Cell Therapy Market Size and Share
Market Overview
| Study Period | 2021 - 2030 |
|---|---|
| Market Size (2025) | USD 5.58 Billion |
| Market Size (2030) | USD 12.27 Billion |
| Growth Rate (2025 - 2030) | 17.05% CAGR |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | High |
Major Players
*Disclaimer: Major Players sorted in no particular order Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0. |
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Cell Therapy Market Analysis by Mordor Intelligence
The Cell Therapy Market size is estimated at USD 5.58 billion in 2025, and is expected to reach USD 12.27 billion by 2030, at a CAGR of 17.05% during the forecast period (2025-2030).
Continued FDA and EMA approvals, greater investment in modular manufacturing, and disease-agnostic clinical pipelines underline a decisive shift from experimental programs to routine care. Early-line authorizations for CAR-T, rapid progress in off-the-shelf allogeneic products, and AI-enabled bioprocessing jointly accelerate time-to-patient while easing capacity bottlenecks. Rising reimbursement clarity in the United States and Germany, Asia-Pacific CDMO scale-ups, and neurologic breakthrough designations extend addressable populations well beyond oncology. Together, these factors keep competitive intensity high as pharmaceutical majors race to secure differentiated platforms and localized supply.
Key Report Takeaways
- By therapy type, autologous products led with 90.25% of cell therapy market share in 2024; allogeneic platforms are on course for a 12.56% CAGR through 2030.
- By cell type, hematopoietic stem cells held 45.65% of the cell therapy market size in 2024, while NK cell programs are expanding at a 12.78% CAGR.
- By application, oncology captured 38.40% revenue in 2024; neurological disorders are projected to register a 13.10% CAGR to 2030.
- By end user, hospitals and clinics accounted for a 64.67% slice of the cell therapy market size in 2024, whereas specialty centers show the fastest 12.89% CAGR trajectory.
- By geography, North America occupied 53.40% revenue share in 2024; Asia-Pacific is set to grow at 14.01% CAGR through 2030.
Global Cell Therapy Market Trends and Insights
Driver Impact Analysis
| Driver | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Rising commercial launches of autologous CAR-T therapies | +2.80% | Global with North America and Europe concentration | Medium term (2–4 years) |
| Expansion of hospital-based manufacturing suites | +2.10% | North America & EU, expanding to APAC | Long term (≥ 4 years) |
| National reimbursement pathways in EU (Germany NUB) | +1.70% | Europe | Short term (≤ 2 years) |
| CDMO capacity build-out in Asia for allogeneic pipelines | +1.90% | Asia-Pacific core, global spill-over | Long term (≥ 4 years) |
| AI-optimised cell-expansion bioreactors | +1.50% | Global, early North America uptake | Medium term (2–4 years) |
| On-site micro-factories for point-of-care therapies | +1.20% | Developed markets | Long term (≥ 4 years) |
| Source: Mordor Intelligence | |||
Rising Commercial Launches of Autologous CAR-T Therapies
Second-line clearance for idecabtagene vicleucel and ciltacabtagene autoleucel tripled the eligible US patient pool to more than 45,000, underpinning immediate revenue upside and justifying the CDMO expansion pipeline. Real-world data indicating 69.1% overall response versus 35% for salvage regimens solidified payer support, yet global manufacturing capacity presently tops out at 25,000 treatments yearly, forcing developers to prioritise supply chain partnerships[1]Source: U.S. Food & Drug Administration, “Approved Cellular and Gene Therapy Products,” fda.gov.
Expansion of Hospital-Based Cell-Therapy Manufacturing Suites
Sixty-three percent of academic centres now run internal CAR-T suites, shrinking vein-to-vein times from 28 to 7 days and removing up to 20% of logistics cost. Regulators have issued multi-site guidance to harmonise batch testing, though each facility requires USD 15–25 million in upfront capital, limiting adoption by smaller hospitals and potentially widening access disparities within the cell therapy market.
National Reimbursement Pathways in EU
Germany’s NUB mechanism approved 75% of 180 cell therapy filings in 2024, bridging EUR 300,000–400,000 price gaps while building real-world evidence that shapes longer-term DRG integration. Comparable fast-track schemes in France and the United Kingdom amplify data pools that influence payer decisions worldwide.
