![]() ![]() In addition to the continuous development of antibody drugs, various new biologics have emerged, expanding the biopharmaceutical CDMO market. The market size of the biopharmaceutical CDMO industry exceeded 10 billion US dollars in 2018. Figure 1 shows an ecosystem of the pharmaceutical industry that is a horizontal division model of drug discovery by biotech and pharmaceutical companies as well as drug manufacture by CDMOs. While the biopharmaceutical industry has made remarkable progress, the contract manufacturing and development organization (CDMO), which performs the development and manufacturing of drug substances in contract with biopharmaceutical companies, has grown simultaneously ( Lakshmikanthan, 2007). Furthermore, new modalities, such as gene therapy drugs, have been developed to treat unmet medical needs. ![]() Global sales of biologics in prescription medicines continue to grow rapidly with an annual average growth rate of 9.6% from 2019 to 2026 ( Evaluate Pharma World Preview 2020, 2021). The share of biologics in the total sales of the top 100 drugs was more than 16% in 2012 and expected to reach 55% by 2026. Eventually, protein therapeutics dominated the sales of new drugs in the pharmaceutical industry, resulting in paradigm shift ( Ecker et al., 2015). Protein therapeutics was a niche market in the 20th century, but it has dramatically changed with the advent of antibody drugs in the 21st century. Unlike small-molecule drugs that are chemically manufactured, biologics are complex molecules, such as proteins, or cells that are used as medicinal ingredients. ![]() Biopharmaceutical drugs or biologics is a general term for drugs manufactured using biotechnology. ![]()
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