New York, USA, June 15, 2026 (GLOBE NEWSWIRE) -- Osteoarthritis Market Expected to Showcase Moderate Growth at a CAGR of 3% During the Forecast Period (2026–2036) Driven by Emerging Therapies and Rising Disease Burden | DelveInsight
The osteoarthritis market is projected to grow from 2026 to 2036, driven by an aging population and rising disease prevalence. The expected launch of emerging therapies such as LEVI-04 (Levicept), ZILOSUL (Paradigm Biopharmaceuticals), TissueGene-C (TG-C) (Kolon TissueGene), AMZ001 (Amzell), SAR446959 (Sanofi), PCRX-201 (enekinragene inzadenovec) (Pacira BioSciences), and others is further supporting market expansion.
Recently published Osteoarthritis Market Insights report includes a comprehensive understanding of current treatment practices, osteoarthritis emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Osteoarthritis Market Summary
- The market size for osteoarthritis was found to be USD 32.5 billion in the 7MM in 2025.
- The United States accounted for the largest osteoarthritis treatment market size in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- In 2025, Opioids captured the highest market size of osteoarthritis by therapies, i.e., around USD 9.5 billion in the US.
- In 2025, the total number of diagnosed cases of osteoarthritis was around 99,000 cases in the 7MM, which is anticipated to increase during the forecast period (2026–2036).
- Key osteoarthritis companies, including Levicept, Paradigm Biopharmaceuticals, Kolon TissueGene, Amzell, Sanofi, Pacira BioSciences, Biosplice Therapeutics, Saol Therapeutics Inc., Ageless Biotech, Inc., 4Moving Biotech, OrthoTrophix, Immunis, Akan Biosciences, and others, are actively working on innovative osteoarthritis drugs.
- Some of the key osteoarthritis therapies in clinical trials include LEVI-04, ZILOSUL, TissueGene-C (TG-C), AMZ001, SAR446959, PCRX-201 (enekinragene inzadenovec), Lorecivivint (SM04690), SL1002, OA-SYS, 4P004, TPX-100, IMM01-STEM, StroMel, and others. These novel osteoarthritis therapies are anticipated to enter the osteoarthritis market in the forecast period and are expected to change the market.
Discover osteoarthritis market growth opportunities @ https://www.delveinsight.com/report-store/osteoarthritis-market
Key Factors Driving the Growth of the Osteoarthritis Market
- Rising Global Disease Burden: Osteoarthritis is a major and increasingly prevalent global health challenge, fueled by demographic shifts such as population aging, rising obesity levels, and sedentary lifestyles. The condition is a leading cause of chronic pain, reduced mobility, and disability, affecting millions of individuals worldwide. As the number of patients continues to grow and the need for long-term disease management intensifies, demand for both symptom-relieving treatments and innovative disease-modifying therapies is expected to increase steadily.
- Advancements in Disease-Modifying Therapies: The development of novel disease-modifying osteoarthritis drugs (DMOADs) and regenerative therapies is creating new opportunities beyond symptomatic pain management.
- Growing Adoption of Biologics and Regenerative Medicine: Emerging treatments such as stem cell therapies, platelet-rich plasma (PRP), and biologic agents are attracting interest for their potential to repair damaged joint tissues and improve long-term outcomes.
- Launch of Emerging Therapies: The dynamics of the osteoarthritis market are expected to change in the coming years due to the launch of emerging therapies such as LEVI-04 (Levicept), ZILOSUL (Paradigm Biopharmaceuticals), TissueGene-C (TG-C) (Kolon TissueGene), AMZ001 (Amzell), SAR446959 (Sanofi), PCRX-201 (enekinragene inzadenovec) (Pacira BioSciences), Lorecivivint (SM04690) (Biosplice Therapeutics), SL1002 (Saol Therapeutics Inc.), OA-SYS (Ageless Biotech, Inc.), 4P004 (4Moving Biotech), TPX-100 (OrthoTrophix), IMM01-STEM (Immunis), StroMel (Akan Biosciences), and others.
According to Aparna Thakur, project manager of forecasting at DelveInsight, single-injection joint function-enhancing hyaluronic acid formulation’s sales are steadily rising, and companies are looking to expand into new markets to increase their single-injection product profit.
Osteoarthritis Market Analysis
- The management of osteoarthritis requires a comprehensive and individualized treatment strategy.
