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Gene Therapy Market, 2015 - 2025

  • February 2015
  • -
  • Roots Analysis Private Ltd.
  • -
  • 279 pages

INTRODUCTION
Several disorders that arise inside the body are a result of either a direct genetic aberration or a dysfunctional/non-functional protein. The attempt to use nucleic acids to correct or delete the genes causing a particular disease is known as gene therapy. Although gene therapy has not contributed significantly to the global pharmaceutical market yet, it is anticipated to grow at a fast pace over the next decade.
Gendicine, developed by SiBionoGeneTech, was the foremost gene therapy that entered market in 2004 in China. Since then four more therapies have received approval in China, Philippines, Russia and the EU. This number for approved / marketed therapies seems weak at present; however, the strong and highly populated pipeline holds tremendous potential. There are 12 gene therapies in late stage of clinical development for the treatment of cancer, ocular and cardiovascular disorders.
There are several concerns that remain to be answered; examples include insertional mutagenesis, treatment of multigene disorders, curbing the risk of immune reactions, eugenics, high cost of therapy and ethical concerns related to making alterations at the genetic level. Despite this, gene therapy does offer a ray of hope for patients who either have no treatment options or show no benefits with drugs that are currently available. Such a benefit far outweighs any disadvantages that may be associated with this upcoming therapeutic field.

There is a lot research underway for the first generation of controlled gene therapy, gene expression cassettes which deliver optimised gene expression and vectors which minimise the risk of immunogenicity. These research efforts have received strong support from various venture capital firms and institutional investors. With the expected launch of several new gene therapies in the US and EU, we expect the market to witness significant growth in the coming decade.

SCOPE OF THE REPORT
The ‘Gene Therapy Market, 2015-2025’ report provides an extensive study on the marketed and pipeline gene therapies. A lot of research has been carried out in this field for over a decade but there are only five approved therapies (four available in Asian markets; one approved in the EU). There are many promising therapies which are currently being developed worldwide; the approach is likely to result in several commercial success stories in the foreseen future. The report covers various aspects, such as key players, marketed gene therapy products, products in clinical / pre-clinical research, associated ethical issues, likely future developments and upcoming opportunities for a variety of stakeholders.

As pharma companies continue to expand their research programs in this area, one of the key objectives outlined for this report is to understand the future potential of the market. This is done by analysing:
- The gene therapy pipeline in terms of phase of development, therapeutic area, target indications, types of vectors, gene types, etc.
- Interest of venture capital firms and recent funding rounds that have taken place in the gene therapy space.
- Development and sales potential based on target consumer segments, likely adoption rate and expected pricing.
- The constraints of gene therapy and future developments planned to overcome these.

The study provides an estimate of the short-midterm and long term market forecast for the period 2015 - 2025. The research, analysis and insights presented in this report include potential sales of the five approved gene therapies and 12gene therapy products in late phases of development.

Owing to niche nature of the market, with most products in the pipeline, we have provided three market forecast scenarios to add robustness to our model. The conservative, base and optimistic scenarios represent three different tracks of industry evolution. All actual figures have been sourced and analysed from publicly available information and discussions with industry experts. The figures mentioned in this report are in USD, unless otherwise specified.

EXAMPLE HIGHLIGHTS
1. Gendicinebecame the first approved gene therapy in China in 2004. So far, there have been three more marketed gene therapies:Rexin-G, Oncorine and Neovasculgen. All of these have been made commercially available in Asian countries. Glybera was the first gene therapy to be approved in the EU in 2012.
2. We have identified a total of 483 gene therapy molecules in the marketed and the clinical pipeline which are designed for different therapeutic areas. Except a few which are in advanced stages of development, majority of the gene therapies are in early development stages.
3. There are several challenges and ethical issues associated with this field; germline gene therapy is one of the important issues. The existing gene therapies use somatic cells. However, research is in progress to introduce germline gene therapy in the market since some of the serious inherited genetic diseases, such as Lecsh-Nyhan Syndrome, can only be treated by germline gene therapy.
4. There has been a growing interest from Venture Capital firms in the gene therapy space. In fact, in 2013 / 2014, several companies were involved in investment in gene therapies; during January 2013 to April 2014, a total USD 600 million was raised by the US companies alone. This activity is likely to increase further and will help companies, especially start-ups, drive their respective products to commercialisation.
5. We expect the genetherapymarket to be worth USD 11 billion by 2025, representing a healthy annual growth rate of 48.9%; specific therapies such as Prostavac, ProstAtak and TroVax are likely to achieve blockbuster status.

RESEARCH METHODOLOGY
Most of the data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Industry analysts’ views

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
Chapter 2 presents an executive summary of the report. The summary offers key highlights of the gene therapy market and a high level view on where the market is headed in the mid-long term.

Chapter 3 provides a detailed introduction to the market. In this section, we have talked about theclassification and routes of administration of gene therapy. It also includes the advantages, challenges and ethical issues associated with gene therapy.