AI-Optimised Cell-Expansion Bioreactors
OmniaBio’s closed-loop reactors halve cost of goods and cut batch failure to under 5% through sensor-driven parameter control. Regulatory agencies now publish AI/ML validation blueprints, encouraging broader rollout across the cell therapy market [2]Source: International Society for Pharmaceutical Engineering, “AI/ML Guidance in Pharma Manufacturing,” ispe.org.
Restraint Impact Analysis
| Restraint | % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| High cost-of-goods for personalised autologous batches | -2.30% | Global, most acute in cost-sensitive markets | Medium term (2-4 years) |
| Supply-chain bottlenecks for viral vectors & plasmids | -1.80% | Global, concentrated in North America & Europe | Short term (≤ 2 years) |
| Source: Mordor Intelligence | |||
High Cost-of-Goods for Personalised Autologous Batches
Autologous production averages USD 150,000–300,000 per patient, driven by labour-intensive 14–21 day cycles and batch-specific release assays. Quality control alone can reach USD 50,000 and remains largely non-automatable, challenging reimbursement in price-pressured health systems.
Supply-Chain Bottlenecks for Viral Vectors & Plasmids
Global demand for high-grade vectors eclipses capacity by 200-300%, with the top five suppliers controlling over 70% of volume. Vector rejection rates of 20-25% aggravate scarcity, delaying clinical timelines for smaller sponsors lacking guaranteed slots, further tightening constraints throughout the cell therapy market.
Segment Analysis
By Therapy Type: Allogeneic Platforms Challenge Autologous Dominance
Autologous products retained 90.25% cell therapy market share in 2024, yet allogeneic lines are expanding at a 12.56% CAGR on the back of Ryoncil’s first-in-class approval. Allogeneic manufacturing costs of USD 25,000–50,000 per dose underpin broader access and sharply contrast autologous expense tiers, positioning the segment to eclipse personalized volumes within the forecast window.
Immunologic engineering now delivers HLA-edited grafts capable of durable engraftment without rejection, eroding the compatibility edge long enjoyed by autologous approaches. Large-batch economics further enable a single run to treat thousands, a scale autologous systems cannot match in the cell therapy market.
Note: Segment shares of all individual segments available upon report purchase
By Cell Type: Immune Cells Accelerate Beyond Stem Cell Staples
Hematopoietic stem cells represented 45.65% of the cell therapy market size in 2024 thanks to mature transplant programs, yet NK cell therapies are growing 12.78% annually as solid-tumor data confirm superior safety relative to CAR-T. Early-stage pluripotent platforms targeting neurological repair add pipeline breadth, diversifying revenues away from traditional graft applications.
NK modalities circumvent cytokine release syndrome and can be produced from healthy donor pools, streamlining manufacturing. Broadening dendritic, fibroblast, and chondrocyte initiatives collectively expand the cell therapy market toolbox, each offering disease-specific advantages.
By Application: Neurological Disorders Drive Next-Generation Growth
Oncology delivered 38.40% of the cell market revenue in 2024, but Parkinson’s and other neurodegenerative programs elevate neurology to a 13.10% CAGR trajectory. Bemdaneprocel’s Phase 1 results secured Phase 3 clearance and validate sustained dopamine restoration, signalling potential disease modification rather than symptom control.
Additional cardiac, autoimmune, and opht halmologic candidates reduce reliance on oncology cash flows. Multi-indication versatility broadens the cell therapy market and distributes regulatory risk across therapeutic categories.
By End User: Specialty Centers Emerge as Growth Catalysts
Hospitals and clinics held 64.67% of the 2024 cell therapy market size, though specialist centres clock a 12.89% CAGR as complex administration protocols demand concentrated expertise. Facilities dedicated to apheresis, cryogenic storage, and CRS management achieve 95%+ batch success, surpassing general hospital averages.
Academic institutes remain discovery engines, yet commercial CDMOs supply scale, allowing smaller innovators to progress without owning capital-intensive facilities—a structure that continues to reshape the cell therapy industry ecosystem.
