The pharmaceutical and biopharmaceutical industry sector is comprised of companies engaged in researching, developing, manufacturing, and distributing drugs. Drugs are products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and products (other than food) intended to affect the structure or any function of the body. The definition also includes components of drugs, such as active pharmaceutical ingredients and excipients.

Subsectors include innovative and generic pharmaceuticals, biologics, biosimilars, and over-the-counter medicines. 

Innovative or originator pharmaceuticals are chemically synthesized drugs that are first approved for an indication by a regulator and are protected by exclusive marketing or intellectual property rights such as patents. Generic pharmaceuticals are copies of innovative pharmaceuticals that meet regulatory bioequivalence standards and can be marketed following expiration of marketing or patent exclusivities or successful challenge of relevant patents of the innovative drug.

Biopharmaceuticals, such as biologics, include a wide range of products such as vaccines, therapeutic proteins, blood and blood components, tissues, etc. In contrast to small molecule chemically synthesized drugs, which have a well-defined structure, biologics are derived from living material (human, animal, microorganism, or plant) and are vastly larger and more complex in structure. Biosimilars (follow-on biologics) are versions of biologic products that reference the originator product in applications submitted for marketing approval to a regulatory body.

Over-the-counter (OTC) drugs are distinguished from innovative and generic drugs in that consumers do not need prescriptions to purchase them. OTC drugs are considered by regulators to be safe for self-diagnosis and self-medication.

Gene therapy and cell therapy are overlapping fields of biomedical research with the goals of repairing the direct cause of genetic diseases in the DNA or cellular population, respectively. Gene therapy is used to modify the expression of an individual’s genes that involves the administration of a specific DNA (or RNA). Cell therapy is used to administer whole cells or maturation of a specific cell population in a patient for the treatment of a disease. In many diseases, gene and cell therapy are combined in the development of promising therapies.

In gene therapy, modified viruses are used as gene delivery vectors. Viral vectors are genetically engineered so that most of their essential genes are missing, which prevents uncontrolled replication of the virus and makes room for insertion of the gene to be delivered.

In cell therapy, a great range of cells can serve in the therapy including blood and bone marrow cells, mature and immature solid tissue cells, adult stem cells and, most controversially, embryonic stem cells.

According to market research by Arizton, the gene and cell therapies market will reach global revenues over $6.6 billion by 2024, and treat incurable disease conditions, providing safe and efficacious treatment compared to small molecule drugs.

Section 201(h) of the Food, Drug and Cosmetics Act defines medical technologies as instruments, apparatus, machines and their component parts and accessories intended for use in the diagnosis of disease, or disease cure, mitigation, treatment, or prevention that are intended to affect the structure or function of the body and which does not achieve its primary intended purposes through chemical action within the body.

The medical technologies industry (sometimes referred to as the medical device industry) contains a wide range of products which help in the diagnosis and treatment of a patient’s medical condition. These include computed tomography (CT) scanners, magnetic resonance imaging (MRI) machines, cardiac stents, X-rays, orthopedic appliances, and defibrillators. 

U.S. manufacturers shipped $141 billion in medical technologies in 2018, according to the U.S. Census Bureau, a $10 billion increase from 2016. The United States has the largest percentage share of the global market, at approximately 40 percent. In addition, U.S. medical technology manufacturers are globally competitive across many product categories, exporting nearly $31 billion in 2019. Medical technology companies also reinvest a significant portion of revenues in Research & Development, both because the average product lifecycle ranges between 18-24 months, and to incorporate new features and innovative technologies to treat patients.

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. 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. Regulatory challenges also pose difficulties for growth of the radiological medicine market.
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.

Health IT is the application of information processing involving both computer hardware and software that deals with the storage, retrieval, sharing, and use of health care information, data, and knowledge for communication and decision making.[1]  Health IT intersects with many subsectors and other industries, including medical devices, pharmaceuticals, software and services, and contributes to the delivery of telehealth and mobile health solutions.

Health IT (sometimes referred to as eHealth, digital health, or connected health) incorporates many components from the health, information and communication technologies (ICT), and services sectors to deliver improved healthcare to patients using technology. These components include healthcare services (managing hospitals, treatment protocols, and administering claims data), data-related services (storage, analytics), ICT hardware (computers, mobile phones), medical devices (collecting and storing data and images to help patient care), tools for educating sector professionals, and software (electronic health records, clinical decision software). Technical standards, availability of high-speed Internet and modern mobile phone networks, reliable power supplies, and security of data and images are also important factors impacting Health IT sector activity.

No distinctive HS codes showing Health IT exports currently exist. Products that could be used to facilitate Health IT are mixed together with products used for other purposes.