Advanced Therapy Medicinal Products (ATMP) CDMO Market Size & Share Analysis - Growth Trends And Forecast (2025 - 2030)

Global Advanced Therapy Medicinal Products (ATMP) CDMO Market Trends and Insights

Capacity-Tight Viral-Vector Manufacturing Drives Outsourcing Acceleration

Viral-vector manufacturing capacity additions have lagged therapy approvals, resulting in average wait-lists of 9-12 months for GMP slots in North America and Europe^{[1]Source: Center for Biologics Evaluation and Research, “2024 Biological License Application Approvals,” fda.gov} . Catalent, Lonza, and Samsung Biologics responded by announcing cumulative vector investments exceeding USD 5 billion since 2024, yet near-term scarcity persists. Sponsors therefore favor multi-year master service agreements that guarantee campaign windows, exchanging volume commitments for priority access. CDMOs benefit by securing predictable utilization rates that justify continuous facility expansion. The imbalance also accelerates off-take of single-use bioreactor systems that enable rapid line-changeovers and higher facility turns. Venture-backed gene-therapy firms, lacking internal infrastructure, increasingly outsource entire CMC programs, cementing the ATMP CDMO market as an essential enabler of commercial launch schedules.

All-in-One CRDMO Models Reshape Small-Biotech Engagement

Resource-constrained biotechs seek integrated research-through-commercial partners to reduce tech-transfer friction, cut overlapping overhead, and streamline regulatory filings. Samsung Biologics, WuXi AppTec, and Lonza now bundle early discovery, IND-enabling studies, and GMP production in single statements of work. This consolidation shortens average development timelines by 8-10 months and eliminates two to three hand-offs that historically introduced batch-failure risk. CDMOs leverage cross-phase data continuity to optimize scale-up parameters faster, while sponsors conserve cash by paying milestone-based installments rather than upfront facility builds. Over the forecast horizon, the CRDMO construct is projected to capture 35% of new outsourcing deals, redefining competitive benchmarks from cost-per-batch to total-lifecycle value.

FDA RMAT Designations Accelerate GMP Scale-Out Demand

The U.S. FDA granted 15 RMAT designations in 2024 and anticipates up to 20 in 2025, cutting review times by roughly 50% and pulling commercial demand forward by one development phase. Sponsors now initiate commercial-scale engineering runs during Phase II, swelling demand for pilot-to-commercial suites that can flex from 50 L to 2,000 L volumes within the same clean-room footprint. CDMOs with prefabricated, plug-and-play modules lock in higher margins because they can accommodate sudden volume jumps without long permitting cycles. The designation trend also raises the premium on regulatory consulting services capable of navigating rolling submissions and post-approval change controls.

M&A-Fueled Platform Consolidation Widens Service Breadth

Between 2024 and 2025, disclosed CDMO deals topped USD 26 billion, headlined by Novo Holdings' USD 16.5 billion acquisition of Catalent. Consolidators pursue vertical integration—pairing plasmid supply, viral-vector suites, cell-therapy fill-finish, and analytical labs—to become indispensable to sponsors. Scale yields procurement leverage on single-use assemblies and raw materials, enabling 4-6% cost relief that can be redeployed into AI and automation upgrades. Smaller pure-play firms respond by specializing in niche modalities such as in-vivo gene-editing or mRNA lipid nanoparticle formulation. The wave also triggers geographic diversification, with acquirers purchasing footprint in both Western and Asian hubs to skirt emerging bio-security policies.

Rising U.S. National-Security Scrutiny Fragments Supply Chains

The BIOSECURE Act bars federal funds from therapies manufactured in China after 2032, prompting 79% of U.S. sponsors to map alternative viral-vector supply within 24 months. WuXi AppTec projected a 15% revenue decline for its viral-vector unit in 2024 after early contract cancellations, signaling near-term demand reallocation. The scramble inflates tech-transfer queues and duplicates validation work, adding 6-12 weeks to commercial-launch critical paths. Multisite redundancy raises opex, eroding the 18-20% cost savings that once underpinned China outsourcing.

EU GMP Annex 1 Sterility Requirements Inflate Compliance Costs

The 2024 revision swelled from 16 to 59 pages, mandating zero colony-forming units in Grade A environments and forcing costly airflow retrofits. Mid-tier European CDMOs budget USD 10-12 million per suite for revamps, tipping ROI scales toward consolidation or facility relocation. Sponsors absorb part of the bill via 5-8% price surcharges on aseptic processing. Long run, the standard accelerates adoption of isolator technology and advanced environmental monitoring sensors, but near-term capacity may dip by 3-4% during retrofit downtime.

