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Subcutaneous Biologics Market (5th Edition), Industry Trends and Global Forecasts, till 2035 – Distribution by Type of Biologic, Type of Therapy, Method of Administration, Fundamental Principle, End User, Payment Method Employed, Therapeutic Area, Drug D

Publisher Roots Analysis
Published Oct 22, 2025
Length 997 Pages
SKU # ROAL20492715

Description

Subcutaneous Biologics Market: Overview

As per Roots Analysis, the global subcutaneous biologics market is estimated to grow from USD 251 billion in the current year to USD 233 billion by 2035.

The market sizing and opportunity analysis has been segmented across the following parameters:

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
Subcutaneous Biologics Market: Growth and Trends

The demand of biologics has risen in the recent years in the pharmaceutical industry. In fact, the industry has witnessed a rise in the number of biologic drugs approved by the USFDA. This shift is due to the ability of biologics to offer targeted treatment, enabling minimal drug interactions owing to their precise binding and unique metabolic pathways.

However, developing biologics involves various challenges. These include high molecular weight, structure complexity susceptibility to degradation after administration, and productional complexities have prompted pharmaceutical companies to adopt new technologies for their development. Formulating subcutaneous biologics via conjugation, amino acid modification, and encapsulation methods are some of these technological innovations.

Additionally, novel drug delivery systems, including autoinjectors, pre-filled syringes, and needle-free methods, have been developed to administer highly viscous formulations. Previously, biologics were administered intravenously because of their swift systemic distribution and strong bioavailability. Although intravenous administration is effective, it frequently necessitates regular administration by healthcare providers, creating a hurdle for medication adherence. In recent years, methods and devices for subcutaneous administration have become increasingly popular among healthcare practitioners due to their effectiveness, safety, and tolerability Moreover, the shift towards subcutaneous biologics is fueled by the increasing need for self-administered treatments and the presence of easy-to-use drug delivery tools such as autoinjectors and pre-filled syringes.

Subcutaneous Biologics Market: Key Insights

The report delves into the current state of the subcutaneous biologics market and identifies potential growth opportunities within industry. Some key findings from the report include:
  • Presently, more than 175 subcutaneous biologics have been approved for the treatment of various chronic disorders; around 50% of these biologics are proteins approved for once daily administration.
  • ~20% of the subcutaneous biologics have been approved post-2020, majority of which are antibodies that can be administered as monotherapy alone.
  • More than 340 subcutaneous biologics are in clinical-stages of development; ~10% of these biologics are antibodies that have received orphan drug designation.
  • Around 60% of the clinical-stage subcutaneous biologics are based on inhibition mechanism; interestingly, majority of these biologics can be administered as monotherapy alone.
  • Close to 20% of technologies are based on encapsulation principle; notably, all these technologies are focused towards providing extended / controlled / sustained drug release
  • The rising interest in this domain is reflected by the rise in partnership activity; in fact, close to 70% of the deals were inked in the last three years.
  • There are several new and innovative drug delivery systems that facilitate subcutaneous administration; we identified over 560 such systems that are presently available / under development.
  • Driven by the increased emphasis towards patient compliance and improved treatment outcome, the approved subcutaneous biologics market is likely to grow at a CAGR of ~5%, till 2027.
  • Owing to the numerous advantages offered by subcutaneous formulation technologies and increase in the number of licensing deals, the market is anticipated to grow at an annualized rate of 22.7% in the coming decade.
Subcutaneous Biologics Market: Key Segments

Approved Subcutaneous Biologics Market

Antibodies Occupy the Highest Share in the Market

Based on type of biologic, the global market for approved subcutaneous biologics is segmented into antibodies, nucleotides and proteins. It is worth mentioning that, currently, antibodies occupy the highest share in the market, attributing to its higher target specificity, increased safety profile and lower toxicity. Further, approved subcutaneous biologics market for nucleotides is expected to witness substantial growth during the forecast period.

