Cell Encapsulation: Focus on Therapeutics and Technologies, 2019-2030

NEW YORK, May 15, 2019 /PRNewswire/ -- INTRODUCTION
Chronic disorders, such as diabetes, cancer, heart disease, obesity, and certain types of mental health problems, are considered among the leading causes of death and disability across the globe. According to a report published by the Center for Managing Chronic Disease at the University of Michigan in 2018, more than 50% of the global population lives with some form of chronic illness. In 2018, the global prevalence of diabetes (considered to be one of the fastest-growing clinical conditions) was estimated to be around 425 million; likewise, around 450 million people worldwide are suffering from some form of mental health problem and / or neurological disorder. In addition, the World Health Organization (WHO) reported that different forms of cancers account for about 0.6 million deaths annually in the US alone. , Over the years, advances in cell biology and regenerative medicine have led to the development of various cell-based therapies, which claim to possess the potential to address several unmet needs related to the treatment of different chronic clinical conditions. However, there are certain evident challenges, such as scarcity of viable donors, inherent immunogenicity, complications related to supply of oxygen / essential nutrients to grafted cells, drug delivery limitations, and the need for frequent re-administration of cells, which have so far restricted the use of cell-based interventions.

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Extensive research on cell encapsulation strategies have enabled the development of a variety of technologies capable of confining therapeutic entities within biocompatible matrices / carriers. Encapsulated therapy products offer a myriad of advantages, and have been shown to be capable of addressing existing concerns related to cell sourcing, obviating the need for complex surgical procedures, and enabling targeted drug delivery without the need for immunosuppressive follow-on regimens. In fact, since 2013, over 3,000 patents have been published related to the aforementioned type of therapy, indicating the rapid pace of R&D activities in this domain. Stakeholders have also received significant support from both private and public investors. However, the commercial success of such products is still dependent on ongoing clinical studies, as no such therapy has yet been approved.

SCOPE OF THE REPORT
The ‘Cell Encapsulation: Focus on Therapeutics and Technologies, 2019-2030’ report features an extensive study of the current market landscape and the future potential of encapsulated cell therapies and affiliated technologies. It is worth mentioning that the study also provides insights on therapy products wherein other active drug substances have been encapsulated within living cells.

Amongst other elements, the report features:
A detailed assessment of the current market landscape of encapsulated cell therapies and affiliated technologies, highlighting various target disease indications, phase of development, encapsulation method, type of cells / API, and route of administration, along with information on various stakeholder companies that are developing novel encapsulation methods / techniques for use in storage and transportation of cells, as well as other applications.
Comprehensive profiles of industry players that are currently engaged in the preclinical / clinical development of their proprietary encapsulated cell therapies, featuring an overview of the company, its financial information (if available), and a detailed description of its product(s), highlighting mechanism of action, current development status, and key preclinical / clinical trial results. Each profile also includes a list of recent developments, highlighting the key milestones achieved, partnership activity, and the likely strategies that may be adopted by these players to fuel growth in the in the foreseen future.
An in-depth analysis of the patents that have been published related to cell encapsulation technologies, since 2013. The analysis also highlights the key trends associated with these patents, across patent type, regional applicability, CPC classification, emerging focus areas, leading industry players (in terms of number of patents filed / granted), and current intellectual property-related benchmarks and valuation.
A comprehensive clinical trial analysis of completed, ongoing and planned studies of various encapsulated cell therapies. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial start year, trial status, phase of development, leading industry and non-industry players (in terms of number of trials conducted), study design, target therapeutic area, key indications, study focus, clinical endpoints, and enrolled patient population and regional distribution of trials.
An analysis of the partnerships that have been established in the domain in the period 2013-2018, covering R&D collaborations, licensing agreements, mergers and acquisitions, product development and / or commercialization agreements, manufacturing agreements, clinical trial agreements, process development agreements, and other relevant deals.
An analysis of the investments made at various stages of development, such as seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings received by companies that are focused in this area. The report also features a detailed study on the various grants that have been awarded to research institutes in this field.
An analysis highlighting potential strategic partners (for instance, manufacturers) for encapsulated therapy developers based on multiple parameters, such as therapeutic focus overlap, cell type overlap, research programs, existing collaborations, and developer strength.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on likely licensing deal structures and agreements that are expected to be signed in the foreseen future, we have provided an informed estimate on the likely evolution of the market for the period 2019-2030. In addition, we have provided information on (potential) sales-based revenues generated by encapsulated cell therapies that are currently in late stages of development for the treatment of different chronic disorders, based on parameters, such as target consumer segments, likely adoption rates and expected pricing. The report features likely distribution of the current and forecasted opportunity across [A] different therapeutic areas (eye disorders, metabolic disorders, neurological disorders, and oncological disorders), [B] target disease indications (ataxia telangiectasia, breast cancer, diabetes, glaucoma, head and neck cancer, macular telangectasia, pancreatic cancer, Parkinson’s disease, and retinitis pigmentosa), [C] type of encapsulation material used (alginate-based microcapsules, cellulose hydrogels, medical-grade plastics, and red blood cells), and [D] key geographical regions (North America, Europe and Asia Pacific). To account for the uncertainties associated with the development of novel therapy products and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