Chapter 4 provides a comprehensive view of the gene delivery systems. It includes details about the different viral and non-viral vectors associated with the process of gene therapy.

Chapter 5 includes information on over 483 molecules which are currently approved orin different stages of development (both clinical and pre-clinical / discovery). The detailed analysis of this pipeline covers information on drug developers, phases of development, therapeutic areas, target indications, vectors used, gene types and the genes involved.

Chapter 6 provides details on the marketed therapies. The chapter includes detailed profiles of marketed gene therapy products. We have presented information on several parameters such as history of development, clinical trial results, manufacturing, costs, collaborations and the likely sales forecast over the next ten years.

Chapter 7 includes detailed profiles of gene therapy products in late stage clinical trials. We have presented information on several parameters such as history of development, technology used, clinical trial results, manufacturing, costs, collaborations and the likely sales forecast over the next ten years.

Chapter 8 highlights the promising new therapeutic areas for gene therapies. It elaborates on the number of products being developed under each therapeutic area.

Chapter 9 includes details about the venture capital investments that have taken place in this field. It also highlights the contract manufacturers participating in development of gene therapy.

Chapter 10 summarises the overall report. In this chapter, we provide a recap of the current gaps in the industry and highlight the future scope of gene therapy.

Chapter 11 is a collection of interview transcripts of the discussions which were held during the course of this study.

Chapter 12 and 13 are appendices, which provide the list of companies and tabulated data for all the figures presented in the report


Table Of Contents

Gene Therapy Market, 2015 - 2025
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. Historical Evolution of Gene Therapy
3.3. Classification of Gene Therapy
3.3.1. Somatic vs. Germline
3.3.2. Ex-vivo vs. In-vivo
3.4. Route of Administration
3.5. How Does Gene Therapy Work?
3.6. Advantages and Disadvantages of Gene Therapy
3.7. Ethical and Social Concerns in Gene Therapy
3.7.1. Somatic Gene Therapy
3.7.2. Germ-line Gene Therapy
3.8. Future Constraints and Challenges
3.8.1 Manufacturing
3.8.2 Reimbursement
3.8.3 Commercial Viability

4. VIRAL AND NON-VIRAL VECTORS
4.1. Chapter Overview
4.2. Viral Methods of Gene Transfer
4.2.1. Retroviruses
4.2.2. Lentiviruses
4.2.3. Adenoviruses
4.2.4. Adeno Associated Virus
4.2.5. Herpes Simplex Virus
4.2.6. Alphavirus
4.2.7. Vaccinia Virus
4.2.8. Simian Virus
4.3. Non-Viral Vectors
4.3.1. Naked/Plasmid Vectors
4.3.2. Biolistic Method: Gene Gun
4.3.3. Electroporation
4.3.4. Receptor Mediated Gene Delivery Methods
4.3.5. Liposomes, Lipoplexes and Polyplexes
4.3.6. Gene Activated Matrix (GAM)

5. PIPELINE OF GENE THERAPY
5.1. Chapter Overview
5.2. Gene Therapy: Pipeline Analysis
5.3 Oncology: The Most Popular Therapeutic Area
5.4. Distribution of Gene Therapies by Phase of Development
5.5. Distribution of Gene Therapies by Type of Vector
5.6. Distribution of Gene Therapies by Type of Genes Targeted
5.7. Distribution of Gene Therapies by Type of Sponsor

6. MARKETED GENE THERAPIES AND APPLICATIONS
6.1. Chapter Overview
6.2. Gendicine (SiBionoGeneTech)
6.2.1. Company and Pipeline Overview
6.2.2. History of Approval
6.2.3. Mechanism of Action and Vectors Used
6.2.4. Target Indication
6.2.5. Development Status
6.2.6. Dosage, Sales and Manufacturing
6.2.7. Patent Portfolio
6.2.8. Gendicine Sales Forecast, 2015 - 2025

6.3. Oncorine (Shanghai Sunway Biotech)
6.3.1. Company and Pipeline Overview
6.3.2. History of Approval
6.3.3. Mechanism of Action and Vectors Used
6.3.4. Target Indication
6.3.5. Development Status
6.3.6. Dosage and Sales
6.3.7. Patent Portfolio
6.3.8. Oncorine Sales Forecast, 2015 - 2025

6.4. Rexin-G (Epeius Biotechnologies)
6.4.1. Company and Pipeline Overview
6.4.2. History of Approval
6.4.3. Mechanism of Action and Vector Used
6.4.4. Target Indication
6.4.5. Development Status
6.4.6. Dosage and Manufacturing
6.4.7. Patent Portfolio
6.4.8. Rexin-G Sales Forecast, 2015 - 2025

6.5. Neovasculgen (Human Stem Cell Institute)
6.5.1. Company and Pipeline Overview
6.5.2. History of Approval
6.5.3. Mechanism of Action and Vector Used
6.5.4. Target Indication
6.5.5. Development Status
6.5.6. Dosage, Sales and Manufacturing
6.5.7. Neovasculgen Sales Forecast, 2015 - 2025

