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Infectious Disease In-vitro Diagnostics Market

Market Study on Infectious Disease In-vitro Diagnostics: Emergence of New Infectious Diseases Opens New Revenue Gate for the Market

Infectious Disease In-vitro Diagnostics Market Segmentation By Product Type - Instruments | Reagents | Services

Infectious Disease In-Vitro Diagnostics Market Outlook (2022-2032)

The global Infectious Disease In-Vitro Diagnostics Market was valued at around US$ 58.7 Bn in 2021. With a projected CAGR of 4.4% for the next ten years, the market is likely to reach a valuation of nearly US$ 93.9 Bn by the end of 2032. A window of opportunity has emerged for the early identification and control of infectious diseases such as severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), Ebola, chikungunya, avian flu, swine flu, and Zika due to their epidemiological burden. This has significant potential to boost Infectious Disease in In-Vitro Diagnostics.

Report Attributes


Infectious Disease In-Vitro Diagnostics Market Size (2021A)

US$ 58.7 Bn

Estimated Market Value (2022E)

US$ 61.2 Bn

Forecasted Market Value (2032F)

US$ 93.9 Bn

Global Market Growth Rate (2022-2032)

4.4% CAGR

United States Growth Rate (2022-2032)

4.1% CAGR

Key Companies Covered

  • Abbott Laboratories
  • Thermo Fisher Scientific Inc.
  • F. Hoffmann-La Roche Ltd.
  • bioMérieux SA
  • Siemens Healthineers AG
  • Danaher Corporation
  • Becton Dickinson and Company

Persistence Market Research’ analysis reveals that in 2022 revenue through the Infectious Disease In-Vitro Diagnostics Market is estimated at US$ 61.2 Bn. The increased demand for early disease detection, the shift in emphasis from centralized laboratories to decentralized POC testing, and the frequency of infectious diseases around the world all contribute to the market's growth.

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Sales Analysis of Infectious Disease In-Vitro Diagnostics Market from 2017 to 2021 Vs Market Outlook for 2022 to 2032

The global market for the Infectious Disease In-Vitro Diagnostics Market expanded at a CAGR of 4.4% over the last four years (2017-2021). The rising burden of infectious diseases across the globe has increased the demand for infectious disease diagnostics products. Around 70% of medical decisions are based on information contained in electronic medical records (IVDs), which is why they are an essential component of patient care. The majority of the IVD market is concentrated in developed countries, but the United States, Europe, and Japan account for over 80% of all global sales.

The United States will continue to be the largest shareholder of the Infectious Disease In-Vitro Diagnostics Market throughout the analysis period accounting for over US$ 9.4 Bn absolute dollar opportunity in the coming 10-year period.

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How are key drivers going to affect the Infectious Disease In-Vitro Diagnostics Market?

Around 10% of the world's GDP is constituted of global healthcare spending, which has been steadily rising in recent years as a result of the population's rising healthcare needs. Over 60% of clinical decisions are influenced by In-Vitro Diagnostics, which is important to the healthcare sector. However, it barely represents 2% of all healthcare costs. This suggests that there is a huge opportunity for in-vitro diagnostics that are affordable. This has been one of the key market drivers.

Government support is a key driver of growth for the In-Vitro Diagnostics market in the near future because increased funding from the government enables research institutions to create quick analysis systems that are helpful for diagnosing a variety of diseases using various samples. For instance, the European Union's "recovery plan" will invest over US$ 250 Bn by the end of 2026.

In-Vitro Diagnostics technologies were only applied in clinical labs in the past. The majority of clinical tests in the fields of chemistry, immunochemistry, and hematology are still carried out utilizing high throughput equipment with intricate automation. Where the patients are located, point of care (POC) testing is implemented and it is expanding quickly. The big manufacturing firms are concentrating on releasing quick, portable, easy-to-use tools that are affordable and suitable for usage outside of laboratories. The delocalization of the diagnostics offers, including auto-diagnostics and home diagnostics, is anticipated to be improved by this need.

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What was the impact of Covid-19 on the Infectious Disease In-Vitro Diagnostics Market?

