Market Trends: Trends in the Solid Oral Drug Delivery Market

In recent years, parenterally delivered biologics have increasingly penetrated the pharmaceutical market due to their growing use in regenerative and personalized medicine as well as the development of new biologics and biosimilars. Despite this increasing use of parenteral drug delivery methods, solid oral dosage forms (SODFs) remain the most common drug delivery method, and the solid oral drug delivery market continues to grow. 

The FDA approval rate for SODFs has increased over the past several years. From 2015 to 2017, the FDA approved 39 tablets and 14 capsules, as shown in Table 1. Of the 45 drug products approved by the FDA in 2015, approximately 55 percent were SODFs. In 2017, half of 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.

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 epilepsy medicine manufactured by Aprecia 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.

ODTs 

In recent years, the pharmaceutical industry has seen increasing development of orally disintegrating or orodispersible tablets (ODTs) due to their growing use for pediatric, geriatric, and psychiatric patients with dysphagia. Many patients accept and often prefer ODTs because the tablets easily dissolve or disintegrate in the mouth. Other factors driving ODT market growth include improved tablet stability, adequate dissolution rates, faster and easier production processes, increased bioavailability or rapid absorption, and smaller packaging. 

Many pharmaceutical companies are developing numerous ODTs using basic manufacturing technologies such as freeze drying, spray drying, molding, sublimation, mass extrusion, and direct compression. To improve ODT quality, pharmaceutical excipient manufacturers are developing novel excipients as well as combining already-existing excipients. These co-processed excipients (Table 2) are designed to improve the formulation’s or final product’s flowability, compressibility, hygroscopicity, palatability, dissolution, and/or disintegration properties. 

Market outlook 

As the pharmaceutical market faces increasing financial pressure, pharmaceutical companies are outsourcing their manufacturing processes, expanding production capacities, and adopting innovative drug development techniques such as 3D printing, freeze drying, spray drying, molding, sublimation, mass extrusion, and direct compression to develop ODTs and optimize their marketed products. In the coming years, these trends should lead to the more widespread adoption of novel technologies in pharmaceutical manufacturing and drive growth in the market for SODFs.