Lyophilized Injectable Market Key Companies and SWOT Analysis by 2028

The 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.

Key factors driving the market are increasing demand for contract research manufacturing services, rising approvals of pharmaceuticals, and growing demand for biologics. However, product recalls restrain the market growth.

Lyophilized injectable are freeze-dried drugs that are stable during transportation. They are stored in single-use vials, point-of-care reconstitution, and specialty packaging for a longer period. At the time of use, required quantity of drugs can be reconstituted with the help of diluents. Lyophilized injectables are also termed as freeze-dried injectable as they are manufactured by the lyophilization process, a technique of isolating a solid material from a solvent by freezing and evaporating the solution under vacuum. Lyophilized injections are often considered as best alternative to oral solid dosage forms. In many case studies, the injections have immensely benefitted bedridden patients. Lyophilized injections are also prescribed to attain maximum bioavailability and stability in patients suffering from several diseases as these injectables have a longer shelf life than other dosage forms.

Lyophilized Injectable Market: Strategic Insights

Market Insights

Rising Approvals of Pharmaceuticals Drive Market Growth

Ongoing studies are emerging about the safety and efficacy of novel lyophilized therapeutic agents used in hospitalized adult patients diagnosed with COVID-19. Manufacturers in the global lyophilized injectable market  are taking approvals from the US FDA for the emergency use authorization (EUA) of such innovations to treat patients suffering from severe COVID-19 symptoms.

Since the COVID-19 pandemic, players in the global lyophilized injectable market are increasing efforts to gain approval by regulatory organizations, such as the Drug Controller General of India (DCGI), for restricted emergency use in India. The growing approvals for pharmaceuticals, such as Remdesivir, eventually lead to the high demand for lyophilized injectables. Following are a few instances of pharmaceuticals approved by the FDA and other regulatory bodies.

• In February 2020, Mylan secured regulatory approval from DCGI for Remdesivir lyophilized powder in India for restricted emergency use in COVID-19 patients.
• In June 2020, Cipla launched Cipremi, Remdesivir lyophilized powder for injection. Also, the US FDA issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc. for emergency use of Remdesivir to treat hospitalized COVID-19 patients. It is the only FDA-approved EUA treatment for adult and pediatric patients hospitalized with suspected or laboratory-confirmed COVID-19 infection. Thus, in May, Gilead Sciences Inc. extended a voluntary nonexclusive license to Cipla to manufacture and market Cipla’s generic version of remedisvir called CIPREMI. 
• In July 2020, Jubilant Life received approval from the Drug Controller General of India (DCGI) to manufacture and market Remdesivir for 100 mg/vial (lyophilized injection) for restricted emergency use in India for the treatment of severe COVID-19.
• In August 2020, Cosentyx lyophilized powder in a single-use vial by Novartis AG received EU approval. The drug approved was highly productive in rapidly improving skin symptoms and improving the quality of patient’s life suffering from psoriasis. 

Thus, the increasing approvals across the world propel the growth of the lyophilized injectables market.

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 disease , 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.

Companies operating in the global lyophilized injectable market adopt the product innovation strategy to meet the evolving customer demands across the world, which also permits them to maintain their brand name in the global market. For instance, in April 2022, Recipharm acquired advanced therapy CDMO Arranta Bio and virotherapy CDMO Vibalogics. The acquisition also enabled 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.

The regional trends and factors influencing the Lyophilized Injectable Market throughout the forecast period have been thoroughly explained by the analysts at The Insight Partners. This section also discusses Lyophilized Injectable Market segments and geography across North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America.

Lyophilized Injectable Market Report Scope

Lyophilized Injectable Market Players Density: Understanding Its Impact on Business Dynamics

The Lyophilized Injectable Market is growing rapidly, driven by increasing end-user demand due to factors such as evolving consumer preferences, technological advancements, and greater awareness of the product's benefits. As demand rises, businesses are expanding their offerings, innovating to meet consumer needs, and capitalizing on emerging trends, which further fuels market growth.

Global Lyophilized Injectable Market – by Geography

Geographically, the global lyophilized injectable market is segmented into North America (the US, Canada, and Mexico), Europe (Germany, the UK, France, Italy, Spain, and the Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Australia, and the Rest of APAC), Middle East & Africa (South Africa, Saudi Arabia, the UAE, and the Rest of MEA), and South and Central America (Brazil, Argentina, and the Rest of South & Central America).

Company Profiles

• Baxter
• Nipro
• Curia Global, Inc.
• Recipharm AB
• Vetter Pharma
• Jubilant HollisterStier LLC (Jubilant Pharma Limited)
• Aristopharma Ltd.
• CordenPharma International
• Credence MedSystems, Inc.
• S. G. Biopharm Pvt. Ltd