Gene Therapy in Oncology – Thematic Research

Gene therapy describes the treatment of various cancers with the use of in vivo treatments: viral and non-viral gene therapy products, therapeutic oligonucleotides, oncolytic viruses and genome editing therapies. There are currently just 3 gene therapies marketed for oncology indications in the eight major pharmaceutical markets (8MM) (US, France, Germany, Italy, Spain, UK, Japan, and China). Oncolytic viruses lead the category with 2 products, followed by viral vector gene therapies with 1 approved drug.

Gene therapies are in development for melanoma and other various solid tumors. As of April 2021, there are 252 clinical trials investigating in vivo gene therapies across the 8MM with 81 drugs in development.

Sales of products that comprise the categories of in vivo gene therapy are forecast to reach over $7B by 2027. The therapeutic oligonucleotide market, which will be galvanized by the success of COVID-19 messenger ribonucleic acid (mRNA) vaccines, is forecast to reach $4.5B by 2027 globally.

KEY QUESTIONS ANSWERED

– What are the late-stage gene therapy pipeline agents in development for cancer? Which class of gene therapy drugs will have the highest peak sales, and why?

– What are the current unmet needs that gene therapies can address in the treatment of cancer? What are the opportunities for R&D?

– How is the field of gene therapy going to move forward? Which technologies are the most promising for combinations?

– What is the regulatory landscape for gene therapies in the US, the 5EU, Japan and China?

Scope

Overview of gene therapy including classification of therapy and technologies, regulatory and market access details, product & company profiles.

Quotes from US- and 5EU-based key opinion leaders and researchers.

Key topics covered for gene therapy in oncology in the 8MM include trends, value chain, market analysis, opportunities, challenges and unmet needs and high-value deals.

Pipeline analysis: Comprehensive data split across different phases and indications, emerging novel trends under development, and analysis of the most promising late-stage pipeline drugs for classes of gene therapy (Phase III and pre-registration).

Analysis of the key dynamics of the gene therapy market. Insightful review of the key industry drivers and challenges. Deals and R&D strategies covered in detail to highlight business opportunities.

Key Highlights

The main drivers of growth include significant industrial investment in the field, as well as regulatory bodies’ recognition of gene therapy potential by creating specialized designations for gene therapy products.

The main barriers to growth include market access issues such as high cost of therapy/lack of reimbursement and lack of expertise as well as clinical issues such as safety concerns.

The most important unmet needs in the oncology gene therapy market include high cost of therapy, improving the safety of delivery systems and providing a valid treatment option to treat several cancer types.

The 8MM have set up programs to expedite gene therapy approvals, especially when they address an unmet need or are targeting orphan indications.

Reasons to buy

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current deals and technologies to identify companies with the highest potential.

Develop business strategies by understanding the trends shaping and driving the global oncology gene therapy market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global oncology gene therapy market in the future.

Design your development strategy through a review of potential novel targets or combinations across indications.

Understand the challenges and strategies impacting the development of oncology gene therapy agents in preclinical studies and clinical trials.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Organize your sales and marketing efforts by identifying the classes of gene therapy and indications that present maximum opportunities for consolidations, investments and strategic partnerships.

Companies mentioned

Amgen

SiBiono

Sunway Biotech

Candel

CG Oncology

Checkmate

Daiichi Sankyo

Ferring

FKD

Geron

Idera

Istari

VBL

Table of Contents

Table of Contents (PowerPoint Deck)

1. Preface

1.1. Table of Contents

1.2. Abbreviations

1.3. Related Reports

2. Executive Summary

2.1. Key Findings

3. Gene Therapy Overview

3.1. What is Gene Therapy?

3.2. History of Gene Therapy Development in Cancer in the 8MM

3.3. Key Twitter Chat

4. Trends

4.1. Industry Trends – Gene Therapy Vectors

4.2. Industry Trends – Therapeutic Oligonucleotides

4.3. Industry Trends – Genome Editing

4.4. Industry Trends – Oncolytic Viruses

4.5. Regulatory Trends

5. Value Chain

5.1. Gene Therapy Value Chain

5.2. Gene Therapy Vectors

5.3. Therapeutic Oligonucleotides

5.4. Genome Editing

5.5. Oncolytic Viruses

5.6. Gene Therapy in Oncology Clinical Trials

6. Marketed Products

6.1. Marketed Gene Therapy Products for Cancer in the 8MM

6.2. Leading Gene Therapy Treatments in The 8MM

7. Pipeline Products

7.1. Gene Therapy Pipeline Products in the 8MM

7.2. Gene Therapy Pipeline Candidates

7.3. Late Stage Gene Therapy Candidates, 8MM

8. Market Analysis and Deals

8.1. Gene Therapy Market Analysis and Forecast by Class of Therapy

8.2. Top 10 Transaction Deals by Size during 2012-2021 in the Oncology Gene Therapy Space

8.3. Latest Transaction Deals in the Oncology Gene Therapy Space

8.4. Mergers and Acquisitions That Include Oncology Gene Therapy Assets: 2019 – 2021

8.5. Mergers and Acquisitions That Include Oncology Gene Therapy Assets: 2014 – 2018

9. Regulatory and Market Access

9.1. Gene Therapy in Clinical Trials

9.2. Regulatory – US

9.3. Market Access – US

9.4. Regulatory – Europe

9.5. Market Access – Europe

9.6. Regulation of Gene Therapy in the US and Europe

9.7. Regulatory and Market Access – Japan

9.8. Comparison of Early Access Schemes in the US, EU, and Japan

9.9. Regulatory and Market Access – China

10. Opportunities, Challenges, and Unmet Needs

10.1. Gene Therapy Vectors, Viral – Opportunities & Challenges

10.2. Gene Therapy Vectors, Non-viral – Opportunities & Challenges

10.3. Therapuetic Oligonucleotides – Opportunities & Challenges

10.4. Genome Editing – Opportunities & Challenges

10.5. Oncolytic Viruses – Opportunities & Challenges

10.6. Clinical Unmet Needs in Gene Therapy – Gap Analysis

10.7. Commercial Unmet Needs in Gene Therapy – Gap Analysis

10.8. Unmet Needs – KOLs Perspective

11. Companies

11.1. Drug Development Scorecard – Regenerative Medicine

11.2. Current Major Players

11.2.1. Amgen

11.2.2. SiBiono

11.2.3. Sunway Biotech

11.3. Future Players Based on Pipeline Strength

11.3.1. Candel

11.3.2. CG Oncology

11.3.3. Checkmate

11.3.4. Daiichi Sankyo

11.3.5. Ferring

11.3.6. FKD

11.3.7. Geron

11.3.8. Idera

11.3.9. Istari

11.3.10. VBL

12. Appendix

12.1. Bibliography

12.2. Primary Research

12.3. Key Themes Impacting the Pharmaceutical Industry

12.4. Our Thematic Research Methodology

12.5. About the Authors

12.6. Contact Us

12.7. Disclaimer

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