LONDON, August 13, 2018 /PRNewswire/ -- INTRODUCTIONBiologics constitute a majority of the top selling drugs of today and also represent one of the fastest growing segments of the overall pharmaceutical industry. In fact, the share of biologics in the overall pharmaceutical market has increased from 16% in 2006 to over 25% in 2017. Having reported over 70% increase in revenues over the past 5-6 years, the market for biologically derived products is currently estimated to be worth more than USD 200 billion. Despite their clinical and commercial success, biopharmaceutical products are associated with high development costs, which are evidently reflected in their prices. Moreover, such therapies are usually designed for intravenous administration, which require a clinical setting (hospitals / infusion centers) for dosing; this further adds to the overall treatment cost. Of late, the subcutaneous route of administration has emerged as a promising and viable approach for the parenteral delivery of biologic drugs. Owing to several compelling advantages, such as patient convenience, potential for self-administration, better therapy adherence and reduced healthcare costs, the concept is steadily gaining traction within the healthcare industry.Download the full report: https://www.reportbuyer.com/product/5483804
Given the robust pipeline of biologics, which include monoclonal antibodies, vaccines and other protein-based therapeutic products, subcutaneous delivery options are being investigated for various clinical candidates across different phases of development. In fact, several approved therapeutic products that are currently delivered intravenously are also being reformulated and evaluated for subcutaneous administration in order to improve their adoption, and for life cycle management of drugs nearing patent expiry.In addition, several drug delivery devices that can be used for self-administration have been developed, and many others are under development. Some of the most popular self-administration enabling devices include large volume wearable injectors, autoinjectors, pen injectors, needle free injectors and prefilled syringes. In fact, these innovative drug-device combination products have witnessed high adoption rates over the past few years and have brought about marked improvements in adherence to prescribed therapeutic regimens. Further, to overcome the limitations and challenges associated with the delivery of subcutaneous formulations, several novel technology platforms have been developed to enable the delivery of (highly) viscous formulations. The rising incidence of chronic clinical conditions (which are characterized by the need for frequent medications) and continuous efforts of therapy / device developers in this field are anticipated to drive the overall growth of this market in the coming years.SCOPE OF THE REPORTThe 'Subcutaneous Biologics, Technologies and Drug Delivery Systems (2nd Edition), 2018-2030' report provides a comprehensive study on the current market landscape and future potential of biologics designed for subcutaneous administration. In addition, the study provides an in-depth analysis of the formulation technologies and drug delivery systems (focusing on large volume wearable injectors, autoinjectors, pen injectors, needle free injectors, prefilled syringes, drug reconstitution systems and implants) that enable subcutaneous delivery of the aforementioned drugs. Amongst other elements, the report features the following:• A detailed assessment of the current market landscape of commercially available biologics that are designed for delivery via the subcutaneous route, along with information on the developer(s), type of molecule, target indication / therapeutic area, approval year, dose strength, treatment regimen and available dosage forms. The study also includes comprehensive case studies on leading subcutaneous biologics, featuring details on annual sales, mechanisms of action, development histories, technology platforms (if available), and a comparison of their intravenous and subcutaneous formulations (if applicable).• An in-depth analysis of the various subcutaneous biologics that are currently under clinical development, with information on the developer(s), phase of development, type of molecule, and target therapeutic area.• A review of various innovative technology platforms that are used for the formulation of drugs for subcutaneous delivery, highlighting their key features and providing information on their developers, mechanisms of action and advantages. The study also includes an insightful three-dimensional analysis of the technology platforms that are presently engaged in developing drug formulations for subcutaneous delivery, comparing them based on pipeline strength (in terms of marketed / under development drugs based on the technology), supplier power (in terms of year of establishment and size of employee base) of the developer and number of collaborations established related to the technology.• A detailed benchmark analysis of technology providers that are based in North America and Europe, highlighting the advantage(s) of their proprietary technology platforms, applicability to other types of molecules, and other possible modes of drug delivery.