Tablets & Capsules

TC0318

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30 March 2018 Tablets & Capsules Rationalization of production capacity During the past several years, many pharmaceutical companies have expanded their production capacities for SODFs. In April 2015, Catalent Pharma Solutions expanded its Winchester, KY, facility to meet increased customer demand for the manufacture of complex SODFs. In June 2017, Takeda Pharmaceutical Company expanded its manufacturing facility at the company's Oranienburg location in Germany. Similarly, in October 2017, Capsugel, now a Lonza company, announced expanded clinical trial capabilities as well as increased development and manufacturing capabilities for specialized drug products utilizing liquid-filled hard capsule (LFHC) technology at its Edinburgh facility in Scotland. In October 2017, Pfizer CentreOne, a global CMO embedded within Pfizer, expanded its contract manufacturing capabilities to Nagoya, Japan to provide in-country manufacturing of highly potent SODFs. Various other pharmaceutical companies operating in the SODF market have also expanded or established new production facilities. 3D printing The solid oral drug delivery market has seen increasing use of 3D printing technologies for the manufacture of oral tablets. In August 2015, Spritam, an e p i l e p s y m e d i c i n e m a n u f a c t u r e d b y A p r e c i a Pharmaceuticals, Blue Ash, OH, became the first 3D-printed drug product to be approved by the FDA. 3D printing offers freedom of design with respect to factors such as API dosage, API distribution within the SODF, excipient use and distribution, and tablet structure and shape, allowing for personalized drug treatment. 3D printing also allows drug developers to create dosage forms with complex shapes for delivering drugs in different ways. Various pharmaceutical companies as well as academic and research institutes are working together to develop different ways of using 3D printers to fabricate active pharmaceutical agents. For example, GlaxoSmithKline is developing a 3D-printed SODF, and scientists from the University College of London are also developing 3D-printed drug products in a wide range of shapes and sizes, such as dinosaur- and octopus-shaped tablets, designed to make prescription adherence easier and more appealing for children. Commercial sale of these 3D-printed tablets is expected to begin within the next 5 to 10 years. With the growing trend of personalized medicine, 3D-printed SODFs have huge potential for growth. the approved drug products were SODFs. The prevalence of SODFs is one of the key factors driving growth in the solid oral drug delivery market. However, several industry trends, such as increased outsourcing, the rationalization of production capacity, 3D printing, and orally disintegrating or orodispersible tablets (ODTs) are also expected to drive growth. Outsourcing To reduce costs, pharmaceutical companies increasingly outsource drug product development and manufacturing functions to contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs). The global outsourced pharmaceutical manufacturing market was valued at approximately $77 to $79 billion in 2016 and is expected to grow at a compound annual rate of 6 to 7 percent over the next five years. SODFs account for nearly 50 percent of total drug product outsourcing. According to a 2016 survey by Nice Insight, around 75 percent of pharmaceutical companies outsource clinical-scale manufacturing of SODFs. For commercial-scale manufacturing, SODFs are the most outsourced dosage form as well, followed by semi-solid and liquid dosage forms. In the coming years, several SODF patents are expected to expire, including the patents for Fentora, Lyrica, and Treximet. These expiring patents will likely cause a surge in the market as companies develop generic counterparts of these drug products. Large pharmaceutical companies will likely outsource the manufacture of these generics to CMOs in order to focus on their core competencies. At the same time, shrinking drug pipelines and the increasing costs of developing new drugs are causing many pharmaceutical companies to evaluate their existing drug molecules for new indications. This is may also increase outsourcing, since these pharmaceutical companies will likely turn to CDMOs and CMOs for the development and manufacturing of any SODF products that result from this research. Table 1 FDA approvals for novel drug products (2015-2017) 2015 2016 2017 Total Total approved products 45 22 46 114 Tablets 15 7 17 39 Capsules 9 0 5 14 Granules 1 0 1 2 Percentage of approved products that were SODFs ~57 ~32 ~50 ~48 Source: US FDA With the growing trend of personalized medicine, 3D-printed SODFs have huge potential for growth.

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