Note: Segment shares of all individual segments available upon report purchase
Geography Analysis
North America commanded 53.40% of 2024 revenue, underpinned by ten FDA approvals that year and Medicare’s MS-DRG 018 payment baseline of USD 274,413. Ongoing domestic investments exceeding USD 2 billion annually ensure resilient capacity and stable reimbursement that fuels procedure volume. Canada’s regulatory alignment and Mexico’s cost-effective manufacturing within USMCA trade rules reinforce continental supply advantages.
Europe remains a science hub, with Germany’s NUB processing over 180 applications in 2024 at a 75% award rate, but reimbursement heterogeneity across member states tempers growth. The hospital exemption route supports investigator-led manufacturing, yet divergent coverage schemes complicate pan-EU launches.
Asia-Pacific is on pace for a 14.01% CAGR, buoyed by USD 5 billion-plus CDMO outlays that cut costs by up to 40% while meeting ICH standards. China’s national cell therapy program, Japan’s regenerative medicine incentives, and South Korea’s strategic biomanufacturing investments collectively position the region to supply 40% of global output by 2028, shifting the fulcrum of the cell therapy market toward the East.
Competitive Landscape
The cell therapy market shows moderate fragmentation, yet M&A momentum is altering boundaries. Roche’s USD 1 billion Poseida buy and AstraZeneca’s USD 245 million Cellectis stake reflect the premium placed on allogeneic and gene-editing capabilities. Technology mastery—in AI-driven bioreactors, rapid ana lytics, and immune-evasion editing—defines competitive advantage as price pressures intensify.
Patent activity surged beyond 2,000 filings in 2024, covering new CAR constructs, vector technologies, and closed-system platforms. Consolidation among CDMOs offers integrated manufacturing and analytics, appealing to emerging sponsors that prioritise speed over ownership.
White-space remains in neurodegeneration, autoimmune therapy, and solid tumors resistant to current CAR-T constructs. Entrants able to combine allogeneic versatility with automated, low-COG manufacturing stand to outpace legacy autologous incumbents within the coming cycle.
Cell Therapy Industry Leaders
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Corestem Inc.
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Chiesi Farmaceutici S.p.A.
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Tego Science
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Allogene Therapeutics Inc.
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Takeda Pharmaceuticals
- *Disclaimer: Major Players sorted in no particular order
Recent Industry Developments
- May 2025: Sana Biotechnology reported first insulin-producing allogeneic cell transplant without immunosuppression in type 1 diabetes.
- May 2025: FDA cleared Zevaskyn, the first autologous skin-cell gene therapy for recessive dystrophic epidermolysis bullosa.
- April 2025: Vertex licensed TreeFrog’s C-Stem technology for USD 25 million upfront plus milestones to scale pancreatic islet production.
- March 2025: FDA approved ENCELTO, the inaugural neuroprotective cell therapy for macular telangiectasia type 2.
Research Methodology Framework and Report Scope
Market Definitions and Key Coverage
Our study treats the cell therapy market as all investigational and commercial products in which viable human cells, stem, immune, or tissue-specific, are introduced into a patient to repair, replace, or modulate biological functions. This spans autologous and allogeneic modalities, with oncology, cardiovascular, neurological, orthopedic, autoimmune, and wound-healing applications included.
Scope Exclusion: Gene-only vectors and acellular regenerative scaffolds lie outside our remit.
Segmentation Overview
- By Therapy Type (Value)
- Autologous Cell Therapy
- Allogeneic Cell Therapy
- By Cell Type (Value)
- Stem Cell Therapy
- Hematopoietic Stem Cells
- Mesenchymal Stem Cells
- Induced Pluripotent Stem Cells
- Immune Cell Therapy
- T Cell Therapy
- NK Cell Therapy
- Dendritic Cell Therapy
- Fibroblast & Chondrocyte-based Therapies
- Stem Cell Therapy
- By Application (Value)
- Oncology
- Cardiovascular Diseases
- Orthopedic & Musculoskeletal
- Neurological Disorders
- Autoimmune Disorders
- Wound Healing & Dermatology
- Ophthalmology
- By End User (Value)
- Hospitals & Clinics
- Specialty Cell- & Gene-Therapy Centers
- Academic & Research Institutes
- Contract Manufacturing & CRO Facilities
- By Geography (Value)
- North America
- United States
- Canada
- Mexico
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Rest of Europe
- Asia-Pacific
- China
- Japan
- India
- South Korea
- Australia
- Rest of Asia-Pacific
- Middle East and Africa
- GCC
- South Africa
- Rest of Middle East and Africa
- South America
- Brazil
- Argentina
- Rest of South America
- North America
Detailed Research Methodology and Data Validation
Primary Research
Multiple conversations with cell-therapy manufacturers, transplant centers, payers, and principal investigators across North America, Europe, and Asia help validate addressable patient pools, average treatment costs, batch yields, and rollout bottlenecks. Insights from these stakeholders let us adjust model variables where desk sources are silent or dated.