The Highest Market Share is Captured by Both Monotherapy and Combination Therapies

The global market for approved subcutaneous biologics is segmented across monotherapy, combination therapy, and both monotherapy and combination therapies. Both monotherapy and combination therapies segments occupy the largest current market share and is expected to witness a substantial growth during the forecast period.

Majority of the Approved Subcutaneous Biologics Market Share is Occupied by Injection

This segment highlights the distribution of global market for approved subcutaneous biologics across different types of methods of administration, such as injection, infusion, and both injection and infusion. It is worth highlighting that, presently, majority of the approved subcutaneous biologics market share is occupied by injection as a method of administration and is expected to remain dominant, during the forecast period. This can be attributed to the fact that delivery via injections is more convenient for the patients as well as healthcare professionals. Additionally, the chances of any allergic reaction and fluid overload are also reduced.

Autoimmune Disorders Segment Occupies the Highest Subcutaneous Biologics Market Share

Based on therapeutic area, the global market for approved subcutaneous biologics is segmented into autoimmune disorders, metabolic disorders, oncological disorders, hematological disorders, inflammatory disorders, neurological disorders, bone disorders and other disorders. Currently, autoimmune disorders segment occupies the highest subcutaneous biologics market share. This can be primarily attributed to the high efficacy of these drugs in the treatment of various prevalent autoimmune disorders, such as psoriasis, ankylosing spondylitis, ulcerative colitis and Crohn's disease. However, during the forecast period, metabolic disorders segment is likely to capture a larger market share owing to the rising preference of subcutaneous injection for the administration in patients suffering from diabetes mellitus and obesity (wherein long-term administration of drugs is required).

North America is Likely to Capture a Majority Share in the Overall Market

This segment highlights the distribution of approved subcutaneous biologics market across various geographies, such as North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America. According to our projections, presently, North America is likely to capture a majority share (~50%) in the overall market. Further, it is worth highlighting that the market in Asia-Pacific is expected to grow at a relatively higher CAGR, during the forecast period, till 2035. The growth of the market in Asia-Pacific can be ascribed to the rapidly growing patient population, the rising incidence of chronic disorders (including neurological disorders, genetic disorders and autoimmune disorders), and the rising demand for effective and advanced therapeutics. Further, the increasing investments and initiatives taken by regulatory bodies in the Asian countries to promote the adoption of biologics among patients and physicians is likely to drive the market in future.

Subcutaneous Biologics Market for Formulation Technologies

Market Share by Fundamental Principle

The global subcutaneous biologics formulation technology market is segmented across various fundamental principles, such as amino acid interaction, complex formation, conjugation, amino acid interaction, encapsulation and other fundamental principles. Presently, the revenues generated through the licensing of technologies that are based on encapsulation principle are likely to capture majority share in the overall market and is expected to remain dominant during the forecast period. It is worth highlighting that encapsulation helps in increasing the solubility of the biologics that are hydrophobic, which further results in increased absorption of the drugs in the patient’s body. Further, drug encapsulation also leads to high target specificity, thereby reducing the likelihood of adverse effects (that usually occur due to high systemic exposure).

Biotechnology Companies are Estimated to Grow at a Relatively Higher CAGR

The global subcutaneous biologics formulation technology market caters to a wide variety of end users, including biotechnology companies, contract development and manufacturing organizations, educational institutes, medical equipment manufacturers, MedTech companies, pharmaceutical and biopharmaceutical companies and other end users. Notably, pharmaceutical and biopharmaceutical companies are expected to currently capture the highest share in the market, However, biotechnology companies are estimated to grow at a relatively higher CAGR, during the forecast period.

Oncological Disorders Hold the Largest Share in the Subcutaneous Technology Market

This segment highlights the distribution of global subcutaneous biologics formulation technology market across different therapeutic areas, such as autoimmune disorders, bone diseases, hematological disorders, infectious diseases, inflammatory disorders, metabolic disorders, neurological disorders, ocular disorders, oncological disorders and other disorders. It is worth highlighting that the oncological disorders hold the largest share in the current technology market. This can be attributed to the high incidence rate of oncological disorders, accounting for around 1.9 million cases in 2022 and over 2 million cases in 2023. Further, the global subcutaneous biologics market for formulation technology for autoimmune disorders is estimated to grow at the highest CAGR, during the forecast period.

