The gene therapy market is projected to grow at an annualized rate of 45%, till 2030

Roots Analysis has done a detailed study on Gene Therapy Market (3rd Edition), 2019-2030, covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

 

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Key Market Insights

• In the past four years, more than 31,000 patents related to gene therapies and gene editing have been filed / granted; this is indicative of the heightened pace of research in this domain
• Presently, there are more than 10 approved gene therapies; over 465 product candidates are being evaluated for the treatment of a variety of disease indications
• Most of the therapeutic leads are in the early stages of clinical development; a variety of viral and non-viral vectors are being used to introduce different types of gene modifications in such therapies
• Although start-ups and mid-sized companies are spearheading the innovation, several big biopharmaceutical companies are also actively engaged
• With multiple approved products and several under development, price is one of the major concerns in this market; the future is likely to witness the establishment of more affordable pricing and reimbursement strategies
• As several candidates progress towards approval, developers are exploring diverse commercialization strategies to be implemented across different stages of a product’s launch cycle
• CMOs offering vector manufacturing services have become an integral part of the gene therapy supply chain, owing to their ability to overcome the various associated challenges
• Several investors, having realized the untapped opportunity within this emerging segment of genetic disorders, have invested over USD 16.5 billion across 280 instances, in the period between 2014 and 2019
• Overall, prevalent trends indicate that the market for gene therapies is poised to grow significantly as multiple late stage molecules get commercialized in the near future for the treatment of different therapeutic areas
• The projected future opportunity is expected to be distributed across different types of gene modifications, therapy delivery routes and key geographical regions

 

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Table of Contents

 

1.         PREFACE
1.1.       Scope of the Report
1.2.       Research Methodology
1.3.       Chapter Outlines

2.         EXECUTIVE SUMMARY

 

3.         INTRODUCTION

3.1.       Context and Background

3.2.       Evolution of Gene Therapies

3.3.       Classification of Gene Therapies

3.3.1.    Somatic and Germline Gene Therapy

3.3.2.    Ex Vivo and In Vivo Gene Therapy

3.4.       Routes of Administration

3.5.       Mechanism of Action of Gene Therapies

3.6.       Concept of Gene Editing

3.7.       Advantages and Disadvantages of Gene Therapies

3.8.       Ethical and Social Concerns Related to Gene Therapies

 

3.9.       Future Constraints and Challenges Related to Gene Therapies

3.9.1.    Concerns Related to Therapy Development

3.9.2.    Concerns Related to Manufacturing

3.9.3.    Concerns Related to Commercial Viability

 

4.         GENE DELIVERY VECTORS

4.1.       Chapter Overview

4.2.       Viral Vectors

4.2.1     Types of Viral Vectors

4.2.1.1. Adeno-associated Viral Vectors

4.2.1.1.1. Overview

4.2.1.1.2. Design

4.2.1.1.3. Advantages

4.2.1.1.4. Limitations

 

4.2.1.2. Adenoviral Vectors

4.2.1.2.1. Overview

4.2.1.2.2. Design

4.2.1.2.3. Advantages

4.2.1.2.4. Limitations

 

4.2.1.3. Lentiviral Vectors

4.2.1.3.1. Overview

4.2.1.3.2. Design

4.2.1.3.3. Advantages

4.2.1.3.4. Limitations

 

4.2.1.4. Retroviral Vectors

4.2.1.4.1. Overview

4.2.1.4.2. Design

4.2.1.4.3. Advantages

4.2.1.4.4. Limitations

 

4.2.1.5. Other Viral Vectors

4.2.1.5.1. Alphavirus

4.2.1.5.2. Herpes Simplex Virus

4.2.1.5.3. Simian Virus

4.2.1.5.4. Vaccinia Virus

 

4.3.       Non-Viral Vectors

4.3.1.    Types of Non-Viral Vectors

4.3.1.1. Plasmid DNA

4.3.1.2. Liposomes, Lipoplexes and Polyplexes

4.3.1.3. Oligonucleotides

 

