Subcutaneous Biologics, Technologies and Drug Delivery Systems (4th Edition) Market, 2022-2035

Subcutaneous Biologics, Technologies and Drug Delivery Systems (4th Edition) Market, 2022-2035

Currently, biologics represent one of the fastest growing classes of the pharmaceutical industry. In fact, the US Food and Drug Administration (USFDA) has approved more than 630 biologic products till date, while over 8,000 such drug candidates are being evaluated in clinical studies. , , Primarily, biologic candidates are being designed for delivery via the parenteral route. However, this route is associated with the need for frequent medication, administered by a professional, in clinics or hospitals. Such visits pose an additional financial burden and are also very time consuming, thereby, negatively impacting the medical adherence. Further, low adherence to prescribed medications is reported to result in a loss of approximately USD 188 billion per year, in the US alone. A number of the aforementioned challenges can be mitigated by delivering drugs via the subcutaneous route, as it enables self-medication by patients. Other benefits associated with the subcutaneous administration include highly effective delivery of biologics (including vaccines, growth hormones and insulin) and substantial cost saving opportunities. , , Considering the various advantages offered by the subcutaneous route for the delivery of biologics, a shift in the preference towards this route has been observed in the pharmaceutical industry.

Presently, more than 330 subcutaneous biologics formulations are being evaluated in different clinical stages. In addition, several approved intravenous therapeutics are being reformulated and evaluated for delivery via the subcutaneous route of 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 demonstrated to form highly viscous formulations when reformulated for subcutaneous delivery. In order to overcome this challenge, companies have developed / are developing a number of novel technology platforms, intended to facilitate the delivery of viscous drug formulations. Such innovations are gradually facilitating a shift towards subcutaneous delivery of biologics, primarily driven by the rising demand for self-administrable therapeutics. In fact, several subcutaneous self-administration drug delivery solutions, equipped with a variety of user-friendly features, are already 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 a high adoption, as they enable substantial reductions in healthcare expenses (incurred by patients) and demonstrate improved therapy adherence. Therefore, considering the rising prevalence of chronic diseases and the ongoing efforts of therapy / device developers engaged in this field, the subcutaneous biologics market is anticipated to grow at a steady pace in the foreseen future.

The ‘Subcutaneous Biologics, Technologies and Drug Delivery Systems (4th Edition) Market by Type of Biologic (Antibodies, Nucleotides, Proteins, Vaccines, Other Biologics), Type of Therapy (Monotherapies and Combination Therapies), Therapeutic Area (Autoimmune Disorders, Blood Disorders, Bone Disorders, Genetic Disorders, Hormonal Disorders, Infectious Disorders, Inflammatory Disorders, Kidney Disorders, Metabolic Disorders, Neurological Disorders, Oncological Disorders, Respiratory Disorders and Other Disorders), Type of Payment (Milestone Payments and Upfront Payments), Type of Drug Delivery System (Large Volume Wearable Injectors, Autoinjectors, Prefilled Syringes, Needle-Free Injection Systems and Novel Drug Reconstitution Systems) and Key Geographical Regions (North America, Europe, Asia, Middle East and North Africa, Latin America and Rest of the World), Industry Trends and Global Forecasts, 2022-2035’ 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 biologics that are designed for delivery via the subcutaneous route, based on several relevant parameters, such as approval year, type of molecule (antibody, nucleotide, protein, vaccine and others), type of therapy (monotherapy and combination therapy), route of administration (subcutaneous, intravenous and intramuscular), method of administration (infusion and injection), dosing frequency, dose concentration (in mg / ml), target disease indication(s) (anemia, arthritis, asthma, diabetes, growth failure, growth hormone deficiency, idiopathic short stature, immunodeficiency, infertility, multiple sclerosis, neutropenia, osteoporosis, psoriasis, rheumatoid arthritis and turner syndrome), therapeutic area (autoimmune disorders, blood disorders, bone disorders, genetic disorders, hormonal disorders, infectious disorders, inflammatory disorders, kidney disorders, metabolic disorders, neurological disorders, oncological disorders, respiratory disorders and other disorders) and type of available formulation (vial, cartridge, prefilled syringe, pen-injector, auto-injector and other devices). In addition, it provides details on the companies offering these approved subcutaneous biologics, along with information on their year of establishment, company size, geographical location and leading developers (in terms of number of approved subcutaneous biologics).

