Blood-Brain Barrier (BBB) Market (2nd Edition), 2020-2030: Focus on Non-Invasive Drug Delivery Technology Platforms and Therapeutics

Blood-Brain Barrier (BBB) Market (2nd Edition), 2020-2030: Focus on Non-Invasive Drug Delivery Technology Platforms and Therapeutics

  • March 2020 •
  • 357 pages •
  • Report ID: 5893051 •
  • Format: PDF
INTRODUCTION
According to a study conducted by the World Health Organization (WHO), diseases that affect the central nervous system (CNS), such as Alzheimer’s disease, brain cancer, multiple sclerosis, Parkinson’s disease and stroke, are characterized by a significant unmet need for effective treatment options. In 2019, it was reported that nearly 1.5 billion people suffer from some form of disorder affecting the CNS across the globe. , , In fact, the incidence of CNS disorders is anticipated to increase by 12% by 2030. In 2019, nearly 5.8 million Americans were reported to have been diagnosed with Alzheimer’s disease. , Similarly, Parkinson’s disease was estimated to affect nearly one million people in America, with approximately 60,000 new patients being diagnosed every year. It was estimated that CNS disorders are responsible for a healthcare burden of nearly USD 2 trillion, in the US and Europe. Developing viable therapies against the aforementioned clinical conditions is largely complicated due to the elusive blood-brain barrier (BBB), a selectively permeable structure, which is very effective in preventing the entry of foreign substances, including drugs, into the brain. It has been reported that over 1,000 currently available / under development drugs targeting CNS disorders do not have the potential to target specific brain receptors responsible for the disease progression due to the hindrance by the BBB. Considering the serious physical, cognitive and psychosocial consequences that such indications have on patients, coupled to the alarming increase in their global prevalence, there is an urgent need for novel and effective treatment options that can cross the BBB.

Over time, extensive R&D efforts have resulted in the development of a number of versatile BBB penetration technologies. These technologies have been designed either to externally alter the permeability of the BBB or augment the BBB penetrating capabilities of compatible pharmacological interventions. As a result, presently, there is a lot of enthusiasm within the medical science community related to these technologies. The growing interest in this field is also evident in the fact that over 1,200 modern scientific articles have been published (as observed on NCBI’s PubMed portal) over the last three years alone. However, it is worth mentioning that there are currently no approved BBB penetrating drugs available in the market. Currently, this niche market is driven by technology licensing activity, with drug developers collaborating with platform providers to grow their respective therapeutic pipelines. In fact, over the last 4-5 years, there has been a marked rise in the number of new entrants in this field. We anticipate this upcoming market to witness substantial growth in the coming years.

