Cell and Gene Therapies in Gastrointestinal Disorders – Therapeutic Analysis, Treatment Options, Pricing and Reimbursement and Future Market

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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.

Scope

– Alcohol consumption is one of the first focal points for changed behavior when consumers seek to pursue healthier lifestyles.

– Half of drinkers globally state they are often or always influenced in their product choice by how an alcoholic beverage impacts their health and wellbeing.

– More than two thirds of alcohol consumers find products that have been fortified with added nutrients to be somewhat or very appealing.

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.

TaTakeda Pharmaceutical
Anterogen
GlaxoSmithKline (GSK)
AstraZeneca
Alnylam Pharmaceuticals
Mesoblast
Shanghai Hexaell Biotech
Pharmicell
LyGenesis
Resolution Therapeutics
Avobis Bio
DK-001

Table of Contents

Table of Contents (PowerPoint Deck)

1. Preface

1.1. Contents

1.2. Abbreviations

1.3. Related Reports

2. Executive Summary

3. Current Treatment Options

3.1. What is Cell & Gene Therapy?

3.2. History of the Development of CGT in GI Disorders

3.3. Marketed Product Profiles – Cell Therapy

3.4. Challenges and Opportunities in CGT in GI Disorders

4. Pricing and Reimbursement Assessment

4.1. Price of Cell Therapy

4.2. Pricing and Reimbursement Case Study: Alofisel

5. Regulations

5.1. Regulation of CGTs in the 8MM

6. Future Market Assessment

6.1. Top 20 GI Disorders with CGT Development

6.2. Top Five GI Disorders with the Most CGT Pipeline Assets

6.3. Top Five GI Disorders Stratified by Molecule Type

6.4. CGT in GI Disorders – Phase III and II/III

6.5. Additional Players Expected to Join the Competition Within Five Years

6.6. Industry Trends in the Application of CGTs in GI Disorders

6.7. Most of CGT Market Catalyst is Concentrated in 2024

7. Likelihood of Approval and Phase – Transition Success Rate Analysis

7.1. CGT Candidates Have Lower Than Average LoA and PTSR

8. Sales Forecast

8.1. Sales are forecast to reach $187 million by 2030

9. Appendix

9.1. Methodology

9.2. Primary Research: Key Opinion Leader Information

9.3. About the Authors

10. Contact Us

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