Subcutaneous Biologics, Technologies and Drug Delivery Systems (3rd Edition), 2020-2030

Subcutaneous Biologics, Technologies and Drug Delivery Systems (3rd Edition), 2020-2030

  • April 2020 •
  • 536 pages •
  • Report ID: 5483804 •
  • Format: PDF
INTRODUCTION
Biologics represent one of the fastest growing classes of therapeutic molecules in modern healthcare. As per an article published in January 2020, the annual global market of biologics is expected to be approximately USD 380 billion by 2024, representing a relatively higher growth rate (~8%) compared to conventional pharmaceuticals. , Considering the necessity to bypass gastric metabolism, biologics are mostly designed for administration via parenteral routes. In fact, majority of such therapies are formulated for intravenous delivery and are usually administered in a clinical setting (hospitals / infusion centers). However, this scenario is cost intensive and is known to be associated with medication adherence related concerns. In this context, the subcutaneous route of drug delivery offers a number of benefits, including self-medication and life cycle management options. Although the pharmacokinetic profiles of intravenous and subcutaneous formulations are different, studies have demonstrated that the latter formulations are preferred by end users (patients and healthcare providers), offering substantial cost saving opportunities.

Presently, the subcutaneous delivery option is being investigated for a number of clinical candidates across different phases of development. Moreover, several approved therapeutic products, which are currently available in intravenous dosage forms, are also being reformulated and evaluated for subcutaneous administration. However, there are certain concerns associated with the subcutaneous route. For instance, most protein-based therapeutics, such as monoclonal antibodies, need to be administered in large quantities and have been shown to result in highly viscous formulations when reformulated for subcutaneous delivery. In order to address this particular challenge, many companies have developed / are developing a number of novel technology platforms to facilitate the delivery of viscous drug formulations. Similar innovations are gradually facilitating a shift to subcutaneous delivery, primarily driven by the demand for self-administrable therapeutics. In fact, there are several self-medication solutions, equipped with a variety of user-friendly features, available in the market; examples include prefilled syringes, pen injectors, autoinjectors, needle-free injectors and large volume wearable injectors. Over the past few years, the aforementioned drug-device combination products have witnessed high adoption, enabled substantial reductions in healthcare expenses (incurred by patients), and improved therapy adherence. In this regard, the rising incidence of chronic clinical conditions (which are characterized by the need for frequent medication) and the ongoing efforts of therapy / device developers engaged in this field, are anticipated to drive the growth of the subcutaneous biologics market in the coming years.

