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Blood Brain Barrier Technologies: Novel CNS Drug Delivery Approaches’

Blood Brain Barrier Technologies: Novel CNS Drug Delivery Approaches’

INTRODUCTION

Several people across the globe suffer from different neurological disorders. However, the drugs currently available in the market provide only symptomatic relief and do not treat the root cause. This is because of their inability to penetrate across the blood brain barrier (BBB). BBB is a highly selective permeable membrane which allows the entry of only specific molecules, across it, into the brain. The widening gap between the demand of effective treatments and supply of BBB permeable drugs is going to provide a major impetus to the BBB market in the coming decade. Several pharma companies have identified the unmet need and have developed proprietary technologies. These technologies cater to the aforementioned concerns and are being deployed to develop drugs and APIs that penetrate across the barrier and reach the brain at therapeutically active amounts. Once approved, these drugs are likely to park a major share of the total market.

With growing advances in R&D, and the increasing demands for specific drugs, BBB technologies have become one of the key focus areas of researchers and companies across the world. Several venture capital firms have backed the start-ups working in this field. In addition, partnerships and collaborations have played a pivotal role in the advancement of this market. Many smaller companies, as a part of their business model, are looking to out-license their technologies to the established players in this industry.

SCOPE OF THE REPORT

The ‘BBB Technologies: Novel CNS Drug Delivery Approaches, 2015 - 2030’ report provides an extensive study of the emerging market of BBB technologies and associated drugs for neurologic diseases. The focus of this study is primarily on the technologies that are non-invasive in nature.

There are other technologies which either disrupt the barrier or use an alternate route to bypass it. These technologies are, for the purpose of this report, considered competing in nature. The report covers various aspects such as research pipeline, technological profiles, recent developments and sales forecast to assess new evolving opportunities. We have also provided a competitive market analysis to compare the potential that resides in the leading neurological indications, such as Parkinson’s disease, Alzheimer’s disease, multiple sclerosis and brain cancer, for which BBB permeable drugs are being developed. In addition to the well-known technologies, we have also provided case studies on four other technologies; these are either in direct competition or have been previously worked upon. Our opinion and insights, presented in this study, were influenced by the discussions that we conducted with different technology providers in this industry.

One of the key objectives of this report is to understand the future state of the BBB technologies market. This is done by analyzing the following:

Pipeline candidates based on these technologies
Size of target consumer segments
Expected launch year and countries where these clinical stage candidates are likely to receive commercialization rights
Likely price points

The base year for the report is 2014. The report provides market forecasts for the period 2019 - 2030. The figures mentioned in this report are in USD, unless otherwise specified.

EXAMPLE HIGHLIGHTS

1. More than 25 companies have developed proprietary non-invasive BBB technologies. Majority of these companies are either university spin-offs or start-up firms. Some pharma giants, such as Roche, AbbVie and Genzyme, have also deployed their expertise to develop novel technology platforms.

2. Majority of BBB technologies (53%) are based on the process of receptor mediated transcytosis (RMT). Within RMT, Trojan horse is the most common strategy. Several companies, such as Vect-Horus, BBB Therapeutics, and Angiochem, have utilized this approach to transport therapeutics into the brain.

3. These technology developers are evaluating their technologies on over 50 drug candidates spread across different development stages. 80% of these drugs are undergoing either preclinical or proof of concept and efficacy studies.

4. Based on several parameters, such as target patient population, and competition (both in terms of number of pipeline and marketed drugs), we believe that indications such as Alzheimer’s disease, epilepsy, and Parkinson’s disease offer a very lucrative future for this market.

5. Interest of venture capital firms, licensing/ partnership opportunities will continue to act as key growth drivers of BBB technologies market. In fact, during our research, we identified several instances where venture capitalists and other strategic investors have actively supported the research efforts.

6. The first batch of BBB permeable drugs, based on these technologies, is anticipated to be launched in 2019/2020; post this, we expect the momentum to rise steadily trending towards a multi-billion dollar market by 2030.

