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Pharmaceuticals and Biopharmaceuticals
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Pharmaceuticals and Biopharmaceuticals

Pharmaceuticals and Biopharmaceuticals

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.

Additional Subsector Information

Please see below for additional information specific to Pharmaceuticals and Biopharmaceuticals

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.[1]

[1] Cision PR Newswire: The Cell and Gene Therapy Market to Reach Revenues of Over $6.6 billion by 2024 - Market Research by Arizton. https://www.prnewswire.com/news-releases/the-cell-and-gene-therapy-market-to-reach-revenues-of-over-6-6-billion-by-2024–market-research-by-arizton-300957463.html. 11/19/2019

Veterinary drugs are medicines used to care for animals in the pursuit of animal welfare. These medicines improve the health of domestic and farm animals and the productivity of livestock. The veterinary drug industry includes product segments such as anti-infectives, parasiticides, and diagnostics, among others. 

The global veterinary drugs market is expected to grow to over $27 billion in value by the end of 2025, driven by increased animal ownership and rising demand for animal-derived products.[1]  

Parasiticides, anti-infectives, and anti-inflammatory medicines are three growing product segments as companion pet ownership and livestock rearing increase. Antibiotic-resistant bacteria are also affecting the health of animals. Thus, the vetindustry aims to develop stronger diagnostic devices and tools to combat the rise of antibiotic-resistant bacteria. Areas experiencing growth include Europe, Asia Pacific, Latin American, the Middle East, and Africa.

[1] Fortune Business Insights: Healthcare/Veterinary Drugs Market Key Market Insights. https://www.fortunebusinessinsights.com/industry-reports/veterinary-drugs-market-100171. 6/5/2020

2019 U.S. Exports of Pharmaceuticals in Millions of Dollars (HS Codes)

291822

Acetlysaliylic Acid (Aspirin) Salts, and Esters

$0

292146

Amphetamines, Benzephetamine, etc., and salts thereof 

$4

292214

Dextropropoxyphene and its salts

$1

292219

Amino-alcohols, ethers, etc., oxygen funct. NESOI

$289

292231

Amfepramone, methadone and normethadone and salts

$1

292241

Lysine and its esters, salts thereof

$156

292250

Amino-alcohol-phenols, amino-acid phenols

$55

292411

Meprobamate (Inn)

$1

292512

Flutethimide (Inn)

$0

293311

Phenazone and its derivatives

$0

293333

Alfentanil, anilerdine, bezitramide, etc, and salts

$5

293339

Compounds containing unfused pyridine ring etc NESOI

$1,052

293341

Levorphanol (Inn) and its salts

$0

293349

Heterocyclic comp. w/quinoline etc. ring-system

$5

293352

Malonylurea (Barbituric acid) and its salts

$0

293353

Allobarbital, amobarbital, barbital butalbital, etc.

$1

293354

Derivatives of malonylurea (barbituric acid) & salts

$0

293359

Comp with pyrimidine or piperazine ring, NESOI

$188

293372

Clobazam (Inn) and methyprylon (Inn)

$0

293391

Alprazolam, camazepam, clonazepam, etc, its salts thereof

$2

293399

Heterocyclic comp w nitrogen hetero-atm only NESOI

$242

293430

Heterocyclic comp w phenothiazine ring-system

$16

293491

Aminores, brotizolam-clotiazepam, etc & salts

$1

293499

Nucleic acids & salts; other heterocyclic cmp, NESOI

$860

293621

Vitamins and their derivatives unmixed

$50

293622

Vitamin B1 (thiamine) and its derivatives

$3

293623

Vitamin B2 (riboflavin) and its derivatives

$2

293624

D or DL pantothetic acid (vitamin B3 or B5) and derivatives

$17

293625

Vitamin B6 (pyridoxine etc) and its derivatives

$2

293626

Vitamin B12 and its derivatives

$5

293627

Vitamin C (ascorbic acid) and its derivatives

$52

293628

Vitamin E and its derivatives unmixed

$77

293629

Vitamins and their derivatives, unmixed, NESOI

$300

293690

Vitamins, including natural concentrates etc. NESOI

$210

293711

Somatotropin, its derivatives and structural analog

$54

293712

Insulin and its salts

$1,516

293719

Polypeptide protein & glycoprotein hormones and derivatives

$1,640

293721

Cortisone, hydrocortisone prednisone, etc.

$23

293722

Halogenated derivatives of adrenal cortical hormones

$13

293723

Estrogens and progestins

$60

293729

Adrenal cortical hormones and derivatives NESOI

$632

293750

Prostaglandins, thromboxanes & leukotrienes & derivatives

$110

293790

Hormones, prostaglandins, etc, & derivatives, NESOI

$67

293810

Rutoside (rutin) and its derivatives

$0

293890

Glycosides, natural or synthetic and derivatives, NESOI

$28

293911

Conc of poppy straw, codeine & other specif opium alko

$20

293919

Alkaloids of opium & derivatives, salts thereof NESOI

$46

293920

Alkaloids of cinchona & derivatives, salts thereof

$0

293930

Caffeine and its salts

$5

293941

Ephedrines and their salts

$0

293942

Pseudoephedrine and their salts

$0

293949

Ephedrines and their salts, NESOI

$0

293951

Fenetlline (inn) and its salts

$0

293959

Theophylline and aminophylline & deriv & salts, NESOI

$0

293961

Ergometrine and its salts

$0

293962

Ergotamine and its salts

$0

293963

Lysergic acid and its salts

$0

293969

Alkaloids of rye ergot and their derivatives, NESOI

$1

294119

Penicillins & derivatives with penicillanic acid and salts

$7

294120

Streptomycins and their derivatives, salts thereof

$1

294130

Tetracyclines and their derivatives, salts thereof

$1

294149

Chloramphenicol and its derivatives, salts thereof

$0

294150

Erythromycin and its derivatives, salts thereof

$47

294190

Antibiotics, NESOI

$391

300120

Extracts of glands or other orgs or secretions

$61

300190

Heparin and its salts, other human or animal substance

$523

300220

Vaccines for human medicine

$1,860

300230

Vaccines for veterinary medicine

$515

300290

Human blood, animal blood prep, toxins, cultures, etc.

$1,682

300310

Medicaments cont penicillins or derivatives, etc.

$8

300320

Medicaments containing antibiotics NESOI, etc.

$36

300331

Medicaments containing insulin, no antibiotics, etc.

$119

300339

Medicaments containing hormones, no antibiotics, no doses

$168

300390

Medicaments NESOI, not in dosage form, etc.

$1,028

300410

Penicillins or streptomycins & derivatives, dosage form

$69

300420

Antibiotics NESOI, in dosage form

$741

300431

Medicaments containing insulin, no antibiotics, dosage

$233

300432

Medicaments containing cortex hormones etc. doses

$439

300439

Hormones etc, (no antibiotics contained) dosage form

$904

300450

Vitamins, natural or synthetic, dosage etc. form

$455

300490

Medicaments, NESOI, measured doses, retail pk NESOI

$16,961

300620

Blood grouping reagents

$80

300630

Opacifying preparations for x-ray examinations, etc.

$61

300660

Chemical contraceptive preps based on hormones

$34

300692

Waste pharmaceuticals

$6

Total

 

$34,245