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Bio-Preservation Market to Reach US$ 44.45 Billion by 2035 | Cold Chain Expansion and Cell & Gene Therapy Commercialization Drive Growth Says Astute Analytica

Bio-Preservation Market to Reach US$ 44.45 Billion by 2035 | Cold Chain Expansion and Cell & Gene Therapy Commercialization Drive Growth Says Astute Analytica

The bio-preservation market shows strong potential driven by cell and gene therapy expansion and precision medicine demands. AI integration and consumables growth will accelerate adoption, though regulatory hurdles may slow new entrants amid rising iPSC applications.

Chicago, Feb. 11, 2026 (GLOBE NEWSWIRE) — The global bio-preservation market size was valued at USD 4.52 billion in 2025 and is projected to hit the market valuation of USD 44.45 billion by 2035 at a CAGR of 25.68% during the forecast period 2026–2035.

The bio-preservation market has historically been viewed through the lens of research and development, but 2024 marked a definitive shift from clinical hope to commercial reality. The sector is no longer driven solely by the potential of future medicine but by the immediate, tangible logistics required to support a record number of FDA-approved cell and gene therapies (CGT). As we move through 2025, the demand for bio-preservation is being reshaped by industrial-scale requirements, where biological integrity must be maintained across global supply chains.

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This analysis dissects the market through meticulously researched data from 2024 and 2025, moving beyond generic growth percentages to focus on the operational metrics that matter: clinical trial volume, infrastructure capacity, and logistical velocity.

Key Findings

  • North America commanded the largest share of the global bio-preservation market at 46% in 2025.
  • By product, the media category is projected to achieve a 32% CAGR over 2026-2035.
  • By volume, the iPSC segment is expected to register robust growth throughout the forecast period.
  • By application, the biobanking category led the global bio-preservation market.

By Product, Where Will the Most Aggressive Revenue Growth Originate?

By product category, the media segment is projected to achieve a staggering CAGR of 32% over the 2026–2035 forecast period. This metric represents the most significant value migration in the industry, signaling a departure from capital-heavy hardware investments toward high-consumable recurrence.

he driving force behind this acceleration is the industry-wide pivot from “home-brew” research cocktails to GMP-grade, serum-free preservation formulations, particularly for CAR-T cell therapy. As cell and gene therapies (CGT) move from academic labs to commercial manufacturing, regulatory bodies like the FDA and EMA are enforcing strict quality standards. Manufacturers can no longer rely on variable, animal-derived serums for preserving patient cells. Instead, they must utilize chemically defined, clinical-grade media that ensures consistency and safety.

By Biospecimen, Which Biological Asset is Fueling Volume Expansion?

In terms of sample volume, the iPSC (induced Pluripotent Stem Cell) segment is expected to register robust growth throughout the forecast period. Unlike embryonic stem cells, iPSCs bypass ethical controversies and offer the unique advantage of autologous compatibility—they can be generated from a patient’s own skin or blood cells.

This “robust growth” is being driven by two distinct engines: Personalized Medicine and High-Throughput Toxicology Screening. Pharmaceutical companies are increasingly relying on libraries of iPSC-derived cells (such as hepatocytes or cardiomyocytes) to test drug toxicity early in the pipeline, reducing the failure rate of clinical trials. Because iPSCs are notoriously fragile and prone to spontaneous differentiation or apoptosis during the freeze-thaw cycle, they require specialized, high-volume preservation protocols.

The expansion of bio-manufacturing facilities dedicated to generating iPSC lines for “off-the-shelf” (allogeneic) therapies is creating a massive, continuous demand for preservation capacity, making iPSCs the fastest-growing volume segment in the market.

By Application, Regenerative Medicine Set to Dominate the Market in the Years to Come

As of 2025, the conversation in bio-preservation has shifted from simple “storage” to “strategic supply chain resilience.” The dominance of regenerative medicine is no longer just about volume, it is driven by the decentralization of manufacturing for autologous therapies. The bio-preservation market is witnessing a granular shift away from serum-based media toward chemically defined, DMSO-free cryopreservation solutions to meet stricter FDA/EMA safety standards for clinical-grade materials.

The market is seeing a surge in demand for smart, cloud-connected cryo-freezers that provide real-time audit trails, essential for high-value oncology and neurology treatments. Furthermore, the explosion of “off-the-shelf” allogeneic therapies is forcing biobanks such as stem cell banking to upgrade infrastructure to handle industrial-scale throughput rather than just batch processing.

