The report features profiles of 62 companies, a majority of which were founded in the past five years. Most are located in the United States; however a few profiled companies are based in Canada, Europe, and Australia. Approximately 50% of the companies are affiliated with a University, and ten companies have initiated human clinical trials.
Collectively, the emerging companies profiled in this report are focused on 11 different therapeutic categories. Oncology is the leading focus among companies investigated, and approximately 25 percent of the companies profiled are developing proprietary technologies designed to improve delivery of macromolecules/biologics. Another 25 percent of the companies are focused on novel delivery devices, ranging from inhalation and nasal devices, to more patient-friendly injectable systems. All of the companies investigated are developing technologies that could potentially transform drug delivery in one or more therapeutic areas.
For each company profiled, the following information is provided:
- Detailed Technology Description
- Development Status / Pipeline Products
- Patents and Publications
- Partnership and Funding Opportunities
- Business Development & Licensing Contact
Examples of Technologies Presented
- Mini-pump for subcutaneous delivery of IV medications
- Targeted nanoparticle micelles
- Antibody-targeted liposomes
- Abuse-deterrent delivery system
- Dry powder particle processing technology
- Oral capsule technology for biologics
- Nanovesicle delivery system for delivery across the blood-brain barrier
- Timed-release intra-ocular implant device
- Non-invasive aerosol device for brain drug delivery
- Extracellular drug conjugate technology
- Nanoparticles and novel device for CNS and inner ear drug delivery
- Next-generation auto-injector technology
- Nanopolymer drug conjugates
- Microneedle patch system
- Pocket-sized ultrasound delivery device
- Biodegradable, topical drug patch
Sample of Companies Profiled
- Aquarius Biotechnologies
- Convoy Therapeutics
- Corinthian Ophthalmic
- Entrega, Inc.
- Inspiro Medical
- Orbis Biosciences
- Qrono, Inc.
- ZetrOZ, LLC
Reasons to Buy
- Identify early stage delivery technologies that will potentially “enable” the delivery of your therapeutic compound
- Learn about investment opportunities with emerging companies, to gain access to promising, early stage technologies
- Identify novel drug delivery formulations available for partnering, to enhance your product portfolio
Table of Contents
Figure 1: Featured Companies by Year Founded
Figure 2: Featured Early Stage Technologies by Delivery Route
Table 1: Sample of Emerging Parenteral DDS Companies
Table 2: Sample of Emerging Delivery Devices in Development
Table 3: Ten Novel Pipeline Products of DDS Start-ups
Table 4: Emerging Companies by Therapeutic Focus
Affinity Therapeutics, LLC
AlignBioscience Laboratory, LLC
Alitair Pharmaceuticals, Inc.
Axxia Pharmaceuticals, LLC
Clearside Biomedical, Inc.
Corinthian Ophthalmic, Inc.
Cristal Delivery, B.V.
Ekteino Laboratories, Inc.
EnduRx Pharmaceuticals, Inc.
Engineered BioPharmaceuticals, Inc.
Extend Biosciences, Inc.
Inspirion Delivery Technologies, LLC
Inspiro Medical, Ltd.
Intensity Therapeutics, Inc.
Kala Pharmaceuticals, Inc.
Lauren Sciences, LLC
Lypro Biosciences, Inc.
NanoMedical Systems, Inc.
NanoSmart Pharmaceuticals, Inc.
On Demand Therapeutics, Inc.
Orbis Biosciences, Inc.
OtoMagnetics & Weinberg Medical Physics
Oval Medical Technologies
PolyActiva Pty, Ltd.
Prometheon Pharma, LLC
ProSolus Pharma, LP
Respira Therapeutics, Inc.
Solstice Biologics, LLC
Xeris Pharmaceuticals, Inc.
Currently, the drug delivery market is dominated by oral delivery products, but many of the emerging technologies are not administered via the oral route. In fact, only six companies in this report are developing oral delivery technologies, while 30 companies are focused on novel parenteral delivery systems. This is indicative of the continued trend toward utilizing novel technologies to actually enable delivery of a drug, rather than extend its life cycle or make the product more convenient for the patient. The increased activity in the parenteral drug delivery space is also due to the growing number of new drugs which are complex molecules or biologics. These drugs require specialized formulation and delivery technologies to be commercially viable.
As evidenced by the companies reviewed in this report, novel parenteral technologies are leading the drug delivery pipeline. However, these are not the traditional parenteral technologies that we've seen in the past such as PEGylated formulations and sustained release PLGA-based depots. The parenteral delivery space has grown to include novel materials, targeted nanoparticles, carrier systems and conjugates that enable site-specific delivery of a variety of drugs, including RNAi-based therapeutics. Many of these technologies enable formulations which are less toxic with fewer side effects. Lauren Sciences LLC for instance, is developing the proprietary V-SmartTM nanovesicle technology which has demonstrated the ability to cross the blood-brain barrier (BBB) and deliver encapsulated contents directly to the brain. Another young start-up, Ekteino Laboratories, is developing a silk-based sustained release system which has certain benefits over traditional PLGA-based systems. Multiple novel delivery devices are also being developed which enable the subcutaneous delivery of drugs, some of which are based on microneedles or micropumps. This report profiles proprietary devices being developed by such companies as scPharmaceuticals and Ratio, Inc.