Subcutaneous Biologics Formulation Technology Market in Asia-Pacific is Expected To Grow with the Highest CAGR

This segment highlights the distribution of subcutaneous biologics formulation technology market across various geographies, such as North America, Europe and Asia-Pacific. It is worth highlighting that North America captures close to 65% of the current global subcutaneous biologics market for formulation technology. Further, the subcutaneous biologics formulation technology market in Asia-Pacific is expected to grow with the highest CAGR, during the forecast period. The growth of market in Asia-Pacific can be attributed to the rise in number of technology developers in this region, that will be actively involved in inking licensing deals with the drug developers.

Milestone Payments Occupy the Majority Share

Based on payment method employed, the global subcutaneous formulation technology market is segmented into milestone payments and upfront payments. It is worth mentioning that milestone payments occupy the majority share in the current market and this trend is unlikely to change in the future.

Example Players in the Subcutaneous Biologics Market
  • Adocia
  • Alteogen
  • Ascendis Pharma
  • CD Bioparticles
  • Creative Biolabs
  • Creative BioMart
  • Foresee Pharmaceuticals
  • Pacira Biosciences
  • The Wyss Institute 
  • Xeris Biopharma
Primary Research Overview

The opinions and insights presented in the market report were influenced by discussions held with stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders:
  • Founder and Chief Executive Officer, Small Company, US
  • Founder and Chief Technology Officer, Mid-sized Company, UK
  • Chief Executive Officer & Founder, Small Company, US
  • Chief Executive Officer, Small Company, Denmark
  • Chief Executive Officer, Mid-sized Company, US
  • Chief Technical Officer, Very Large Company, India
  • Vice President and Chief Scientist, Large Company, Israel
  • Senior Portfolio Director, Large Company, US
  • Managing Director, Small Company, Austria
  • Communication Leader, Mid-sized Company, France
  • Former Founder and Chief Scientific Officer, Vice President and Product Development, Former Senior Scientist Formulation, Mid-sized Company, US
  • Former Chief Commercial Officer, Large Company, Germany
  • Anonymous, a US-based company
  • Anonymous, a Europe-based company
Subcutaneous Biologics Market: Research Coverage
  • Market Sizing and Opportunity Analysis: The report features a thorough analysis of the global subcutaneous biologics market, in terms of the key market segments, including [A] type of primary packaging container, [B] type of biologic, [C] type of therapy, [D] method of administration, [E] fundamental principle, [F] end-user, [G] payment method employed, and [H] therapeutic area, [I] type of drug delivery device and [J] geographical regions.
  • Market Landscape: An in-depth assessment of the companies involved in the subcutaneous biologics market, based on several relevant parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] status of development, [E]type of biologic, [F] type of therapy, [G] mechanism of action, [H] dosing frequency, [I] target disease indication, [J] therapeutic area and [K] drug designation.
  • Technology Landscape: An in-depth assessment of the landscape of subcutaneous formulation technologies in the subcutaneous biologics market, based on several relevant parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] as fundamental principle, [E] type of molecule, [F] route of administration, [G] therapeutic area and [H] key characteristics.
  • Technology Competitive Analysis: A comprehensive analysis of subcutaneous formulation technologies based on parameters, such as [A] company strength and [B] technology strength.
  • Company Profiles: In-depth profiles of leading subcutaneous formulation technology developers based in North America, Europe and Asia-Pacific engaged in the subcutaneous market, focused on parameters such as [A] company overview, [B] financial information (if available), [C] service portfolio, [D] manufacturing facilities and [E] recent developments and an informed future outlook.
  • Partnerships and Collaborations: An in-depth analysis of the partnership’s activity reported in this domain, based on parameters such as [A] year of partnership, [B] type of partnership [C] type of partner company.
  • SWOT Analysis: 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.

