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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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Customize Research To Suit Your Requirement
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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
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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
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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