6.6. Glybera (uniQure)
6.6.1. Company and Pipeline Overview
6.6.2. History of Approval
6.6.3. Target Indication
6.6.4. Technology
6.6.5. Development Status
6.6.6. Dosage and Manufacturing
6.6.7. Collaborations
6.6.8. Glybera Sales Forecast, 2015 - 2025

7. GENE THERAPY: PIPELINE PRODUCTS
7.1. Chapter Overview
7.2. Generx (TaxusCardium)
7.2.1. Company and Pipeline Overview
7.2.2. History of Development
7.2.3. Target Indication
7.2.4. Technology
7.2.5. Development Status
7.2.6. Dosage and Manufacturing
7.2.7. Collaborations
7.2.8. Generx Sales Forecast, 2015 - 2025

7.3. TK (MolMedS.p.A)
7.3.1. Company and Pipeline Overview
7.3.2. History of Development
7.3.3. Target Indication
7.3.4. Technology
7.3.5. Development Status
7.3.6. Dosage and Manufacturing
7.3.7. Collaborations
7.3.8. TK Sales Forecast, 2015 - 2025

7.4. Collategene (AnGes MG)
7.4.1. Company and Pipeline Overview
7.4.2. History of Development
7.4.3. Target Indication
7.4.4. Technology
7.4.5. Development Status
7.4.6. Dosage and Manufacturing
7.4.7. Collaborations
7.4.8. Collategene Sales Forecast, 2015 - 2025

7.5. TissueGene-C (TissueGene Inc./Kolon Life Sciences)
7.5.1. Company and Pipeline Overview
7.5.2. History of Development
7.5.3. Target Indication
7.5.4. Technology
7.5.5. Development Status
7.5.6. Dosage and Manufacturing
7.5.7. Collaborations
7.5.8. TissueGene-C Sales Forecast, 2015 - 2025

7.6. SPK-RPE65 (Spark Therapeutics)
7.6.1. Company and Pipeline Overview
7.6.2. History of Development
7.6.3. Target Indication
7.6.4. Technology
7.6.5. Development Status
7.6.6. Dosage and Manufacturing
7.6.7. Collaborations
7.6.8. SPK-RPE65 Sales Forecast, 2015 - 2025

7.7. Prostvac (Bavarian Nordic)
7.7.1. Company and Pipeline Overview
7.7.2. History of Development
7.7.3. Target Indication
7.7.4. Technology
7.7.5. Development Status
7.7.6. Dosage and Manufacturing
7.7.7. Collaborations
7.7.8. Prostvac Sales Forecast, 2015 - 2025

7.8. T-VEC (Amgen)
7.8.1. Company and Pipeline Overview
7.8.2. History of Development
7.8.3. Target Indication
7.8.4. Technology
7.8.5. Development Status
7.8.6. Dosage and Manufacturing
7.8.7. Collaborations
7.8.8. T-Vec Sales Forecast, 2015 - 2025
7.9. ProstAtak (Advantagene)
7.9.1. Company and Pipeline Overview
7.9.2. History of Development
7.9.3. Target Indication
7.9.4. Technology
7.9.5. Development Status
7.9.6. Dosage and Manufacturing
7.9.7. Collaborations
7.9.8. ProstAtak Sales Forecast, 2015 - 2025

7.10. TroVax (Oxford BioMedica)
7.10.1. Company and Pipeline Overview
7.10.2. History of Development
7.10.3. Target Indication
7.10.4. Technology
7.10.5. Development Status
7.10.6. Dosage and Manufacturing
7.10.7. Collaborations
7.10.8. TroVax Sales Forecast, 2015 - 2025

7.11. Algenpantucel-L (Newlink Genetics Corporation)
7.11.1. Company and Pipeline Overview
7.11.2. History of Development
7.11.3. Target Indication
7.11.4. Technology
7.11.5. Development Status
7.11.6. Dosage and Manufacturing
7.11.7. Collaborations
7.11.8. Algenpantucel-L Sales Forecast, 2015 - 2025

7.12. ASP0113 (Vical/Astellas Pharma)
7.12.1. Company and Pipeline Overview
7.12.2. History of Development
7.12.3. Target Indication
7.12.4. Technology
7.12.5. Development Status
7.12.6. Dosage and Manufacturing
7.12.7. Collaborations
7.12.8. ASP0113 Sales Forecast, 2015 - 2025

7.13. E10A (Marsala Biotech)
7.13.1. Company and Pipeline Overview
7.13.2. History of Development
7.13.3. Target Indication
7.13.4. Technology
7.13.5. Development Status
7.13.6. Dosage and Manufacturing
7.13.7. Collaborations
7.13.8. E10A Sales Forecast, 2015 - 2025
7.14. Other Late Phase Gene Therapies
7.15. Overall Gene Therapy Market, 2015 - 2025

