While development of a parenteral drug formulation is challenging, highly regulated, and requires high investment, the market of specialty excipients is forecast to grow faster in the parenteral route compared to the oral solids route. Driven by a growing need for oncology drugs, the market of specialty excipients in the parenteral segment is expected to grow at 7.5% annually in the United States and Europe combined in the next five years, finds the recently published Specialty Excipients for Parenteral Pharmaceuticals: Market Analysis and Opportunities report.
“There is no doubt that oral route continues to be the major market for excipients globally due to their high patient compliance and competitive manufacturing costs; however, injectable is a much faster growing segment,” comments Shilpi Mehrotra, the report’s manager. “With the emergence of increasingly complex APIs, notably large biologics, and poorly soluble small molecules, the parenteral pharmaceuticals segment is creating new opportunities for excipients suppliers.”
Biologics that are widely used to treat serious and life-threatening diseases is a significant trend driving the demand for parenteral formulations. It is estimated that around 50% to 60% of drugs currently in development are biologics. Due to their complexity, instability, and poor solubility, biologics are mainly developed into parenteral formulations.
Moreover, the loss of patent protection of nearly 50% of current biologics reference products by 2022 is driving the development of biosimilars. Biosimilars are administered the same way as their biologics counterparts, mainly as parenteral preparations also aiding growth of parenteral administration.
North America and Europe together make up more than 80% of the market of specialty parenteral excipients. Liquid solutions is the largest formulation market for parenteral excipients, while market shares vary by volume and value due to their prices. Certain excipients have very high prices, which leads to a high value share despite its low volume consumption.
Dextrose is the most widely used specialty excipient in the parenteral formulations segment by both volume and value. The wide use of dextrose and sodium chloride is primarily because they are used as tonicity adjusting agents crucial for parenteral formulations, which must be isotonic with blood.
The growth of specialty excipients for pharmaceutical parenteral formulations is estimated at nearly 8%. Polysorbate-80 is expected to witness the highest growth as it is one of the most used surfactants in parenteral formulations in lyophilized, liquid solutions, and suspensions. Some drugs using Polysorbate-80 include Humira (AbbVie), Rituxan (Roche), Avastin (Roche), and Prevenar (Pfizer).
The competitive landscape is consolidated for high specialty excipients and relatively fragmented for lesser specialty excipients. Overall, Roquette is the leading supplier in Europe and the United States, with Cargill also in the top three. Among the other top suppliers are those that offer relatively large volume excipients, such as US Salt and Motron Salt, but also suppliers of smaller quantity high-value products, such as Pfanstiehl.
With the growing need of advanced drug formulation science, excipient suppliers will increasingly have to work with specialized drug delivery laboratories instead of offering their products to pharmaceutical companies directly. This will take care of the guidelines of March 19, 2015 on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use.
To learn more about this market, REQUEST your access to a recently held webinar Market Spotlight: Specialty Excipients for Parenteral Pharmaceuticals.