With an Investment of Over USD 1 Billion and an Intellectual Capital Spread Across ~3,000 Patents, the Encapsulated Cell Therapies and Encapsulation Technologies Market is Set to Witness a Rapid Growth, Predicts Roots Analysis

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May 09, 2019, 11:00 ET

LONDON, May 9, 2019 /PRNewswire/ -- Roots Analysis has announced the addition of "Cell Encapsulation: Focus on Therapeutics and Technologies, 2019-2030" report to its list of offerings.

Nupur Singh, the principal analyst, stated, "Extensive research on cell encapsulation strategies has enabled the development of a variety of technologies capable of immobilizing / enclosing therapeutic entities within biocompatible matrices / carriers. Such products offer a myriad of advantages, and have demonstrated the capability to address existing challenges related to cell therapies and certain other types of interventions as well. Currently, more than 25 encapsulated therapy products are being evaluated across different stages of development for the treatment of various chronic disorders. Of these, 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."

The report presents opinions on several key aspects of the market. Among other elements, it includes:

A detailed assessment of the current market landscape of encapsulated cell therapies and affiliated technologies, highlighting various target disease indications, phase of development of various encapsulated therapy candidates, 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 various applications. It is worth noting that around 45% of the 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, no specific selection criteria) ßAir Bio-artificial Pancreas (Beta-O2 Technologies), hPSC (Kadimastem), Neo-Islets (SymbioCellTech), PEC-Encap™ (ViaCyte), Sig-002 (Sigilon Therapeutics / Eli Lilly), SR-01 (Seraxis), and TARGETBCD (Evotec / Sanofi).
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. During our research, we came across more than 3,000 patents that have been filed / granted since 2013. In fact, since 2014, more than 500 patents have been filed / granted each year across the globe; close to 580 patents were filed / granted in 2018 alone. It is worth noting that the R&D activity was observed to be concentrated in the US, which is evident from over 1,600 patents that were filed / granted in this region during the given time period. 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.
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, enrolled patient population and regional distribution of trials. In the past few years, several organizations, such as (in decreasing order of number of trials conducted) 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 the leading non-industry sponsors / collaborators that are engaged in clinical research efforts in this domain. It is also worth highlighting that disease-related parameters and safety / efficacy are amongst the most important clinical end points (measured across all trial phases) considered in studies evaluating encapsulated therapy products.
An analysis of contemporary development landscape of more than 300 stakeholders that are engaged in the cell therapies domain. The analysis reveals companies that have the necessary expertise to help encapsulated cell therapy developers across various development processes in this field, highlighting the likely strategic partners across different regions. More than 40 cell therapy developers emerged as the most likely potential strategic partners in North America, based on multiple parameters, such as therapeutic focus overlap, cell type overlap, research programs, existing partnerships and developer strength. Examples of such companies include (in alphabetical order, no specific selection criteria) Gradalis, Innovative Cellular Therapies, Iovance Biotherapeutics, Juno Therapeutics, Kite Pharma, Tmunity Therapeutics, and TVAX Biomedical.
A comprehensive market forecast analysis based on the primary growth drivers, the licensing deal structures and agreements that are expected to be signed over the course of next ten years. In addition, the report also includes information on (potential) sales-based revenues generated by encapsulated therapy products 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. It features likely distribution of the current and forecasted opportunity across the following segments:

Type of therapeutic area (eye disorders, metabolic disorders, neurological disorders, and oncological disorders)
Type of target disease indication (ataxia telangiectasia, breast cancer, diabetes, glaucoma, head and neck cancer, macular telangiectasia, metastatic and non-metastatic pancreatic cancer, Parkinson's disease, and retinitis pigmentosa)
Type of encapsulation material used (alginate-based microcapsules, cellulose hydrogels, medical-grade plastics, and red blood cells)
Key geographical regions (North America, Europe and Asia Pacific).

Licensing deals are expected to remain the primary source of income for stakeholders in the short-mid term. It is also worth highlighting that encapsulated therapy products intended for the treatment of oncological disorders are expected to capture majority of the market share (~45%) by 2030, while therapy candidates being evaluated for the treatment of metabolic disorders are anticipated to grow at a relatively faster rate during the forecast period. Further, North America (primarily the US) and Europe are anticipated to capture the majority share by 2030, in terms of the sales-based revenues. This can be attributed to the fact that majority of mid-late stage product development programs in this domain, are centered in these regions. In 2030, North America is projected to capture around 50% of the overall market share in this domain.
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. It is worth noting that close to USD 400 million was raised through venture capital financing, representing around 40% of the total capital raised by industry players in the period 2013-2018. Within these instances, we noted that the maximum amount invested was through Series B funding rounds, wherein a sum of over USD 150 million was raised by various companies, from multiple investors. Further, in the 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 (research grants), followed by grants awarded under R21 mechanism (exploratory / development grants, 14%).
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. It is worth noting that 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. Other popular agreement models adopted by companies in this industry include product / technology licensing agreements, clinical trial agreements, distribution agreements, regulatory service agreements, and product development and commercialization agreements.
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. In addition, each profile 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 foreseen future.

The report features inputs from a number of eminent industry stakeholders. Singh remarked, "Most industry experts concur on the opinion that the market is still niche and, in the short-term, technology developers will continue to rely on technology access fees, and other payments from licensing deals related to their proprietary technologies". The report also features detailed transcripts of discussions held with the following experts:

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)

The research covers detailed profiles and assesses product portfolios of several companies, including (illustrative list, no specific selection criteria):