8. PROMISING THERAPEUTICS AREAS
8.1. Chapter Overview
8.2. Cancer
8.3. Neurological Disorders
8.3.1. Neurodegenerative Disorders
8.3.2. Lysosomal Storage Disorders (LSDs)
8.4. Ocular Diseases
8.5. Muscle Disorders
8.6. Blood Disorders (Anemia and Hemophilia)
8.7. Immunodeficiency Diseases

9. GENE THERAPY: ADDITIONAL CONSIDERATIONS
9.1. Chapter Overview
9.2 Venture Capital Investment in Gene Therapy
9.3. Conferences and Exhibitions on Gene Therapy
9.4. Contract Manufacturing in Gene Therapy

10. CONCLUSION
10.1. Move From Monogenic Diseases To Cancer
10.2. Controlled Gene Therapy for Optimised Gene Expression: Gradually Evolving
10.3. mRNA Mediated Gene Therapy: A Promising Approach to Improve Transfection Efficiency
10.4. Germline Gene Therapy: Potential yet to Unveil
10.5. A Strong Pipeline Likely To Result In A Multi-Billion Dollar Market

11. INTERVIEW TRANSCRIPTS

12. APPENDIX1: TABULATED DATA

13. APPENDIX 2: LIST OF COMPANIES AND ORGANISATIONS

LIST OF FIGURES

Figure 3.1 History of Evolution: Timeline
Figure 3.2 Gene Transfer using Viral Vectors
Figure4.1 Gene Transfer: Viral and Non-Viral Methods
Figure 5.1 Pipeline Analysis: Distribution by Therapeutic Area
Figure 5.2 Pipeline Analysis: Distribution by Phase of Development
Figure 5.3 Pipeline Analysis: Distribution by Type of Vector
Figure 5.4 Pipeline Analysis: Distribution by Target Gene Type
Figure 5.5 Pipeline Analysis: Distribution by Drug Developer Type
Figure 6.1 Pipeline Overview: SiBionoGeneTech
Figure 6.2 Gendicine: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure 6.3 Pipeline Overview: Shanghai Sunway Biotech
Figure 6.4 Adenovirus Construct in Oncorine
Figure 6.5 Oncorine: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure 6.6 Pipeline Overview: Epeius Biotechnologies
Figure 6.7 Rexin-G: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure 6.8 Pipeline Overview: Human Stem Cell Institute
Figure 6.9 Human Stem Cell Institute: Revenues (RUB'000)
Figure 6.10 Neovasculgen: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure 6.11 Pipeline Overview: uniQure
Figure 6.12 Glybera: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure7.1 Pipeline Overview: TaxusCardium
Figure 7.2 Generx: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure 7.3 Pipeline Overview: MolMedS.p.A.
Figure 7.4 TK: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure 7.5 Pipeline Overview: AnGes
Figure 7.6 Collategene: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure 7.7 Pipeline Overview: Kolon Life Science
Figure 7.8 TissueGene-C: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure 7.9 Pipeline Overview: Spark Therapeutics
Figure 7.10 SPK-RPE65: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure 7.11 Pipeline Overview: Bavarian Nordic
Figure 7.12 Incidence and Mortality 2012: Prostate Cancer (in ‘000)
Figure 7.13 Prostvac: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure 7.14 Pipeline Overview: Amgen
Figure 7.15 Incidence and Mortality 2014: Melanoma (in ‘000)
Figure 7.16 Skin Cancer: Geographical Distribution of Death Rate (Cases per 100,000 People)
Figure 7.17 T-Vec: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure 7.18 Pipeline Overview: Advantagene
Figure 7.19 Incidence and Mortality 2012: Prostate Cancer (in ‘000)
Figure 7.20 ProstAtak: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure 7.21 Pipeline Overview: Oxford BioMedica
Figure 7.22 Incidence and Mortality 2012: Colorectal Cancer (in ‘000)
Figure 7.23 TroVax: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure 7.24 Pipeline Overview: NewLink Genetics
Figure 7.25 Age-Standardised Rate 2012: Pancreatic Cancer
Figure7.26 Incidence and Mortality 2012: Pancreatic Cancer (in ‘000)
Figure 7.27 Algenpantucel-L: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure 7.28 Pipeline Overview: Vical
Figure 7.29 ASP0113: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure 7.30 Pipeline Overview: Marsala Biotech
Figure 7.31 E10A: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Figure 7.32 Overall Gene Therapy Market Outlook 2015-2025 (USD Million)
Figure 7.33 Contribution of Oncology to Gene Therapy Market
Figure 8.1 Number of Gene Therapies in Pre-clinical/Clinical Development for Cancer: By Disease Area
Figure 8.2 Number of Gene Therapies in Pre-clinical/Clinical Development for Cancer: By Transfer Vectors
Figure 8.3 Number of Gene Therapies in Pre-clinical/Clinical Development for Neurological Disorders: By Disease Area
Figure 8.4 Number of Gene Therapies in Pre-clinical/Clinical Development for Neurological Disorders: By Transfer Vectors
Figure 8.5 Number of Gene Therapies in Pre-clinical/Clinical Development for Lysosomal Storage Disorders: By Disease Area
Figure 8.6 Number of Gene Therapies in Pre-clinical/Clinical Development for Lysosomal Storage Disorders: By Transfer Vectors
Figure 8.7 Number of Gene Therapies in Pre-clinical/Clinical Development for Ocular Disorders: By Disease Area
Figure 8.8 Number of Gene Therapies in Pre-clinical/Clinical Development for Ocular Disorders: By Transfer Vectors
Figure 8.9 Number of Gene Therapies in Pre-clinical/Clinical Development for Muscle Disorders: By Disease Area
Figure 8.10 Number of Gene Therapies in Pre-clinical/Clinical Development for Muscle Disorders: By Transfer Vectors
Figure 8.11 Number of Gene Therapies in Pre-clinical/Clinical Development for Blood Disorders: By Disease Area
Figure 8.12 Number of Gene Therapies in Pre-clinical/Clinical Development for Blood Disorders: By Transfer Vectors
Figure 8.13 Number of Gene Therapies in Pre-clinical/Clinical Development for Immunodeficiency Diseases - By Disease Area
Figure 8.14 Number of Gene Therapies in Pre-clinical/Clinical Development for Immunodeficiency Diseases: By Transfer Vectors
Figure 9.1 Gene Therapy: Type of Investments in 2013 and 2014
Figure 9.2 Gene Therapy: Investments Made for Different Body Systems (USD Million)
Figure 9.3 Gene Therapy Conferences in 2015: Distribution by Month
Figure 9.4 Gene Transfer: Top Conference Sponsors
Figure 9.5 Contract Manufacturing in Gene Therapy: By Capability
Figure 9.6 Contract Manufacturing in Gene Therapy: By Location
Figure 10.1 Gene Therapy Market (USD Million), 2017, 2021 and 2025

