- 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 MA 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 therapy 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
- PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines
2. EXECUTIVE SUMMARY
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
- 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
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