The global lyophilized injectable market is projected to reach US$ 4,001.27 million by 2028 from US$ 2,719.42 million in 2021; it is expected to grow at a CAGR of 5.8% from 2022 to 2028.

The increasing demand for contract research manufacturing services, rising approvals of pharmaceuticals, and growing demand for biologics drive the growth of the market. However, high product recalls hamper the market growth.

Freeze drying, or lyophilization, 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 that are 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 propelling the demand for contract research manufacturing services (CRAMs) for manufacturing. Furthermore, CRAMs play crucial roles to mitigate the risk of supply shortages by offering additional sites for pharmaceutical companies with multisite supply strategies and backup capacities. For instance, in 2019, Samsung Biologics and GI Innovation signed a contract for immunochemotherapy. Under the agreement, Samsung Biologics provided services ranging from the development of cell line to the production of Phase I drug substances.

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 globally.

The global impacts of COVID-19 pandemic are witnessed across several markets. Due to stringent lockdown and movement restrictions, clinical trials were temporarily halted. In the healthcare sector, the focus was shifted primarily to the treatment of COVID-19 patients and the development of the COVID-19 vaccine. All these factors had a positive impact on market growth in the initial phase of pandemic.

There was an unusual demand for Remdesivir, an antiviral medicine used to treat patients, during the peak of the COVID-19 outbreak. Manufacturers in the lyophilized injectables market are preparing for the future by keeping adequate supply chains to avoid any COVID-19-like vulnerabilities. Gilead Sciences and other big pharma companies received an Emergency Use Authorization (EUA) by the US FDA for the use of remdesivir for the treatment of hospitalized COVID-19 patients. Further, in May 2020, Gilead Sciences Inc. extended a voluntary nonexclusive license to Cipla to manufacture and market Cipla's generic version of remdesivir called CIPREMI. Companies are utilizing government programs and financing schemes given by the BFSI industry to streamline their operations in response to turbulent market conditions. For instance, in May 2020, the US government entered an agreement with a group of American generic medicine manufacturers potentially worth US$ 812 million to bolster the country's drug supply amid the pandemic. Thus, the growing demand for drugs due to the COVID-19 pandemic bolstered the global lyophilized injectable market.

Geography-Based Insights

North America holds the largest share of the global lyophilized injectable market, whereas Asia Pacific is the fastest-growing region. The market in North America is expected to grow during the forecast period owing to the increasing demand for lyophilized injectables for safe packaging and prolonged shelf life, growing pharmaceutical production due to the COVID-19 pandemic, and rising research and development in the healthcare industry.

During 2022-2028, Asia Pacific is likely to register the highest CAGR in the global lyophilized injectable market. The market in the region is expected to grow significantly in countries, including China, India, and Japan, in the coming years. The growing research & development activities due to the increase in the investments by biotechnology, pharmaceutical, and biopharmaceutical companies and rising applications of lyophilized injectable drug in various fields are among the factors propelling the demand for lyophilized injectables in Asia Pacific.

Type of Packaging- Based Insights

The global lyophilized injectable market, based on type of packaging, is segmented into single-use vials, point-of-care reconstitution, and specialty packaging. In 2021, the single-use vials segment accounted for the largest market share, whereas the specialty packaging segment is expected to register the highest CAGR of 6.7% during the forecast period.

Type of Delivery- Based Insights

Based on type of delivery, the global lyophilized injectable market is segmented into prefilled diluent syringes, proprietary reconstitution devices, single-step devices, and multi-step devices. The prefilled diluent syringes segment held the largest market share in 2021 and is anticipated to register the highest CAGR of 6.3% during the forecast period.

Indication- Based Insights

Based on indication, the global lyophilized injectable market is segmented into metabolic and oncology conditions, infectious diseases, autoimmune diseases, and other indications. The metabolic and oncology conditions segment held the largest market share in 2021 and is anticipated to register the highest CAGR of 6.2% during the forecast period.

End User- Based Insights

Based on end user, the global lyophilized injectable market is segmented into hospitals, ambulatory surgical centers, specialty clinics, and others. The hospitals segment held the largest market share in 2021. However, the specialty clinics segment is estimated to register the highest CAGR of 6.3% in the market during the forecast period.

The World Health Organization (WHO), Globocan, World Bank Data, National Health Service (NHS), National Library of Medicine (NLM), and Association for the Advancement of Medical Instrumentation are a few secondary sources referred to while preparing the report on the global lyophilized injectable market.