SCOPE OF THE REPORT
The ‘Subcutaneous Biologics, Technologies and Drug Delivery Systems (3rd Edition), 2020-2030’ report provides a detailed 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, drug reconstitution systems, prefilled syringes and implants) that enable subcutaneous delivery of the biologic drugs. Amongst other elements, the report features the following:
• A detailed assessment of the current market landscape of commercially available and clinical-stage biologics that are designed for delivery via the subcutaneous route, along with information on approval year, phase of development, type of pharmacological molecule, target therapeutic area, dosing frequency, available dosage forms and key players.
• A case study on leading subcutaneous biologics (in terms of revenues generated), featuring details on mechanism of action, development history, annual sales, technology platform (if available), and a comparison of their intravenous and subcutaneous formulations (if applicable).
• An assessment of the various subcutaneous formulation technologies along with information on developers, type of pharmacological molecule, route of administration, mechanisms of action and primary advantage(s).
• An insightful three-dimensional comparison of the subcutaneous formulation technology developers, based on pipeline strength (number of drugs developed using a particular technology), supplier power (number of years of experience and company size) of the developer and primary advantages offered by their respective technologies. Also, the study includes a detailed benchmark analysis of the technology developers based in North America and Europe, highlighting the primary advantage(s) offered by their proprietary technologies, applicability to other types of pharmacological molecules, and other possible routes of drug administration.
• Elaborate profiles of key technology developers, featuring a brief overview of the company, its technology portfolio, product portfolio, financial information (if available), recent developments and an informed future outlook.
• An analysis of collaborations and partnership agreements inked by the subcutaneous formulation technology developers since 2011; it includes details of deals that were / are focused on subcutaneous formulation technologies, which were analyzed on the basis of year of agreement, type of agreement, and upfront and milestone payments.
• An in-depth review of the most advanced and popular subcutaneous drug delivery systems, including large volume wearable injectors, autoinjectors, pen injectors, needle-free injectors, drug reconstitution systems, prefilled syringes and implants, providing information on their developer(s) and device specific features. Details of specific parameters captured for different device categories are mentioned as follows:
• Large volume wearable injectors: Stage of development (commercialized and under development), type of device (infusion pump and patch pump), type of dose administered (continuous and bolus), volume / storage capacity (in mL), mode of injection (needle, needle / cannula and needle / catheter) and mechanism of action (driving force).
• Autoinjectors: Usability (disposable and reusable), type of primary container (syringe, cartridge and others), volume / storage capacity (in mL), type of dose (fixed dose and variable dose) and actuation mechanism (automatic, semi-automatic and manual).
• Pen injectors: Usability (disposable and reusable), volume / storage capacity (in mL), and type of dose (fixed dose and variable dose).
• Needle-free injection systems: Stage of development (commercialized and under development), volume / storage capacity (in mL), usability (disposable and reusable), and actuation mechanism (spring-based, gas-powered and others).
• Drug reconstitution systems: Usability (disposable and reusable), device type (dual chambered systems and other novel systems) and type of drug container (cartridge, vials and others).
• Prefilled syringes: Barrel fabrication material (glass and plastic), number of barrel chambers (single chamber and dual chamber), type of needle system (fixed needle system, luer lock and luer cone) and volume / storage capacity (in mL).
• Implants: Stage of development (commercialized and under development), target therapeutic area, implant material (silicone, titanium, polymers and others) and treatment duration.
• A comprehensive product competitiveness analysis of subcutaneous large volume wearable injectors, subcutaneous autoinjectors, subcutaneous needle-free injectors and pre-filled syringes, taking into consideration the supplier power and product specific information.
• A discussion on affiliated trends, key drivers and challenges, which are likely to impact the industry’s evolution, under a comprehensive SWOT framework; it includes a Harvey ball analysis, highlighting the relative effect 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 existing market size and the future growth potential of the subcutaneous biologics, technologies and drug delivery systems 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 2020-2030. The report also provides details on the likely distribution of the current and forecasted opportunity across [A] phase of development (approved, preregistration & phase III and phase II & phase II/III)), [B] type of pharmacological molecule (proteins, peptides (recombinant), monoclonal antibodies, other antibody based products, cell / gene therapies and vaccines), [C] target therapeutic areas (autoimmune disorders, metabolic disorders, blood disorders, bone disorders, oncological disorders, genetic disorders, neurological disorders, respiratory disorders and other disorders) and [D] key geographical regions (North America, Europe, Asia-Pacific and rest of the world). In addition to the market forecast for subcutaneous biologic drugs, we have also provided a 10-year forecast for subcutaneous delivery systems, covering the market for large volume wearable injectors, autoinjectors, prefilled syringes, needle-free injectors 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 generated from the deals related to the development of subcutaneous formulation of biologics. In order to account for future uncertainties and to add robustness to our model, we have provided three 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:
• Deborah Bitterfield (Chief Executive Officer and Founder, Lindy Biosciences)
• Matthew Young (Founder and Chief Technology Officer, Oval Medical Technologies)
• Steve Prestrelski (Chief Scientific Officer and Founder, Xeris Pharmaceuticals), Hong Qi ( Vice President, Product Development, Xeris Pharmaceuticals) and Scott Coleman (Sr. Scientist Formulation, Xeris Pharmaceuticals)
• David Daily (Chief Executive Officer and Co-Founder, DALI Medical Devices)
• Michael Reilly (Chief Executive Officer and Co-Founder, Excelse Bio)
• Poonam R Velagaleti (Co-Founder, i-novion)
• Michael Hooven (Chief Executive Officer, Enable Injections)
• Frederic Ors (Chief Executive Officer, Immunovaccine Technologies)
• Patrick Anquetil (Chief Executive Officer, Portal Instruments)
• Menachem Zucker (Vice President and Chief Scientist, Elcam Medical)
• Tiffany H. Burke (Director, Global Communications, West Pharmaceutical Services) and Graham Reynolds (Vice President and 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 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.

CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of the subcutaneous biologics, technologies and drug delivery systems market, in the short to mid 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 molecular size, molecule structure, immunogenicity and stability. The chapter also highlights different types of biologically derived products that are currently being developed by various stakeholders in this industry. It further discusses the challenges associated with the parenteral route of drug delivery, specifically, those related to the traditional intravenous (infusion) route. 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 450 subcutaneous biologic drug candidates that are currently approved / being developed. It features a comprehensive analysis of marketed and clinical-stage biologics based on the approval year, phase of development type of pharmacological molecule, target therapeutic area, dosing frequency, available dosage forms and key players.

Chapter 5 is a collection of case studies on the leading subcutaneous biologics, in terms of the annual global sales. Each case study includes drug / therapy specifications, their respective mechanism of action, development history, annual sales, technology platform (if available), and a comparison of their intravenous and subcutaneous formulations (if applicable).

Chapter 6 provides a list of subcutaneous formulation technologies that are currently available / being developed by various firms in this domain. The chapter highlights key features of each technology and provides information on their developers. It also features an analysis based on the type of pharmacological molecule, route of administration, mechanisms of action and primary advantage(s).

Chapter 7 features a three-dimensional comparison of the subcutaneous formulation technology developers, based on pipeline strength (number of drugs developed using a particular technology), supplier power (number of years of experience and company size) of the developer and primary advantages offered by their respective technologies. It also includes a benchmark analysis of technology developers that are based in North America and Europe, highlighting the advantage(s) of their proprietary technologies, applicability to other types of pharmacological molecules, and other possible routes of drug administration

Chapter 8 includes elaborate profiles of key technology developers, featuring overview of the company, its technology portfolio, product portfolio, financial information (if available), recent developments and an informed future outlook.

