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Organ–based / Targeted Drug Delivery Devices Market for Biologics (Intra-organ / Intra-tumoral), 2020-2030

Organ–based / Targeted Drug Delivery Devices Market for Biologics (Intra-organ / Intra-tumoral), 2020-2030

  • July 2020
  • 283 pages
  • ID: 5955646
  • Format: PDF
  • Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
Over the years, advances in cell biology and pharmacology have led to the development of a variety of advanced biologics, which experts believe, possess the potential to address several unmet needs associated with the treatment of different types of diseases. Currently, there are more than 1,000 cell and gene therapies under development; most of which are being developed for the treatment of oncological disorders, cardiovascular disorders and neurological disorders. , , Additionally, over the last decade, multiple immunotherapies have been developed, and have led to a decrease in lung cancer and melanoma-related mortality. Despite their many benefits, biologics present a number of challenges, such as drug delivery-related complexities, and immunogenicity concerns, which have been shown to result in systemic toxicity post therapy administration. To avoid such systemic toxic effects, a limited volume of drug is administered, which often results in a small amount of drug reaching the target organ. Further, from a pharmacological point of view, the drug stays at the target site for a limited time, hence decreasing the final therapeutic effect that can be achieved through prolonged and controlled drug delivery. Moreover, some of such treatment options, such as cell therapies, require periodic administration of additional therapy material, or complementary products, thereby, adding to the already complex invasive dosing procedure.

In order to address some of the abovementioned challenges, a number of innovator companies in the biopharmaceutical sector are actively engaged in identifying targeted and effective delivery strategies for biologics, including gene therapies, cell / stem cell therapies, immunotherapies and therapeutic proteins. Examples of devices designed for the targeted delivery of biologics include (in alphabetic order, no selection criteria) Advance® CS, ExtroducerTM microcatheter, HelixTM biotherapeutic delivery system, ImmunoPulse® IL-12, SmartFlow® neuro ventricular cannula and MailPan®. Some of the aforementioned drug delivery devices have been demonstrated to have an improved therapeutic safety index, and are capable of accurately delivering biological interventions to the target physiological site. Further, certain implantable delivery systems have also been developed in order to prolong the therapeutic effect of biologics. , , , Given the rapid pace of growth within the biopharmaceutical market, the demand for effective delivery systems is anticipated to increase in the foreseen future. This may be expected to create lucrative opportunities for stakeholders in the targeted drug delivery systems market.

SCOPE OF THE REPORT
The ‘Organ-based / Targeted Drug Delivery Devices Market for Biologics (Intra-organ / Intra-tumoral), 2020-2030’ report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of such medical devices, over the next decade. The study features an in-depth analysis of the key drivers and trends related to this domain. Amongst other elements, the report includes:
A detailed assessment of the companies involved in the development of targeted delivery devices for biologics, providing information and analyses based on a number of relevant parameters, such as type of device (encapsulated device, catheter, implant, electroporation delivery system, balloon, cannula and microrobot), status of development (approved, clinical and preclinical), target organ (brain, heart, abdomen, breast, eye, and others), target indication (Parkinson’s disease, heart failure, diabetes, breast cancer, myocardial infarction, Alzheimer’s, solid tumors (specific type unknown), and others), target therapeutic area (oncological disorders, neurological disorders, cardiovascular disorders, metabolic disorders and ophthalmic diseases), type of biologic delivered (cells, proteins, antibodies, enzymes, plasmids, growth factors, small peptides, neurotransmitters and modified RNA), type of therapy delivered (gene therapy, stem cell therapy, cell therapy, immunotherapy and RNA therapeutics) and route of administration (intra-tumoral, implantable, intraocular, intraputamen, intra-abdominal, intracardiac and others). In addition, the chapter includes information on the device developers, including details on type of stakeholder (industry and non-industry), year of establishment, company size (only for industry players) and location of headquarters.
Elaborate profiles of devices that are currently approved or being evaluated in later stages of clinical development (phase III and above), featuring an overview of the device, its mechanism of action, current development status and key clinical trial results.
An assessment of the research activity in the neurological and cardiovascular disorders domain, in terms of the development of stem cell and gene therapies for the treatment these disorders. The chapter provides information and analysis on the recent publications and grants that are focused on the stem cell and gene therapies being developed for these therapeutic areas.
A clinical trial analysis of completed, ongoing and planned studies of various stem cell and gene therapies, based on various parameters, such as trial registration year, trial phase, trial status, type of sponsor / collaborator, type of therapy, therapeutic area, target indication, route of administration, key players, geographical location and enrolled patient population.
An analysis presenting the potential strategic partners (primarily stem cell and gene therapy developers) for targeted drug delivery device developers, based on different parameters, such as pipeline strength, target therapeutic area(s) and location of the headquarters of the company.

