At 5.9% CAGR, the North America Lyophilized Injectable Market is projected to be worth US$ 1,612.66 million by 2028, says Business Market Insights 

According to Business Market Insights' research, the North America lyophilized injectable market was valued at US$ 1,145.21 million in 2022 and is expected to reach US$ 1,612.66 million by 2028, registering a CAGR of 5.9% from 2022 to 2028. Increasing demand for contract research manufacturing services and increasing demand of biologics are the critical factors attributed to the market expansion. 

Freeze drying, or lyophilization, is a drying process that consists of the sublimation of ice crystals into vapor. Lyophilization is a process based on negative temperatures, the product's activity, and stability, along with active ingredients are better retained while limiting any damage to the product and avoiding any degradation of the molecules. Thus, freeze-drying is especially popular in the pharmaceutical & diagnostic sectors. The increased quality and extended shelf life of lyophilized injectable drugs created growth opportunities for manufacturers to implement the lyophilization process in product manufacturing. The contract manufacturing and research services are in huge demand, delivering lyophilized injectable drugs to offer high-quality products to the end users. Moreover, many pharmaceutical companies are refocusing on their core capabilities such as research and development, leading to divestments of in-house manufacturing capacities, which is growing the demand of contract research manufacturing services (CRAMs) for manufacturing. Furthermore, CRAMs play crucial roles in providing additional capacities to mitigate the risk of supply shortages by offering additional sites for pharmaceutical companies with multisite supply strategies and backup capacities. Furthermore, the advantages offered by the lyophilized injectables, such as safe transit and extended pharmaceutical storage life, increased the adoption of the lyophilization technique by many enterprises across the region. 

On the contrary, growing rate of product recalls hurdles the growth of North America lyophilized injectable market. 

Based on type of packaging, the North America lyophilized injectable market is segmented into single-use vials, point-of-care reconstitution, and specialty packaging. The single-use vials segment held 48.0% market share in 2022, amassing US$ 549.79 million. It is projected to garner US$ 767.16 million by 2028 to expand at 5.7% CAGR during 2022-2028. 

Based on type of delivery, the North America lyophilized injectable market is segmented into prefilled diluent syringes, single-step devices, proprietary reconstitution devices, and multi-step devices. The prefilled diluent syringes segment held 43.3% market share in 2022, amassing US$ 495.97 million. It is projected to garner US$ 718.30 million by 2028 to expand at 6.4% CAGR during 2022-2028. 

Based on indication, the North America lyophilized injectable market is segmented into metabolic and oncology conditions, infectious diseases, autoimmune diseases, and others. The metabolic and oncology conditions segment held 45.6% market share in 2022, amassing US$ 522.38 million. It is projected to garner US$ 752.16 million by 2028 to expand at 6.3% CAGR during 2022-2028. 

Based on end user, the North America lyophilized injectable market is segmented into hospitals, ambulatory surgical centers, specialty clinics, and others. The hospitals segment held 48.1% market share in 2022, amassing US$ 550.53 million. It is projected to garner US$ 781.11 million by 2028 to expand at 6.0% CAGR during 2022-2028. 

Based on country, the North America lyophilized injectable market has been categorized into the US, Canada, and Mexico. Our regional analysis states that the US captured 85.0% market share in 2022. It was assessed at US$ 973.06 million in 2022 and is likely to hit US$ 1,389.09 million by 2028, exhibiting a CAGR of 6.1% during the forecast period. 

Key players dominating the North America lyophilized injectable market are Aristopharma Ltd.; Baxter; CordenPharma International; Credence MedSystems, Inc.; Curia Global, Inc.; Jubilant HollisterStier (Jubilant Pharma Limited); Nipro; Recipharm AB; S.G. Biopharm Pvt. Ltd.; and Vetter Pharma among others. 

In April 2022, Recipharm acquires advanced therapy CDMO Arranta Bio and virotherapy CDMO Vibalogics. The acquisitions reflect Recipharm's strategy of building its presence in the Biologics market, with a particular focus on drug substance manufacturing of novel ATMPs (advanced therapy medicinal products). The acquisitions also enable Recipharm to establish a robust base in the US, with facilities in Boxborough, MA, and provide a platform from which to build its capabilities in new biologics modalities. 

In March 2021, Baxter International Inc. and Moderna, Inc. announced that they have entered into an agreement for Baxter BioPharma Solutions to provide fill/finish sterile manufacturing services and supply packaging for approximately 60-90 million doses of the Moderna COVID-19 Vaccine in 2021.

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