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Knee Osteoarthritis Drug Pipeline Analysis Report 2025

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    Drug Pipelines

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102765
Knee osteoarthritis (OA) is a degenerative joint disease that causes pain, stiffness, and swelling as the knee's cartilage gradually deteriorates. It can be divided into two categories, namely, primary and secondary. Primary has no known origin, while secondary is brought on by things like injuries or aberrant joint mechanics. It is most common in older persons. The symptoms include joint stiffness after rest. It usually gets worse with activity. Treatments range from conservative therapy to surgical alternatives for severe instances. Moreover, the rising prevalence of the condition is anticipated to positively impact the pipeline landscape for knee osteoarthritis drugs.

Report Coverage

The Knee Osteoarthritis Drug Pipeline Insight Report by the publisher gives comprehensive insights into knee osteoarthritis therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for knee osteoarthritis. The knee osteoarthritis report assessment includes the analysis of over 25 pipeline drugs and 10+ companies. The knee osteoarthritis pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials including their adverse effects on patients suffering from the condition, and alignment with knee osteoarthritis treatment guidelines to ensure optimal care practices.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to knee osteoarthritis.

Knee Osteoarthritis Drug Pipeline Outlook

Inflammatory and chondrocyte activity drives bone remodeling and cartilage degradation in knee osteoarthritis (OA). In the condition, articular cartilage is eroded by enzymes that break down collagen and proteoglycans35. Osteophyte and cyst development result from sclerosis of the underlying bone. Even while chondrocytes make an initial attempt at repair, cartilage loss eventually surpasses these attempts. This process is facilitated by metabolic alterations, mechanical strain, and inflammation. All parts of the joint, including the synovium and subchondral bone, are impacted by osteoarthritis
Hyaluronic acid and other small molecules and polymers are frequently recommended for the treatment of osteoarthritis in the knee. NSAIDs and COX-2 inhibitors are examples of small molecules that are used to treat pain and inflammation. Polymers, more especially, hyaluronic acid are given through viscosupplementation to serve as a lubricant and shock absorber. Injections of HA have demonstrated efficacy in reducing pain and enhancing functionality. Compared to small compounds and HA, gene therapy, recombinant fusion proteins, monoclonal antibodies, and peptides are less well-established and less frequently employed in the regular treatment of osteoarthritis, despite their potential. Further, the rising focus on the development of knee osteoarthritis emerging drugs and the advances in the understanding of the molecular pathogenesis of the disease are expected to support the pipeline expansion in the coming years.

Knee Osteoarthritis Epidemiology

About 32.5 million persons in the US alone suffer with osteoarthritis, the most prevalent kind of arthritis. In 2020, around 595 million individuals worldwide or 7.6% of the world's population were living with osteoarthritis. With over 43% of those afflicted being 65 years of age or older, the prevalence rises with age. Women account for 62% of osteoarthritis cases, making them disproportionately afflicted. Ageing populations and rising obesity rates are among the causes contributing to the increased prevalence, which has serious negative effects on both health and the economy.

Knee Osteoarthritis - Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of knee osteoarthritis drug candidates based on several segmentations including:

By Phase

  • Late-Stage Products (Phase 3 and Phase 4)
  • Mid-Stage Products (Phase 2)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

By Drug Class

  • Recombinant Fusion Proteins
  • Small Molecule
  • Peptide
  • Polymer
  • Monoclonal Antibody
  • Gene Therapy
  • Others

By Route of Administration

  • Oral
  • Parenteral
  • Others

Knee Osteoarthritis - Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to analysis, phase II covers a major share of the total clinical trials, with a substantial number of knee osteoarthritis drugs undergoing clinical development.

Knee Osteoarthritis - Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under knee osteoarthritis pipeline analysis include recombinant fusion proteins, small molecules, peptides, polymers, monoclonal antibodies and gene therapies, among others. The knee osteoarthritis report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for knee osteoarthritis.

