The Subcutaneous Biologics Market is valued at USD 236 billion in the current year and is poised for steady growth during the forecast period.
The subcutaneous biologics market growth over the next decade is anticipated to stem from the increased adoption of self-administration devices, coupled with various technological advancements related to subcutaneous delivery of biologic drugs. In recent years, the pharmaceutical industry has witnessed a rise in the number of biologic drugs, including gene therapies, blood products, cell products, antibodies, and protein therapeutics. Unlike traditional chemical-based medications, which are easier and affordable to develop, biologics present unique challenges during drug development. These include their high molecular weight, complex structures, susceptibility to degradation after administration, and complex manufacturing processes.
To overcome these challenges, pharmaceutical companies are leveraging new technologies to develop biologics that can treat a wide range of diseases. These technological innovations involve the formulation of subcutaneous biologics via conjugation, amino acid modification, and encapsulation principles. Additionally, novel drug delivery systems, such as autoinjectors, pre-filled syringes, and needle-free delivery methods have been designed to deliver highly viscous formulations. The industry has witnessed a rise in the number of biologic drugs approved by the US Food and Drug Administration (FDA) in recent years, with nine approvals in the first quarter of 2024 alone. The shift in preference towards biologics can be attributed to their ability to offer targeted treatment, enabling minimal drug interactions due to their precise binding and unique metabolic pathways.
Traditionally, biologics were administered intravenously due to their rapid systemic circulation and potent bioavailability. While intravenous administration is effective, it often requires regular administration by healthcare professionals, which can pose a challenge in terms of medication adherence. However, in recent years, subcutaneous administration methods and devices have gained popularity among healthcare providers owing to their effectiveness, tolerability and safety. In addition, the shift towards subcutaneous biologics is driven by the growing demand for self-administrable therapies and the availability of user-friendly drug delivery devices such as autoinjectors and pre-filled syringes.
Key Market Segments
Type of Biologic
- Antibodies
- Nucleotides
- Proteins
Type of Therapy
- Monotherapies
- Combination Therapies
- Both (Monotherapies and Combination Therapies)
Method of Administration
- Injection
- Infusion
- Both (Injection and Infusion)
Fundamental Principle
- Encapsulation
- Complex Formation
- Conjugation
- Amino acid Interaction
- Other Fundamental Principles
End User
- Pharmaceutical and Biopharmaceutical Companies
- Biotechnology Companies
- MedTech Companies
- Contract Development and Manufacturing Organizations
- Educational Institutes
- Medical Equipment Manufacturers
- Other End Users
Payment Method Employed
- Milestone Payments
- Upfront Payments
Therapeutic Area
- Autoimmune Disorders
- Bone Disorders
- Hematological Disorders
- Infectious Diseases
- Inflammatory Disorders
- Metabolic Disorders
- Neurological Disorders
- Ocular Disorders
- Oncological Disorders
- Other Disorders
Type of Drug Delivery Device
- Large Volume Wearable Injectors
- Autoinjectors
- Needle-free Injection System
- Novel Drug Reconstitution System
- Prefilled Syringes
Geographical Regions
- North America
- Europe
- Asia-Pacific
- Middle East and North Africa
- Latin America
Research Coverage:
- A preface providing an introduction to the full report, Subcutaneous Biologics Market (5th Edition), till 2035.
- An outline of the systematic research approach used for the study of subcutaneous biologics market, featuring an overview of key assumptions, research methodologies, and quality control measures employed to ensure the accuracy and reliability of our findings.
- An overview of the diverse methodologies and frameworks used to forecast and analyze trends in the subcutaneous biologics market. Additionally, it examines the key factors that influence market dynamics and highlights the strong quality control framework implemented to ensure transparency and credibility in the insights provided in this report.
- A detailed view on the various economic factors that are expected to impact the overall market for subcutaneous biologics including currency fluctuations, foreign exchange rates, and known trade barriers. In addition, it evaluates the effects of global recession and inflation on the overall growth of the market, drawing insights from key historical events to make informed decisions in the future.
- An executive summary of the insights captured during our research, offering an insightful overview of the current subcutaneous biologics market. It presents information on the most relevant trends, challenges and opportunities shaping the industry's development.
- A general introduction to various types of therapeutic molecules (biologics and small molecules), along with a comparison of their characteristics, such as molecular size, molecular weight, molecular structure, immunogenicity, stability and manufacturing. Further, it also highlights different types of biologically derived products that are currently under development. Additionally, it highlights various challenges associated with the parenteral route of drug delivery, especially those related to the traditional intravenous (infusion) route of administration. The report further discusses subcutaneous formulations, different delivery approaches for such biologics, methods of administration, and advantages and limitations associated with subcutaneous route.
- A detailed assessment of the current overall market landscape of approved subcutaneous biologics, based on several relevant parameters, such as initial approval year, type of biologic, type of therapy, route of administration, method of administration, dosing frequency, concentration of dose, target disease indication, therapeutic area and type of drug delivery device. Further, it includes an overview of the developers in this domain, presenting a detailed analysis based on several relevant parameters, such as year of establishment, company size and location of headquarters and most active developers.
- An exhaustive success protocol analysis of the leading subcutaneous biologics (in terms of value creation), based on 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.
