Infectious Disease In-vitro Diagnostics Market (By Product: Instruments, Reagents; By Application MRSA, Streptococcus; By Technology: Immunoassay, Molecular Diagnostics; By End-use) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook 20212030

The global Infectious Disease In-vitro Diagnostics market size is expected to be worth around US$ 86.0 billion by 2030, according to a new report by Vision Research Reports.

The global Infectious Disease In-vitro Diagnostics market size was valued at US$ 66.1 billion in 2020 and is anticipated to grow at a CAGR of 4.9% during forecast period 2021 to 2030.

Growth Factors

This growth is owing to factors such as the increasing prevalence of infectious diseases, the outbreak of COVID-19, growing market penetration of available treatments, and increasing consumer awareness.

Diagnostics for SARS-CoV-2 detection are being continuously launched for catering to markets that have specific regulatory requirements. For instance, in September 2019, Roche launched its CE Marked antibody diagnostic test Elecsys Anti-SARS-CoV-2 S. Thus, the launch of new diagnostics is expected to lead to an increase in demand owing to their usage in the characterization of the vaccine-induced immune response, thereby boosting development.

Technological advancements, such as the introduction of portable instruments like Cobas 4800 developed by Roche Diagnostics and GeneXpert by Cepheid are expected to drive market growth over the forecast period. Furthermore, increasing use of these systems to develop new tests that can detect infectious diseases is expected to fuel market growth.

An increase in the prevalence of MRSA infection, high consumer awareness, and the presence of high unmet patient needs are some of the factors expected to drive the market during the forecast period. Diagnosis of MRSA infection involves rapid culture methods and molecular techniques for assessment of MRSA colonization. The presence of a large number of diagnostic tests and the introduction of new products, such as LightCycler, TaqMan, RotorGene, and Stratagene, are expected to propel segment growth.

The launch of new products is becoming a key strategy adopted by players, as new SARS-CoV-2 diagnostics are being launched by major players such as BD, bioMérieux SA, and F. Hoffmann-La Roche Ltd. For instance, in March 2020, Abbott launched the RealTime SARS-CoV-2 assay, a PCR-based test for the diagnosis of COVID-19, and BioMedomics launched a PoC COVID-19 test that can detect antibodies in blood within 15 minutes.

Report Highlights

The reagents segment dominated the market for infectious diseases in-vitro diagnostics and accounted for the largest revenue share of 65.6% in 2020. It is anticipated to grow at a significant rate in upcoming years owing to its wide usage in diagnostics. Furthermore, the launch of new products is boosting the growth of the segment. Some recent launches include GeneFinder COVID-19 Plus RealAmp Kit in 2020, and VITROS Immunodiagnostic Anti-SARS-CoV-2 Total Reagent Pack and Calibrators.

Furthermore, the growing use of instruments to detect coronavirus, which were earlier developed for other infectious diseases, is anticipated to boost the growth of the market for infectious diseases in-vitro diagnostics. For instance, in March 2020, Abbott received Emergency Use Authorization (EUA) for RealTime SARS-CoV-2 EUA tests to be used on the m2000 RealTime System.

Increasing adoption of in vitro diagnostic systems with analyzer software at diagnostic centers is anticipated to fuel the growth of the market for infectious diseases in-vitro diagnostics. For instance, in January 2018, Mobidiag Ltd. entered into an agreement with Pro Med Diagnostics for Novodiag solution and Amplidiag solution distribution in African countries. Amplidiag solution consists of Amplidiag Analyzer Software that automates the complete process of detection of Helicobacter pylori and clarithromycin infection, C. difficile infection, and other infectious diseases.

The COVID-19 segment dominated the market for infectious diseases in-vitro diagnostics and accounted for the largest revenue share of 71.0% in 2020. The segment is anticipated to grow at a significant rate in upcoming years owing to increasing technological advancements to enable automated and high-throughput testing. The presence of favorable and flexible regulatory scenarios due to the increasing number of cases and prevalence rate of infectious diseases is anticipated to boost the market growth. For instance, in March 2020, bioMérieux received EUA from the U.S. FDA for the Biofire COVID-19 test that runs on FILMARRAY 2.0 and FILMARRAY TORCH platforms.

