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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.

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.

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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.

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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.

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Analysts’ Viewpoint

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.

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

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.
    • BD
    • 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

Lyophilized Injectable Market – Scope of the Report

TMR’s report on the global lyophilized injectable market studies the past as well as the current growth trends and opportunities to gain valuable insights of the indicators of the market during the forecast period from 2021 to 2031. The report provides the revenue of the global lyophilized injectable market for the period of 2017–2031, considering 2020 as the base year and 2031 as the forecast year. The report also provides the compound annual growth rate (CAGR %) of the global lyophilized injectable market from 2021 to 2031.

The report has been prepared after extensive research. Primary research involved bulk of research efforts, wherein analysts carried out interviews with key industry leaders and opinion makers. Secondary research involved referring to key players’ product literature, annual reports, press releases, and relevant documents to understand the global lyophilized injectable market.

Secondary research also included Internet sources, statistical data from government agencies, websites, and trade associations. Analysts employed a combination of top-down and bottom-up approaches to study various attributes of the global lyophilized injectable market.

The report includes an elaborate executive summary, along with a snapshot of the growth behavior of various segments and sub-segments included in the scope of the study. Moreover, the report sheds light on changing competitive dynamics in the global lyophilized injectable market. These serve as valuable tools for existing market players as well as entities interested in participating in the global lyophilized injectable market.

The report also delves into the competitive landscape of the global lyophilized injectable market. Key players operating in the global lyophilized injectable market have been identified and each one of these has been profiled in terms of various attributes. Company overview, financial standings, recent developments, and SWOT are attributes of players in the global lyophilized injectable market that have been profiled in this report.

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 – Research Objectives and Research Approach

The comprehensive report on the global lyophilized injectable market begins with an overview, followed by the scope and objectives of the study. Following this, the report provides detailed explanation of the objectives behind this study and key vendors and distributors operating in the market and regulatory scenario for approval of product.

For reading comprehensibility, the report has been compiled in a chapter-wise layout, with each section divided into smaller ones. The report comprises an exhaustive collection of graphs and tables that have been appropriately interspersed. Pictorial representation of actual and projected values of key segments is visually appealing to readers. This also allows comparison of market shares of key segments in the past and at the end of the forecast period.

The report analyzes the global lyophilized injectable market in terms of type of packaging, type of delivery, indication, end user, and region. Key segments under each criteria have been studied at length, and the market share for each of these at the end of 2031 has been provided. Such valuable insights enable market stakeholders to make informed business decisions for investment in the global lyophilized injectable market.

Lyophilized Injectable Market – Segmentation

TMR’s study on the global lyophilized injectable market includes information divided into five segments: type of packaging, type of delivery, indication, end user, and region. Changing industry trends and other crucial market dynamics associated with these segments of the global lyophilized injectable market have been discussed in detail.

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
Indication
  • Autoimmune Diseases
  • Infectious Diseases
  • Metabolic Conditions
  • Others
End User
  • Hospitals
  • Ambulatory Surgical Centers
  • Specialty Clinics
  • Others
Region
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

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