First Research US Industry Profile

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Diagnostic Substance Manufacturing
SIC Codes: 2835
NAICS Codes: 325413
Last Quarterly Update: 9/9/2019
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 $68 billion in 2018 to $107 billion in 2027, according to MarketsandMarkets. Growth is strongest in developing nations with growing economies and rising middle-class populations.
The US diagnostic substances industry includes about 250 establishments (single-location companies and units of multi-location companies) with combined annual revenue of about $16 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 top eight companies account for about 65% 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
Substances manufactured by this industry are utilized either in vitro (in glass containers such as test tubes) or in vivo (in the body). They are used ... plus:
Sales & Marketing
Finance & Regulation
Regional & International Issues
Human Resources
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Quarterly Industry Update
Industry Indicators
Business Challenges
Trends and Opportunities
Call Preparation Questions
Financial Information
Industry Forecast
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Glossary of Acronyms

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