In-Vitro Diagnostics Market

Market Overview

The global in-vitro diagnostics market size was valued at USD 73 million in 2021. It is expected to reach USD 116 million by 2030, growing at a CAGR of 5.2% during the forecast period (2022–2030).

In-vitro diagnostics, also called IVD, are medical devices and reagents used to examine specimens such as blood, urine, stool, tissues, and other body fluids derived from the human body to diagnose diseases, conditions, and infections. The examinations may be carried out in a laboratory that is not affiliated with a hospital, in a laboratory affiliated with a hospital, or in point-of-care centers.

The polymerase chain reaction (PCR), microarray techniques, sequencing technology, and mass spectrometry are essential technologies incorporated into in vitro diagnostics. These technologies are used for the preparation of test samples. In addition, other methods, such as clinical chemistry, tissue diagnostics, immunodiagnostics, hematology, and others, are utilized in the process of performing an in vitro diagnosis. In clinical chemistry, for instance, several diagnostic procedures, such as liver panel tests, lipid profiles, thyroid function tests, and others, are carried out in the laboratory.

In addition, continuous IVD products, service designs, and technology innovations have encouraged physicians and researchers to shift their attention away from traditional diagnostic methods and personalized medicines. This shift has occurred due to a growing interest in personalized medicine. Natural time PCR detection systems, immunoassay systems, and other products are among those that can be utilized in the performance of a wide range of in vitro diagnostic tests that make use of a variety of technologies. The surge in the number of in vitro diagnostic tests performed, which can be attributed to the rise in chronic and infectious diseases, is the primary factor contributing to the expansion of the market for in vitro diagnostics.

A further significant factor contributing to the market expansion is the expanding population of older adults, who are more likely to suffer from immune system dysfunctions. Another contributing factor to expanding the market is the growing application of personalized medicine in treating various persistent diseases, such as cancer. The expansion of technological capabilities associated with in vitro diagnostic products, technologies, software, and services is another factor that contributes to the escalating demand in this market.

Market Dynamics

Market Driving Factors

Increasing Number of People Suffering from Chronic and Infectious Diseases

There has been an increase in chronic diseases like tuberculosis (TB), cancer, cardiovascular diseases, and diabetes. In addition, there has been a noticeable increase in patients afflicted with infectious diseases such as the digestive tract, the respiratory system, and STDs (sexually transmitted diseases). It is anticipated that the increase in the prevalence of these diseases will increase the demand for diagnostic devices, which drives the market for in vitro diagnostics.

Additionally, cardiovascular disease and diabetes increase the demand for in vitro diagnostic solutions. Diabetes and obesity are two diseases caused by genetics, lifestyle, and diet. According to the American Diabetes Association, the factors that are contributing to the diabetes epidemic are as follows: an increase in the prevalence of smoking, an increase in the consumption of alcohol and refined carbohydrates (white rice), a decrease in the amount of time spent engaging in physical activity, inadequate nutrition, and a westernized diet and way of life. Inflammation, cirrhosis of the liver, and hepatocellular carcinoma are all examples of liver pathologies found in patients with chronic liver disease. In addition, the production of proteins necessary for the coagulation process is the liver's responsibility.

On the other hand, patients with liver cirrhosis that has progressed to a decompensated state have significantly impaired synthetic function or cannot synthesize proteins. Because of this, this medical condition needs prompt medical attention and a diagnosis from a medical professional. As a result, the rise in the number of people who have diabetes is driving the market expansion.

Technological Advancements to Augment Market Growth Prospect

In the past, pregnancy tests were carried out in clinical settings; however, these tests can now be carried out in the comfort of one's own home by placing urine samples on test sticks. These examinations are precise, take significantly less time than others, and are simple. Similarly, checking the glucose level in one's blood can be done using point-of-care testing devices like glucometers. The results of an HIV test can be obtained in 20–40 minutes using a mouth swab fitted with a diagnostic device at home. In the same vein, the test for HIV can also be performed at home. These examinations were performed in clinical laboratories, and each patient's blood sample was drawn and analyzed.

Many advancements in conventional methods, such as digital pathology, have been introduced in recent years. These changes have been made possible by recent technological developments. It is cutting-edge technology that uses digital instruments in the diagnostic procedures carried out in pathology labs. The production of glass slides is an integral part of the digital pathology process. These glass slides are then transformed into digital pathology slides through digital pathology solutions. The market for IVD is seeing an increase in demand due to various advancements made in the conventional technologies of IVD, which are driving this demand. These developments all contribute to the expansion of the in vitro diagnostics market worldwide.

In addition, point-of-care (POC) testing, which is carried out outside of a laboratory setting, can deliver results in a short amount of time, which has contributed to an increase in the utilization of this method worldwide. These point-of-care tests, for instance, can be utilized quickly and without much difficulty by both patients and healthcare professionals. As a result, point-of-care technology has emerged as an essential component of the growing demand for the speedy diagnosis of chronic and infectious diseases.

