A surging number of biologic APIs and their growing penetration into multiple therapies create an attractive market segment for pharmaceutical ingredient suppliers but not one without challenges, analyzes Kline’s recently published Biologics: Market Opportunities for Chemicals Suppliers. To learn about key findings from the study, REGISTER for a complimentary webinar, taking place on October 17, 2019.
Currently, more than 350 biologics are commercially presented in the biopharmaceuticals market. Some established biologics, such as Humira and Avastin, maintained their growth of the last decade in 2018, with sales growing by 8.2% and 9.5%, respectively. New drugs such as Opdivo, which was first introduced in 2017, witnessed particularly robust growth in the overall biopharmaceutical market.
Biologics are administered generally through the parenteral route, which gives them an advantage of a higher success rate in terms of treatment. However, because they 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. All 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 constitute more than 40% of the pharmaceutical industry pipeline.
Oncology leads therapeutic areas in terms of the focus of research in biologics development. The development period of biologics for cancer treatment is far longer than other therapeutic areas. However, research on biologics for cancer started many years earlier than it did for other therapy areas. Apart from oncology, auto-immune disorders and rheumatology are growing areas of focus for biologics.
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. 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.
Biologics drug development is an impending opportunity for ingredient suppliers, especially, because specialty 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, include Roche, Amgen, Sanofi, AbbVie, Novo Nordisk, Merck & Co., Pfizer, Johnson & Jonson, Eli Lilly, and GlaxoSmithKline. Cumulatively, these leading companies comprise approximately 65% of the biologics market in terms of revenue.
With a growing demand for biologics, many pharmaceutical companies are now focusing on gaining in-house expertise. However, the trend for outsourcing and utilizing the services offered by contract manufacturing organizations (CMOs) or CDMOs has been increasing in the last few years.
Biologics: Market Opportunities for Chemicals Suppliers assists chemical suppliers in understanding the entire biologics value chain and identifying business opportunities.