Lyophilized Injectable Market

Lyophilized Injectable Market Outlook (2023 to 2033)

The global lyophilized injectable market is projected to register at a moderate-paced (Compound Annual Growth Rate) CAGR of 5.8% over the forecast period. The lyophilized injectable market is currently valued at USD 3043.55 Million in 2023. By 2033, demand for lyophilized injectables is expected to reach a high of USD 5348.56 Million.

This growth in the adoption of lyophilized injectables is supported by the following:

• Increased investments from the biotech, pharma and biopharma industries have led to a rise in research and development efforts.
• Increases in both study and adoption of lyophilized injectable drugs
• Expansion of government spending

Increasing approval of pharmaceutical products

Trials that are still going on are revealing added information about the safety and effectiveness of new lyophilized medicines that are being used to treat COVID-19. Manufacturers in the global lyophilized injectable market are getting licenses from the USA Food and Drug Administration (FDA) for the Emergency Use Authorization (EUA) of these products so they can treat people with severe COVID-19 symptoms.

Since the COVID-19 pandemic, companies that export lyophilized injectables have worked harder to obtain authorization from authorities like the Drug Controller General of India (DCGI) so that their goods may be used in India for limited emergency purposes. As more medications, like Remdesivir, get approved, the need for lyophilized injections will inevitably rise. The Food and Drug Administration (FDA) and other regulatory agencies have given their approvals for the following:

• In February 2020, the Drug Controller General of India (DCGI) granted regulatory approval to Mylan for the use of lyophilized Remdesivir powder in India for restricted emergency usage in COVID-19 patients.
• In June 2020, Cipla introduced Cipremi, which is a lyophilized powder form of Remdesivir intended for injection. Furthermore, the USA Food and Drug Administration (FDA) granted Gilead Sciences Inc. an Emergency Use Authorization (EUA) for the use of Remdesivir in the treatment of hospitalized COVID-19 patients. It is the only EUA medication that has been approved by the FDA for both adult and pediatric patients who are hospitalized and suspected of having or have laboratory confirmation of having COVID-19 infection. Therefore, in May, Gilead Sciences Inc. granted Cipla a license to produce and distribute CIPREMI, which is Cipla's generic version of remdesivir. This license was granted voluntarily and was not exclusive.
• The Drug Controller General of India (DCGI) granted Jubilant Life approval in July 2020 to manufacture and market Remdesivir for 100 mg/vial (lyophilized injection) for restricted emergency use in India for the treatment of severe COVID-19. This approval was granted to Jubilant Life for the treatment of severe COVID-19.
• EU approval for the lyophilized powder in a single-use vial formulation of Cosentyx was granted by Novartis AG in August 2020. Psoriasis patients who took the medication that was eventually approved saw significant and speedy improvements in their skin problems, which led to an overall improvement in the patient’s quality of life.

As a result, the expansion of the market for lyophilized injections is being driven by the rising number of approvals being granted all over the world.

Attribute	Details
Market Value (2023)	USD 3043.55 Million
Market Value (2033)	USD 5348.56 Million
CAGR	5.8%

Key Drivers and Restraints for the Lyophilized Injectable Market

There has been a significant increase in the number of businesses throughout the world using lyophilization technology because of the superior quality and longer shelf life of lyophilized medications. There has been a substantial uptick in the utilization of lyophilized injection pharmaceuticals by global contract research and manufacturing firms during the past few years. The primary motivation for this change is to supply final consumers with better goods. Opportunities in the global lyophilized injectable market are being created by reasons such as the fast growth of Contract Research Manufacturing Services (CRAMS).

Due to their safety and capacity to fulfill their stated functions, lyophilized products have witnessed a substantial increase in usage recently compared to non-lyophilized ones. Besides this, the cold chain is not necessary for these items. Therefore, they contribute to lower carbon footprints and total expenses. As a result of these factors, the lyophilized injectable market is predicted to expand into new lucrative areas in the coming years.

The expansion of the sector for lyophilized injection drugs may be hampered by several incidents involving the recall of products containing complex medications. In recent years, there has been a significant increase in product recalls that have been reported by manufacturers. These recalls have been brought about by the presence of unwanted foreign substances or by adverse drug effects. Recalls have the potential to harm a company's reputation as well as its ability to generate revenue.

Category-wise Insights

It is anticipated that the injection supplies pharmaceuticals market coming from the retail pharmacy segment is anticipated to hold more than 30 percent of the total industry share by 2033. As they provide convenient access, cheap rates, high-end customer care, and an extensive selection of items, retail pharmacies have emerged as one of the primary distribution channels. This is because retail pharmacies offer all these benefits.

In addition to this, pharmacies and other retail locations sell pharmaceuticals and offer individuals individualized guidance that caters to their specific healthcare issues and needs. In recent years, there has been a considerable increase in the number of retail pharmacies as well as pharmacy chains, which is indicative of a strong preference among customers for this type of distribution channel.

