Stem Cell Therapy for Premature Ovarian Failure Industry Analysis: Reach USD 51 Million by 2031 at 11.6% CAGR

The global market for Stem Cell Therapy for Premature Ovarian Failure (also called Primary Ovarian Insufficiency) is transitioning from early clinical exploration to structured, data-driven development. According to the recent report from QYResearch, the new industry outlook projects market growth from US$23.9 million in 2024 to US$51.0 million by 2031, reflecting a CAGR of 11.6% from 2025 to 2031. Clinical programs in Asia, Europe, and North America delivered several first-in-human and randomized designs across 2024-2025, while the supply side moved toward cGMP standardization and a rising interest in exosome-based, cell-free approaches. Across human studies, ovarian rejuvenation success is typically described in the 15-20% range for tightly selected cohorts, with meaningful heterogeneity by cell source, dose, route, and baseline ovarian reserve.

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Leading Companies

Bioscience Institute (OvoSkill)
CHABiotech Co., Ltd.
Beike Biotechnology
Vitti Labs, LLC
RoosterBio, Inc.

Classification - By Type

Mesenchymal Stem Cells
Extra-embryonic Stem Cells
Others

Applications - By Age Group

Less than 20 Years Old
20 to 30 Years Old
30 to 45 Years Old
45 Years Old and Older

Latest Market and Clinical Data

• Global market size: US$23.9M in 2024, forecast to US$51.0M in 2031
• Growth rate: 11.6% CAGR during 2025-2031
• Indicative clinical success rate for ovarian rejuvenation: ~15-20%
• Competitive structure: leading innovators capture a majority of revenue, with OvoSkill currently prominent in commercial activity
• Regional outlook: North America, Europe, and Asia-Pacific remain the principal demand centers; China, Japan, South Korea, and Southeast Asia lead APAC growth

2024-2025 Highlights - New Results and Signals

Korea sets a clinical marker with CHABiotech
CHABiotech reported Phase 1 safety and early ovarian function signals in a cohort of women aged 25-39 using umbilical-cord-derived mesenchymal stem cells under the CordSTEM-ST program. The study completed dosing at CHA Bundang Medical Center, with resumption observed in some participants alongside a favorable tolerability profile. This program is shaping dose, route, and follow-up windows for allogeneic hUC-MSC approaches.

Exosomes emerge as a parallel route
Vitti Labs advanced a first-in-human pilot using placenta-MSC-derived extracellular vesicles for POI and diminished ovarian reserve. The design emphasizes safety, endocrine recovery, follicular activity, and quality-of-life endpoints. The cell-free architecture is drawing interest for its manufacturing, storage, and regulatory advantages.

Quantifying clinical benefit
Across published human studies and aggregated summaries, developers increasingly report functional readouts including return, follicular recruitment, and conception in a subset of patients. Complementing the market report's 15-20% success reference, several cohorts show directional improvements in endocrine markers such as AMH and estradiol, reductions in FSH, and rising antral follicle counts.

Peer-reviewed momentum
Systematic reviews across 2024-2025 point to paracrine and immunomodulatory mechanisms for MSCs and their secretome, including anti-apoptotic and pro-angiogenic effects in ovarian tissue. The evidence base is still maturing and continues to stress the need for standardized endpoints and long-term follow-up.

Five Product Snapshots - One Product per Company

1) Bioscience Institute - OvoSkill
• Modality: autologous adipose-derived mesenchymal stem cells expanded to high-dose lots and delivered via minimally invasive intra-ovarian administration
• Harvest and manufacturing: small-volume lipoaspirate collection in an outpatient setting, followed by expansion in controlled facilities; cryopreservation enables retreatment cycles
• Reported physiological signals: improvement trends in estradiol, ovarian size and blood-flow parameters, endometrial thickness, and documented ovulation resumption in selected idiopathic POI cases
• Positioning: among the most widely publicized clinical offerings in Europe for ovarian rejuvenation using autologous MSCs

2) CHABiotech - CordSTEM-ST (CBT210-POI)
• Modality: allogeneic human umbilical-cord-derived MSCs administered under a Phase 1 safety-first design
• Population and endpoints: women 25-39 years with a history of ovarian failure; primary endpoints focus on safety and tolerability, with secondary measures including return and endocrine milieu
• Status and sites: dosing completed in 2025 at CHA Bundang Medical Center; program informs dose, MTD, and procedural standards for allogeneic, off-the-shelf therapies
• Strategic role: anchors Korea's leadership position in standardized MSC development and trial design for POI

3) Vitti Labs - VL-PX10 / EV-Pure
• Modality: placenta-MSC-derived exosomes intended for cell-free regenerative signaling
• Study design: early-phase evaluation targeting POI and diminished ovarian reserve; measures emphasize hormone normalization trends, follicular activity, and patient-reported outcomes
• Rationale: exosomes may deliver paracrine benefits without live-cell handling, enabling scalable manufacturing, longer shelf life, and potentially simpler regulatory paths
• Development focus: dose-finding, dosing intervals, and integration with assisted reproductive technology cycles