There seems to be a renewed interest in ophthalmic drug delivery technologies, with at least five new companies founded since 2009 that specifically focus on novel delivery technologies for the eye. These companies include Clearside Biomedical, Corinthian Ophthalmic, and iVeena. Each of these companies is advancing new devices or formulations that are expected to provide superior treatment of ocular inflammation, glaucoma, and age-related macular degeneration (AMD). Clearside Biomedical has already taken its first product into human clinical trials, while having only been founded in 2011.
Far fewer of the new start-ups are focusing on pulmonary, nasal, and transdermal drug delivery. This may be in part because there are fewer feasible drug candidates and these routes tend to be less preferred and accepted by patients. There are however, some promising technologies and formulations that show commercial promise. FluGen for example, expects to be in the clinic in 2014 with its first microneedle-based patch for influenza. If successful, this product could be game-changing, as it would be virtually painless and is anticipated to greatly enhance patient compliance. Inhaled insulin for diabetes is a focus of multiple pulmonary drug delivery firms, including young companies such as Dance Pharma. This type of product could be commercially successful; however, there are questions about broad patient acceptance, cost, and long-term safety.
Traditionally, the drug delivery market has been dominated by oral controlled release formulations for cardiovascular indications, central nervous system conditions, and pain management; inhalers for asthma; transdermal patches for hormone replacement therapy; and implants for prostate cancer. But the market is changing and over the next 10-15 years we expect to see a number of innovative medicines reaching the market, some of which, potentially changing the way certain conditions are treated.
Reviewing the pipelines of both established and emerging drug delivery firms, there is evidence of significant focus on developing improved formulations for cancer, infectious disease, ocular disorders, autoimmune and CNS conditions. Using cancer as an example, there are more than 12 million new cases of cancer diagnosed each year and many of the therapeutics used are toxic and have severe side effects. Innovative drug delivery technologies are being developed which can more effectively target and deliver therapeutics to tumors. These include targeted nanoparticles, extracellular drug conjugates and intra-lymphatic drug carrier systems. Examples of companies profiled which are developing breakthrough treatments for cancer include Blend Therapeutics, Centrose, and Intensity Therapeutics.
While some emerging drug delivery companies focus narrowly on a specific therapeutic category such as oncology or pain, others are developing technologies for specific types of molecules, including macromolecular drugs or biologics. A growing proportion of new drugs in development are biologics, aimed at treating advanced-stage cancers, chronic inflammatory diseases, and autoimmune disorders. These therapeutics are generally administered via the parenteral route, and are often difficult to formulate. Some of the key formulation challenges include high viscosity, chemical and physical instability, denaturation, and solubility issues. A majority of these drugs are delivered via injection or infusion, which is uncomfortable and ultimately undesirable for the patient, and lends to poor patient compliance. For these reasons, drug delivery technologies play a key role in the success of biologics and complex drug products. This report highlights some of the emerging technologies designed to effectively delivery large molecular weight drugs such as antibody-based therapeutics, proteins, and peptides. Companies developing such technologies include Entrega, Extend Biosciences, and Solstice Biologics.
- Affinity Therapeutics, LLC
- AiroMedica, LLC
- AlignBioscience Laboratory, LLC
- Alitair Pharmaceuticals, Inc.
- Aquarius Biotechnologies
- Axxia Pharmaceuticals, LLC
- Blend Therapeutics
- Centrose, LLC
- Civitas Therapeutics
- Clearside Biomedical, Inc.
- Convoy Therapeutics
- Corinthian Ophthalmic, Inc.
- Cristal Delivery, B.V.
- Dance Pharma
- DLVR Therapeutics
- Ekteino Laboratories, Inc.
- EnduRx Pharmaceuticals, Inc.
- Engineered BioPharmaceuticals, Inc.
- Entrega, Inc.
- Extend Biosciences, Inc.
- FluGen, Inc.
- GrayBug, LLC
- Impel Neuropharma
- Inspirion Delivery Technologies, LLC
- Inspiro Medical, Ltd.
- Intensity Therapeutics, Inc.
- iVeena, LLC
- KAER Biotherapeutics
- Kala Pharmaceuticals, Inc.
- Keystone Nano
- LaserLeap Technologies
- Lauren Sciences, LLC
- LyoGo, LLC
- Lypro Biosciences, Inc.
- NanoMedical Systems, Inc.
- NanoSmart Pharmaceuticals, Inc.
- On Demand Therapeutics, Inc.
- Orbis Biosciences, Inc.
- OtoMagnetics & Weinberg Medical Physics
- Oval Medical Technologies
- PolyActiva Pty, Ltd.
- PolyPid, Ltd.
- ProLynx, LLC
- Prometheon Pharma, LLC
- ProSolus Pharma, LP
- Prosonix, Ltd.
- Quiet Therapeutics
- Qrono, Inc.
- Ratio, Inc.
- Respira Therapeutics, Inc.
- scPharmaceuticals, LLC
- SipNose, Ltd.
- Solstice Biologics, LLC
- SpherIngenics, Inc.
- Versartis, Inc.
- Xeris Pharmaceuticals, Inc.
- ZetrOZ, LLC