LIST OF TABLES

Table 3.1 Differences between Ex vivo and In vivo Gene Therapy
Table 3.2 Price comparison of Marketed Gene Therapies
Table 3.3 Approved ATMPs in EU
Table 4.1 Features of Retrovirus
Table 4.2 Features of Lentivirus
Table 4.3 Features of Adenovirus
Table 4.4 Features of Adeno-associated Virus Vectors
Table 4.5 Features of Herpes Simplex Virus Vectors
Table 5.1 Pipeline: Approved/Marketed Gene Therapies
Table 5.2 Pipeline: Pre-registration/Phase III Gene Therapies
Table 5.3 Pipeline: Phase II/III Gene Therapies
Table 5.4 Pipeline: Phase II Gene Therapies
Table 5.5 Pipeline: Phase I/II Gene Therapies
Table 5.6 Pipeline: Phase I Gene Therapies
Table 5.7 Pipeline: Preclinical Stage
Table 5.8 Gene Therapy: University Spin-offs
Table 6.1 Marketed and Approved Gene Therapies
Table 6.2 Company Overview: SiBionoGeneTech
Table 6.3 Gendicine: Status of Development
Table 6.4 Gendicine: Patent Portfolio
Table 6.5 Company Overview: Shanghai Sunway Biotech
Table 6.6 H100 Series: Status of Development
Table 6.7 Company Overview: Epeius Biotechnologies
Table 6.8 Rexin-G: Status of Development
Table 6.9 Rexin G: Patent Portfolio
Table 6.10 Company Overview: Human Stem Cell Institute
Table 6.11 Neovasculgen: Status of Development
Table 6.12 Company Overview: uniQure
Table 6.13 Glybera: Status of Development
Table 7.1 Gene Therapy: Late Stage Development Products
Table 7.2 Company Overview: TaxusCardium
Table 7.3 Generx: Status of Development
Table 7.4 Company Overview: MolMedS.p.A.
Table 7.5 TK: Status of Development
Table 7.6 Company Overview: AnGes MG
Table 7.7 Collategene: Status of Development
Table 7.8 Company Overview: Kolon Life Science
Table 7.9 TissueGene-C: Status of Development
Table 7.10 Company Overview: Spark Therapeutics
Table 7.11 SPK-RPE65: Status of Development
Table 7.12 Company Overview: Bavarian Nordic
Table 7.13 Prostvac: Status of Development
Table 7.14 Company Overview: Amgen
Table 7.15 T-Vec: Status of Development
Table 7.16 Company Overview: Advantagene
Table 7.17 ProstAtak: Status of Development
Table 7.18 Company Overview: Oxford BioMedica
Table 7.19 TroVax: Status of Development
Table 7.20 Company Overview: NewLink Genetics
Table 7.21 Algenpantucel-L: Status of Development
Table 7.22 Company Overview: Vical
Table 7.23 ASP0113: Status of Development
Table 7.24 Company Overview: Marsala Biotech
Table 7.25 E10A: Status of Development
Table 7.26 Gene Therapies in Phase II/III
Table 7.27 Important Highlights of Gene Therapies in Phase II/III
Table 7.28 Gene Therapy: Expected Years of Launch
Table 8.1 Gene Therapy for Cancer
Table 8.2 Gene Therapy for Neurological Disorders
Table 8.3 Classification of Lysosomal Storage Disorders
Table 8.4 Gene Therapy for Lysosomal Storage Disorders
Table 8.5 Gene Therapy for Ocular Disorders
Table 8.6 Gene Therapy for Muscle Disorders
Table 8.7 Gene Therapy for Blood Disorders
Table 8.8 Gene Therapy for Immunodeficiency Diseases
Table 9.1 Recent Investments in Gene Therapy
Table 9.2 Gene Transfer: Conferences 2015
Table 9.3 Contract Manufactures in Gene Therapy
Table 12.1 Pipeline Analysis: Distribution by Therapeutic Area
Table 12.2 Pipeline Analysis: Distribution by Phase of Development
Table 12.3 Pipeline Analysis: Distribution by Type Gene Delivery Methods
Table 12.4 Pipeline Analysis: Distribution by the Gene Type
Table 12.5 Pipeline Analysis: Distribution by Drug Developer Type
Table 12.6 Gendicine: Sales Forecast 2015 - 2025, Base Scenario (USD Million
Table 12.7 Gendicine: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.8 Gendicine: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.9 Oncorine: Sales Forecast 2015 - 2025, Base Scenario (USD Million
Table 12.10 Oncorine: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.11 Oncorine: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.12 Rexin-G: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Table 12.13 Rexin-G: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.14 Rexin-G: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.15 Human Stem Cell Institute: Revenues (RUB '000)
Table 12.16 Neovasculgen: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Table 12.17 Neovasculgen: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.18 Neovasculgen: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.19 Glybera: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Table 12.20 Glybera: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.21 Glybera: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.22 Generx: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Table 12.23 Generx: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.24 Generx: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.25 TK: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Table 12.26 TK: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.27 TK: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.28 Collategene: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Table 12.29 Collategene: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.30 Collategene: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.31 TissueGene-C: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Table 12.32 TissueGene-C: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.33 TissueGene-C: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.34 SPK-RPE65: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Table 12.35 SPK-RPE65: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.36 SPK-RPE65: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.37 Incidence and Mortality Rate 2012: Prostate Cancer
