Report Overview

Global In-Vitro Diagnostics(IVD) market reached USD 82.3 billion in 2020 and is further projected to reach USD 102.4 billion by 2027, growing at a CAGR of 3.2% during 2021-2027 (forecast period).

Global In-Vitro Diagnostics(IVD) Market- Industry Trends & Forecast Report 2027

Global In-Vitro Diagnostics(IVD) market reached USD 82.3 billion in 2020 and is further projected to reach USD 102.4 billion by 2027, growing at a CAGR of 3.2% during 2021-2027 (forecast period).  The growth of the global IVD market has been positively impacted by the growing demand for POC (Point-of-Care) IVD devices. The newly launched IVD instruments/devices are efficient and easy to use, which has increased their adoption among healthcare professionals. Also, the demand for some over-the-counter diagnostics devices such as glucose monitoring kits available in the market to minimize hospital visits is highly preferred by the elderly. Since individuals prefer easy diagnostics tests that can be done in-home healthcare settings, the demand for such items went up during the COVID-19 pandemic. These factors, combined with the rising prevalence of chronic diseases, such as cancer and diabetes, increasing awareness about disease diagnosis, and growing levels of disposable income are likely to drive the growth of the industry.

Source: BlueWeave Consulting

Global IVD Market Forecast and Trends

Growth Drivers

Growing Prevalence of Chronic and Infectious Diseases in Geriatric Population

The growth of the IVD market would be positively influenced by the growing geriatric population in developed as well as emerging regions. With the exponential growth of the geriatric population globally, it is predicted that the incidence of age-related diseases will increase significantly. The number of older people living in the US in 2019 was 54 million according to the OECD. Huge and increasing geriatric populations also exist in other developed economies around the world. For example, in Japan, followed by Germany, the ratio of the elderly population to the active population is the largest. Japan's total population is about 126 million, with older people accounting for more than 28% of the population.

The geriatric population in Germany accounts for about 21% of the population of the country. The risk of contracting diseases rises proportionately with age. For example, approximately 80% of the elderly population in the US suffers from one chronic illness, according to the Centers for Disease Control and Prevention. And by 2030, 60% of people aged 65 years or older are expected to be living with more than one chronic condition, according to American Medical Association. In the age group of 60 years and beyond, pneumonia is one of the deadly infectious diseases affecting the elderly population.

Technological Advancements in IVD Tools

Demand for point-of-care (POC) devices is likely to increase with the advent of new technologies, such as biochips and nano-biotechnology, and the miniaturization of microfluidic instruments. These advanced methods have allowed easy access to Diagnostics point-of-care testing and deliver quick and valid test results, fueling the market for IVD tools. Subsequently, these factors are anticipated to drive market growth during the forecast period. For example, in June 2019, Abbott released the first rapid point-of-care test for the diagnosis of diabetes among the general population, the Afinion HbA1c Dx assay.

The growth of the market is likely to be driven by increased investment by key market players in the production of technologically advanced and rapid testing instruments. Recently, the market is driven by rapid and precise tests for the diagnosis of infectious diseases and other chronic diseases. Sekisui Diagnostics announced the introduction of the Silaris Influenza A& B Test for point-of-care (POC) for infectious disease diagnosis in March 2018. Such product launches would move the choice of patients from standard Diagnostics instruments to advanced IVD services.

Restraints

Unfavorable Reimbursement Scenario

A major factor restraining the growth of the IVD market is inadequate reimbursement. In the United States, a few years ago, Medicare updated its reimbursement mechanism for certain IVD studies, including molecular tests. Some of these tests for molecular pathology do not have codes for their own Healthcare Standard Procedure Coding System (HCPCS) and are billed using unlisted codes instead. In such cases, a reimbursement amount for their local jurisdictions is set up by Medicare Administrative Contractors (MACs). Approximately 75% of studies reported decreases in reimbursement rates as of January 2017, according to CMS. Some of those studies include genetic tests, five to 50 gene-targeted NGS review tables, and cancer tests. It is anticipated that these advances would have a negative effect on the US market for molecular and genetic testing, which would impede the growth of the IVD market.

Impact of COVID-19 on Global IVD Market

Major Tier I and II suppliers, such as Roche Diagnostics, Abbott Laboratories, and Siemens Healthineers, compose the IVD industry. Throughout the Asia-Pacific, Europe, North America, South America, and RoW, these suppliers have their manufacturing facilities spread across different countries. COVID-19 has also affected their companies. In order to survive market competition, companies began to implement rapid Diagnostics tests. The importance of these things has increased since the COVID-19 pandemic, as people prefer basic screening tests that can be carried out in-home health care settings. The positive influence of COVID-19 on the market for IVD products may be attributed to the high growth rate of kit and reagent products.

