(Albany, US), November 9, 2026 – DelveInsight’s ‘Osteoarthritis Market Insights, Epidemiology, and Market Forecast – 2036’ report delivers an in-depth understanding of Osteoarthritis, historical and forecasted epidemiology, as well as the Osteoarthritis market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
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Key Takeaways from the Osteoarthritis Market Report
Paradigm Biopharmaceuticals stated that its FY2026 priorities include achieving key clinical milestones, particularly completing patient enrolment in the Phase III PARA_OA_012 trial evaluating ZILOSUL for osteoarthritis. The company is also advancing preparations for the planned interim analysis, with topline data expected to be reported in mid-2026
According to DelveInsight’s analysis, the Osteoarthritis market size was found to be ~USD 32,500 million in the 7MM (the United States, the EU4, the United Kingdom, and Japan) in 2025.
The 2036 projected Osteoarthritis market size is ~USD 47,000 million, with a growth rate of 3% CAGR during 2026–2036.
In 2025, opioids captured the highest market size by therapies in the US osteoarthritis market, at around USD 9,500 million.
Among the EU4 and the UK, Germany is expected to capture the maximum revenue share, followed by Spain and France, in 2036.
The total number of diagnosed cases of osteoarthritis was around 99,000 in the 7MM in 2025, and the number is anticipated to increase during the forecast period (2026–2036).
In Japan, the total diagnosed cases of knee osteoarthritis reached 11,500,000 in 2025.
Mild-to-moderate knee osteoarthritis that is resistant to conservative treatment but not yet severe enough to warrant joint replacement represents a specific management challenge and a huge unmet need.
JTA-004 from BioSenic failed its Phase III trial overall but showed promising post-hoc benefits in severe, inflammatory type-3 osteoarthritis, and is now available for potential out-licensing.
Resiniferatoxin, a TRPV1 agonist acquired from Mestex, failed to meet primary endpoints in two Phase III osteoarthritis pain trials, leading Grünenthal to end the program after completing its ongoing safety study in 2025.
The leading Osteoarthritis companies include Ono Pharmaceutical/Seikagaku Corporation, Fidia Farmaceutici, Hanmi Pharmaceutical/Teva Pharmaceuticals, Bioventus, Pacira BioSciences/Flexion Therapeutics, and others.
Promising Osteoarthritis therapies include LEVI-04, ZILOSUL (pentosan polysulfate sodium), TissueGene-C (TG-C), AMZ001, SAR446959, and others.
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Osteoarthritis Overview
Osteoarthritis is the most common form of arthritis and a chronic, degenerative joint disease that primarily affects middle-aged and older adults. It is characterized by the progressive breakdown of joint cartilage, most commonly in the hands, knees, hips, and spine. It is classified into primary and secondary types and progresses through stages from 0 (normal) to 4 (severe), which shapes the primary osteoarthritis market. The condition is closely associated with age, as radiographic evidence of osteoarthritis occurs in most people by age 65 years and in more than 75% of people older than age 75 years. A higher prevalence has been reported among older women, although many associations and mechanisms are not well understood.
Diagnosis does not rely on a single definitive laboratory test. It involves a combination of clinical evaluation and diagnostic tools. Blood tests such as CBC, ESR, rheumatoid factor, and ANA are typically normal, while imaging techniques like X-rays and ultrasound help confirm structural changes such as cartilage loss, osteophytes, synovial inflammation, and joint effusion.
Osteoarthritis Epidemiology Segmentation in the 7MM
Total Diagnosed Prevalence Cases of Osteoarthritis
Joint site-specific Prevalence of Osteoarthritis
Gender-specific Prevalence of Osteoarthritis
Age-specific Prevalence of Osteoarthritis
Severity-specific Prevalence of Osteoarthritis
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Osteoarthritis Epidemiology Key Findings
Osteoarthritis is one of the most common chronic diseases in the elderly population, contributing approximately 90–95% of all osteoarthritis cases (people above 40), and its prevalence increases with age.
The number of osteoarthritis cases is estimated to rise in the coming years because of the rising aging population and obesity, affecting the total pool of knee osteoarthritis.
As per Nalamachu et al. (2020), 41%, 37%, and 22% of patients with knee osteoarthritis in the US reported mild, moderate, and severe pain, respectively.
In a study by Schild et al. (2021), patient-level data was extracted from the German Institut für Angewandte Gesundheitsforschung (InGef) database. Of 4,932,543 individuals sampled, 238,306 patients with osteoarthritis were included in the analysis: 80,055 (34%) were categorized as having chronic pain (24,463 via opioid prescription) and 158,251 (66%) as not having chronic pain.
According to Iolascon et al. (2024), knee osteoarthritis significantly affects the national healthcare system and society in Italy, accounting for over 5 million prevalent cases and an age-standardized prevalence rate of 4066 cases per 100,000.
Approved Therapies for Osteoarthritis
Current treatment classes for osteoarthritis include NSAIDs, opioids, intra-articular corticosteroids, intra-articular hyaluronic acid, and others. FDA-approved hyaluronate products for knee OA comprise SUPARTZ, ORTHOVISC, EUFLEXXA, and GEL-ONE. ZILRETTA, approved in October 2017, is a corticosteroid that demonstrated significant pain reduction in its pivotal Phase III trial for knee OA. Key approved therapies are detailed below.