Desk Research
Mordor analysts first map the evidence base through open sources such as FDA CBER approval archives, EMA PRIME listings, ClinicalTrials.gov, WHO Global Observatory for Cell and Gene Therapies, and trade association digests from ARM or ISCT. Company 10-Ks, investor decks, and hospital reimbursement schedules provide real-world pricing and uptake clues. Paid databases, D&B Hoovers for revenue splits and Dow Jones Factiva for deal flow, supply financial alignment and news velocity. Many additional references underpin each data point, the above list being illustrative rather than exhaustive.
Market-Sizing and Forecasting
A blended top-down build starts with treated patient volumes drawn from registry data, prevalence-to-eligibility filters, and recorded CAR-T, MSC, or iPSC dose releases, which are then multiplied by median therapy price bands. Supplier roll-ups and sampled ASP times dose counts provide a selective bottom-up check that reconciles gaps. Key drivers in the model include clinical trial success ratios, regulatory approval cadence, manufacturing capacity, liters of bioreactor output, reimbursement penetration, and allogeneic share gains. Five-year outlooks employ multivariate regression layered over ARIMA time series to reflect lagged relationships between trial readouts, capacity expansion, and price compression.
Data Validation and Update Cycle
Outputs pass three-stage peer review, variance thresholds trigger re-checks against external indices, and material events such as landmark approvals prompt mid-cycle refreshes. The dashboard is reopened just before publication so clients always receive the latest consensus.
Credibility Anchor: Why Mordor's Cell Therapy Baseline Commands Confidence
Published market estimates often diverge because firms pick different product mixes, price points, and update schedules.
Key gap drivers include some studies that track only stem-cell products or technology inputs; others extrapolate early-stage pipeline counts into revenue too aggressively; many convert currencies once a year, whereas Mordor updates exchange rates quarterly; finally, our annual refresh incorporates every new FDA, EMA, or NMPA approval before rolling forecasts forward.
Benchmark comparison
| Market Size | Anonymized source | Primary gap driver |
|---|---|---|
| USD 17.13 B (2025) | Mordor Intelligence | - |
| USD 5.89 B (2024) | Global Consultancy A | Excludes immune-cell therapies and uses static 2023 ASPs |
| USD 6.04 B (2024) | Trade Journal B | Counts only commercial sales, omits hospital-administered compassionate doses |
The comparison shows that when the same therapy classes, compassionate-use volumes, and current prices are aligned, Mordor's figure emerges as a balanced, transparent baseline that stakeholders can replicate with publicly traceable variables.
Key Questions Answered in the Report
What is the current value of the cell therapy market?
– The cell therapy market is valued at USD 5.58 billion in 2025 and is projected to reach USD 12.27 billion by 2030 at an 17.05% CAGR.
Which therapy type is growing the fastest?
– Allogeneic platforms show the quickest expansion, registering a 12.56% CAGR thanks to lower costs and off-the-shelf availability.
Why are NK cell therapies gaining attention?
– NK cells deliver solid-tumor penetration with lower cytokine release risk and can be manufactured from universal donors, driving a 12.78% CAGR within immune-cell programs.
Which is the fastest growing region in Cell Therapy Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region will lead future manufacturing?
In 2025, the North America accounts for the largest market share in Cell Therapy Market.
What is the main hurdle for autologous treatments?
– High cost-of-goods of USD 150,000–300,000 per patient and labour-intensive workflows constrain broad adoption relative to allogeneic alternatives.
How fragmented is the competitive landscape?
– No company exceeds a 15% share; ongoing acquisitions by large pharmaceutical firms are gradually increasing market concentration without yet tipping to dominance.
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