Lyophilization Equipment And Services Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)

Global Lyophilization Equipment And Services Market Trends and Insights

Rising Demand for Lyophilized Biologics & Injectables

Monoclonal antibodies, vaccines, and antibody-drug conjugates accounted for 68% of FDA biologics approvals in 2025, and most relied on freeze-drying to ensure multi-year room-temperature stability.^{[1]U.S. Food and Drug Administration, “Biologics Approvals 2025,” fda.gov} Patent expiries accelerated biosimilar launches: Trastuzumab biosimilar Bisintex gained European approval in December 2024, and adalimumab biosimilars captured a 42% U.S. share by mid-2025, each emulating the originator's stability with lyophilized vials.^{[2]European Medicines Agency, “Human Medicines Highlights 2024,” ema.europa.eu} Next-generation allogeneic CAR-T platforms are evaluating dry formats to avoid liquid-nitrogen logistics, potentially expanding required capacity by 15%-20% if commercialized at scale. Moderna disclosed pilot sugar-glass drying for mRNA vaccines in its 2024 10-K, signaling that nucleic-acid modalities may also pivot to freeze-drying. These pipelines directly swell order books for the lyophilization equipment and services market.

Expansion of Contract Lyophilization Capacity

CDMOs have outpaced in-house investments three-to-one since 2024, a pattern underscored by Samsung Biologics’ Plant 5 build in Incheon and Lonza’s eight-dryer expansion at Visp in 2025.^{[3]Samsung Biologics, “Plant 5 Ground-Breaking Press Release,” samsungbiologics.com} Vetter’s EUR 150 million project in Ravensburg added a high-speed line for pre-filled syringes, which command premium prices because aseptic freeze-drying prevents moisture ingress. Outsourcing eases capital burdens for start-ups yet concentrates know-how within a handful of service providers, reinforcing end-to-end offerings that now underpin a sizable share of the lyophilization equipment and services market.

Advances in High-Capacity Continuous & Microwave-Assisted Freeze-Drying

A University of Connecticut pilot demonstrated a belt-based continuous dryer that trimmed residence time from 48 hours to 12 hours for monoclonal antibodies while achieving 98% moisture removal. Regulatory pathways remain nascent because the FDA has not issued dedicated guidance; however, equipment vendors are preemptively patenting hybrid microwave-vacuum designs, such as IMA’s 2025 filing, to capture a first-mover advantage once standards mature. Commercial uptake, therefore, hinges on validation frameworks yet promises to raise throughput and reshape the lyophilization equipment and services market by 2028.

Cold-Chain-Independent Vaccine Distribution Initiatives

The World Health Organization updated its controlled-temperature-chain guidance in 2024, allowing lyophilized vaccines to withstand temperatures of up to 40°C for up to five days. Gavi earmarked USD 1.2 billion in 2025 to source such thermostable doses for 73 low-income nations. In response, the Serum Institute of India increased its Pune capacity by 40% and Biological E commissioned a new line in Hyderabad, both targeting WHO pre-qualification for heat-stable vaccines. Facility upgrades in emerging regions, therefore, enlarge the addressable base for the lyophilization equipment and services market.

High Capital & Maintenance Costs of Freeze-Dryers

A 100 m² industrial tray dryer lists at USD 3 million to USD 5 million, and maintenance contracts consume up to 12% of the capital cost annually. Facility integration can add 30% due to HVAC and clean-room retrofits, as demonstrated by a 2024 Charleston project that spent USD 1.2 million on a single installation. Import tariffs of 15%-25% in India and Brazil elevate landed prices. At the same time, sparse local service networks increase downtime, prompting small firms to turn to CDMOs and limiting direct purchases in the lyophilization equipment and services market.

Adoption of Alternative Drying Methods

Spray drying accounts for roughly 18% of pharmaceutical drying tasks in 2026, being favored for heat-stable compounds and vaccines where reconstitution speed is secondary. GEA’s PHARMA-SD platform completes four-hour cycles, slashing production cost 60% for suitable formulations. Supercritical CO₂ and low-temperature vacuum drying nibble an additional share, especially for diagnostic enzymes. While these alternatives rarely match freeze-drying for biologic stability, they impose pricing pressure and incremental share loss on the lyophilization equipment and services market.

