NEW YORK, March 26, 2019 /PRNewswire/ — INTRODUCTION
Given their high target specificity and limited toxicity compared to small molecule drugs, biotherapeutics have revolutionized treatment paradigms across a myriad of clinical conditions, including metabolic disorders, cancers, neurological disorders and autoimmune disorders. In fact, the extent of growth of such therapies can be gauged from the fact that more than 300 biopharmaceuticals have been approved between 2002 and 2018. In 2018, over 15 biological license applications (BLA) received approval. Previously, in 2017, 12 new biologics were approved by the US FDA, which included antibodies (9), antibody-drug conjugates (1), and enzymes (2). Such products are inherently complex, and their full potential continues to remain untapped owing to an array of concerns associated with their development, manufacturing and administration. Specifically, the challenges associated with the delivery of such drugs can be attributed to their large molecular weight, short half-lives, and instability in the gastrointestinal (GI) tract and intestinal lumen. Owing to their susceptibility to enzymatic degradation, the parenteral route of administration is considered to be the most acceptable mode of delivery, enabling such drugs to directly enter systemic circulation. However, parenteral administration often requires patients to visit healthcare centers / clinics for dosing. As a result, non-adherence to prescribed therapeutic regimens is rampant among end-users.
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Despite these challenges, the demand for biologics is high because of their favorable safety profiles, greater systemic compatibility and fewer side effects. As a result, medical researchers and therapy developers are actively attempting to identify and exploit alternative delivery strategies for such products; examples include aerosol generation systems, lipid nanoparticles, DNA-based delivery technologies, and brain shuttles (designed to facilitate increased drug penetration across the elusive blood-brain barrier). Currently, several biopharmaceutical companies have undertaken initiatives to develop cell-specific drug delivery technologies and have superior formulation technologies, imparting improved release properties to drugs being delivered. Consequently, pharmaceutical developers are likely to witness a rise in available options for the delivery of their respective products in the foreseen future.
SCOPE OF THE REPORT
The “Novel Technologies for Delivery of Proteins, Antibodies and Nucleic Acids, 2019-2030” report features an extensive study of the current market landscape and the likely future adoption of such technologies, over the next twelve years. The study features an in-depth analysis, highlighting:
A detailed assessment of the current market landscape of companies offering technologies for delivery of biotherapeutics, including information on their geographical location, types of biologics delivered (proteins, peptides, antibodies and nucleic acids), routes of administration used (parenteral, oral, transdermal / topical, inhalation and others) and impact on drug properties / patient compliance.
A comprehensive competitiveness analysis of the drug delivery technologies captured in our report database, taking into consideration the supplier power (based on year of establishment) and key technology-related specifications, such as the type(s) of biologics delivered, extent of impact on drug properties / patient compliance and the route of administration.
Elaborate profiles of prominent technology developers engaged in this domain, featuring a brief overview of the company, its financial performance (if available), information on its product portfolio, recent developments and a comprehensive future outlook. Additionally, the report includes profiles of certain technologies that emerged as relatively superior in our proprietary competitiveness analysis.
An in-depth analysis of the various patents that have been filed / granted related to novel drug delivery technologies, till November 2018. It includes information on key parameters, such as patent type, publication year, issuing authority, CPC classification, emerging focus areas and leading industry / academic players (in terms of size of intellectual property portfolio).
A detailed analysis of the partnerships and collaborations focused on technologies for the delivery of biotherapeutics, featuring a comprehensive set of analyses based on various parameters, such as the year of establishment, type of partnership, type of therapeutic areas, most active players and geographical location.
A discussion on the upcoming opportunities in the field of biotherapeutic drug delivery that are likely to impact the evolution of this market in the coming years.
One of the key objectives of the report was to estimate the existing market size and identify potential future growth opportunities for novel technologies designed for the administration of proteins, antibodies and nucleic acids. 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 evolution of the market over the period 2018-2030. The report features likely distribution of the current and forecasted opportunity across the [A] type of therapeutic area (oncology and non-oncology), [B] route of administration (parenteral and non-parenteral), [C] key contributing technologies and [D] key geographical regions (North America, Europe, Asia Pacific and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.