- Non-pharmacological measures, including regular exercise, weight reduction, and physical therapy, play a vital role in enhancing joint mobility and reducing pain.
- Pharmacological treatments such as analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), and intra-articular injections are commonly used to control pain and inflammation. In advanced stages of the disease, surgical procedures such as joint replacement may be recommended to restore function and improve quality of life.
- Additionally, complementary approaches, including acupuncture, as well as heat and cold therapies, can help provide symptomatic relief. Patient education and self-management programs are equally important, enabling individuals to better understand their condition and actively participate in its long-term management.
- Several hyaluronate-based therapies have received FDA approval, including SUPARTZ (January 2001), ORTHOVISC (February 2004), EUFLEXXA (2005), and GEL-ONE cross-linked hyaluronate (2011).
- Additionally, ZILRETTA, which gained FDA approval in October 2017, demonstrated notable pain-relieving benefits in its pivotal Phase III clinical study.
- The osteoarthritis treatment pipeline is evolving with the development of innovative therapeutic approaches, including TRPV1 receptor agonists, pan-CLK/DYRK modulators, stem cell-based therapies, GLP-1 receptor agonists, selective cyclooxygenase-2 (COX-2) inhibitors, and other novel mechanisms.
- Among the leading emerging candidates for osteoarthritis symptom management are LEVI-04 (Levicept), ZILOSUL (pentosan polysulfate sodium; Paradigm Biopharmaceuticals), TissueGene-C (TG-C; Kolon TissueGene), AMZ001 (Amzell), SAR446959 (Sanofi), and others, all of which are attracting significant attention for their potential to address unmet treatment needs.
Learn more about disease-modifying therapies for osteoarthritis @ Osteoarthritis Treatment Market
Osteoarthritis Competitive Landscape
Some of the osteoarthritis drugs under development include LEVI-04 (Levicept), ZILOSUL (Paradigm Biopharmaceuticals), TissueGene-C (TG-C) (Kolon TissueGene), AMZ001 (Amzell), SAR446959 (Sanofi), PCRX-201 (enekinragene inzadenovec) (Pacira BioSciences), Lorecivivint (SM04690) (Biosplice Therapeutics), SL1002 (Saol Therapeutics Inc.), OA-SYS (Ageless Biotech, Inc.), 4P004 (4Moving Biotech), TPX-100 (OrthoTrophix), IMM01-STEM (Immunis), StroMel (Akan Biosciences), and others.
Paradigm Biopharmaceuticals’ ZILOSUL (pentosan polysulfate sodium; PPS) is a semi-synthetic compound derived from European beech wood chips. It exhibits anti-inflammatory, tissue-regenerative, and mild antithrombotic properties. Owing to its multifaceted mechanism of action, PPS is being investigated across a range of inflammation-driven disorders, including osteoarthritis. Paradigm has established a long-term partnership with Bene PharmaChem, the sole FDA-approved manufacturer and supplier of PPS. Through close collaboration with Bene PharmaChem and its European injectable PPS (iPPS) manufacturing partners, Paradigm has successfully advanced the development of its clinical-stage product for ongoing trials.
Levicept’s LEVI-04 is a fully human chimeric fusion protein that combines the Fc region of human IgG1 with the p75 neurotrophin receptor (p75NTR). As a first-in-class neurotrophin-3 (NT-3) inhibitor, it is designed to restore neurotrophin balance and deliver potent pain relief while avoiding the joint-damaging effects associated with anti-NGF therapies. The company is currently preparing a Phase III clinical development program for LEVI-04.
Amzell’s AMZ001 is a high-concentration (3.06% diclofenac sodium), odorless, noninvasive topical gel developed for direct application to the knee. Utilizing a proprietary technology platform approved by both the FDA and EMA, the therapy has completed a four-week Phase II/III efficacy study involving 440 patients across the United States, Denmark, and the Czech Republic. According to the company's pipeline updates, AMZ001 is currently progressing through Phase III clinical evaluation for the treatment of knee osteoarthritis.
The anticipated launch of these emerging osteoarthritis therapies are poised to transform the osteoarthritis market landscape in the coming years. As these cutting-edge osteoarthritis therapies continue to mature and gain regulatory approval, they are expected to reshape the osteoarthritis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about emerging osteoarthritis therapies, visit @ Osteoarthritis Medication
Recent Developments in the Osteoarthritis Market
- In February 2026, Levicept announced the appointment of James Sandy as Chief Development Officer (CDO).
