In Vitro Diagnostics (IVD) Market Size, Share & Trends Report

In Vitro Diagnostics (IVD) Market Size, Share & Trends Analysis Report By Product (Instruments, Reagents), By Test Location, By End-use (Hospitals, Laboratory), By Application (Diabetes, Oncology), By Technology, By Region, And Segment Forecasts, 2024 - 2030

  • Report ID: 978-1-68038-080-4
  • Number of Pages: 200
  • Format: Electronic (PDF)
  • Historical Range: 2018 - 2023
  • Industry: Healthcare

Research Methodology

A three-pronged approach was followed for deducing the in vitro diagnostics market estimates and forecasts. The process has three steps: information procurement, analysis, and validation. The whole process is cyclical, and steps repeat until the estimates are validated. The three steps are explained in detail below:

Information procurement: Information procurement is one of the most extensive and important stages in our research process, and quality data is critical for accurate analysis. We followed a multi-channel data collection process for in vitro diagnostics market to gather the most reliable and current information possible.

  • We buy access to paid databases such as Hoover’s and Factiva for company financials, industry information, white papers, industry journals, SME journals, and more.
  • We tap into Grand View’s proprietary database of data points and insights from active and archived monitoring and reporting.
  • We conduct primary research with industry experts through questionnaires and one-on-one phone interviews.
  • We pull from reliable secondary sources such as white papers and government statistics, published by organizations like WHO, NGOs, World Bank, etc., Key Opinion Leaders (KoL) publications, company filings, investor documents, and more.
  • We purchase and review investor analyst reports, broker reports, academic commentary, government quotes, and wealth management publications for insightful third-party perspectives.

Analysis: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilized different methods of in vitro diagnostics market data depending on the type of information we’re trying to uncover in our research.

  • Market Research Efforts: Bottom-up Approach for estimating and forecasting demand size and opportunity, top-down Approach for new product forecasting and penetration, and combined approach of both Bottom-up and Top-down for full coverage analysis.

  • Value-Chain-Based Sizing & Forecasting: Supply-side estimates for understanding potential revenue through competitive benchmarking, forecasting, and penetration modeling.

  • Demand-side estimates for identifying parent and ancillary markets, segment modeling, and heuristic forecasting.

  • Qualitative Functional Deployment (QFD) Modelling for market share assessment.

Market formulation and validation: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilize different methods of data analysis depending on the type of information we’re trying to uncover in our research.

  • Market Formulation: This step involves the finalization of market numbers. This step on an internal level is designed to manage outputs from the Data Analysis step.

  • Data Normalization: The final market estimates and forecasts are then aligned and sent to industry experts, in-panel quality control managers for validation.

  • This step also entails the finalization of the report scope and data representation pattern.

  • Validation: The process entails multiple levels of validation. All these steps run in parallel, and the study is forwarded for publishing only if all three levels render validated results.

In Vitro Diagnostics Market Categorization:

The in vitro diagnostics market was categorized into six segments, namely product (Instruments, Reagents, Services), application (Infectious Disease, Diabetes, Oncology, Cardiology, Nephrology, Autoimmune Disease, Drug Testing), technology ( Immunoassay, Hematology, Clinical Chemistry, Molecular Diagnostics, Coagulation, Microbiology, ), end-use (Hospitals, Laboratories, Home Care), test location (Point of Care, Home Care), and region (North America, Europe, Asia Pacific, Latin America, Middle East & Africa).

Segment Market Methodology:

The in vitro diagnostics market was segmented into product, application, technology, end-use, test location and regions. The demand at a segment level was deduced using a funnel method. Concepts like the TAM, SAM, SOM, etc., were put into practice to understand the demand. We at GVR deploy three methods to deduce market estimates and determine forecasts. These methods are explained below:

Market research approaches: Bottom-up

  • Demand estimation of each product across countries/regions summed up to from the total market.

  • Variable analysis for demand forecast.

  • Demand estimation via analyzing paid database, and company financials either via annual reports or paid database.

  • Primary interviews for data revalidation and insight collection.

