Kline Confirms that Excipients are on the Rise in a New Era for Biologics and Topicals


The global pharmaceutical industry is facing a surge biologics. In recent years, biologic drugs have enjoyed a better approval rating than traditional drugs, as biologic drugs have been found to treat major chronic and complex diseases with higher safety and efficacy. The global production of biologics is expected to grow at a rate of around 10% annually.

The selection and use of the right ingredients and excipients are extremely critical for biologics because are not only key components of the biologic drug dosage but also play a very important role in the development and manufacturing of the biologic drug itself. The market of ingredients and excipients in biopharma is expected to grow at around 9% over the next five years. Carbohydrates, polymers, and amino acids are among the particularly fast-growing ingredient groups in this industry.

Some ingredients are consumed in the early upstream production stage in the bioreactor, such as the various cell culture media and expression system platforms, while certain types of ingredients are used in high quantities in the recovery and purification stages, such as surfactants and certain sugars. There are also some that are used in considerable amounts across all the stages. A much bigger market of bioprocessing ingredients and excipients can be found in the upstream and downstream manufacturing processes than that in the final drug formulation. Cell culture nutrients and supplements is a fast-growing category in the upstream, while poloxamers and amino acids are observed to be growing fast in the downstream processes.

Pfanstiehl, Merck, and Roquette are few of the largest suppliers of ingredients/excipients in this market by value. The biologics ingredients market has large potential not only for growth but also for new entrants.

Kline’ upcoming report Biologics: Market Opportunities for Chemicals Suppliers will assist chemical suppliers in understanding the entire biologics value chain and identifying business opportunities within this key growth area.


Although currently holding a relatively small share of the pharmaceutical market, topical drug delivery is witnessing robust growth because of its ability to surpass the metabolism pathways of the stomach and liver and deliver localized treatment. In addition, topical drug delivery industry is witnessing technological advancements through the introduction of solid lipid nanoparticles, nano-encapsulation, micro-needles, and microspheres, which will further drive the demand of specialty excipients in this application market.

The United States and Europe are the two biggest markets for specialty excipients for the topical pharmaceuticals globally, with the U.S. market growing at a slightly higher rate than Europe. Emollients is by far the biggest category of excipients and accounts for nearly 70% of the total excipients volume in the topical pharmaceutical applications of both regions combined. As sensory feel is an increasingly important factor demanded in topical pharmaceuticals as it is in the cosmetics industry, the need to improve flow properties and smoothness will lead to a relatively faster growth of rheology modifiers and emollients categories of excipients in the topical application.

The major suppliers in the overall topical excipients market in the two regions taken together are Sonneborn, Sasol, Calumet, BASF, and Croda.

Excipients for Topical Pharmaceuticals Market report, scheduled to be published in July, will closely look at the excipients used in topical pharmaceutical formulations, the functions and properties each of the excipients brings to the formulations, their consumption and supply, and the drivers and restraints affecting the market. It will be comprised of two key deliverables—a fully interactive database based on a new platform and a report per excipient category and excipient group for each region covered in the study.

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