The Economics and Regulation of PRP in the Evolving Field of Orthopedic Biologics
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Purpose of Review
This review provides an update on the current status of platelet-rich plasma (PRP). Topics covered include the current regulatory environment, economic outlook, and current clinical evidence.
The global PRP market is expected to grow to between 380 million and 4.5 billion (USD) over the next 5–10 years. The cost of a single treatment, which is not covered by most insurance, is roughly $500–$2500, with patients often returning for additional treatments.
While PRP is not ‘FDA-approved’, it can be legally offered in the clinic ‘off-label’ in the USA for a myriad of musculoskeletal indications. Recently published meta-analyses have demonstrated statistically significant improvements that, in some cases, suggest that PRP may have clinically meaningful effects. However, given the fact that clearance is not synonymous with approval, PRP is a costly treatment not covered by insurance, and clinical trials have not demonstrated definitive efficacy, we recommend informing patients when providing PRP ‘off-label’.
KeywordsHCT/Ps Platelet-rich plasma PRP Orthopedics Sports medicine Regenerative medicine
Compliance with ethical standards
Conflict of Interest
Ian A. Jones and Ryan C. Togashi declare that they have no conflict of interests. C. Thomas Vangsness is a shareholder of CarthroniX.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance
- 2.FDA. Code of Federal Regulations - Title 21, Volume 7 [Internet]. Code of Federal Regulations Code of Federal Regulations; Apr 1, 2017. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=640.34.
- 5.Mazzucco L, Balbo V, Cattana E, Guaschino R, Borzini P. Not every PRP-gel is born equal. Evaluation of growth factor availability for tissues through four PRP-gel preparations: Fibrinet, RegenPRP-Kit, Plateltex and one manual procedure. Vox Sang. Blackwell Publishing Ltd; 2009;97:110–8.Google Scholar
- 7.• Andia I, Maffulli N. Platelet-rich plasma for managing pain and inflammation in osteoarthritis. Nat Rev Rheumatol. Nature Publishing Group; 2013;9:721–30. Available from: http://www.nature.com/articles/nrrheum.2013.141 . A comprehensive review of the bioactive molecules in PRP.CrossRefGoogle Scholar
- 15.LaPrade RF, Geeslin AG, Murray IR, Musahl V, Zlotnicki JP, Petrigliano F, et al. Biologic treatments for sports injuries II think tank-current concepts, future research, and barriers to advancement, part 1: biologics overview, ligament injury, tendinopathy. Am J Sports Med. SAGE PublicationsSage CA: Los Angeles, CA. 2016;44:3270–83.CrossRefGoogle Scholar
- 16.Khoshbin A, Leroux T, Wasserstein D, Marks P, Theodoropoulos J, Ogilvie-Harris D, et al. The efficacy of platelet-rich plasma in the treatment of symptomatic knee osteoarthritis: a systematic review with quantitative synthesis. Arthroscopy. 2013;29:2037–48. https://doi.org/10.1016/j.arthro.2013.09.006.CrossRefPubMedGoogle Scholar
- 18.• Chen X, Jones IA, Park C, Vangsness CT. The efficacy of platelet-rich plasma on tendon and ligament healing: a systematic review and meta-analysis with bias assessment. Am J Sports Med. 2017;2016:363546517743746. A meta-analysis evaluating the therapeutic effectiveness of PRP for tendon and ligament injury/pathology. The paper finds that PRP may reduce pain associated with lateral epicondylitis and rotator cuff injuries.Google Scholar
- 25.Gutman SI. 510(k) SUMMARY [internet]. The United States Department of Health and Human Services; 2000 Feb. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf/K994148.pdf.
- 26.Melkerson MN. 510(k) SUMMARY [Internet]. The United States Department of Health and Human Services; 2009 Nov. Report No.: K082333. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf8/K082333.pdf.
- 32.Research GV. Platelet Rich Plasma (PRP) Market analysis by product (pure, leukocyte-rich, leukocyte-rich fibrin), by application (orthopedics, cosmetic surgery, ophthalmic surgery, neurosurgery), and segment forecasts, 2014–2025 [Internet]. www.grandviewresearch.com. 2017 [cited 2018 Mar 17]. p. 100. Available from: https://www.grandviewresearch.com/industry-analysis/platelet-rich-plasma-prp-market.
- 33.Engine MR. Platelet rich plasma market by type analysis (pure-PRP, leukocyte-rich-PRP, pure-PRF); by origin analysis (autologous PRP, allogeneic PRP, homologous PRP); by applications analysis (orthopedic surgery, cosmetic surgery, general surgery, neurosurgery) and by regional analysis – global forecast by 2016 - 2024 [Internet]. www.marketresearchengine.com; 2017 Jun. Report no.: PPRPM617. Available from: https://www.marketresearchengine.com/platelet-rich-plasma-market.
- 34.Platelet-rich plasma (PRP) market was valued at USD 201.2 Mn in 2016. SA-BRC; 2017.Google Scholar
- 35.Oudelaar BW, Peerbooms JC, Huis In't Veld R, Vochteloo AJH. Concentrations of blood components in commercial platelet-rich plasma separation systems: a review of the literature. Am J Sports Med. 2018;14:363546517746112.Google Scholar
- 39.Tashjian RZ, Hung M, Keener JD, Bowen RC, McAllister J, Chen W, et al. Determining the minimal clinically important difference for the American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and visual analog scale (VAS) measuring pain after shoulder arthroplasty. J Shoulder Elb Surg. 2017;26:144–8.CrossRefGoogle Scholar
- 40.Hurley ET, Lim Fat D, Moran CJ, Mullett H. The efficacy of platelet-rich plasma and platelet-rich fibrin in arthroscopic rotator cuff repair: a meta-analysis of randomized controlled trials. Am J Sports Med. SAGE PublicationsSage CA: Los Angeles, CA. 2018;363546517751397:79.Google Scholar
- 46.Kanchanatawan W, Arirachakaran A, Chaijenkij K, Prasathaporn N, Boonard M, Piyapittayanun P, et al. Short-term outcomes of platelet-rich plasma injection for treatment of osteoarthritis of the knee. Knee Surg Sports Traumatol Arthrosc. Springer Berlin Heidelberg. 2016;24:1665–77.CrossRefGoogle Scholar
- 51.Grassi A, Napoli F, Romandini I, Samuelsson K, Zaffagnini S, Candrian C, et al. Is platelet-rich plasma (PRP) effective in the treatment of acute muscle injuries? A systematic review and meta-analysis. Sports Med. Springer International Publishing. 2018;39:1226–19.Google Scholar
- 53.Moraes VY, Lenza M, Tamaoki MJ, Faloppa F, Belloti JC. Platelet-rich therapies for musculoskeletal soft tissue injuries. In: Moraes VY, editor. Cochrane Database Syst Rev, vol. 40. Chichester: John Wiley & Sons, Ltd; 2014. p. CD010071.Google Scholar