Subcutaneous Biologics Market

Subcutaneous Biologics Market Overview

The subcutaneous biologics market is estimated to be worth $113 billion in 2022 and is expected to grow at compounded annual growth rate (CAGR) of over 40% during the forecast period. 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 subcutaneous biologics market, the subcutaneous biologics market is anticipated to witness a steady market growth during the forecast period.

Key Companies in Subcutaneous Biologics Market 

Examples of key companies engaged in subcutaneous biologics market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Adocia, Ajinomoto Bio-Pharma Services, Alteogen, Arecor, Ascendis Pharma, Avadel Pharmaceuticals, Camurus, Creative Biolabs, Creative BioMart, DURECT, Eagle Pharmaceuticals, Halozyme Therapeutics, MedinCell, Serina Therapeutics and Xeris Pharmaceuticals. This market report includes an easily searchable excel database of all the companies providing subcutaneous biologics, technologies and drug delivery systems, worldwide.

Recent Developments in Subcutaneous Biologics Market:

Several recent developments have taken place in the field of subcutaneous biologics market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In August 2023, Comera Life Sciences published data focusing on development of caffeine as a viscosity reducing agent for subcutaneous formulations of monoclonal antibodies. 
• In June 2023, Halozyme Therapeutics announced the FDA approval of VYVGART® Hytrulo injection with ENHANZE® for subcutaneous use for the treatment of generalized myasthenia gravis in adult patients with anti-acetylcholine receptor antibody positive.

Scope of the Report

The ‘Subcutaneous Biologics Market (4th Edition) by Type of Biologic (Antibodies, Nucleotides, Proteins, Vaccines, Other Biologics), Type of Therapy (Monotherapies and Combination Therapies and Both (Monotherapies and Combination Therapies)), Therapeutic Area (Autoimmune Disorders, Blood Disorders, Bone Disorders, Cardiovascular Disorders, Genetic Disorders, Hormonal Disorders, Infectious Disorders, Inflammatory Disorders, Metabolic Disorders, Neurological Disorders, Oncological Disorders, Respiratory Disorders, Women’s Health 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’ market report provides a detailed study on the current market landscape, market size, market forecast and future opportunities for biologics designed for subcutaneous administration during the forecast period. In addition, the market research report 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 market 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 approved subcutaneous biologics, dosing frequency, drug efficacy, existing competition, geographical reach, prevalence, and therapy price.
• 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 market report is to provide a detailed market forecast analysis in order to estimate the existing market size and future opportunity associated with subcutaneous biologics, technologies and drug delivery systems during the forecast period. 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 market 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, combination therapy and both (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)
• 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 
• Geographical 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 market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in the market report were influenced by discussions held with several senior stakeholders in the industry. The market research 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 market research report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What are subcutaneous biologics?

Answer: Subcutaneous biologics refer to a special class of drugs which are administered via the subcutaneous route, as it enables self-medication by patients. Other benefits associated with subcutaneous administration include highly effective delivery of biologics and substantial cost saving opportunities.

Question 2: How big is the subcutaneous biologics market?

Answer: The subcutaneous biologics market size is estimated to be worth $113 billion in 2022.

Question 3: What is the projected market growth of the subcutaneous biologics market?

Answer: The subcutaneous biologics market is expected to grow at compounded annual growth rate (CAGR) of over 40% during the forecast period 2022 - 2035.

Question 4: Who are the leading companies in the subcutaneous biologics market?

Answer: Examples of key companies engaged in subcutaneous biologics market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Adocia, Ajinomoto Bio-Pharma Services, Alteogen, Arecor, Ascendis Pharma, Avadel Pharmaceuticals, Camurus, Creative Biolabs, Creative BioMart, DURECT, Eagle Pharmaceuticals, Halozyme Therapeutics, MedinCell, Serina Therapeutics and Xeris Pharmaceuticals.

Question 5: How many drug delivery systems for the administration of subcutaneous biologics are currently available in the market?

Answer: Presently, over 450 drug delivery systems are marketed / being developed for subcutaneous delivery by companies engaged in the subcutaneous biologics market.

Question 6: How many subcutaneous biologics are currently marketed / under development by the stakeholders engaged in this industry?

Answer: Presently, more than 400 drug candidates are marketed / being developed by players engaged in the subcutaneous biologics market.

Question 7: Which region is the hub for companies engaged in the subcutaneous biologics market?

Answer: North America emerged as the hub for companies engaged in the subcutaneous biologics market, with 45% of the players established in the region.