Overview
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.
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?
Table of Contents
Companies Mentioned
- 4D Molecular Therapeutics
- AbbVie
- Abeona Therapeutics
- Advanced Materials and BioEngineering Research
- Advantagene
- Advaxis
- Adverum Biotechnologies
- Alcyone Lifesciences
- Allergan
- AlphaVax
- Altaco XXI
- American Gene Technologies International
- Amgen
- Amicus Therapeutics
- Anaeropharma Science
- Anchiano Therapeutics
- AnGes
- Angionetics
- apceth Biopharma
- Apic Bio
- Applied Genetic Technologies Corporation
- AskBio
- Astellas Pharma
- Athersys
- Atrium Medical
- Austrianova
- AveXis
- Axis Biotec Brasil
- Axovant
- Azidus Brasil
- BHI Therapeutic Sciences
- BioCardia
- Biogen
- BioGenCell
- BioInvent
- Bioquark
- BioRestorative Therapies
- Biosense Webster
- bluebird bio
- Boehringer Ingelheim
- Bone Therapeutics
- Boston Scientific
- Boston TransTec
- BrainStorm Cell Therapeutics
- Bristol-Myers Squibb
- Bukwang Pharmaceutical
- Caladrius Biosciences
- California Institute for Regenerative Medicine
- Capricor Therapeutics
- CAR-T (Shanghai) Biotechnology
- Celixir
- CellProthera
- Celsion
- Celyad
- Cesca Therapeutics
- CHA Biotech
- Children's Hospital of Chongqing Medical University
- Chonbuk National University
- ClearPoint Neuro
- Cold Genesys
- CombiGene
- Cook Regentec
- Copernicus Therapeutics
- Corestem
- Cornell University
- CRISPR Therapeutics
- Cynvec
- Cytopeutics
- Daegu Gyeongbuk Institute of Science & Technology
- Defymed
- DiscGenics
- DNAlite Therapeutics
- DNAtrix
- Duke University
- EdiGene
- Editas Medicine
- Endsulin
- Epeius Biotechnologies
- Ever Supreme Bio Technology
- Eyevensys
- Ferrer Internacional
- FKD Therapies
- Gemini Therapeutics
- Genelux
- Genenta Science
- Genentech
- Generation Bio
- Genexine
- Genprex
- GenSight Biologics
- Global Cell Med
- Gloriana Therapeutics
- Gradalis
- Gwo Xi Stem Cell
- Gyroscope Therapeutics
- Harvard University
- Hebei Newtherapy BIo-Pharma Technology
- Hemera Biosciences
- Hemostemix
- Hitachi Chemical
- Homology Medicines
- Hope Biosciences
- HORAMA
- Houston Methodist Research Institute
- Inovio Pharmaceuticals
- Institute of Robotic and Intelligent Systems
- IVERIC bio
- Janssen
- Japan Regenerative Medicine
- Japan Tissue Engineering
- jCyte
- Jennerex Biotherapeutics
- Juventas Therapeutics
- Kadimastem
- Karolinska Institutet
- Kolon TissueGene
- K-Stem Cell
- Kubota Pharmaceutical
- Lacerta Therapeutics
- Lifecells
- Lineage Cell Therapeutics
- Living Cell Technologies
- Lokon Pharma
- Longeveron
- Lysogene
- Marsala Biotech
- Massachusetts Institute of Technology
- Med Cell Bahamas
- MedImmune
- MEDIPOST
- MeiraGTx
- Mercator MedSystems
- Merck
- Meridigen Biotech
- Mesoblast
- Michael J. Fox Foundation
- Momotaro-Gene
- MultiVir
- NanoCor Therapeutics
- National Cancer Institute
- National University of Ireland, Galway
- Nature Cell
- Neuracle Genetics
- Neuralgene
- Neurocrine Biosciences
- Neurogene
- NeuroGeneration
- Neurotech Pharmaceuticals
- NextCell Pharma
- Nightstar Therapeutics
- Nipro
- Noray Biosciences Group
- Novadip Biosciences
- Novartis
- Novo Nordisk
- NuVasive
- Ocugen
- Oncolys BioPharma
- Oncos Therapeutics
- OncoSec Medical
- Orbit Biomedical
- ORCA Therapeutics
- Oxford BioMedica
- Passage Bio
- Pattern BioScience
- PeriphaGen
- Pfizer
- PharmaCyte Biotech
- Pharmicell
- Pluristem Therapeutics
- Plus Therapeutics
- Prevail Therapeutics
- Promethera Biosciences
- PsiOxus Therapeutics
- PTC Therapeutics
- Q Therapeutics
- Regeneron Pharmaceuticals
- REGENXBIO
- Reliance Life Sciences
- ReNeuron
- Renishaw
- Renova Therapeutics
- Riordan Technologies
- Roche
- ROHTO Pharmaceutical
- Royal College of Surgeons in Ireland
- SanBio
- Sangamo Therapeutics
- Sanofi
- Sarepta Therapeutics
- Scancell
- Sclnow Biotechnology
- SCM LifeScience
- Seneca Biopharma
- Sentien Biotechnologies
- Seraxis
- Shandong Qilu Stem Cells Engineering
- Shanghai East Hospital
- Shanghai Sunway Biotech
- Shenzhen Hornetcorn Biotechnology
- Shire
- Sibiono GeneTech
- Sigilon Therapeutics
- SillaJen
- Smartwise
- SOTIO
- Southwest Research Institute
- Spark Therapeutics
- Stem Med
- Stemedica Cell Technologies
- Steminent Biotherapeutics
- Stempeutics Research
- StrideBio
- SWIB Holding
- Taiwan Bio Therapeutics
- Takeda
- Targovax
- Taxus Cardium Pharmaceuticals
- Tenaya Therapeutics
- The Emmes Company
- TheraBiologics
- Theravectys
- Tianhe Stem Cell Biotechnologies
- Tianjin Weikai Biological Engineering
- TICEBA
- Tocagen
- Transgene
- Translational Research Institute
- TransVascular
- Trinity College Dublin
- U.S. Stem Cell
- Ultragenyx Pharmaceutical
- uniQure
- United Therapeutics
- University of Milan
- University of Minnesota Medical School
- University of Pennsylvania
- University of Texas
- VBL Therapeutics
- VcanBio Center for Translational Biotechnology
- VCN Biosciences
- Vericel
- Verve Therapeutics
- Vessl
- ViroMed
- Virttu Biologics
- Viscofan BioEngineering
- Voyager Therapeutics
- XyloCor Therapeutics
Methodology
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