The gene therapy market is projected to grow at an annualized rate of 30%, {till 2030}

Roots Analysis has done a detailed study on Gene Therapy Market (4th Edition), 2020-2030, covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

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Key Market Insights

§  The gene therapy market is characterized by a healthy drug pipeline, with 10 approved molecules and over 820 product candidates being evaluated for the treatment of multiple disease indications, worldwide

§  Most of the contemporary therapeutic leads are currently in the early stages of clinical development; a variety of viral and non-viral vectors are being used across different therapeutic approaches for gene therapies

§  Around 400 gene therapy focused clinical trials have been registered across the globe; most of these trials are evaluating the therapies for the treatment of oncological indications

§  In order to tap into the lucrative opportunity offered by gene therapies, big pharma players have adopted various approaches, from proprietary product development to strategic investments

§  Several patents related to gene therapies and affiliated technologies have been filed / granted; the value of this intellectual capital is being realized through both licensing agreements and marketing exclusivity

§  In the recent past, a considerable increase in the M&A activity has been observed among industry stakeholders; this trend can be attributed to the ongoing capability / portfolio consolidation efforts of involved players

§  Foreseeing a lucrative return, many public and private investors have made investments worth over USD 25 billion, across more than 350 instances, in the period between 2015 and 2020

§  Case Study: CMOs offering vector manufacturing services have become an integral part of the gene therapy supply chain, owing to their ability to overcome the associated challenges

§  Treatment cost is one of the major concerns in this market; we anticipate more affordable pricing and reimbursement strategies to evolve in due course

§  Prevalent trends indicate that the demand for gene therapies is poised to grow significantly as more late-stage therapies get commercialized in the short team using different vectors and type of therapies

§  The projected future opportunity is expected to be distributed across different therapeutic areas, types of therapies, types of therapeutic approaches, routes of administrations and key geographical regions

§  To monetize the full potential, stakeholders are already actively exploring diverse commercialization strategies, across different stages of a product’s launch cycle

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Table of Contents

1.         PREFACE
1.1.       Scope of the Report
1.2.       Research Methodology
1.3.       Key Questions Answered

1.4.       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 Therapies

3.3.2.    Ex Vivo and In Vivo Therapies

3.4.       Routes of Administration

3.5.       Mechanism of Action of Gene Therapies

3.6.       Overview of the Basic Concepts of Gene Editing

3.6.1.    Evolution of Genome Editing

3.6.2.    Applications of Genome Editing

3.6.3.    Genome Editing Techniques

3.7.       Advantages and Disadvantages of Gene Therapies

3.8.       Ethical and Social Concerns Related to Gene Therapies

3.9.       Constraints and Challenges Related to Gene Therapies

3.9.1.    Therapy Development Concerns

3.9.2.    Manufacturing Concerns

3.9.3.    Commercial Viability Concerns

4.         GENE DELIVERY VECTORS
4.1.       Chapter Overview

4.2.       Viral and Non-Viral Methods of Gene Transfer

4.3.       Viral Vectors for Genetically Modified Therapies

4.4.       Types of Viral Vectors

4.4.1.    Adeno-associated Viral Vectors

4.4.1.1. Overview

4.4.1.2. Design and Manufacturing

4.4.1.3. Advantages

4.4.1.4. Limitations

4.4.2.    Adenoviral Vectors

4.4.2.1. Overview

4.4.2.2. Design and Manufacturing

4.4.2.3. Advantages

4.4.2.4. Limitations

4.4.3.    Lentiviral Vectors

4.4.3.1. Overview

4.4.3.2. Design and Manufacturing

4.4.3.3. Advantages

4.4.3.4. Limitations

4.4.4.    Retroviral Vectors

4.4.4.1. Overview

4.4.4.2. Design and Manufacturing

4.4.4.3. Advantages

4.4.4.4. Limitations

4.4.5.    Other Viral Vectors

4.4.5.1. Alphavirus

4.4.5.2. Foamy Virus

4.4.5.3. Herpes Simplex Virus

4.4.5.4. Sendai Virus

4.4.5.5. Simian Virus

4.4.5.6. Vaccinia Virus

4.5.       Types of Non-Viral Vectors

4.5.1.    Plasmid DNA

4.5.2.    Liposomes, Lipoplexes and Polyplexes

4.5.3.    Oligonucleotides

4.5.4.    Other Non-Viral Vectors

4.5.5.    Gene Delivery Using Non-Viral Vectors

4.5.5.1. Biolistic Methods

4.5.5.2. Electroporation

4.5.5.3. Receptor Mediated Gene Delivery

4.5.5.4. 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.    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