Market research approaches: Top-down

  • Used extensively for new product forecasting or analyzing penetration levels.

  • Tool used invoice product flow and penetration models Use of regression multi-variant analysis for forecasting Involves extensive use of paid and public databases.

  • Primary interviews and vendor-based primary research for variable impact analysis.

Market research approaches: Combined

  • This is the most common method. We apply concepts from both the top-down and bottom-up approaches to arrive at a viable conclusion.

Regional Market Methodology:

The in vitro diagnostics market was analyzed at a regional level. The globe was divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa, keeping in focus variables like consumption patterns, export-import regulations, consumer expectations, etc. These regions were further divided into twenty countries, namely, the U.S.; Canada; Germany; the UK.; France; Italy; Spain; Russia; China; Japan; India; Australia; South Korea; Singapore; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE.

All three above-mentioned market research methodologies were applied to arrive at regional-level conclusions. The regions were then summed up to form the global market.

In vitro diagnostics market companies & financials:

The in vitro diagnostics market was analyzed via companies operating in the sector. Analyzing these companies and cross-referencing them to the demand equation helped us validate our assumptions and conclusions. Key market players analyzed include:

  • BIOMÉRIEUX SA, BioMérieux SA was founded in 1963 and headquartered in France. The company is a subsidiary of Institut Mérieux, which provides in vitro diagnostics, especially for infectious diseases. Moreover, the company produces equipment, chemical substances, and computer programs utilized by medical laboratories to detect various types of infections, including tuberculosis, sepsis, hospital-acquired infections, AIDS, and cardiovascular and cancer-related illnesses. The business operates 19 production facilities and 20 R&D centers. It has a presence in 43 nations and distributes its goods in 160 nations, and the business has a global workforce of 13,000. Considering the last couple of years, the business showcased a strong commercial performance, with a 10.5% increase in overall sales. This can be attributed to the company's extensive installed base of equipment worldwide, which enables it to cater to a larger consumer base.

  • BIO-RAD LABORATORIES, INC, Bio-Rad Laboratories, Inc. is headquartered in the U.S. and was established in 1952. The company specializes in manufacturing products and systems that are utilized to separate complex biological and chemical materials. Again, the company analyzes, identifies, and purifies their respective components. Additionally, the organization operates in two segments such as clinical diagnostics and life sciences. Under the clinical diagnostics segment, Bio-Rad Laboratories designs, manufactures, supports and sells test systems, informatics systems, test kits, and quality controls to clinical laboratories worldwide. On the other hand, the life sciences segment is involved in creating and discovering tools necessary for biological processes. Bio-Rad Laboratories, Inc. produces reagents, laboratory instruments, and apparatus used in biopharmaceutical production, research techniques, and food testing regimes. Key applications of Bio-Rad products include hospitals, laboratories, research institutions, biotechnology companies, and pharmaceutical firms. The company has direct distribution channels in around 35 countries and has a workforce of over 8,000 employees globally. Moving forward, the company is looking for expansion in the near future.

  • BECTON, DICKINSON AND COMPANY, Becton, Dickinson and Company, founded in 1897, is a leading medical technology company operating worldwide. The company specializes in manufacturing and marketing a diverse range of medical devices, diagnostic products, and laboratory equipment, along with medical supplies. BD operates through three business segments: BD Diagnostics, BD Medical, and BD Biosciences. BD Diagnostics offers a wide range of products and instruments for collecting and safely transporting diagnostic specimens. Furthermore, it provides reagent systems and instruments that accurately detect various healthcare-associated infections, infectious diseases, and cancer. Additionally, the segment offers fully automated molecular systems that provide rapid results, require less hands-on time, and are user-friendly. BD has a global presence, with offices in around 50 countries and employs over 65,000 employees worldwide.

