Pharmaceuticals Industry

The Pharmaceutical Industry The pharmaceutical industry develops, produces, and markets drugs or pharmaceuticals licensed for use as medications. Pharmaceutical companies are allowed to deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations regarding the patenting, testing and ensuring safety and efficacy and marketing of drug.

Continue……… Most of today's major pharmaceutical companies were founded in the late 19th and early 20th centuries. Key discoveries of the 1920s and 1930s, such as insulin and penicillin, became mass-manufactured and distributed. Switzerland, Germany and Italy had particularly strong industries, with the United Kingdom, the United States, Belgium and the Netherlands following them.

Drug Discovery Drug discovery is the process by which potential drugs are discovered or designed. In the past most drugs have been discovered either by isolating the active ingredient from traditional remedies or by unexpected discovery. Modern biotechnology often focuses on understanding the metabolic pathways related to a disease state. A great deal of early-stage drug discovery has traditionally been carried out by universities and research institutions.

Drug Development Drug development refers to activities undertaken after a compound is identified as a potential drug in order to establish its suitability as a medication. Objectives of drug development are to determine appropriate formulation and dosing, as well as to establish safety. Research in these areas generally includes a combination of in vitro studies, in vivo studies, and clinical trials. The amount of capital required for late stage development has made it a historical strength of the larger pharmaceutical companies.

The cost of innovation Drug companies are like other companies in that they manufacture products that must be sold for a profit in order for the company to survive and grow. Drug business is very risky. For instance, only one out of every ten thousand discovered compounds actually becomes an approved drug for sale. Much expense is incurred in the early phases of development of compounds. In addition, it takes about 7 to 10 years and only 3 out of every 20 approved drugs bring in sufficient revenue to cover their developmental costs, and only 1 out of every 3 approved drugs generates enough money to cover the development costs of previous failures. This means that for a drug company to survive, it needs to discover a blockbuster (billion-dollar drug) every few years

Industry Competitors (Market Share)

Product approval According to Forbes, development costs between $4 billion to $11 billion per drug. In the united States, new pharmaceutical products must be approved by the Food and Drug Administrtaion (FDA) as being both safe and effective. This process generally involves submission of an Investigational New Drug (IND) with sufficient pre-clinical data to support proceeding with human trials. Following IND approval, three phases of human clinical trials may be conducted. Phase I studies toxicity using healthy volunteers. Phase II can include pharmacokinetics and dosing in patients, and Phase III is a very large study of efficacy in the intended patient population. Successful completion of phase III testing, a NEW Drug Application is submitted to the FDA. The FDA review the data and if the product is seen as having a positive benefit-risk assessment, approval to market the product in the US is granted.

Marketing Pharmaceutical companies commonly spend a large amount on advertising, marketing and lobbying. Pharmaceutical companies generally employ sales people (often called 'drug reps' or, an older term, 'detail men') to market directly and personally to physicians and other healthcare providers.

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