Table 12.38 Prostvac: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Table 12.39 Prostvac: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.40 Prostvac: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.41 Incidence and Mortality Rate 2014: Melanoma
Table 12.42 Skin Cancer: Geographical Distribution of Death Rate (Cases per 100,000 People)
Table 12.43 T-Vec: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Table 12.44 T-Vec: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.45 T-Vec: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.46 Incidence and Mortality Rate 2012: Prostate Cancer
Table 12.47 ProstAtak: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Table 12.48 ProstAtak: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.49 ProstAtak: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.50 Incidence and Mortality Rate 2012: Colorectal Cancer
Table 12.51 TroVax: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Table 12.52 TroVax: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.53 TroVax: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.54 Age-Standardised Rate 2012: Pancreatic Cancer
Table 12.55 Incidence and Mortality Rate 2012: Pancreatic Cancer
Table 12.56 Algenpantucel-L: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Table 12.57 Algenpantucel-L: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.58 Algenpantucel-L: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.59 ASP0113: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Table 12.60 ASP0113: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.61 ASP0113: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.62 E10A: Sales Forecast 2015 - 2025, Base Scenario (USD Million)
Table 12.63 E10A: Sales Forecast 2015 - 2025, Conservative Scenario (USD Million)
Table 12.64 E10A: Sales Forecast 2015 - 2025, Optimistic Scenario (USD Million)
Table 12.65 Overall Gene Therapy Forecast 2015-2025: Base Scenario (USD Million)
Table 12.66 Overall Gene Therapy Forecast 2015-2025: Conservative Scenario (USD Million)
Table 12.67 Overall Gene Therapy Forecast 2015-2025: Optimistic Scenario (USD Million)
Table 12.68 Contribution of Oncology in Gene therapy market (USD Million)
Table 12.69 Number of Gene Therapies in Pre-clinical/Clinical Development for Cancer: By Disease Area
Table 12.70 Number of Gene Therapies in Pre-clinical/Clinical Development for Cancer: By Transfer Vectors
Table 12.71 Number of Gene Therapies in Pre-clinical/Clinical Development for Neurological Disorders: By Disease Area
Table 12.72 Number of Gene Therapies in Pre-clinical/Clinical Development for Neurological Disorders: By Transfer Vectors
Table 12.73 Number of Gene Therapies in Pre-clinical/Clinical Development for Lysosomal Storage Disorders: By Disease Area
Table 12.74 Number of Gene Therapies in Pre-clinical/Clinical Development for Lysosomal Storage Disorders: By Transfer Vectors
Table 12.75 Number of Gene Therapies in Pre-clinical/Clinical Development for Ocular Disorders: By Disease Area
Table 12.76 Number of Gene Therapies in Pre-clinical/Clinical Development for Ocular Disorders: By Transfer Vectors
Table 12.77 Number of Gene Therapies in Pre-clinical/Clinical Development for Muscle Disorders: By Disease Area
Table 12.78 Number of Gene Therapies in Pre-clinical/Clinical Development for Muscle Disorders: By Transfer Vectors
Table 12.79 Number of Gene Therapies in Pre-clinical/Clinical Development for Blood Disorders: By Disease Area
Table 12.80 Number of Gene Therapies in Pre-clinical/Clinical Development for Blood Disorders: By Transfer Vectors
Table 12.81 Number of Gene Therapies in Pre-clinical/Clinical Development for Immunodeficiency Diseases: By Disease Area
Table 12.83 Number of Gene Therapies in Pre-clinical/Clinical Development for Immunodeficiency Diseases: By Transfer Vectors
Table 12.83 Gene Therapy: Type of Investments in 2013 and 2014
Table 12.84 Gene Therapy: Investments made for different Body Systems
Table 12.85 Gene Therapy Conferences in 2015: Distribution by Month
Table 12.86 Contract Manufacturing in Gene Therapy: By Capability
Table 12.87 Contract Manufacturing in Gene Therapy: By Location
Table 12.88 Gene Therapy Market (USD Million), 2017, 2021 and 2025

