White Paper

Monoclonal Antibody Manufacturing For Biopharma: Should I Build Or Outsource?

By Dan Slone, Head of DS Manufacturing

Samsung-1

A company’s strategy is crucial for determining future success, and therefore, it needs to constantly change in line with market dynamics.

According to Coherent Market Insights, the global biologics market held an estimated value of $255.19 billion in 2019 and is expected to exhibit a CAGR of 7.6% between 2019 and 2027.1 Market indicators for monoclonal antibodies (mAbs) appear even stronger, with an estimated market value of $143.5 billion in 2020 and 14.4% CAGR expected over the same forecast period.2 Today, mAbs represent the dominant product class within biopharmaceuticals, driven largely by the increasing prevalence – and increasingly sophisticated approaches to treating – severe and complex diseases, including cancers. Additionally, in 2020, 55% of biologics reached the clinical stage (628 of 1133), with 426 products related to mAbs. Accordingly, most development stage biologics today are mAbs or mAb-related.3

In recent years, the standardization of biologics manufacturing processes has given product developers multiple viable options for producing mAbs. These options include building an in-house mAb production system or partnering with a contract biologics manufacturer. Although building in-house does offer the advantage of direct control, the time, labor, and spend required to implement this often makes it the inefficient choice. Working with an innovative, strategic, and experienced contract manufacturer can help you make better use of valuable internal resources, leverage a deep pool of industry experience, and help you mitigate risk across development cycles, keeping you competitive in a rapidly evolving market.

The process of selecting the right CDMO partner needs to be performed after careful analysis of many factors: any of which, if overlooked, can create risk of delay or cost overrun. To stay ahead of your competitors as you execute go-to-market, consider the following parameters.

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