Osteoarthritis - Market Insight, Epidemiology and Market Forecast - 2032

Key Highlights

• In 2022, the market size of osteoarthritis was highest in the US among the 7MM, accounting for approximately USD 18,690 million, which is further expected to increase by 2032.
• Amongst EU4 and the UK, Germany will capture the maximum revenue share, followed by Spain and France in 2032.
• In 2022, Opioids captured the highest market size of osteoarthritis by therapies, i.e., around USD 9,130 million in the US.
• In December 2023, Bioventus agreed to a nationwide contract with Aetna Medicare Advantage plans. Beginning January 1, 2024, over 3 million Aetna Medicare Advantage plan members will have access to DUROLANE to treat knee osteoarthritis pain.
• In December 2023, Levicept announced that it had completed recruitment in its Phase II clinical trial of LEVI-04, a novel neurotrophin-modulating biological agent. Top-line data are expected to be announced in the late first half of 2024.
• BioSolution is planning to apply for conditional product approval for CARTILIFE from the US FDA in 2024. Currently, Phase II clinical trials are underway in the US, and the last patient is to be administered. The final results are expected to be released as early as the end of 2024.
• Many key players are developing cell therapies for OA in various stages of development. If approved, these therapies may provide better treatment options as they can slow disease progression and possibly cure it.

This Osteoarthritis- Market Insights, Epidemiology and Market Forecast- 2032” report delivers an in-depth understanding of the Osteoarthritis, historical and forecasted epidemiology as well as the Osteoarthritis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

Osteoarthritis market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Osteoarthritis market size from 2019 to 2032. The report also covers current Osteoarthritis treatment practice/algorithm, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2019-2032

Osteoarthritis Disease Understanding and Treatment Algorithm

Osteoarthritis is the most common form of arthritis; it is a chronic degenerative joint disease that affects mostly middle-aged and older adults. OA causes the breakdown of joint cartilage. It can occur in any joint but most often affects the hands, knees, hips, or spine. OA can be divided into two types, primary and secondary. OA is broken down into five stages, as it can take many years to progress fully, it includes Stage 0, Stage 1: Minor, Stage 2: Mild, Stage 3: Moderate, and Stage 4: Severe.

Osteoarthritis Diagnosis

There is currently no standard lab test to verify the presence of OA. Instead of a single lab test, physicians commonly use various diagnostic tools to determine if a patient has OA or another medical condition. However the diagnosis includes blood tests such as CBC, ESR, rheumatoid factor, and ANA are usually normal in OA, X-rays of the affected joint can show findings consistent with OA and Ultrasound can also identify synovial inflammation, effusion, and osteophytes related to OA.

Osteoarthritis Treatment

OA is a progressive and degenerative condition, with unlikely regression and restoration of damaged structures. Thus, current management modalities are targeted towards symptom control unless the degree of severity dictates the necessity of surgical intervention with joint replacement. The Current treatment of OA includes Nonsteroidal anti-inflammatory drugs (NSAIDS), Arcoxia (Etoricoxib), Opioids, Currently DUROLANE, GELSYN-3, CINGAL, JOYCLU and others HA formulations are available in market for the treatment of knee OA.

Osteoarthritis Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Cases of OA, Joint site-specific Prevalence of OA, Gender-specific Prevalence of OA, Age-specific Prevalence of OA, Severity-specific Prevalence of OA in the 7MM market covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032.

This section provides glimpse of the Osteoarthritis epidemiology in the 7MM:

• The total number of diagnosed cases in the US rise from 2019-2032. In 2022, there were approximately 38,122,000 cases of OA in the US. As per the analysis, a higher percentage of mild cases of OA was observed in the US, followed by moderate OA in 2022.
• Amongst EU4 and the UK, in 2022, the highest proportion of age-specific cases were observed in 70 years and above, followed by age group of 60-69 years and 50-59 years.
• As per the analysis, the highest percentage of gender-specific distribution of OA was observed among female population than the male population in 2022. About 24,017,000 cases of OA in the US were contributed by female population.
• In Japan, there were around 7,749,600 cases of mild knee osteoarthritis in 2019, which are projected to increase during the study period.

Osteoarthritis Drug Chapters

The drug chapter segment of the Osteoarthritis report encloses the detailed analysis of Osteoarthritis mid and late stage pipeline drugs. It also helps to understand the Osteoarthritis clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.