Carbapenem-resistant bacteria are gram-negative bacteria resistant to carbapenem and almost all classes of antibiotics. The infection is prevalent in hospital patients using ventilators, urinary catheters, and intravenous catheters and patients on long-term antibiotic therapy. The rising incidence of hospital-acquired infections and chronic diseases is expected to fuel the growth of the carbapenem-resistant bacteria testing market in the near future.

The prevalence of C. difficile infections depends on antibiotic prescription patterns, patient population, and endemic strains. The prevalence of CDIs may be as high as 50% in hospitalized patients. In addition, the presence of key market players, such as Quidel Corporation, F. Hoffmann-La Roche Ltd, Abbott, and Luminex Corporation, that have a range of in vitro diagnostic tests for detection is anticipated to boost the market growth. For instance, Quidel Corporation offers a range of assays, such as AmpliVue C. difficile Assay, Lyra Direct C. difficile Assay, and Solana C. difficile Assay, for diagnosis of C. difficile infection.

The central laboratories segment dominated the market for infectious diseases in-vitro diagnostics and held the largest revenue share of 60.2% in 2020. The significant presence of these laboratories in emerging and underdeveloped markets can be attributed to its large share. The presence of extensive ancillary support with respect to manpower and infrastructure is also a key propeller of growth. Moreover, regulatory authorities are undertaking initiatives to improve laboratory services and ease the process of diagnosis.

There is an increasing interest in the development of molecular diagnostic platforms that can also be used in PoC settings. Therefore, various companies are designing assays and molecular diagnostic platforms for POC or near-patient testing. In addition, the growing development of new assays that offer quick PoC results is anticipated to boost the growth of the market for infectious diseases in-vitro diagnostics. For instance, in October 2018, U.S. FDA cleared Abbott’s Influenza A and B2 and Strep A2 assay for PoC testing, which can be used on the ID NOW platform.

Kits used for self-testing, which are used at home, independent of any health care specialist, are available on the internet and OTC and are categorized under this segment. Self-testing assists in early diagnosis and constant patient monitoring. In addition, self-test diagnostics aid in curbing costs associated with healthcare establishments and practitioners. A few of the home diagnostics tests are the Home Access Express HIV-1 Test and Home Access Hepatitis C Test developed by Home Access Health Corp and ADEXUSDx HIV 1/2 Test developed by NOWDiagnostics.

The immunoassay segment accounted for a revenue share of 31.2% in 2020 in the infectious disease in-vitro diagnostics market. This is attributed to its use in the detection of infectious microorganisms such as viruses, bacteria, and fungus and their toxins and coat antigens. An increase in the outbreak of infectious diseases and a rise in the need for early diagnosis are among the key drivers responsible for the increased demand for immunoassay methods involving different types of Enzyme-Linked Immunosorbent Assay (ELISA).

Molecular diagnostics is considered as the basis of medical diagnosis for all major viral, bacterial, and parasitic infections. Increasing use of high-throughput PCR technology to detect infectious diseases is expected to drive the market for infectious diseases in-vitro diagnostics. For instance, in April 2020, Mobidiag Ltd. received EUA for Amplidiag COVID-19 for use in clinical laboratories in Finland. The EUA of the product is underway in France, Sweden, and the U.K.

Antibiotic susceptibility testing is considered one of the fastest-growing applications in microbiology testing. An increase in multidrug resistance is driving the demand for microbiological tests for increasing the efficiency of drugs against microorganisms. The rise in the prevalence of pathogenic diseases is expected to fuel the growth of the microbiology segment. In addition, extensive R&D being conducted for the identification of pathogens is expected to further enhance the market growth.

North America dominated the infectious disease in-vitro diagnostics market and accounted for the largest revenue share of 36.5% in 2020. The region is expected to maintain its lead over the forecast period. This is attributed to the rising epidemiology of infectious diseases, thus, encouraging the R&D activities, thereby boosting the market growth.

