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58 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 P h a r mTe c h . c o m Operations Market potential According to a recent survey, the global blow-fill- seal market was $2.52 billion in 2018 and was pro- jected to reach $4.5 billion by the end of 2025, grow- ing at a compound annual growth rate (CAGR) of 7.5% from 2019–2025 (14). The global PFS market is estimated at $1.9 bil- lion in annual sales as of 2020 and is expected to sustain 6.8% CAGR from 2021 through 2030 (15). PFS market expansion is driven by the rapid growth in innovative and targeted molecular en- tities such as monoclonal antibodies (mAbs), in- terferons, peptides, vaccines, and ophthalmics, as well as injectable drugs for chronic diseases and cancers (4). These products tend to be the high- priced end of the sector where specialty products can cost more than $30 per syringe or dose. This market primarily serves patients covered by insur- ance who self-administer medicines for chronic conditions such as allergies, diabetes, or hepatitis. More than 100 drugs and vaccines are shipped in prefilled syringes (4). The economic efficiencies of BFS could enable wider adoption of PFS for injectable drug products at the low-priced end including generic drugs and vaccines. Process advantages including the elimina- tion of steps that potentially could cause microbial contamination and costs associated with conven- tional aseptic liquid filling processes offer economic incentives for companies considering BFS. A 2017 study compared the cost of parenteral vac- cine delivery formats including compact prefilled auto-disabled devices, but not BFS prefilled sy- ringes. The study found that 10-dose glass vials had the lowest total cost of delivery (TCOD)—including all manufacturing, transportation, and storage—at $1.56 per dose delivered. Of the polymer containers for parenteral vaccines studied, BFS multi mono- dose ampoules achieved the lowest TCOD at $1.89 per dose delivered. The study authors concluded that polymer containers should be considered as alternatives to glass for vaccine packaging due to the material's potential to address the limitations of glass and reduce the cost of goods sold (COGS) and cost of delivery (16). New technology developments and the advent of the BFS prefilled syringe format may change the comparative COGS and TCOD, and thus create at- tractive economic efficiencies for BFS. A 2015 study indicated that compared to multi-dose vial and syringe formats, a compact prefilled auto-disable injection device, similar to a BFS prefilled syringe, cost 6.5% and 7.1% less in the administration of a pentavalent vaccine to children in two of the three countries examined. The study measured costs for the vaccine, safe injection equipment, and associ- ated management; storage, transport, and distribu- tion; administration of vaccine; medical waste man- agement; and costs to change delivery formats (17). Another factor driving economic efficiencies for BFS prefilled syringes is the need for less overfill, which reduces waste. Vials are sometimes overfilled by 20–30% to make accessing the drug easier (18). Prefilled syringes for a 0.5-mL dose may require less than 2% overfill, potentially enabling the same bulk drug to produce 18–23% more doses (19). As for potential global health impact, the authors believe BFS is economically efficient enough to en- able low- and medium-income countries to embrace BFS prefilled syringes may require only 2% overfill, reducing drug waste.