• Elaborate profiles of key technology providers, featuring overview of the companies, a review of their proprietary technologies, mechanisms of action, key advantages, list of product candidates developed using the technology, recent developments related to the technology (funding and collaborations) and a comprehensive future outlook.• An in-depth review of the most advanced and popular subcutaneous drug delivery systems, focused on large volume wearable injectors, autoinjectors, pen injectors, needle free injectors, prefilled syringes, drug reconstitution systems and implants, providing information on their developer(s) and device specifications / features. Details of specific parameters captured for different device categories are mentioned as follows:• Large volume wearable injectors: Type of device (infusion pump and patch pump), type of dose delivered (continuous and bolus), volume of drug container / storage capacity (in mL), usability (disposable and reusable) and stage of development (commercialized and under development).• Autoinjectors: Type of drug container (syringe, cartridge and others), usability (disposable and reusable), mechanism of action (automatic, semi-automatic and manual), volume of the drug container (in mL) and dosage type (fixed dose and variable dose).• Pen injectors: Usability (disposable and reusable), volume of the drug container (in mL) and dosage type (fixed dose and variable dose).• Needle free injection systems: Type of technology (jet, spring and gas), usability (disposable and reusable) and drug volume delivered (in mL).• Prefilled syringes: Type of syringe (glass and plastic).• Drug reconstitution systems: Type of device (dual chambered systems and other novel systems), type of container (cartridge and others) and usability (disposable and reusable).• Implants: Type of material (silicone, titanium, polymers and others), target therapeutic indication, type of implant (biodegradable and non-biodegradable), treatment duration, type of drug delivered, dose strength and stage of development.• A comprehensive product competitiveness analysis of large volume wearable injectors and subcutaneous autoinjectors taking into consideration the supplier power (based on size of employee base) and product specifications.• A discussion on affiliated trends, key drivers and challenges, under a SWOT framework. The analysis features a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall subcutaneous products market.One of the key objectives of this study was to understand the primary growth drivers and estimate the future potential of the market. Based on historical trends and sales related information for subcutaneous biologic drugs, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. In addition, we have segmented the market based on [A] therapeutic areas (autoimmune disorders, metabolic disorders, blood disorders, bone disorders, oncological disorders, genetic disorders, neurological disorders, respiratory disorders and others) and [B] molecule type (proteins, peptides (recombinant), monoclonal antibodies, other antibody based products, cell / gene therapies and vaccines). In addition to the market forecast for subcutaneous biologic drugs, we have also provided an 8-year forecast for subcutaneous delivery systems, covering large volume wearable injectors, autoinjectors, prefilled syringes and drug reconstitution systems. Further, we have also forecasted the revenues that subcutaneous formulation technology developers are likely to generate through licensing agreements; for this, we have provided a view on the likely upfront payments and milestone payments that will be involved in the deals signed or planned with an aim to develop subcutaneous formulation of biologics. To account for the uncertainties associated with the growth of the subcutaneous formulation technologies market, we have provided three forecast scenarios, portraying conservative, base and optimistic tracks of the market's evolution.The research, analysis and insights presented in this report is backed by a deep understanding of insights gathered both from secondary and primary sources. This enabled us to solicit inputs on upcoming opportunities and challenges that were considered to develop estimates for a more inclusive growth. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following individuals:• David Daily (Chief Executive Officer & Co-Founder, DALI Medical Devices)• Deborah Bitterfield (Chief Executive Officer and Founder, Lindy Biosciences)• Frederic Ors (Chief Executive Officer, Immunovaccine Technologies)• Matthew Young (Founder & Chief Technology Officer, Oval Medical Technologies)• Menachem Zucker (Vice President & Chief Scientist, Elcam Medical)• Michael Reilly (Chief Executive Officer & Co-Founder, Excelse Bio)• Michael Hooven (Chief Executive Officer, Enable Injections)• Poonam R Velagaleti (Co-Founder, i-novion)• Tiffany H. Burke (Director, Global Communications, West Pharmaceutical Services) and Graham Reynolds (Vice President & General Manager, Global Biologics, West Pharmaceutical Services)• David Heuzé (Communication Leader, MedinCell)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.RESEARCH METHODOLOGYThe 