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