The diagnosis of COVID-19 has become dependent on in-vitro testing. This is demonstrated by the vast array of test kits that have been launched globally for the detection of Covid-19. All of these tests have received permission under an emergency use authorization, which exempts them from usual FDA review requirements (EUA). The majority of market participants’ attention has been focused on the creation of quick detection test kits for Covid-19. For instance, the primary In-Vitro Diagnostics assay for Covid-19 relies on a real-time reverse transcriptase-polymerase chain reaction (RT-PCR), which can identify the virus in just a few hours. The improved simplicity of products during Covid-19 has accelerated the market growth.

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What are the restraints to the growth of the Infectious Disease In-Vitro Diagnostics Market?

The diagnostics industries are more susceptible to changes in the macroeconomic cycle than other sectors of the healthcare system, it is crucial to take into account how the overall economic environment will affect the diagnostic market. The ability of the sector to generate income comes to about 20–25% through exposure to industrial (as opposed to clinical) end markets like food testing, which frequently have higher macroeconomic vulnerability.

Different regional areas have different regulations governing the production and sale of in-vitro diagnostic instruments. For instance, the European Commission's Directive 98/79/EC lays out regulatory principles for Europe. Some IVDs may take a while to receive regulatory approval, and any R&D expenditures may be in vain if the regulatory authority rejects them. This is impeding the market expansion for in vitro diagnostics for infectious disorders.

The reimbursement policies have been more stringent. The restrictions are severe, particularly for the creators of novel diagnostics whose coverage evaluation procedure is opaque and changes depending on the payer. Developers of novel diagnostics lack a clear understanding of what level of proof is required for reimbursement. This has introduced inefficiencies in the development of novel diagnostics and an increase in R&D costs. This has been one of the key restraints to the growth of the infectious disease in-vitro diagnostics market.

Region-wise Insights

How does the Infectious Disease In-Vitro Diagnostics Market in North America have a dominant share?

North America is anticipated to dominate the in-vitro diagnostics market for infectious diseases. Under its Rapid Acceleration of Diagnostics initiative, the National Institutes of Health contributed US$ 248.7 Mn to help scale up the production of diagnostic tests. The market for in-vitro diagnostics for infectious diseases is becoming more competitive due to the introduction of new innovative products, which makes the dynamics of the industry and the product selection process significantly difficult.

Country-wise Insights

U.S. Infectious Disease In-Vitro Diagnostics Market Analysis

The United States will account for over 28.4 Bn of the global Infectious Disease In-Vitro Diagnostics Market by 2032. The market was projected to develop at a CAGR of 4.1% from 2017 to 2021. Less than 50% of the world's in-vitro diagnostics business is dominated by the United States, while POC diagnostics are expected to account for 12% of the country's overall IVD market.

Decentralization of the pathology market, or the movement of some types of testing away from larger reference labs and toward POC, is a significant theme in the United States. Depending on the indicator, this has happened to certain degrees. Many hospitals are attempting to consolidate their lab operations or volumes in order to take advantage of economies of scale as a result of cost pressures throughout the healthcare system in the United States. To the extent that new diagnostics can avoid the necessity of using larger reference labs in favor of doing so by using hospital labs, the United States may be able to benefit from this trend of consolidation.

U.K. Infectious Disease In-Vitro Diagnostics Market Analysis

The market in the U.K. is expected to reach a valuation of US$ 4.7 Bn by 2032. With a CAGR of 4.7% during 2022 – 2032, the market in the country is expected to garner an absolute dollar opportunity of US$ 1.7 Bn.

Japan Infectious Disease In-Vitro Diagnostics Market Analysis

The market in Japan is expected to be valued at US$ 5 Bn. The market during 2022 – 2032 is expected to grow at a CAGR of 5.4% with an absolute dollar opportunity of 2 Bn.

Category-wise Insights

Why are the Reagents dominating the product category of the Infectious Disease In-Vitro Diagnostics Market?

