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6 Pharmaceutical Technology ® Bio/Pharma Outsourcing Innovation eBook 2023 PharmTech.com industry outlook and tasks continue to make up a sizable percentage of tod ay 's out sou rc i ng. It i s wor t h ment ion i ng t hat many businesses v iew process development activities as key competencies that should not, or cannot, be outsourced. The BioPlan survey asked respondents about their outsourcing of some of the 26 different areas typi- cally outsourced. This year, 86.9% of respondents were outsourcing in the "Analytical testing (other bioassays)" categor y (See Figure 1). Over the past 12 years, this has grown from only 61% back in 2010. While issues associated with COVID-19 and diffi- culties finding and retaining qualified employees have contributed to some of the rise in outsourced work, the grow th pre-COVID is a clear indication t hat t he underly ing factors w i l l continue to bias towa rd outsourci ng cer ta i n task s even a f ter t he COVID-19 environment has normalized. Of the 26 areas typically outsourced, the primary activities in 2022 included: • "A n a ly t ica l tes t i ng (ot her bioa ssays)" w it h 86.9% of respondents, wh ich is an increase from 82.6% in 2021 • "Testing: toxicity testing," which was at 79.4% in 2022 compared to 78.0% in 2021 • " Va l id at ion ser v ices" rem a i n s i n t he t h i rd position in 2022, with 75.7% of respondents • "Testing: Product characterization" remains in the fourth position, with 72.9% of respondents • "Testing: Cell line stability" rounds out the top five areas this year at 67.3%. The lower ranked areas include: • "Cell or Gene Therapies R&D" • "Design of Experiments (DoE)" • "Downstream Process Development" • "Upstream Process Development," which takes the last position with 46.7% in 2022. Analytical testing, bioassays, fill/finish, and tox- icological testing are a few examples of the kind of specialized, repetitive, non-core, or less technical t a sk s t hat a re i ncrea si ng ly out sou rced. Tox icol- og y testing is one of the only areas where a select few, t y pica l ly ver y la rge, compa n ies cont inue to conduct in-house. Average percentage of activities outsourced The respondents were asked to estimate how much outsourcing of key operations was done at their fa- cilities, and the averages revealed that: • The activity with the highest average percent- age outsourced today is "Analy tical testing/ bioassays" at 31.7%, which is increased slightly from 30.3% in 2021, following a generally in- creasing trend over the past 12 years, since 2010 where this averaged 18.9% of total testing done by facilities. • In the second position, "Toxicity testing" reached 31.6%, which is down from 33.1% in 2021. • "Fi l l/f in ish Operations" was t h ird t h is year, with an average of 26.7% of these operations being outsourced and v ir t ua l ly unchanged from 26.1% in 2021" (1) (See Figure 2). 86.9% 79.4% 75.7% 72.9% 67.3% 66.4% 65.4% 63.6% Analytical testing: Other bioassays Testing: Toxicity testing Validation services Testing: Product characterization Testing: Cell line stability Contract Research (laboratory) Testing: Lot release Fill/Finish Operations 100% 0% 50% 10% 20% 30% 40% 60% 70% 80% 90% Analytical testing: Other bioassays Testing: Toxicity testing 26.7% Fill/Finish Operations 26.7% Testing: Cell line stability 23.4% Validation services API biologics manufacturing 24.8% 0% 10% FIGURE 1. Selected operations: percent of biomanufacturers outsourcing at least some activity (2022). ALL FIGURES COURTESY OF THE AUTHOR.