How the Biologics Pipeline Is Driving Demand for ULT Cold Storage

Biologics, drugs derived from living systems rather than synthesized chemically, now account for a growing share of new drug approvals, clinical trial activity, and pharmaceutical revenue. The downstream effect on cold storage infrastructure is significant, because most biologics require temperature-controlled environments well beyond what standard refrigeration provides.

Global biologics sales surpassed $400 billion in 2025, and the pipeline keeps growing. As of early 2026, more than 7,200 biologics were in active development globally. Roughly one in three newly approved drugs is a biologic, and over 85% of those require some form of cold chain management.

Monoclonal antibodies, vaccines, gene therapies, cell therapies, mRNA-based drugs, and biosimilars all fall under the biologics umbrella, and each carries specific temperature requirements that traditional pharmaceutical storage was not built around.

What's in the Pipeline and What It Needs

Temperature requirements vary by product category, but the trajectory points consistently toward colder, tighter, and more precisely controlled storage.

Monoclonal antibodies (mAbs) are the largest biologics category by revenue. Most require refrigerated storage at 2°C to 8°C, with some formulations needing frozen storage at −20°C. Production volume alone is driving demand for large-scale validated cold rooms and refrigerated warehousing.

mRNA therapeutics, which gained global attention through COVID-19 vaccines, typically need storage at −20°C to −80°C depending on formulation. As mRNA platforms expand into oncology, rare diseases, and autoimmune conditions, ULT freezer capacity has to expand with them.

Cell and gene therapies sit at the extreme end of the cold chain. CAR-T products, gene-modified cell therapies, and other advanced therapy medicinal products (ATMPs) generally require cryogenic storage below −130°C, often in vapor-phase liquid nitrogen systems. With more than 1,100 active clinical trials globally, this category is the fastest-growing driver of cryogenic infrastructure investment.

Vaccines continue to diversify across new platforms (mRNA, viral vector, protein subunit), each with different temperature profiles. Traditional vaccines may still operate at 2°C to 8°C, but newer platforms increasingly require −20°C or colder.

Biosimilars, follow-on versions of approved biologics, inherit the cold chain requirements of their reference products. As more biologics lose patent exclusivity, biosimilar launches keep adding volume to a constrained cold chain.

Why This Is an Infrastructure Problem

Individual products need cold storage. That part is straightforward. The harder problem is that aggregate demand across all these categories is scaling faster than the infrastructure available to support it.

The pharmaceutical cold storage market was valued at $16.5 billion in 2024 and is projected to reach $34.5 billion by 2035. ULT storage (−40°C to −86°C and below) is the fastest-growing segment, holding a 35.2% share in 2025 and expanding at an 8.9% CAGR. Cryogenic capacity (below −150°C) is expected to grow even faster as cell and gene therapies transition from clinical trials to commercial manufacturing.

The bio-pharmaceutical warehousing market more broadly was valued at $29.6 billion in 2024 and is expected to reach $68.1 billion by 2033, growing at 8.7% CAGR. That growth reflects three concurrent forces: expansion of biologics production, diversification of temperature-sensitive product categories, and rising complexity in global pharmaceutical distribution.

For facilities operating cold storage on behalf of pharmaceutical clients, the planning horizon now has to assume colder temperatures, tighter tolerances, and more rigorous documentation than was standard five years ago.

Regulatory Pressure Is Increasing in Parallel

Volume and temperature are not the only variables shifting. Regulatory expectations around biologics cold storage have grown more prescriptive in the same window.

FDA and EMA have both sharpened their focus on cold chain data integrity, requiring validated, IoT-enabled monitoring with real-time temperature tracking and alarm capabilities. GDP (Good Distribution Practice) extends temperature control obligations through the entire supply chain, from manufacturer to patient. For cell and gene therapies, cGMP requirements apply to storage facilities as well as manufacturing sites: the freezer holding a CAR-T product carries the same quality system expectations as the cleanroom where it was made.

Cold storage that used to live in operations is now functionally part of compliance, with audit exposure, documentation obligations, and validation requirements that resemble those of the manufacturing process itself.

What This Means for Cold Storage Planning

For any organization building, expanding, or upgrading pharmaceutical cold storage, the biologics pipeline offers a clear planning signal in four directions.

Design for colder ranges. The trend is unambiguous: more products need ULT and cryogenic storage, fewer get by on standard refrigeration alone. New facilities should accommodate −80°C mechanical freezers, −150°C cryogenic systems, and the full range in between.

Build validation in from day one. Every freezer, monitoring system, and alarm protocol has to be validated through IQ/OQ/PQ and maintained in a validated state through documented preventive maintenance and calibration. The requirement holds whether the operator is a pharmaceutical manufacturer, a CDMO, a biobank, or a third-party logistics provider.

Treat redundancy as non-optional. The value of what sits in a pharmaceutical ULT freezer, whether clinical trial material, commercial drug product, or a patient-specific cell therapy, eliminates the case for single points of failure. Backup power, backup cooling, backup monitoring, and documented emergency procedures belong in the original design rather than as retrofits.

Default to audit-ready documentation. Continuous temperature monitoring with unbroken records is the baseline. Facilities should be able to produce temperature histories, alarm response logs, calibration records, and chain of custody documentation on demand for any product in storage.

Pipeline growth, temperature diversity, and regulatory rigor are all moving in the same direction at the same time. For organizations that build, operate, or rely on cold storage infrastructure, the practical question is whether current capacity can absorb what is already in development, with enough headroom for what comes next.

Where NWR Comes In

The four planning directions above (colder ranges, built-in validation, redundancy, audit-ready documentation) align with the work we have been doing with cold storage operators for years. NWR designs and manufactures custom ultra-low temperature refrigeration systems for facilities operating under GMP, GDP, and cGMP requirements, then validates them through full IQ/OQ/PQ programs. Our technicians support those systems around the clock once they are in operation.

That combination matters because the biologics pipeline does not reward generalist infrastructure. A −80°C freezer holding clinical trial material, a cryogenic system supporting a CAR-T program, and a refrigerated warehouse running mAb inventory each carry different engineering, validation, and monitoring profiles. We build to those profiles rather than around them.

If you are scoping a new facility, expanding existing capacity, or assessing whether your current systems can absorb what is in your pipeline, our engineering and validation teams can walk through the specifics with you.

Request a quote or contact NWR to start the conversation.