SCOPE OF THE REPORT
The ‘Blood-Brain Barrier (BBB) Market, 2020-2030: Focus on Non-Invasive Drug Delivery Technology Platforms and Therapeutics (2nd Edition) (based on Receptor Mediated Transcytosis, Trojan Horse, and Nanoparticle based Approaches)’ report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of BBB penetration technologies and affiliated drugs, over the next decade. The report features an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in this domain. In addition to other elements, the study includes:
• An overview of the overall landscape of BBB penetration technologies, featuring an in-depth analysis of the technologies based on a number of parameters, such as status of development (developed and under development), affiliated approach, type of compatible pharmacological molecule(s) crossing the BBB (small molecule and biologic), target receptor(s), target disease indication(s), patent availability, and licensing activity. In addition, it presents a detailed assessment of BBB technology developers and analyses based on parameters, such as year of establishment, company size, and location of headquarters.
• A detailed assessment of the current market landscape of BBB penetrant drugs (based on the abovementioned technologies), providing information on drug developer(s) (such as year of establishment, company size, and location of headquarters), phase of development (clinical, preclinical, and discovery stage), type of molecule (small molecule and biologic), affiliated BBB penetration technology, route of administration (oral, intravenous, transmucosal and others), target disease indication(s), key therapeutic area(s), and information on special drug designation (if any).
• Identification of contemporary market trends, depicted using three schematic representations, which include [A] a tree map representation of the various industry players involved in the development of BBB penetrant drugs, distributed on the basis of the target disease indication(s) of pipeline candidates and size of the companies (small, mid-sized and large companies), [B] a bubble analysis comparing the leading players engaged in the development of BBB penetrant drugs, on the basis of parameters such as pipeline strength (based on the number of drug candidates developed by a particular company, across different phases of development), number of target disease indication(s) and the size of the developer company, and [C] an informative heptagon representation, highlighting the distribution of BBB penetrant drugs across popular target disease indication(s) (based on the number of drug candidates across each target disease indication).
• An insightful competitiveness analysis of BBB penetration technologies, taking into consideration the supplier power (based on company size and years of experience in this field) and key technology specific information, such as type of compatible pharmacological molecule(s) crossing the BBB, availability of patent protection, number of deals signed for a particular technology (2014-2020 (till March)), and popularity of the technology (in terms of the number of drugs developed using the technology).
• Elaborate profiles of prominent technology developers that are engaged in the development of at least four drugs (which are presently in both preclinical and clinical stages of development), featuring a brief overview of the company, its financial information (if available), BBB penetration technology overview, BBB penetrant product portfolio and an informed future outlook.
• An analysis of the partnerships that have been established in the domain, in the period between 2014 and 2020 (till March), covering product licensing agreements, technology licensing agreements, acquisitions and mergers, product development and commercialization agreements, research and development agreements, manufacturing agreements, service agreements and other agreements.
• An elaborate discussion on the deal structures of various types of technology licensing agreements inked in this domain, including details of the rights associated with product ownership, associated royalties and upfront payments, and other contractual terms / conditions involved as a part of the agreement between various industry stakeholders.
• An analysis of the investments made in the domain, in the period between 2014 and 2020 (till March), including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings, at various stages of development in companies that are engaged in this field.
• An in-depth analysis of the various patents that have been filed / granted related to BBB penetration technologies, till November 2019, taking into consideration various parameters, such as patent type, application year, issuing authority / patent offices involved, CPC symbols, emerging focus areas, type of organization and leading industry / academic players (in terms of size of intellectual property portfolio). It also includes a patent benchmarking analysis and a detailed valuation analysis.
• An insightful chessboard analysis highlighting the most preferred / popular drug development strategies / paths adopted by majority of the drug developers (with clinical candidates) in order to progress their lead drug candidates.
• An assessment of the most commonly targeted disorders affecting the CNS (shortlisted on the basis of number of BBB penetrant drugs in development), along with [A] an insightful 3D bubble chart highlighting the market potential of these disorders, based on the number of already approved drugs, number of pipeline drugs and the target patient population, and [B] an elaborate discussion on key epidemiological facts about specific diseases, causes, symptoms, details of BBB penetrant drugs that are being developed against them, currently available treatment options and details of already marketed drugs for each indication.
• A list of 240+ drug developers targeting Alzheimer’s disease and Parkinson’s disease that are likely to partner with BBB penetration technology providers, and have been shortlisted on the basis of parameters, such as developer strength (based on company size and years of experience in this field), company’s pipeline strength and maturity (based on the number of drugs and affiliated stage of development), indication overlap, molecule type overlap, route of administration, mechanism of action, and the availability of in-house delivery technology.
• A case study highlighting the working principle of the most common approaches that are being employed for the development of BBB penetration technologies, such as receptor mediated transcytosis (RMT) (including bispecific antibodies and molecular trojan horse mediated delivery either by direct coupling or using nanocarriers), increasing permeability to the BBB, passive diffusion approach, and other novel approaches (including cell-penetrating peptides, macrocycles, and organ-on-a-chip technology).
• An informative analysis of contemporary Google Trends in the time period between 2015 and 2019 (till December) and insights generated from recent news articles related to the BBB, indicating the increasing popularity of this domain.
One of the key objectives of the report was to estimate the existing market size and identify potential growth opportunities for BBB penetration technologies and affiliated therapeutics, over the next decade. Based on likely licensing deal structures and agreements that are expected to be inked in the foreseen future, we have provided an informed estimate of the evolution of the market for the period 2020-2030. In addition, we have provided information on (potential) sales-based revenues generated by BBB penetrant drugs that are currently in late stages of development for the treatment of different CNS disorders, based on parameters, such as target consumer segments, likely adoption rates, expected pricing and associated risk-adjustment sales opportunity. The report also features the likely distribution of the current and forecasted opportunity across [A] type of molecule (small molecules and biologics), [B] target disease indications (brain metastases in breast cancer, glioblastoma multiforme, Hurlers syndrome, and Hunter syndrome), [C] key contributing technologies, [D] leading drug developers, and [E] key geographical regions (North America, Europe, Asia-Pacific and rest of the world). In order to account for the uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in this study were also influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:
• Ram Bhatt (Chief Executive Officer, Chairman and Founder, Innovative California Biosciences International (ICBI))
• Frank S Walsh (Chief Executive Officer and Founder, Ossianix)
• Pieter Gaillard (Chief Executive Officer and Co-Founder, 2-BBB)
• Mathias Schmidt (Chief Executive Officer, ArmaGen)
• Rob Hutchison (Chief Executive Officer and Chairman, biOasis Technologies)
• Mark L Peterson (Chief Operating Officer, Cyclenium Pharma)
• Xavier Rivero (Chief Operating Officer, Sagetis Biotech)
• Carole Desseaux (Head of Clinical Affairs, CarThera)
• Jamal Temsamani (Head of Drug Development, Vect-Horus)
• Kevin Kit Parker (Professor, Wyss Institute, Harvard University)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
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 till 2030, the report also provides our independent view on 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 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of BBB penetration technologies and therapeutics market and its likely evolution in the short-mid term and long term.

