In Vitro Diagnostics Market Size, Competitive Landscape and Market Forecast - 2029

SKU: DMCD1058 | Last Updated On: Jun 23 2022 | Available Formats

> Global In Vitro Diagnostics Market Expected to reach a high CAGR of 5.8% By 2029: DataM Intelligence

Global In-Vitro Diagnostics Market is segmented by Technique (Immunoassays, POC diagnostics, Molecular diagnostics, and Others), By Products (Instruments, Reagents, Data Management Systems), By Application (Infectious Diseases, Diabetes, Cancer/Oncology, Cardiology, and Others), By End User (Laboratories, Hospitals, Academics and Others), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis,  2022-2029


Market Overview

The Global "In-Vitro Diagnostics Market" is expected to grow at a CAGR of 5.8% during the forecast period ( 2022-2029).

  • in vitro diagnostics are the tests done on samples such as blood or tissue that have been taken from the human body. These tests can detect diseases or other conditions, and are also used to monitor a person’s overall health to help cure, treat, or prevent diseases. IVD tests are also being increasingly used in precision medicine to identify patients who are likely to benefit from specific medical interventions or drug therapies.

Market Growth

  • The Global in-vitro diagnostics market is estimated to grow at a CAGR of 6.2% in the forecast period 2019-2026.
  • The market is driven by the increasing prevalence of various diseases and rising awareness for diagnosis among consumers. The growth in the market is further supported by developments such as portable and point-of-care testing equipment.
  • Increasing price pressures and low budgets, and low reimbursements are the market restraints hampering the growth of the market.
  • By Application, Infectious diseases have the largest share with a market share of approximately 40% of the global market, followed by oncology and diabetes. By End User, hospitals have the predominant share of almost 50% of the global IVD market.
  • By Geography, North America accounted for the largest segment of the global IVD market followed by Europe with 31% of the global market in 2018.
  • New product launches, partnerships, and acquisitions are a few of the major strategies adopted by the leading companies in the industry.

Market Dynamics

  • Rising demand for personalized medicine, increasing development of point of care devices and rising technological advancements, and rise in the prevalence of chronic and acute diseases across the globe are the key factors driving the market.
  • Personalized medicines or treatments improve the access and clinical development of various diagnostic procedures. Personalized medicine is still relatively in the nascent stages as compared to conventional medical treatments.
  • However various companies are increasingly offering personalized medicine. A cancer diagnosis is a prominent field for personalized medicines.
  • Genome sequencing of a tumor can be a useful tool, but cancer cells have the ability to mutate and change their genome quickly executing an ineffective treatment. Which lead doctors to revert to more traditional treatment systems.
  • Companies such as Sartorius that have expertise in the production of specific, varied, and custom microporous membranes are placed for continued growth due to their swiftness in personalized medicine.
  • Automation and implementation of multiple processes are leading to new product developments. Manufacturers are aiming to automate molecular processes to the same level of automation achieved for clinical chemistry. Key Companies such as BD Diagnostics, Roche Diagnostics, and Hologic (Gen-Probe) have developed and introduced automated molecular platforms that integrate both analytical and pre-analytical processes.
  • Automation in diagnostics has led to quicker analysis and few errors in less time and also reduced the requirement of several lab scientists. In the past, in-vitro diagnostics were only available in the clinical setting. However, this trend is changing with the increasing development of advanced devices such as home care tests and point of care systems, which offer instant results. More advanced diagnostics were developed, which require only a single drop of blood, urine, or saliva to perform diagnosis and interpret diseases within minutes.
  • Increasing price pressures and low budgets, and lower reimbursements are the market restraints that hamper the growth of the market. Poor reimbursement policies for diagnostic testing are hampering the growth of the IVD market Globally. Reimbursement policies for diagnostic testing are not the same across geographies and are moving in a downward trend.
  • Hospitals and diagnostic laboratories are forced to reduce their expenditure on IVD instruments to have even or profitable revenue. Lowered reimbursement and payment for a few instruments like SMBG in European countries like Germany and the UK have reduced the SMBG segment growth. Reduction of reimbursement by Medicare for IVD instruments is limiting the demand for certain diagnostic testing across all segments.