Marketed drugs

ZILRETTA: Flexion Therapeutics/Pacira BioSciences

ZILRETTA is an intra-articular therapy for patients confronting OA knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide commonly administered, immediate-release corticosteroid - with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief. The pivotal Phase III trial, on which the approval of ZILRETTA was based, showed that ZILRETTA significantly reduced OA knee pain for 12 weeks, with some people experiencing pain relief through Week 16. In October 2017, Flexion Therapeutics announced the US FDA approval of ZILRETTA for knee OA. ZILRETTA's extended-release profile may also provide effective treatment for osteoarthritis pain in the shoulder, and the company intends to initiate a Phase III trial investigating ZILRETTA in shoulder osteoarthritis in the first half of 2024.

CINGAL: Anika Therapeutics

CINGAL is a commercially available combination viscosupplement and is currently being used successfully by physicians to provide rapid and long-lasting relief from pain and discomfort caused by OA for patients in a growing number of countries. CINGAL is a patented formulation composed of the company's proprietary crosslinked sodium hyaluronate and triamcinolone hexacetonide. CINGAL is Anika's third-generation viscosupplement to treat pain associated with knee OA, following its other products, ORTHOVISC and MONOVISC. In June 2016, Anika Therapeutics announced the commercial launch of CINGAL in the European Union. In November 2022, company announced positive Phase III data of CINGAL 19-01 study, as per the company statement it plans meeting with FDA to discuss next steps for the US regulatory approval. Moreover the company is actively assessing options to advance CINGAL, including potential commercial partnerships in the US and select Asian markets.

TRIVISC: OrthogenRx / Avanos Medical

TRIVISC is from a class of products known as hyaluronic acid, sodium hyaluronate, or hyaluronan (HA), also referred to as viscosupplementation therapy. It is used in a nonsurgical procedure that helps supplement the viscous properties of the fluid in the knee joint. In November 2017, the company announced that the US FDA had approved TRIVISC for the treatment of knee OA in patients who failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics.

VISCO-3: Zimmer Biomet/Seikagaku Corporation

VISCO-3 is a solution made of highly purified sodium hyaluronate. Hyaluronan is a natural chemical found in the body and is found in particularly high amounts in joint tissues and in the fluid (synovial fluid) that fills the joints. In December 2015, Seikagaku Corporation (Tokyo) announced that the US FDA had approved VISCO-3 for the treatment of knee OA in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

Note: Detailed Current therapies assessment will be provided in the full report of OA

OA Emerging Drugs

LNA043: Novartis

LNA043 is an ANGPTL3 (angiopoietin-like 3) agonist that targets damaged cartilage and modulates several pathways in cartilage regeneration. The drug is being developed as a potential first-in-class disease-modifying treatment for OA. LNA043 is among several early investigational programs in Novartis's portfolio that target cartilage damage and inflammation in OA. In 2021, the US FDA granted Fast Track Designation (FTD) to LNA043 for knee OA treatment. A Phase IIb study (ONWARDS) in patients with knee OA is ongoing and the company anticipated the data readout for the Phase IIb (ONWARDS) trial in 2024. Additionally, the expected NDA submission for this trial is by 2026 and beyond.

ReNu (Amniotic Suspension Allograft): Organogenesis

ReNu (Replace with NuTech Medical) is a cryopreserved, amniotic suspension allograft (ASA) to manage symptomatic knee OA. It consists of amniotic fluid cells and micronized amniotic membrane and contains cellular, growth factor, and extracellular matrix components. In January 2021, ReNu received the US FDA Regenerative Medicine Advanced Therapy (RMAT) designation for knee OA.

CNTX-4975: Centrexion Therapeutics

Centrexion Therapeutics' lead product candidate, CNTX-4975, is being evaluated for the treatment of moderate to severe pain of knee OA. CNTX-4975 is an ultra-pure, synthetic form of trans-capsaicin injected directly into the pain site. In January 2018, the US FDA granted FTD to CNTX-4975 for treating the pain associated with knee OA. In December 2018, Centrexion Therapeutics completed the patient enrollment ahead of schedule in its pivotal Phase III VICTORY-1 trial. Then, in June 2019, Centrexion Therapeutics completed patient enrollment in its second pivotal trial, VICTORY-2. Lastly, in September 2019, Centrexion Therapeutics stated the completion of patient enrollment in its third Phase III trial, VICTORY-3.