RESEARCH METHODOLOGY

Most of the data presented in this report has been gathered by secondary research. We have also conducted 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 shape up across different regions and drug 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
Other analysts’ opinion reports

While the focus has been on forecasting the market over the coming nine 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.


1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. BLOOD BRAIN BARRIER: AN INTRODUCTION
3.1. Overview
3.2. Structure of Human Brain
3.3. Strategies for Drug Delivery to the CNS
3.3.1. Systemic Administration of Therapeutics
3.3.2. Direct Administration of Therapeutics
3.3.3. Drug Delivery by Manipulation of the Drug
3.3.4. Chemical Delivery Systems
3.3.5. Drug Delivery Using Devices
3.4. Blood Brain Barrier
3.4.1. Historical Evolution
3.4.2. Structure
3.4.3. Associated Functions
3.5. Strategies for Drug Delivery Across BBB
3.5.1. Increasing the Permeability of the BBB
3.5.2. Pharmacological Strategies to Facilitate Transport Across the BBB
4. MARKET OVERVIEW
4.1. Chapter Overview
4.2. BBB Non-Invasive Technology Providers
4.2.1. Distribution By Type Of Technology
4.2.1.1. Receptor Mediated Transcytosis
4.2.1.2. Increasing Permeability
4.2.1.3. Passive Diffusion
4.3. BBB Pipeline Drugs
4.3.1. Distribution by Type of Indication
4.3.2. Distribution by Phase of Development
4.3.3. Distribution by Technology Providers
4.4. BBB Penetrant Biologic Drugs: Distribution by Nature of Molecule
4.5. Other BBB Penetrant Drugs
4.6. Competing Technologies
4.7. Comparison Between Non-Invasive BBB Technologies and Competing BBB Technologies
5. NEUROLOGICAL INDICATIONS: MARKET POTENTIAL
5.1. Chapter Overview
5.2. Neurological Disorders: Market Potential Analysis
5.3. Neurological Indications: Market Potential
5.3.1. Alzheimer’s Disease
5.3.1.1. Overview
5.3.1.2. Facts
5.3.1.3. Example Marketed Drugs
5.3.1.4. Pipeline Drugs
5.3.1.5. Roots Analysis’ Perspective
5.3.2. Epilepsy
5.3.2.1. Overview
5.3.2.2. Facts
5.3.2.3. Example Marketed Drugs
5.3.2.4. Pipeline Drugs
5.3.2.5. Roots Analysis’ Perspective
5.3.3. Parkinson’s Disease
5.3.3.1. Overview
5.3.3.2. Facts
5.3.3.3. Example Marketed Drugs
5.3.3.4. Pipeline Drugs
5.3.3.5. Roots Analysis’ Perspective
5.3.4. Multiple Sclerosis
5.3.4.1. Overview
5.3.4.2. Facts
5.3.4.3. Example Marketed Drugs
5.3.4.4. Pipeline Drugs
5.3.4.5. Roots Analysis Perspective
5.3.5. Hunter’s Syndrome
5.3.5.1. Overview
5.3.5.2. Facts
5.3.5.3. Example Marketed Drugs
5.3.5.4. Pipeline Drugs
5.3.5.5. Roots Analysis’ Perspective
5.3.6. Brain Cancer
5.3.6.1. Overview
5.3.6.2. Facts
5.3.6.3. Example Marketed Drugs
5.3.6.4. Pipeline Drugs
5.3.6.5. Roots Analysis’ Perspective
6. BBB TECHNOLOGIES: UNDERLYING CONCEPTS
6.1. Chapter Overview
6.2. Receptor Mediated Transcytosis
6.2.1. Receptor-Mediated Targets for Brain Entry
6.2.2. Approaches Under RMT
6.2.2.1. Bispecific Antibodies
6.2.2.2. Trojan Horses
6.3. Increasing Permeability
6.4. Passive Diffusion
7. BBB TECHNOLOGY PROFILES