The advent of the pandemic has increased the need for reagents and kits that provide rapid diagnosis and help combat the harmful consequences of coronavirus. It is expected that the outbreak of COVID-19 would have a positive effect on the market being examined, as IVD requires testing of different biological samples. The diagnosis of infectious diseases, such as COVID-19, is supposed to support this growth factor. In controlling the COVID-19 pandemic, testing remains a critical step. As the number of COVID-19 cases are rising worldwide, the possibilities of enabling private laboratories to scale up research are being discussed by governments of different countries. The rapid launch of diagnostics kits by key players for the diagnosis of COVID-19 is also driving the market during the pandemic.

Global IVD Market- By Type

Based on type, the market has been segmented into- products (reagents & kits, instruments), and services (software, testing services). It is anticipated that the reagents segment would dominate the market during the forecast period. The growth of this segment can be attributed to the growing demand for rapid, accurate, and sensitive devices. Additionally, their large use in in-vitro diagnostics research, increased demand for self-testing and point-of-care products, and an increase in the number of reagent-related R&D initiatives are expected to support market development. Equipment and machines are referred to as analytical tools that simplify the diagnostics process and bring reagents and samples together. Commercial kits and robots are used for identifying and measuring infectious microorganisms, blood antigens, and viral load in polymerase chain reaction (PCR) laboratories.

Global IVD Market- By Application

Based on applications, the market is segmented into- oncology, infectious diseases, diabetes, cardiology, nephrology, autoimmune diseases, and drug testing/ pharmacogenomics. It is anticipated that the infectious disease segment would dominate the market during the forecast period. This is due to the growing prevalence of infectious diseases such as SARS-CoV-2, HIV, AIDS, tuberculosis, and pneumonia. Additionally, the segment is expected to be powered by a rise in the production of infectious disease detection assays by market players for IVD. In December 2018, for example, Siemens Healthineers received U.S.(Food and Drug Administration) FDA premarket approval for its 12 new assays for viral hepatitis and other diseases.

Source: BlueWeave Consulting

Global IVD Market- By Region

Based on region, the market has been segmented into North America, Europe, the Asia-Pacific, Latin America, and the Middle East and Africa. It is anticipated that North America will witness the largest revenue in the market due to the presence of numerous local market players in the region. Additionally, the growing demand for improved diagnostics devices are being propelled by the increasing prevalence of diseases and increased customer awareness. The market is projected to exhibit the highest growth over the forecast period in the Asia-Pacific, with a CAGR of 4.3%. because of the existence of emerging economies. Additionally, increased healthcare awareness and the growing demand for early diagnosis of patients in the area, along with a high prevalence of chronic diseases are likely to fuel the market.

Competitive Landscape

The presence of leading players in this market space is diminishing the opportunities for new entrants to the market as it is difficult to match the high capital requirements. Some of the key players include Abbott, Danaher, Siemens Healthineers AG, Roche Diagnostics, Sysmex Corporation, QIAGEN, Quidel Corporation, Quest Diagnostics, Agilent Technologies, and Bio-Rad Laboratories. The IVD market is price-sensitive, so players are competing intensively in terms of producing cost-effective and productive goods. In order to improve their production capability, product portfolio, and provide competitive differentiation, companies are increasingly participating in acquisitions, alliances, and mergers. Furthermore, companies are focused on securing consumer acceptance for novel drugs for the diagnosis of various infectious diseases.

Recent Developments

• On 11^th November 2020, Sysmex obtained marketing and manufacturing approval for a SARS-CoV-2 Antigen Detection Reagent. The launch of new diagnosis/treatment procedures for COVID-19 had a positive impact on the growth of the company.

• In September 2020, Roche Diagnostics released an antibody test for SARS-CoV-2. The launch of innovative products is driving the company’s growth significantly. Additionally, the introduction of antigen tests amid the pandemic favored the growth of the business.

Scope of Report

Scope of Report

By Type

• Product
  • Reagents & Kits
  • Instruments
• Service
  • Software
  • Testing Services

• By Technology

• Clinical Chemistry
• Immunoassay/ Immunochemistry
• Molecular Diagnostics
• Hematology
• Microbiology
• Coagulation & Hemostasis
• Urinalysis

• By Application

• Oncology
• Infectious Disease
• Diabetes
• Cardiology
• Nephrology
• Autoimmune disease
• Drug testing/ pharmacogenomics

• By End-User

• Hospitals
• Point of Care Testing
• Laboratories
• Academic Institutes

• By Region

• North America
• Europe
• The Asia-Pacific
• Latin America
• The Middle East and Africa