Surge in Clinical Trials Drives Immediate Demand for Advanced Sample Preservation Solutions

The most potent indicator of future demand in the bio-preservation sector is the volume of active clinical trials, particularly those entering late-stage development. As of December 31, 2024, the market witnessed a significant uptick in activity, with key logistics provider Cryoport supporting a total of 701 global clinical trials. This represents a net increase of 26 trials year-over-year, signaling a robust pipeline that requires temperature-controlled logistics.

Crucially, the maturity of this pipeline is accelerating. In 2024, 81 of these supported trials were in Phase 3, the final hurdle before commercialization. This high volume of late-stage therapies creates an immediate need for scalable preservation solutions that can transition from the lab to the patient bedside. Industry reports from Novotech in late 2024 indicate that the annual growth rate for cell and gene therapy trials is tracking to surpass 36% between 2022 and 2030, suggesting this demand curve will only steepen.

Global Biobanking Infrastructure Reaches Critical Mass with New Billion Sample Capacity Milestones

As clinical trials multiply, the physical infrastructure required to house biological assets is undergoing a massive expansion. The “real estate” of biology—biobanks and biorepositories—is seeing unprecedented density. By 2024, Azenta Life Sciences reached a cumulative installed base of over 300 automated storage systems globally. More impressively, these systems are now managing more than 1 billion samples worldwide, a milestone that underscores the sheer volume of biological data being preserved for future research.

This growth is not uniform; it is punctuated by regional spikes in demand. China, for example, reported approximately 10,000 new cord blood clinical applications between May 2023 and May 2024, reflecting a surging domestic interest in regenerative medicine. Similarly, the global inventory of public cord blood banks reached 800,000 units in 2024, while private banks held an estimated 4,000,000 units.

Genomic research is also driving storage needs. In November 2024, the UK Biobank partnered with Oxford Nanopore to sequence 50,000 epigenetic samples. This initiative alone necessitates high-integrity preservation to ensure that subtle epigenetic markers remain stable for sequencing, proving that modern bio-preservation is as much about data integrity as it is about tissue survival.

Innovation in Organ Preservation Extends Geographic Viability for Global Transplant Logistics Operations

Technological breakthroughs in 2024 have begun to rewrite the rules of organ transport, moving the market away from simple ice coolers toward sophisticated, sub-zero preservation systems. X-Therma achieved a landmark success in 2024 by demonstrating a 48-hour preservation time for a pig kidney. This extended window enabled the successful transport of the organ across the Atlantic Ocean, involving 5 separate transatlantic flights to validate stability.

This technological leap has profound commercial implications. By extending the viability window, preservation technology allows for global organ matching rather than local-only distribution. The study utilized ice-free cryopreservation at sub-zero temperatures, preventing the cellular damage typically caused by freezing.

Simultaneously, storage hardware is evolving to meet these new standards. In April 2024, Thermo Fisher Scientific launched a new line of ultra-low temperature (ULT) freezers specifically designed for regenerative medicine. Furthermore, BioLife Solutions introduced the CellSeal CryoCase in May 2024, addressing the critical need for packaging integrity that can withstand the rigors of extended transport chains.

Massive Capital Investment in Cold Chain Fleets Supports Rapid Commercial Therapy Rollout

The physical movement of biologic material has attracted billions in infrastructure investment, transforming logistics providers into specialized healthcare partners. DHL Group’s Life Sciences & Healthcare division generated over EUR 5 billion in revenue in 2024, providing the financial bedrock for future expansion. Consequently, DHL has committed to investing EUR 2 billion by 2030 into health logistics, a strategy solidified by their 2024 operational performance.

The Asia-Pacific region is a key focus for this expansion. UPS Healthcare opened a new 11,500 square meter facility in Singapore in 2024 to serve as a cold chain hub for the region. Similarly, CryoPDP operated 14 facilities in India in 2024, directly supporting the approval of the country’s first cell therapy, Qartemi.

The volume of goods moving through these networks is rising sharply. IAG Cargo reported a 22% year-over-year increase in tonnage for its constant climate product in 2024. To sustain this velocity, Cryoport repurchased $185 million in convertible senior notes in 2024, strengthening its balance sheet to fund the heavy operational costs associated with supporting 19 commercial therapies as of December 31, 2024.