Chapter 3 is an introductory chapter that highlights important concepts related to the structure of human brain, its components and their functions in the central nervous system (CNS). It also presents an elaborate discussion on the different invasive and non-invasive strategies used to deliver drugs into the CNS. Further, the chapter provides an overview of the concept of BBB, historical evolution, including its role for efficient drug delivery. Furthermore, it provides information on the popular concepts used to develop BBB permeable drugs and technologies or to bypass the barrier. The chapter also includes a discussion on the key challenges associated with the use of BBB penetration technologies for efficient drug delivery to CNS. Additionally, it includes an analysis of contemporary Google Trends (till 2019) and insights from recent news articles related to the BBB, indicating the increasing popularity of this domain.

Chapter 4 provides a detailed overview of the overall landscape of BBB penetration technology providers. It features an in-depth analysis of the BBB penetration technologies, based on a number of parameters, such as status of development (developed and under development), affiliated approach, type of compatible pharmacological molecule(s) crossing the BBB (small molecule and biologic), target receptor(s), target disease indication(s), patent availability, and licensing activity. In addition, the chapter highlights a detailed landscape of BBB technology developers and analyses based on parameters, such as year of establishment, company size, and location of headquarters.

Chapter 5 includes a detailed assessment of the current market landscape of over 100 BBB penetrant drugs that are currently being evaluated in different stages of development. It features a comprehensive analysis of pipeline molecules based on their phase of development (clinical, preclinical, and discovery stage), type of molecule (small molecule and biologic), affiliated BBB penetration technology, route of administration (oral, intravenous, transmucosal and others), target disease indication(s), key therapeutic area(s), and information on special drug designation (if any). Further, the chapter provides information on drug developer(s), highlighting their year of establishment, company size, and location of headquarters. It also focuses on the identification of contemporary market trends, depicted using three schematic representations, which include [A] a tree map representation of the various industry players involved in the development of BBB penetrant drugs, distributed on the basis of the target disease indication(s) of pipeline candidates and size of the companies (small, mid-sized and large companies), [B] a bubble analysis comparing the leading players engaged in the development of BBB penetrant drugs, on the basis of parameters such as pipeline strength (based on the number of drug candidates developed by a particular company, across different phases of development), number of target disease indication(s) and the size of the developer company, and [C] an informative heptagon representation, highlighting the distribution of BBB penetrant drugs across popular target disease indication(s) (based on the number of drug candidates across each target disease indication).

Chapter 6 features elaborate profiles of prominent technology developers that are engaged in the development at least four drugs (which are presently in both preclinical and clinical stages of development). Each company profile features a brief overview of the company, its financial information (if available), BBB penetration technology overview, BBB penetrant product portfolio and an informed future outlook.
Chapter 7 presents a competitiveness analysis of BBB technologies, taking into consideration the supplier power (based on company size and years of experience in this field) and key technology specific information, such as type of compatible pharmacological molecule(s) crossing the BBB, availability of patent protection, number of deals signed for a particular technology (2014-2020 (till March)), and popularity of the technology (in terms of the number of drugs developed using the technology). The analysis was designed to enable stakeholder companies to compare their existing capabilities within and beyond their respective peer groups and identify opportunities to achieve a competitive edge in the industry.

Chapter 8 features a discussion on the working principle of the most common approaches being utilized for the development of BBB penetration technologies, such as RMT (including bispecific antibodies and molecular trojan horse mediated delivery either by direct coupling or using nanocarriers), increasing permeability to the BBB, passive diffusion approach, and other novel approaches (including cell-penetrating peptides, macrocycles, and organ-on-a-chip technology).

