Global Subcutaneous Biologics Market Size, Share, and COVID-19 Impact Analysis, By Type of Biologic (Antibodies, Nucleotides, and Proteins), By Method of Administration (Injection, Infusion, and Both (Injection & Infusion)), By Therapeutic Area (Autoimmune Disorders, Bone Diseases, Hematological Disorders, Infectious Diseases, Inflammatory Disorders, Metabolic Disorders, Neurological Disorders, Ocular Disorders, Oncological Disorders, and Others), and By Region (North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa), Analysis and Forecast 2025 - 2035

Global Subcutaneous Biologics Market Insights Forecasts to 2035

• The Global Subcutaneous Biologics Market Size Was Estimated at USD 1.85 Billion in 2024
• The Market Size is Expected to Grow at a CAGR of around 11.05% from 2025 to 2035
• The Worldwide Subcutaneous Biologics Market Size is Expected to Reach USD 5.86 Billion by 2035
• Asia Pacific is Expected to Grow the Fastest during the forecast period.

The Global Subcutaneous Biologics Market size was worth around USD 1.85 billion in 2024 and is predicted to grow to around USD 5.86 billion by 2035 with a compound annual growth rate (CAGR) of 11.05% from 2025 and 2035. The growing focus on patient compliance and improved treatment outcomes, the shift towards self-administered therapies, and technological advancements are driving the subcutaneous biologics market globally.

Market Overview

The subcutaneous biologics market refers to the production, distribution, and sale of medications administered under the skin via subcutaneous injections. Subcutaneous biologics are complex therapeutic products, such as vaccines, body proteins, and blood-derived products that are typically administered via intravenous and subcutaneous routes. The growing inclination towards biologic drugs, including gene therapies, blood products, cell products, antibodies, and protein therapeutics in the pharmaceutical industry, is driving the growth of the subcutaneous biologics market. Targeted treatment approaches with minimal drug interaction are responsible for driving the subcutaneous biologics market.

An increasing demand for self-administerable therapies and availability of user-friendly drug delivery devices, including autoinjectors and prefilled syringes, are promoting the market growth for subcutaneous biologics.

Report Coverage

This research report categorizes the subcutaneous biologics market based on various segments and regions, forecasts revenue growth, and analyzes trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the subcutaneous biologics market. Recent market developments and competitive strategies such as expansion, type launch, development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the subcutaneous biologics market.

Driving Factors

The growing technological advancements in subcutaneous drug delivery, emphasizing patient compliance and improved treatment outcomes, are driving the subcutaneous biologics market. The shift towards self-administration therapies, including the designing of many antibody drugs through subcutaneous injection, leads to market growth. Further, the growing prevalence of chronic diseases, such as cancers, immune disorders, and rare genetic diseases, is contributing to driving the market demand for subcutaneous biologics.

Restraining Factors

The challenges associated with the subcutaneous biologics formulation may hamper the market. Further, the immunogenicity challenge and need for robust drug delivery devices are restraining the subcutaneous biologics market. Product recalls, side effects, and strict regulatory approvals may further hinder the market growth.

Market Segmentation

The subcutaneous biologics market share is classified into type of biologic, method of administration, and therapeutic area.

• The antibodies segment dominated the market with the largest market share in 2024 and is projected to grow at a substantial CAGR during the forecast period.

Based on the type of biologic, the subcutaneous biologics market is divided into antibodies, nucleotides, and proteins. Among these, the antibodies segment dominated the market with the largest market share in 2024 and is projected to grow at a substantial CAGR during the forecast period. Advantages of subcutaneous administration of antibodies include reduced treatment burden and potential for self-administration. An increased target specificity with a high safety profile and lower toxicity is responsible for driving the market in the antibodies segment.

• The injection segment accounted for a major market share and is anticipated to grow at a significant CAGR during the forecast period.

Based on the method of administration, the subcutaneous biologics market is divided into injection, infusion, and both (injection & infusion). Among these, the injection segment accounted for a major market share and is anticipated to grow at a significant CAGR during the forecast period. Administration via injection is a quick procedure and involves the delivery of a single dose of medication directly into the muscle, skin, or vein. The reduced chance of allergic reaction and fluid overload, as well as the convenience of the injection method of administration, is contributing to driving the market growth.