A detailed assessment of the current market landscape of clinical-stage biologics that are designed for delivery via the subcutaneous route, based on several relevant parameters, such as phase of development (phase I, phase II, Phase III, and FDA registration), mechanism of action (inhibition, modulation, stimulation and others), type of molecule (antibody, antisense oligonucleotides, protein, small interfering RNA, vaccine and others), type of therapy (monotherapy and combination therapy), dosing frequency, target disease indication(s) (asthma, atopic dermatitis, breast cancer, Crohn’s disease, lung cancer, myasthenia gravis, non-alcoholic steatohepatitis, prostate cancer, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, type I diabetes, type II diabetes and ulcerative colitis), therapeutic area (autoimmune disorders, bone disorders, cardiovascular disorders, dermatological disorders, genetic disorders, hematological disorders, hormonal disorders, infectious disorders, inflammatory disorders, kidney disorders, metabolic disorders, neurological disorders, oncological disorders, respiratory disorders and other disorders) and special designation(s) awarded (if any). In addition, it provides details on the companies engaged in the development of clinical-stage subcutaneous biologics, based on year of establishment, company size, location of headquarters and leading players (in terms of number of clinical-stage drugs).

An insightful success protocol analysis of leading subcutaneous biologics (in terms of value creation), taking into consideration several relevant parameters, such as drug efficacy / success rate, target disease indication burden, global competition (with respect to industry players), therapy price, geographical reach and disease prevalence.

A detailed assessment of the current market landscape of various subcutaneous formulation technologies, based on several relevant parameters, such as fundamental principle of technology, type of molecule (biologics and small molecule), route of administration, therapeutic area and primary advantage(s) offered. In addition, it provides details on the subcutaneous formulation technologies providers, along with information on their year of establishment, company size and location of headquarters.

An in-depth company competitiveness analysis of subcutaneous formulation technology providers, based on several relevant parameters, such as the company’s technology strength (taking into consideration years of experience, type of molecule, route of administration, therapeutic area and advantage(s) offered), and partnership strength (in terms of the number of partnerships inked and type of agreement).

Elaborate profiles of key subcutaneous technology providers, featuring a brief overview of the company, details related to its financial information (if available), technology portfolio, drug portfolio, recent developments and an informed future outlook.

An analysis of several partnerships and collaborations inked by subcutaneous formulation technology providers, during the period pre-2016 – 2021, based on several relevant parameters, such as year of partnership, type of partnership, type of partner, therapeutic area, focus area and country wise distribution.

An in-depth review of the most advanced and popular subcutaneous drug delivery systems, including large volume wearable injectors, drug device combination products, autoinjectors, pen injectors, needle-free injectors, novel 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: These devices have been analyzed based on their phase of development, type of device, actuation mechanism, technology used, route of administration, method of administration, therapeutic area, type of dose, storage volume / capacity, usability, availability of prefilled drug reservoir, availability of connectivity, drug compatibility, type of drug container, combination insulin, non-interoperable devices, availability of continuous glucose monitoring / blood glucose monitoring systems, availability of automated delivery feature, availability of automatic insulin delivery / artificial pancreas, and device control features

Autoinjectors: These devices have been analyzed based on their actuation mechanism, route of administration, type of dose, storage volume / capacity, usability, type of primary container and type of feedback mechanism.

Pen injectors: These devices have been analyzed based on their type of dose, storage volume / capacity and usability.

