LYOPHILIZED DRUGS MARKET ANALYSIS

Lyophilized Drugs Market Size and Trends

The global lyophilized drugs market is estimated to be valued at USD 340.11 Bn in 2024 and is expected to reach USD 618.10 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 8.9% from 2024 to 2031.

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The market for lyophilized drugs is expected to witness a positive growth trend over the forecast period. Factors such as rising prevalence of chronic diseases, growing geriatric population, and increasing demand for long-term stable drugs are expected to drive the demand for lyophilized drugs during this period. This technique is widely used for the manufacturing of parenteral pharmaceuticals and biopharmaceuticals as it removes moisture completely from the product which helps in long term stability. With growing need for long term stable drug formulations for conditions such as cancer, infectious diseases, etc., the lyophilized drugs market is anticipated to grow significantly from 2024 to 2031.

Increasing adoption of lyophilization in pharmaceuticals companies

The adoption of lyophilization as a technique for drug formulation is growing rapidly among pharmaceutical companies globally. Lyophilization, also known as freeze-drying, allows for longer shelf life and more stable storage of drugs without refrigeration. This has immense benefit for drugs that need to be transported or stored in difficult geographic and climatic conditions where maintaining cold chains is a challenge. The process removes water from the frozen form of the drug product, resulting in a highly porous cake that can be reconstituted on addition of water. More pharmaceutical firms are opting for lyophilization as it helps extend the life of drugs from 2-3 years to 5 or more years. This reduces loss due to drugs expiring before use. It also ensures drugs maintain their potency even when stored at room temperature for longer durations. For example, lyophilization is extensively used for formulation of life-saving vaccines that need to be administered in remote regions with limited cold storage facilities. According to UNICEF supply data, lyophilized vaccines like those for hepatitis, rabies, and yellow fever comprised over 60% of global public health vaccine stockpile in 2021. This shows the preference for longer shelf life vaccines that lyophilization offers. The anticipated growth in biologics and monoclonal antibody drugs in the coming years will further drive the lyophilization usage. As biologics require sensitive cold chain management for stability, lyophilization alleviates such needs and eases global distribution of these drugs. It is projected that over 500 new biologic drugs will be commercialized between 2020 and 2025.

Market Concentration and Competitive Landscape

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Growing need for temperature-controlled manufacturing process

The global pharmaceutical industry has seen growing demand for drugs that need temperature-controlled manufacturing processes. Many biologic drugs and vaccines require strict temperature control during manufacturing as well as storage and distribution to maintain their efficacy and safety. Lyophilization or freeze drying has emerged as a critical process to meet this demand. Lyophilization involves freezing the drug product and then reducing the pressure to allow the frozen water in it to sublimate or transition from solid to gas. This process removes water from the product but retains its overall structure. It allows for the drugs to maintain stability without refrigeration for longer durations of time. This makes lyophilized drugs easier to distribute in regions with limited cold chain infrastructure as well as store and transport in developing countries with warmer climates. The COVID-19 pandemic has underscored the need for vaccines and biologics that have longer shelf lives and do not require constant refrigeration. According to the World Health Organization, as of September 2022, over 12 billion doses of COVID-19 vaccines had been administered globally. Ensuring efficacy of these doses during storage and distribution in diverse geographic locations worldwide was challenging. Lyophilization provided answers by producing stable vaccines like Pfizer and Moderna's MRNA shots which maintain quality unrefrigerated for months. This significantly boosted uptake in places lacking cold storage. 

Key Takeaways from Analyst:

The global lyophilized drugs market holds promising growth opportunities over the forecast period. Rising chronic diseases and increasing preference for biologics which require freeze drying technology for stabilization are major drivers. Further, lyophilized formulations offer the benefits of increased shelf life and stability which aids long-term transportation and storage. This will increase demand from pharmaceutical companies. However, high costs associated with lyophilization equipment and lengthy production processes pose challenges.

The Asia Pacific region is expected to witness the highest growth. Rapid economic development, growing healthcare expenditure, and rising patient pool make it an attractive market. China, India, and Japan are likely to account for majority share. North America will continue dominating due to the presence of many lyophilized drug manufacturers and favorable regulatory environment supporting new product approvals.

In terms of drug class, vaccines are projected to be the fastest growing segment attributed to increasing immunization programs worldwide and rising focus on stockpiling communicable disease vaccines. Monoclonal antibodies hold significant market share owing to extensive R&D and their increasing role in cancer and autoimmune disease treatment.

Overall, the lyophilized drugs market shows strong prospects against the backdrop of innovations to simplify lyophilization, reduce costs, and expedite processes.

Market Challenges: High manufacturing costs associated with lyophilization equipment and process.

The high manufacturing costs associated with lyophilization equipment and process pose a significant challenge for the growth of the global lyophilized drugs market. Lyophilization or freeze drying is a complex and expensive process that requires sophisticated machinery and a controlled manufacturing environment. The equipment used for lyophilization such as freeze dryers, drying chambers, temperature, and vacuum controllers are extremely capital intensive with freeze dryers itself costing anywhere between US$0.5 million and US$3 million depending on their size and capacity. Additionally, the process of freeze drying is an energy intensive and slow process requiring several days to weeks to complete. It involves freezing the material, reducing pressure to allow the frozen water in the material to sublimate, and maintaining low temperatures and pressures for optimal results. This makes lyophilization a costly manufacturing route for pharmaceutical products compared to alternative techniques like baking or solvent evaporation. The high initial capital investment required for lyophilization plant and equipment as well as ongoing operational expenses associated with freeze drying processes poses financial challenges, especially for smaller pharmaceutical manufacturers and generics companies in developing regions. This acts as a barrier for widespread adoption of lyophilization technology. For instance, according to the International Trade Center, access to financing remains a key constraint for small and medium enterprises in Africa's pharmaceutical sector. The high costs and investment requirements for lyophilization often make it unfeasible for such companies with limited budgets to manufacture and commercialize lyophilized drugs. This has restricted the growth of availability of affordable lyophilized drug products particularly in developing markets.

Market Opportunities: Collaborations with CMOs for large-scale lyophilization

Collaborations with Contract Manufacturing Organizations (CMOs) for large-scale lyophilization presents a noteworthy opportunity in the global lyophilized drugs market. Lyophilization, commonly known as freeze-drying, is a process that is integral to increasing the shelf life of various pharmaceutical drugs. However, lyophilization also requires high capital investment and specialized infrastructure. Partnering with CMOs allows pharmaceutical companies, especially smaller ones, to benefit from lyophilization without having to bear the associated high setup costs. CMOs specializing in lyophilization offer drug makers access to their sterile lyophilization facilities, equipment, expertise and validation capabilities. This helps pharmaceutical firms outsource their large-scale commercial lyophilization needs and focus on their core drug development activities. Such outsourcing arrangements provide pharmaceutical companies better flexibility and capacity utilization. They also help CMOs expand their service portfolio and better utilize their existing facilities. Important drugs including vaccines often require lyophilization to achieve greater stability at ambient temperatures. As development of novel biologic drugs and vaccines gain prominence, need for robust lyophilization infrastructure is also growing steadily. As per the World Health Organization, nearly 50% of global vaccine production is outsourced to CMOs. This outsourcing is expected to rise further with growing demand for affordable vaccines worldwide and complexities in vaccine manufacturing. Similarly, the biopharmaceutical market is expected to grow substantially in the coming years owing to biologic drug approvals and their increasing usage. As biologics generally have short shelf lives and require lyophilization for storage and distribution, their rising demand will further augment the requirement for large-scale lyophilization capacity. Collaborations between drug firms and CMOs can help match this growing need for lyophilization and enhance availability of important biologic drugs and vaccines across global markets.

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By Drug Class - Rising prevalence of infectious diseases pushes the adoption of anti-infective drugs

In terms of drug class, the anti-infective segment is expected to contribute the highest share of the market with 25% in 2024 owing to the rising global prevalence of both communicable and non-communicable infectious diseases. The advent of drug-resistant forms of various pathogens has necessitated the development of novel anti-infective drugs with improved efficacy. Furthermore, the growing geriatric population worldwide is also amplifying the demand for anti-infective drugs since aged individuals are more susceptible to different infections. The ability of lyophilized anti-infective drugs to withstand harsh storage conditions without losing potency also contributes to their widespread use in tropical and resource-constrained settings. Advances in lyophilization technologies have further enhanced the stability and shelf-life of various anti-infective drugs.

By Indication - Oncology indications spearhead the adoption of lyophilized drug formulations

In terms of indication, the oncology segment is expected to contribute the highest share of the market with 25.12% in 2024 due to the increasing cancer burden worldwide and growing focus on targeted therapies. Lyophilization allows for improved stability and extended shelf life of potent anti-cancer drugs during storage and transportation to remote areas. It also facilitates flexible dosing and reconstitution of drugs as per patient needs. The advent of personalized medicine and preference for oral formulations of cancer drugs are supporting the demand for lyophilized oncology drugs. Moreover, lyophilization preserves the biological activity of peptides and proteins used in biologic therapies for cancer.

By Packaging Type- Vials gain prominence among lyophilized drug packages owing to multiple advantages

In terms of packaging type, the vial segment is expected to contribute the highest share of the market with 40% in 2024 because of various inherent advantages. Vials facilitate precise dosing of drugs along with ease of handling during reconstitution. Their break-resistant and leak-proof properties make vials suitable for shipping and transporting fragile lyophilized drugs. Furthermore, vials allow visual identification of powder content and maintain sterility until puncturing for injection or infusion. Vials are also recyclable and environment-friendly, contributing to their widespread popularity among pharmaceutical manufacturers and healthcare providers for packaging lyophilized drugs.

Regional Insights

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North America has established itself as the dominant region in the global lyophilized drugs market.  The region is expected to account for 40.2% of the market in 2024. The presence of major pharmaceutical companies conducting extensive R&D and focused on new drug development has enabled early technology adoption of lyophilization. Furthermore, the region has a well-established cold chain and logistics infrastructure facilitating Just-In-Time delivery of these temperature sensitive drugs across the extensive healthcare networks.

Stringent regulatory oversight and quality standards enforced by reputed bodies such as the FDA also encourage pharmaceutical companies based in North America to produce lyophilized products meeting global standards. This has enhanced the exports of these products from North America to other regions worldwide. However, pricing pressure from payers has started impacting the average selling prices of some products in the U.S. market in recent times.

Asia Pacific has emerged as the fastest growing regional market for lyophilized drugs. Countries such as China, India, Japan, and South Korea are witnessing increased demand chiefly arising from rising income levels and expanding healthcare infrastructures. Local manufacturing capabilities of several lyophilized drug formulations are being established via technology transfers and licensing agreements between multinational and domestic firms.

Notably, China's 'Made in China 2025' policy aims to increase self-sufficiency in production of critical medical technologies. This has progressively reduced its dependence on imports while also making Chinese lyophilized products competitive in global markets through economies of scale. Other Asian nations are also actively promoting the development of biosimilars and generic injectable lyophilized drugs to address the growing needs of their large patient populations in a more affordable manner.

Market Report Scope

Lyophilized Drugs Industry News

• In January 2023, Berkshire Sterile Manufacturing (BSM), a biotechnology company based in Massachusetts, plans to double its lyophilization capacity by adding a second lyophilizer to its fully automated, isolator-based filling line. This expansion aims to meet increasing demand, allowing them to process up to 70,000 10R vials per run to better serve client needs and patient populations.
• In July 2020, Mylan N.V. received regulatory approval from the Drug Controller General of India (DCGI) for its remdesivir lyophilized powder for injection, 100 mg/vial, for restricted emergency use in treating severe COVID-19 cases in India. Marketed under the brand name DESREM, it will be available starting July at INR 4,800 per vial, significantly cheaper than in developed countries.
• In September 2021, Lonza invested in additional drug product manufacturing capabilities in Switzerland with a new aseptic flexible filling line at its Stein facility. This line will handle liquid and lyophilized vial filling, cartridges, and pre-filled syringes, accommodating various modalities including monoclonal antibodies and gene therapy products. It will feature state-of-the-art robotic and freeze-drying technology with a sustainable air-cooling system.

*Definition: The global lyophilized drugs market provides customers with lyophilized or freeze-dried pharmaceutical drugs that can be stored at room temperature for longer periods without refrigeration. These drugs are dehydrated versions of injectable medications, vaccines, biologics and other sterile products that are reconstituted with sterile water or saline prior to administration. Lyophilization helps extend the shelf life of drugs and makes transportation and storage easier at a global scale. The lyophilized drugs marketed worldwide are designed to improve access and affordability of medications.

Market Segmentation

• Drug Class Insights (Revenue, USD Bn, 2019 - 2031)
  • Anti-infective
  • Antineoplastic
  • Diuretics
  • Proton Pump Inhibitor
  • Anesthetic
  • Anticoagulant
  • NSAID’s
  • Others
•  Indication Insights (Revenue, USD Bn, 2019 - 2031)
  • Oncology
  • Infectious Disease
  • Autoimmune Disease
  • Gastrointestinal Disease
  • Dermatological Disorders
  • Respiratory Diseases
  • Ophthalmic Diseases
  • Hormonal Disorders
  • Others
•  Packaging Type Insights (Revenue, USD Bn, 2019 - 2031)
  • Vial
  • Injection
  • Cartridge
•  Distribution Channel Insights (Revenue, USD Bn, 2019 - 2031)
  • Hospital Pharmacy
  • Retail Pharmacy
  • Online Pharmacy
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Pfizer Inc.
  • Novartis AG
  • Roche Holding AG
  • Johnson & Johnson
  • Sanofi S.A.
  • Amgen Inc.
  • AbbVie Inc.
  • Merck & Co., Inc.
  • Eli Lilly and Company
  • AstraZeneca PLC
  • Bristol Myers Squibb Company
  • GlaxoSmithKline plc
  • Gilead Sciences, Inc.
  • Biogen Inc.
  • Teva Pharmaceutical Industries Ltd.
  • Mylan N.V.
  • Celgene Corporation
  • Novo Nordisk A/S
  • Vertex Pharmaceuticals Incorporated
  • Takeda Pharmaceutical Company Limited