostics is due to increasing chronic and infectious diseases throughout the world. These diseases include heart disease, cancer, diabetes, respiratory diseases, Alzheimer’s disease, kidney diseases, malaria, jaundice, dengue, tuberculosis, and others. For instance, according to the Centers for Disease Control and Prevention (CDC), in 2020, around 5.8 million Americans are suffering with Alzheimer’s disease. Moreover, in 2020, across the globe, 241 million cases of malaria were detected. Every year, about 2,000 cases of malaria are diagnosed in the U.S. Moreover, adoption of advanced diagnostic machine in pathological labs and services will boost the demand for in-vitro diagnostics proving beneficial for the overall market progression.
 

In-vitro diagnostics is widely applicable for point-of-care testing enabling healthcare providers to perform testing in outpatient clinics, nursing homes, care centers, or at patient’s home. This has brought fundamental restructuring of delivering patient care in hospitals or clinics. Furthermore, with rising cases of COVID-19 across the globe, the demand for point of care testing has increased drastically. The point of care testing for COVID-19 detection includes Nucleic Acid Amplification Tests (NAATs), antigen, or antibody tests. Therefore, rising adoption of point of care testing for various diseases will have a positive impact on the market demand.
 

The growing demand of instruments will augment the overall market progress

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Based on product type, the in-vitro diagnostics market is bifurcated into reagents & kits and instruments. The instruments segment is expected to witness around 2.4% CAGR through 2030. This is attributed to the adoption of new instruments with advanced technology. For instance, in August 2018, Illumina received approval from the China National Drug Administration for the launch of MiSeq Dx Sequencing System in China. The clinical laboratories can develop and perform next generation sequencing (NGS) tests for gene testing to determine the order of nucleotides in entire genome or targeted regions of DNA or RNA. Thus, patients and various medical institutions have increased access to next generation sequencing technology. Hence, with advanced technologies the demand of new instruments surges, thereby propelling the overall market expansion.
 

Increasing demand for advanced molecular diagnostics testing will propel the market statistics

Based on test type, the in-vitro diagnostics market is classified into clinical chemistry, immunoassay/immunochemistry, molecular diagnostics, hematology, urinalysis, and others. The molecular diagnostics segment accounted for around USD 22.7 billion market value in 2021. This is attributed to the increasing demand in diagnosis of infectious and chronic diseases such as COVID-19 and heart diseases. For instance, according to the World Health Organization (WHO), in December 2021, 2,714, 352 new confirmed cases of COVID-19 were recorded in the U.S. In addition, according to the Centers for Disease Control and Prevention (CDC)’s 2021 report, every year, around 659,000 people in the U.S. die due to heart disease. Thus, to cure and treat these diseases, personalized medicines are being adopted in the market. Such factors will propel the global market outlook over the forecast period.
 

Increasing application of in-vitro diagnostics for oncology will drive the market expansion

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On the basis of application, the in-vitro diagnostics market is segmented into oncology, infectious diseases, cardiology, nephrology, diabetes, autoimmune disease, drug testing/pharmacogenomics, and others. Among them, the cardiology segment accounted for around USD 9.8 billion in 2021. The high segmental growth is attributed to rising mortality rate due to cardiovascular diseases. For instance, according to the American Heart Association, in 2017, 868,662 people died due to various forms of cardiovascular diseases in the U.S. Moreover, in 2018, coronary heart disease (42.1%) was one of the leading causes of death along with high blood pressure (11%), stroke (17%), arteries diseases (2.9%), and heart failure (9.6%). Therefore, for detection and treatment of these cardiovascular diseases, in-vitro diagnostics methods are highly preferred by the doctors. Thus, rising number of cardiovascular diseases will accelerate the global industry landscape. Similarly, major market players are focusing to introduce new in-vitro diagnostic methods in the industry with higher prevalence of infectious diseases, thus proving beneficial for the overall market expansion.
 

Hospitals segment is expected to showcase exponential market demand

Based on end-user, the market is categorized into hospitals, diagnostic laboratories, academic & research institutes, and others. Among these, hospital segment accounted for over USD 35.9 billion in 2021, owing to rising adoption of advanced diagnostic machines in hospitals. With growing technologies, new inventions of smart devices and instruments has enabled easy detection of pathogens with improved outcomes. Additionally, increasing patient visits in hospitals for health-related issues, disease detection and testing leads to increased usage of in-vitro diagnostics in hospitals. The aforementioned factors will augment the market progression.
 

Growing adoption of point of care testing in North America will prove favorable for the market expansion

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North America in-vitro diagnostics industry is poised to grow at 3% CAGR during the projected timeline. High regional growth is attributed to growing adoption of point of care testing. Point of care testing is mainly conducted through rapid diagnostic tests such as nucleic acid amplification technology, antigen, or antibody tests. Recently, during COVID-19, rapid diagnostic testing increased to diagnose and detect SARS-CoV-2 infection by various point of care testing methods. Additionally, key industry players are focusing on developing effective and accurate instruments, reagents and assays for in-vitro diagnostic testing method that will further accelerate the regional market outlook.
 

Innovative approach by key business participants will surge the market growth

Some of the key market players operating in the in-vitro diagnostics industry includes Abbott, F Hoffmann-La Roche AG, Qiagen, Ortho Clinical Diagnostics, bioMerieux, and others. These market participants are formulating various growth strategies with continued innovations and technology improvements to sustain market competition in the in-vitro diagnostics market.
 

Some of the recent market developments:

• In June 2022, Becton, Dickinson and Company and CerTest Biotec announced collaboration to develop a diagnostics test to detect Monkeypox virus. This will allow the company to expand its product portfolio and advance its research activities.
   
• In April 2020, Abbott launched COVID-19 antibody detection test kit. This helped the company increase its product portfolio and expand its customer base.
   

The in-vitro diagnostics market report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2017 to 2030, for the following segments:

By Product Type

• Reagents & Kits
• Instruments

By Test Type

• Clinical Chemistry
• Immunoassay/Immunochemistry
• Molecular Diagnostics
• Hematology
• Urinalysis
• Others

By Application

• Oncology
• Infectious diseases
• Diabetes
• Cardiology
• Nephrology
• Autoimmune diseases
• Drug testing/pharmacogenomics
• Others

By End-user

• Hospitals
• Diagnostic laboratories
• Academic & research institutes
• Others

The above information is provided for the following regions and countries:

• North America 
  • U.S.
  • Canada
• Europe 
  • Germany
  • UK
  • France
  • Italy
  • Spain
• Asia Pacific 
  • Japan
  • China
  • India
  • Australia
  • South Korea
• Latin America 
  • Brazil
  • Mexico
• Middle East & Africa 
  • South Africa
  • Saudi Arabia
  • UAE