Segment Analysis

By Modality: Services Outpace Equipment as Outsourcing Deepens

Services generated the fastest growth in 2026 and are on track to post a 10.29% CAGR to 2031 as sponsors reallocate budgets from ownership to per-batch outsourcing. Accessories accounted for 39.28% of revenue in 2025, driven by a sizable installed base that requires vacuum pumps, SIP/CIP modules, and control upgrades. Lonza charges USD 150,000-USD 250,000 to validate a freeze-drying cycle, which is far less than the USD 3 million-USD 5 million required for an in-house dryer, encouraging smaller clients to outsource. CDMOs operating three dryers at 90% utilization achieve vial costs 40%-50% lower than single-dryer plants running at 60%, a structural advantage that expands the lyophilization equipment and services market through service revenues.

Tray-style systems retain the majority of equipment sales due to their flexibility across vial formats, while manifold units focus on personalized medicine. Rotary dryers claim premium niches where 10%-15% faster cycles offset 30% higher prices. Accessories demand remains linked to Process Analytical Technology (PAT) retrofits; adding tunable diode laser sensors can cut cycle development time by 30% and deliver a payback within two years for high-volume users.

Note: Segment shares of all individual segments available upon report purchase

By Application: Medical Diagnostics Surge as Point-of-Care Testing Expands

Food processing and packaging contributed 45.83% of revenue in 2025, due to products such as instant coffee, freeze-dried fruit, and premium pet food; however, its growth is slowing in developed regions as consumers shift to fresh alternatives. Medical and diagnostics applications are set to climb at an 11.21% CAGR to 2031, underpinned by point-of-care test growth of 18% in 2025. Lyophilized primers in Abbott’s Alinity m RESP assay remain stable 24 months at 25°C, eliminating cold-chain costs that once captured 20% of per-test expenses. Pharmaceutical and biotech companies benefit from the development of antibody-drug conjugates and potential mRNA vaccines, yet rising biosimilar competition pressures their margins. Other segments, cosmetics, nutraceuticals, and industrial enzymes, represent a fragmented 8%-10% share with modest visibility.

Note: Segment shares of all individual segments available upon report purchase

Geography Analysis

North America generated 36.86% of global revenue in 2025, driven by over 2,000 industrial dryers operating under FDA regulations. PCI Pharma Services completed a USD 100 million expansion of its New Hampshire plant in 2024, adding 12 dryers. Expansion at Charleston brought four additional units online. Although high labor and electricity costs temper new purchases, frequent retrofits for PAT compliance keep accessories and services buoyant. Canada’s smaller base and Mexico’s early-stage biosimilar capacity add incremental volume, with Lonza studying a Monterrey site for near-shored manufacturing in 2025.

The Asia-Pacific region is the fastest-growing, projected to post a 13.19% CAGR through 2031. WuXi Biologics commissioned three new suites in 2024 to serve export clients, leveraging 40%-50% lower production costs. The Serum Institute and Biological E each expanded their lines to supply thermostable vaccines, underscoring the pull of vaccine manufacturing on the lyophilization equipment and services market. Tofflon boosted exports by 47% in 2025 by pricing tray dryers 25%-30% below those of its Western peers, although limited FDA penetration persists. Australia and South Korea contribute modestly, while operator-skill gaps across China and India constrain ramp-ups, underscoring the demand for validated, turnkey capacity.

Europe maintained roughly 28% of revenue in 2025, led by Germany, Italy, France, the United Kingdom, and Spain. Industrial electricity prices in Germany averaged EUR 0.22 per kWh in 2025, nearly triple the U.S. rates, eroding the economics for energy-intensive dryers. Compliance with the EU’s F-gas cuts incurs retrofit costs, yet major CDMOs remain committed. For instance, Recipharm invested EUR 3.7 million in Italy in 2024, and Vetter spent EUR 150 million in Ravensburg the same year. Nonetheless, European equipment shipments slipped 6% in 2025 as some projects migrated to lower-cost Asia-Pacific hubs.

South America and Middle East & Africa together form a sub-scale share below 15%, driven by Brazil’s pharmaceutical investments and South Africa’s vaccine ambitions. Infrastructure gaps and import duties dampen growth, though Gavi-funded vaccine rollouts could spur incremental demand, extending the global footprint of the lyophilization equipment and services market.