Chapter 9 features an in-depth analysis and discussion on the various partnerships inked between the players in this market in the time period between 2014 and 2020 (till March), covering product licensing agreements, technology licensing agreements, acquisitions and mergers, product development and commercialization agreements, research and development agreements, manufacturing agreements, service agreements and other agreements.

Chapter 10 provides an elaborate discussion on the deal structures of various types of technology licensing agreements inked in this domain, including details of the rights associated with product ownership, associated royalties and upfront payments, and other contractual terms / conditions involved as a part of the agreement between various industry stakeholders.

Chapter 11 presents details on various investments received by companies that are focused on developing BBB penetration technologies and drugs. It also includes an analysis of the funding instances that have taken place in the market, up to 2020 (till March), highlighting the growing interest of the venture capital (VC) community and other strategic investors within this domain.

Chapter 12 provides an in-depth patent analysis to provide an overview of how the industry is evolving from the R&D perspective. For this analysis, we considered those patents that have been filed / granted related to BBB penetration technologies till November 2019. The analysis also highlights the key trends associated with these patents, across patent type, application year, issuing authority / patent offices involved, CPC symbols, emerging focus areas, type of organization and leading industry / academic players (in terms of size of intellectual property portfolio). It also includes a patent benchmarking analysis and a detailed valuation analysis.
Chapter 13 features an insightful chessboard analysis highlighting the most preferred / popular drug development strategies / paths adopted by majority of the drug developers with clinical candidates engaged in this domain. The analysis was designed to enable stakeholder companies to improve their existing drug development strategies in order to accelerate the progress of their lead drug candidates.

Chapter 14 presents an insightful 3D bubble chart highlighting the market potential of the most commonly targeted disorders affecting the CNS (shortlisted on the basis of number of BBB penetrant drugs in development), based on the number of already approved drugs, number of pipeline drugs and the target patient population. It also includes an elaborate discussion on key epidemiological facts about specific diseases, causes, symptoms, details of BBB penetrant drugs that are being developed against them, currently available treatment options and details of already marketed drugs for each respective indication.

Chapter 15 presents a list of 240+ drug developers targeting Alzheimer’s disease and Parkinson’s disease that are likely to partner with BBB penetration technology providers, and have been shortlisted on the basis of parameters, such as developer strength (based on company size and years of experience in this field), company’s pipeline strength and maturity (based on the number of drugs and affiliated stage of development), indication overlap, molecule type overlap, route of administration, mechanism of action, and the availability of in-house delivery technology.

Chapter 16 features a comprehensive market forecast, highlighting the future potential of this market till 2030 based on likely licensing deal structures and agreements that are expected to be signed in the foreseen future. In addition, we have provided information on (potential) sales-based revenues generated by BBB penetrant drugs that are currently in late stages of development for the treatment of different CNS disorders, based on parameters, such as target consumer segments, likely adoption rates, expected pricing and associated risk-adjustment sales opportunity. The chapter also features the likely distribution of the current and forecasted opportunity across [A] type of molecule (small molecules and biologics), [B] target disease indications (brain metastases in breast cancer, glioblastoma multiforme, Hurlers syndrome, and Hunter syndrome), [C] key contributing technologies, [D] leading drug developers, and [E] key geographical regions (North America, Europe, Asia-Pacific and rest of the world).

Chapter 17 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 18 is a collection of interview transcripts of discussions held with various key stakeholders in this market. The chapter provides a brief overview of the companies and details of interviews held with Ram Bhatt (CEO, Chairman and Founder, Innovative California Biosciences International (ICBI)), Frank S Walsh (CEO and Founder, Ossianix), Pieter Gaillard (CEO And Co-Founder, 2-BBB), Mathias Schmidt (CEO, ArmaGen), Rob Hutchison (CEO and Chairman, biOasis Technologies), Mark L Peterson (Chief Operating Officer, Cyclenium Pharma), Xavier Rivero (Chief Operating Officer, Sagetis Biotech), Carole Desseaux (Head of Clinical Affairs, CarThera), Jamal Temsamani (Head of Drug Development, Vect-Horus), and Kevin Kit Parker (Professor, Wyss Institute, Harvard University)

Chapter 19 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 20 is an appendix, which contains the list of companies and organizations mentioned in the report.