Chapter 9 features an elaborate analysis and discussion of the various collaborations and partnerships related to the subcutaneous formulation technologies, which have been inked amongst players. It includes a brief description of the purpose of the partnership models (including licensing agreements, mergers / acquisitions, product development, service alliances, manufacturing, and others) that have been adopted by the stakeholders in this domain, since 2011. It consists of a schematic representation showcasing the players that have forged the maximum number of alliances. Furthermore, we have provided a world map representation of the deals inked in this field, highlighting those that have been established within and across different continents.

Chapter 10 features an elaborate discussion on subcutaneous delivery systems with special focus on large volume wearable injectors, autoinjectors, pen injectors, needle-free injectors, drug reconstitution systems, prefilled syringes and implants. It includes a detailed analysis based on specific parameters for each device category, namely [A] large volume wearable injectors, by stage of development (commercialized and under development), type of device (infusion pump and patch pump), type of dose administered (continuous and bolus), volume / storage capacity (in mL), mode of injection (needle, needle / cannula and needle / catheter) and mechanism of action (driving force), [B] autoinjectors, by usability (disposable and reusable), type of primary container (syringe, cartridge and others), volume / storage capacity (in mL), type of dose (fixed dose and variable dose) and actuation mechanism (automatic, semi-automatic and manual), [C] pen-injectors, by usability (disposable and reusable), volume / storage capacity (in mL), and type of dose (fixed dose and variable dose), [D] needle-free injection systems, by stage of development (commercialized and under development), volume / storage capacity (in mL), usability (disposable and reusable), and actuation mechanism (spring-based, gas-powered and others), [E] drug reconstitution systems, by usability (disposable and reusable), device type (dual chambered systems and other novel systems) and type of drug container (cartridge, vials and others), [F] prefilled syringes, by barrel fabrication material (glass and plastic), number of barrel chambers (single chamber and dual chamber), type of needle system (fixed needle system, luer lock and luer cone) and volume / storage capacity (in mL), and [G] implants, by stage of development (commercialized and under development), target therapeutic area, implant material (silicone, titanium, polymers and others) and treatment duration. As large volume wearable injectors, pre-filled syringes, needle-free 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 11 provides a detailed analysis capturing the key parameters and trends that are likely to impact the industry’s evolution, under a comprehensive SWOT framework; it includes a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall subcutaneous products market.

Chapter 12 presents an informed estimate of the current and future opportunity in the subcutaneous biologics, technologies and drug delivery systems market, highlighting the likely growth of the market till the year 2030. It also includes future sales projections of various subcutaneous biologic drug candidates that are currently being evaluated by different players. The chapter presents a detailed market segmentation on the basis of phase of development (approved, preregistration & phase III and phase II and phase II/III), type of pharmacological molecule (proteins, peptides (recombinant), monoclonal antibodies, other antibody based products, cell / gene therapies and vaccines), target therapeutic areas (autoimmune disorders, metabolic disorders, blood disorders, bone disorders, oncological disorders, genetic disorders, neurological disorders, respiratory disorders and other disorders) and key geographical regions (North America, Europe, Asia-Pacific and rest of the world). In addition to the market forecast for subcutaneous biologic drugs, we have also provided a 10-year forecast for subcutaneous delivery systems, covering the market for large volume wearable injectors, autoinjectors, prefilled syringes, needle-free injectors, 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 generated from the deals related to the development of subcutaneous formulation of biologics.

Chapter 13 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 14 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 Deborah Bitterfield (Chief Executive Officer and Founder, Lindy Biosciences), Matthew Young (Founder and Chief Technology Officer, Oval Medical Technologies), Steve Prestrelski (Chief Scientific Officer and Founder, Xeris Pharmaceuticals), Hong Qi ( Vice President, Product Development, Xeris Pharmaceuticals) and Scott Coleman (Sr. Scientist Formulation, Xeris Pharmaceuticals), David Daily (Chief Executive Officer and Co-Founder, DALI Medical Devices), Michael Reilly (Chief Executive Officer and Co-Founder, Excelse Bio), Poonam R Velagaleti (Co-Founder, i-novion), Michael Hooven (Chief Executive Officer, Enable Injections), Frederic Ors (Chief Executive Officer, Immunovaccine Technologies), Patrick Anquetil (Chief Executive Officer, Portal Instruments), Menachem Zucker (Vice President and Chief Scientist, Elcam Medical), Tiffany H. Burke (Director, Global Communications, West Pharmaceutical Services) and Graham Reynolds (Vice President and General Manager, Global Biologics, West Pharmaceutical Services) and David Heuzé (Communication Leader, MedinCell).

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 16 is an appendix, which provides the list of companies and organizations mentioned in the report.