EUA of Remdesivir Lyophilized Powder for COVID-19 Treatment in India
The ever-evolving nature of coronavirus has become a major threat to the public health, owing to its severe respiratory symptoms. Ongoing studies are surfacing about the safety and efficacy of novel lyophilized therapeutic agents in hospitalized adult patients diagnosed with COVID-19. Amid all this, healthcare giant Cipla – a global pharmaceutical company is gaining recognition for introducing its CIPREMI, a remdesivir lyophilized powder for injection (100mg). Manufacturers in the lyophilized injectable market are taking cues from such innovations to increase the availability of the U.S. FDA-approved emergency use authorization (EUA) treatment for patients with severe COVID-19 symptoms.
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Since India is suffering from a third wave of the pandemic, companies in the India lyophilized injectable market are increasing efforts to gain regulatory approval by the Drug Controller General of India (DCGI) for restricted emergency use in the country.
Alternative Vial Designs Help Reduce Lyo-breakage Risk, Side-load Force
The lyophilized injectable market is expected to surpass US$ 5 Bn by 2031. Packaging plays a crucial role in the lyophilization of injectable drugs. Though lyo-breakage is generally not a routine occurrence, however, even at a low frequency, it can lead to high cost and operational impacts. Hence, companies are adopting alternative vial designs to reduce lyo-breakage risk and reduce significant side-load force during vial transfer in/out of the lyophilizer.
Since lyophilization is a demanding process performed with costly equipment, manufacturers are reducing significant vertical-load forces during stopper closure to avoid lyo-breakage.
Freeze-drying Preserve Liquid Formulations for Longer Periods
The lyophilized injectable market is estimated to clock a CAGR of ~5% during the forecast period. However, many biotechnologically manufactured substances are not sufficiently stable in aqueous solutions. This becomes challenging to preserve liquid formulations for longer periods. In order to overcome this, companies are adopting freeze-drying by which water is extracted from the substance under vacuum and low temperatures. There is a growing awareness to reconstitute drugs before administering them to patients.
Companies in the lyophilized injectable market are bolstering their production capabilities in freeze-dried substances, which are being packaged in vials, dual-chamber syringes, and dual-chamber cartridges. Vials have set the gold standard for freeze-dried products.
Embedded Electronic Features to Transform Market Landscape
Universal, customizable, and upgradable drug devices are anticipated to help companies in the lyophilized injectable market gain a competitive edge over other market players during the forecast period. Manufacturers are boosting their R&D to develop devices and injectors that are universal in nature and capable of operating with the help of any primary container, sans the need for a drug transfer step.
Embedded electronic features in devices and injectors are predicted to emerge as a game changer for stakeholders in the global lyophilized injectable market. These features will allow customization depending on the intended user type. Other connectivity capabilities will enable devices to be remotely upgraded, whilst making the task of lifecycle management easier.
Improving Durability of Molded Vials Yields Better Performance in Lyophilization Applications
As companies in the lyophilized injectable market are gaining awareness about the exact causes of lyo-breakage, they are increasing their production capabilities in stronger vials that may lead to a reduced likelihood of occurrence. SGD Pharma – a specialist in the production of pharmaceutical glass primary packaging has introduced its EasyLyo vial range, which combines the strength and chemical durability of molded vials with characteristics of thin-walled vials.
Manufacturers in the lyophilized injectable market are increasing efforts to reduce breakage rates and heat-transfer capability in vials. They are conducting several lyo-breakage tests using worst-case injectable formulations and cycle designed to break vials. Companies are producing flat base vials with squared-off shoulder and heel vials to yield better performance in lyophilization applications.
Companies in the lyophilized injectable market are anticipated to enter into partnerships to increase accessibility to remdesivir for patients suffering from COVID-19 in India. Injectable devices are expected to align with the increased requirement of greener technologies. However, lyo-breakage is emerging as a major issue in packaging applications. Hence, companies should develop vials with improved uniformity and cosmetic nature to offer better inspectability & performance as compared to standard molded vials. They are developing injectors that will allow patients to take control of their disease by monitoring their drug performance. Dual-chamber syringes are one of the most innovative packaging forms for freeze-dried products.
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Lyophilized Injectable Market: Overview
Lyophilization is the most commonly used method for the manufacturing of parenteral pharmaceutical products, when the product is unstable in aqueous solution. It is central to the protection of materials, which require low moisture content (less than 1%) in order to ensure stability and require a sterile and gentle preservation process.
Improved quality and shelf life of lyophilized drugs has attracted industry experts to implement lyophilization in their manufacturing processes. Contract research and manufacturing organizations have increased the use of lyophilized injectable drugs to provide quality products to customers. Therefore, rapidly growing contract research manufacturing services (CRAMS) is projected to drive the global lyophilized injectable market.
Lyophilized injectable drugs are stable at ambient temperatures and only require simple rehydration to be ready to use. This removes many sources of pipetting errors, while streamlining and simplifying workflows.
Elimination of the cold chain minimizes costs and carbon footprint, and provides a positive environmental impact by minimizing the need of expanded polystyrene (EPS or ‘Styrofoam’) containers often utilized to ship temperature-controlled products
Lyophilized products are considered safe for use, while delivering the desired functionality compared to non-lyophilized products. Moreover, lyophilization helps retain the biological and chemical activity of the chemical compound in the final product. This drives the demand for lyophilized injectable drugs in the pharmaceutical and biotechnology industries.