Record Regulatory Approvals and Expedited Pathways Accelerate Commercial Cold Chain Market Requirements

Regulatory bodies are acting as accelerators for the bio-preservation market. The FDA approved 8 new cell and gene therapies in 2024, setting a new annual record. Each approval creates an immediate, permanent demand for cold chain logistics to move the therapy from manufacturer to patient. Notably, Cryoport supported 11 Biologic License Applications (BLA) or Marketing Authorization Applications (MAA) filings in 2024, with expectations for up to 23 additional filings in 2025.

The speed of these approvals is also notable. Of the 50 novel drugs approved in 2024, 33 utilized expedited programs like Fast Track or Breakthrough Therapy designations. Furthermore, 37 of these approvals were granted on the first cycle of review. This regulatory efficiency forces supply chains to be “commercial-ready” faster than ever before.

Specific therapies are driving distinct logistic streams. Casgevy saw full commercial rollout efforts in 2024, while Amtagvi (lifileucel) became the first one-time T-cell therapy for solid tumors approved in February 2024. The approval of Lenmeldy in March, Beqvez in April, Tecelra in August, and Aucatzyl in November 2024 has created a diverse calendar of shipping requirements, each demanding validated preservation protocols.

Consumer Demand for Fertility Preservation Creates Robust Long Term Storage Revenue Opportunities

While commercial therapies drive logistics, the reproductive health sector provides a stable, volume-based revenue stream for bio-preservation. In Hong Kong alone, licensed centers reported 7,533 IVF and frozen-thawed embryo transfer cycles in 2024. Of these, 2,551 were strictly banking cycles, where genetic material is frozen for future use without immediate transfer.

The market dynamics here are defined by the “storage arbitrage”—the gap between freezing and utilizing. A 2024 study released by UCLA analyzed elective egg freezing and found that while cycles reached 16,436 (a 4x increase), only 5.7% of women returned to use the frozen eggs within the study window. This low utilization rate transforms fertility clinics into long-term storage facilities, requiring robust inventory management systems. Extend Fertility also presented data in 2024 on 4,000 egg freezing cycles, validating the long-term survival rates that underpin consumer confidence in this service.

Future Outlook for Bio Preservation Market Based on Current Pipeline Data

The bio-preservation market in 2025 is characterized by high-velocity commercialization. The “wait and see” era of clinical trials has ended. With 23 anticipated BLA/MAA filings in 2025 and a record-breaking 2024 for approvals, the infrastructure built today will be tested immediately. Stakeholders must now focus on density, energy efficiency, and global logistics capability to capture the value of the biological century.

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Bio-preservation Market Major Players:

  • Azenta US, Inc.
  • BioLife Solutions
  • LabVantage Solutions, Inc.
  • Biomatrica, Inc.
  • MVE Biological Solutions
  • Thermo Fisher Scientific, Inc.
  • Panasonic
  • X-Therma Inc.
  • PrincetonCryo
  • Stirling Ultracold
  • Taylor-Wharton
  • Other Prominent Players

Key Market Segmentation:

By Product

  • Equipment
    • Refrigerators
    • Freezers
    • Consumables
      • Straws
      • Vials
      • Microtiter Plates
      • Bags
    • Liquid Nitrogen
  • Media
    • Home-brew
    • Pre-formulated
  • Laboratory Information Management System (LIMS)

By Application

  • Regenerative Medicine
    • Gene Therapy
    • Cell Therapy
    • Others
  • Bio-banking
    • Human Sperms
    • Human Eggs
    • Veterinary IVF
  • Drug Discovery

By Cell Providers Volume

  • CD19+
  • CD34+
  • iPSC
  • MSC
  • Tumor Cells
  • hESC
  • Others

By Region

  • North America
  • Europe
  • Asia Pacific
  • Middle East and Africa
  • South America

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About Astute Analytica

Astute Analytica is a global market research and advisory firm providing data-driven insights across industries such as technology, healthcare, chemicals, semiconductors, FMCG, and more. We publish multiple reports daily, equipping businesses with the intelligence they need to navigate market trends, emerging opportunities, competitive landscapes, and technological advancements.

With a team of experienced business analysts, economists, and industry experts, we deliver accurate, in-depth, and actionable research tailored to meet the strategic needs of our clients. At Astute Analytica, our clients come first, and we are committed to delivering cost-effective, high-value research solutions that drive success in an evolving marketplace.

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CONTACT: Contact Us:
Astute Analytica
Phone: +1-888 429 6757 (US Toll Free); +91-0120- 4483891 (Rest of the World)
For Sales Enquiries: sales@astuteanalytica.com
Website: https://www.astuteanalytica.com/ 

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