History of Pharmaceutical Industry
Pharmaceutical industry is a trillion-dollar industry that produces products that improve the quality of life of billions of people. It can be viewed as a complex system of drug discovery and development. The development of pharmaceutical industry experienced a major leap forward in 19th century. Since then, the evolution of scientific knowledge has paved the foundation for most modern pharmaceutical inventions. A large number of pharmaceutical companies around the world have emerged to participate in the activities of pharmaceutical industry operations. As the pharmaceutical industry grows, the regulatory bodies play a major role in overseeing the approval, production, marketing, consumption, and surveillance of pharmaceuticals.
Fig.1 History of Pharmaceutical Regulations (Suzanne, 2013)
A history of pharmaceutical companies
The roots of the modern pharmaceutical industry lie back with local apothecaries and pharmacies in the second half of the 19th century. The earliest company to move the development of pharmaceutical industry is Merck in Germany, which began the transition towards an industrial and scientific concern in 1827. Similarly, GlaxoSmithKline (GSK), Pfizer, and Lilly became involved in the industrial production of medicine. Later, discoveries in genetics, biochemistry, vaccine, and bacteriology have paved the foundation for most modern pharmaceutical inventions. Many pharmaceutical companies have emerged in Switzerland, Germany, Italy, the United Kingdom, and the United States. With the advances in pharmaceutical-related sciences, such as molecular biology, a large number of effective pharmaceuticals were invented and produced.
Introduction to pharmaceutical regulation
Throughout the history of pharmaceutical development, pharmaceutical regulations are aimed to maintain the standards of the drug at every step and ensure the quality of the drugs available to consumers. In the early years of pharmaceutical medicine, pioneers were only focused on innovation and entrepreneurship. With the development of pharmaceutical industry, people realized that all pharmaceutical organizations must adhere to regulatory oversights. Every country has its regulations that apply to the drug discovery and development process, such as the well-known United States Food and Drug Administration (FDA). The pharmaceutical regulations are accomplished through a range of regulatory activities throughout a drug's life cycle. In the early years of pharmaceutical medicine, pioneers were focused on innovation and entrepreneurship, but the regulatory framework for the drug industry has become increasingly complex currently.
Global pharmaceutical manufacturing market
With the emergence of advanced technologies, the pharmaceutical industry has undergone a massive transformation. Artificial Intelligence (AI) has reduced manufacturing costs and time, and the increasing investment flow has had a positive impact on market growth. In 2020, the global pharmaceutical manufacturing market size was valued at USD 405.52 billion and is expected to grow at a high compound annual growth rate in the next few years. In addition, mergers & acquisitions have increased in the past few years in the pharmaceutical industry. Many well-established companies are consolidating to enhance their market position and strict regulations have capped drug prices resulting in a large number of mergers & acquisitions. All the highly competitive environments have propelled drug manufacturing.
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Dunne, S., Shannon, B., Dunne, C. and Cullen, W., 2013. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacology and Toxicology, 14(1).
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