4.4.       Methods of Transfection

4.4.1.    Biolistic Method

4.4.2.    Electroporation

4.4.3.    Receptor Mediated Gene Delivery

4.4.4.    Gene Activated Matrix (GAM)

 

5.         REGULATORY LANDSCAPE AND REIMBURSEMENT SCENARIO

5.1.       Chapter Overview

5.2.       Regulatory Guidelines in North America

5.2.1.    The US Scenario

5.2.2.    The Canadian Scenario

5.3.       Regulatory Guidelines in Europe

5.4.       Regulatory Guidelines in Asia Pacific

5.4.1.    Chinese Scenario

5.4.2.    Japanese Scenario

5.4.3.    South Korean Scenario

5.4.4.    Australian Scenario

5.5.       Reimbursement Scenario

5.5.1.    Challenges Related to Reimbursement

5.6.       Payment Models for Gene Therapies

 

6.         COMPETITIVE LANDSCAPE

6.1.       Chapter Overview

6.2.       Gene Therapy Market: Clinical and Commercial Pipeline

6.2.1.    Analysis by Phase of Development

6.2.2.    Analysis by Therapeutic Area

6.2.3.    Analysis by Type of Vector Used

6.2.4.    Analysis by Type of Gene

6.2.5.    Analysis by Type of Modification

6.2.6.    Analysis by Type of Gene Therapy

6.2.7.    Analysis by Route of Administration

 

6.3.       Gene Therapy Market: Early Stage Pipeline

6.3.1.    Analysis by Stage of Development

6.3.2.    Analysis by Therapeutic Area

6.3.3.    Analysis by Type of Vector Used

6.3.4.    Analysis by Type of Gene

6.3.5.    Analysis by Type of Modification

6.3.6.    Analysis by Type of Gene Therapy

 

6.4.       Gene Therapy: Special Designation Awarded

6.4.1.    Analysis by Special Designation Awarded

6.5.       Key Players: Analysis by Number of Product Candidates

6.6.       Developer Landscape

6.6.1.    Distribution by Year of Establishment

6.6.2.    Distribution by Size of Developer

6.6.3.    Distribution by Geographical Location

6.7.       Regional Landscape

 

7.         MARKETED GENE THERAPIES

7.1.       Chapter Overview

7.2.       Gendicine® (Shenzhen Sibiono GeneTech)

7.2.1.    Company Overview

7.2.2.    Development Timeline

7.2.3.    Mechanism of Action and Vectors Used

7.2.4.    Target Indication(s)

7.2.5.    Current Status of Development

7.2.6.    Manufacturing, Dosage and Sales

 

7.3.       Oncorine® (Shanghai Sunway Biotech)

7.3.1.    Company Overview

7.3.2.    Development Timeline

7.3.3.    Mechanism of Action and Vectors Used

7.3.4.    Target Indication(s)

7.3.5.    Current Status of Development

7.3.6.    Manufacturing, Dosage and Sales

 

7.4.       Rexin-G® (Epeius Biotechnologies)

7.4.1.    Company Overview

7.4.2.    Development Timeline

7.4.3.    Mechanism of Action and Vector Used

7.4.4.    Target Indication(s)

7.4.5.    Current Status of Development

7.4.6.    Manufacturing, Dosage and Sales

 

7.5.       Neovasculgen® (Human Stem Cells Institute)

7.5.1.    Company Overview

7.5.2.    Development Timeline

7.5.3.    Mechanism of Action and Vectors Used

7.5.4.    Target Indication(s)

7.5.5.    Current Status of Development

7.5.6.    Manufacturing, Dosage and Sales

 

7.6.       Imlygic® (Amgen)

7.6.1.    Company Overview

7.6.2.    Development Timeline

7.6.3.    Mechanism of Action and Vectors Used

7.6.4.    Target Indication(s)

7.6.5.    Current Status of Development

7.6.6.    Manufacturing, Dosage and Sales

 

7.7.       Strimvelis® (Orchard Therapeutics)

7.7.1.    Company Overview

7.7.2.    Development Timeline

7.7.3.    Mechanism of Action and Vectors Used

7.7.4.    Target Indication(s)

7.7.5.    Current Status of Development

7.7.6.