7.1. Chapter Overview
7.2. Technologies Based on Bispecific Antibody RMT Approach
7.2.1. Ossianix Blood-Brain Barrier Technology (Ossianix)
7.2.1.1. Technology Description
7.2.1.2. Company Overview
7.2.1.3. Pipeline
7.2.1.4. Partnerships/ Funding
7.2.2. Brain Shuttle Technology (Roche)
7.2.2.1. Technology Description
7.2.2.2. History of Development
7.2.2.3. Company Overview
7.2.2.4. Pipeline
7.2.2.5. Partnerships
7.2.3. Other Bispecific Antibodies Based Technologies
7.3. Technologies Based on Trojan Horse Approach
7.3.1. Transcend Technology (biOasis)
7.3.1.1. Technology Description
7.3.1.2. History of Development
7.3.1.3. Company Overview
7.3.1.4. Pipeline
7.3.1.5. Partnerships
7.3.1.6. Recent Developments
7.3.2. LRP Technology (Angiochem)
7.3.2.1. Technology Description
7.3.2.2. Company Overview
7.3.2.3. Pipeline
7.3.2.4. Partnerships
7.3.2.5. Funding
7.3.2.6. Recent Developments
7.3.3. IPRO Technology (Iproteos)
7.3.3.1. Protein-Protein Interactions (PPIs)
7.3.3.2. Protease Targeted Therapeutics
7.3.3.3. Technology Description
7.3.3.4. Identification of New Peptidomimetics
7.3.3.5. Company Overview
7.3.3.6. Pipeline
7.3.4. ArmaGen Technology Platform (ArmaGen)
7.3.4.1. Technology Description
7.3.4.2. Mode of Action
7.3.4.3. Company Overview
7.3.4.4. Pipeline
7.3.4.5. Partnerships
7.3.4.6. Funding
7.3.4.7. Recent Developments
7.3.5. Vect-Horus Technology Platform (Vect-Horus)
7.3.5.1. Technology Description
7.3.5.2. Company Overview
7.3.5.3. Pipeline
7.3.5.4. Partnerships
7.3.5.5. Funding
7.3.5.6. Recent Developments
7.3.6. G-Technology (BBB Therapeutics)
7.3.6.1. Technology Description
7.3.6.2. History of Development
7.3.6.3. Company Overview
7.3.6.4. Pipeline
7.3.6.5. Partnerships
7.3.6.6. Funding
7.3.6.7. Recent Developments
7.3.7. Nano BBB Technology Platform (Sagetis Biotech)
7.3.7.1. Technology Description
7.3.7.2. Company Overview
7.3.7.3. Pipeline
7.3.7.4. Funding
7.3.7.5. Partnerships
7.3.8. Other Technologies Based on Trojan Horse Approach
7.4. Technologies Based on Increasing the Permeability of BBB
7.4.1. SonoCloud Technology (CarThera)
7.4.1.1. Technology Description
7.4.1.2. Medical Applications
7.4.1.3. Company Overview
7.4.2. SPG Technology (BrainsGate)
7.4.2.1. Spheno-Palatine Ganglion
7.4.2.2. Technology Description
7.4.2.3. Current Developments Using this Technology
7.4.2.4. Company Overview
7.4.2.5. Funding
7.4.3. Other Technologies Based on Increasing Permeability of BBB
7.5. Technologies Based on Passive Diffusion
7.5.1. SciFluor Life Sciences
7.6. Other Non-Invasive BBB Technologies
7.6.1. SMART Molecule Technology (ICBI)
7.6.1.1. Technology Description
7.6.1.2. Company Overview
7.6.1.3. Pipeline
7.6.1.4. Partnerships
7.6.1.5. Recent Developments
7.6.2. Molecular Envelope Technology (Nanomerics)
7.6.2.1. Technology Description
7.6.2.2. Company Overview
7.6.2.3. Pipeline
7.6.2.4. Partnerships
7.6.2.5. Funding
7.6.2.6. Recent Developments
7.6.3. Other Approaches (JCR Pharma, Cyclenium, Cerecor, Lauren Sciences, Protheragen)
8. CASE STUDIES
8.1. Chapter Overview
