Summary

KEY INSIGHTS
INVOSSA is a groundbreaking cell and gene therapy designed to treat knee osteoarthritis with a single intra-articular injection. Clinical trials conducted in the United States and globally have demonstrated that INVOSSA can significantly relieve pain, improve mobility, and potentially slow osteoarthritis progression while enhancing joint structure.
As an allogeneic, off-the-shelf therapy, it presents a promising alternative to traditional osteoarthritis treatments and surgeries, potentially postponing the need for multiple surgical procedures. Developed by Kolon TissueGene Inc, Phase II clinical trials in the US showed sustained improvements in pain and function over two years. The company is now preparing for a national Phase III clinical trial in the US to further confirm these results and support the drug's potential advantages.
Kolon TissueGene Inc, a biopharmaceutical company based in Maryland, the United States, was founded in June 1999. Specializing in the development of cell and gene therapies, the company focuses on treating orthopedic diseases and degenerative disorders. Its therapies are designed to improve quality of life by reducing pain, enhancing function, and slowing disease progression. Over the past 20 years, Kolon TissueGene has developed a unique technology platform aimed at regenerating cartilage, bone, discs, and nerves.
MARKET POTENTIAL AND POSITIONING
INVOSSA is strategically positioned as a groundbreaking cell and gene therapy for knee osteoarthritis (OA), offering a major advancement over traditional treatments. As a first-in-class therapy, it delivers long-lasting pain relief and improved mobility through a single intra-articular injection. Clinical trials in the United States and globally have shown its ability to not only ease symptoms but also potentially slow disease progression and enhance joint structure.
This allogeneic, off-the-shelf therapy presents a less invasive alternative to surgery and conventional treatments, with the potential to delay the need for multiple surgical interventions. Kolon TissueGene's recent completion of a Phase III trial, along with efforts to secure a disease-modifying osteoarthritis drug (DMOAD) designation from the US FDA, strengthens INVOSSA's status as a pioneering treatment. Its approval in South Korea and ongoing progress in the United States underscore its global potential and its impact on future OA treatment strategies.
REGIONAL ANALYSIS
Inkwood Research offers an analysis of seven key markets:
• United States
• Germany
• France
• United Kingdom
o Osteoarthritis (OA) is a major public health issue in the United Kingdom, especially with the aging population. According to the National Institute for Healthcare and Excellence (NICE) Clinical Knowledge Summaries, approximately 10 million people in the UK are affected by osteoarthritis, with around 5.4 million specifically experiencing knee osteoarthritis.
o The condition is more common in women than in men and is the leading cause of pain and disability in the UK. Osteoarthritis places a significant burden on those affected, limiting their ability to work, participate in social activities, and maintain a good quality of life.
• Italy
• Spain
• Japan

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Table of Contents

TABLE OF CONTENTS
1. INTRODUCTION TO THE REPORT
2. INVOSSA OVERVIEW
2.1. PRODUCT DETAIL
2.2. CLINICAL DEVELOPMENT
2.2.1. CLINICAL STUDIES
2.2.2. CLINICAL TRIALS INFORMATION
2.3. OTHER DEVELOPMENTAL ACTIVITIES
2.4. PRODUCT PROFILE
3. COMPETITIVE LANDSCAPE
3.1. MARKETED THERAPIES
3.2. LATE-STAGE EMERGING THERAPIES
4. INVOSSA MARKET ASSESSMENT
4.1. MARKET OUTLOOK OF INVOSSA IN OSTEOARTHRITIS
5. 7 MAJOR MARKET’S ANALYSIS
5.1. MARKET SIZE OF INVOSSA IN THE 7 MAJOR MARKETS FOR OSTEOARTHRITIS
5.2. 7 COUNTRY ANALYSIS
5.2.1. MARKET SIZE OF INVOSSA IN UNITED STATES FOR OSTEOARTHRITIS
5.2.2. MARKET SIZE OF INVOSSA IN GERMANY FOR OSTEOARTHRITIS
5.2.3. MARKET SIZE OF INVOSSA IN FRANCE FOR OSTEOARTHRITIS
5.2.4. MARKET SIZE OF INVOSSA IN ITALY FOR OSTEOARTHRITIS
5.2.5. MARKET SIZE OF INVOSSA IN SPAIN FOR OSTEOARTHRITIS
5.2.6. MARKET SIZE OF INVOSSA IN UNITED KINGDOM FOR OSTEOARTHRITIS
5.2.7. MARKET SIZE OF INVOSSA IN JAPAN FOR OSTEOARTHRITIS
6. SWOT ANALYSIS
7. ANALYST PERSPECTIVE