Needle-free injection systems: These devices have been analyzed based on their phase of development, actuation mechanism, therapeutic area and usability

Drug reconstitution systems: These devices have been analyzed based on their storage volume / capacity, usability, type of device, type of chamber, physical state of drugs and container fabrication material

Prefilled syringes: These devices have been analyzed based on their storage volume / capacity, barrel fabrication material, number of barrel chambers and type of needle system

Implants: These devices have been analyzed based on their phase of development, therapeutic area, implant material, treatment duration and type of delivery system

An elaborate product competitiveness analysis of subcutaneous drug delivery systems, such as large volume wearable injectors, autoinjectors, 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 evolution, under an elaborate SWOT framework; it also 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 associated with subcutaneous biologics, technologies and drug delivery systems. Based on historical trends and sales related information for subcutaneous biologics, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term.

The report also provides details on the likely distribution of the current and forecasted opportunity for [A] Approved Subcutaneous Biologics across following segments:

Type of Biologic (antibodies, nucleotides, proteins, vaccines and other biologics)

Type of Therapy (monotherapy and combination therapy)

Therapeutic Area (autoimmune disorders, blood disorders, bone disorders, genetic disorders, hormonal disorders, infectious disorders, inflammatory disorders, kidney disorders, metabolic disorders, neurological disorders, oncological disorders, respiratory disorders, and other disorders)

Geographical Region (North America, Europe, Asia, Middle East and North Africa, Latin America and rest of the world)

Further, we have forecasted the revenues generated by approved subcutaneous biologics; for this, we have included information from yearly company biologics sales, biologics peak sales and patents.

[B] Subcutaneous Formulation Technology Providers across following segments:

Type of Payment (milestone payments and upfront payments)

Fundamental Principle (amino acid interaction principles, complex formation principles, encapsulation principles and other fundamental principles)

End-User (biopharmaceutical companies, contract development and manufacturing organizations, educational institutes, investors, pharmaceutical companies, research institutes and other end users)

Therapeutic Area (autoimmune disorders, genetic disorders, infectious disorders, metabolic disorders, oncological disorders, ophthalmic disorders and other disorders) and V. region (North America, Europe and Asia)

[C] Subcutaneous Biologics Drug Delivery Systems across following segments:

Type of Drug Delivery Systems (large volume wearable injectors, autoinjectors, prefilled syringes, needle-free injection systems and novel drug reconstitution systems). The opportunity has been segmented

Type of Large Volume Wearable Injectors (infusion pumps and patch pumps)

Usability of Large Volume Wearable Injectors (disposable and reusable)

Therapeutic Area of Large Volume Wearable Injectors (cardiovascular disorders, infectious diseases, neurological disorders oncological disorders and others)

Type of Autoinjector (disposable and reusable)

Therapeutic Indication of Autoinjector (anaphylaxis, multiple sclerosis, rheumatoid arthritis, migraine, diabetes, and others)

Type of Syringe Barrel Material for Prefilled Syringes (glass and plastic)

Type of Chamber System for Prefilled Syringes (single chamber and dual chamber)

Therapeutic Area for Prefilled Syringes (autoimmune disorders, infectious diseases, neurological disorders, blood disorders, oncological disorders, psychiatric disorders, respiratory disorders, cardiovascular disorders, metabolic disorders, ophthalmic diseases, orthopedic disorders and others)

Type of Needle-Free Injection Systems (disposable and re-usable)

Types of Actuation Mechanisms for Needle-Free Injection Systems (spring-based, gas powered and others)

Therapeutic Area for Needle-Free Injection System (infectious diseases, diabetes and others)

Type of Container Novel Drug Reconstitution System (cartridge, infusion bag and prefilled syringe)

Type of Fabrication Material Used for Novel Drug Reconstitution System (glass and plastic)

Physical State of Drug in Syringe and Cartridge for Novel Drug Reconstitution System (liquid / powder, liquid / liquid)

Physical State of Drug in Infusion Bag for Novel Drug Reconstitution System (liquid mixture, frozen mixture)

Volume of Novel Drug Reconstitution System (<1 ml, 1-2.5 ml, 2.5-5 ml, >5 ml for prefilled syringe and cartridge; <250 ml, 250-500 ml, 500-1,000 ml, >1,000 ml for infusion bag) and

Key Geographical Regions for Drug Delivery Systems (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, and rest of the world).

