PUBLISHER: Roots Analysis | PRODUCT CODE: 1337364
PUBLISHER: Roots Analysis | PRODUCT CODE: 1337364
The global market for cryopreservation bags and freezing bags is expected to grow at compounded annual growth rate (CAGR) of 8% during the forecast period.
Cryopreservation is a technique that aids in maintaining biological materials at cryogenic temperatures for an extended period of time, while preserving the original cell structures. Owing to its ability to store a wide variety of elements, including cells, tissues, blood and DNA, cryopreservation has emerged as a key focus area for stakeholders in the biopharmaceutical industry. It is worth highlighting that, since 1980s, there have been significant advancements made in the cryopreservation methods used for storing stem cells, particularly hematopoietic stem cells and embryonic stem cells, which are essential in various medical applications, including regenerative medicines and biobanking. Driven by the rising demand for promising storage containers that safeguard the quality, viability, stability, and integrity of the preserved samples, cryopreservation bags, also known as cryobags, have emerged as the most reliable and safest choice for storage. These cryopreservation bags and freezing bags provide researchers and drug developers with rapid access to vital components used across research focused on cellular and genetic therapies, diagnosis and drug development. Hence, with the advancement of technologies, a surge in morbidity across the globe and growing demand for advanced therapeutic medicinal products (ATMPs), the cryopreservation bags market and freezing bags market is anticipated to witness substantial growth during the forecast period.
"The Cryopreservation Bags and Freezing Bags Market: Distribution by Type of Analyte Stored (Blood, Biologics and Tissues) and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, and Rest of the World): Industry Trends and Global Forecasts, 2023-2035" report features an extensive study of the current market landscape, market size and future opportunities associated with the cryopreservation bags and freezing bags market, during the given forecast period. Further, the market report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the cryobags market are briefly discussed below.
ATMPs are revolutionary therapies for human use that are based on genes, tissues or cells and present novel therapeutic prospects for treating a wide range of disorders. Cryopreservation plays a crucial role in the ATMP production process as it extends the shelf life of raw materials and final products. Furthermore, cryopreservation facilitates extensive testing of the raw materials before they undergo manufacturing, thereby enhancing patient safety. Despite the expensive and limited storage strategies, the cryopreservation bags market (blood, biologics and tissues) is expected to experience accelerated market growth due to the growing need for biobanking and the increase in popularity of cell therapies and gene therapies.
The cryopreservation bags and freezing bags providers landscape features a mix of large, mid-sized and small companies that offer various cryobags. Presently, more than 70 cryogenic storage bags for biologic products have been / are being developed by over 30 industry stakeholders to enable long-term preservation of various materials. Further, cryobags can be used to store a wide spectrum of analytes; of these, 50% are capable of storing blood, followed by those storing cell cultures (44%), biologics (21%) and tissues (21%). It is worth highlighting that Miltenyi Biotec's CryoMACS freezing bags can store blood and cell cultures and have obtained ISO 13845 certification. The company received CE marking for marketing across EU in 2009 and FDA 510(k) clearance in 2010 for marketing in the US.
Another factor that influences the manufacturing of cryopreservation bags in pursuit of sustaining biological materials in cold chains is choosing the ideal form of packaging material. It is important to highlight that a significant portion of commercially available cell freezing bags are primarily made of ethylene vinyl acetate (EVA) and polyvinyl chloride (PVC) polymer compositions. In this context, it is worth highlighting that in February 2022, OriGen Biomedical launched its cryopreservation product, CryoStore FLEX freezing bag. This EVA bag is intended for the storage of blood components and has received CE mark clearance that confirms its compliance with specific requirements of the European medical device directives.
Driven by advancements in biomedical research, the growing prevalence of blood disorders and transfusion rates, and rising demand for ATMPs, cord blood stem cells and biobanking applications, lucrative opportunities are expected to emerge for companies offering cryogenic storage products. The cryopreservation bags and freezing bags market is anticipated to grow at a CAGR of 8% during the forecast period 2023-2035.