  • SIEMENS HEALTHINEERS AG, Siemens Healthcare GmbH, a Germany-based healthcare company, specializes in providing cutting-edge healthcare solutions, including in vitro and in vivo diagnostics. In addition, the company offers imaging and therapy systems, audiology solutions, clinical products, and healthcare IT solutions. The company was established in 2015 as a separate entity and provides medical accessories, medical electronics solutions, OEM components, and refurbished medical imaging and therapy systems. Its vast range of products and solutions includes therapeutic drug monitoring, cardiology, organ transplant, urology, infectious disease, diabetes, women's health, surgery, oncology, neurology, and growth disorders. The company has a global workforce of about 54,000 employees and also provides technical, maintenance, and professional consulting services.

  • QIAGEN, Qiagen is a holding company that provides samples and assay technologies for various areas such as academic research, applied testing, molecular diagnostics, and pharmaceutical research. The company markets more than 500 products, including consumable kits and automation systems. Qiagen products for molecular diagnostics cover relevant areas of healthcare such as early disease diagnosis, establishment of diagnosis, diagnostic testing for suitable treatment determination, and point-of-need testing. The company's customers include healthcare providers, pharmaceutical and biotechnology companies, government or industrial customers, and researchers. It was incorporated in 1984 and is headquartered in Germany, employing over 5,610 people globally.

  • QUIDEL CORPORATION, Quidel Corporation was established in 1979 and headquartered in the U. S. The company specializes in developing and manufacturing point-of-care diagnostic solutions for contagious diseases such as group A streptococcal infections and influenza. The company mainly aims to develop and market diagnostic solutions. These testing solutions are mainly developed to cure women’s health, gastrointestinal diseases, and infectious diseases. Moreover, the company is proficient in selling its commodities to distributors and end-users. It has supply chain channels in the U. S. markets to distribute products in the local market. The company employs more than 1600 people in its worldwide offices.

  • F. HOFFMANN-LA ROCHE LTD., F. Hoffmann-La Roche Ltd., a Switzerland-based healthcare company, operates in two divisions - pharmaceuticals and diagnostics. One of its segments, Roche Diagnostics, consists of Roche Professional Diagnostics (RPD), Roche Molecular Diagnostics (RMD), Roche Tissue Diagnostics, and Roche Diabetes Care. Roche Diagnostics offers a range of products such as blood glucose meters, point-of-care testing devices, high-throughput analyzers for commercial and hospital diagnostic laboratories, and reagents and instruments for life sciences research. RMD, a segment of Roche Diagnostics, is involved in the development, manufacturing, and distribution of tests based on PCR technology and medical diagnostic products, platforms, and services. RMD's automated platforms and diagnostic tests focus on areas including virology, genomics and oncology, blood screening tests, HPV and CT/NG, and microbiology. The company caters to various clients such as physicians, researchers, laboratories, hospitals, patients, and blood banks. With a global workforce of 101,465 employees, Roche is a leading name in the healthcare industry.

  • SYSMEX CORPORATION, Sysmex Corporation is a Japanese medical devices company that was established in 1968. The company primarily focuses on the field of in vitro diagnostics, manufacturing and developing laboratory test drugs, clinical laboratory equipment, and other products associated with laboratory testing. Sysmex operates through three major divisions: Diagnostic business, life sciences business, and other businesses. The Diagnostic business division is responsible for producing and selling instruments, reagents, and laboratory systems that cater to hematology, hemostasis, immunochemistry, clinical chemistry, and urinalysis fields. Sysmex has a strong presence both in domestic as well as international markets, such as Europe, the Americas, and Asia Pacific. The company currently employs more than 9,000 people worldwide.

  • CHARLES RIVER LABORATORIES, Charles River Laboratories is headquartered in the U.S.. It was founded in 1947 and is a leading provider of clinical and preclinical laboratory services. Its clientele includes biotechnology industries, government agencies, and pharmaceutical and medical device companies. The company specializes in basic research, clinical support, and process manufacturing and offers a diverse range of products, such as biomarkers, cellular therapeutics, biosimilars, and vaccines. Its services are not limited to healthcare and extend to industries such as agrochemicals, veterinary medicines, dairy, food & beverage, home & beauty, medical devices, nutraceuticals, and dietary supplements. With 65 facilities spanning 16 countries, the company has a global presence and employs over 12,400 people.