- In January 2026, Levicept announced the FDA had accepted its Investigational New Drug (IND) application for LEVI-04.
What is Osteoarthritis?
Osteoarthritis is the most common form of arthritis and a chronic, progressive joint disorder characterized by the gradual breakdown of cartilage, the protective tissue that cushions the ends of bones. As cartilage deteriorates, bones begin to rub against each other, leading to pain, stiffness, swelling, and reduced joint mobility. Osteoarthritis most commonly affects weight-bearing joints such as the knees, hips, and spine, although it can also occur in the hands and other joints. The condition is primarily associated with aging, but factors such as obesity, joint injuries, genetic predisposition, and repetitive joint stress can increase the risk of developing the disease. As a leading cause of disability worldwide, osteoarthritis significantly impacts patients' quality of life and represents a growing healthcare burden due to the rising aging population and increasing prevalence of obesity.
Osteoarthritis Epidemiology Segmentation
The osteoarthritis epidemiology section provides insights into the historical and current osteoarthritis patient pool and forecasted trends for the leading markets. 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 osteoarthritis market report proffers epidemiological analysis for the study period 2022–2036 in the leading markets segmented into:
- 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
Download the report to understand the future of osteoarthritis treatment @ Osteoarthritis Treatment Options
| Osteoarthritis Market Report Metrics | Details |
| Study Period | 2022–2036 |
| Osteoarthritis Market Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
| Osteoarthritis Market CAGR | 3% |
| Osteoarthritis Market Size in 2025 | USD 32.5 Billion |
| Key Osteoarthritis Companies | Levicept, Paradigm Biopharmaceuticals, Kolon TissueGene, Amzell, Sanofi, Pacira BioSciences, Biosplice Therapeutics, Saol Therapeutics Inc., Ageless Biotech, Inc., 4Moving Biotech, OrthoTrophix, Immunis, Akan Biosciences, Ono Pharmaceutical, Seikagaku Corporation, Fidia Farmaceutici, Hanmi Pharmaceutical, Teva Pharmaceuticals, and others |
| Key Osteoarthritis Therapies | LEVI-04, ZILOSUL, TissueGene-C (TG-C), AMZ001, SAR446959, PCRX-201 (enekinragene inzadenovec), Lorecivivint (SM04690), SL1002, OA-SYS, 4P004, TPX-100, IMM01-STEM, StroMel, JOYCLU, TRILURON, SYNOJOYNT, and others |
Scope of the Osteoarthritis Market Report
- Osteoarthritis Patient Population Forecast
- Osteoarthritis Therapeutics Market Size
- Osteoarthritis Pipeline Analysis
- Osteoarthritis Market Size and Trends
- Osteoarthritis Market Opportunity
- Osteoarthritis Market Unmet Needs
- KOL’s Views on Osteoarthritis
- Osteoarthritis Market Access and Reimbursement
Discover more about next-generation OA drugs @ Osteoarthritis Clinical Trials
Table of Contents
| 1 | Osteoarthritis Market Key Insights |
| 2 | Osteoarthritis Market Report Introduction |
| 3 | Executive Summary |
| 4 | Key Events |
| 5 | Epidemiology and Market Methodology |
| 6 | Osteoarthritis Market Overview at a Glance |
| 6.1 | Emerging Therapies Analysis (By Phase, RoA, and Molecule Type) |
| 6.2 | Market Share by Therapies (%) Distribution of Osteoarthritis in 2025 in the 7MM |
| 6.3 | Market Share by Therapies (%) Distribution of Osteoarthritis in 2036 in the 7MM |
| 7 | Disease Background and Overview of Osteoarthritis |
| 7.1 | Introduction |
| 7.2 | Definition and Classification |
| 7.3 | Etiology |
| 7.4 | Risk Factors |
| 7.5 | Pathophysiology |
| 7.6 | Relevance to Other Disease States |
| 7.7 | Diagnosis and |
| 8 | Treatment and Management of Osteoarthritis |
| 9 | Epidemiology and Patient Population of Osteoarthritis |
| 9.1 | Key Findings |