In terms of type of analyte stored, blood bags capture 55% share of the cryopreservation bags and freezing bags market. However, in terms of market growth, the tissue freezing bags market size is expected to grow at a relatively high CAGR of 11% during the forecast period. Further, amongst the key geographical regions, Asia-Pacific is anticipated to capture the highest blood bags market share in 2035, with India and China being the major contributors to this industry. For instance, an India based company, CellBios, provides CellStor Freezing EVA bags for the cryopreservation of blood and blood components, tissues, organs, biologic therapies, ATMPs, and cells, including stem cell cryopreservation.
Many stakeholders are undertaking initiatives to achieve greater durability in cryopreservation bags. Cryopreservation bags are specially designed containers used to store biological samples at ultra-low temperatures or in liquid nitrogen, typically below -150 degrees Celsius (-238 degrees Fahrenheit). Undoubtedly, cryobags are effective in preserving biological materials, however, they still possess limitations in terms of long-term durability and robustness.
Further, EVA (ethylene-vinyl acetate) is believed to undergo glass transition at temperatures lower than -15 degrees Celsius, which makes it fragile and susceptible to breakage, leaving EVA bags vulnerable to contaminations. This has prompted stakeholders to shift from conventional packaging materials to unparalleled packaging materials, such as polytetrafluoroethylene (PTFE) and fluorinated ethylene propylene (FEP). It is worth highlighting that these materials are likely to be more widely recognized for exhibiting greater resilience for long-term applications. , Given the inclination of stakeholders towards exploring novel innovative approaches that boost durability, we believe that the cryopreservation bags and freezing bags market size is likely to evolve at a rapid pace over the forecast period.
Examples of companies engaged in this industry include (which have also been captured in this report) American Durafilm, Biomed Device, CellBios, Charter Medical, Instant Systems, Macopharma, OriGen Biomedical and Sartorius. This market report includes an easily searchable excel database of all the companies providing cryopreservation and freezing bags for biologics, blood, cell cultures and tissues.
The research report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry, across different geographies. Amongst other elements, the research report includes:
One of the key objectives of the market report was to estimate the current market size, opportunity and the future growth potential of the cryopreservation bags and freezing bags market. We have provided an informed estimate on the likely evolution of the market for the forecast period, 2023-2035. Our year-wise projections of the current and forecasted opportunity have been further segmented based on several relevant parameters, such as type of analyte stored (biologics, blood, tissues), and key geographical regions (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, and Rest of the World). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic scenarios, representing different tracks of the industry's evolution.
The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this industry. The report features detailed transcripts of interviews held with the following individuals:
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.
While the focus has been on forecasting the market till 2035, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
Answer: Cryopreservation is the use of very low temperatures to preserve structurally intact living cells and tissues for a long period of time.
Answer: The major steps in cryopreservation are: (1) mixing of cryoprotective agents (CPA) with cells or tissues before cooling; (2) cooling of the cells or tissues at low temperatures at which the metabolic processes of the cells stop; (3) thawing of the cells or tissues; and (4) removal of CPAs from the cells or tissues after thawing. The appropriate use of CPAs is, therefore, important to improve the viability of the sample to be cryopreserved.
Answer: Generally, there are two basic methods of cryopreservation, the conventional slow freezing (SF) and the rapid freezing method, also known as vitrification (Vit). These protocols require different concentrations of CPAs and appropriate cooling rates.
Answer: A cryobag is a bag designed for the cryopreservation of cellular products in a closed-bag system at ultra-low or cryogenic temperatures.
Answer: More than 70 bags are currently available, across the globe for the storage and preservation of different biological samples.
Answer: At present, more than 30 companies are engaged in providing cryopreservation and freezing bags. Examples of leading companies engaged in this market (which have also been captured in this report) include American Durafilm, Biomed Device, CellBios, Charter Medical, Instant Systems, Macopharma, OriGen Biomedical and Sartorius.
Answer: Presently, the cryopreservation bags and freezing bags market is dominated by North America, followed by Asia-Pacific.
Answer: The cryopreservation bags and freezing bags market is projected to grow at an annualized rate (CAGR) of ~8%, during the forecast period 2023-2035.