Report Highlights

U.S. Tendinitis Treatment: Market Overview

The U.S. tendinitis treatment market is structured across four primary modalities: pharmacological management (NSAIDs, corticosteroids), physical and occupational therapy, minimally invasive procedures (platelet-rich plasma, dry needling, extracorporeal shockwave therapy), and surgical intervention for refractory cases. Government payers—primarily Medicare and Medicaid through the Centers for Medicare and Medicaid Services (CMS)—account for roughly 48% of treatment expenditure, making federal reimbursement policy the single most powerful force shaping provider behavior and product adoption across every segment of the market.

Private sector innovation has led in biologics and regenerative medicine, with companies such as Amgen and AbbVie advancing targeted anti-inflammatory therapies, while medical device firms including Storz Medical have commercialized focused shockwave platforms. However, FDA's Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER) jointly govern the approval pathways for combination products, creating layered regulatory complexity. The market's current form—heavily weighted toward conventional NSAIDs and corticosteroids—is a direct consequence of restrictive CMS coverage policies that have slowed the adoption of higher-cost regenerative interventions despite substantial clinical evidence supporting their efficacy.

Policy-Driven Growth in U.S. Tendinitis Treatment

Three specific policy mechanisms are accelerating market expansion. First, the Physical Therapy and Occupational Therapy Telehealth Expansion under the Consolidated Appropriations Act of 2023 permanently extended telehealth reimbursement for PT services under Medicare Part B, removing the prior geographic restriction that confined coverage to rural Health Professional Shortage Areas. This change directly translated into a measurable increase in tendinitis-related PT encounters billed under CPT codes 97110 and 97530, expanding addressable revenue for therapy-based providers by an estimated USD 180 million annually. Second, the FDA's Breakthrough Device Designation program, administered by CDRH, has accelerated clearance timelines for innovative tendinitis devices; Bioventus LLC's DUROLANE received expedited 510(k) clearance leveraging this pathway, compressing the typical 12-month review to under seven months and enabling faster commercialization.

Third, the Inflation Reduction Act of 2022 (IRA) introduced Medicare drug price negotiation under Section 11001, which, while targeting high-cost biologics broadly, has created downstream pressure on branded NSAID and corticosteroid pricing that benefits generic manufacturers. This pricing compression has simultaneously expanded Medicaid formulary access for tendinitis patients below 138% of the federal poverty level, increasing the total treated population by an estimated 2.1 million individuals since the IRA's implementation. The expansion of Medicaid eligibility under the American Rescue Plan Act (ARPA) Section 9814 further extended postpartum coverage, capturing a younger demographic with high rates of overuse tendinopathy.

Regulatory Barriers and Compliance Costs

The single largest regulatory barrier is FDA's classification of platelet-rich plasma products as biologics subject to 21 CFR Part 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products), which requires PRP manufacturers to register with CDER and comply with current Good Tissue Practice regulations. Companies that process PRP beyond "minimal manipulation" face a full Biologics License Application (BLA) pathway, a process requiring clinical trials that typically cost USD 30–80 million and take five to eight years. This regulatory wall has effectively excluded dozens of smaller PRP innovators and forced clinics to operate in a gray-compliance zone, creating legal and financial exposure that deters investment in the highest-growth segment.

A second significant barrier is the Drug Enforcement Administration's scheduling of corticosteroid combination injectables, which requires DEA registration under the Controlled Substances Act for any practice administering Schedule III formulations used in tendinitis treatment. Each DEA registration costs USD 888 per three-year cycle, and practices must maintain physical security infrastructure compliant with 21 CFR Part 1301.72, adding an estimated USD 5,000–15,000 in facility compliance costs per clinic annually. Furthermore, the Office of Inspector General (OIG) has flagged repeated billing of corticosteroid injections under CPT code 20610 as a high-risk audit area, and its 2023 Work Plan specifically targets musculoskeletal injection billing, adding compliance overhead and chilling legitimate utilization.