• The autoimmune disorders segment accounted for the largest market share and is anticipated to grow at a significant CAGR during the forecast period.

Based on the therapeutic area, the subcutaneous biologics market is divided into autoimmune disorders, bone diseases, hematological disorders, infectious diseases, inflammatory disorders, metabolic disorders, neurological disorders, ocular disorders, oncological disorders, and others. Among these, the autoimmune disorders segment accounted for the largest market share and is anticipated to grow at a significant CAGR during the forecast period. Rheumatoid arthritis, psoriasis, and psoriatic arthritis are some of the autoimmune disorders that are treated with SC formulation. An increasing preference for subcutaneous injection among diabetic and obese patients is driving the market.

Regional Segment Analysis of the Subcutaneous Biologics Market

• North America (U.S., Canada, Mexico) 
• Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
• Asia-Pacific (China, Japan, India, Rest of APAC)
• South America (Brazil and the Rest of South America) 
• The Middle East and Africa (UAE, South Africa, Rest of MEA)

North America is anticipated to hold the largest share of the subcutaneous biologics market over the predicted timeframe.

North America is anticipated to hold the largest share of the subcutaneous biologics market over the predicted timeframe. The presence of strong healthcare infrastructure and biopharmaceutical companies & academic institutions is responsible for driving the subcutaneous biologics market. Further, the increased emphasis on advanced biologic medicine, along with the increased prevalence of chronic diseases, is bolstering the market growth.  

Asia Pacific is expected to grow at a rapid CAGR in the subcutaneous biologics market during the forecast period. An increasing number of collaborations between technology developers and drug developers significantly contributes to driving the market growth. With the growing patient population, the rising need for advanced therapeutics in subcutaneous biologics is propelling the market in the region.

Middle East and Africa is expected to hold a substantial share of the subcutaneous biologics market during the predicted timeframe. The growing healthcare spending, along with the upsurging advancements in drug delivery technologies, are contributing to driving the subcutaneous biologics market. In addition, the growing demand for precision medicine, along with the significant rise in biopharmaceutical industries in the region responsible for promoting market growth.

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the subcutaneous biologics market, along with a comparative evaluation primarily based on their type of offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes type development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

List of Key Companies

• Adocia
• Alteogen
• Ascendis Pharma
• CD Bioparticles
• Creative Biolabs
• Creative BioMart
• Foresee Pharmaceuticals
• Pacira Biosciences
• Wyss Institute
• Xeris Biopharma
• Others

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting And Research Firm
• Venture capitalists
• Value-Added Resellers (VARs) 

Recent Development

• In July 2024, OneSource Specialty Pharma entered into a strategic licensing agreement with Bhami’s Research Laboratory. Partnership grants access to BRL’s HILOPRO technology, enhancing subcutaneous delivery of high-concentration biologic therapies and improving patient care.
• In June 2024, the FDA received a biologics license application (BLA) seeking the approval of the fixed combination of amivantamab-vmjw (Rybrevant) and recombinant human hyaluronidase (subcutaneous amivantamab) for use in all currently approved or submitted indications of the intravenous (IV) formulation in select patients with EGFR-positive non-small cell lung cancer (NSCLC)

Market Segment

This study forecasts revenue at global, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the subcutaneous biologics market based on the below-mentioned segments: 

Global Subcutaneous Biologics Market, By Type of Biologic

• Antibodies
• Nucleotides
• Proteins

Global Subcutaneous Biologics Market, By Method of Administration

• Injection
• Infusion
• Both (Injection & Infusion)

Global Subcutaneous Biologics Market, By Therapeutic Area

• Autoimmune Disorders
• Bone Diseases
• Hematological Disorders
• Infectious Diseases
• Inflammatory Disorders
• Metabolic Disorders
• Neurological Disorders
• Ocular Disorders
• Oncological Disorders
• Others

Global Subcutaneous Biologics Market, By Regional Analysis

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of Asia Pacific
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Middle East & Africa
  • UAE
  • Saudi Arabia
  • Qatar
  • South Africa
  • Rest of the Middle East & Africa