4) Beike Biotechnology - hUC-MSC Combinations with HRT
• Modality: randomized and blinded study design testing HRT alone versus HRT combined with cord-derived cell products
• Structure: multi-arm comparison using standardized follow-up across 12 cycles to quantify endocrine endpoints and follicular dynamics
• Clinical intent: determine incremental benefit over standard hormone therapy and define responder profiles for cord-derived cell inputs
• Implication: raises the bar with comparative controls and masked assessments to isolate true treatment effects

5) RoosterBio - RoosterVial hUC-20M-CC
• Modality: cGMP, xeno-free human umbilical-cord-derived MSCs supplied as 20-million-cell clinical vials for downstream therapeutic manufacturing
• Use case: provides consistent, qualified starting material to accelerate IND filings and support process scalability for allogeneic programs
• Value proposition: chain-of-identity/chain-of-custody documentation, release testing, and lot-to-lot comparability for clinical developers
• Strategic impact: underpins the supply-side standardization required by regulators and payers

Downstream Customers - Verified Organizations Using or Trialing These Approaches

CHA Bundang Medical Center
Optimal Health Associates
Reproductive Medicine Center, Affiliated Drum Tower Hospital of Nanjing University Medical School
University of Illinois at Chicago
Royan Institute
Institute of Biophysics and Cell Engineering, National Academy of Sciences of Belarus
Mongolian National University of Medical Sciences
Special Hospital Jevremova
Saint James Hospital, Malta
Remedica Skopje Hospital
Instituto Valenciano de Infertilidad (IVI Valencia)
D. O. Ott Research Institute of Obstetrics, Gynecology and Reproductology
MD Anderson Cancer Center
El-Rayadh Fertility Centre
Al-Azhar University

Market Trend

From Whole Cells to Exosomes and Other Cell-Free Strategies

Program momentum in 2024-2025 shows a strong pivot to extracellular vesicles derived from MSCs. Developers cite practical advantages such as standardized potency assays, non-viable product profiles, and streamlined logistics. Early human programs in POI and diminished ovarian reserve are building baseline safety and endocrine-response data. The next wave should prioritize comparative studies of cells versus exosomes, exploration of dosing intervals, and combination designs that synchronize EV administration with ART cycles.

Asia's Clinical Flywheel

China and South Korea remain the most active regions for formal POI trials, including randomized and blinded designs that incorporate active controls. Korea's 2025 Phase 1 readout on umbilical-cord MSCs provided a template for dose exploration and follow-up. China's hospital networks continue to register and complete MSC-based studies with standardized imaging, endocrine panels, and ultrasound-derived follicular metrics. This cadence is setting operational norms for enrollment criteria, route of administration, and timing of outcome assessments.

Standardization, cGMP Sourcing, and Analytics

The supply landscape is maturing. Clinical developers increasingly rely on cGMP-qualified hUC-MSCs with comprehensive documentation. Qualified starting materials shorten development cycles, support batch comparability, and simplify the validation of potency assays. This standardization is especially critical for allogeneic products where consistent release testing and scale-up are prerequisites for regulatory acceptance and payer confidence.

Trial Design Matures: Randomized, Blinded, and Controlled

The field is moving past single-arm case series. Sponsors are now implementing masked comparisons such as HRT alone versus HRT plus cell therapy, four-arm factorial designs, and prospective endocrine and ultrasound endpoints tied to decision-relevant biomarkers. These trials are necessary to isolate true treatment effect, avoid regression-to-the-mean artifacts, and clarify the patient segments most likely to benefit.

Integration With IVF and Assisted Reproduction

Emerging protocols align biologics with ART workflows. As more cohorts report return and follicular activity, centers are timing ovarian stimulation and oocyte retrieval after biologic intervention. This integrated model connects endocrine recovery with practical endpoints like oocyte yield, embryo quality, and pregnancy achievement, improving the translational relevance of trial outcomes.

Mechanism-Led Optimization

Mechanistic evidence emphasizes paracrine signaling. MSCs and their secretome have been associated with reductions in granulosa-cell apoptosis, enhancement of angiogenesis, and modulation of oxidative stress pathways. Developers are refining dose, preconditioning strategies such as hypoxia priming, and delivery innovations including slow-release matrices and targeted intra-ovarian techniques to improve tissue residency and signal persistence.

Regulatory Scrutiny and the Path to Reimbursement

Professional guidance in 2024-2025 maintains that stem-cell-based ovarian interventions remain investigational outside formal trials. Authorities have also reiterated expectations around cGMP sourcing and IRB oversight. To advance toward reimbursement, sponsors will need to deliver controlled data sets with standardized endpoints and long-term safety, including comprehensive follow-up for ectopic tissue formation risk, immunogenicity, and oncologic vigilance.

Evidence Consolidation Through Meta-Analysis

Recent meta-analyses aggregate human data and consistently show directional improvements in ovarian biomarkers after MSC-based interventions, alongside reminders about heterogeneity in cell source, route, and concomitant therapies. The field is moving toward harmonized definitions for clinical response, commonly accepted time points for assessment, and data packages that pair endocrine signals with reproductive outcomes.

Regional Outlook

Asia-Pacific: China and South Korea drive the registered-trial count and early readouts, with Japan and Southeast Asia preparing to expand cell-free programs and technology transfers.
North America: academic centers advance early-phase exosome studies and methodical MSC trials with tight oversight.
Europe: select IVF hubs and research institutes contribute multi-site experience, while private clinics focus on carefully selected autologous protocols and long-term observation.

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