Segment Analysis

By Therapy Type: Cell Therapy Consolidates Leadership

Cell therapy retained 60 .20% share of 2024 revenue, buoyed by CAR-T approvals moving into earlier-line indications. The segment is forecast to record a 24.98% CAGR, outpacing gene therapy owing to shorter vein-to-vein timelines and expanding hematological applications. This dominance compels CDMOs to invest in modular, closed-system workcells optimized for autologous volumes under 20 L. The ATMP CDMO market size for cell therapy services is projected to reach USD 12.3 billion by 2030, underpinning sustained capital deployment. Gene therapy follows, boosted by the commercial rollout of the first CRISPR-edited treatment, CASGEVY, and averaging 22% CAGR as rare-disease indications transition to in-vivo vectors.

Commercialization momentum shifts investment toward allogeneic pipelines, where scale economies improve cost-of-goods profiles. Tissue-engineered products and combined ATMPs collectively account for single-digit revenue shares but attract niche demand for orthopedic and dermatological implants. CDMOs leverage platform commonalities—such as aseptic fill-finish and quality-by-design analytics—to serve these smaller modalities without discrete infrastructure. Ongoing harmonization of pharmacopeial standards is expected to facilitate cross-border market access, reinforcing multi-therapy manufacturing hubs in the United States, South Korea, and Ireland.

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

By Service Type: Manufacturing Dominates While Compliance Soars

cGMP manufacturing led with 45.78% revenue share in 2024 as sponsors outsourced both clinical and commercial volumes to de-risk capital exposure. The ATMP CDMO market share for manufacturing is anticipated to remain above 40% through 2030 despite rising internalization by big pharma, thanks to smaller biotech reliance on external capacity. Regulatory & QA support, though currently sub-10% of revenue, is expanding at 25.19% CAGR as RMAT, PRIME, and Sakigake pathways shorten filing windows and amplify compliance workload. 

Process development captures sustained demand because iterative optimization remains critical for yield improvements exceeding 30% from Phase I to commercial scale. Fill-finish and cold-chain packaging, once treated as downstream commodities, increasingly require bespoke isolators and cryo-logistics that command premium pricing. Analytical & QC testing grows in lockstep, propelled by multi-attribute methods (MAM) and next-generation sequencing assays that regulators now expect for potency validation.

By Development Phase: Revenue Concentration Migrates Earlier

Phase III programs comprised 43.82% of fee revenue in 2024, reflecting the surge of pivotal trials following a record wave of IND filings in 2021-2022. Yet pre-clinical activities post the strongest 25.72% CAGR as VCs funnel capital into first-in-human innovations and sponsors front-load CMC readiness to secure accelerated approvals. The ATMP CDMO market size for early-phase services is therefore projected to nearly triple between 2025 and 2030, creating pipeline visibility for CDMOs five years in advance of commercial launch. 

Phase I and II remain essential volume drivers because regulatory agencies expect demonstration of manufacturing comparability at each scale-up milestone. Commercial manufacturing retains the highest EBITDA margins—often 35-40%—but its revenue share grows more gradually as only a subset of pipeline assets reach approval. CDMOs that provide seamless transition packages are able to retain 70-80% of clients from toxicology lots through commercial launch, a key differentiator in competitive bidding.

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

Geography Analysis

North America kept 42.23% of 2024 turnover owing to FDA regulatory clarity and a concentration of sponsor headquarters. However, capacity bottlenecks and rising wage costs restrain incremental share gains. Asia-Pacific, led by China, South Korea, and Australia, is poised to register a 25.92% CAGR, benefiting from supportive industrial policies and lower cost bases. Europe delivers steady high-single-digit growth but faces capital-intensive Annex 1 retrofits that may shutter sub-scale plants. 

Latin America and the Middle East & Africa remain nascent, accounting for less than 5% combined revenue, yet targeted government incentives—such as Brazil’s cell-therapy tax credits—could stimulate localized fill-finish and packaging in the outer forecast years. CDMOs with distributed footprints mitigate geo-political disruptions and currency volatility, enabling multi-jurisdictional release strategies for global trials.