The following companies have been mentioned in this report:
1. AAV Life
2. Abeona Therapeutics
3. ActoGenix
4. Adaptimmune
5. Aduro Biotech
6. Advantagene
7. Advaxis
8. Aeras
9. Alphavax
10. Amgen
11. AmphliPhi Biosciences
12. Amsterdam Molecular Therapeutics
13. Anaeropharma Science
14. AnGes MG
15. Applied Genetic Technologies Corp
16. AsklepiosBioPharmaceutical Inc.
17. Astellas Pharma
18. Audentes Therapeutics
19. Avalanche Biotechnologies
20. AveXis Inc
21. Bavarian Nordic
22. Baxter Healthcare Corporation
23. Bellicum Pharmaceuticals
24. Benitec BioPharma
25. BioCancell
26. Bioheart
27. Biomics Biotechnologies
28. Biontech
29. Biovex
30. Bluebird Bio
31. BN ImmunoTherapeutics
32. Calimmune
33. Cardium Therapeutics
34. Cell Therapy Catapult
35. Celladon Corporation
36. Ceregene
37. ChiesiFarmaceutici
38. ClinDatrix
39. Cold Genesys, Inc.
40. Crucell
41. CytRx Corporation
42. Daiichi Sankyo
43. Diamyd Inc.
44. Digna Biotech S.L.
45. DNAtrix
46. DNAVEC Corporation
47. EGEN, Inc.
48. Emergent Biosolutions
49. Enzo Biochem
50. Epeius Biotechnologies
51. Errant Gene Therapeutics
52. ESTEVE
53. Etubics Corporation
54. FKD Therapies Oy
55. Fondazione Telethon
56. Genable Technologies
57. Gene Medicine Japan
58. GeneCure Biotechnologies
59. Genelux Corporation
60. GeneOne Life Sciences
61. GeneSight Biologics
62. Genethon
63. Genexine
64. Genprex
65. GenVec
66. Genzyme
67. GeoVax Inc.
68. GlaxoSmithKline
69. GlobeImmune
70. Guangzhou DoublleBioproducts
71. Gradalis Inc.
72. Heat Biologics
73. Helica Labs
74. Herantis Pharma
75. Ichor Medical Systems
76. Imaxio
77. Immune Design
78. Inovio Pharmaceuticals
79. Invivodata
80. INVIVOGEN
81. Ion Channel Innovations
82. IrsiCaixa
83. Isis Innovation
84. Jennerex Biotherapeutics
85. Juventas Therapeutics, Inc.
86. Kolon Life Science
87. LYSOGENE
88. Marsala Biotech
89. Medison Pharma
90. Medigen Biotechnology Corporation
91. Memgen Bio
92. Merck
93. Milo Biotechnology
94. MiroVAX
95. Mitsubishi Tanabe
96. MolMedS.p.A
97. Mologen AG
98. Momotaro-Gene Inc
99. MultiGene Vascular Systems
100. NanoCor Therapeutics
101. NEURALGENE
102. Neurotech Pharmaceuticals
103. Newlink Genetics Corporation
104. Nightstar
105. Novartis
106. Oncolys BioPharma
107. OncoSec Medical Incorporated
108. Oncos Therapeutics
109. Orca Therapeutics
110. Oxford BioMedica
111. Quintiles
112. Pacific-Link Consulting
113. Paragon Biomedical
114. Pfizer
115. PNP Therapeutics
116. Profectus Biosciences
117. Regen BioPharma
118. Regeneron
119. RegenX Biosciences
120. ReiThera Sri
121. REPLIcor
122. Roche
123. SanBio
124. Sangamo Biosciences
125. Sanofi
126. Scancell Ltd
127. Schering AG
128. Shanghai Sunway Biotech
129. SiBionoGeneTech
130. SillaJen
131. SironRX Therapeutics
132. Spark Therapeutics
133. SynerGene Therapeutics
134. Tacere Therapeutics
135. Takara Bio
136. Theradex
137. Theravectys S.A.
138. Tocagen
139. Transgene
140. Treeway
141. uniQure
142. UCSF
143. Vascular Biogenics
144. Vaximm GmbH
145. VCN Biosciences
146. Vical
147. ViroMed
148. VIRxSYS Corporation
149. Voyager Therapeutics
150. VGXI
151. Virttu Biologics
152. Ziopharm


