(Albany, New York) – October 07, 2026 – The market dynamics for Knee Osteoarthritis are witnessing steady growth driven by the rising disease burden among aging populations, increasing prevalence of knee osteoarthritis, growing preference for minimally invasive and non-surgical treatment approaches, and continued demand for intra-articular therapies for pain management. Additionally, the availability of therapies such as JOYCLU, TRILURON, and ZILRETTA, along with emerging candidates such as ZILOSUL (pentosan polysulfate sodium), AMZ001, CLS2901C, and lorecivivint, is expected to further shape the Knee Osteoarthritis market during the forecast period.
DelveInsight, a leading market research firm, announces the release of its latest report, “DelveInsight’s Knee Osteoarthritis Market Insights, Epidemiology, and Market Forecast – 2036.” This comprehensive report provides an in-depth understanding of Knee Osteoarthritis, including historical and forecasted epidemiology, market trends, treatment scenarios, emerging therapies, and competitive dynamics across the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan.
Key Takeaways from the Knee Osteoarthritis Market
The 7MM Knee Osteoarthritis market was approximately USD 15,500 million in 2025.
The Knee Osteoarthritis market across the 7MM is projected to reach approximately USD 26,000 million by 2036, growing at a 5% CAGR during 2026–2036.
The United States accounted for the largest Knee Osteoarthritis market size, at approximately USD 9,600 million in 2025.
According to DelveInsight’s estimates, the United States accounted for approximately 1,937,600 diagnosed prevalent cases of Knee Osteoarthritis in 2025.
Approximately 63% of Knee Osteoarthritis cases in the United States were contributed by the female population.
Among the EU4 and the UK, Germany had the highest prevalence of Knee Osteoarthritis cases, followed by France, while Italy had the lowest number of cases in 2025.
In 2025, Germany had nearly 6,972,862 diagnosed prevalent cases of Knee Osteoarthritis.
In Japan, the 70 years and above age group accounted for the highest number of Knee Osteoarthritis cases, whereas the 18–39 years age group accounted for the fewest cases.
Approved intra-articular therapies, including JOYCLU, TRILURON, and ZILRETTA, continue to anchor the current Knee Osteoarthritis treatment landscape.
Leading Knee Osteoarthritis companies include Ono Pharmaceutical, Fidia Farmaceutici, Pacira BioSciences, Paradigm Biopharma, Amzell, CellSeed, and others.
Promising Knee Osteoarthritis therapies include ZILOSUL (pentosan polysulfate sodium), AMZ001, CLS2901C, lorecivivint, and others.
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Key Factors Driving the Knee Osteoarthritis Market
Rising Prevalence and Aging Population: Knee Osteoarthritis is highly prevalent among individuals over 50, with the disease burden increasing alongside population aging and longer life expectancy. The high prevalence among older adults is expected to sustain demand for pharmacological and interventional treatment options.
Growing Preference for Minimally Invasive and Non-Surgical Procedures: Patients and healthcare providers increasingly utilize non-surgical approaches to manage knee pain and improve joint function. Intra-articular therapies, including hyaluronic acid injections and corticosteroid-based treatments, continue to play an important role in the treatment landscape.
Increasing Adoption of Intra-Articular Therapies: Therapies such as JOYCLU, TRILURON, and ZILRETTA provide localized treatment approaches for knee osteoarthritis. JOYCLU combines hyaluronic acid with diclofenac, TRILURON provides hyaluronic acid-based viscosupplementation, and ZILRETTA utilizes sustained intra-articular corticosteroid delivery.
Expansion of Disease-Modifying and Regenerative Approaches: The Knee Osteoarthritis pipeline is increasingly focused on therapies designed to address inflammation, cartilage degradation, and tissue regeneration. Candidates such as ZILOSUL, AMZ001, CLS2901C, and lorecivivint represent emerging approaches that could expand treatment options beyond symptomatic management.
Knee Osteoarthritis Competitive Landscape
Several Knee Osteoarthritis therapies are currently marketed or under clinical development, including JOYCLU (Ono Pharmaceutical/Seikagaku Corporation), TRILURON (Fidia Farmaceutici), ZILRETTA (Pacira BioSciences/Flexion Therapeutics), ZILOSUL (Paradigm Biopharma), AMZ001 (Amzell), and CLS2901C (CellSeed).