Asia Pacific is anticipated to exhibit the fastest CAGR of 5.4 % during the forecast period. The presence of developing economies such as China and India that have a high prevalence of infectious diseases and access to healthcare is gradually rising. Increasing healthcare expenditure in the region is anticipated to fuel the market for infectious diseases in-vitro diagnostics.

Key Players

• BD

• bioMérieux SA

• Abbott

• Quidel Corporation

• OraSure Technologies, Inc.

• Hologic, Inc. (Gen Probe)

• Danaher

• QIAGEN

• F. Hoffmann-La Roche, Ltd.

• Siemens Healthineers AG

• Bio-Rad Laboratories, Inc.

Market Segmentation

• Product Outlook

  • Instruments

    • MRSA

    • Streptococcus

    • Clostridium Difficile

    • VRE

    • CRE

    • Respiratory Virus

    • Candida

    • TB and Drug-resistant TB

    • Gastro-intestinal Panel Testing

    • Chlamydia

    • Gonorrhea

    • HPV

    • HIV

    • Hepatitis C

    • Hepatitis B

    • COVID-19

    • Others

  • Reagents

    • MRSA

    • Streptococcus

    • Clostridium Difficile

    • VRE

    • CRE

    • Respiratory Virus

    • Candida

    • TB and Drug-resistant TB

    • Gastro-intestinal Panel Testing

    • Chlamydia

    • Gonorrhea

    • HPV

    • HIV

    • Hepatitis C

    • Hepatitis B

    • COVID-19

    • Others

  • Services

    • MRSA

    • Streptococcus

    • Clostridium Difficile

    • VRE

    • CRE

    • Respiratory Virus

    • Candida

    • TB and Drug-resistant TB

    • Gastro-intestinal Panel Testing

    • Chlamydia

    • Gonorrhea

    • HPV

    • HIV

    • Hepatitis C

    • Hepatitis B

    • COVID-19

    • Others

• Technology Outlook Immunoassay

  • Molecular Diagnostics

  • Microbiology

  • Others

• Application Outlook 

  • MRSA

  • Streptococcus

  • Clostridium Difficile

  • VRE

  • CRE

  • Respiratory Virus

  • Candida

  • TB and Drug-resistant TB

  • Gastro-intestinal Panel Testing

  • Chlamydia

  • Gonorrhea

  • HPV

  • HIV

  • Hepatitis C

  • Hepatitis B

  • COVID-19

  • Others

• End-use Outlook

  • Point of care

  • Central Laboratories

  • Others

• Regional Outlook

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • UAE

    • Saudi Arabia

The Infectious Disease In-vitro Diagnostics market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of Infectious Disease In-vitro Diagnostics market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global Infectious Disease In-vitro Diagnostics market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Infectious Disease In-vitro Diagnostics market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Infectious Disease In-vitro Diagnostics market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Infectious Disease In-vitro Diagnostics capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Infectious Disease In-vitro Diagnostics by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Infectious Disease In-vitro Diagnostics market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Infectious Disease In-vitro Diagnostics market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Infectious Disease In-vitro Diagnostics market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Infectious Disease In-vitro Diagnostics industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

The Infectious Disease In-vitro Diagnostics market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Infectious Disease In-vitro Diagnostics market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Infectious Disease In-vitro Diagnostics market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Infectious Disease In-vitro Diagnostics market. These factors have benefited the growth of the global market for Infectious Disease In-vitro Diagnostics. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Infectious Disease In-vitro Diagnostics. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of Infectious Disease In-vitro Diagnostics are as follows:

• Historic Year: 2017-2020
• Base Year: 2021
• Forecast Year 2021 to 2030

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

• To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2030);
• Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
• Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
• To define, describe and forecast the market by type, application and region.
• To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
• To identify significant trends and factors driving or inhibiting the market growth.
• To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
• To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
• To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
• To strategically profile the key players and comprehensively analyze their growth strategies.