5.4.5.    Hong Kong Scenario

5.5.       Reimbursement Scenario

5.5.1.    Challenges Related to Reimbursement

5.6.       Commonly Offered Payment Models for Gene Therapies

6.         MARKET OVERVIEW
6.1.       Chapter Overview

6.1.1.    Analysis by Phase of Development of Gene Therapy

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 Therapeutic Approach

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 Phase 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 Therapeutic Approach

6.3.6.    Analysis by Type of Gene Therapy

6.2.7.    Analysis by Route of Administration

6.4.       Gene Therapy Candidates: Special Designations

6.4.1.    Analysis by Special Designation(s) Awarded

6.5.       Grid Representation: Analysis by Phase of Development, Therapeutic Area and Therapeutic Approach

7.         COMPETITIVE LANDSCAPE 
7.1.       Chapter Overview

7.2.       Gene Therapy Market: List of Developers

7.2.1.    Analysis by Year of Establishment

7.2.2.    Analysis by Company Size

7.2.3.    Analysis by Geography

7.3.       Key Players: Analysis by Number of Product Candidates 

8.         MARKETED GENE THERAPIES
8.1.       Chapter Overview

8.2.       Gendicine® (Shenzhen Sibiono GeneTech)

8.2.1.    Company Overview

8.2.2.    Development Timeline

8.2.3.    Mechanism of Action and Vectors Used

8.2.4.    Target Indication(s)

8.2.5.    Current Status of Development

8.2.6.    Manufacturing, Dosage and Sales

8.3.       Oncorine® (Shanghai Sunway Biotech)

8.3.1.    Company Overview

8.3.2.    Development Timeline

8.3.3.    Mechanism of Action and Vectors Used

8.3.4.    Target Indication(s)

8.3.5.    Current Status of Development

8.3.6.    Manufacturing, Dosage and Sales

8.4.       Rexin-G® (Epeius Biotechnologies)

8.4.1.    Company Overview

8.4.2.    Development Timeline

8.4.3.    Mechanism of Action and Vector Used

8.4.4.    Target Indication(s)

8.4.5.    Current Status of Development

8.4.6.    Manufacturing, Dosage and Sales

8.5.       Neovasculgen® (Human Stem Cells Institute)

8.5.1.    Company Overview

8.5.2.    Development Timeline

8.5.3.    Mechanism of Action and Vectors Used

8.5.4.    Target Indication(s)

8.5.5.    Current Status of Development

8.5.6.    Manufacturing, Dosage and Sales

8.6.       Imlygic® (Amgen)

8.6.1.    Company Overview

8.6.2.    Development Timeline

8.6.3.    Mechanism of Action and Vectors Used

8.6.4.    Target Indication(s)

8.6.5.    Current Status of Development

8.6.6.    Manufacturing, Dosage and Sales

8.7.       Strimvelis® (Orchard Therapeutics)

8.7.1.    Company Overview

8.7.2.    Development Timeline

8.7.3.    Mechanism of Action and Vectors Used

8.7.4.    Target Indication(s)

8.7.5.    Current Status of Development

8.7.6.    Manufacturing, Dosage and Sales

8.8.       Luxturna™ (Spark Therapeutics)

8.8.1.    Company Overview

8.8.2.    Development Timeline

8.8.3.    Mechanism of Action and Vector Used

8.8.4.    Target Indication(s)

8.8.5.    Current Status of Development

8.8.6.    Manufacturing, Dosage and Sales

8.9.       Zolgensma™ (Novartis Gene Therapies)

8.9.1.    Company Overview

8.9.2.    Development Timeline

8.9.3.    Mechanism of Action and Vector Used

8.9.4.    Target Indication(s)

8.9.5.    Current Status of Development

8.9.6.    Manufacturing, Dosage and Sales

8.10.     Collategene® (AnGes)

8.10.1.  Company Overview

8.10.2.  Development Timeline

8.10.3.  Mechanism of Action and Vector Used

8.10.4.  Target Indication(s)

8.10.5.  Current Status of Development

8.10.6.  Manufacturing, Dosage and Sales

8.11.     Zyntelgo™ (bluebird bio)

8.11.1.  Company Overview

8.11.2.  Development Timeline

8.11.3.  Mechanism of Action and Vector Used

8.11.4.  Target Indication(s)

8.11.5.  Current Status of Development

8.11.6.  Manufacturing, Dosage and Sales

9.         KEY COMMERCIALIZATION STRATEGIES
9.1.       Chapter Overview

9.2.       Successful Drug Launch Strategy: ROOTS Framework

9.3.       Successful Drug Launch Strategy: Product Differentiation

9.4.       Commonly Adopted Commercialization Strategies based on Phase of Development of Product

9.5.       List of Currently Approved Gene Therapies

9.6.       Key Commercialization Strategies Adopted by Companies Focused on Gene Therapy

9.6.1.    Strategies Adopted Before Therapy Approval

9.6.2.    Strategies Adopted During / Post Therapy Approval

9.7.       Concluding Remarks

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com