DUBLIN--(BUSINESS WIRE)--The "Gene Therapy Market by Type of Therapy, Type of Gene Delivery Method Used, Type of Vector Used, Target Therapeutic Areas, Route of Administration, and Key Geographical Regions: Industry Trends and Global Forecasts, 2022-2035" report has been added to ResearchAndMarkets.com's offering.

Gene Therapy Market (5th Edition) report features an extensive study of the current market landscape and the likely future potential associated with the gene therapy market, primarily focusing on gene augmentation-based therapies, oncolytic viral therapies, immunotherapies and gene editing therapies.

One of the key objectives of the report was to estimate the existing market size and the future opportunity associated with gene therapies, over the next decade. Based on multiple parameters, such as target patient population, likely adoption rates and expected pricing, we have provided informed estimates on the evolution of the market for the period 2022-2035.

Over the last two decades, there have been several breakthroughs related to the development of gene therapies. In 2020, LibmeldyT, an ex vivo gene therapy received approval for the treatment of metachromatic leukodystrophy. To provide more context, the treatment regimen of such therapies, encompassing gene replacement and gene-editing modalities, is aimed at correction of the mutated gene in patients using molecular carriers (viral and non-viral vectors).

Further, post the onset of the COVID-19 pandemic, there has been a steady increase in the investigational new drug (IND) applications filed for cell and gene therapies. In fact, in 2021, more than 200 gene therapies were being evaluated in phase II and III studies. Moreover, in 2022, six gene therapies are expected to receive the USFDA market approval. Promising results from ongoing clinical research initiatives have encouraged government and private firms to make investments to support therapy product development initiatives in this domain.

In 2021 alone, gene therapy developers raised around USD 9.5 billion in capital investments. Taking into consideration the continuous progress in this domain, gene therapies are anticipated to be used for the treatment of 1.1 million patients suffering from a myriad of disease indications, by 2035.

Presently, more than 250 companies are engaged in the development of various early and late-stage gene therapies, worldwide. In recent years, there has been a significant increase in the integration of novel technologies, such as gene modification, gene-editing, genome sequencing and manipulation technologies (molecular switches), in conjugation with gene delivery methods.

For instance, the CRISPR-Cas9 based gene-editing tool is one of the remarkable technological advancements, which enables the precise alteration of the transgene. It is worth mentioning that the new generation delivery platforms, including nanoparticles and hybrid vector systems, have been demonstrated to be capable of enabling effective and safe delivery of gene based therapeutics.

Further, a variety of consolidation efforts are currently ongoing in this industry. Such initiatives are primarily focused on expanding and strengthening the existing development efforts; this can be validated from the fact that 56% of the total acquisitions reported in the domain were focused on drug class consolidation.

Driven by the collective and consistent efforts of developers and the growing demand for a single dose of effective therapeutic, the gene therapy market is anticipated to witness significant growth in the foreseen future.

Key Questions Answered

Key Topics Covered:

1. PREFACE

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 Therapies

3.3.2. Ex Vivo and In Vivo Gene Therapies

3.4. Routes of Administration

3.5. Mechanism of Action

3.6. Overview of Gene Editing

3.6.1. Evolution of Genome Editing

3.6.2. Applications of Genome Editing

3.6.3. Available Genome Editing Techniques

3.7. Advantages and Disadvantages of Gene Therapies

3.7.1 Ethical and Social Concerns Related to Gene Therapies

3.7.2. Constraints and Challenges Related to Gene Therapies

3.7.3. Therapy Development Concerns

3.7.4. Manufacturing Concerns

3.7.5. 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

4.5. Types of Non-Viral Vectors

5. REGULATORY LANDSCAPE AND REIMBURSEMENT SCENARIO

5.1. Chapter Overview

5.2. Regulatory Guidelines in North America

5.3. Regulatory Guidelines in Europe

5.4. Regulatory Guidelines in Asia-Pacific

5.5. Reimbursement Scenario

5.6. Commonly Offered Payment Models for Gene Therapies

6. MARKET OVERVIEW

6.1. Chapter Overview

6.2. Gene Therapy Market: Clinical and Commercial Pipeline

6.3. Gene Therapy Market: Early-Stage Pipeline

6.4. Gene Therapy Market: Special Drug Designations

6.5. Analysis by Phase of Development, Therapeutic Area and Type of Therapy (Grid Representation)

7. COMPETITIVE LANDSCAPE

7.1. Chapter Overview

7.2. Gene Therapy Market: List of Developers

7.3. Key Players: Analysis by Number of Pipeline Candidates

8. MARKETED GENE THERAPIES

8.1. Chapter Overview

8.2. Gendicine (Shenzhen Sibiono GeneTech)

8.3. Oncorine (Shanghai Sunway Biotech)

8.4. Rexin-G (Epeius Biotechnologies)

8.5. Neovasculgen (Human Stem Cells Institute)

8.6. Imlygic (Amgen)

8.7. Strimvelis (Orchard Therapeutics)

8.8. LuxturnaT (Spark Therapeutics)

8.9. ZolgensmaT (Novartis)

8.10. Collategene (AnGes)

8.11. ZyntelgoT (bluebird bio)

8.12. LibmeldyT (Orchard Therapeutics)

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 Gene Therapy Developers

9.6.1. Strategies Adopted Before Therapy Approval

9.6.1.1. Participation in Global Events

9.6.1.2. Collaboration with Stakeholders and Pharmaceutical Firms

9.6.1.3. Indication Expansion

9.6.2. Strategies Adopted During/Post Therapy Approval

9.6.2.1. Geographical Expansion

9.6.2.2. Participation in Global Events

9.6.2.3. Patience Assistance Programs

9.6.2.4. Awareness through Product Websites

9.6.2.5. Collaboration with Stakeholders and Pharmaceutical Firms

9.7. Concluding Remarks

10. LATE STAGE (PHASE II/III AND ABOVE) GENE THERAPIES

10.1. Chapter Overview

10.2. Lumevoq (GS010): Information on Dosage, Mechanism of Action, Clinical Trials and Clinical Trial Results

10.3. OTL-103

10.4. PTC-AADC

10.5. BMN 270

10.6. rAd-IFN/Syn3

10.7. beti-cel

10.8. eli-cel

10.9. lovo-cel

10.10. SRP-9001

10.11. EB-101

10.12. ProstAtak

10.13. D-Fi

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Gene Therapy Market Research Report 2022 - ResearchAndMarkets.com - Business Wire

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