The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names):
Mathias Schmidt (Chief Executive Officer, ArmaGen)
Ram Bhatt (Chief Executive Officer, Chairman and Founder, ICB International)
Donovan Yeates (Chief Executive Officer and Chief Scientific Officer, Chairman and Founder, KAER Biotherapeutics)
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.
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
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 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the current state of the market for novel technologies for delivery of proteins, antibodies and nucleic acids, in the short-mid term and long term.
Chapter 3 provides a general introduction on the importance of effective drug delivery systems for biotherapeutics. It highlights the different types of biologics and the various route of administration used for the delivery of such products. It includes a discussion on the growing demand for biotherapeutics. The chapter lays emphasis on the key challenges faced during drug delivery and, subsequently, provides an overview of advanced drug delivery technologies that are already available in the market or under development.
Chapter 4 presents a list of novel technologies designed for the delivery of biotherapeutics. It includes a detailed analysis of the aforementioned technologies based on the type of biologics, impact on drug properties and patient compliance, route of administration and the developer details (such has company size and location of company headquarters). In addition, the chapter features a list of companies developing formulation technologies.
Chapter 5 presents a competitiveness analysis of all technologies based on supplier power and key technology specifications. The analysis was designed to enable stakeholder companies to compare their existing capabilities within and beyond their respective peer groups and identify opportunities to achieve a competitive edge in the industry.
Chapter 6 provides detailed profiles of the technologies which emerged to be relatively more superior than the others in the product competitiveness analysis. Each profile presents a brief overview of the company, technology description, intellectual property portfolio and recent developments.
Chapter 7 provides detailed profiles of some of the leading stakeholders in this field. Each profile includes a brief overview of the company, its financial performance (if available), information on its product portfolio, recent developments and a comprehensive future outlook.
Chapter 8 provides an in-depth patent analysis, presenting an overview on the filed / granted patents related to novel technologies for administration of biologics. For this analysis, we looked at the patents that have been published by various players, till November 2018. The analysis highlights the key information and trends associated with these patents, including patent type (granted patents, patent applications and others), publication year, patent issuing authorities / patent offices (USPTO, WIPO, APO, EPO and others), CPC classification, emerging focus areas and the leading industry / academic players. The chapter also includes a patent benchmarking analysis and comprehensive valuation analysis.
Chapter 9 features an analysis of the various collaborations and partnerships that have been inked amongst players in this market. We have also discussed the different partnership models (including product development and commercialization, licensing agreements, manufacturing agreements, mergers / acquisitions and R&D agreements) and the most common forms of deals / agreements that have been established between 2010 to 2018.
Chapter 10 features a comprehensive market forecast analysis, highlighting the likely growth of novel technologies for delivery of biologics market till the year 2030. We have provided inputs on the likely distribution of the opportunity by type of therapeutic area (oncological, neurodegenerative, metabolic, infectious, ophthalmology and others), route of administration (parenteral, oral, inhalation and others), different regions (North America, Europe, Asia Pacific and rest of the world) and key contributing technologies.
Chapter 11 features a discussion on upcoming technologies / trends that are likely to present future growth opportunities in the field of biotherapeutic delivery. It highlights the key drivers of growth and projected adoption trends of technical innovations that are likely to have a notable influence on the industry’s evolution over the coming decade.
Chapter 12 is a collection of interview transcripts of discussions held with key stakeholders in this market. In this chapter, we have presented the details of interviews held with (in alphabetical order of company name) Mathias Schmidt (Chief Executive Officer, ArmaGen), Ram Bhatt (Chief Executive Officer, Chairman and Founder, ICB International), Donovan Yeates (Chief Executive Officer and Chief Scientific Officer, Chairman and Founder, KAER Biotherapeutics).
Chapter 13 is an appendix, which provides tabulated data and numbers for all the figures included in the report.
Chapter 14 is an appendix, which contains a list of companies and organizations mentioned in this report.
1. Currently, over 80 technologies are available / being developed for the delivery of a variety of biotherapeutics, including proteins, peptides, antibodies and nucleic acids. Majority of the aforementioned technologies are known to employ unique strategies, which developers claim are capable of improving therapeutic stability and drug release properties as well. A significant proportion (25%) of these technologies use lipid and / or other nanoparticles to facilitate drug / therapy delivery. These are followed by nucleic acid and polymer-based (13% each) methods. Other types of platforms have been designed to use carriers, aerosols, proteins, silica / other gels and brain shuttles, for the administration of pharmacological interventions.
