Osteoarthritis Market Set for Strong Expansion Through 2036 Amid Rising Investment Interest - DelveInsight

DelveInsight's report, "Osteoarthritis Market Insights, Epidemiology, and Market Forecast-2036," provides a comprehensive analysis of the Osteoarthritis landscape. The report delivers detailed insights into the disease, including historical and projected epidemiology, helping stakeholders understand the prevalence, incidence, and patient demographics across key regions.
Additionally, it examines Osteoarthritis market dynamics, offering a thorough assessment of current and emerging market trends, treatment patterns, and therapeutic developments. The analysis spans major markets, including the United States, EU4 (Germany, Spain, Italy, France, and the United Kingdom), and Japan, equipping decision-makers with actionable intelligence for strategic planning, investment, and research initiatives.

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Some of the key facts of the Osteoarthritis Market Report:
• The Osteoarthritis market size was valued at approximately USD 32.5 billion in 2025 and is projected to reach nearly USD 47.0 billion by 2036, registering a CAGR of 3% during the forecast period from 2026 to 2036.
• In 2025, Opioids captured the highest market size of osteoarthritis by therapies, i.e., around USD 9,500 million in the US.
• Amongst EU4 and the UK, Germany will capture the maximum revenue share, followed by Spain and France in 2036.
• The upcoming therapies for osteoarthritis are expected to combat the current unmet needs faced by patients with osteoarthritis.
• In July 2026, Enlivex Ltd. (Nasdaq: ENLV), a biotechnology company focused on advancing quality longevity through innovative immunotherapies, has announced that the U.S. FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to AllocetraTM, its investigational immunotherapy, for the treatment of age-related symptomatic knee osteoarthritis (OA) in patients aged 64 years and older. The company stated that this regulatory milestone reflects the encouraging clinical outcomes observed in its Phase I/IIa trial, particularly among older patients who experienced the greatest therapeutic benefit. Based on these findings, Enlivex plans to prioritize the development of AllocetraTM for this patient population as it advances the therapy through clinical development.
• In July 2026, The U.S. FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Allocetra, Enlivex's investigational cell therapy, for the treatment of age-related symptomatic knee osteoarthritis (OA) in patients 64 years of age and older. Established under the 21st Century Cures Act, the RMAT designation is awarded to regenerative medicine therapies, including cell and gene therapies, that demonstrate the potential to treat, modify, reverse, or cure serious conditions with significant unmet medical needs. The designation provides advantages similar to those of both Fast Track and Breakthrough Therapy programs, including enhanced collaboration with the FDA during development and potential eligibility for accelerated approval and priority review.
• In July 2026, Organogenesis Holdings Inc. (Nasdaq: ORGO), a regenerative medicine company focused on advanced wound care, surgical care, and sports medicine solutions, has announced that the U.S. FDA has accepted its Biologics License Application (BLA) for ReNu® for regulatory review. ReNu® is a cryopreserved amniotic suspension allograft being developed to relieve pain associated with symptomatic knee osteoarthritis (OA). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2027, marking an important step toward the potential approval of the therapy.
• In January 2026, 4Moving Biotech (4MB), a clinical-stage biotechnology company dedicated to developing next-generation disease-modifying therapies for osteoarthritis (OA), has announced that the U.S. FDA has cleared its Investigational New Drug (IND) application for 4P004. The approval enables the company's Phase IIa INFLAM MOTION clinical trial to expand into the United States. This regulatory milestone marks a significant step in 4MB's global clinical development strategy, complementing ongoing studies across Europe and Canada, while reinforcing the company's commitment to advancing what could become the first disease-modifying osteoarthritis drug (DMOAD) for patients worldwide.
• In February 2026, OrthoTrophix Inc., a privately held company focused on developing innovative investigational treatments for Osteoarthritis, has announced the ahead-of-schedule completion of patient enrollment in its Phase 2b clinical trial. The study is assessing intra-articular TPX-100 for Knee osteoarthritis. This multicenter trial in the United States began in May 2025 and is anticipated to conclude in the first quarter of 2027.
• In January 2026, 4Moving Biotech (4MB), a clinical-stage biotechnology company focused on developing next-generation, disease-modifying therapies for osteoarthritis (OA), announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for 4P004. This clearance allows the Phase 2a INFLAM MOTION clinical trial to expand into the United States. The FDA approval represents a strategic milestone in 4MB's global clinical efforts across Europe, Canada, and now the U.S., strengthening the company's position as a leader in the pursuit of the first disease-modifying osteoarthritis drug (DMOAD) for patients worldwide.