  • Key Questions Answered in this Report
    • How many companies are currently engaged in this market?
    • Which are the leading companies in this market?
    • What factors are likely to influence the evolution of this market?
    • What is the current and future market size?
    • What is the CAGR of this market?
    • How is the current and future market opportunity likely to be distributed across key market segments?
    Reasons to Buy this Report
    • The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
    • Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
    • The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.
    • Complimentary PPT Insights Packs

Table of Contents

997 Pages
1. Preface
1.1. Introduction
1.2. Market Share Insights
1.3. Key Market Insights
1.4. Report Coverage
1.5. Key Questions Answered
1.6. Chapter Outlines
2. Research Methodology
2.1. Chapter Overview
2.2. Research Assumptions
2.2.1. Market Landscape And Market Trends
2.2.2. Market Forecast And Opportunity Analysis
2.3. Database Building
2.3.1. Data Collection
2.3.2. Data Validation
2.3.3. Data Analysis
2.4. Project Methodology
2.4.1. Secondary Research
2.4.1.1. Annual Reports
2.4.1.2. Academic Research Papers
2.4.1.3. Company Websites
2.4.1.4. Investor Presentations
2.4.1.5. Regulatory Filings
2.4.1.6. White Papers
2.4.1.7. Industry Publications
2.4.1.8. Conferences And Seminars
2.4.1.9. Government Portals
2.4.1.10. Media And Press Releases
2.4.1.11. Newsletters
2.4.1.12. Industry Databases
2.4.1.13. Roots Proprietary Databases
2.4.1.14. Paid Databases And Sources
2.4.1.15. Social Media Portals
2.4.1.16. Other Secondary Sources
2.4.2. Primary Research
2.4.2.1. Types Of Primary Research
2.4.2.1.1. Qualitative Research
2.4.2.1.2. Quantitative Research
2.4.2.1.3. Hybrid Approach
2.4.2.2. Advantages Of Primary Research
2.4.2.3. Techniques For Primary Research
2.4.2.3.1. Interviews
2.4.2.3.2. Surveys
2.4.2.3.3. Focus Groups
2.4.2.3.4. Observational Research
2.4.2.3.5. Social Media Interactions
2.4.2.4. Key Opinion Leaders Considered In Primary Research
2.4.2.4.1. Company Executives (Cxos)
2.4.2.4.2. Board Of Directors
2.4.2.4.3. Company Presidents And Vice Presidents
2.4.2.4.4. Research And Development Heads
2.4.2.4.5. Technical Experts
2.4.2.4.6. Subject Matter Experts
2.4.2.4.7. Scientists
2.4.2.4.8. Doctors And Other Healthcare Providers
2.4.2.5. Ethics And Integrity
2.4.2.5.1. Research Ethics
2.4.2.5.2. Data Integrity
2.4.3. Analytical Tools And Databases
3. Market Dynamics
3.1. Chapter Overview
3.2. Forecast Methodology
3.2.1. Top-down Approach
3.2.2. Bottom-up Approach
3.2.3. Hybrid Approach
3.3. Market Assessment Framework
3.3.1. Total Addressable Market (Tam)
3.3.2. Serviceable Addressable Market (Sam)
3.3.3. Serviceable Obtainable Market (Som)
3.3.4. Currently Acquired Market (Cam)
3.4. Forecasting Tools And Techniques
3.4.1. Qualitative Forecasting
3.4.2. Correlation
3.4.3. Regression
3.4.4. Extrapolation
3.4.5. Convergence
3.4.6. Sensitivity Analysis
3.4.7. Scenario Planning
3.4.8. Data Visualization
3.4.9. Time Series Analysis
3.4.10. Forecast Error Analysis
3.5. Key Considerations
3.5.1. Demographics
3.5.2. Government Regulations
3.5.3. Reimbursement Scenarios
3.5.4. Market Access