Market Segmentation: Lyophilized Injectable Market
In terms of type of packaging, the global lyophilized injectable market has been classified into single-use vials, point-of-care reconstitution, and specialty packaging
Based on type of delivery, the global lyophilized injectable market has been categorized into prefilled diluent syringes, proprietary reconstitution devices, single-step devices, and multi-step devices
In terms of indication, the global lyophilized injectable market has been segregated into autoimmune diseases, metabolic conditions, infectious diseases, and others
Based on end user, the global lyophilized injectable market has been divided into hospitals, specialty clinics, ambulatory surgical centers, and others
Each of the segments has been analyzed in detail for trends, recent trends & developments, drivers, restraints, opportunities, and useful insights. The lyophilized injectable market report provides current and future revenue (US$ Mn) for each of these segments for the period from 2017 to 2031, considering 2020 as the base year. The compound annual growth rate (% CAGR) has been provided for each segment and market from 2021 to 2031, along with market size estimations.
Regional Overview: Lyophilized Injectable Market
In terms of region, the global lyophilized injectable market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The regions have been divided into major countries and sub-regions.
The U.S. held a prominent share of the lyophilized injectable market in North America in 2019. The region is projected to dominate the global market during the forecast period, owing to increase in incidence rate of chronic diseases and higher rate of adoption of lyophilized injectable drugs in countries in the region.
The lyophilized injectable market in Asia Pacific is anticipated to expand at the fastest CAGR from 2018 to 2026. The region comprises emerging economies such as China, India, Indonesia, Malaysia, Singapore, and Thailand. Asia Pacific offers significant opportunities in the healthcare sector, and was the third-largest market in the world in 2017. These countries present large opportunities in the healthcare sector. The lyophilized injectable market in Asia Pacific is expected to grow at a rapid pace over the next few years due to untapped opportunities, improving healthcare infrastructure, and increasing availability of contract manufacturing & research services.
The study also offers a list of recommendations, highlights, and useful insights of the market, which are likely to help new companies willing to enter the lyophilized injectable market and existing companies to increase market share and in the decision-making process
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Major Lyophilized Injectable Market Players
The report concludes with the company profiles section that includes key information about the major players in the global lyophilized injectable market
Leading players analyzed in the lyophilized injectable market report are
- B. Braun Melsungen AG
- Baxter International, Inc.
- Schott AG
- Aristopharma Ltd.
- Vetter Pharma
- Jubilant HollisterStier LLC
- among others
Each of these players has been profiled in the lyophilized injectable market report based on parameters such as company overview, financial overview, business strategies, product portfolio, business segments, and recent developments
Key Questions Answered in Lyophilized Injectable Market Report
- What is the sales/revenue generated by lyophilized injectable providers across all regions during the forecast period?
- What are the opportunities in the global lyophilized injectable market?
- What are the major drivers, restraints, opportunities, and threats in the global market?
- Which region is set to expand at the fastest CAGR during the forecast period?
- Which application segment is expected to generate the highest revenue globally in 2030?
- What are the market positions of different companies operating in the global market?
Lyophilized Injectable Market – Segmentation
Type of Packaging
- Single-use Vials
- Point-of-care Reconstitution
- Specialty Packaging
Type of Delivery
- Prefilled Diluent Syringes
- Proprietary Reconstitution Devices
- Single-step Devices
- Multi-step Devices
- Autoimmune Diseases
- Infectious Diseases
- Metabolic Conditions
- Ambulatory Surgical Centers
- Specialty Clinics
- North America
- Asia Pacific
- Latin America
- Middle East & Africa
TABLE OF CONTENT
1.1. Market Definition and Scope
1.2. Market Segmentation
1.3. Key Research Objectives
1.4. Research Highlights
- Assumptions and Research Methodology
- Executive Summary: Global Lyophilized Injectable Market
- Market Overview
4.1. Introduction & Overview
4.2. Market Dynamics
4.3. Global Lyophilized Injectable Market Analysis and Forecast, 2017–2030
- Market Outlook
5.1. COVID-19 Pandemics Impact on Industry
5.2. Key Industry Developments
5.3. Pipeline Analysis
5.4. Top 10 Lyophilized Drug Products
5.5. Regulatory Scenario
- Global Lyophilized Injectable Market Analysis and Forecast, by Type of Packaging
6.1. Introduction & Definition
6.2. Global Lyophilized Injectable Market Value (US$ Mn) Forecast, by Type of Packaging, 2017–2030
6.2.1. Single-use Vials
6.2.2. Point-of-care Reconstitution
6.2.3. Specialty Packaging
6.3. Global Lyophilized Injectable Market Attractiveness Analysis, by Type of Packaging
- Global Lyophilized Injectable Market Analysis and Forecast, by Type of Delivery
7.1. Introduction & Definition
7.2. Global Lyophilized Injectable Market Value (US$ Mn) Forecast, by Type of Delivery, 2017–2030
7.2.1. Prefilled Diluent Syringes
7.2.2. Proprietary Reconstitution Devices
7.2.3. Single-step Devices
7.2.4. Multi-step Devices
7.3. Global Lyophilized Injectable Market Attractiveness Analysis, by Type of Delivery
- Global Lyophilized Injectable Market Analysis and Forecast, by Indication
8.1. Introduction & Definition
8.2. Global Lyophilized Injectable Market Value (US$ Mn) Forecast, by Indication, 2017–2030
8.2.1. Autoimmune Diseases
8.2.2. Metabolic Conditions
8.2.3. Infectious Diseases
8.3. Global Lyophilized Injectable Market Attractiveness Analysis, by Indication
- Global Lyophilized Injectable Market Analysis and Forecast, by End-user
9.1. Introduction & Definition
9.2. Global Lyophilized Injectable Market Value (US$ Mn) Forecast, by End-user, 2017–2030
9.2.2. Ambulatory Surgical Centers
9.2.3. Specialty Clinics
9.3. Global Lyophilized Injectable Market Attractiveness Analysis, by End-user
- Global Lyophilized Injectable Market Analysis and Forecast, by Region
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