The opinions and insights presented in this study were influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:
Alexander Scheer (Chief Scientific Officer, Erytech Pharma)
Manuel Pires (Business Developer, Defymed)
Michel Revel (Chief Scientist, Kadimastem) and Galit Mazooz-Perlmuter (Business Development Manager, Kadimastem)
Mick McLean (Chief Executive Officer, Atelerix)
Quinton Oswald (Former President and Chief Executive Officer, Neurotech Pharmaceuticals)
William L Rust (Founder and Chief Executive Officer, Seraxis)
Yuval Avni (Former Chief Executive Officer, Beta-O2 Technologies)

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 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 various 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 insights captured in our research. The summary offers a high-level view on the likely evolution of encapsulated cell therapies and affiliated technologies market in the mid to long term.

Chapter 3 is an introductory chapter that presents a general overview of cell-based therapies and the intricacies of their development and administration, along with information on the key challenges associated with them. Further, it features a detailed discussion on cell encapsulation, including a comprehensive history of development, and information on different types of cell encapsulation methods and materials. It also features a discussion on the key advantages / challenges associated with encapsulated cell therapies and affiliated technologies, providing information on their potential usability across different application areas. Further, the chapter features a discussion on the key growth drivers and road blocks related to cell encapsulation technologies and their use in treating various chronic conditions.

Chapter 4 includes information on more than 40 encapsulated cell therapies and affiliated technologies that are currently being developed by industry players for treating different chronic conditions. It features a comprehensive analysis of pipeline therapies and technologies, highlighting the target disease indications, phase of development, encapsulation method, type of cells / API, and route of administration. The chapter also highlights the contributions of various stakeholder companies that are developing novel encapsulation methods / techniques for use in storage and transportation of cells, as well as other applications. Additionally, the chapter features information on the initiatives undertaken by big pharmaceutical companies and academic players within this domain.

Chapter 5 includes elaborate profiles of industry players that are currently engaged in the clinical development of their proprietary encapsulated cell therapies for the treatment of metabolic disorders; each profile features an overview of the company, its financial information (if available), and a detailed description of its product(s), highlighting mechanism of action, current development status, and key clinical trial results. Each profile also includes a list of recent developments, the key milestones achieved, partnership activity, and the likely strategies that may be adopted by these players to fuel growth in the foreseen future. Further, for developers with early stage (preclinical) candidates, we have presented brief profiles, highlighting key details about the company, product portfolio, recent developments, and the likely roadmap / future plans related to the development and commercialization of their products (if available).

Chapter 6 includes elaborate profiles of industry players that are currently engaged in the clinical development of their proprietary encapsulated cell therapies for the treatment of non-metabolic disorders; each profile features an overview of the company, its financial information (if available), and a detailed description of its product (s), highlighting mechanism of action, current development status, and key clinical trial results. Each profile also includes a list of recent developments, the key milestones achieved, partnership activity, and the likely strategies that may be adopted by these players to fuel growth in the foreseen future. Further, for developers with early stage (preclinical) candidates, we have presented brief profiles, highlighting key details about the company, product portfolio, recent developments, and the likely roadmap / future plans related to the development and commercialization of their products (if available).

Chapter 7 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 published since 2013 related to the cell encapsulation domain. The analysis also highlights the key trends associated with these patents, including patent type, regional applicability, CPC classification, emerging focus areas, leading industry players (in terms of number of patents filed / granted), and current intellectual property-related benchmarks and valuation.

Chapter 8 provides a comprehensive clinical trial analysis of completed, ongoing and planned studies of various encapsulated cell therapies. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial start year, trial status, phase of development, leading industry and non-industry players (in terms of number of trials conducted), study design, targeted therapeutic area, key indications, study focus, clinical endpoints, and enrolled patient population and regional distribution of trials.