Finally, in order to account for future uncertainties and 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 the report were influenced by discussions held with several senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders:

Steve Prestrelski (Chief Scientific Officer and Founder, Xeris Pharmaceuticals), Hong Qi (Vice President, Product Development, Xeris Pharmaceuticals) and Scott Coleman (Former Sr. Scientist Formulation, Xeris Pharmaceuticals)

Patrick Anquetil (Chief Executive Officer, Portal Instruments)

Deborah Bitterfield (Chief Executive Officer and Founder, Lindy Biosciences)

David Daily (Chief Executive Officer and Co-Founder, DALI Medical Devices)

Poonam R Velagaleti (Co-Founder, i-novion)

Frederic Ors (Former Chief Executive Officer, Immunovaccine Technologies)

David Heuzé (Communication Leader, MedinCell)

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)

Michael Reilly (Chief Executive Officer and Co-Founder, Excelse Bio)

Michael Hooven (Chief Executive Officer, Enable Injections)

Matthew Young (Founder and Chief Technology Officer, Oval Medical Technologies)

All actual figures have been sourced and analyzed from publicly available information forums and secondary sources. 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 have conducted interviews with various experts in this domain (academia, industry, medical practice and other associations) in order 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. 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’ views

While the focus has been on forecasting the market over the period, 2022-2035, 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.

KEY QUESTIONS ANSWERED

Who are the key players that have marketed their proprietary subcutaneous biologics?

Who are the leading players currently engaged in the development of clinical-stage subcutaneous biologics?

Which popular therapeutic areas are being targeted by clinical-stage subcutaneous biologics?

What are the crucial factors that impact the sales of a subcutaneous biologic product?

Who are the leading players involved in the development of subcutaneous formulation technologies?

What type of drug delivery systems are being most commonly used for the delivery of subcutaneous biologics?

What type of partnership models are most commonly adopted by stakeholders engaged in this industry?

How is the current and future market opportunity likely to be distributed across key market segments?

CHAPTER OUTLINES

Chapter 2 is an executive summary of key insights captured during our research. It offers a high-level view on the likely evolution of subcutaneous biologics, formulation technologies and drug delivery systems market, in the short to mid and long term.

Chapter 3 provides a general introduction on different types of therapeutic molecules (biologics and small molecules) comparing their characteristics, such as molecular size, molecular weight, molecular structure, immunogenicity, stability and manufacturing. The chapter also highlights different types of biologically derived products that are currently being developed by several players in the industry. Additionally, it includes information on the various challenges associated with the parenteral route of drug delivery, specifically those related to the traditional intravenous (infusion) route. Further, this chapter discusses about subcutaneous formulations, which includes different approaches of delivery of such biologics, method of administration, advantages and limitations associated with this route, along with the relevant regulatory guidelines.

Chapter 4 includes information on around 120 subcutaneous biologic drug candidates that are currently approved. The chapter features an elaborate analysis of marketed biologics based on several relevant parameters, such as approval year, type of molecule (antibody, nucleotide, protein, vaccine and others), type of therapy (monotherapy and combination therapy), route of administration (subcutaneous, intravenous and intramuscular), method of administration (infusion and injection), dosing frequency, dose concentration (in mg/ml), target disease indication(s) (anemia, arthritis, asthma, diabetes, growth failure, growth hormone deficiency, idiopathic short stature, immunodeficiency, infertility, multiple sclerosis, neutropenia, osteoporosis, psoriasis, rheumatoid arthritis and turner syndrome), therapeutic area (autoimmune disorders, blood disorders, bone disorders, genetic disorders, hormonal disorders, infectious disorders, inflammatory disorders, kidney disorders, metabolic disorders, neurological disorders, oncological disorders, respiratory disorders and other disorders) and type of drug delivery device (vial, cartridge, prefilled syringe, pen-injector, auto-injector and other devices). In addition, it provides details on the companies offering these approved subcutaneous biologics, along with information on their year of establishment, company size, geographical location and leading developers (in terms of number of approved subcutaneous biologics).