JTA-004: BioSenic (Bone Therapeutics)

JTA-004 is a new-generation treatment for osteoarthritic knee pain, which is currently in development for intra-articular injectables, developed by BioSenic. A unique patented blend of plasma proteins, hyaluronic acid - naturally present in the synovial fluid of all joints, and a fast-acting analgesic, JTA-004 - aims to improve lubrication and protection of osteoarthritic joint cartilage and relieve associated pain. In March 2023, BioSenic re-evaluated the results of its Phase III trial of JTA-004 targeting knee osteoarthritis. The company announced that it has used the statistical analysis capabilities of Artialis to study the results of the Phase III JTA-004 trial in the subset of patients with the most painful and inflammatory form of knee osteoarthritis. The Marketing Authorization Application (MAA) could be submitted as soon as three years after the start of the Phase III trial, and as a result, JTA could reach the market in 2027.

Note: Detailed emerging therapies assessment will be provided in the final report.

Osteoarthritis Market Outlook

Osteoarthritis (OA), also known as degenerative joint disease, is typically the result of wear and tear and progressive loss of articular cartilage; it is most common in the elderly. Several pharmacologic treatments are available to manage knee OA-related pain and improve its functionality.

Common pharmacologic interventions to help alleviate knee OA symptoms include nonsteroidal anti-inflammatory drugs (NSAIDs), intra-articular corticosteroids, intra-articular hyaluronic acid, and opioids. The US FDA-approved sodium hyaluronate includes SUPARTZ (Smith & Nephew) - approved on January 24, 2001; ORTHOVISC (Anika Therapeutics) - approved on February 4, 2004; EUFLEXXA (Ferring Pharmaceuticals) - approved in 2005; and GEL-ONE Cross-linked Hyaluronate (Seikagaku Corporation) - approved in 2011. In October 2017, Flexion Therapeutics announced the US FDA approval of ZILRETTA for knee OA. The pivotal Phase III trial, on which the approval of ZILRETTA was based, showed that ZILRETTA significantly reduced OA knee pain for 12 weeks, with some people experiencing pain relief through Week 16. In December 2016, Shionogi and Eli Lilly Japan announced that the MHLW approved CYMBALTA for an additional indication of pain associated with OA. In addition, in January 2020, the regulatory data and patent exclusivity for CYMBALTA expired in Japan.

The current developmental pipeline for knee OA is robust; several companies have initiated clinical trials investigating new treatment options or studying how to use existing treatment options better. The dynamics of the OA market are also anticipated to change in the coming years, owing to the rise in healthcare spending globally.

This section includes a glimpse of the OA the 7MM

• The United States accounts for the largest market size of OA, in comparison to EU4 (Germany, France, Italy, and Spain) and the UK, and Japan.
• The total market size of OA in the United States is expected to increase with a CAGR of 3.3% during the study period.
• Amongst EU4 and the UK, Germany had the highest market size in 2022, while Italy had the smallest market size of OA in 2022.
• The total market size of OA in EU4 and the UK is expected to increase with a CAGR of 2.3% during the study period.
• Currently, the drugs used for the treatment of OA include NSAIDs, Opioids, Intra Articular Corticosteroids, Intra Articular-Hyaluronic acid and others.
• The upcoming therapies of OA are expected to combat the current unmet needs faced by the patients with OA.

Osteoarthritis Drugs Uptake

This section focusses on the rate of uptake of the potential drugs expected to get launched in the market during the study period 2019-2032. The analysis covers Osteoarthritis market uptake by drugs; patient uptake by therapies; and sales of each drug. For example- ZILOSUL (PPS) is a non-nucleoside reverse transcriptase inhibitors. Currently, the drug is in the Phase III stage of clinical development for Osteoarthritis. In April 2022, the company announced that FDA has granted Fast Track Designation (FTD) to pentosan polysulfate sodium (PPS; ZILOSUL) for the treatment of (OA). The drug is expected to launch in the US in 2025.

Osteoarthritis Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for Osteoarthritis emerging therapies.

