Autologous Stem Cell and Non-Stem Cell Based Therapies Market Companies
- Vericel Corporation
- Holostem Terapie Avanzate
- Anterogen Co. Ltd.
- BrainStorm Cell Therapeutics
- Fibrocell Science
- Cytori Therapeutics
- TiGenix (Takeda)
- CORESTEM Inc.
- Smith & Nephew (via Osiris Therapeutics)
- Pluristem Therapeutics
- ThermoGenesis Holdings
- Regenexx
- Gilead Sciences
- Novartis
- Fate Therapeutics
- Medeor Therapeutics
- Lineage Cell Therapeutics
- GenCure
- Aastrom Biosciences (Vericel)
- Celgene
Vericel Corporation (HQ: Cambridge, MA, USA)
Product offerings:
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MACI® – autologous cultured chondrocytes on porcine membrane for knee cartilage defects.
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Epicel® – autologous cultured epidermal autografts for severe burns.
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NexoBrid® – non-cell enzymatic debridement (U.S. commercial rights).
Revenue (2024): $255.6M total, with MACI and NexoBrid driving growth.
Recent developments: Scaling U.S. launch of NexoBrid and expanding indications for MACI.
Competitive positioning: U.S. leader in autologous surgical cell therapies for ortho and burn; strong hospital and specialty center presence.
Key customers: Orthopedic centers, burn units, hospital systems.
Holostem Terapie Avanzate (HQ: Modena, Italy)
Product offerings:
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Holoclar® – autologous ex-vivo expanded limbal stem cells for eye surface reconstruction (EMA-approved).
Revenue: Not publicly disclosed.
Recent developments: Corporate restructuring and liquidation proceedings in 2022, but Holoclar remains authorized in the EU.
Competitive positioning: Pioneer in ocular stem cell therapy, niche focus on ophthalmology.
Key customers: Corneal surgeons, tertiary ophthalmology hospitals.
Anterogen Co., Ltd. (HQ: Seoul, South Korea)
Product offerings:
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Cupistem® – autologous adipose-derived MSCs for complex perianal fistulas.
Revenue: Limited to domestic Korea; not disclosed.
Recent developments: Ongoing R&D around adipose-derived cell products.
Competitive positioning: Among the first to commercialize autologous adipose MSC therapies in Asia.
Key customers: Colorectal surgeons and IBD specialists in Korea.
BrainStorm Cell Therapeutics (HQ: Petach Tikva, Israel & NYC, USA)
Product offerings:
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NurOwn® – autologous bone marrow-derived MSC therapy for ALS (clinical-stage).
Revenue: None; pre-commercial.
Recent developments: Advancing regulatory and clinical pathway in ALS.
Competitive positioning: Positioned as a high-risk neurology-focused autologous therapy innovator.
Key customers (future): ALS treatment centers and neurology hospitals.
Fibrocell Science (Now Castle Creek Biosciences; HQ: Exton, PA, USA)
Product offerings:
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D-Fi (FCX-007) – autologous gene-modified fibroblasts for recessive dystrophic epidermolysis bullosa (Phase 3).
Revenue: None; clinical stage.
Recent developments: Phase 3 underway; strong in-house manufacturing capacity.
Competitive positioning: Specialized in autologous gene-modified therapies for rare dermatological diseases.
Key customers (future): Genetic and dermatology specialty centers.
Cytori Therapeutics (Now Plus Therapeutics; HQ: Houston, TX, USA)
Product offerings (legacy):
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Celution® system – autologous adipose-derived regenerative cells (sold via partners in Asia).
Current focus: Pivoted to radiotherapeutics under Plus Therapeutics.
Revenue: No longer in cell therapy; legacy sales discontinued.
Competitive positioning: Legacy brand in adipose-based autologous therapies.
Key customers (legacy): Plastic surgeons, reconstructive specialists, cardiology researchers.
TiGenix (Now Takeda; HQ: Tokyo/Osaka & Cambridge, MA, USA)
Product offerings:
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Alofisel® (darvadstrocel) – allogeneic adipose-derived MSC therapy for Crohn’s fistulas (EMA-approved, later withdrawn).
Revenue: Limited prior to withdrawal; no longer marketed.
Recent developments: Takeda voluntarily withdrew EU marketing authorization in late 2024.
Competitive positioning: Exited this niche, but retains leadership in GI and inflammation therapies.
Key customers (historic): IBD centers.
CORESTEM Inc. (HQ: Seongnam, South Korea)
Product offerings:
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Neuronata-R® / Lenzumestrocel – autologous bone marrow-derived MSC therapy for ALS (conditionally approved in Korea).
Revenue: Limited domestic revenue since 2014.
Recent developments: Phase 3 updates with positive interim results; over 400 patients treated in Korea.
Competitive positioning: One of the very few commercialized autologous neuro therapies globally.
Key customers: ALS clinics in Korea.
Smith & Nephew (via Osiris Therapeutics; HQ: London, UK)
Product offerings:
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Grafix® / Stravix® – placental tissue-based wound care biologics.