• In November 2025, Novo Nordisk has released new findings from the OASIS 4 Phase 3 trial, which investigated various patient populations and hypotheses, further supporting the potential of this therapy. Injectable semaglutide 2.4 mg, marketed as Wegovy®, is approved in the EU as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with a BMI of ≥30 kg/m2 (obesity) or ≥27 kg/m2 (overweight) with at least one weight-related comorbidity. Wegovy® is also approved for pediatric patients aged 12 and older with an initial BMI at or above the 95th percentile and body weight over 60 kg. The label highlights clinical evidence of major adverse cardiovascular event (MACE) risk reduction, improvements in HFpEF-related symptoms and physical function, and pain relief for knee osteoarthritis.
• In May 2025, Lipogems announced the successful completion of its ARISE I U.S. FDA IDE Study, with the final patient visit now concluded. This marks a significant milestone in progressing Lipogems as a treatment option for knee osteoarthritis (OA) in patients who are not eligible for or ready to undergo knee replacement. The double-blind, randomized controlled trial included 173 participants across 18 leading U.S. clinical sites. The study's primary focus is on assessing pain relief and functional improvement 12 months after injection. Results on efficacy and safety are anticipated by late 2025.
• In May 2025, Genascence Corporation, a clinical-stage biotech firm focused on transforming musculoskeletal disease treatment through gene therapy, reported positive 12-month safety and biomarker findings from its Phase 1b DONATELLO trial of GNSC-001. This investigational gene therapy targets interleukin 1 (IL-1) for treating knee osteoarthritis (OA). The 12-month results confirmed the trial met its primary endpoint, showing consistent safety and tolerability across all tested doses. Additionally, the study met a key secondary endpoint, demonstrating sustained IL-1Ra expression in synovial fluid, reinforcing the six-month data previously reported.
• In May 2025, Moximed, a pioneering medical device company focused on enhancing care for individuals with knee osteoarthritis (OA), announced that the first patients have been treated in its latest randomized controlled trial (RCT). The MOTION study is a prospective, multicenter trial designed to compare the effectiveness of the MISHA Knee System against non-surgical treatment options in patients with medial knee osteoarthritis.
• In April 2025, Pacira BioSciences reported that its gene therapy candidate, PCRX-201 (enekinragene inzadenovec), showed long-lasting improvements in knee pain, mobility, and stiffness for up to two years in a Phase I trial. Participants received a single local injection of the therapy. The study included 72 individuals aged 30 to 80, categorized based on the severity of their knee osteoarthritis using the Kellgren-Lawrence (K/L) grading system.
• In April 2025, Israel-based Enlivex Therapeutics announced the completion of enrollment for the Phase II portion of its Phase I/II trial evaluating Allocetra, an off-the-shelf cell therapy for moderate to severe knee osteoarthritis. In this phase, over 133 subjects were randomized and treated. The multi-center, randomized trial is divided into two stages, with Phase I being an open-label, dose-escalation study focused on assessing the safety and tolerability of Allocetra injections into the knee.
• In March 2025, RION, a clinical-stage company specializing in regenerative medicine and exosome-based therapies, announced the enrollment of the first patient in its Phase 1b trial of Purified Exosome ProductTM (PEPTM) for treating Osteoarthritis (OA). This marks a significant step in RION's mission to develop cutting-edge regenerative solutions for unmet medical needs.
• Currently, the classes used for the treatment of 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.
• Emerging therapies for osteoarthritis include novel agents such as TRPV1 receptor agonists, pan-CLK/DYRK inhibitors, stem cell-based approaches, GLP-1 receptor agonists, selective COX-2 inhibitors, and others. Prominent pipeline candidates include LEVI-04 (Levicept), ZILOSUL (pentosan polysulfate sodium; Paradigm Biopharmaceuticals), TissueGene-C (TG-C; Kolon TissueGene), AMZ001 (Amzell), and SAR446959 (Sanofi)
• In 2025, Opioids captured the highest market size of osteoarthritis by therapies, i.e., around USD 9,500 million in the US.
• Amongst EU4 and the UK, Germany will capture the maximum revenue share, followed by Spain and France in 2036.
• As per the study by Nalamachu et al. (2020), 41%, 37%, and 22% of the patients with knee osteoarthritis were reported for mild, moderate, and severe pain, respectively, in the US.
• 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%) categorised as having chronic pain (24,463 via opioid prescription) and 158,251 (66%) categorised as not having chronic pain.
• 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.
• It is estimated that the number of cases of osteoarthritis will rise in the coming years because of the rising aging population and obesity, affecting the total pool of knee osteoarthritis.
• 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].
• According to Iolascon et al. (2024), in Italy, the knee osteoarthritis burden significantly affects the national healthcare system and society. Knee osteoarthritis accounts for over 5 million prevalent cases and an age-standardized prevalence rate of 4066 cases per 100,000.
• In Japan, the total diagnosed cases of knee osteoarthritis reached 11,500,000 in 2025.
• Key Osteoarthritis Companies: Merck KGaA, Peptinov, LG Chem, Akan Bioscience, BioTissue,Inc., Eupraxia Pharmaceuticals Inc., OliPass Corporation, Bone Therapeutics, Techfields Pharma, Biosplice Therapeutics, and others
• Key Osteoarthritis Therapies: M6495, PPV 06, LG00034053, StroMel, TTAX03, EP-104IAR, OLP 1002, JTA-004, X 0002, Lorecivivint, and others
• The Osteoarthritis market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Osteoarthritis pipeline products will significantly revolutionize the Osteoarthritis market dynamics.