8.2. Intrathecal Drug Delivery (Shire)
8.2.1. Technology Description
8.2.2. Company Overview
8.2.3. Pipeline
8.2.4. Recent Developments
8.3. TTP Technology (Eisai)
8.3.1. Technology Description
8.3.2. Company Overview
8.3.3. Pipeline
8.4. Technology Platform (BioMarin)
8.4.1. Technology Description
8.4.2. Company Overview
8.4.3. Pipeline
8.5. NeuroTrans Technology (Raptor Pharmaceuticals)
9. BBB TECHNOLOGIES: MARKET FORECASTING
9.1. Chapter Overview
9.1.1. Scope and Forecast Methodology
9.1.2. Overall Market Size and Forecast
9.2. ANG1005
9.3. 2B3-101
9.4. AGT-181
9.5. AGT 182
9.6. NP03
10. INTERVIEW TRANSCRIPTS
10.1. Xavier Rivero, Chief Operating Officer, Sagetis Biotech
10.2. Dr. Frank S Walsh, Ossianix, Founder & CEO
10.3. Rob Hutchison, biOasis, CEO & Chairman
11. CONCLUSION
11.1. BBB Technologies: Early Stages of Development but Highly Promising
11.2. Start-Ups Lead the Baton; Landscape Likely to Evolve in Mid-Long Term
11.3. Growing Patient Population and A Huge Unmet Need are Amongst the Several Growth Drivers
11.4. Concluding Remarks
12. APPENDIX 1: TABULATED DATA
13. APPENDIX 2: LIST OF COMPANIES
LIST OF FIGURES
Figure 3.1 BBB: Historical Evolution
Figure 3.2 BBB: Developmental Milestones
Figure 3.3 BBB: Transport Systems
Figure 4.1 BBB Technologies: Distribution by Type of Technology
Figure 4.2 BBB RMT Technologies: Distribution by Process Followed
Figure 4.3 BBB Penetrant Drugs: Distribution by Target Indication
Figure 4.4 BBB Penetrant Drugs: Distribution by Phase of Development
Figure 4.5 BBB Penetrant Drugs: Distribution by Technology Developers
Figure 4.6 BBB Penetrant Biologic Drugs: Distribution by Nature of Molecule
Figure 5.1 Neurological Indications: Bubble Chart Analysis
Figure 5.2 Alzheimer’s Disease: Market Potential
Figure 5.3 Epilepsy: Market Potential
Figure 5.4 Parkinson’s disease: Market Potential
Figure 5.5 Multiple Sclerosis: Market Potential
Figure 5.6 Hunter’s Syndrome: Market Potential
Figure 5.7 Brain Cancer: Market Potential
Figure 7.1 Nanomerics: Fabrication of a MET nanoparticle
Figure 9.1 BBB Technologies Sales Forecast: Short-Mid Term, 2019 - 2025: Base Scenario (USD Million)
Figure 9.2 BBB Technologies Sales Forecast: Mid-Long Term, 2025 - 2030: Base Scenario (USD Million)
Figure 9.3 ANG1005 Sales Forecast: Short-Mid Term, 2019 - 2025: Base Scenario (USD Million)
Figure 9.4 ANG1005 Sales Forecast: Mid-Long Term, 2025 - 2030: Base Scenario (USD Million)
Figure 9.5 2B3101 Sales Forecast: Short-Mid Term, 2020 - 2025: Base Scenario (USD Million)
Figure 9.6 2B3101 Sales Forecast: Mid-Long Term, 2025 - 2030: Base Scenario (USD Million)
Figure 9.7 AGT181 Sales Forecast: Mid-Long Terms, 2023 - 2030: Base Scenario (USD Million)
Figure 9.8 AGT182 Sales Forecast: Mid-Long Terms, 2023 - 2030: Base Scenario (USD Million)
Figure 9.9 NP03 Sales Forecast: Short-Mid Term, 2020 - 2025: Base Scenario (USD Million)
Figure 9.10 NP03 Sales Forecast: Mid-Long Term, 2025 - 2030: Base Scenario (USD Million)
Figure 11.1 BBB Technologies Market: Key Growth Drivers
