First Research US Industry Profile

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Diagnostic Substance Manufacturing
SIC Codes: 2835
NAICS Codes: 325413
Last Quarterly Update: 6/27/2022
Companies in this industry develop and manufacture biological, chemical, and radioactive substances used in the process of detecting, diagnosing, and monitoring health conditions. Major companies include Beckman Coulter and Bio-Rad Laboratories (both based in the US), as well as bioMerieux and Guerbet (both in France) and the diagnostic divisions of major pharmaceutical companies such as Abbott (US), Roche (Switzerland), and Siemens (Germany).
The global market for in-vitro diagnostics, which includes drugs and devices, is forecast to grow from about $70 billion in 2020 to $105 billion in 2025, according to the Business Research Company. Demand for point-of-care diagnostic devices is increasing as these provide rapid results, are cost effective, and have advanced diagnosis feature for patients. The risk of getting disease increases while aging.
The US diagnostic substances industry includes about 240 establishments (single-location companies and units of multi-location companies) with combined annual revenue of about $14 billion.
Companies that make diagnostic equipment such as x-ray machines are covered in a separate profile.
Competitive Landscape
Demand for diagnostics is driven by the desire to detect and treat illness and disease. The profitability of individual companies depends on their ability to promote easy-to-use, effective tests and to develop new tests. Growth is fueled by increasing rates of chronic and infectious diseases. Large companies have economies of scale in research, manufacturing, and marketing. Smaller companies can compete effectively by specializing in certain types of tests or disease targets, or through advanced product development efforts. The US industry is highly concentrated: the 50 largest firms account for more than 95% of revenue.
The diagnostic industry, like the pharmaceutical industry, is dependent on scientific discovery to gain competitive advantages in areas such as accuracy and efficiency of the test. Competition is fierce to develop tests that detect new conditions, especially molecular diagnostics that connect genetic strains to specific conditions.
Products, Operations & Technology
Companies manufacture substances either in vitro (in glass containers such as test tubes) or in vivo (in the body). They are used to diagnose and detect ... plus:
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Finance & Regulation
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Regional & International Issues
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Human Resources
Also includes the following chapters:
Quarterly Industry Update
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Industry Indicators
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Business Challenges
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Trends and Opportunities
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Call Preparation Questions
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Financial Information
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Industry Forecast
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Industry Websites
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Glossary of Acronyms

Historical Profiles (PDF format)

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