Market Segmentation

  • Based on technique, the global market for in-vitro diagnostics is broadly segmented as immunoassays, POC diagnostics, molecular diagnostics, hematology, tissue diagnostics, microbiology, self-blood-glucose monitoring, and others. By-products, the global market for in-vitro diagnostics is classified into instruments, reagents, and data management systems.
  • Based on application, the global market for in-vitro diagnostics is divided into infectious diseases, diabetes, cancer/oncology, cardiology, autoimmune diseases, nephrology, drug testing, and others. The global Infection diseases diagnostics market was worth US$ 24.94 billion in 2018 and is expected to reach US$ YY billion by 2026 at a CAGR of YY% during the forecast period 2019-2026. The infection diseases diagnostics segment occupied the largest market share in 2018. Infectious diseases are disorders caused by organisms such as bacteria, viruses, fungi, or parasites. Infectious diseases include HIV, Hepatitis, and other diseases. HIV is considered one of the major global public health issues. In 2017, 940,000 people died from HIV-related causes globally. According to the World health organization (WHO), the African region is the most affected region, with an HIV prevalence of 25.7 million in 2017. The African region also accounts for over two-thirds of the global total of new HIV infections. This will grow the in vitro diagnosis market in Africa.
  • The increase in approval of in vitro devices will drive the global in-vitro diagnosis market.
  • For instance, In October 2018, South Korean biotech company Bioneer Corp. received the CE-IVD mark for its quantity analysis kit for human immunodeficiency virus-1 from Europe.
  • Based on end-user, the global market for in-vitro diagnostics is categorized as laboratories, hospitals, academics, and others. Among all end-users, hospitals and laboratories occupied a majority of the market share with 47% and 26% respectively in 2018. The IVD market in the hospital's segment was valued at US$ 27.59 billion in 2018 and is estimated to reach US$ YY billion by 2026 with a CAGR of YY% during the forecast period. Hospitals and diagnostic laboratory services are an integral part of disease diagnosis, treatment, monitoring response to treatment, disease surveillance programs, and clinical research. The laboratories segment accounted for the second-largest share in the market. The number of patients is very high in hospitals and to reduce the turnaround time, cost, and manpower the hospitals refer the few complicated tests to the reference laboratories who can manage the high-test volume with advanced instruments and specific laboratory technicians.

Geographical Analysis

  • The global in-vitro diagnostics market is segmented into North America, Europe, Asia Pacific, South America, and Middle East & Africa.
  • North America's in-vitro diagnostics market is estimated to reach US$ YY billion by 2026 from the initial value of US$ 21.54 billion in 2018. The market is growing at a CAGR of YY% during the forecast period from 2018 to 2026. North America is one of the major regions for the IVD Diagnostics market.
  • The US holds the majority of share with 91% of the total regional market followed by Canada and Mexico with YY% and YY% respectively. The IVD instruments market in North America is witnessing significant growth, primarily because of the growing aging population as well as the high prevalence of chronic and infectious diseases. Additionally, the increased awareness among the population has resulted in most people in the US having regular tests and check-ups, which has increased the sales of IVD products in the country.
  • Europe's in-vitro diagnostics market is estimated to reach US$ YY billion by 2026 from the initial value of US$ 17.80 billion in 2018. The market is likely to grow at a CAGR of YY% during the forecast period. Europe is one of the major regions for the IVD market. Germany is one of the largest markets for the IVD Diagnostics market, and it is in a leading position in the European region. Germany holds the majority of share with almost one-fifth of the total regional market followed by Italy and France.
  • Globally, the country accounted for approximately 6% of the total IVD Diagnostics Market in 2018. Germany has the biggest market share with sales of almost EUR 1.6 billion, accounting for 24% of the total European market in 2013. Increasing government support and funding for the development of patient monitoring systems is one of the key drivers of the market in this country. In 2016, the German IVD-Market grew only about +0.3%. This is a reduction of the growth rate compared to 2015 (+1.0%). The market development differed strongly between the various segments. Laboratory diagnostics (reagents and instruments) increased by +1.9%, which is a stronger growth rate compared to 2015 (+1.5%) and 2014 (+0.8%).
  • Among the Middle East and Africa, Saudi Arabia IVD market in 2018 is estimated to be around USD YY million, for the year 2018 and is expected to grow at a CAGR of about 7.8% over the forecast period. Also Africa IVD market would reach a market size of 1.9X by 2026. Furthermore, China is the fastest-growing market among all the Asia Pacific countries.

Competitive Analysis

  • Some of the key market players are BioMérieux, Danaher Corporation, Roche Diagnostics, Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., Abbott Laboratories, Bayer AG, Arkray, Inc., Sysmex Corporation, Johnson & Johnson, and Siemens AG.
  • Danaher and Abbott Laboratories are estimated to have the same or slightly higher market share in 2022 while the rest of the top eight companies will see a slight decline in market share. Siemens will have the highest decline of the market share of around two followed by Roche with 1%.
  • The companies are heavily investing in the market to develop new products and are collaborating and acquiring other companies which help in increasing their market share and will also strengthen the R & D.
  • New product launches, partnerships, and acquisitions are a few of the major strategies adopted by the leading companies in the industry.
  • For instance, on May 03, 2018, bioMérieux launched ENDOZYME II GO, a new endotoxin test in the bioMérieux ENDONEXT range of recombinant horseshoe crab Factor C (RFC) assays. This new assay results from the combined expertise of bioMérieux in microbiology and Hyglos GmbH in endotoxin detection enables endotoxin testing in pharmaceutical grade water, injectable drugs, and other pharmaceutical products.

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