Chapter 9 features an elaborate discussion and analysis of partnerships / collaborations that have been established in the domain in the period 2013-2018. It includes a brief description of various types of partnership models (such as product development / commercialization agreements, R&D collaborations, technology licensing deals, distribution agreements, mergers / acquisitions, and others) that have been employed by stakeholders within this domain. It also consists of a schematic representation showcasing the players that have established the maximum number of alliances related to encapsulated cell therapies and affiliated technologies. Furthermore, we have provided a world map representation of all the deals inked in this field, highlighting those that have been established within and across different continents.

Chapter 10 provides information on funding instances and investments that have been made within the cell encapsulation domain. The chapter includes details on various types of investments (such as seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings) received by companies between 2013 and 2018, highlighting the growing interest of the venture capital community and other strategic investors in this domain.

Chapter 11 provides a detailed analysis of academic grants that have been awarded to support research related to encapsulated cell therapies and affiliated technologies. For the purpose of this analysis, we considered those academic grants that have been awarded within this domain since 2013. In addition to highlighting key funding institutes, the chapter provides several emerging encapsulation methods, target indications and type of cells, across which majority of the research work is currently focused.

Chapter 12 features an insightful analysis, highlighting potential strategic partners (for instance, manufacturers) for encapsulated therapy developers, based on multiple parameters, such as therapeutic focus overlap, cell type overlap, research programs, existing collaborations, and developer strength. The analysis aims to provide the necessary inputs to the latter type of stakeholders, enabling them to make the right decisions to take their proprietary therapies / technologies from concept to the market with the help the appropriate partner entities.

Chapter 13 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 encapsulated cell therapies that are currently in late stages of development for the treatment of different chronic disorders, based on parameters, such as target consumer segments, likely adoption rates and expected pricing. The report features likely distribution of the current and forecasted opportunity across [A] different therapeutic areas (eye disorders, metabolic disorders, neurological disorders, and oncological disorders), [B] target disease indications (ataxia telangiectasia, breast cancer, diabetes, glaucoma, head and neck cancer, macular telangectasia, pancreatic cancer, Parkinson’s disease, and retinitis pigmentosa), [C] type of encapsulation material used (alginate-based microcapsules, cellulose hydrogels, medical-grade plastics, and red blood cells), and [D] key geographical regions (North America, Europe and Asia Pacific).

Chapter 14 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 15 is a collection of executive insights of the discussions that were held with various key stakeholders in this market. The chapter provides a brief overview of the companies and details of interviews held with Alexander Scheer (Chief Scientific Officer, Erytech Pharma), Manuel Pires (Business Developer, Defymed), Michel Revel (Chief Scientist, Kadimastem) and Galit Mazooz-Perlmuter (Business Development Manager, Kadimastem), Mick McLean (Chief Executive Officer, Atelerix), Quinton Oswald (Former President and Chief Executive Officer, Neurotech Pharmaceuticals), William L Rust (Founder and Chief Executive Officer, Seraxis), and Yuval Avni (Former Chief Executive Officer, Beta-O2 Technologies).

Chapter 16 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 17 is an appendix, which provides the list of companies and organizations mentioned in the report.