KOL-Views

To keep up with current market trends, we take KOLs and SME's opinion working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders are Chief Executive Officer, MD, chief medical officer of Centrexion, MD, University of Texas at Houston and Director of Chronic Pain at Lotus Clinical Research, An official from PMG Pharmaceuticals and others. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Osteoarthritis market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

The publisher performs Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial's primary and secondary outcome measures are evaluated. Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

Market Access and Reimbursement

Reimbursement is a crucial factor affecting the drug's market access. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, payers and other industry insiders are considering many payment models. Viscosupplementation therapy for the knee via intra-articular injections of hyaluronic preparations will be considered medically reasonable and necessary when all of the following conditions are met:

• The patient is symptomatic. Such symptoms may include pain that interferes with the activities of daily living, such as ambulation and prolonged standing, or pain interrupting sleep, crepitus, and/or knee stiffness.
• The clinical diagnosis is supported by radiologic evidence of knee osteoarthritis, such as joint space narrowing, subchondral sclerosis, osteophytes, and sub-chondral cysts.
• If appropriate, other diagnoses have been excluded by appropriate evaluation and management services, laboratory, and imaging studies (i.e., the pain and functional disability are not considered likely to be due to a diagnosis other than knee osteoarthritis).

- The patient has failed at least 3 months of conservative therapy. Conservative therapy is defined as:

? Nonpharmacologic therapy (such as but not limited to home exercise program, education, weight loss, physical therapy if indicated)
? If not contraindicated, simple analgesics (e.g., acetaminophen) or NSAIDS per hyaluronan product prescribing information

• The patient has failed to respond to aspiration of the knee when effusion is present and intra-articular corticosteroid injection therapy when inflammation is a significant component of the patient's symptoms and intra-articular corticosteroids are not contraindicated.

Scope of the Report

• The report covers the descriptive overview of Osteoarthritis, explaining its causes, signs and symptoms, pathogenesis and currently available therapies.
• Comprehensive insight has been provided into the Osteoarthritis epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Osteoarthritis are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of Osteoarthritis market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Osteoarthritis market.

Report Highlights

• Many key players are developing cell therapies for OA in various stages of development. If approved, these therapies may provide better treatment options as they can slow disease progression and possibly cure the disease
• Companies are investing heavily in developing disease-modifying therapies for the treatment of OA, which will fulfill a major unmet need
• The report also encompasses other major segments, i.e Total Diagnosed Cases of OA, Joint site-specific Prevalence of OA, Gender-specific Prevalence of OA, Age-specific Prevalence of OA, Severity-specific Prevalence of OA
• Expected Launch of potential therapies LNA043 (Novartis), ReNu (Organogenesis), AMZ001 (Amzell), and others might change the landscape in treatment of OA.

Osteoarthritis Report Insights

• Patient Population
• Therapeutic Approaches
• Osteoarthritis Pipeline Analysis
• Osteoarthritis Market Size and Trends
• Market Opportunities

- Impact of upcoming Therapies

Osteoarthritis Report Key Strengths

• Ten Years Forecast
• 7MM Coverage
• Osteoarthritis Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Osteoarthritis Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• SWOT
• Attribute Analysis

Key Questions Answered

Market Insights:

• What was the Osteoarthritis market share (%) distribution in 2022 and how it would look like in 2032?
• What would be the Osteoarthritis total market size as well as market size by therapies across the 7MM during the study period (2019-2032)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Osteoarthritis market size during the study period (2019-2032)?
• At what CAGR, the Osteoarthritis market is expected to grow at the 7MM level during the study period (2019-2032)?
• What would be the Osteoarthritis market outlook across the 7MM during the study period (2019-2032)?
• What would be the Osteoarthritis market growth till 2032 and what will be the resultant market size in the year 2032?
• How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What is the disease risk, burden and unmet needs of Osteoarthritis?
• What is the historical Osteoarthritis patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• What would be the forecasted patient pool of Osteoarthritis at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Osteoarthritis?
• Out of the above-mentioned countries, which country would have the highest prevalent population of Osteoarthritis during the study period (2019-2032)?
• At what CAGR the population is expected to grow across the 7MM during the study period (2019-2032)?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

• What are the current options for the treatment of Osteoarthritis? What are the current treatment guidelines for the treatment of Osteoarthritis in the US and Europe?
• What are the Osteoarthritis marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
• How many companies are developing therapies for the treatment of Osteoarthritis?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of Osteoarthritis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Osteoarthritis therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Osteoarthritis and their status?
• What are the key designations that have been granted for the emerging therapies for Osteoarthritis?
• What are the 7MM historical and forecasted market of Osteoarthritis?

Reasons to Buy

• The report will help in developing business strategies by understanding trends shaping and driving the Osteoarthritis.
• To understand the future market competition in the Osteoarthritis market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Osteoarthritis in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for Osteoarthritis market.
• To understand the future market competition in the Osteoarthritis market.