Global Lyophilized Injectables Market - 2024-2031

Global Lyophilized Injectables Market - 2024-2031

The global lyophilized injectables market reached US$ 3.1 billion in 2023 and is expected to reach US$ 4.6 billion by 2031, growing at a CAGR of 5.2% during the forecast period 2024-2031.

Lyophilized injectables are pharmaceuticals that are freeze-dried to produce a stable, solid state by eliminating water from their compositions. For sensitive biologics and vaccines that may be reconstituted with a solvent before administration, this procedure improves drug stability and allows for long-term storage.

The rise in complex molecules and biologics, improvements in drug delivery, technological developments in lyophilization procedures, the incidence of chronic illnesses, and the growing need for biopharmaceuticals are the main factors driving the global market for lyophilized injectables.

Market Dynamics: Drivers

Rise in Biologics and Complex Molecules

The demand for the global lyophilized injectables market is driven by multiple factors. The growth of biologics and complicated molecules is one of the main drivers propelling the Market. Therapeutic substances called biologics, which are derived from living things, are becoming more and more popular in the treatment of autoimmune illnesses, infectious diseases, and cancer.

These unique compounds fill gaps in medicine by providing highly specific and effective targeted therapeutic alternatives that enhance patient outcomes. Injectable formulations that are lyophilized are essential for the delivery of biologics because they maintain the biologics' stability and biological activity throughout storage and transit.

Pharmaceutical firms can use outside resources to research and produce lyophilized injectable pharmaceuticals thanks to CMOs' specialized knowledge, infrastructure, and lyophilization capacity.

For instance, in May 2022, Pfizer established a worldwide center for drug development in India. The development of finished dosage forms (FDFs) of differentiated products, such as complex/value-added formulations, controlled-release dosage forms, device-combination products, lyophilized injections, powder-fill products, and ready-to-use formulations, will be one of the center's capabilities.

Furthermore, major key players in the market introduce new drugs help to drive this market growth. For instance, in June 2022, Dupixent, also known as dipilumab, was approved by the U.S. Food and Drug Administration for use in children with moderate-to-severe atopic dermatitis between the ages of six months and five years.

The illness cannot be sufficiently controlled with topical prescription medications, or such therapies are not recommended. For the treatment of moderate-to-severe atopic dermatitis in children and adults, dupixent is the first and only biologic medication authorized for use.

Restraints

Factors such as product recalls, stringent regulatory requirements, presence of glass particles in the product, high costs of lyophilization, production complexities, patient training & convenience, packaging issues impacting product quality, and technological challenges in formulation development, are expected to hamper the market.

For more details on this report - Request for Sample

Segment Analysis

The global lyophilized injectables market is segmented based on drug type, type of delivery, form, route of administration, application, type of packaging, end-user, and region.

The oncology segment accounted for approximately 37.4% of the global lyophilized injectables market share

The oncology segment is expected to hold the largest market share over the forecast period. Cyclophosphamide is used to treat various types of cancer. It is a chemotherapy drug that works by slowing or stopping cell growth. Cyclophosphamide also works by decreasing your immune system's response to various diseases.

For instance, in February 2024, Fresenius Kabi introduced Cyclophosphamide for Injection, USP, a generic substitute for Cytoxan, for use in treating several forms of cancer. Now available in the U.S., Cyclophosphamide for Injection, USP is the newest addition to Fresenius Kabi’s broad portfolio of generic oncology injectables.

Also, in March 2024, Avenacy, a specialty pharmaceutical company focused on supplying injectable medications, launched Fosaprepitant for Injection and Fulvestrant Injection. The product contains 150 mg of Fosaprepitant as a lyophilized powder in a single-dose vial for reconstitution.

Moreover, major players in the industry launch new drugs and approvals would drive this market growth. For instance, in April 2024, Gland Pharma received approval from the United States Food and Drug Administration (USFDA) for Eribulin Mesylate Injection. It is used to treat breast cancer that has spread to other parts of the body and that has already been treated with certain other chemotherapy medications.

Similarly, in August 2022, Accord Healthcare, Inc., a leading generic pharmaceutical company, added Carmustine to its line of chemotherapy drugs. The drug is formulated as a sterile lyophilized (freeze-dried) powder to be reconstituted for intravenous infusion. Carmustine is approved for use in the treatment of certain types of brain tumors and blood cancers.