These therapies represent different approaches to knee osteoarthritis management. JOYCLU combines hyaluronic acid and diclofenac for intra-articular treatment, while TRILURON is a high-molecular-weight hyaluronic acid viscosupplement. ZILRETTA provides sustained intra-articular corticosteroid delivery through PLGA microspheres. In the emerging pipeline, ZILOSUL is being investigated for its anti-inflammatory and tissue-regenerative properties, AMZ001 is a topical gel, and CLS2901C represents a regenerative cell-based therapy.
Discover more about therapies set to grab major Knee Osteoarthritis market share @Knee Osteoarthritis Treatment Landscape
Recent Developments in the Knee Osteoarthritis Market
In January 2026, Biosplice submitted an NDA to the US FDA for lorecivivint (LOR), described by DelveInsight as a disease-modifying candidate for Knee Osteoarthritis.
In July 2025, Genascence announced that the US FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to GNSC-001 for the treatment of Knee Osteoarthritis.
In March 2023, Paradigm Biopharma received parallel European regulatory and ethics approvals for the pivotal PARA_OA_002 global clinical trial evaluating its Knee Osteoarthritis therapy.
In July 2023, UnicoCell Biomed successfully enrolled the first participant in its Phase III clinical trial for Knee Osteoarthritis after receiving US FDA approval for the trial in March 2023.
What is Knee Osteoarthritis?
Knee Osteoarthritis is a degenerative joint disease characterized by progressive loss and deterioration of articular cartilage. It is most common among older adults and can be classified into primary and secondary osteoarthritis. Primary osteoarthritis involves articular degeneration without an identifiable underlying cause, whereas secondary osteoarthritis can result from abnormal forces across the joint or underlying cartilage abnormalities.
Symptoms generally develop gradually as cartilage deterioration changes joint structure and function. Common clinical manifestations include knee pain, stiffness, reduced mobility, and functional limitations. Diagnosis is based on a combination of patient history, physical examination, imaging, and laboratory testing to rule out other conditions.
Current pharmacological treatment options include NSAIDs, opioids, intra-articular corticosteroids, intra-articular hyaluronic acid, and other therapies. Non-pharmacological and surgical approaches may also be incorporated depending on disease severity and patient requirements.
Knee Osteoarthritis Epidemiology Segmentation
The Knee Osteoarthritis epidemiology section provides insights into the historical and current Knee Osteoarthritis patient pool and forecasted trends across the leading markets. The Knee Osteoarthritis market report provides epidemiological analysis for the study period 2022–2036, segmented into:
Total Prevalent Cases of Knee Osteoarthritis
Gender-specific Prevalent Cases of Knee Osteoarthritis
Age-specific Prevalent Cases of Knee Osteoarthritis
Severity-specific Prevalent Cases of Knee Osteoarthritis
Among the EU4 and the UK, the highest proportion of age-specific cases in 2025 was observed in individuals aged 70 years and above, followed by the 60–69 and 50–59 age groups. Germany recorded the highest prevalence among the EU4 and the UK, followed by France.
In Japan, individuals aged 70 years and above accounted for the highest number of cases, while the 18–39 years age group represented the lowest number of cases.
Current Treatment Landscape
The current Knee Osteoarthritis treatment landscape includes pharmacological and non-pharmacological approaches aimed primarily at reducing pain, improving function, and maintaining mobility.
Common pharmacological interventions include NSAIDs, opioids, intra-articular corticosteroids, and intra-articular hyaluronic acid. Intra-articular therapies remain an important component of treatment, particularly for patients seeking non-surgical approaches.
Among the approved therapies highlighted by DelveInsight, JOYCLU, TRILURON, and ZILRETTA represent important intra-articular treatment options. ZILRETTA uses PLGA microspheres to provide sustained intra-articular corticosteroid release, while TRILURON provides viscosupplementation using hyaluronic acid.
Approved TherapiesJOYCLU – Ono Pharmaceutical/Seikagaku Corporation
JOYCLU is a formulation in which hyaluronic acid and diclofenac are chemically bound using Seikagaku’s proprietary technology. The formulation is designed to release diclofenac through hydrolysis within the joint. It is approved for the treatment of osteoarthritis involving the knee and hip joints and is administered through intra-articular injection once every 4 weeks.
TRILURON – Fidia Farmaceutici
TRILURON is a high-molecular-weight hyaluronic acid viscosupplement containing purified sodium hyaluronate. It is administered as a three-injection intra-articular regimen for the relief of knee osteoarthritis pain in patients whose symptoms remain inadequately controlled with conservative measures and simple analgesics.
