Science & Society
The Increasingly Human and Profitable Monoclonal Antibody Market

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The monoclonal antibody (mAb) market has changed rapidly in the past 5 years: it has doubled in size, becoming dominated by fully human molecules, launched bispecific molecules, and faced competition from biosimilars. We summarize the market in terms of therapeutic applications, type and structure of mAbs, dominant companies, manufacturing locations, and emerging markets.

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2013–2017: More mAbs and the Emergence of Bispecifics and Biosimilars

Following the latest mAb market update in 2013 1, 2, 3, several major changes have occurred. Specifically, whereas the pace of regulatory approval had plateaued by 2013 [1], a surge in approvals has more recently been observed (Figure 1A). Since 2013, 31 new mAbs and ten biosimilars have been introduced, creating a global market of a total of 57 mAbs and 11 biosimilars in clinical use by the end of 2017, based on public information provided by the FDA in the USA and the European Medicines

mAb Disease Targets, Molecular Structure, and Manufacture

Most mAbs have multiple disease targets and most have at least one cancer target (lymphoma, myeloma, melanoma, glioblastoma, neuroblastoma, sarcoma, colorectal, lung, breast, ovarian, head and neck cancers). Considering all disease targets, a total of 15 mAbs target oncology diseases, rendering it the medical specialty most accessible to mAb treatments, followed by hematology (12 mAbs), as shown in Figure 1B. Despite the recent approvals of bispecific drugs and mAb fragments, full-length mAbs

The Magnificent Seven: Can Biosimilars and Emerging Markets Threaten Them?

According to financial reports disclosed, 22 companies were active in the mAb market as of December 2017; the market exceeded US$98 billion in sales, an 18.3% growth since 2016 (Figure 1D). Since 2013, the mAbs market has grown between 7.2% and 18.3% every year. Currently, it is anticipated that a faster approval pace and a healthy pipeline will contribute to market growth while more biosimilars and other drug forms (e.g., antibody–drug conjugates) may contribute negatively to the growth of the

Is the Future Bright?

Past market data (2012–2017) indicated a doubling of the mAb market, a trend that is anticipated to continue to 2022 when mAb sales are expected to reach US$130–200 billion driven by a healthy pipeline and increasing roles for biosimilars and emerging economies. The market is currently dominated by seven companies (who hold an 87% market share), a landscape that is not projected to change. Intramarket competition by biosimilars is expected to strengthen. To counteract the ‘biosimilars effect’,

Acknowledgments

This work was supported by the European Commission under the Marie Sklodowska-Curie Horizon 2020 Innovative Training Network ModLife (Grant Agreement no. 675251).

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