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 may evolve across different regions and technology segments. Wherever 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' viewsWhile the focus has been on forecasting the market over the period 2018-2030, 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.CHAPTER OUTLINESChapter 2 provides an executive summary of the insights captured in our research. The summary offers a high-level view on the likely evolution of subcutaneous products market, in the short-mid-term and long term.Chapter 3 provides a general introduction to the various types of therapeutic molecules (biologics and small molecules) comparing their characteristics such as size, structure, immunogenicity and stability. The chapter also highlights different types of biologically derived products that are currently being developed. Further, the chapter features a discussion on the different routes of administration, specifically focusing on the subcutaneous route, highlighting its advantages and associated limitations.Chapter 4 includes information on over 330 subcutaneous biologic drug candidates that are currently approved / under development. It features a comprehensive analysis of marketed molecules based on the type of molecule, target indication, target therapeutic area, approval year, dose strength, treatment regimen and available dosage forms. On the other hand, pipeline molecules have been analyzed based on parameters such as type of molecule, target indication and target therapeutic area.Chapter 5 is a collection of comprehensive case studies on the leading subcutaneous biologics in terms of annual sales. Each case study includes drug / therapy specifications, their respective mechanisms of action, development histories, target therapeutic indication(s), available dosage forms, historical annual sales, technology platforms (if available), and a comparison of intravenous and subcutaneous formulations (if applicable).Chapter 6 provides a list of subcutaneous delivery technology platforms that are either currently available, or being developed by various firms, for the formulation of subcutaneous drugs. The chapter highlights key features of each technology and provides information on their developers. It also features an analysis based on the advantage(s) of their proprietary technology platforms, applicability to other types of molecules, and other possible modes of drug delivery.Chapter 7 features a three-dimensional analysis of the technology platforms that are presently available for developing drug formulations for subcutaneous delivery. The analysis takes into consideration several parameters, such as pipeline strength (in terms of product candidates developed based on the technology, both marketed and under development), supplier power of the developer (in terms of year of establishment and employee size of the company) and number of collaborations established related to the technology, over the past few years. It also includes a benchmark analysis of technology providers that are based in North America and Europe, highlighting the advantage(s) of their proprietary technology platforms, applicability to other types of molecules, and other possible modes of drug delivery.Chapter 8 includes elaborate profiles of key technology providers, featuring overview of the companies, a review of their proprietary technologies, mechanisms of action, key advantages, list of product candidates developed using the technology, recent developments related to the technology (funding and collaborations) and a comprehensive future outlook.Chapter 9 features an elaborate discussion on subcutaneous delivery systems with special focus on large volume wearable injectors, autoinjectors, pen injectors, needle free injectors, prefilled syringes, drug reconstitution systems and implants. It includes a detailed analysis based on specific parameters for each device category, namely [A] large volume wearable injectors, by type of device (infusion pump and patch pump), type of dose delivered (continuous and bolus), volume of drug container / storage capacity (in mL), usability (disposable and reusable) and status of development (commercialized and under development), [B] autoinjectors, by type of drug container (syringe, cartridge and others), usability (disposable and reusable), mechanism of action (automatic, semi-automatic and manual), volume of the drug container (in mL) and dosage type (fixed dose and variable dose) [C] pen injectors, by usability (disposable and reusable), volume of the drug container (in mL) and dosage type (fixed dose and variable dose) [D] needle free injection systems, by type of technology (jet, spring and gas), usability (disposable and reusable) and drug volume delivered, [E] prefilled syringes, by type of syringe (glass and plastic), [F] drug reconstitution systems, by type of device (dual chambered systems and other novel systems), type of container (cartridge and others) and usability (disposable and reusable), [G] implants, by type of material (silicone, titanium, polymers and others), indication, type of implant (biodegradable and non-biodegradable), treatment duration, drug delivered, dosage strength and status of development. As large volume