More than half of pharmaceutical companies have no in-house sterile injectable drug product manufacturing capacity, and the proportion relying entirely on CDMOs is set to grow.
According to ISR’s Sterile Injectable Drug Product Manufacturing Market Outlook 2025–2030, 57% of survey respondents outsource all of their sterile injectable drug product manufacturing to contract manufacturers, with a further 38% using CDMOs to supplement their own internal capacity. Just 2% engage CDMOs only for emergency needs, and 4% to access manufacturing in countries where they otherwise have no presence.
Within that 57%, 37% outsource all their sterile injectable manufacturing but retain manufacturing capacity for other dosage forms elsewhere. The remaining 20% are fully virtual, outsourcing 100% of production, including API, with no in-house manufacturing of any kind.
Outsourcing Drivers: Sterile Injectable Drug Product Manufacturing (% of respondents, n=101)
Among companies with R&D spend below $100M, an average of 85% of packaging is currently outsourced, rising to a projected 95% within five years. For clinical trial manufacturing, the equivalent figures are 79% today, climbing to 88%.
Even large biopharma companies — those spending $1B or more on R&D — are deepening their reliance on CDMOs. Commercial manufacturing outsourcing among large companies is expected to hold steady at 43% over the next five years, while mid-size companies project an increase from 62% to 74%.
What’s driving the shift?
Respondents cited high growth in emerging markets (43%), demand for patient-friendly parenteral delivery systems such as prefilled syringes (40%), and growth in orphan drug portfolios (39%) as the top factors likely to push outsourcing levels higher over the next five years. Across all these drivers, the message is consistent: sterile injectable manufacturing is becoming more complex, more specialized, and more capital-intensive.
Spending reflects the same direction of travel. Currently, 18% of respondents spend $100M or more annually on outsourced sterile injectable manufacturing. By 2030, that figure is projected to nearly double to 38%, while the share spending less than $5M is expected to fall from 20% to just 4%.
About the data
The findings are drawn from a 25-minute quantitative online survey conducted in Q3 2025 with 102 respondents at biopharmaceutical companies. Participants were required to have been actively involved in outsourced sterile injectable manufacturing within the past 18 months and to play a direct role in gathering information about, selecting, or managing contract manufacturers. Respondents were split 61% North America, 38% Europe, and 1% Middle East, with company sizes ranging from virtual biotechs to global pharma organizations with R&D spend exceeding $1B.
Source: ISR, Sterile Injectable Drug Product Manufacturing Market Outlook: 2025–2030