The following organisations and universities have been mentioned in this report.
1. Alpha-1 Foundation
2. Assistance Publique - Hôpitaux de Paris; Paris 12 Val de Marne University; Universite Paris VI
3. ALS Therapy Development Institute
4. Baylor College of Medicine
5. Centro de InvestigaciónMedicaAplicada (CIMA)
6. Children's Hospital Boston
7. Children's Hospital of Philadelphia (CHOP)
8. Choroideremia Research Foundation
9. Christie Hospital NHS Foundation Trust Erasmus Medical Center
10. City of Hope Medical Center
11. Duke University Medical Center
12. Erasmus Medical Center
13. European and Developing Countries Clinical Trials Partnership (EDCTP)
14. European Commission
15. European Organisation for Research and Treatment of Cancer (EORTC)
16. Fred Hutchinson Cancer Research Center; National Heart, Lung and Blood Institute (NHLBI)
17. Goethe University
18. Great Ormond Street Hospital for Children NHS Foundation Trust
19. H. Lee Moffitt Cancer Center and Research Institute
20. Hadassah Medical Organization
21. Health Innovation Challenge Fund;
22. Henry Ford Health System
23. HIV Vaccine Trials Network (HVTN)
24. Hospital InfantilUniversitario Niño Jesús
25. Huazhong University of Science and Technology
26. Human Stem Cells Institute
27. Ichor Medical Systems
28. Institut National de la Sante Et de la RechercheMedicale, France
29. International AIDS Vaccine Initiative
30. Jiangsu Province Hospital
31. Jonsson Comprehensive Cancer Center
32. King Khaled Eye Specialist Hospital
33. Kuopio University Hospital
34. Kyushu University Hospital
35. Leukemia Lymphoma Research
36. Loyola University
37. M.D. Anderson Cancer Center
38. Malaria Vectors Vaccines Consortium (MVVC)
39. Massachusetts General Hospital
40. Mayo Clinic
41. Memorial Sloan-Kettering Cancer Center
42. Mie University
43. Milton S. Hershey Medical Center
44. National Center for Research Resources
45. National Eye Institute
46. National Institute for Longevity Sciences of Japan
47. National Institute of Allergy and Infectious Diseases
48. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
49. National Institute of Dental and Craniofacial Research (NIDCR)
50. National Institute of Health (NIH)
51. National Institute of Infectious Diseases of Japan
52. National Institutes of Health Clinical Center (CC)
53. National Taiwan University Hospital
54. Nationwide Children's Hospital
55. Naval Medical Research Center (NMRC)
56. Cancer Research UK
57. Memorial Sloan-Kettering Cancer Center
58. Weill Medical College of Cornell University
59. Oregon Health and Science University
60. Phase One Foundation
61. Public Health Agency of Canada
62. ReiTheraSrl
63. Research Center for Hematology of the Russian Ministry of Healthcare
64. Rockefeller University
65. Royal Brompton andHarefield NHS Foundation Trust
66. Sidney Kimmel Comprehensive Cancer Center
67. Shanxi Taxus Pharmaceuticals
68. St. Jude Children's Research Hospital
69. Stanford University
70. Stichting Het NederlandsKankerInstituut
71. Sun Yat-Sen University Cancer Center
72. Swedish Institute for Infectious Disease Control
73. Texas Children's Hospital
74. The Ellis Lab; University of Texas Southwestern
75. The Methodist Hospital System
76. The University of Kansas Medical Center
77. Tianjin Medical University Cancer Institute and Hospital
78. Tumor Hospital of Medical Sciences Academy of China
79. United Kingdom Cystic Fibrosis Gene Therapy Consortium
80. Universidad de Navarra
81. University College London
82. University Hospital Birmingham
83. University of Alabama at Birmingham
84. University of Birmingham
85. University of California, Berkeley
86. University of Cambridge
87. University of Connecticut
88. University of Florida
89. University of Miami
90. University of Michigan
91. University of Nairobi
92. University of Nebraska Medical Center
93. University of New South Wales
94. University of Oxford
95. University of Pennsylvania
96. University of Pittsburgh
97. University of Southern California
98. University of Tennessee
99. University of Texas
100. University of Tokyo Hospital
101. University of Washington
102. University of Wisconsin
103. University of Zurich
104. Uppsala University Hospital
105. Wayne State University
106. West China Hospital
107. WuxiAppTec

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