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.
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Lyophilized Injectable Market: Strategic Insights
Market Size Value in US$ 2,719.42 Million in 2021 Market Size Value by US$ 4,001.27 Million by 2028 Growth rate CAGR of 5.8% from 2022 to 2028 Forecast Period 2022-2028 Base Year 2021
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Lyophilized Injectable Market: Strategic Insights
| Market Size Value in | US$ 2,719.42 Million in 2021 |
| Market Size Value by | US$ 4,001.27 Million by 2028 |
| Growth rate | CAGR of 5.8% from 2022 to 2028 |
| Forecast Period | 2022-2028 |
| Base Year | 2021 |
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Lucrative Regions for Global Lyophilized Injectable Market
- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
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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.
Global Lyophilized Injectable Market, by Type of Packaging – 2021 and 2028
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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.
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
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Type of Packaging, Type of Delivery, Indication, and End User
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States
Frequently Asked Questions
Lyophilized injectables are freeze-dried drugs that are more stable and can be transported and stored for a longer period. At the time of use, the required quantity of drugs can be reconstituted with the help of diluents. Lyophilized injectable are also termed as freeze-dried injectable as they are produced by the lyophilization process which is the technique of isolating a solid material from a solvent by freezing and evaporating the solution under vacuum. The lyophilized injectable market is segmented into type of packaging, type of delivery, indication, end user, and geography.
Increasing demand of contract research manufacturing services and rising approvals of pharmaceuticals are the most significant factors responsible for the overall market growth.
Based on type of packaging, single-use vials segment took the forefront lead in the worldwide market by accounting largest share in 2021 and is expected to continue to do so till the forecast period.
Based on type of delivery, prefilled diluent syringes segment accounted for the largest share in 2021 in the worldwide market and is expected to continue to do so till the forecast period.
The metabolic and oncology conditions segment dominated the indication segment in the global lyophilized injectable market and accounted for the largest market share of 46.05% in 2021.
Based on end user, hospital segment took the forefront lead in the worldwide market by accounting largest share in 2021 and is expected to continue to do so till the forecast period.
Baxter, Nipro, Curia Global, Inc., Recipharm AB, Vetter Pharma, Jubilant HollisterStier (Jubilant Pharma Limited), Aristopharma Ltd., CordenPharma International, Credence MedSystems, Inc., and S. G. Biopharm Pvt. Ltd. are among the leading companies operating in the lyophilized injectable market.
Global lyophilized injectable market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America. In North America, the U.S. is the largest market for lyophilized injectable market. The growth of the market in North America is expected due to the factors such as increasing demand for lyophilized injectable for safer packaging and prolonged shelf life, growing pharmaceutical production due to pandemic, and rising research and development in the healthcare industry. Further, the growing research & development activities owing to the investments by biotechnology, pharmaceutical, and biopharmaceutical companies and the rise in the research & applications of the lyophilized injectable drug in various fields are the key factors responsible for the Asia-Pacific regional growth for lyophilized injectable accounting for the fastest growth of the region during the coming years.
The List of Companies - Lyophilized Injectable Drugs Market
- 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
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