Global Lyophilized Injectable Market Overview

The global market for lyophilized injectables is anticipated to reach US$ 4,001.27 million by 2028, up from US$ 2,719.42 million in 2021, reflecting a compound annual growth rate (CAGR) of 5.8% from 2022 to 2028.

Market Drivers and Challenges

The growth of this market is primarily driven by the increasing demand for contract research manufacturing services, a rise in pharmaceutical approvals, and a growing interest in biologics. However, the market faces challenges, particularly from high rates of product recalls, which can hinder growth.

Understanding Lyophilization

Lyophilization, commonly known as freeze-drying, involves the sublimation of ice crystals into vapor. This process operates under low temperatures, preserving the activity and stability of the product while retaining active ingredients and minimizing damage or degradation. Consequently, lyophilization is highly favored in the pharmaceutical and diagnostic industries. The enhanced quality and prolonged shelf life of lyophilized injectable medications have opened up new avenues for manufacturers to adopt this process in their production lines.

There is a significant demand for contract manufacturing and research services, which provide lyophilized injectable products that meet high-quality standards for end users. Many pharmaceutical companies are now concentrating on their core competencies, such as research and development, leading to a reduction in in-house manufacturing capabilities. This shift is increasing the demand for contract research manufacturing services (CRAMs), which help mitigate supply chain risks by offering additional production sites and backup capacities. For example, in 2019, Samsung Biologics partnered with GI Innovation to provide comprehensive services from cell line development to the production of Phase I drug substances.

Impact of COVID-19

The COVID-19 pandemic has had widespread effects across various markets, including the lyophilized injectables sector. Lockdowns and movement restrictions led to the temporary suspension of clinical trials, while the healthcare focus shifted towards treating COVID-19 patients and developing vaccines. Interestingly, these factors initially contributed positively to market growth.

During the peak of the pandemic, there was a surge in demand for Remdesivir, an antiviral drug used for treating COVID-19 patients. Manufacturers in the lyophilized injectables market are now preparing for future challenges by ensuring robust supply chains to prevent vulnerabilities similar to those experienced during the pandemic. Gilead Sciences and other major pharmaceutical companies received Emergency Use Authorization (EUA) from the US FDA for Remdesivir, facilitating its use in hospitalized patients. Additionally, in May 2020, Gilead extended a voluntary nonexclusive license to Cipla to produce a generic version of Remdesivir, named CIPREMI. Companies are also leveraging government programs and financial support from the banking and financial services industry to adapt to the volatile market conditions. For instance, the US government entered into a potential US$ 812 million agreement with a consortium of American generic drug manufacturers to strengthen the national drug supply during the pandemic. Thus, the heightened demand for pharmaceuticals during this period has significantly boosted the global lyophilized injectable market.

Geographical Insights

North America currently dominates the global lyophilized injectable market, while the Asia Pacific region is the fastest-growing area. The North American market is expected to expand during the forecast period due to the increasing need for lyophilized injectables, which offer safe packaging and extended shelf life, alongside a rise in pharmaceutical production driven by the pandemic and ongoing research and development in healthcare.

From 2022 to 2028, the Asia Pacific region is projected to experience the highest CAGR in the global lyophilized injectable market. Countries such as China, India, and Japan are expected to see significant growth, fueled by increased research and development activities, driven by investments from biotechnology, pharmaceutical, and biopharmaceutical companies, as well as the rising applications of lyophilized injectables across various sectors.

Market Segmentation

Packaging Type

The global lyophilized injectable market is categorized by packaging type into single-use vials, point-of-care reconstitution, and specialty packaging. In 2021, the single-use vials segment held the largest market share, while the specialty packaging segment is projected to grow at the highest CAGR of 6.7% during the forecast period.

Delivery Type

In terms of delivery methods, the market is divided into prefilled diluent syringes, proprietary reconstitution devices, single-step devices, and multi-step devices. The prefilled diluent syringes segment accounted for the largest market share in 2021 and is expected to achieve the highest CAGR of 6.3% in the coming years.

Indications

Based on medical indications, the 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 grow at the highest CAGR of 6.2% during the forecast period.

End Users

Regarding end users, the market is segmented into hospitals, ambulatory surgical centers, specialty clinics, and others. The hospitals segment dominated the market in 2021, but the specialty clinics segment is projected to grow at the highest CAGR of 6.3% during the forecast period.

Research Sources

Key secondary sources utilized in compiling this report include the World Health Organization (WHO), Globocan, World Bank Data, National Health Service (NHS), National Library of Medicine (NLM), and the Association for the Advancement of Medical Instrumentation.