Review analyses the trajectory of biologic APIs


Kline review has predicted that growth of biologics and biosimilars will drive above-average demand for a range of ingredients through 2023

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Since biologics are quite large in comparison to small APIs and made up of proteins, they require extra care to maintain their size, shape, form, and stability. These factors correlate to the intended effect and efficiency of the biologic drug. Because of this, the development of biologics is difficult compared to small APIs. Aside from all the aforementioned challenges, the share of biologics in the development pipeline has been steadily increasing in the last decade.

In 2018, biologics constituted more than 40% of the pharmaceutical industry pipeline said Kline's recently published Biologics: Market Opportunities for Chemicals Suppliers

Among the competition to biologics are the generic versions of novel biologic drugs called biosimilars.

"While biologics remained fairly insulated from the threat of generic competition in the past, it has changed with the passage of the Affordable Care Act," said Shilpi Mehrotra, Manager of Kline's project. "Due to patent expirations, there will be an increase in the number of biosimilars in the biopharmaceutical market. However, biopharmaceutical companies continue to invest in novel biologics research, especially for oncology and immunology, which ensures that the pharmaceutical pipeline is filled with biologics."

Speciality ingredients are required in not only the formulation of biologic drugs but also in their production

Biologics drug development is an impending opportunity for ingredient suppliers, especially, because speciality ingredients are required in not only the formulation of the biologic drugs but also in their production, starting from the upstream cell culture in bioreactors, followed by downstream processing, pre-formulation of the drug, and, finally, the fill-finish. While excipients are mainly used in the later stages of formulation and fill-finish, there is a wide range of bioprocessing ingredients essential to the upstream and downstream stages.

The demand for bioprocessing ingredients is currently dominated by the cell culture ingredients and supplements category. The category is expected to grow at an above-market average compound annual growth rate (CAGR) of around 10% between 2018 and 2023. Moreover, the consumption of fill-finish and pre-formulation excipients is expected to increase at a high rate with the growth of biologics production. The consumption of biologic excipients is forecast to grow at an average annual rate of 8% to 9% in the next five years.

The market of biologics is presently dominated by the United States and Europe. The development of novel drugs is advanced in these regions, whereas the rest of the world is focusing on the development of biosimilars. For comparison, by the end of 2018, more than 20 biosimilars have entered the European market, whereas India already has over 50 approved biosimilars.

The top 10 leaders in the biologics market, having extensive product pipelines and in-house manufacturing capacities, comprise approximately 65% of the biologics market in terms of revenue.

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With a growing demand for biologics, many pharmaceutical companies are now focusing on gaining in-house expertise. However, the trend for outsourcing and utilising the services offered by contract manufacturing organisations (CMOs) or CDMOs has been increasing in the last few years.