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.
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.
Thus, the increasing approvals across the world propel the growth of the lyophilized injectables market.
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.
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.
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.
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 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.
| Report Attribute | Details |
|---|---|
| Market size in 2021 | US$ 2.72 Billion |
| Market Size by 2028 | US$ 4 Billion |
| Global CAGR (2021 - 2028) | 5.8% |
| Historical Data | 2019-2020 |
| Forecast period | 2022-2028 |
| Segments Covered |
By Type of Packaging
|
| Regions and Countries Covered | North America
|
| Market leaders and key company profiles |
The Lyophilized Injectable Market 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.
Market players density refers to the distribution of firms or companies operating within a particular market or industry. It indicates how many competitors (market players) are present in a given market space relative to its size or total market value.
Major Companies operating in the Lyophilized Injectable Market are:
Disclaimer: The companies listed above are not ranked in any particular order.
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).
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.
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.
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.
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 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.
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.