EXAMPLE HIGHLIGHTS
1. Till date, more than 30 encapsulated cell therapy products have been evaluated across different stages of development; while majority of pipeline candidates are presently in preclinical / early discovery stage, some products are already in mid to late-stage (phase II and above) of development and are likely to enter the market in the next 5-10 years. Examples of late stage clinical candidates include (in alphabetical order) DIABECELL® (Diatranz Otsuka), GRASPA® (Erytech Pharma), EryDex System (EryDel), MXV-ONCO-1 (MaxiVAX), NT-501 (Neurotech Pharmaceuticals), NTCELL®, and Cell-in-a-Box® (PharmaCyte Biotech).
2. The niche market landscape is fragmented, featuring a mix of small-sized, mid-sized and large companies. Some of the players that have recently (over the past 5-6 years) entered the market include (in reverse chronological order), Atelerix (2017), Encellin (2016), Betalin Therapeutics (2015), Semma Therapeutics (2015), Sigilon Therapeutics (2015), ViCapsys (2015), MaxiVAX (2013), and Seraxis (2013). It is worth mentioning that the field has also witnessed significant contributions from the established players, such as (in alphabetical order) Eli Lilly, Novo Nordisk, Otsuka Pharmaceutical Factory, Sanofi, and Takeda Pharmaceutical. Most of such companies are presently evaluating proprietary therapy candidates in the preclinical / early stages of development.
3. Around 45% of pipeline candidates are being developed for the treatment of metabolic disorders; of these, more than 70% are being investigated for the treatment of type 1 diabetes. Examples include (in alphabetical order) •Air Bio-artificial Pancreas (Beta-O2 Technologies), hPSC (Kadimastem), Neo-Islets (SymbioCellTech), PEC-Encapâ„¢ (ViaCyte), Sig-002 (Sigilon Therapeutics / Eli Lilly), SR-01 (Seraxis), and TARGETBCD (Evotec / Sanofi). Further, close to 20% of product candidates in the pipeline are being evaluated for the treatment of different forms of cancers (such as abdominal cancer, breast cancer, head and neck cancer, pancreatic cancer, and other solid tumor indications). Other therapeutic areas for which such therapies are under evaluation include neurological disorders, eye disorders, inflammatory disorders, cardiovascular disorders, and orthopedic injuries.
4. Nearly 25% of pipeline candidates are based on alginate-based microcapsule technologies, owing to favorable properties, such as biocompatibility, biodegradability, stability and adjustable porosity. Other materials that are increasingly being utilized in encapsulated therapy products include (in decreasing order of number of pipeline candidates) biocompatible polymer membranes (13), cellulose hydrogels (11), and red blood cells (8), and three-dimensional biological scaffolds (5).
5. Further, around 20% of encapsulated therapy products utilize certain types of recombinant cell lines that can secrete growth factors / immune-boosters for treating chronic clinical conditions. Examples of such therapy candidates include (in alphabetical order) Cell-in-a-Box® (PharmaCyte Biotech), EC-NGF and EC-GDNF (Gloriana Therapeutics), MVX-ONCO-1 (MaxiVAX), NT-501 (Neurotech Pharmaceuticals), and TheraCyte™ system (TheraCyte).
6. Over 3,000 patents related to various cell encapsulation technologies were filed / granted in the period 2013-2018. In fact, since 2014, more than 500 patents have been filed / granted each year across the globe, with close to 580 in 2018 alone. It is worth highlighting that around 52% of the aforementioned patents were filed / granted in the US; other key regions with significant intellectual capital related to encapsulated cell therapies include (in decreasing order of number of patents filed / granted) Australia, Europe, Canada, Japan, China, and Israel.
7. Presently, more than 50 clinical studies have been registered (completed / ongoing / planned) across different geographies, evaluating various encapsulated therapy products. It is important to mention that several organizations, such as Stanford University, National Eye Institute, National Institutes of Health Clinical Center, University Hospital Brussels, Lowy Medical Research Institute, and Thomas Jefferson University have emerged as leading non-industry sponsors / collaborators in clinical research efforts in this domain.
8. Development efforts have been backed by various private and public investors, resulting in significant capital investments. In fact, since 2013, close to USD 1.0 billion (across 98 funding instances) has been invested in companies involved in the development of encapsulated cell therapies and affiliated technologies. In 2018 alone, 12 funding instances were reported, amounting to a total capital investment worth around USD 150 million. Moreover, in last six years, more than 70 grants were awarded to various academic / research institutes in the US alone. Majority of these grants were provided to support research projects (31%) under the R01 mechanism, followed by grants awarded under R21 mechanism (exploratory / development grants, 14%). Around 15% of the instances were Small Business Innovation Research (SBIR) grants (R43 / R44 mechanism).
9. Multiple partnerships and collaborations have also been established between various stakeholders in the period 2013-2018. Research and product development agreements were the most popular type of deals inked in this domain, each representing 20% of the total number of collaborations. Recent examples of such deals include agreement between Sigilon Therapeutics and Massachusetts Institute of Technology (December 2018), Sernova and HemAcure Consortium (November 2018), Betalin Therapeutics and Zhongguancun Lianchuang Medical Engineering Transformation Center (October 2018), Kadimastem and Defymed (June 2018), and Biogelx and PL BioScience (May 2018). In addition, based on past deal trends, we analyzed the contemporary development landscape (300+ companies) to identify companies that have the necessary expertise to help other players across various development processes in this field, highlighting the likely strategic partners across different regions.
10. The encapsulated cell therapies and encapsulation technologies market is poised to experience rapid growth over the coming decade. Licensing deals are expected to remain the primary source of income for stakeholders in the short-mid term. In the coming 5-6 years, encapsulated therapy products intended for the treatment of eye, neurological and oncological disorders are likely to capture a relatively higher market share. By 2030, it is likely that revenue from the sales of marketed products targeting metabolic disorders, such as diabetes, will grow at a relatively faster pace compared to other products. North America and Europe are expected remain the majority shareholders in this market as several mid-late stage therapies are likely to first be approved within these regions.

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