The sterile injectable market is comprised of roughly 30% small molecules, although these estimates are difficult to confirm. [12] While the small molecules market is growing, they are generally more amenable to oral solid dosage (OSD) formulations, and therefore the majority of the sterile market is driven by the biologics and advanced therapies markets. A survey of several market research reports (Table 3) estimates the market is growing at around 13% CAGR and will exceed $130 billion by 2030.
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The drive to develop patient-centric medications now pervades all aspects of the pharmaceutical industry, including sterile injectable drugs. It has been argued, in fact, that this sector of the pharma market has led the way with respect to the development of novel delivery methods focused on addressing ease of use and convenience.[26] Examples include prefilled syringes, pens, and autoinjectors for subcutaneous delivery, use of digital solutions, and wearable injectors. Combination ready-to-mix devices, such as those incorporating freeze-dried vials paired with aseptically filled bags, are more recent developments.[30]
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The rising complexity of drug formulations and the growing percentage of personalized, niche, and self-administered medicines has made legacy off-the-shelf systems, namely vials and simple syringes, appropriate on a less frequent basis. Instead, medical devices more often need to be tailored to the requirements of specific sterile injectable formulations with respect to fill volumes, injection volumes, injection times, needle requirements, container materials, and other considerations.[33]
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Self-administration of injectable drugs, on the rise before the COVID-19 pandemic, received even more interest during lockdowns as a means for patients to continue receiving treatments without risking exposure to the SARS-CoV-2 virus. The move is expected to continue due to the greater convenience that self-administration affords.[37] Self-administration enables hospitals to reduce overcrowding and increase patient participation in their own treatments.[38]
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Demand for prefilled syringes (PFS) has been growing and is expected to continue. The key drivers for this demand are the following:
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The shifting focus toward orphan drugs has created opportunities for small and emerging pharma and biotech companies focused on developing highly specialized therapies that address diseases involving smaller patient populations.[26] These smaller firms tend to rely on contract development and manufacturing organizations (CDMOs) for support throughout the development and commercialization of their products, particularly for complex sterile injectable drugs.
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Large-volume parenterals (LVPs), or sterile injectable drugs delivered in quantities of 100 mL or greater, are also experiencing demand growth due to the increasing number of patients with chronic diseases, the rising number of surgeries performed each year, and the desire to address patient preferences for fewer doses of their medications.[51]
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Development of highly potent drug products is increasing at a healthy rate in response to the ongoing emphasis by large and small companies on the oncology space, the growing number of targeted therapies, which are often more potent than systemically delivered drugs, and the increasing preference for more potent drugs that require less frequent dosing regimens.[53]
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Related to the rise in high potency drugs are high concentration drugs, especially antibodies. High-concentration antibody products (HCAPs) represent a transformative development in the sterile biotherapeutics market. Defined in this discussion as injectable mAb therapies with concentrations above 100 mg/mL, HCAPs offer a unique combination of therapeutic efficacy and patient convenience. Unlike traditional IV therapies, which often require hospital visits or infusion centers, HCAPs enable SC self-administration, empowering patients with greater flexibility while significantly reducing healthcare costs. This patient-centric approach has made HCAPs a vital tool for managing chronic diseases, particularly those requiring long-term treatment.
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The astounding adoption of GLP-1 agonist drugs (commonly referred to as GLP-1 drugs) has had a significant impact on the sterile injectibles market. The two largest manufacturers, Lilly and Novo Nordisk, were the drivers of significant market changes as they established their own supply chains for GLP-1 vials and prefilled syringes. Novo Nordisk bought Catalent and converted most of Catalent’s capacity to GLP-1 drug substance (DS) and drug product (DP) production. Lilly then pulled most of their DP work from Catalent and reestablished their supply chain with a series of other fill/finish suppliers. Demand for vaccines has fallen, mostly in the U.S., as consumer vaccine hesitancy continues. This reluctance relieves sterile capacity contraints somewhat, but not enough to mitigate an overall sterile shortage. The remaining sterile customers are now scrambling for “leftover” capacity and often find themselves needing multiple suppliers to fill their requirements as slots are available.
As one might expect, the capacity crunch has led to longer lead times for smaller players and increased prices. One subject matter expert (SME) from a major DS/DP vendor told us that fill/finish prices have been increasing by >10% annually since the GLP-1s came onto the market. This means that sterile pricing is increasing at a far faster rate than any other aspect
Companies are expanding their sterile capacity, as we noted in Section X, so the manufacturing capacity will eventually catch up with current demand. Additional drugs, however, such as GLP-1 biosimilars and next-generation GLP-1 drugs with reduced side effects or longer dosing schedules, have the potential to keep the supply chain constrained in the short term.
When assessing market capacity constraints, it is important to recognize that vials and syringes are usually filled on the same production lines. As a result, any company with these capabilities can supply GLP-1 drugs, which in turn reduces manufacturing availability for smaller customers. Because GLP-1 drugs are typically not lyophilized, however, this aspect of the market has not been impacted by GLP-1 demand. Lyophilization capacity, however, has traditionally been constrained for several years due to the difficulty and expense of upgrading equipment and this trend will continue in the short term.
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