Market Restraining Factors

Stringent Regulatory Policies and Practices to Restrict Market Growth

When it comes to treating patients, the healthcare industry uses a wide variety of different kinds of products. In addition, the marketing of these products is governed by several stringent guidelines established by several other regulatory bodies. This is done to ensure that these medical products continue to be of a high standard of both safety and quality. In the same vein, in vitro diagnostics are subject to oversight from various governmental organizations worldwide. As an illustration, the Food and Drug Administration (FDA) is in charge of regulating the precision of in vitro diagnostic tests. In addition, before a product is released onto the market, it is subject to regulation to ensure that it is effective in diagnosing a specific condition.

Additionally, in vitro diagnostics are subject to regulation based on the risk associated with using them. For instance, risk-based regulation categorizes in vitro diagnostics into three classes. Class I denotes the lowest potential for error associated with the tests' results (such as a cholesterol test). Similarly, in vitro diagnostics belonging to class II carry a low to moderate risk, including pregnancy tests. On the other hand, tests belonging to class III are considered to carry the most significant potential threat if they are inaccurate.

Key Market Opportunities

Significant Growth as a Result of Potential Outsourcing to Boost Market Opportunities

IVD tests offer less complicated methods for testing a sample, as they are carried out away from the body of the patient. Currently, IVD tests are carried out in public hospitals; however, the role of private laboratories has increased because hospitals increasingly contract out their pathology work to private laboratories. Outsourcing these tests to laboratories is a current trend in Germany, and it is anticipated that this trend will continue into the foreseeable future. Private labs and international laboratory chains are introducing new regulations in their emerging markets to expand their networks in various regions. In the in vitro diagnostics market, there are a lot of opportunities available for private laboratories because many hospitals are now sending their IVD testing to be performed in private laboratories.

Regional Analysis

The global in-vitro diagnostics market has been studied across North America, Europe, Asia-Pacific, and LAMEA.

North America is the highest revenue contributor, growing with a CAGR of 3.5% during the forecast period. This is partly because of a large patient population and the early adoption of advanced IVD techniques for disease diagnosis. A large aging population in North America has led to steady growth in the market. Growth in infectious and chronic diseases is a significant factor in the region's market. As a result, rising cancer rates are expected to fuel the expansion of this industry in the region. In addition, the market's growth is aided by significant efforts to raise awareness about the importance of early cancer detection.

Asia-Pacific is the second-largest contributor to the market and is estimated to reach around USD 36,799.92 million at a CAGR of 8.1% during the forecast period. An increasing number of elderly residents in the area is an important growth factor for the market. Chronic diseases like cancer are becoming more common among the elderly, which explains the rise in the number of people in their golden years—the market for in vitro diagnostics. In addition, rising healthcare costs and advances in cancer screening technology are expected to boost the market over the next few years.

Europe is the third-largest contributor to the market. The market expansion in Europe is primarily driven by an increase in the region's elderly population, a high prevalence of chronic diseases, and an uptick in the amount of money invested in hospital infrastructure. Because of how easy they are to use and how convenient they are, point-of-care testing has become very popular in Europe.

It is anticipated that healthcare expenditure will increase throughout the forecast period. LAMEA is an emerging market, creating lucrative growth opportunities for in-vitro diagnostics market players. It is expected that the region will experience an increase in demand for in-vitro diagnostics due partly to the high prevalence of infectious diseases.

Segmental Analysis

The global in-vitro diagnostics market has been divided into product and service, technique, application, and end-user.

By Product

Based on the Product, the global in-vitro diagnostics market has been categorized into reagents, instruments, and services & software.

The reagents segment is the highest contributor to the market, growing at a CAGR of 4.3% during the forecast period. Reagents are specialized chemicals that are used in in-vitro diagnostics. These chemicals can react with specific substances in a patient's sample, such as urine, blood, or tissue. In-vitro diagnostics are used to diagnose medical conditions. These reagents are essential to every in vitro diagnostic test and are consumed during the procedure. As a result, there is a demand for the consistent repurchase of these reagents, which contributes to the expansion of the market. The market's growth is also driven by additional factors, such as the concentration of key players in introducing new reagents.

The second-largest segment is the instruments segment which is expected to reach around USD 38464.53 million by 2030 at a CAGR of 6.8% during the forecast period. As a result of their ability to streamline processes while simultaneously improving precision and dependability in output, fully automated instruments are experiencing a surge in demand on the market at present. Opportunities for the in-vitro diagnostics market are created by a variety of factors, including newly emerging technologies, rapidly expanding markets, and various initiatives undertaken by the government.