| 9.2 | Assumption and Rationale of Osteoarthritis: The 7MM Analysis |
| 9.3 | Total Diagnosed Cases of Osteoarthritis in the 7MM |
| 9.4 | The United States |
| 9.4.1 | Total Diagnosed Prevalent Cases of Osteoarthritis in the US |
| 9.4.2 | Joint site-specific Diagnosed Prevalent Cases of Osteoarthritis in the US |
| 9.4.3 | Gender-specific Diagnosed Prevalent Cases of Osteoarthritis in the US |
| 9.4.4 | Age-specific Diagnosed Prevalent Cases of Osteoarthritis in the US |
| 9.4.5 | Severity-specific Prevalent Cases of Osteoarthritis in the US |
| 9.5 | EU4 and the UK |
| 9.6 | Japan |
| 10 | Patient Journey |
| 11 | Marketed Osteoarthritis Therapies |
| 11.1 | Marketed Competitive Landscape of Osteoarthritis |
| 11.2 | JOYCLU (diclofenac etalhyaluronate sodium): Ono Pharmaceutical/Seikagaku Corporation |
| 11.2.1 | Product Description |
| 11.2.2 | Regulatory Milestones |
| 11.2.3 | Other Development Activities |
| 11.2.4 | Summary of Pivotal Trial |
| 11.2.5 | Clinical Development |
| 11.2.5.1 | Clinical Trial Information |
| 11.2.6 | Safety and Efficacy of Ongoing Clinical Trials |
| 11.2.7 | Analyst Views |
| 11.3 | DUROLANE: Bioventus |
| 12 | Emerging Osteoarthritis Therapies |
| 12.1 | Emerging Competitive Landscape of Osteoarthritis |
| 12.2 | ZILOSUL (pentosan polysulfate sodium): Paradigm Biopharmaceuticals |
| 12.2.1 | Product Description |
| 12.2.2 | Other Developmental Activities |
| 12.2.3 | Clinical Development |
| 12.2.3.1 | Clinical Trials Information |
| 12.2.4 | Safety and Efficacy |
| 12.2.5 | Analyst Views |
| 12.3 | AMZ001: Amzell |
| 12.4 | LEVI-04: Levicept |
| 13 | Osteoarthritis Market: 7MM Analysis |
| 13.1 | Key Findings |
| 13.2 | Osteoarthritis Market Outlook |
| 13.3 | Conjoint Analysis |
| 13.4 | Key Market Forecast Assumptions |
| 13.5 | Total Market Size of Osteoarthritis in the 7MM |
| 13.6 | Total Market Size of Osteoarthritis by Therapies in 7MM |
| 13.7 | The United States Osteoarthritis Market Size |
| 13.7.1 | Total Market Size of Osteoarthritis in the United States |
| 13.7.2 | Total Market Size of Osteoarthritis by Therapies in the United States |
| 13.8 | EU4 and the UK Osteoarthritis Market Size |
| 13.9 | Japan Osteoarthritis Market Size |
| 14 | Unmet Needs of Osteoarthritis |
| 15 | SWOT Analysis of Osteoarthritis |
| 16 | Key Opinion Leaders’ Views |
| 17 | Market Access and Reimbursement of Osteoarthritis |
| 17.1 | The United States |
| 17.2 | In EU4 and the UK |
| 17.3 | Japan |
| 17.4 | Summary and Comparison of Market Access and Pricing Policy Developments in 2025 |
| 17.5 | Market Access and Reimbursement of Osteoarthritis |
| 18 | Acronyms and Abbreviations |
| 19 | Bibliography |
| 20 | Osteoarthritis Market Report Methodology |
Related Reports
Osteoarthritis Clinical Trial Analysis
Osteoarthritis Pipeline Insight – 2026 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key osteoarthritis companies, including Biosplice Therapeutics, Cynata Therapeutics, Bone Therapeutics S.A, Regeneron Pharmaceuticals, Techfields Pharma, Ampio Pharmaceuticals, Asahi Kasei Pharma, Taiwan Bio Therapeutics, OliPass Corporation, Bioventus, Medipost, LG Chem, ICM Biotech, Cells for Cells SA, GWOXI Stem Cell Applied Technology, UnicoCell Biomed, Magellan Biologicals, Levicept, Arthrogen, Personalized Stem Cells, Peptinov, Orient Europharma, ZYUS Life Sciences, Lubris Biopharma, Saol Therapeutics, Ageless Biotech, Synartro AB, Plakous Therapeutics, Ribomic, Meluha Therapeutics, and others.
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Erosive Hand Osteoarthritis Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key erosive hand osteoarthritis companies, including AbbVie, Celgene Corporation, Amgen, XOMA (US) LLC, and others.
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