Knee Osteoarthritis Clinical Trials Therapeutic Assessment - Competitive Dynamics

The report for the knee osteoarthritis drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed knee osteoarthritis therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in knee osteoarthritis clinical trials:
  • Novartis Pharmaceuticals
  • Paradigm Biopharmaceuticals Inc.
  • Pacira Pharmaceuticals, Inc.
  • Kolon TissueGene, Inc.
  • Taiwan Bio Therapeutics Inc.
  • Genascence Corporation
  • Orient Europharma Co., Ltd.
  • Xindu Pty Ltd
  • Kiomed Pharma
  • Organogenesis

Knee Osteoarthritis Emerging Drugs Profile

Major drugs currently in the drug pipeline are as follows:

Drug: QUC398

Novartis Pharmaceuticals is conducting a Phase IIa clinical trial to evaluate the efficacy, safety, and tolerability of QUC398, an investigational ADAMTS5 inhibitor, in patients with symptomatic knee osteoarthritis. The study aims to determine if QUC398 can alleviate knee pain and preserve cartilage. Participants will receive subcutaneous injections every four weeks over a 16-month period. Enrollment has concluded, and the trial is currently active but not recruiting new participants.

Drug: FX201

Pacira Pharmaceuticals is developing FX201, an innovative gene therapy designed to treat osteoarthritis of the knee. FX201 utilizes a helper-dependent adenovirus vector to deliver the interleukin-1 receptor antagonist (IL-1Ra) gene directly into the joint, aiming to provide long-term anti-inflammatory effects. A Phase 1 clinical trial is currently underway to evaluate the safety and tolerability of FX201 in patients aged 30 to 80 with painful knee osteoarthritis. The study involves single ascending doses, with participants monitored for adverse events and therapeutic outcomes over an extended period.

Reasons To Buy This Report

The Knee Osteoarthritis Drug Report provides a strategic overview of the latest and future landscape of treatments for knee osteoarthritis. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into market trends, regulatory environments, and potential growth opportunities within the knee osteoarthritis pipeline insights.

Key Questions Answered in the Knee Osteoarthritis - Pipeline Insight Report

  • What is the current landscape of knee osteoarthritis pipeline drugs?
  • Which companies/institutions are developing knee osteoarthritis emerging drugs?
  • How many phase II drugs are currently present in knee osteoarthritis pipeline drugs?
  • Which company is leading the knee osteoarthritis pipeline development activities?
  • What is the current knee osteoarthritis therapeutic assessment?
  • What are the opportunities and challenges present in the knee osteoarthritis drug pipeline landscape?
  • What is the efficacy and safety profile of knee osteoarthritis pipeline drugs?
  • Which companies/institutions are involved in knee osteoarthritis collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in knee osteoarthritis?