The growth through the reagents expanded at a CAGR of 4.3% during 2017-2021. With a projected CAGR of 4.4% for the next ten years. The market for in-vitro diagnostics for infectious diseases is expected to develop as more diagnostic centers adopt in vitro diagnostic systems with analyzer software. For instance, Mobidiag Ltd. partnered with Pro Med Diagnostics for Novodiag and Amplidiag solution distribution in the MEA region. The Amplidiag solution includes Amplidiag Analyzer Software, which automates the entire process of diagnosing infections with C. difficile, clarithromycin-resistant Helicobacter pylori, and other infectious disorders.

The launch of new products is boosting the growth of the segment. Some recent launches include GeneFinder COVID-19 Plus RealAmp Kit and VITROS Immunodiagnostic Anti-SARS-CoV-2 Total Reagent Pack and Calibrators.

Competitive Landscape

Market participants are tying with sister companies to combine new innovative products. The key companies operating in the Infectious Disease In-Vitro Diagnostics Market include Abbott Laboratories, Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd., bioMérieux SA, Siemens Healthineers AG, Danaher Corporation, Becton Dickinson and Company, PerkinElmer, Inc., Hologic, Inc., QIAGEN N.V., Grifols S.A., DiaSorin S.p.A, Bio-Rad Laboratories, Inc., Sysmex Corporation, Ortho Clinical Diagnostics Holdings plc, Quidel Corporation, Meridian Bioscience, Genetic Signatures Ltd., OraSure Technologies, Trinity Biotech Plc., Chembio Diagnostic Systems, Seegene, Inc., Co-Diagnostics, ELITechGroup, Epitope Diagnostics, Trivitron Healthcare, Meril Life Sciences Pvt. Ltd., InBios International, Vela Diagnostics, and Uniogen Oy.

Some of the recent developments by key providers of the Infectious Disease In-Vitro Diagnostics Market are as follows:

  • In February 2019, Abbott was awarded CE Mark for DETERMINE HBSAG 2 test for the detection and diagnosis of Hepatitis B surface antigen.
  • In March 2021, a merger agreement between GenMark diagnostics Inc. and F. Hoffmann-La Roche Ltd. With just one patient sample, Roche will now have larger access to GenMark's cutting-edge technology for testing for a variety of infections.
  • In March 2021, in nations that recognize the CE mark, F. Hoffmann-La Roche Ltd. launched the Cobas pure integrated solution. Three technologies are combined on a single platform in this new compact analyzer, which makes operations in small to medium-sized labs easier.

Similarly, recent developments related to companies have been tracked by the team at Persistence Market Research, which is available in the full report.

Key Segments Covered in Infectious Disease In-Vitro Diagnostics Market Survey

By Product Type:

  • Instruments
  • Reagents
  • Services

By Technology:

  • Immunoassay
  • Molecular Diagnostics
  • Microbiology
  • Other Technologies

By Application:

  • MRSA
  • Streptococcus
  • Clostridium Difficile
  • Respiratory Virus
  • TB and Drug-resistant TB
  • Gonorrhea
  • HPV
  • HIV
  • Hepatitis C
  • Hepatitis B
  • COVID-19
  • Other Applications

By End-use:

  • Point of care
  • Central Laboratories
  • Other End-uses

By Region:

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East & Africa

- Companies Covered in This Report -

  • Becton, Dickinson and Company
  • bioMérieux SA
  • Abbott
  • Quidel Corporation
  • OraSure Technologies, Inc
  • Hologic Inc.
  • Cepheid
  • Qiagen
  • F. Hoffmann-La Roche Ltd.
  • Siemens Healthcare GmbH
  • Bio-Rad Laboratories, Inc.

- Frequently Asked Questions -

The global market was valued at US$ 58.7 Bn in 2021.

The market is set to witness a growth rate of 4.4% over the forecast period and be valued at US$ 93.9 Bn by 2032.

The market expanded by 4.2% from 2017 through 2021.

The key players are Abbott Laboratories, Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd., bioMérieux SA, Siemens Healthineers AG, Danaher Corporation, and Becton Dickinson and Company.

United States, United Kingdom, China, Japan, and South Korea are expected to drive the most sales growth in the Infectious Disease In-Vitro Diagnostics Market.

The market in China accounts for US$ 7 Bn of the global market share by end of the forecast year.

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