Figure 11.2 BBB Technologies Market, 2019, 2025, 2030 (USD Million)
LIST OF TABLES
Table 3.1 Component of Human Brain: Important Characteristics
Table 3.2 CNS Drug Delivery Devices
Table 3.3 BBB: Functions Involved
Table 3.4 Saturable Blood to Brain Transporters
Table 4.1 BBB Technology Platforms
Table 4.2 BBB Technologies: Pipeline Drugs
Table 4.3 Other Potential Candidates
Table 4.4 Competing Technologies
Table 4.5 Comparison Chart: Non-Invasive BBB Technologies v/s Competing BBB Technologies
Table 5.1 Alzheimer’s disease: Key Facts
Table 5.2 Alzheimer’s disease: Example Marketed Drugs
Table 5.3 Epilepsy: Key Facts
Table 5.4 Epilepsy: Example Marketed Drugs
Table 5.5 Parkinson’s Disease: Key Facts
Table 5.6 Parkinson’s Disease: Example Marketed Drugs
Table 5.7 Parkinson’s disease: Pipeline Drugs Based on BBB Technologies
Table 5.8 Multiple Sclerosis: Key Facts
Table 5.9 Multiple Sclerosis: Example Marketed Drugs
Table 5.10 Hunter’s Syndrome: Key Facts
Table 5.11 Hunter’s Syndrome: Pipeline Drugs Based on BBB Technologies
Table 5.12 Brain Cancer: Key Facts
Table 5.13 Brain Cancer: Example Marketed Drugs
Table 5.14 Brain Cancer: Pipeline Drugs Based on BBB Technologies
Table 7.1 BBB Technologies: Concepts Involved
Table 7.2 Ossianix: Company Overview
Table 7.3 Roche: Company Overview
Table 7.4 Roche: Neurology Pipeline
Table 7.5 Other Bispecific Antibodies Based BBB Technologies
Table 7.6 biOasis: Company Overview
Table 7.7 biOasis: Pipeline
Table 7.8 biOasis: Partnerships Deals
Table 7.9 Angiochem: Company Overview
Table 7.10 Angiochem: Pipeline
Table 7.11 Iproteos: Company Overview
Table 7.12 Iproteos: Pipeline
Table 7.13 ArmaGen: Company Overview
Table 7.14 ArmaGen: Pipeline
Table 7.15 Vect-Horus: Company Overview
Table 7.16 Vect-Horus: Pipeline
Table 7.17 Vect-Horus: Patents
Table 7.18 BBB Therapeutics: Company Overview
Table 7.19 BBB Therapeutics: Pipeline
Table 7.20 BBB Therapeutics: Partnerships
Table 7.21 Sagetis Biotech: Company Overview
Table 7.22 Sagetis Biotech: Pipeline
Table 7.23 Other BBB Technologies Based on Trojan Horse Approach
Table 7.24 CarThera: Company Overview
Table 7.25 BrainsGate: Company Overview
Table 7.26 Other BBB Technologies Based on Increasing the Permeability
Table 7.27 ICBI: Company Overview
Table 7.28 ICBI: Pipeline
Table 7.29 Nanomerics: Company Overview
Table 7.30 Nanomerics: Pipeline
Table 7.31 Other Non-Invasive BBB Approaches
Table 8.1 Shire: Company Overview
Table 8.2 Shire: Neurology Pipeline
Table 8.3 Eisai: Company Overview
Table 8.4 Eisai: Neurology Pipeline
Table 8.5 BioMarin: Company Overview
Table 8.6 BioMarin: Neurology Pipeline
Table 9.1 Current Development Phase and Expected Launch Year of Drugs in Clinical Development
Table 12.1 BBB Technologies: Distribution by Type of Technology
Table 12.2 BBB RMT Technologies: Distribution by Process Followed
Table 12.3 BBB Penetrant Drugs: Distribution by Target Indication
Table 12.4 BBB Penetrant Drugs: Distribution by Phase of Development
Table 12.5 BBB Penetrant Drugs: Distribution by Technology Developers