Chapter 5 includes information of over 340 subcutaneous biologics that are currently in clinical stage of development. The chapter features an elaborate analysis of clinical-stage biologics based on several relevant parameters, such as phase of development (phase I, phase II, Phase III, and FDA registration), mechanism of action (inhibition, modulation, stimulation and others), type of molecule (antibody, antisense oligonucleotides, protein, small interfering RNA, vaccine and others), type of therapy (monotherapy and combination therapy), dosing frequency, target disease indication(s) (asthma, atopic dermatitis, breast cancer, Crohn’s disease, lung cancer, myasthenia gravis, non-alcoholic steatohepatitis, prostate cancer, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, type I diabetes, type II diabetes and ulcerative colitis ), therapeutic area (autoimmune disorders, bone disorders, cardiovascular disorders, dermatological disorders, genetic disorders, hematological disorders, hormonal disorders, infectious disorders, inflammatory disorders, kidney disorders, metabolic disorders, neurological disorders, oncological disorders, respiratory disorders and other disorders)and special designation(s) awarded (if any). In addition, it provides details on the several companies engaged in the development of clinical-stage subcutaneous biologics, based on the year of establishment, company size, location of headquarters and leading players (in terms of number of clinical-stage drugs).

Chapter 6 is an insightful success protocol analysis of the leading subcutaneous biologics, biologics (in terms of value creation), taking into consideration several relevant parameters, such as drug efficacy / success rate, target disease indication burden, global competition (with respect to industry players), therapy price, geographical reach and disease prevalence.

Chapter 7 includes information on over 30 subcutaneous formulation technologies. It features an elaborate analysis of clinical-stage biologics based on several relevant parameters, such as fundamental principle of technology (amino acid interaction, complex formation, encapsulation and others), type of molecule (biologics and small molecule), route of administration (intramuscular, intraocular, intravenous, local (unspecified), oral, pulmonary, subcutaneous and others), therapeutic area (autoimmune disorders, genetic disorders, isank-deficiency disorders, infectious disorders, inflammatory disorders, metabolic disorders, neurological disorders, oncological disorders, other disorders) and primary advantage(s) offered. In addition, it provides details on the subcutaneous formulation technologies providers along with information on their year of establishment, company size and location of headquarters.

Chapter 8 features an insightful company competitiveness analysis of the subcutaneous formulation technology developers, based on several relevant parameters, such as the company’s technology strength (taking into consideration years of experience, type of molecule, route of administration, therapeutic area and advantage(s) offered), and partnership strength (in terms of the number of partnerships inked and type of agreement).

Chapter 9 provides detailed profiles of key subcutaneous formulation technology providers engaged in this domain. Each profile features a brief overview of the company (including information on the year of establishment, number of employees, location of headquarters and key executives), details related to its financial information (if available), list of drug candidates developed using the formulation technology, details related to its recent developments, and an informed future outlook.

