How the Biologics Pipeline Is Driving Demand for ULT Cold Storage

The pharmaceutical industry's center of gravity has shifted. Biologics, meaning 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. That shift has direct consequences for cold storage infrastructure, because the vast majority of biologics require temperature-controlled environments that go well beyond standard refrigeration.

The Numbers Behind the Shift

Global biologics sales surpassed $400 billion in 2025, and the pipeline is expanding rapidly. As of early 2026, the global biopharmaceutical pipeline contained more than 7,200 biologics in active development. Roughly one in three newly approved drugs is now a biologic, and more than 85% of those require some form of cold chain management.

This isn't a niche trend. It's a structural change in how drugs are made, stored, and distributed. Monoclonal antibodies, vaccines, gene therapies, cell therapies, mRNA-based drugs, and biosimilars all fall under the biologics umbrella, and each comes with specific temperature requirements that traditional pharmaceutical storage was never designed to handle.

What's in the Pipeline and What It Needs

Different categories of biologics require different temperature ranges, but the overall trend is toward colder and more precise storage conditions.

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

mRNA therapeutics, which gained global attention through COVID-19 vaccines, typically require storage at −20°C to −80°C depending on the formulation. As mRNA platforms expand beyond vaccines into oncology, rare diseases, and autoimmune conditions, the demand for ULT freezer capacity is growing 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 expand as well, with new platforms (mRNA, viral vector, protein subunit) carrying varied temperature requirements. Traditional vaccines may need standard 2°C to 8°C refrigeration, but newer platforms increasingly require −20°C or colder.

Biosimilars, which are essentially follow-on versions of approved biologics, carry the same cold chain requirements as their reference products. As more biologics lose patent exclusivity, biosimilar launches add volume to an already constrained cold chain.

Why This Is an Infrastructure Problem

The challenge isn't just that individual products need cold storage. It's that the aggregate demand across all these categories is scaling faster than the infrastructure 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. The ULT segment (storage at −40°C to −86°C and below) is the fastest-growing temperature range, holding a 35.2% share in 2025 and expanding at an 8.9% CAGR. The cryogenic segment (below −150°C) is expected to grow even faster as cell and gene therapies move 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 is driven by the simultaneous expansion of biologics production, the diversification of temperature-sensitive product categories, and the increasing complexity of global pharmaceutical distribution.

For facilities that operate cold storage for pharmaceutical clients, this means planning for a future where more products require colder temperatures, tighter tolerances, and more rigorous documentation than they did five years ago.

Regulatory Pressure Is Increasing Too

It's not just the volume and temperature requirements that are changing. Regulatory expectations around cold storage for biologics have been getting more prescriptive.

The FDA and EMA have both increased their focus on cold chain data integrity, requiring validated, IoT-enabled monitoring systems with real-time temperature tracking and alarm capabilities. GDP (Good Distribution Practice) requirements extend 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, meaning that the freezer holding a CAR-T product is subject to the same quality system expectations as the cleanroom where it was made.

Facilities that previously managed cold storage as an operational function are increasingly finding that it's a compliance function, with audit exposure, documentation requirements, and validation obligations that mirror 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 provides a clear planning signal.

Plan for colder. The trend is unambiguous. More products need ULT and cryogenic storage, and fewer can get by with standard refrigeration alone. New facilities should be designed with flexibility to support −80°C mechanical freezers, −150°C cryogenic systems, and everything in between.

Plan for validation. Every freezer, monitoring system, and alarm protocol needs to be validated through IQ/OQ/PQ and maintained in a validated state through documented preventive maintenance and calibration programs. This is true whether you're a pharmaceutical manufacturer, a CDMO, a biobank, or a third-party logistics provider.

Plan for redundancy. The value of what's stored in pharmaceutical ULT freezers, whether it's clinical trial material, commercial drug product, or a patient-specific cell therapy, makes backup systems and failure contingencies non-negotiable. Backup power, backup cooling, backup monitoring, and documented emergency procedures should be part of any facility plan.

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

Looking Ahead

The biologics pipeline is not slowing down. The number of biologics in development, the diversity of temperature requirements they carry, and the regulatory standards attached to their storage are all increasing. For organizations that build, operate, or depend on cold storage infrastructure, the question isn't whether to invest in ULT capability. It's whether the current infrastructure can keep up with what's already in the pipeline.