2. Over 50 technologies have been designed to deliver more than one type of biologic product. Notably, seven technologies are designed to deliver proteins, peptides, antibodies and nucleic acids (all the types of biologics considered in the report); examples include (in alphabetical order) 3DNA® (Genisphere), DelSiTechTMSilica Matrix (DelSiTech), HEPtune® technology (Caisson Biotech), PLEX™ Texhnology (PolyPid) and V-Smart® Platform (Lauren Sciences).
3. Given the susceptibility of biological molecules to enzymatic degradation in the GI tract, majority of the technologies (over 35) utilize the parenteral route of administration. It is worth highlighting that several technologies have been designed to deliver drugs / therapies via more than one route; examples include (in alphabetical order) Eligen® Technology, EuPort™ technology, ImSus® technology, Intravail® Technology, Nano-E™ Drug Delivery System and NexACT®.
4. Innovation in this field is primarily being driven by start-ups / small companies, which represent over 70% of all the stakeholders in the market. Further, a large number (70%) of these players are based in North America, primarily in the US; prominent examples include (in alphabetical order, no selection criteria) Adhera Therapeutics, Aphios, ArmaGen, Kurve Technology and RoverMed BioSciences. Noteworthy players that have undertaken initiatives in this domain and are based in other geographical regions (Europe and Asia-Pacific) include (in alphabetical order, no selection criteria) ALRISE Biosystems, Arecor, InnoCore Pharmaceuticals, Cerenis Therapeutics, Merrion Pharmaceuticals and Oramed Pharmaceuticals. The more established players, such as (in alphabetical order, no selection criteria) Evonik Industries, Pacira Pharmaceuticals, Roche and Tamarisk Technologies, are also making substantial contributions in this field.
5. Nearly 2,400 patents pertaining to novel drug delivery strategies have been filed / granted till November 2018. A detailed analysis of these patents / patent applications revealed that the innovation in this domain is presently focused on nanoparticle-based, polymer-based and nucleic-acid based technologies, which are being developed for use across various clinical conditions, such as cancer, neurodegenerative disorders, metabolic disorders and other chronic diseases / disorders. It is worth highlighting that many nanoparticle-based technologies claim to be capable of facilitating a reduction in dosing frequency, improvements in bioavailability, and have provisions for enabling the controlled release of drug molecules from the formulation matrix. Examples of companies working on such technologies include (in alphabetical order, no selection criteria) Aphios, Acuitas Therapeutics, Arbutus Biopharma, Camurus, Cureport, Lauren Sciences and Peptineo.
6. Over 100 strategic partnerships were inked between drug developers and technology providers during the period 2010-2018. It is worth noting that most of the aforementioned deals were licensing agreements (33%), signed with an aim to use a licensor’s proprietary platform to formulate biotherapeutics with higher stability and improved release properties. Research and development agreements were the second most popular type of agreements, representing 27% of the total number of deals. Prominent technology providers that have entered into strategic relationships in the recent past include (in decreasing order of number of revealed deals) Halozyme Therapeutics, Genisphere, BiOasis Technologies, Novo Nordisk, Arbutus Biopharma, Caisson Biotech, Ichor Medical Biosystems and Aegis Therapeutics.
7. Licensing deals are expected to remain the primary source of income for stakeholders offering innovative technology platforms in this market. In this context, North America, which presently has the maximum number of licensing deals, is expected to capture over 60% of the market share, followed by Europe. It is also worth highlighting that technologies that use the parenteral route hold the dominant market share (over 40%), in terms of revenue from licensing deals. However, given their relative ease of administration and capability to ensure high drug adherence, technologies enabling oral administration are likely to grow at a comparatively faster pace in the foreseen future.
8. Presently, technologies that are intended for use in oncological disorders capture a relatively higher market share (over 25%). By 2030, sales-based revenues in this domain are likely to be driven by neurological disorders (such as Alzheimer’s disease and Parkinson’s disease); this can be attributed to the increasing incidence of the aforementioned clinical conditions and the limited availability of therapeutic delivery options that are capable of facilitating the transport of therapeutic interventions across the blood brain barrier.
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