The global regenerative medicine market was worth an estimated $41 billion in 2025 and is projected to reach roughly $162 billion by 2034, growing at a compound annual rate of about 16 per cent, according to a forecast by DelveInsight, a market-research firm. Cell therapy, including stem cell treatments and immunotherapy, makes up the largest segment in the firm's breakdown, alongside gene therapy, tissue engineering, and platelet-rich plasma and other biologic therapies.
For Dr. David Borenstein, founder of Manhattan Integrative Medicine and a physician board certified in Physical Medicine and Rehabilitation, that growth tracks with what he sees in his own practice. A researcher who has served as chief investigator on a controlled clinical trial, Borenstein says the same scrutiny he'd apply to any clinical trial belongs in the regenerative medicine conversation. "Patients ask about PRP and stem cells by name now, something that almost never happened ten years ago," Borenstein said. "The demand for alternatives to surgery for joint pain, tendon injuries, and soft tissue damage is real, and some of the underlying science backing specific applications has matured in ways it hadn't a decade ago."
Years of enforcement
That same boom has drawn sustained scrutiny from regulators. The FDA has spent years pursuing what one health-policy outlet described as a "whack-a-mole" effort against clinics marketing stem cell treatments that were never approved, reviewed, or shown to be safe. In one widely cited case, reported in the New England Journal of Medicine in 2017, three women aged 72 to 88 suffered severe vision loss after receiving fat-derived stem cell injections in both eyes at a Florida clinic; one was left with no light perception in either eye. FDA officials have stated plainly that, outside established uses in certain cancers and blood disorders, adult stem cells and birth-tissue-derived stem cells have not been shown to be safe and effective. The conditions clinics have marketed them for have included everything from sore knees to Alzheimer's disease to heart failure.
The scrutiny hasn't let up. In January 2025, the FDA sent a warning letter to BioStem Life Sciences, a Pompano Beach, Florida regenerative-product maker, finding that several of its umbilical cord and amniotic tissue products were unapproved biologics and citing significant manufacturing violations, including in aseptic processing, for products labelled "not sterile" whose instructions described injection. The company told the FDA the products had been removed from the market. It's the same core problem regulators keep flagging across cases years apart: products that haven't gone through the approval process required for anything outside narrow exceptions, such as the one for cells removed from and returned to the same patient during the same surgical procedure.
Where he draws the line
Borenstein draws a sharp line between that category of clinic and the kind of evidence-based orthobiologic work his practice performs. "Not everything marketed under the regenerative medicine umbrella is regulated the same way, and patients usually don't realize that," he said.
His advice to patients considering any regenerative treatment starts before they ever book an appointment. "Ask what the product actually is, whether it has FDA clearance or falls under an approved exception, and what data exists for the specific condition you're being treated for, not just the word 'stem cell' on a brochure," Borenstein said. "A legitimate provider will walk you through that without hesitation. If a clinic can't answer those questions clearly, that's the answer."
The case against writing it all off
He also pushes back on the idea that skepticism of the unregulated end of the market should extend to dismissing regenerative medicine altogether. "The field has real, well-studied applications, and writing off the whole category because of bad actors does patients a disservice too," he said. "The goal in my practice has always been the same. Look at the mechanism, look at the evidence, and build a treatment plan around the individual patient rather than around whatever is trending."
As the market keeps expanding toward that projected $162 billion ceiling, Borenstein said the gap between fast-moving commercial growth and slower-moving regulatory oversight is unlikely to close on its own. That puts more of the burden on patients and their physicians to ask the right questions before treatment, not after.
Sources
- DelveInsight, Regenerative Medicine Market report page: https://www.delveinsight.com/report-store/regenerative-medicine-market
- KFF Health News, Morning Briefing, 4 April 2019: https://kffhealthnews.org/morning-breakout/fda-continues-whack-a-mole-efforts-to-crack-down-on-dangerous-but-trendy-stem-cell-clinics/
- Kuriyan et al., "Vision Loss after Intravitreal Injection of Autologous 'Stem Cells' for AMD," New England Journal of Medicine, 2017: https://pmc.ncbi.nlm.nih.gov/articles/PMC5551890/
- FDA, statement by Scott Gottlieb and Peter Marks, 3 April 2019: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-biologics-center-director-peter-marks-md-phd-fdas
- FDA, warning letter to BioStem Life Sciences, 17 January 2025: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/biostem-life-sciences-673788-01172025
- 21 CFR 1271.15(b): https://www.law.cornell.edu/cfr/text/21/1271.15
- David Borenstein, MD, curriculum vitae: https://www.davidborensteinmd.com/assets/pdf/Curriculum_Vitae.pdf
Market figures and segments come from DelveInsight's Regenerative Medicine Market report page and its 6 August 2026 press release. The "whack-a-mole" description and the clinics' marketed uses come from KFF Health News's Morning Briefing of 4 April 2019. The vision-loss cases come from Kuriyan et al., New England Journal of Medicine, 16 March 2017. The FDA position on adult and birth-tissue stem cells comes from the statement by Commissioner Scott Gottlieb and Dr. Peter Marks of 3 April 2019. The BioStem findings come from FDA warning letter CBER 25-673788 of 17 January 2025. The same-surgical-procedure exception is 21 CFR 1271.15(b). Dr. Borenstein's credentials come from his practice website and curriculum vitae. His quotes were supplied to Cranberry Journal in writing. The analysis is our own.
