Lyophilization Services for Biopharmaceuticals Global Market Report 2024

The lyophilization services for biopharmaceuticals market size has grown rapidly in recent years. It will grow from $1.66 billion in 2023 to $1.83 billion in 2024 at a compound annual growth rate (CAGR) of 10.5%. The expansion observed in the historical period can be attributed to several factors, including the growth of the biopharmaceutical sector, the expiration of drug patents, the surge in personalized medicine adoption, an increase in clinical trials, and the globalization of the biopharmaceutical market.

The lyophilization services for biopharmaceuticals market size is expected to see rapid growth in the next few years. It will grow to $2.74 billion in 2028 at a compound annual growth rate (CAGR) of 10.6%. The anticipated growth in the forecast period can be linked to various factors, including the emergence of mRNA and nucleic acid therapeutics, outsourcing trends within the pharmaceutical industry, a heightened emphasis on continuous manufacturing, advancements in combination therapies, and the expanding production of biosimilars. Notable trends expected during this period encompass the implementation of Quality-by-Design (QbD), integration of automation and robotics, a heightened focus on sustainability, customization tailored for complex molecules, and a notable shift towards continuous lyophilization.

The lyophilization services for the biopharmaceuticals market are anticipated to experience substantial growth due to the increasing demand for biologics. Biologics, which are therapeutic products derived from living organisms, or containing components of living organisms, are prominently utilized in the pharmaceutical and biopharmaceutical industries. Lyophilization services play a crucial role in preserving the stability of biologics by preventing denaturation or degradation, thereby enhancing stability and improving product integrity. Notably, reports from the Canadian Institute for Health Information reveal that biologics accounted for a significant portion of total spending on public medication programs in 2021, underlining the growing importance of these products. Additionally, the US Food and Drug Administration's approval of numerous biosimilars underscores the increasing competition and demand for biologics in the United States, further fueling the need for lyophilization services in the biopharmaceuticals market.

The growth of disposable incomes is expected to be a key driver for the lyophilization services market in the biopharmaceutical sector. Rising disposable incomes empower individuals and healthcare systems to invest in advanced medical treatments, including biopharmaceuticals. This increased demand contributes to heightened investments in the development and manufacturing of these products, with a specific focus on specialized services such as lyophilization. For instance, data from the Statistics Bureau of Japan and the U.S. Bureau of Economic Analysis reveal substantial increases in disposable personal income in Japan and the United States, respectively. This upward trend in disposable incomes is a significant factor propelling the growth of lyophilization services in the biopharmaceuticals market.

The lyophilization services for biopharmaceuticals market is witnessing a notable trend towards technological advancements, with major companies focusing on developing innovative specialized products to enhance their market standing. An example of this trend is evident in the launch of the SP Hull LyoStar 4.0 R&D freeze dryer by SP Industries Inc., a prominent US-based pharmaceutical product manufacturer. This pilot-scale freeze dryer, introduced in June 2021, is designed to expedite the market for biopharmaceutical products. Leveraging features such as superior shelf mapping, rapid shelf freezing, unmatched process accuracy, and reliability, LyoStar 4.0 is based on a full-scale production freeze dryer, supporting rapid scale-up. It incorporates an innovative suite of Process Analytical Technology (PAT) tools, providing real-time data on the lyophilization process. This technology ensures precise process control, robust reliability, and protection of valuable products, potentially reducing the time and cost associated with developing new biopharmaceutical products while improving their quality and consistency.

Major companies in the lyophilization services for biopharmaceuticals market are actively engaging in strategic collaborations to drive innovation in drug product development, particularly for novel modalities in the biologics sector. An illustrative collaboration occurred in July 2023 between Coriolis Pharma, a Germany-based service provider and formulation R&D company, and RheaVita, a Belgium-based supplier of continuous freeze-drying technology for biopharmaceutical products. This collaboration aims to integrate RheaVita's single vial unit (SVU) technology into Coriolis Pharma's service portfolio. The SVU technology enables continuous and controlled freeze-drying, contributing to the stabilization of novel modalities as part of biologic drug product development.

In October 2021, PCI Pharma Services, a US-based provider of integrated pharmaceutical development services, made a strategic move by acquiring Lyophilization Services of New England Inc. (LSNE) for an undisclosed amount. This acquisition is expected to enhance PCI Pharma Services' global presence and offer customers a more comprehensive range of services, supporting them in international markets. LSNE, a US-based provider of lyophilization services to the pharmaceutical, biotechnology, and medical device industries, brings its expertise to contribute to the growth and expansion of PCI Pharma Services in the lyophilization services for biopharmaceuticals market.

Major companies operating in the lyophilization services for biopharmaceuticals market report are Strides Pharma Science Limited, Baxter International Inc., Catalent Pharma Solutions Inc., W. L. Gore & Associates Inc., Emergent BioSolutions Inc., Vetter Pharma International GmbH, Curia Global Inc., Corden Pharma GmbH, CinnaGen Co., Lyophilization Services of New England Inc., Jubilant HollisterStier LLC, Dalton Pharma Services, IDT Biologika GmbH, Ardena Group, Axcellerate Pharma LLC, Symbiosis Pharmaceutical Services, Lyka Labs Limited, Biofortuna Limited, Rentschler Fill Solutions GmbH, Lyophilization Technology Inc., Pyramid Laboratories Inc., ATTWILL Medical Solutions, AB BioTechnologies Inc., Biopharma Process Systems, Labyrinth Biopharma LLC, Gilyos GmbH, ProJect Pharmaceutics GmbH, BioZed Engineering Pvt. Ltd., Berkshire Sterile Manufacturing, Millrock Technology Inc.

North America was the largest region in the lyophilization services for biopharmaceuticals market in 2023. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the lyophilization services for biopharmaceuticals market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the lyophilization services for biopharmaceuticals market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The key categories within lyophilization services for biopharmaceuticals include product and cycle development, clinical manufacturing, commercial manufacturing, and freeze-drying analytical services. Product and cycle development encompass the process of designing, developing, and optimizing a product along with its manufacturing cycle. This includes the utilization of various packaging systems, such as vials, syringes, cartridges, ampoules, and others. These services cater to diverse applications, including pharmaceutical and biotechnology companies, research institutes, and other relevant industries.

The lyophilization services for biopharmaceuticals market research report is one of a series of new reports that provides lyophilization services for biopharmaceuticals market statistics, including lyophilization services for biopharmaceuticals industry global market size, regional shares, competitors with a lyophilization services for biopharmaceuticals market share, detailed lyophilization services for biopharmaceuticals market segments, market trends and opportunities, and any further data you may need to thrive in the lyophilization services for biopharmaceuticals industry. This lyophilization services for biopharmaceuticals market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The lyophilization services for biopharmaceuticals market includes revenues earned by entities by providing scale-up and manufacturing, process optimization services, packaging solutions, stability studies, regulatory support, consulting, and technical support. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.