Subcutaneous Biologics Market Size for Approved Drugs to Hit USD 275 Billion by 2027 | Roots Analysis

Subcutaneous Biologics Market Overview

The global subcutaneous biologics market is estimated to be valued at USD 251 billion in 2025, growing to USD 275 billion in 2027 and be valued at 233 billion by 2035.

Historically, biologics were primarily developed for intravenous administration due to their swift systemic circulation and high bioavailability through this method. While intravenous delivery is effective, it often requires healthcare professionals to administer the treatment regularly, posing challenges for medication adherence. However, subcutaneous biologics can be self-administered by patients at home, reducing their dependence on healthcare facilities and lowering both costs and time commitments. Moreover, subcutaneous biologics carry a reduced risk of infusion-related infections, resulting in fewer adverse effects. As patient and healthcare professional acceptance of subcutaneous biologics continues to grow, along with advancements in formulation technologies and drug delivery systems, the market for subcutaneous biologics is expected to experience significant growth in the foreseen future.

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Key Report Takeaways

1. More than 175 biologics have been approved for administration through subcutaneous route; around 50% of these biologics are proteins approved for once daily administration.
2. Currently, more than 340 biologics are being investigated clinical-stages of development for administration through subcutaneous route; around 10% of these biologics are antibodies that have received orphan drug designation.
3. Recent advances in the field of subcutaneous biologics have prompted stakeholders to develop novel technology platforms to aid the development and administration of drugs.
4. In order to gain a competitive edge in the industry, stakeholders are actively innovating and developing new and innovative subcutaneous formulation technologies that can be utilized for the treatment of various indications.
5. Close to 70% of the deals were inked in the last three years, reflecting a rising interest in the subcutaneous formulation technologies domain.
6. Over 560 new and innovative drug delivery systems that facilitate subcutaneous administration are presently available / under development.
7. Developers are actively engaged in differentiating their portfolio of self-medication enabling devices, such as autoinjectors and wearable injector, by incorporating advanced, patient-friendly features.
8. The approved subcutaneous biologics market is likely to grow at a CAGR of ~5%, till 2027 owing to the heightened emphasis towards patient compliance and improved treatment outcome.
9. Driven by the increasing number of technology licensing deals and numerous advantages offered by subcutaneous formulation technologies, the market is anticipated to grow at an annualized rate of 22.7% in the coming decade.

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Competitive Landscape of Approved Subcutaneous Biologics Market
The approved subcutaneous biologics market landscape features the presence of over 175 approved subcutaneous biologics developed for the treatment of various chronic disorders. The subcutaneous biologics market for approved drugs is predominantly characterized by the presence of very large and large players, which constitutes close to 90% of all the players. Further, majority of the drug developers are located in North America (48%). This is followed by the players based in Europe (38%) and Asia-Pacific (10%). Further, highest number of subcutaneous biologics were approved between 2011 and 2020.

Approved Subcutaneous Biologics Market Regional Outlook

Based on the geographical regions, the approved subcutaneous biologics market can be segmented into five major regions, including North America, Europe, Asia Pacific, Middle East and North Africa, and Latin America. North America is anticipated to capture the majority share of the approved subcutaneous biologics market in the current year and this trend is likely to remain unchanged during the forecast period. This can be attributed to the presence of major market players, well-established infrastructure and necessary expertise for the development of subcutaneous biologics in North America. Additionally, intensified focus on improving healthcare amenities and increased expenditure on research and innovation is facilitating the progress Asia-Pacific region, due to which the market is poised for the highest growth during the forecast period.
Subcutaneous Formulation Technology Market Companies Profiled
Examples of companies engaged in subcutaneous formulation technologies domain (the complete list of companies is available in the full report) include:

1. Adocia
2. Alteogen
3. Ascendis Pharma
4. CD Bioparticles
5. Creative Biolabs
6. Creative BioMart
7. Foresee Pharmaceuticals
8. Pacira Biosciences
9. Wyss Institute
10. Xeris Biopharma

It is interesting to note that in January 2024, Creative BioMart expanded its existing product portfolio and launched recombinant coagulation factor III (F3) protein for studying blood clotting and its associated diseases. Further, the company is anticipated to launch additional products in order to further expand the existing capabilities in subcutaneous biologics industry.

Subcutaneous Biologics Market Segments

Based on the research, Roots Analysis has segmented the Subcutaneous Biologics Market into Type of Biologic, Type of Therapy, Method of Administration, Fundamental Principle, End User, Payment Method Employed, Therapeutic Area, Drug Delivery Device and Geographical Regions.

Subcutaneous Biologics Market, by Type of Biologic
1. Antibodies
2. Proteins
3. Nucleotides

Subcutaneous Biologics Market, by Type of Therapy
1. Monotherapy
2. Combination Therapy
3. Both monotherapy and combination therapy

Subcutaneous Biologics Market, by Method of Administration
1. Injection
2. Infusion
3. Both injection and infusion

Subcutaneous Biologics Market, by Fundamental Principle
1. Encapsulation
2. Complex Formation
3. Conjugation
4. Amino Acid Interaction
5. Other Fundamental Principles

Subcutaneous Biologics Market, by End User
1. Pharmaceutical and Biotechnology Companies
2. Biotechnology Companies
3. MedTech Companies
4. Contract Drug Manufacturing Organizations
5. Educational Institutes
6. Medical Equipment Manufacturers
7. Other End Users

Subcutaneous Biologics Market, by Payment Method Employed
1. Milestone Payments
2. Upfront Payments

Subcutaneous Biologics Market, by Therapeutic Area
1. Autoimmune Disorders
2. Bone Disorders
3. Hematological Disorders
4. Infectious Diseases
5. Inflammatory Disorders
6. Metabolic Disorders
7. Neurological Disorders
8. Ocular Disorders
9. Oncological Disorders
10. Other Disorders

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Subcutaneous Biologics Market, by Drug Delivery Device
1. Large Volume Wearable Injectors
2. Autoinjectors
3. Needle-free Injection System
4. Novel Drug Reconstitution System
5. Prefilled Syringes

Subcutaneous Biologics Market, by Geographical Regions
1. North America
2. Europe
3. Asia-Pacific
4. Middle East and North Africa
5. Latin America

Contact Details
Gaurav Chaudhary
Email: Gaurav.chaudhary@rootsanalysis.com or sales@rootsanalysis.com
Website: https://www.rootsanalysis.com

About Roots Analysis
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by us are structured in a way that enables the reader to develop a thorough perspective on the given subject. Apart from writing reports on identified areas, we provide bespoke research / consulting services dedicated to serve our clients in the best possible way.

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