The aging population, rise of chronic diseases, expanded access to healthcare, and increasing prevalence of biologics and advanced therapies are all strong drivers of the sterile injectables market. Sterile injectables forecasts typically combine both small molecules and biologics, but one report estimated the small molecule injectables market to be $155B in 2023, growing at a 7.1% CAGR. This projection yields an estimated $289B market in 2032.[148] A survey of several market research reports (Table 9) estimates that the market is growing at around 10% CAGR and will exceed $29 billion by 2030.
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The traditional base of the sterile injectables market is, of course, the sterile vial. Production of sterile, depyrogenated vials has increased along with the overall market. The vials support not only liquid formulations but are also commonly used as the primary packaging for lyophilized products. Compounding facilities also use sterile vials for most of their products. The U.S. is currently the largest market for sterile vials and is anticipated to remain so. Germany and China are also major suppliers. A survey of several market research reports (Table 10) estimates that the market is growing at around 7% CAGR and will exceed $130 billion by 2030.
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Ampoules are a small but important part of the sterile market, which is concentrated in Asia–Pacific and Europe. The most common size is 6–8 mL and it is estimated that over 74 million units of all sizes will be in use by 2031. Korean beauty (K-beauty) skincare is a major driver of market demand, along with morphine packaging and veterinary etamsylate, which is used to reduce postoperative hemorrhaging. A survey of several market research reports (Table 11) estimates that the market is growing at around 7% CAGR and will exceed $9 billion by 2030.
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Growth of the large-volume parenteral (LVP) market is driven by the rise in chronic diseases. The most common containers of LVPs are in soft bags, glass bottles, and plastic bottles. A survey of several market research reports (Table 12) estimates that the market is growing at around 7% CAGR and will exceed $15 billion by 2030.
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The fastest growing portion of the sterile market is the demand for prefilled syringes. A survey of several market research reports (Table 13) estimates that the market is growing at around 12% CAGR and will exceed $15 billion by 2030.
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A specialized subset of the PFS market is the autoinjector market, which includes cartridge-based and prefilled syringe–based systems. These devices are prevalently used in treatments for chronic diseases such as diabetes, anaphylactic shock, asthma, multiple sclerosis, and migraine. North American sales account for approximately 60% of the market. A survey of several market research reports (Table 14) estimates that the market is growing at around 13% CAGR and will exceed $230 billion by 2030.
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The global injectable drug-delivery device market includes conventional syringes, needle-free injectors, autoinjectors, pen injectors, and dual-chamber devices (powder and liquid) and is driven by the trends toward at-home care and patient-centric care, especially for the aging population and increasing prevalence of chronic diseases. Smart inhalers and autoinjectors are key devices driving the market. The U.S. represents about half of the market. A survey of several market research reports () estimates that the market is growing at around 5% CAGR and will exceed $43 billion by 2030.
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Drivers of the lyophilization market are much the same as the overall sterile injectables market: the rise of chronic diseases and expanded access to healthcare. Lyophilization, however, is more prevalent with small molecules although more than 60% of marketed biologics products are lyophilized.113 Rapid growth of lyophilized therapeutics is enabled by recent advances in lyophilization equipment. The Asia–Pacific region, especially China, is the fastest-growing market for both lyophilization equipment and lyophilized manufacturing of therapeutics. A survey of market research firms (Table 15) indicates that the global lyophilized injectables market is expanding at a CAGR of around 8% and is expected to reach a value of over $6 billion by 2030.
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The blow/fill/seal market is driven mostly by niche products, such as ophthalmic solutions and nasal sprays. Polyethylene (PE) is the most common type, accounting for 40–60% of the products, of which bottles comprise the largest portion (27%). The market is distributed relatively equally around the globe, with Asia–Pacific being the largest segment (35%), followed by North America (30%), and Europe (25%).[173][174][175]
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