ZILRETTA – Pacira BioSciences/Flexion Therapeutics
ZILRETTA is an intra-articular corticosteroid formulation designed to provide sustained release of triamcinolone acetonide. The therapy utilizes PLGA microspheres to support prolonged corticosteroid delivery within the joint and is indicated for the management of pain associated with mild-to-moderate Knee Osteoarthritis.
Emerging TherapiesZILOSUL (Pentosan Polysulfate Sodium) – Paradigm Biopharma
ZILOSUL, or pentosan polysulfate sodium, is being investigated for moderate-to-severe Knee Osteoarthritis. Paradigm Biopharma is exploring its anti-inflammatory and tissue-regenerative properties across conditions associated with inflammation. The candidate is listed in Phase III development and is administered subcutaneously.
AMZ001 – Amzell
AMZ001 is an emerging therapy being developed for Knee Osteoarthritis. According to the DelveInsight report, the candidate is in Phase III development and is being evaluated as a topical gel with a COX inhibitor mechanism.
CLS2901C – CellSeed
CLS2901C is an emerging regenerative cell-based therapy under development for Knee Osteoarthritis. The candidate is listed in Phase III development and is administered through an injectable route.
Unmet Needs in Knee Osteoarthritis
Despite the availability of multiple pharmacological and intra-articular therapies, several unmet needs remain in Knee Osteoarthritis management, including:
Need for improved patient phenotyping and stratification for clinical trials
Significant impact of Knee Osteoarthritis on patients’ quality of life
Insufficient understanding of the disease paradigm
Need for therapies with fewer side effects
Need for disease-modifying treatment approaches
Need for therapies capable of addressing cartilage degradation and disease progression
These unmet needs continue to support research into disease-modifying, regenerative, and targeted treatment approaches for Knee Osteoarthritis.
Scope of the Knee Osteoarthritis Market Report
Therapeutic Assessment: Knee Osteoarthritis current marketed and emerging therapies, including intra-articular therapies, corticosteroids, hyaluronic acid products, and emerging disease-modifying and regenerative approaches.
Knee Osteoarthritis Market Dynamics: Key market forecast assumptions, therapy uptake, market share, patient burden, market drivers and barriers, reimbursement, and market outlook.
Key Companies: Ono Pharmaceutical, Fidia Farmaceutici, Pacira BioSciences, Paradigm Biopharma, Amzell, CellSeed, and others.
Key Therapies: JOYCLU, TRILURON, ZILRETTA, ZILOSUL, AMZ001, CLS2901C, and others.
Competitive Intelligence Analysis: SWOT analysis, conjoint analysis, KOL views, reimbursement analysis, unmet needs, market drivers, and market barriers.
Unmet Needs, KOL’s Views, Analyst’s Views, Knee Osteoarthritis Market Access and Reimbursement
To know more about Knee Osteoarthritis companies working in the treatment market, visit @Knee Osteoarthritis Clinical Trials and Therapeutic Assessment
Table of Contents
Knee Osteoarthritis Market Report Introduction
Executive Summary for Knee Osteoarthritis
Key Events in Knee Osteoarthritis
SWOT Analysis of Knee Osteoarthritis
Knee Osteoarthritis Patient Share (%) Overview at a Glance
Knee Osteoarthritis Market Overview at a Glance
Knee Osteoarthritis Background and Overview
Knee Osteoarthritis Epidemiology and Patient Population
Country-Specific Patient Population of Knee Osteoarthritis
Knee Osteoarthritis Current Treatment and Medical Practices
Knee Osteoarthritis Unmet Needs
Knee Osteoarthritis Emerging Therapies
Knee Osteoarthritis Market Outlook
Country-Wise Knee Osteoarthritis Market Analysis (2022–2036)
Knee Osteoarthritis Market Access and Reimbursement of Therapies
Knee Osteoarthritis Market Drivers
Knee Osteoarthritis Market Barriers
Knee Osteoarthritis Appendix
Knee Osteoarthritis Report Methodology
DelveInsight Capabilities
Disclaimer
About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in the life sciences and healthcare industries. Founded in 2014, the company provides comprehensive market intelligence, epidemiology, and insights across pharmaceuticals, biotechnology, medical devices, and emerging therapies. DelveInsight helps healthcare organizations make informed strategic decisions through data-driven research and industry expertise.
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