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 parameters, such as target patient population, likely adoption rates and expected pricing, we have provided an informed estimate of the likely evolution of the market, for the time period 2020-2030. Our year-wise projections for the current and future opportunity have further been segmented on the basis of [A] type of device (encapsulated device, catheter, electroporation delivery system, and cannula), [B] target organ (brain, heart, breast, eye, skin and pancreas), [C] target therapeutic area (oncological disorders, neurological disorders, cardiovascular disorders, metabolic disorders and ophthalmic diseases), [D] target indication (Parkinson’s disease, heart failure, breast cancer, melanoma, glioblastoma, myocardial ischemia, geographic atrophy, glaucoma, macular telangectasia, retinitis pigmentosa, non-infectious uveitis and mucopolysaccharidosis type III A) and [E] key geographical regions (North America, Europe and Asia-Pacific). To account for the uncertainties associated with the development of the devices 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 the report were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders:
Dr William L Rust, Founder and Chief Executive Officer, Seraxis
Manuel Pires, Junior Business Developer, Defymed
R. Lyle Hood, Assistant Professor, University of Texas at San Antonio
Anonymous, Postdoctoral Associate, Massachusetts Institute of Technology

All actual figures have been sourced and analysed 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 over the next decade, 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.

KEY QUESTIONS ANSWERED
 What type of devices are capable of providing targeted delivery of biologics?
 Who are the leading device developers in this domain?
 What are the key promising therapeutic areas for the development of targeted drug delivery devices for stem cell and gene therapies?
 Which companies can be considered as potential strategic partners for device developers?
 How is the current and future opportunity likely to be distributed across key market segments and geographical regions?

CHAPTER OUTLINES
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the likely evolution of the medical devices that are capable of targeted delivery of biologics market in the mid to long-term.

Chapter 3 provides a general overview of drug delivery devices for biologics, focusing on the different routes of administration and the challenges associated with these delivery devices. The chapter also highlights the need for the development of targeted delivery devices for biologics. In addition, it presents the information on the different types of these targeted devices, the key advantages offered and a section on concluding remarks.

Chapter 4 provides a detailed assessment of the companies involved in the development of targeted delivery devices for biologics, providing information and analyses based on a number of relevant parameters, such as type of device (encapsulated device, catheter, implant, electroporation delivery system, balloon, cannula and microrobot), status of development (approved, clinical and preclinical), target organ (brain, heart, abdomen, breast, eye, and others), target indication (Parkinson’s disease, heart failure, diabetes, breast cancer, myocardial infarction, Alzheimer’s, solid tumors (specific type unknown), and others), target therapeutic area (oncological disorders, neurological disorders, cardiovascular disorders, metabolic disorders and ophthalmic diseases), type of biologic delivered (cells, proteins, antibodies, enzymes, plasmids, growth factors, small peptides, neurotransmitters and modified RNA), type of therapy delivered (gene therapy, stem cell therapy, cell therapy, immunotherapy and RNA therapeutics) and route of administration (intra-tumoral, implantable, intraocular, intraputamen, intra-abdominal, intracardiac and others). In addition, the chapter includes information on the device developers, including details on type of stakeholder (industry and non-industry), year of establishment, company size (only for industry players) and location of headquarters.
Chapter 5 features elaborate profiles of devices that are currently approved or being evaluated in later stages of clinical development (phase III and above), featuring an overview of the device, its mechanism of action, current development status and key clinical trial results.

Chapter 6 features an elaborate assessment of the research activity in the neurological and cardiovascular disorders domain, in terms of the development of stem cell and gene therapies for the treatment these disorders. The chapter provides information and analysis on the recent publications and grants that are focused on the stem cell and gene therapies being developed for these therapeutic areas, since 2015.

Chapter 7 features a geographical clinical trial analysis of completed, ongoing and planned studies of various stem cell and gene therapies, based on various parameters, such as trial registration year, trial phase, trial status, type of sponsor / collaborator, type of therapy, therapeutic area, target indication, route of administration, key players, geographical location and enrolled patient population.

Chapter 8 features an analysis presenting the potential strategic partners (primarily stem cell and gene therapy developers) for targeted drug delivery device developers, based on different parameters, such as pipeline strength, target therapeutic area(s) and location of the headquarters of the company.

Chapter 9 presents a comprehensive market forecast analysis, highlighting the likely growth of the targeted drug delivery devices market for biologics, for the time period 2020-2030. In order to provide an informed future outlook, our projections have been segmented on the basis of [A] type of device (encapsulated device, catheter, electroporation delivery system, and cannula), [B] target organ (brain, heart, breast, eye, skin and pancreas), [C] target therapeutic area (oncological disorders, neurological disorders, cardiovascular disorders, metabolic disorders and ophthalmic diseases), [D] target indication (Parkinson’s disease, heart failure, breast cancer, melanoma, glioblastoma, myocardial ischemia, geographic atrophy, glaucoma, macular telangectasia, retinitis pigmentosa, non-infectious uveitis and mucopolysaccharidosis type III A) and [E] key geographical regions (North America, Europe and Asia-Pacific). To account for the uncertainties associated with the development of the devices 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.
Chapter 10 summarizes 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 11 contains the transcripts of interviews conducted with representatives from renowned organizations that are engaged in this domain. In this study, we spoke to William L Rust (Founder and Chief Executive Officer, Seraxis), Manuel Pires (Junior Business Developer, Defymed), R. Lyle Hood (Assistant Professor, University of Texas at San Antonio) and Anonymous (Postdoctoral Associate, Massachusetts Institute of Technology).

Chapter 12 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 13 is an appendix that provides the list of companies and organizations mentioned in the report.

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