Chapter 10 features an analysis of recent partnerships and collaborations that have been inked by several stakeholders engaged in this domain, pre-2016-2021. The chapter includes a brief description of the partnership models (including licensing agreement, formulation development agreement, product development agreement, R&D agreement, manufacturing and supply agreement, product development and commercialization agreement, joint venture and other related agreements). Additionally, it comprises of analysis based on the year of partnership, type of partnership, type of partner, therapeutics area and focus area. Further, 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 11 features an elaborate discussion on subcutaneous delivery systems with special focus on large volume wearable injectors, autoinjectors, pen injectors, needle-free injectors, novel drug reconstitution systems, prefilled syringes and implants. The chapter includes a detailed analysis based on specific parameters for each device category, namely [A] large volume wearable non-insulin biologics injectors based on their phase of development, type of device, actuation mechanism, technology used, route of administration, method of administration, therapeutic area, type of dose, storage volume / capacity, usability, availability of prefilled drug reservoir, availability of connectivity, drug compatibility, availability of drug containers and key players, [B] large volume wearable insulin biologics injectors based on their phase of development, type of device, type of dose, storage volume / capacity, usability, combination insulin, non-interoperable devices, availability of prefilled drug reservoir, availability of continuous glucose monitoring (CGM) / blood glucose meters (BGM) system, availability of automated insulin delivery (AID) feature, automatic insulin delivery (AID) / artificial pancreas, availability of connectivity, availability of device control features and key players, [C] drug device combination products based on their phase of development, type device, mechanisms of action, technology used, route of administration, method of administration, therapeutics area, type of dose, storage volume/ capacity, usability, drug compatibility, drug container and key players, [D] autoinjector, by actuation mechanism, route of administration, type of dose, storage volume / capacity, usability, type of primary container, type of feedback mechanisms, and key players [E] pen-injectors based on their type of dose, storage volume / capacity, usability, and key player, [F] needle-free injection systems based on their phase of development, actuation mechanisms, therapeutic area, usability and key players [G] novel drug reconstitution systems based on their volume of container, usability, type of device, type of chambers, physical state of drugs, container fabrication material and key player, [I] prefilled syringes based on their storage volume / capacity, barrel fabrication material, number of barrel chamber, type of needle system and key players and [J] implants based on their phase of development, therapeutic area, implant material, treatment duration, type of delivery system and key players.

Chapter 12 features an insightful product competitiveness analysis of the subcutaneous delivery system, such as large volume wearable injectors, autoinjectors, needle-free injectors and pre-filled syringes, taking into consideration the supplier power and product specific information.

Chapter 13 presents an elaborate market forecast analysis, highlighting the future potential of the approved subcutaneous biologics market till 2035. Additionally, the chapter includes future sales projections of various approved subcutaneous biologic drug candidates. The chapter presents a detailed market segmentation on the basis of type of biologic (antibodies, nucleotides, proteins, vaccines and other biologics), [B] type of therapy (monotherapy and combination therapy), [C] therapeutic area (autoimmune disorders, blood disorders, bone disorders, genetic disorders, hormonal disorders, infectious disorders, inflammatory disorders, kidney disorders, metabolic disorders, neurological disorders, oncological disorders, respiratory disorders, and other disorders) and [D] geographical regions (North America, Europe, Asia, Middle East and North Africa, Latin America and Rest of the World).

Chapter 14 presents an elaborate market forecast analysis, highlighting the future potential of the subcutaneous formulation technology market till the year 2035. The chapter presents a detailed market segmentation on the basis of [A] type of payment (milestone payments and upfront payments), [B] fundamental principle (amino acid interaction, complex formation, encapsulation and other fundamental principles), [C] end user (biopharmaceutical companies, biotechnology companies, contract development and manufacturing organizations, educational institutes, investors and other end users), [D] therapeutic area (autoimmune disorders, genetic disorders, infectious disorders, metabolic disorders, oncological disorders, ophthalmic disorders and other disorders) and [E] geographical regions (North America, Europe and Asia).

Chapter 15 presents an elaborate market forecast analysis, highlighting the future potential of the approved subcutaneous biologics market till the year 2035. In addition, it provides a 14-year forecast of subcutaneous delivery systems, including large volume wearable injectors, autoinjectors, prefilled syringes, needle-free injection systems and novel drug reconstitution systems.

Chapter 16 provides a detailed analysis capturing the key parameters and trends that are likely to impact the industry’s evolution, under an elaborate SWOT framework; it also includes a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall subcutaneous biologics market.

Chapter 17 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 18 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), Scott Coleman (Former 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 (Former 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), Graham Reynolds (Vice President and General Manager, Global Biologics, West Pharmaceutical Services) and David Heuzé (Communication Leader, MedinCell).

Chapter 19 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 20 is an appendix, which provides the list of companies and organizations mentioned in the report.