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Table of Contents

1 Preface
1.1 Introduction
1.2 Objectives of the Study
1.3 Research Methodology & Assumptions
2 Executive Summary
3 Overview of Knee Osteoarthritis
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Types of Knee Osteoarthritis
3.5 Diagnosis
3.6 Treatment
4 Patient Profile: Knee Osteoarthritis
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Knee Osteoarthritis: Epidemiology Snapshot
5.1 Knee Osteoarthritis Incidence by Key Markets
5.2 Knee Osteoarthritis - Patients Seeking Treatment in Key Markets
6 Knee Osteoarthritis: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Knee Osteoarthritis: Key Facts Covered
7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
7.2 Top Countries Contributing to Clinical Trials in Europe
7.3 Top Countries Contributing to Clinical Trials in North America
7.4 Top Countries Contributing to Clinical Trials in Other Regions
8 Knee Osteoarthritis, Drug Pipeline Assessment
8.1 Assessment by Treatment Type
8.2 Assessment by Route of Administration
8.3 Assessment by Drug Class
9 Drug Pipeline Comparative Analysis
9.1 List of Knee Osteoarthritis Pipeline Drugs
9.1.1 By Company
9.1.2 By Phase
9.1.3 By Indication
9.1.4 By Trial Status
9.1.5 By Funder Type
9.2 Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
10 Knee Osteoarthritis Drug Pipeline - Mid-Stage Products (Phase III & IV) (Top Drugs)
10.1 Comparative Analysis for Mid-Stage Drugs
10.1.1 Study Type
10.1.2 Recruitment Status
10.1.3 Company
10.1.4 Funder Type
10.2 Product Level Analysis*
10.2.1 Drug: TG-C
10.2.1.1 Product Description
10.2.1.2 Trial ID
10.2.1.3 Sponsor Name
10.2.1.4 Study Type
10.2.1.5 Drug Class
10.2.1.6 Eligibility Criteria
10.2.1.7 Study Record Dates
10.2.1.7.1 First Submitted
10.2.1.7.2 First Posted
10.2.1.7.3 Last Update Posted
10.2.1.7.4 Last Verified
10.2.1.8 Indication
10.2.1.9 Study Design
10.2.1.10 Recruitment Status
10.2.1.11 Enrollment (Estimated)
10.2.1.12 Location Countries
10.2.1.13 Recent Results
10.2.2 Drug: KiOmedine CM-Chitosan
10.2.3 Other Drugs
11 Knee Osteoarthritis Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
11.1 Comparative Analysis for Mid-Stage Drugs
11.1.1 Study Type
11.1.2 Recruitment Status
11.1.3 Company
11.1.4 Funder Type
11.2 Product Level Analysis*
11.2.1 Drug: BM-MSCs
11.2.1.1 Product Description
11.2.1.2 Trial ID
11.2.1.3 Sponsor Name
11.2.1.4 Study Type
11.2.1.5 Drug Class
11.2.1.6 Eligibility Criteria
11.2.1.7 Study Record Dates
11.2.1.7.1 First Submitted
11.2.1.7.2 First Posted
11.2.1.7.3 Last Update Posted
11.2.1.7.4 Last Verified
11.2.1.8 Indication
11.2.1.9 Study Design
11.2.1.10 Recruitment Status
11.2.1.11 Enrollment (Estimated)
11.2.1.12 Location Countries
11.2.1.13 Recent Results
11.2.2 Drug: QUC398
11.2.3 Other Drugs
12 Knee Osteoarthritis Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
12.1 Comparative Analysis for Early-Stage Drugs
12.1.1 Study Type
12.1.2 Recruitment Status
12.1.3 Company
12.1.4 Funder Type
12.2 Product Level Analysis*
12.2.1 Drug: FX201
12.2.1.1 Product Description
12.2.1.2 Trial ID
12.2.1.3 Sponsor Name
12.2.1.4 Study Type
12.2.1.5 Drug Class
12.2.1.6 Eligibility Criteria
12.2.1.7 Study Record Dates
12.2.1.7.1 First Submitted
12.2.1.7.2 First Posted
12.2.1.7.3 Last Update Posted
12.2.1.7.4 Last Verified
12.2.1.8 Indication
12.2.1.9 Study Design
12.2.1.10 Recruitment Status
12.2.1.11 Enrollment (Estimated)
12.2.1.12 Location Countries
12.2.2 Drug: GNSC-001
12.2.3 Other Drugs
13 Knee Osteoarthritis, Key Drug Pipeline Companies
13.1 Novartis Pharmaceuticals
13.1.1 Company Snapshot
13.1.2 Pipeline Product Portfolio
13.1.3 Financial Analysis
13.1.4 Recent News and Developments
13.2 Paradigm Biopharmaceuticals Inc.
13.2.1 Company Snapshot
13.2.2 Pipeline Product Portfolio
13.2.3 Financial Analysis
13.2.4 Recent News and Developments
13.3 Pacira Pharmaceuticals, Inc.
13.3.1 Company Snapshot
13.3.2 Pipeline Product Portfolio
13.3.3 Financial Analysis
13.3.4 Recent News and Developments
13.4 Kolon TissueGene, Inc.
13.4.1 Company Snapshot
13.4.2 Pipeline Product Portfolio
13.4.3 Financial Analysis
13.4.4 Recent News and Developments
13.5 Taiwan Bio Therapeutics Inc.
13.5.1 Company Snapshot
13.5.2 Pipeline Product Portfolio
13.5.3 Financial Analysis
13.5.4 Recent News and Developments
13.6 Genascence Corporation
13.6.1 Company Snapshot
13.6.2 Pipeline Product Portfolio
13.6.3 Financial Analysis
13.6.4 Recent News and Developments
13.7 Orient Europharma Co., Ltd.
13.7.1 Company Snapshot
13.7.2 Pipeline Product Portfolio
13.7.3 Financial Analysis
13.7.4 Recent News and Developments
13.8 Xindu Pty Ltd.
13.8.1 Company Snapshot
13.8.2 Pipeline Product Portfolio
13.8.3 Financial Analysis
13.8.4 Recent News and Developments
13.9 Kiomed Pharma
13.9.1 Company Snapshot
13.9.2 Pipeline Product Portfolio
13.9.3 Financial Analysis
13.9.4 Recent News and Developments
13.10 Organogenesis
13.10.1 Company Snapshot
13.10.2 Pipeline Product Portfolio
13.10.3 Financial Analysis
13.10.4 Recent News and Developments
14 Regulatory Framework for Drug Approval, By Region15 Terminated or Suspended Pipeline Products