- In-depth assessment of the overall market landscape of clinical-stage subcutaneous biologics, based on several relevant parameters, such as status of development, type of biologic, type of therapy, mechanism of action, dosing frequency, target disease indication, therapeutic area and drug designation. Further, it comprises of an insightful analysis of the developers in this domain, on the basis of several parameters, such as year of establishment, company size, location of headquarters and most active developers.
- A detailed overview of the current market landscape of subcutaneous formulation technologies, along with information on several relevant parameters, such as fundamental principle, type of molecule, route of administration, therapeutic area and key characteristics. Further, it provides a detailed assessment of subcutaneous formulation technology developers on the basis of several relevant parameters, such as their year of establishment, company size and location of headquarters.
- An informative technology competitiveness analysis of the subcutaneous formulation technologies, based on various parameters, such as company strength (in terms of years of experience) and technology strength (in terms of fundamental principle, type of molecule, route of administration, therapeutic area and key characteristics).
- Elaborate profiles of leading subcutaneous formulation technology developers based in North America, Europe and Asia-Pacific. Each company profile features a brief overview of the company, along with information on the location of headquarters, year of establishment, number of employees, leadership team, contact details, financial information (if available), technology portfolio, recent developments and an informed future outlook.
- In-depth analysis of the partnerships inked between several stakeholders in subcutaneous formulation technology domain, since 2020. Further, it covers technology licensing agreements, technology evaluation agreements, product development agreements, acquisitions and other relevant agreements.
- Detailed discussion on subcutaneous delivery systems with emphasis on the large volume wearable injectors, autoinjectors, pen injectors, needle-free injectors, novel drug reconstitution systems, prefilled syringes and implants.
- An informative product competitiveness analysis of the subcutaneous delivery systems, such as large volume wearable injectors, autoinjectors, needle-free injectors and prefilled syringes, based on various parameters, such as supplier power and product specific information.
- Deep insights on industry affiliated trends, opportunities and challenges, under SWOT analysis, which are anticipated to impact the overall evolution of the subcutaneous biologics market. It includes Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the industry dynamics.
- An in-depth market forecast analysis of approved subcutaneous biologics to estimate the current market size and future opportunity associated with the subcutaneous biologics market, till 2035.
- A detailed market forecast analysis for approved subcutaneous biologics based on different types of biologics, namely antibodies, proteins and nucleotides.
- Detailed market forecast analysis for approved subcutaneous biologics across different types of therapies, namely monotherapy, combination therapy, and both monotherapy and combination therapy.
- A detailed market forecast analysis for approved subcutaneous biologics market across different methods of administration, namely injection, infusion, and both injection and infusion.
- A detailed market forecast analysis for approved subcutaneous biologics based on different therapeutic areas, namely autoimmune disorders, metabolic disorders, oncological disorders, hematological disorders, inflammatory disorders, neurological disorders, bone disorders and other disorders.
- A detailed market forecast analysis for approved subcutaneous biologics market across different geographical regions, namely North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America.
- A detailed projection of the current and anticipated future revenues from the sales of approved subcutaneous biologics.
- A detailed projection of the leading players engaged in the development of subcutaneous biologics.
- A detailed market forecast analysis to estimate the current market size and future opportunity in the subcutaneous formulation technologies market, till 2035. Based on multiple parameters, such as revenues generated from technology licensing deals and comprehensive secondary research, we have provided an informed estimate on the market evolution over the next decade. 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.
- A detailed projection of the current size and future opportunity within the subcutaneous formulation technologies market across different fundamental principles, namely encapsulation, complex formation, conjugation, amino acid interaction and other fundamental principles.
- A detailed projection of the current size and future opportunity within the subcutaneous formulation technologies market across different end users, namely pharmaceutical and biopharmaceutical companies, biotechnology companies, MedTech Companies, contract development and manufacturing organizations, educational institutes, medical equipment manufacturers and other end users.
- A detailed projection of the current size and future opportunity within the subcutaneous formulation technologies market across different therapeutic areas, namely oncological disorders, metabolic disorders, ocular disorders, infectious disorders, autoimmune disorders, neurological disorders, immunological disorders and other disorders.
- A detailed projection of the current size and future opportunity within the subcutaneous formulation technologies market across different geographical regions, namely North America, Europe and Asia-Pacific.
- A detailed projection of the current size and future opportunity within the subcutaneous formulation technologies market across different payment methods employed, namely milestone payments and upfront payments.
- Detailed information on the leading players engaged in the subcutaneous biologics formulation and technology market.
- A detailed market forecast analysis in order to estimate the existing market size and future opportunity across different drug delivery systems, namely large volume wearable injectors, autoinjectors, needle-free injection systems, novel drug reconstitution systems and prefilled syringes.
Key Benefits of Buying this Report
- The report offers valuable insights into revenue estimation for both the overall market and its sub-segments in order to empower market leaders and newcomers with critical information requisite for establishing their footprint in the industry.
- The report can be utilized by stakeholders to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
- The report provides stakeholders with a comprehensive view on the Subcutaneous Biologics Market, covering essential information on significant market drivers, barriers, opportunities, and challenges.
Example Companies Profiled
- Adocia
- Alteogen
- Ascendis Pharma
- CD Bioparticles
- Creative Biolabs
- Creative BioMart
- Foresee Pharmaceuticals
- Pacira Biosciences
- The Wyss Institute
- Xeris Biopharma