By Technique

Based on the technique, the global in-vitro diagnostics market has been categorized into immunodiagnostics, hematology, molecular diagnostics, tissue diagnostics, and clinical chemistry.

The clinical chemistry segment is the highest contributor to the in-vitro diagnostics market, growing at a CAGR of 4.0% during the forecast period. Clinical chemistry, also known as clinical pathology or biochemistry, is the study of the body's biochemical mechanisms related to a disease. This study is conducted primarily by analyzing body fluids like urine or blood. Other names for clinical chemistry include clinical pathology and clinical biochemistry. Because clinical chemistry tests are used so frequently for various medical conditions, this particular subsegment of the in-vitro diagnostics market held the largest share.

The immunodiagnostics segment is the second-largest segment and is estimated to grow at a CAGR of 6.6% during the forecast period. This market is very lucrative because it is led by numerous point-of-care and rapid tests that are based on immunochemistry. Some examples of these tests include calprotectin and immunochemical occult blood tests. Several factors drive this method's expansion, including an increase in the prevalence of chronic diseases, a decrease in the price of tests currently available on the market, widespread awareness of the importance of proper medical care, and so on. The need for immunodiagnostics is ripe for numerous opportunities thanks to the advanced research in the pipeline and technologically improved diagnostic devices.

Due to the rising demand for molecular detection in infectious disorders, the molecular diagnostics segment retained a sizable proportion in 2022. The SARS-CoV-2 virus, which causes COVID-19, was identified using Real-Time Quantitative Reverse Transcription P.C. as the COVID-19 epidemic spread over the globe (qRT-PCR). In addition, the Japanese medical regulatory authorities granted Sysmex Corporation permission to produce and distribute the Detect Amp SARS-CoV-2 RT-PCR kit in April 2021. A SARS coronavirus nucleic acid kit (SARS-CoV-2) is used to identify the RNA of the new coronavirus.

By Application

Based on the application, the global in-vitro diagnostics market has been categorized into infectious diseases, cancer, cardiac diseases, immune system disorders, nephrological diseases, and gastrointestinal diseases.

The Infectious diseases segment is the highest contributor to the market, growing at a CAGR of 6.7% during the forecast period. This increase can be attributed to the rising incidence rates of tuberculosis and sexually transmitted diseases (STDs). The cancer segment is the second-largest and is estimated to grow at a CAGR of 6.1% by 2030. This expansion is because cancer has such a high incidence rate all over the world.

By End-User Type

Based on the End-user type, the global in-vitro diagnostics market has been categorized into standalone laboratories, hospitals, academics & medical schools, and point-of-care.

The standalone laboratories segment is the highest contributor to the market, growing at a CAGR of 4.3% during the forecast period. Independent laboratories, also known as medical facilities that perform various in vitro tests, are the definition of a standalone laboratory. Because of this, there is a significant increase in demand for these diagnostic services in these medical facilities, contributing to the market growth for Standalone laboratories.

The Hospitals segment is the second-largest segment and is estimated to grow at a CAGR of 5.4% during the forecast period. Such medical facilities treat patients afflicted with various medical conditions, all of which call for using in vitro diagnostics to arrive at an accurate diagnosis. As a result, hospitals typically consist of either an in-house laboratory or an attached laboratory capable of performing various in vitro diagnostic tests. The market will be driven forward by these factors.

In 2022, the point-of-care test location market had a moderate revenue share of over 25%. Due to the increased need for early detection of diseases near patients to enable quicker decision-making, point-of-care tests, and devices are in higher demand. Small, portable, quick, and simple-to-use instruments are being introduced by manufacturers in response to this trend, making it simpler to utilize these instruments outside of laboratories. For instance, QuantuMDx announced the introduction of the Q-POC system in July 2021. This system provides quick PoC molecular diagnostics that are useful for settings including ICUs, clinics, and birthing facilities.

Recent Developments

• In February 2023, Abbott announced two approvals today as part of its expanding line of electrophysiological products on the global in-vitro diagnostics market. The business's TactiFlexTM Ablation Catheter, Sensor EnabledTM, the only ablation catheter in the world with a flexible tip and contact force sensing, has been granted CE Mark1 to treat persons with irregular heart rhythms such as atrial fibrillation (AFib). The U.S. Food and Drug Administration recently granted an additional indication2 for using Abbott's FlexAbilityTM Ablation Catheter, Sensor EnabledTM, to treat patients with complicated cardiac conditions (FDA).
• In February 2023, a High-Throughput Single-Cell Multiomics Platform was Introduced by B.D. to Widen the Scope of Scientific Discovery.
• In January 2023, MAESTRIA™is introduced by bioMérieux, a leader in in vitro diagnostics. This new generation of middleware for the microbiology laboratory intends to deliver a central software solution for the workflow management of all regular tasks.