wearable injectors and autoinjectors represent the most novel and advanced types of devices, we have also provided a comprehensive product competitiveness analysis of these products taking into consideration the supplier power (based on size of employee base) and product specifications.Chapter 10 presents a comprehensive market forecast analysis, highlighting the future potential of the market till the year 2030. It also includes future sales projections of various subcutaneous biologic drug candidates. The chapter presents a detailed market segmentation on the basis of therapeutic areas (autoimmune disorders, metabolic disorders, blood disorders, bone disorders, oncological disorders, genetic disorders, neurological disorders, respiratory disorders and others) and molecule type (proteins, peptides (recombinant), monoclonal antibodies, other antibody based products, cell / gene therapies and vaccines). In addition to the market forecast for subcutaneous biologic drugs, we have also provided an 8-year forecast of subcutaneous delivery systems, including large volume wearable injectors, autoinjectors, prefilled syringes and drug reconstitution systems. It also includes the forecast of revenues that subcutaneous formulation technology developers are likely to generate through licensing agreements. We have provided a view on the likely upfront payments and milestone payments that will be involved in the deals signed or planned with an aim to develop subcutaneous formulation of biologics.Chapter 11 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of the subcutaneous products market, under a comprehensive SWOT framework. The chapter also features a schematic Harvey ball analysis to highlight the relative impact of each SWOT parameter on the overall subcutaneous products market.Chapter 12 is a summary of the overall report. In this chapter, we have provided a list of the key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.Chapter 13 is a collection of interview transcripts of discussions held with key stakeholders in this market. In this chapter, we have presented the details of our conversations with David Daily (Chief Executive Officer and Co-Founder, DALI Medical Devices), Deborah Bitterfield (Chief Executive Officer & Founder, Lindy Biosciences), Frederic Ors (Chief Executive Officer, Immunovaccine Technologies), Matthew Young (Founder and Chief Technology Officer, Oval Medical Technologies), Menachem Zucker (Vice President and Chief Scientist, Elcam Medical), Michael Reilly (Chief Executive Officer & Co-Founder, Excelse Bio), Michael Hooven (Chief Executive Officer, Enable Injections), Poonam R Velagaleti (Co-Founder, i-novion), Tiffany H. Burke (Director, Global Communications, West Pharmaceutical Services) and Graham Reynolds (Vice President & General Manager, Global Biologics, West Pharmaceutical Services), and David Heuzé (Communication Leader, MedinCell).Chapter 14 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.Chapter 15 is an appendix, which provides the list of companies and organizations mentioned in the report.EXAMPLE HIGHLIGHTS1. Till date, over 95 biologics have been approved as subcutaneous formulations. In fact, more than 10 such products were approved in 2017 / 2018 by the FDA; these include (in alphabetical order) Admelog® (Sanofi), Benlysta® (Human Genome Sciences and GSK), CRYSVITA® (Kyowa Hakko Kirin and Ultragenyx), DUPIXENT® (Regeneron Pharmaceuticals and Sanofi), FASENRA® (AstraZeneca), Fiasp® (Novo Nordisk), HAEGARDA® (CSL Behring), HEMLIBRA® (Roche), ILUMYA™ (Merck and Sun Pharma), Kevzara® (Regeneron Pharmaceuticals and Sanofi), Kyntheum® / SILIQ™ / Lumicef® (AstraZeneca, LEO Pharma, Valeant Pharmaceuticals and Kyowa Hakko Kirin), RITUXAN HYCELA™ (Roche, Biogen and Chugai Pharmaceutical) and TREMFYA® (Janssen Pharmaceuticals). In addition, close to 240 products are presently being investigated across various stages of clinical development. Around 25% of the clinical candidates are currently in phase III trials; of these, marketing applications have been filed for 15% of the candidates. Notable examples of products that are likely to receive approval in the near future include (in alphabetical order) burosumab (Kyowa Hakko Kirin and Ultragenyx), fremanezumab (Teva Pharmaceutical and Otsuka Pharmaceutical) and galcanezumab (Eli Lilly).2. The market is characterized by the presence of several big pharmaceutical companies that have multiple subcutaneous biologics in their product portfolios; examples include (in decreasing order of number of marketed / clinical products in their portfolio) Amgen, Roche, Sanofi, Novo Nordisk, Eli Lilly, Pfizer, Novartis, AstraZeneca, Merck, Janssen Pharmaceuticals and Merck Serono. In addition, several small-sized companies and start-ups have undertaken initiatives in this area; examples include (in alphabetical order, no selection criteria) Acer Therapeutics, Altor BioScience, Anthera Pharmaceuticals, Araclon Biotech, ARMO Biosciences, Avillion, Bird Rock Bio, Boston Pharmaceuticals, Catalyst Biosciences, Centocor Ortho Biotech, Corvidia Therapeutics, CuraVac, CytoDyn, Cytori Therapeutics, DiaMedica Therapeutics, Diasome Pharmaceuticals, Genor Biopharma, GlobeImmune, Harbour