JOYCLU (Ono Pharmaceutical/Seikagaku)
A formulation in which hyaluronic acid and diclofenac are chemically bound using Seikagaku’s proprietary technology, designed to release diclofenac by hydrolysis in the joint. It is approved in Japan (2021) for osteoarthritis of the knee and hip joint, administered by intra-articular injection once every 4 weeks, and is the first ethical drug indicating osteoarthritis of the hip joint in Japan among joint function improvement agents.
TRILURON (Fidia Farmaceutici)
A viscous, sterile solution of high molecular weight (500,000–730,000 Da) purified sodium hyaluronate derived from rooster combs. This FDA-approved (US: 2019) intra-articular viscosupplement relieves knee osteoarthritis pain in patients failing conservative measures like exercise, physical therapy, or simple analgesics.
SYNOJOYNT (Hanmi Pharmaceutical/Teva Pharmaceuticals)
An intra-articular hyaluronic acid modulator for knee osteoarthritis, marketed in the US since 2018.
Osteoarthritis Pipeline Analysis
ZILOSUL (pentosan polysulfate sodium): Paradigm Biopharma
A semi-synthetic drug manufactured from the wood chips of European beech trees, with anti-inflammatory and tissue regenerative properties as well as mild anti-thrombotic activity. It is in Phase III for moderate to severe knee osteoarthritis. Paradigm is focused on completing patient enrolment in the Phase III PARA_OA_012 trial, with an interim analysis planned and a data readout expected in mid-2026.
LEVI-04: Levicept
A fully human chimeric fusion protein combining the Fc fragment of human IgG1 with the p75 neurotrophin receptor (p75NTR). It is a first-in-class neurotrophin-3 (NT-3) inhibitor designed to restore neurotrophin homeostasis and provide strong analgesia without the joint-damage risks seen with anti-NGF antibodies. In a Phase II knee osteoarthritis trial (NCT05618782) in over 510 patients, it showed significant analgesic efficacy and good tolerability, meeting all endpoints without increased rapid joint deterioration versus placebo. Levicept is developing a Phase III clinical plan.
Other late-stage candidates: ELIXCYTE (UnicoCell Biomed) and Retatrutide (LY3437943; Eli Lilly and Company) are also in Phase III for knee osteoarthritis and osteoarthritis, respectively.
Discover more about therapies set to grab Major Osteoarthritis Market Share @ Osteoarthritis Drugs Market
Osteoarthritis Market Outlook
Osteoarthritis management involves a comprehensive approach, including exercise, weight management, physical therapy, medications, and surgery in severe cases. Treatment options include analgesics, NSAIDs, corticosteroid injections, and hyaluronic acid therapies to reduce pain and improve joint function. While NSAIDs remain widely used, their long-term use may cause gastrointestinal, renal, and cardiovascular complications. COX-2 inhibitors, such as celecoxib and etoricoxib, offer alternative treatment options. DUROLANE provides single-injection hyaluronic acid therapy for knee osteoarthritis. The osteoarthritis market is expected to expand through 2036, driven by an aging population and rising prevalence, with Germany leading EU4 and UK revenue, followed by Spain and France.
Osteoarthritis Market Drivers
Rising global disease burden driven by aging populations, increasing obesity rates, and lifestyle factors, leading to a high prevalence of chronic pain and disability
Expanding patient pool and long-term disease management needs, sustaining demand for symptomatic and disease-modifying therapies
Advancements in disease-modifying therapies, regenerative medicine approaches, and novel pain management options
Improved imaging and diagnostic tools
Increasing research focus, growing biopharma investments, and heightened awareness of unmet needs
Osteoarthritis Market Barriers
High treatment costs and limited reimbursement.
Adverse effects associated with long-term NSAID use.
Inconsistent clinical evidence for hyaluronic acid injections.
Limited effectiveness of existing therapies in advanced disease.
Lack of disease-modifying osteoarthritis treatments.
To know more about Osteoarthritis Companies working in the treatment market, visit @ Osteoarthritis Market Size
Scope of the Osteoarthritis Market Report
Coverage- 7MM
Study Period- 2022–2036
Historical Year- 2022–2025
Forecast Period- 2026–2036
Osteoarthritis Market CAGR- 3% (2026–2036)
Osteoarthritis Companies- Ono Pharmaceutical/Seikagaku Corporation, Fidia Farmaceutici, Hanmi Pharmaceutical/Teva Pharmaceuticals, Bioventus, Pacira BioSciences/Flexion Therapeutics, and others.
Osteoarthritis Therapies- JOYCLU, TRILURON, SYNOJOYNT, DUROLANE, ZILRETTA, TRIVISC, and others.
Osteoarthritis Market Dynamics: Osteoarthritis market drivers and market barriers
Osteoarthritis Competitive Intelligence Analysis: SWOT Analysis, Conjoint Analysis
Osteoarthritis Unmet Needs, KOL Views, Reimbursement
Table of Contents
Key Insights
Report Introduction
Executive Summary
Key Events
Epidemiology and Market Methodology
Osteoarthritis Market Overview at a Glance
Disease Background and Overview of Osteoarthritis
Treatment and Management of Osteoarthritis
Epidemiology and Patient Population of Osteoarthritis
Patient Journey
Marketed Therapies
Emerging Therapies
Osteoarthritis: 7MM Analysis
Unmet Needs of Osteoarthritis
SWOT Analysis of Osteoarthritis
Key Opinion Leaders’ Views
Market Access and Reimbursement of Osteoarthritis
Appendix
DelveInsight Capabilities
Disclaimer
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