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BIO4® – viable bone matrix allograft.
Revenue: Integrated into Advanced Wound Management division; not separately disclosed.
Recent developments: Continued expansion of biologics in wound care.
Competitive positioning: Strong position in advanced wound and orthopedic biologics.
Key customers: Wound care clinics, hospitals, podiatry practices.
Pluristem Therapeutics (Now Pluri; HQ: Haifa, Israel)
Product offerings:
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Placenta-derived allogeneic cell therapy platform (pipeline-stage).
Revenue: No commercial revenue; R&D only.
Recent developments: Rebranded as Pluri in 2022, expanding platform applications.
Competitive positioning: Positioned as a developer of scalable allogeneic therapies.
Key customers: Biopharma partners and research institutions.
ThermoGenesis Holdings (HQ: Rancho Cordova, CA, USA)
Product offerings:
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CAR-TXpress®, PXP®, and X-Series® cell processing platforms.
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CDMO services for cell and gene therapy developers.
Revenue: ~$2M per quarter (2024).
Recent developments: Scaling CDMO services alongside device portfolio.
Competitive positioning: “Picks and shovels” supplier for CGT developers.
Key customers: Cell therapy companies, transplant labs, research centers.
Regenexx (HQ: U.S.; multi-clinic network)
Product offerings:
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Orthopedic procedures using autologous bone marrow concentrate and PRP injectates.
Revenue: Private, not disclosed.
Recent developments: Expanding U.S. and employer-network coverage.
Competitive positioning: Direct-to-consumer orthopedic biologics brand.
Key customers: Orthopedic patients, self-insured employers.
Gilead Sciences / Kite Pharma (HQ: Foster City, CA & Santa Monica, CA, USA)
Product offerings:
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Yescarta® and Tecartus® – autologous CAR-T therapies.
Revenue: $2.02B in 2024 from cell therapy products.
Recent developments: Acquired Interius BioTherapeutics (2025) for in-vivo CAR-T expansion.
Competitive positioning: Global leader in commercial autologous CAR-T.
Key customers: Comprehensive cancer centers, academic hospitals, insurers.
Novartis (HQ: Basel, Switzerland)
Product offerings:
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Kymriah® – autologous CAR-T therapy.
Revenue: $113M sales in Q2 2024 (quarterly data point).
Recent developments: Continued investment in CAR-T infrastructure and indication expansion.
Competitive positioning: One of the top two autologous CAR-T providers worldwide.
Key customers: Certified CAR-T treatment centers.
Fate Therapeutics (HQ: San Diego, CA, USA)
Product offerings:
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iPSC-derived off-the-shelf NK and CAR-T therapies (allogeneic, pipeline-stage).
Revenue: None; clinical stage.
Recent developments: Pivot to autoimmune pipeline in 2025; extended cash runway into 2027.
Competitive positioning: Disruptive innovator focused on allogeneic “off-the-shelf” therapies.
Key customers (future): Oncology and autoimmune specialty centers.
Medeor Therapeutics (HQ: South San Francisco, CA, USA)
Product offerings:
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MDR-101 – donor-derived therapy for kidney transplant tolerance.
Revenue: None; clinical stage.
Recent developments: Phase 3 trials showing strong potential for immunosuppression-free transplant survival.
Competitive positioning: Positioned as a disruptor in transplant tolerance.
Key customers (future): Kidney transplant programs.
Lineage Cell Therapeutics (HQ: Carlsbad, CA, USA)
Product offerings:
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OpRegen® – retinal pigment epithelium therapy for dry AMD/GA (partnered with Roche/Genentech).
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Pipeline programs for spinal cord injury and oncology.
Revenue: Primarily from milestones and services (Genentech partnership worth up to $670M).
Recent developments: Expanded partnership activities with Roche/Genentech.
Competitive positioning: Specialist in allogeneic replacement therapies.
Key customers (future): Ophthalmology and neurology centers.
GenCure (Subsidiary of BioBridge Global; HQ: San Antonio, TX, USA)
Product offerings:
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CDMO services for cell therapies.
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Texas Cord Blood Bank and biomanufacturing support.
Revenue: Service-based, not disclosed.
Recent developments: Expanding biomanufacturing facilities and university collaborations.
Competitive positioning: Regional CDMO and supply chain partner for ATMP developers.
Key customers: Biotech sponsors, academic centers, hospitals.
Aastrom Biosciences (Now Vericel)
Rebranded as Vericel in 2014 and now focused on MACI and Epicel.
Celgene (Now Bristol Myers Squibb)
Product offerings (legacy Juno acquisition):
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Breyanzi® and Abecma® – autologous CAR-T therapies under BMS.
Revenue: Q3 2024 sales – Breyanzi $224M (+143% YoY), Abecma $124M (+33% YoY).
Recent developments: Expanding global CAR-T access and indications.
Competitive positioning: One of the top three global CAR-T players.
Key customers: Accredited CAR-T centers worldwide.