Continuous manufacturing technology is a process which involves uninterrupted manufacturing which enables faster production with more reliable products. Continuous manufacturing in the pharmaceutical industry has brought significant changes which enabled the industry to grow at a faster pace meeting the requirements of the increasing demand. Continuous manufacturing in the pharmaceutical industry has made the industry realize that the cost incurred on drug development is significant, new products are to be manufactured in lesser quantities, and but there is a requirement of novel treatments the development of a commercial manufacturing process is not always guaranteed.
Continuous manufacturing technologies have brought factors such as cost pressures, risk, and timelines associated with traditional batch based technologies under scrutiny. Continuous manufacturing technology in pharmaceutical means that an active ingredient is produced in compact, closed unit, with high degree of automation and requires few manual intervention. According to a report published by the National Science and Technology Council (NSTC) in April 2016, continuous manufacturing in pharmaceuticals is one of the five manufacturing technology areas of emerging priority.
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Growth of continuous manufacturing technology in pharmaceuticals is attributed to verification of product quality and real time production, less investment and manufacturing cost with higher efficiency and low carbon dioxide production, faster availability of product to the market, greater flexibility in production during the entire product life cycle, minimal waste, less energy consumption, and less raw material requirement. However, technical challenges, business and operational challenges, regulatory challenges, and workforce challenges restrain the growth of the pharmaceutical continuous manufacturing technology market.
Technical challenges include characterization and handling of drug substance, development of accurate process for operations, optimal approach for startup, and shutdown of the process. The conservative business culture of the pharmaceutical industry is also considered to be a restrain the continuous manufacturing technology market. The pharmaceutical sector is highly regulated and aligns strongly through the FDA and ICH guidelines. Pharmaceutical manufacturing companies require to gain approval for their products in multiple countries undergoing country specific regulatory approval process.
The FDA has been promoting continuous manufacturing for almost a decade, but not all regulatory bodies are willing to approve the same. Skilled workforce is a major challenge in the smooth working of pharmaceutical continuous manufacturing technology. The designing, implementation, and regulation of the activities require highly skilled workforce at both levels: industry and regulatory bodies.
The pharmaceutical continuous manufacturing technology market can be segmented base on application, end-user, and region. In terms of application, the market can be segmented into drug development, development of new process, and others. Based on end-user, the market can be segmented into pharmaceutical companies, research organization, and CMOs.
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In terms of region, the pharmaceutical continuous manufacturing technology market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominates the pharmaceutical continuous manufacturing technology market in terms of revenue. Well-structured economy, increasing spending on innovation in the pharmaceutical field, and rising competition are likely to drive the pharmaceutical continuous manufacturing technology market in North America. Europe is the second largest market for pharmaceutical continuous manufacturing technology in terms of revenue.
Innovation in medical technology is likely to boost the growth of the pharmaceutical continuous manufacturing technology market in Europe. Asia Pacific has high potential for continuous pharmaceutical technology, as economic development has led to increase in government spending on the development of health care infrastructure. In-house production will make health care services available at low cost to the population and contribute to the growth of the industry. Latin America and Middle East & Africa are emerging markets due to increased emphasis on industrialization.
Companies using continuous manufacturing technologies are Novartis AG, Siemens Healthineers, Genzyme, Bayer AG, Janssen, Merck-Serono, and Eli Lilly and Company, among others.
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