BioMed, Immutep, Neumedicines, Neurimmune, Oncolix, PhaseBio Pharmaceuticals, Provenance Biopharmaceuticals, Qu Biologics, REMD Biotherapeutics, Taisho Pharmaceutical, Viela Bio, Vitaeris and XEME Biopharma3. Close to 45% of the subcutaneous biologics under clinical development are monoclonal antibodies. These are followed by other types of protein-based therapeutics, including interferons, interleukins, hormones, enzymes and cytokines, which account for approximately 27% of the clinical pipeline. Vaccines, recombinant peptides and cell / gene therapies are other therapy types being investigated for subcutaneous administration. Further, about 25% of the products in the development pipeline are designed to treat autoimmune disorders, such as (in the decreasing order of number of biologics under development) rheumatoid arthritis, systemic lupus erythematosus, psoriasis, Crohn's disease and ulcerative colitis. On the other hand, nearly 20% of the candidates are being developed for the treatment of metabolic disorders, primarily focused on diabetes. Other prominent therapeutic areas for which such product formulations are under development include cardiovascular diseases, neurological disorders and certain cancer indications.4. In order to overcome the challenges related to the formulation of biologics for subcutaneous delivery, multiple companies have developed innovative technology platforms. During our research, we came across close to 20 technology platforms that have been developed to facilitate the subcutaneous administration of biologics. We observed that most of the technology developers in this domain are small or mid-sized companies with a workforce of up to 200 employees; in fact, five such companies were established post 2013; these are (in order of year of establishment) Elektrofi (2016), Lindy Biosciences (2016), i-novion (2015), Excelse Bio (2014) and ReForm Biologics (2014). As per our proprietary company competitiveness analysis, Halozyme Therapeutics, Camurus, Adocia, MedinCell, Ascendis Pharma and Xeris Pharmaceuticals have emerged as key players in terms of supplier power, pipeline strength and number of collaborations signed specific to the subcutaneous formulation technology.5. The increasing preference for self-administration has prompted several device manufacturers to develop novel systems for the subcutaneous delivery of drugs. During our research, we came across over 110 companies that are currently involved in the development of over 230 drug delivery systems. Of all the device categories, we observed that several companies (28) are involved in the development / manufacturing of prefilled syringes (glass / plastic), whereas large volume wearable injectors is the second most popular category, with such solutions being developed by 27 players. Other types of delivery systems being evaluated for subcutaneous delivery include (in the decreasing order of number of companies involved) implants, needle free injection systems, autoinjectors, novel drug reconstitution systems and pen injectors. It is worth highlighting that around 10 players are involved in the development of more than one type of delivery system; these are (in alphabetical order) Antares Pharma, Becton Dickinson, Crossject, ELCAM Medical, Future Injection Technologies, Gerresheimer, Owen Mumford, SHL Group, West Pharmaceuticals and Ypsomed.6. Despite the various limitations associated with subcutaneous formulations, the field offers immense opportunities to pharmaceutical companies, device manufacturers and technology developers. Companies are also reformulating their intravenous drugs for subcutaneous administration for life cycle management and product differentiation purposes; prominent examples of such products include (in the reverse chronological order of approval year for subcutaneous formulation, in the US) MabThera® SC / RITUXAN HYCELA™ (2017), Benlysta® (2017), Actemra®/RoActemra® (2013) and ORENCIA® (2011). The rising incidence of chronic clinical conditions (which are characterized by the need for frequent administration of medications) and continuous efforts of therapy / device developers in this field are anticipated to drive the growth in this market in the coming years.7. The current size of the subcutaneous biologics market is estimated to be more than USD 80 billion and it is expected to grow at an annualized rate of ~6% over the next decade. The drugs developed / being developed for the treatment of autoimmune disorders and metabolic disorders contribute the highest share (over 40%) of the current market; we anticipate the revenue generation potential to increase for other therapeutic areas, such as cardiovascular disorders, blood disorders and genetic disorders, in the future.8. In terms of the devices / systems that facilitate subcutaneous administration, we expect prefilled syringes to continue to dominate the market, followed by autoinjectors, large volume wearable injectors and novel drug reconstitution systems. In addition, technology developers are likely to significantly benefit from upfront / milestone payments as a result of multi-billion dollar licensing deals.Download the full report: https://www.reportbuyer.com/product/5483804
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