Clinical Chemistry and Diagnostics

Radiological Medicine

Radiological medicine employs imaging technology and small amounts of radioactive materials to diagnose and treat diseases. The market is driven mostly by diagnostic radiology but also by an increasing share of therapeutic radiology. Additionally, interventional radiology is a specialization within this industry that is based on image-guided procedures to treat various illnesses. 

The global radiological medicine market is expected to grow to over $5.2 billion in value by 2024, driven primarily by increased rates of cancer and cardiac disease.[1]  The radioisotope most used in diagnostic radiology is technetium-99m, the decay product of molybdenum-99. 

Molybdenum-99’s short half-life and the fact that molybdenum-99 is currently produced only overseas has inhibited growth of this industry, but the United States government is currently supporting several U.S. producers to develop a domestic supply.[2]  Regulatory challenges also pose difficulties for growth of the radiological medicine market.[3]  

The demand for radiological goods and technologies is greatest in North America, followed by Europe. Rising demand is anticipated for the Asia Pacific region in the coming years.

In Vitro Diagnostics

In vitro diagnostics (IVDs) are tests used to determine the status of one’s health, predict future health conditions, evaluate and monitor ongoing treatment, and screen sectors of the population for medical conditions. The U.S. Food and Drug Administration (FDA) broadly defines IVD products as “those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.”

In general terms, the IVD industry produces reagents, analytical instruments, and accessory products that are needed to perform diagnostic laboratory tests. 

• Reagents are solutions of biological or chemical substances that react with target substances in samples. This process will result in a measurable outcome.
• Analytical instruments are the various machines and equipment that bring samples and reagents together and measure results or other qualities in samples.
• Accessory products, such as the software that manages and checks the performance of the systems, are also produced by the IVD industry. 

Collectively, reagents, analytical instruments, and accessory products are referred to as IVD systems. IVDs are not regulated uniformly among global health agencies, as in some jurisdictions, certain IVD medical devices may be covered by additional or different rules. 

The International Trade Administration has historically tracked trends and developments relative to IVDs by following U.S. exports of three classes of reagents used in IVD systems. These classes are 1) diagnostic or laboratory reagents on a backing, prepared diagnostic, or laboratory reagents whether or not on a backing, 2) prepared culture media for development of microorganisms, and 3) blood grouping reagents.[4] 
 

The leading U.S.-based medical diagnostics products industry association, AdvaMedDx, has utilized an expanded set of harmonized tariff system codes to calculate the size and follow trends in export markets. These include not only those codes that ITA uses, but also encompasses testing apparatus, monitoring systems, sterilizers, test kits and parts and accessories.[5] 
 

[1] Markets and Markets: Nuclear Medicine/Radiopharmaceuticals Market.  https://www.marketsandmarkets.com/Market-Reports/radiopharmaceuticals-market-417.hmtl.  6/10/2020

[2] United States Department of Energy: NNSA’s Molybdenum-99 Program: Establishing a Reliable Supply of Mo-99 Produced Without Highly Enriched Uranium. https://www.energy.gov/nnsa/nnsa-s-molybdenum-99-program-establishing-reliable-supply-mo-99-produced-without-highly. 6/10/2020 

[3] Medical Imaging & Technology Alliance: FDA Regulation. https://www.medicalimaging.org/policy-and-positions/approval-regulation. 6/10/2020

^[4] HS codes 3822000002, 3821000000, 3006200000

^[5] HS codes 300211, 300620, 30062000, 300630, 30063010, 30063050, 382100, 382200, 3822001010, 3822001090, 3822005010. 3822005090, 38220060, 841920, 8419905040, 901819, 90181940, 90181955, 9018199550, 9018199560, 901820, 90182000, 9018200080, 901831, 9018310040, 9018310080, 9018310090, 901832, 90183200, 901839, 9018390020, 9018390040, 9018390050, 90189010, 90189020