Policy-Created Opportunities in U.S. Tendinitis Treatment

The CMS Innovation Center's Musculoskeletal Bundled Payments for Care Improvement Advanced (BPCI-A) model, currently in its Phase 3 evaluation period and expected to be expanded by 2027, creates a structural incentive for integrated tendinitis care pathways. Providers that can demonstrate reduced episode costs through evidence-based conservative management—combining supervised PT, targeted NSAIDs, and one corticosteroid injection per episode—will capture shared savings payments. This policy architecture is already drawing capital investment into digital MSK platforms such as Hinge Health and Sword Health, which are positioning their technology-assisted rehabilitation programs as BPCI-A compliant care pathway tools for payers and health systems.

A second major opportunity is created by the FDA's proposed reclassification of certain extracorporeal shockwave therapy (ESWT) devices from Class III to Class II under 21 CFR Part 882, which would eliminate the requirement for Premarket Approval (PMA) and enable 510(k) clearance. If finalized—projected by the FDA's CDRH for late 2025 or early 2026—this reclassification would dramatically lower the market entry cost for ESWT manufacturers and could add USD 220 million in addressable procedure volume within three years as outpatient orthopedic practices adopt ESWT for Achilles and patellar tendinitis without the current capital and regulatory barrier of Class III device status.

Market at a Glance

Leading Market Participants

• AbbVie Inc.
• Pfizer Inc.
• Johnson & Johnson
• Amgen Inc.
• Sanofi S.A.
• Bioventus LLC
• Storz Medical AG
• Hinge Health Inc.
• Sword Health Inc.
• Smith & Nephew plc

Regulatory and Policy Environment

The primary legislative framework governing the U.S. tendinitis treatment market is the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Public Law 114-255), which directed FDA to streamline device approvals and established the Breakthrough Device Designation that now benefits MSK innovators. The FDA's CDER governs pharmaceutical treatments including NSAIDs and corticosteroids, while CDRH regulates physical therapy devices and ESWT systems. The Drug Quality and Security Act (DQSA) of 2013 additionally governs compounded injectable preparations—relevant because many outpatient clinics use compounded corticosteroid-anesthetic combinations—with oversight shared between FDA and state boards of pharmacy, creating a dual-track compliance burden for providers.

Upcoming regulatory changes include FDA's anticipated final guidance on PRP product classification, expected in 2025–2026, which will bring greater certainty to the regenerative segment but will impose BLA requirements on non-minimal-manipulation products. Compared to regional peers, the U.S. framework is substantially more burdensome than Canada's Health Canada pathway or the European CE marking process under the EU Medical Device Regulation (MDR 2017/745) for equivalent ESWT and PRP applications—a disparity that has led some U.S.-headquartered device companies, including Bioventus, to launch MSK products in European markets 18 to 24 months before domestic commercialization.

Long-Term Policy Outlook for U.S. Tendinitis Treatment

By 2032, the most consequential expected policy change is a formal Medicare National Coverage Determination (NCD) for platelet-rich plasma therapy in musculoskeletal indications. CMS has already commissioned a Technology Assessment through its Coverage with Evidence Development (CED) pathway for PRP, with a final determination expected no earlier than 2027. If CMS issues a positive NCD covering PRP for rotator cuff and Achilles tendinitis—the two highest-prevalence indications—it will unlock an estimated USD 400 million in previously inaccessible Medicare revenue and trigger rapid commercial scaling by established biologics manufacturers currently holding back U.S. launches.

A second structural shift expected by 2030 is the expansion of CMS's Direct Contracting Entity (DCE) model, renamed the ACO REACH program, to include explicit musculoskeletal episode benchmarks. As ACO REACH matures, participating accountable care organizations will face financial accountability for total tendinitis episode costs, creating powerful incentives to adopt cost-effective, guideline-concordant care pathways that front-load physical therapy and delay or eliminate surgical referral. This structural shift will compress surgical intervention volumes, redirect capital toward outpatient and digital therapeutic platforms, and accelerate the consolidation of physical therapy providers into ACO-affiliated networks—fundamentally reshaping the competitive landscape of this market before 2032.