Pharmaceutical chemicals (APIs, intermediates, raw materials), contract research and manufacturing services (CRAMS), biotechnology, specialty lab and research services
Pharmaceutical industry is the part of the healthcare sector that deals with medications. It is generally comprised of drug manufacturers, drug marketing companies, and biotechnology which generally focuses on novel drug development.
Pharmaceutical chemicals include
active pharmaceutical ingredients (APIs), chemical intermediates and raw materials used in drug manufacture. APIs are also referred to as bulk pharmaceuticals and are the central ingredients responsible for the therapeutic effects of the drugs. Notable API manufacturers include Teva Active Pharmaceutical Ingredients, AstraZeneca, Dr. Reddy’s, Sandoz-Lek-Biochemie, Ranbaxy, Matrix, and Sun. Today, the greatest concentrations of API manufacturers are located around Asia, specifically in India and China, leading to more and more companies outsourcing API manufacturing to these places.
Besides the bulk API products, research and development as well as manufacturing of finished pharmaceuticals is increasingly outsourced, giving rise to the Contract Research and Manufacturing Services (CRAMS). A Contract Research Organization (CRO) provides research services (biopharmaceutical development, preclinical & clinical research, clinical trials management, regulatory consulting, site management and pharmacovigilance, etc.) to the pharmaceutical, biotechnology, and medical device industries on a contract basis. A Contract Manufacturing Organization (CMO) sometimes also referred to as a contract development and manufacturing organization (CDMO), provides diverse services ranging from development to manufacturing (e.g. pre-formulation, formulation development, stability studies, method development, pre-clinical and phase I/II/III clinical trial materials, late-stage clinical trial materials, stability studies, scale-up, and registration batches and commercial production). The CROs and CDMOs are supplemented by specialty laboratories that fill in the gaps in their product and service offerings.
The global pharmaceutical industry is above $1 trillion in size. The United States is the world’s largest market for pharmaceuticals and the world leader in biopharmaceutical research. An aging workforce and population, rapid expansion of tertiary education both in developed as well as emerging economies, higher concentration and levels of R&D funding, and declining barriers for entrepreneurs are some of the trends driving the growth of the industry.
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