Osteoarthritis Overview
Osteoarthritis is the most common form of arthritis, characterized by the gradual breakdown of cartilage the protective tissue at the ends of bones. As the cartilage wears down, bones begin to rub against each other, leading to pain, stiffness, swelling, and reduced joint mobility.
It most commonly affects weight-bearing joints such as the knees, hips, and spine, as well as the hands. Osteoarthritis is strongly associated with aging, but other risk factors include obesity, joint injuries, genetics, and repetitive stress on joints.

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Osteoarthritis Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2022 to 2036. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Osteoarthritis Epidemiology Segmentation:
The Osteoarthritis market report proffers epidemiological analysis for the study period 2022-2036 in the 7MM 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

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Osteoarthritis Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Osteoarthritis market or expected to get launched during the study period. The analysis covers Osteoarthritis market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Osteoarthritis Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Osteoarthritis Therapies and Key Companies
• JOYCLU: Ono Pharmaceutical/Seikagaku
• TRILURON: Fidia Farmaceutici
• Pentosan polysulfate sodium (ZILOSUL): Paradigm Biopharma
• LEVI-04: Levicept
• ELIXCYTE
• UnicoCell Biomed
• Retatrutide (LY3437943): Eli Lilly Company
• ZILRETTA: Flexion Therapeutics/Pacira BioSciences
• CINGAL: Anika Therapeutics
• TRIVISC: OrthogenRx / Avanos Medical
• VISCO-3: Zimmer Biomet/Seikagaku Corporation
• LNA043: Novartis
• ReNu (Amniotic Suspension Allograft): Organogenesis
• CNTX-4975: Centrexion Therapeutics
• JTA-004: BioSenic (Bone Therapeutics)
• M6495: Merck KGaA
• PPV 06: Peptinov
• LG00034053: LG Chem
• StroMel: Akan Bioscience
• TTAX03: BioTissue,Inc.
• EP-104IAR: Eupraxia Pharmaceuticals Inc.
• OLP 1002: OliPass Corporation
• JTA-004: Bone Therapeutics
• X 0002: Techfields Pharma
• Lorecivivint: Biosplice Therapeutics

Discover more about therapies set to grab major Osteoarthritis market share @ Osteoarthritis Treatment Landscape
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Osteoarthritis Market Drivers
• Rising global prevalence driven by aging populations and increasing life expectancy
• Growing incidence of obesity and sedentary lifestyles, key risk factors for osteoarthritis
• Increasing awareness and early diagnosis of joint disorders
• Advancements in pain management therapies, including NSAIDs, biologics, and regenerative approaches
• Expanding pipeline of disease-modifying osteoarthritis drugs (DMOADs)
• Technological progress in joint replacement surgeries and minimally invasive procedures
• Increased healthcare spending and improved access to orthopedic care
• Growing adoption of combination therapies (pharmacological + physical therapy)

Osteoarthritis Market Barriers
• Lack of curative or disease-modifying treatments, with most therapies focused on symptom relief
• High cost associated with advanced treatments and joint replacement surgeries
• Side effects linked to long-term use of NSAIDs and pain medications
• Stringent regulatory requirements for approval of novel therapies (especially DMOADs)
• Heterogeneous disease progression, making clinical trial design complex
• Limited awareness and delayed diagnosis in low- and middle-income regions
• Reimbursement challenges for newer and high-cost interventions
• Patient reluctance toward surgical procedures due to risks and recovery time

Scope of the Osteoarthritis Market Report
• Study Period: 2022-2036
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Osteoarthritis Companies: Merck KGaA, Peptinov, LG Chem, Akan Bioscience, BioTissue,Inc., Eupraxia Pharmaceuticals Inc., OliPass Corporation, Bone Therapeutics, Techfields Pharma, Biosplice Therapeutics, and others
• Key Osteoarthritis Therapies: M6495, PPV 06, LG00034053, StroMel, TTAX03, EP-104IAR, OLP 1002, JTA-004, X 0002, Lorecivivint, and others
• Osteoarthritis Therapeutic Assessment: Osteoarthritis current marketed and Osteoarthritis emerging therapies
• Osteoarthritis Market Dynamics: Osteoarthritis market drivers and Osteoarthritis market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Osteoarthritis Unmet Needs, KOL's views, Analyst's views, Osteoarthritis Market Access and Reimbursement

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