Geographical Analysis

North America accounted for approximately 42.3% of the global lyophilized injectables market share

North America region is expected to hold the largest market share over the forecast period owing to the increasing incidence of chronic diseases and a higher adoption rate of lyophilized injectable drugs in the region.

In this region, advanced healthcare infrastructure, robust research and development activities, technological advances, and an established regulatory framework are propelling market growth.

Research and development initiatives combined with key pharmaceutical players playing an instrumental role in driving growth and innovation within the lyophilized injectable drug market are factors of growth and innovation that contribute to its leadership position.

For instance, in January 2024, Avenacy launched the Melphalan Hydrochloride for Injection in the United States as a therapeutic equivalent generic for Alkeran for Injection (melphalan hydrochloride) which is approved by the U.S. Food and Drug Administration.

Also, in November 2022, Cipla Limited announced the launch of Leuprolide Acetate Injection Depot 22.5mg. The product was approved by the United States Food and Drug Administration based on a New Drug Application (NDA) submitted under the 505(b)(2) regulatory pathway.

COVID-19 Impact Analysis

The COVID-19 pandemic positively impacted the global lyophilized injectables market. The pandemic has accelerated the development and approval of lyophilized medicines, particularly for the treatment of severe COVID-19 symptoms. For instance, in May 2020, Cipla introduced CIPREMI, a Remdesivir lyophilized powder for injection (100mg), which has received FDA approval for emergency use authorization (EUA) in the United States.

Manufacturers are working to obtain regulatory approvals and EUAs from authorities like the FDA and the Drug Controller General of India (DCGI) to use their products in emergencies. This has led to a surge in the number of approvals and EUAs granted, driving the market growth.

The pandemic has highlighted the benefits of lyophilization technology, such as longer shelf life and reduced cold chain requirements. This has led to increased adoption of lyophilization technology by pharmaceutical companies, further driving market growth.

Market Segmentation

By Drug Type
• Anti-infective
• Anti-neoplastic
• Anticoagulant
• Hormones
• Others

By Type of Delivery
• Multi-step Devices
• Prefilled Diluent Syringes
• Proprietary Reconstitution Devices
• Single-step Devices

By Form
• Powder
• Liquid

By Route of Administration
• Intravenous/Infusion
• Intramuscular
• Others

By Application
• Autoimmune Diseases
• Infectious Diseases
• Metabolic Conditions
• Oncology
• Others

By Type of Packaging
• Point-of-Care Reconstitution
• Specialty Packaging
• Single-use Vials

By End User
• Hospitals
• Specialty Clinics
• Ambulatory Surgical Centers
• Others

By Region
• North America
U.S.
Canada
Mexico
• Europe
Germany
U.K.
France
Spain
Italy
Rest of Europe
• South America
Brazil
Argentina
Rest of South America
• Asia-Pacific
China
India
Japan
South Korea
Rest of Asia-Pacific
• Middle East and Africa

Competitive Landscape

The major global players in the lyophilized injectables market include Merck & Co., Inc., Protech Telelinks, Cirondrugs, Aristopharma Ltd, Pfizer Inc., Novartis AG, F. Hoffmann-La Roche Ltd, Sanofi, Amgen Inc., Novo Nordisk A/S, among others.

Key Developments

 In May 2024, Global contract development and manufacturing organization (CDMO), Sterling Pharma Solutions, announced that it has invested $3 million into expanding its integrated antibody-drug conjugate (ADC) development and manufacturing capabilities in its Germantown, Wis. facility in the United States.

 In July 2023, WuXi STA, a contract research development and manufacturing organization (CRDMO) that functions as a subsidiary of WuXi AppTech, announced the launch of its first high potency (HP) fully automated sterile injectable manufacturing line at its drug product site in Wuxi City, China.

 In February 2023, Thermo Fisher Scientific announced that its Applied Biosystems business introduced the TaqMan 2.5X Lyo-Ready 1-step qPCR Master Mix with an excipient, optimized, ready-to-use formulation for a lyophilization process.

Why Purchase the Report??
• To visualize the global lyophilized injectables market segmentation based on drug type, type of delivery, form, route of administration, application, type of packaging, end-user, and region, as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of global lyophilized injectables market level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping is available in excel consisting of key products of all the major players.

The global lyophilized injectables market report would provide approximately 94 tables, 97 figures, and 182 Pages.

Target Audience 2024
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies