Lyophilization Services For Biopharmaceuticals Global Market- Size, Share | Industry Trend & Forecast 2025 - 2033

Lyophilization Services For Biopharmaceuticals Global Market Overview

The Lyophilization Services For Biopharmaceuticals market size is forecast to reach USD 4.46 billion by 2033, after growing at a CAGR of 10.09% during the forecast period 2025-2033. Lyophilization services for biopharmaceuticals employ freeze-drying techniques to improve product stability, increase shelf life, and optimize storage and transportation. This process preserves and stabilizes biopharmaceuticals by extracting water while the product remains frozen. Governments worldwide have supported the expansion of lyophilization capacities as part of broader efforts to enhance domestic vaccine production. The growing pipeline of biologics and biosimilars will continue to boost demand for lyophilization services.

Report Coverage

The report “Lyophilization Services For Biopharmaceuticals Market– Forecast (2025-2033)”, by IndustryARC, covers an in-depth analysis of the following segments of Lyophilization Services For Biopharmaceuticals.

By Type: Product And Cycle Development, Clinical Manufacturing, Commercial Manufacturing, Freeze Drying Analytical Services

By Primary Packaging Type: Vials, Syringes, Cartridges, Ampoules, Other Primary Packaging System

By Application: Pharmaceutical And Biotechnology Companies, Research Institutes, Other Applications

By Geography:  North America, Europe, Western Europe, Eastern Europe, Asia-Pacific, Middle East
Africa

Key Takeaways

• The growth of biologics and biosimilars has significantly increased the demand for lyophilization services, as these products require stable and long-term storage solutions.
• Government initiatives, particularly in the U.S. and Europe, are focused on bolstering domestic pharmaceutical manufacturing capabilities, which include investments in lyophilization infrastructure.
• Innovations in lyophilization technology, including continuous manufacturing processes and automation, have improved efficiency and reduced costs, making these services more accessible and attractive to biopharmaceutical companies.

By Type - Segment Analysis

Commercial Manufacturing led the market in 2024. The demand for biologics, vaccines, and gene and cell therapies is driving the biopharmaceutical industry's rapid expansion. Many of these products need to be lyophilized to keep their stability as they are extremely sensitive to environmental factors. Lyophilization services are critical in helping biopharmaceutical goods reach the commercial scale by guaranteeing that large-scale production satisfies mass distribution's stability and quality standards.

For instance, on 13th October 2023, Lonza, a manufacturing partner serving the pharmaceutical, biotech, and nutraceutical markets, announced the expansion of a partnership with a significant biopharmaceutical partner for the commercial-scale filling of ADCs. At its Stein (CH) location, Lonza is required under the agreement to build a specialized aseptic cGMP filling line on a commercial scale. The new dedicated filling line will make the aseptic filling of extremely potent ADCs and containment lyophilization possible. The inclusion of these filling capabilities further strengthens Lonza's ability to support the clinical and commercial supply of bioconjugates.

By Primary Packaging Type- Segment Analysis

The Cartridges segment dominated the semiconductor fabrication material market in 2024. The ability of the Cartridges Packaging Type to work with drug delivery devices like auto-injectors and pen injectors, which are frequently used for self-administered treatments, is what is driving its rise in the Lyophilization Services for Biopharmaceuticals Market. Because they fit into these devices easily and allow for precise and controlled dosing, cartridges are quite convenient for patients. For biologics and biosimilars used in the treatment of chronic diseases like diabetes and autoimmune disorders, where frequent and accurate dosing is necessary, this sort of packaging is becoming more and more common.

For instance, in February 2024, the US-based contract development and manufacturing organization (CDO) NCOG BioPharma Services, which specializes in sterile injectables, is expanding its capacity to fill syringes and cartridges by 100 million units by installing a high-speed OPTIMA filling line. This summer, the second filling line will be delivered to the location and qualified for GMP production in the second quarter of 2025. By adding to its current multi-purpose filling plant, the company will be able to fill 140 million units annually.  An OPTIMA MultiUse filling line, which can fill up to 40 million units a year in a range of formats, including cartridges, is being used in those projects.    

By Application – Segment Analysis

Pharmaceutical And Biotechnology Companies Dominated the Semiconductor Fabrication Material Market in 2024. Companies in the pharmaceutical and biotechnology industries are making significant investments in the creation of biologics, including gene treatments, vaccines, and monoclonal antibodies. Lyophilization is frequently necessary for these items to guarantee their potency, stability, and shelf life. The requirement for lyophilization services to preserve these products by drying and freeze-drying grows as these businesses progress in producing more intricate and sensitive biologics.
As reported in the 2020 PhRMA member annual survey, companies within the Pharmaceutical Research and Manufacturers of America (PhRMA) invested $83 billion in research and development (R&D) in 2019. This was the largest level of investment in R&D ever made. PhRMA member firms have invested around $1 trillion in finding and developing new and improved medicines and cures during the last 20 years.  For instance, according to IBEF India, India is a significant pharmaceutical exporter; by 2023, the country's pharmaceutical market is expected to be worth $50 billion. By 2030, it is anticipated that India's pharmaceutical market will be worth $130 billion. The strong pharmaceutical industry favors the market for lyophilization services for biopharmaceuticals.

For instance, in April 2024, Fujifilm invested $1.2 billion in its large-scale cell culture CDMO business to further expand the planned Fujifilm Diosynth Biotechnologies end-to-end bio-manufacturing facility in North Carolina, bringing the investment in the facility to over $3.2 billion. The demand for biopharmaceuticals' lyophilization services is growing with increasing investments in the advanced biotechnology industry.

By Geography - Segment Analysis

The APAC region is expected to dominate the Lyophilization Services For Biopharmaceuticals Market, with a projected CAGR of 10.5% from 2025 to 2033. The growing pharmaceutical and biotechnology sectors in the Asia-Pacific area are fueling the market's quick rise for lyophilization services for biopharmaceuticals. In the field of biopharmaceutical development, nations like China, India, Japan, and South Korea are becoming increasingly important, especially when it comes to the manufacturing of biologics, biosimilars, vaccines, and cell treatments. In the biopharmaceutical supply chain, lyophilization, or freeze-drying, is a critical process that helps maintain the potency, stability, and shelf life of medications that are sensitive to temperature. Several government efforts in the Asia-Pacific (APAC) region are promoting the discovery and production of biologics and advanced medicines, which in turn is propelling the expansion of lyophilization services for biopharmaceuticals:

Made in China 2025 is a strategic plan that focuses on the growth of high-tech manufacturing, particularly biopharmaceuticals, intending to enhance the industry's capacity for research and production. The National Medical Products Administration (NMPA) has implemented regulatory changes aimed at streamlining biologics licensing procedures and raising industry standards. These changes have indirectly increased the demand for sophisticated lyophilization services. 

Drivers – Lyophilization Services For Biopharmaceuticals Market

• Increasing Rising Demand For Biologics And Biosimilars

The growing prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders is driving the demand for biologics, which are complex, protein-based therapies requiring careful handling and storage. Biologics are highly sensitive to environmental conditions, making lyophilization a critical step in ensuring their stability and shelf life. 

For instance, blockbuster drugs like monoclonal antibodies and next-generation vaccines are increasingly relying on lyophilization to maintain their efficacy over extended periods. Companies such as Roche and Amgen have significantly expanded their production of biologics, further propelling the need for advanced lyophilization services. Moreover, the biopharmaceutical industry's focus is shifting towards biosimilars, which are biologic medical products highly similar to already approved biologics. This shift is further fueling the demand for lyophilization, as biosimilars also require stringent stability conditions. 

The global push for cost-effective healthcare solutions, coupled with the expiration of patents for several leading biologics, has intensified the production of biosimilars, thus expanding the lyophilization market. Samsung Bioepis and Celltrion, for example, have increased their lyophilization capacities to support the growing biosimilars market.

• Technological Advancements In Lyophilization

The Innovations in lyophilization technology are revolutionizing the biopharmaceutical industry, making the process more efficient, cost-effective, and scalable. One of the significant advancements is the development of continuous lyophilization, which allows for a more streamlined and faster production process compared to traditional batch lyophilization. 

This technology reduces the time required for lyophilization cycles, enabling manufacturers to increase their output and meet growing demand. Merck KGaA is a pioneer in this field, having invested heavily in continuous lyophilization technology, which has shown promising results in reducing production costs and time.

Automation is another key technological advancement that is driving market growth. Automated lyophilization systems are equipped with advanced control mechanisms that ensure precise regulation of temperature, pressure, and other critical parameters, minimizing the risk of human error. This not only enhances product quality but also improves operational efficiency. SP Industries and Millrock Technology have introduced state-of-the-art automated lyophilization equipment that is gaining traction among biopharmaceutical manufacturers seeking to optimize their production processes.
Challenges – Lyophilization Services For Biopharmaceuticals Market

• High Intial Capital Investment

One of the most significant barriers to the growth of the lyophilization services market is the high initial capital investment required to set up advanced facilities. Lyophilization is a complex and resource-intensive process that demands sophisticated equipment, including freeze dryers, vacuum pumps, and automation systems. The cost of acquiring this equipment, along with the need for specialized infrastructure to house it, can be prohibitively expensive, particularly for smaller companies and new entrants. For example, installing a state-of-the-art lyophilization unit can cost millions of dollars, making it a challenging investment for companies without substantial financial backing.

In addition to equipment costs, companies must also invest in skilled personnel to operate and maintain lyophilization systems. The need for highly trained staff who can manage the intricate lyophilization process adds another layer of expense, further increasing the financial burden on companies. This high capital requirement often leads to delays in setting up new facilities, limiting the market's growth potential and making it difficult for smaller firms to compete with established players who already have the necessary infrastructure in place.

Market Landscape

In 2023, the top players in the Lyophilization Services For Biopharmaceuticals market share accounted for 89% of the share. Major players in the Lyophilization Services For Biopharmaceuticals market are Baxter International, W.L.Gore & Associates, Catalent Pharma, Emergent BioSolutions, Vetter Pharma International GmbH, Corden Pharma GmbH, Curia Global Inc, Stride pharma, SK Bioscience and Others.

Developments:

• In November 2022, LTI announced its role in the development, process engineering, and preparation of clinical material for the tuberculosis vaccine candidate ID93/GLA-SE, which has successfully progressed to Phase 2 clinical trials. This study represents the first successful lyophilization of a thermostable subunit vaccine candidate that includes an emulsion-based adjuvant.
• In May 2022, Jubilant HollisterStier LLC entered into a cooperative agreement with the Army Contracting Command, collaborating with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense on behalf of the Biomedical Advanced Research and Development Authority within the U.S. Department of Health and Human Services.
• In October 2021, PCI Pharma Services, a U.S.-based provider of integrated pharmaceutical development solutions, acquired Lyophilization Services of New England Inc. for an undisclosed sum. This acquisition enables PCI Pharma Services to broaden its global presence, enhancing its ability to offer a wider range of services and better support customers in international markets.

For more Lifesciences and Healthcare Market reports, please click here