Pharmaceutical industry

The pharmaceutical industry is a medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications. Medications are then administered to (or self-administered by) patients for curing or preventing disease or for alleviating symptoms of illness or injury. Generic drugs are typically not protected by patents, whereas branded drugs are covered by patents. The industry's various subdivisions include distinct areas, such as manufacturing biologics and total synthesis. The industry is subject to a variety of laws and regulations that govern the patenting, efficacy testing, safety evaluation, and marketing of these drugs. The global pharmaceutical market was valued at approximately US$1.48 trillion in 2022, reflecting steady growth from 2020 and continuing expansion despite the impacts of the COVID-19 pandemic. The sector showed a compound annual growth rate (CAGR) of 1.8% in 2021, including the effects of the COVID-19 pandemic. In historical terms, the pharmaceutical industry, as an intellectual concept, arose in the middle to late 1800s in nation-states with developed economies such as Germany, Switzerland, and the United States. Some businesses engaging in synthetic organic chemistry, such as several firms generating dyestuffs derived from coal tar on a large scale, were seeking out new applications for their artificial materials in terms of human health. This trend of increased capital investment occurred in tandem with the scholarly study of pathology as a field advancing significantly, and a variety of businesses set up cooperative relationships with academic laboratories evaluating human injury and disease. Examples of industrial companies with a pharmaceutical focus that have endured to this day after such distant beginnings include Bayer (based in Germany) and Pfizer (based in the U.S.). The pharmaceutical industry has faced extensive criticism for its marketing practices, including undue influence on physicians through pharmaceutical sales representatives, biased continuing medical education, and disease mongering to expand markets. Pharmaceutical lobbying has made it one of the most powerful influences on health policy, particularly in the United States. There are documented cases of pharmaceutical fraud, including off-label promotion and kickbacks, resulting in multi-billion dollar settlements. Drug pricing continues to be a major issue, with many unable to afford essential prescription drugs. Regulatory agencies like the FDA have been accused of being too lenient due to revolving doors with industry. During the COVID-19 pandemic, major pharmaceutical companies received public funding while retaining intellectual property rights, prompting calls for greater transparency and access.

History

Mid-1800s–1945 The modern era of the pharmaceutical industry began with local apothecaries that expanded their traditional role of distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid-1800s. Intentional drug discovery from plants began with the extraction of morphine – an analgesic and sleep-inducing agent – from opium by the German apothecary assistant Friedrich Sertürner somewhere between 1803 and 1805. Sertürner later named this compound after the Greek god of dreams, Morpheus. Multinational corporations including Merck, Hoffman-La Roche, Burroughs-Wellcome (now part of GSK), Abbott Laboratories, Eli Lilly, and Upjohn (now part of Pfizer) began as local apothecary shops in the mid-1800s. By the late 1880s, German dye manufacturers had perfected the purification of individual organic compounds from tar and other mineral sources and had also established rudimentary methods in organic chemical synthesis. The development of synthetic chemical methods allowed scientists to systematically vary the structure of chemical substances, and growth in the emerging science of pharmacology expanded their ability to evaluate the biological effects of these structural changes.

Epinephrine, norepinephrine, and amphetamine By the 1890s, the profound effect of adrenal extracts on many different tissue types had been discovered, setting off a search both for the mechanism of chemical signaling and efforts to exploit these observations for the development of new drugs. The blood pressure raising and vasoconstrictive effects of adrenal extracts were of particular interest to surgeons as hemostatic agents and as a treatment for shock, and several companies developed products based on adrenal extracts containing varying purities of the active substance. In 1897, John Abel at the Johns Hopkins University identified the active substance as epinephrine, which he isolated in an impure state as the sulfate salt. Industrial chemist Jōkichi Takamine later developed a method for obtaining epinephrine in a pure state and licensed the technology to Parke-Davis. Parke-Davis marketed epinephrine under the trade name Adrenalin. Injected epinephrine proved to be especially efficacious for the acute treatment of asthma attacks, and an inhaled version is sold over the counter in the United States. (Primatene Mist). By 1929 epinephrine had been formulated into an inhaler for use in the treatment of nasal congestion. While highly effective, the requirement for injection limited the use of epinephrine and orally active derivatives were sought. A structurally similar compound, ephedrine, was identified by Japanese chemists in the Ma Huang plant and marketed by Eli Lilly as an oral treatment for asthma. Following the work of Henry Dale and George Barger at Burroughs-Wellcome, academic chemist Gordon Alles synthesized amphetamine and tested it in asthma patients in 1929. The drug proved to have only modest anti-asthma effects but produced sensations of exhilaration and palpitations. Amphetamine was developed by Smith, Kline and French as a nasal decongestant under the trade name Benzedrine Inhaler. Amphetamine was eventually developed for the treatment of narcolepsy, post-encephalitic parkinsonism, and mood elevation in depression and other psychiatric indications. It received approval as a New and Nonofficial Remedy from the American Medical Association for these uses in 1937, and remained in common use for depression until the development of tricyclic antidepressants in the 1960s.

Discovery and development of the barbiturates

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