Table 12.6 BBB Penetrant Biologic Drugs: Distribution by Nature of Molecule
Table 12.7 BBB Technologies Sales Forecast: Short-Mid Term, 2019 - 2025: Base Scenario (USD Million)
Table 12.8 BBB Technologies Sales Forecast: Mid-Long Term, 2025 - 2030: Base Scenario (USD Million)
Table 12.9 BBB Technologies Sales Forecast: Short-Mid Term, 2019 - 2025: Conservative Scenario (USD Million)
Table 12.10 BBB Technologies Sales Forecast: Mid-Long Term, 2025 - 2030: Conservative Scenario (USD Million)
Table 12.11 BBB Technologies Sales Forecast: Short-Mid Term, 2019 - 2025: Optimistic Scenario (USD Million)
Table 12.12 BBB Technologies Sales Forecast: Mid-Long Term, 2025 - 2030: Optimistic Scenario (USD Million)
Table 12.13 ANG1005 Sales Forecast: Short-Mid Term, 2019 - 2025: Base Scenario (USD Million)
Table 12.14 ANG1005 Sales Forecast: Mid-Long Term, 2025 - 2030: Base Scenario (USD Million)
Table 12.15 ANG1005 Sales Forecast: Short-Mid Term, 2019 - 2025: Conservative Scenario (USD Million)
Table 12.16 ANG1005 Sales Forecast: Mid-Long Term, 2025 - 2030: Conservative Scenario (USD Million)
Table 12.17 ANG1005 Sales Forecast: Short-Mid Term, 2019 - 2025: Optimistic Scenario (USD Million)
Table 12.18 ANG1005 Sales Forecast: Mid-Long Term, 2025 - 2030: Optimistic Scenario (USD Million)
Table 12.19 2B3-101 Sales Forecast: Short-Mid Term, 2020 - 2025: Base Scenario (USD Million)
Table 12.20 2B3-101 Sales Forecast: Mid-Long Term, 2025 - 2030: Base Scenario (USD Million)
Table 12.21 2B3-101 Sales Forecast: Short-Mid Term, 2020 - 2025: Conservative Scenario (USD Million)
Table 12.22 2B3-101 Sales Forecast: Mid-Long Term, 2025 - 2030: Conservative Scenario (USD Million)
Table 12.23 2B3-101 Sales Forecast: Short-Mid Term, 2020 - 2025: Optimistic Scenario (USD Million)
Table 12.24 2B3-101 Sales Forecast: Mid-Long Term, 2025 - 2030: Optimistic Scenario (USD Million)
Table 12.25 AGT-181 Sales Forecast: Mid-Long Term, 2023 - 2030: Base Scenario (USD Million)
Table 12.26 AGT-181 Sales Forecast: Mid-Long Term, 2023 - 2030: Conservative Scenario (USD Million)
Table 12.27 AGT-181 Sales Forecast: Mid-Long Term, 2023 - 2030: Optimistic Scenario (USD Million)
Table 12.28 AGT-182 Sales Forecast: Mid-Long Term, 2023 - 2030: Base Scenario (USD Million)
Table 12.29 AGT-182 Sales Forecast: Mid-Long Term, 2023 - 2030: Conservative Scenario (USD Million)
Table 12.30 AGT-182 Sales Forecast: Mid-Long Term, 2023 - 2030: Optimistic Scenario (USD Million)
Table 12.31 NP03 Sales Forecast: Short-Mid Term, 2020 - 2025: Base Scenario (USD Million)
Table 12.32 NP03 Sales Forecast: Mid-Long Term, 2025 - 2030: Base Scenario (USD Million)
Table 12.33 NP03 Sales Forecast: Short-Mid Term, 2020 - 2025: Conservative Scenario (USD Million)
Table 12.34 NP03 Sales Forecast: Mid-Long Term, 2025 - 2030: Conservative Scenario (USD Million)
Table 12.35 NP03 Sales Forecast: Short-Mid Term, 2020 - 2025: Optimistic Scenario (USD Million)
Table 12.36 NP03 Sales Forecast: Mid-Long Term, 2025 - 2030: Optimistic Scenario (USD Million)

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