  • QUEST DIAGNOSTICS, Quest Diagnostics, an American-based company that offers clinical laboratory tests, is a publicly traded corporation. It was established as an independent entity known as Quest Diagnostics in 1997. The company has its headquarters in the United States and administrative offices in Lyndhurst, Collegeville, and Pennsylvania. In the field of pharmacy and other services, it was ranked at the top by Fortune magazine in 2013. Quest Diagnostics conducts more than 150 million tests annually and has formed partnerships with various clinics and hospitals around the world. It currently operates over 6,850 patient and retail access points and serves approximately 50% of the hospitals in the United States. The firm employs mergers and acquisitions as one of the primary strategies to expand its reach.

Value chain-based sizing & forecasting

Supply Side Estimates

  • Company revenue estimation via referring to annual reports, investor presentations, and Hoover’s.

  • Segment revenue determination via variable analysis and penetration modeling.

  • Competitive benchmarking to identify market leaders and their collective revenue shares.

  • Forecasting via analyzing commercialization rates, pipelines, market initiatives, distribution networks, etc.

Demand side estimates

  • Identifying parent markets and ancillary markets

  • Segment penetration analysis to obtain pertinent

  • revenue/volume

  • Heuristic forecasting with the help of subject matter experts

  • Forecasting via variable analysis

In Vitro Diagnostics Market Report Objectives:

  • Understanding market dynamics (in terms of drivers, restraints, & opportunities) in the countries.

  • Understanding trends & variables in the individual countries & their impact on growth and using analytical tools to provide high-level insights into the market dynamics and the associated growth pattern.

  • Understanding market estimates and forecasts (with the base year as 2022, historic information from 2018 to 2021, and forecast from 2023 to 2030). Regional estimates & forecasts for each category are available and are summed up to form the global market estimates.

In Vitro Diagnostics Market Report Assumptions:

  • The report provides market value for the base year 2022 and a yearly forecast till 2030 in terms of revenue/volume or both. The market for each of the segment outlooks has been provided on region & country basis for the above-mentioned forecast period.

  • The key industry dynamics, major technological trends, and application markets are evaluated to understand their impact on the demand for the forecast period. The growth rates were estimated using correlation, regression, and time-series analysis.

  • We have used the bottom-up approach for market sizing, analyzing key regional markets, dynamics, & trends for various products and end-users. The total market has been estimated by integrating the country markets.

  • All market estimates and forecasts have been validated through primary interviews with the key industry participants.

  • Inflation has not been accounted for to estimate and forecast the market.

  • Numbers may not add up due to rounding off.

  • Europe consists of EU-8, Central & Eastern Europe, along with the Commonwealth of Independent States (CIS).

  • Asia Pacific includes South Asia, East Asia, Southeast Asia, and Oceania (Australia & New Zealand).

  • Latin America includes Central American countries and the South American continent

  • Middle East includes Western Asia (as assigned by the UN Statistics Division) and the African continent.

Primary Research

GVR strives to procure the latest and unique information for reports directly from industry experts, which gives it a competitive edge. Quality is of utmost importance to us, therefore every year we focus on increasing our experts’ panel. Primary interviews are one of the critical steps in identifying recent market trends and scenarios. This process enables us to justify and validate our market estimates and forecasts to our clients. With more than 8,000 reports in our database, we have connected with some key opinion leaders across various domains, including healthcare, technology, consumer goods, and the chemical sector. Our process starts with identifying the right platform for a particular type of report, i.e., emails, LinkedIn, seminars, or telephonic conversation, as every report is unique and requires a differentiated approach.

We send out questionnaires to different experts from various regions/ countries, which is dependent on the following factors:

  • Report/Market scope: If the market study is global, we send questionnaires to industry experts across various regions, including North America, Europe, Asia Pacific, Latin America, and MEA.

  • Market Penetration: If the market is driven by technological advancements, population density, disease prevalence, or other factors, we identify experts and send out questionnaires based on region or country dominance.

The time to start receiving responses from industry experts varies based on how niche or well-penetrated the market is. Our reports include a detailed chapter on the KoL opinion section, which helps our clients understand the perspective of experts already in the market space.

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