It is anticipated that the demand for lyophilized injectable medicines in the prefilled device category is likely to reach USD 210 Billion by 2033. Prefilled devices are becoming increasingly popular because of their ability to reduce the amount of time that patients are required to wait during hospital visits and to improve the level of medical care.

Along with ensuring the safe and convenient delivery of treatment, it also guarantees an elevated level of precision in the dosing of medications. Although the introduction of prefilled devices across a spectrum of drug classes and therapeutic categories can look quite different, it is anticipated that demand for the product is likely to remain steady.

Regional Insights

What are the driving factors for the USA Lyophilized Injectable Market?

The lyophilized Injectable market is estimated to grow profitably in North America in the upcoming years because of the rising frequency of disorders in the United States. . The presence of significant manufacturers, like Fresenius Kabi and Merck & Co. Inc., and Amneal Pharmaceutical, both are involved in the production of lyophilized injections and helping to drive growth in the USA Lyophilized Injectable Market. Furthermore, the increasing number of product approvals made by regulatory authorities in North America is anticipated to be fueling the expansion of the USA Lyophilized Injectable Market.

What are the defining characteristics of the European Lyophilized Injectable Market?

It is expected that the size of the lyophilized injectable market in Europe is expected to exceed USD 185 Billion by 2030. This region is predicted to become a suitable region for the expansion of existing businesses due to the rising incidence of cancer and other ailments. Europe, which has one of the oldest populations overall, is home to some of the world's oldest individuals. The growth of the senior population, which has a compromised immunological and metabolic system and is consequently at a higher risk of developing life-threatening illnesses, is another significant factor that is projected to propel the sector. According to several studies, the native populations of Belgium, the Netherlands, Denmark, and Ireland have the greatest incidence of cancer patients compared to that of any other European nation.

Remdesivir Lyophilized Powder Receives End-User Authorization in India for the Treatment of COVID-19

The coronavirus has grown to pose a significant threat to public health because it causes such severe respiratory symptoms and is ever-evolving. Adult hospitalized patients with COVID-19 are the focus of ongoing research on the efficacy and safety of novel lyophilized treatment medicines. Within this context, Cipla, a worldwide pharmaceutical business, is getting attention for releasing CIPREMI, a remdesivir lyophilized powder for injection (100 mg). Manufacturers in the lyophilized injectable market are adopting cues from these developments to enhance access to the Emergency Use Authorization (EUA) medication approved by the USA Food and Drug Administration for people experiencing severe COVID-19 symptoms.

With the third wave of the pandemic hitting India, manufacturers in the lyophilized injections industry there are stepping up their efforts to secure regulatory permission from the Drug Controller General of India (DCGI) for limited emergency use in the country.

Competitive Landscape

Major players catering to the global demand for lyophilized injectables are showing a rising interest in the creation of drug delivery systems that are universal, upgradeable, and configurable. To do this, they are putting a significant amount of money into research and development-related operations.

A trend toward the incorporation of electronic components into injectors and other types of devices is likely to emerge among industry participants in the years to come. It is anticipated that these capabilities are expected to permit modification as per the user type that is proposed. Soon, it's anticipated that these devices' networking capabilities will allow for remote upgrades. As of this element, the process of managing the lifecycle of these devices is anticipated to become less difficult.

Key players in this industry rely on a strategy of continuous product development and improvement to meet the needs of their clients throughout the world and maintain their reputation in the cutthroat global lyophilized injectable market. In April of 2022, for instance, Recipharm purchased both the advanced therapy CDMO (Contract Development and Manufacturing Organization) Arranta Bio and the virotherapy CDMO Vibalogics. As a result of the purchase, Recipharm now has a sturdy foundation in the USA owing to its new Boxborough, Massachusetts facilities, and a solid foundation upon which to expand its capabilities into other biologics modalities.

Key Segments in the Lyophilized Injectable Market

By Packaging:

• Single-Use Vials
• Point-of-Care Reconstitution
• Specialty Packaging

By Type of Delivery:

• Prefilled Diluent Syringes
• Single-Step Devices
• Proprietary Reconstitution Devices
• Multi-Step Devices

By Indication:

• Metabolic and Oncology Conditions
• Infectious Diseases
• Autoimmune Diseases
• Others

By End User:

• Hospitals
• Ambulatory Surgical Centers
• Specialty Clinics
• Others

By Region:

• North America
• Latin America
• Asia Pacific
• MEA (Middle East and Africa)
• Europe

Frequently Asked Questions

What is the Growth Outlook for the Lyophilized Injectable Market?

The growth outlook for the Lyophilized Injectable market is predicted to advance at a CAGR of 5.8% from 2022 to 2032.

Which Region Leads the Lyophilized Injectable Market?

Europe region is anticipated to lead the Lyophilized Injectable market over the forecast period.

What is the market valuation of Lyophilized Injectable in 2023?

The valuation of the Lyophilized Injectable market stands at USD 3043.55 Million in 2023.

How much Growth Potential do Lyophilized Injectable hold?

The Lyophilized Injectable market is likely to hold a valuation of USD 5348.56 Million by 2033.