Cell & Gene Therapies in Dermatology Disorders: Therapeutic Analysis
Summary
Currently, there are only two cell and gene therapies (CGTs) on the market across all gastroenterology (GI) indications. Anterogen’s Cupistem, indicated for the treatment of anal fistula in adult patients, was the first adipose tissue-derived mesenchymal stem cell (ASC) asset to receive approval in the GI market in Japan, 2012. This was followed by Takeda Pharmaceutical’s Alofisel (darvadstrocel), which received approval from the European Medicines Agency (EMA) in 2018 and from Japan’s Pharmaceuticals and Medical Devices Agency (PDMA) in 2021. However, on December 13th, 2024, the EMA announced the withdrawal of Alofisel (darvadstrocel) from the EU market citing lack of data that demonstrated the benefit of this therapy in Crohn’s fistulas.Both marketed therapies are prescribed when a patient has shown an inadequate response to at least one conventional or biologic therapy.
Reasons to Buy
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the CGT in Gastrointestinal market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact Gastrointestinal disease targeting CGT therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counterstrategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.
- 1. Preface
- 1.1. Contents
- 1.2. Abbreviations
- 1.3. Related Reports
- 2. Executive Summary
- 3. Introduction and Scope
- 4. Current Treatment Options
- 4.1. What is Cell & Gene Therapy?
- 4.2. History of the Development of CGT in Dermatology Disorders
- 4.3. Marketed Product Profiles – Cell and Gene Therapy
- 4.4. Challenges and Opportunities in CGT in Dermatology Disorders
- 5. Pricing and Reimbursement Assessment
- 5.1. High Cost of CGTs Requires Adaptation of Payment Models to Ensure Affordability and Patient Access
- 5.2. Price of Cell Therapy
- 6. Regulations
- 6.1. Regulation of CGTs in the 8MM
- 7. Future Market Assessment
- 7.1. Top 20 Dermatology Disorders with CGT Development
- 7.2. Top Five Dermatology Disorders with the Most CGT Pipeline Assets
- 7.3. Top Five Dermatology Disorders Stratified by Molecule Type
- 7.4. CGT in Dermatology Disorders – Pre-reg and Phase II/III
- 7.5. Additional Players Expected to Join the Competition Within Five Years
- 7.6. Industry Trends in the Application of CGTs in Dermatology Disorders
- 7.7. Most of CGT Market Catalyst is Concentrated in 2025
- 8. Likelihood of Approval and Phase - Transition Success Rate Analysis
- 8.1. CGT Candidates Have Higher LoA and PTSR vs. Indication Benchmarks
- 9. Sales Forecast
- 9.1. Sales are forecast to reach $1.5 billion by 2030
- 10. Appendix
- 10.1. Methodology
- 10.2. Primary Research: Key Opinion Leader Information
- 10.3. About the Authors
- 11. Contact Us
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