3.5.5. Supply Chain
3.5.6. Industry Consolidation
3.5.7. Pandemic / Unforeseen Disruptions Impact
3.6. Key Market Segmentation
3.7. Robust Quality Control
3.8. Limitations
4. Economic And Other Project Specific Considerations
4.1. Chapter Overview
4.2. Market Dynamics
4.2.1. Time Period
4.2.1.1. Historical Trends
4.2.1.2. Current And Future Estimates
4.2.2. Currency Coverage And Foreign Exchange Rate
4.2.2.1. Major Currencies Affecting The Market
4.2.2.2. Factors Affecting Currency Fluctuations And Foreign Exchange Rates
4.2.2.3. Impact Of Foreign Exchange Rate Volatility On The Market
4.2.2.4. Strategies For Mitigating Foreign Exchange Risk
4.2.3. Trade Policies
4.2.3.1. Impact Of Trade Barriers On The Market
4.2.3.2. Strategies For Mitigating The Risks Associated With Trade Barriers
4.2.4. Recession
4.2.4.1. Historical Analysis Of Past Recessions And Lessons Learnt
4.2.4.2. Assessment Of Current Economic Conditions And Potential Impact On The Market
4.2.5. Inflation
4.2.5.1. Measurement And Analysis Of Inflationary Pressures In The Economy
4.2.5.2. Potential Impact Of Inflation On The Market Evolution
5. Executive Summary
6. Introduction
6.1. Chapter Overview
6.2. Types Of Therapeutic Molecules
6.3. Biologically Derived Molecules
6.3.1. Type Of Products
6.3.2. Routes Of Administration And Formulations
6.3.3. Subcutaneous Formulations
6.3.3.1. Approaches In Subcutaneous Delivery Of Biologics
6.3.3.1.1. Reformulation
6.3.3.1.2. Differing Potencies
6.3.3.1.3. Novel Technologies
6.3.3.2. Methods Of Subcutaneous Administration
6.3.3.3. Advantages Of Subcutaneous Administration
6.3.3.4. Limitations Of Subcutaneous Administration
6.4. Regulatory Considerations
6.4.1. Medical Devices
6.4.2. Drug Device Combination Products
6.5. Future Perspectives
7. Approved Subcutaneous Biologics: Market Landscape
7.1. Chapter Overview
7.2. Approved Subcutaneous Biologics: Overall Market Overview
7.2.1. Analysis By Initial Approval Year
7.2.2. Analysis By Type Of Biologic
7.2.3. Analysis By Type Of Therapy
7.2.4. Analysis By Route Of Administration
7.2.5. Analysis By Method Of Administration
7.2.6. Analysis By Dosing Frequency
7.2.7. Analysis By Concentration Of Dose
7.2.8. Analysis By Target Disease Indication
7.2.9. Analysis By Therapeutic Area
7.2.10. Analysis By Type Of Drug Delivery Device
7.3. Approved Subcutaneous Biologics: List Of Developers
7.3.1. Analysis By Year Of Establishment
7.3.2. Analysis By Company Size
7.3.3. Analysis By Location Of Headquarters (Region)
7.3.4. Analysis By Location Of Headquarters (Country)
7.3.5. Most Active Developers: Analysis By Number Of Approved Drugs
8. Approved Subcutaneous Biologics: Success Protocol Analysis
8.1. Chapter Overview
8.2. Methodology
8.3. Success Protocol Analysis Of Top Approved Subcutaneous Biologics
8.3.1. Benlysta® (Human Genome Sciences)
8.3.1.1. Overview
8.3.1.2. Development History
8.3.1.3. Phase Of Development, Route Of Administration, And Target Disease Indication
8.3.1.4. Success Protocol Analysis
8.3.2. Besremi® (Pharmaessentia)
8.3.2.1. Overview
8.3.2.2. Development History
8.3.2.3. Phase Of Development, Route Of Administration, And Target Disease Indication
8.3.2.4. Success Protocol Analysis
8.3.3. Cosentyx® (Novartis)
8.3.3.1. Overview
8.3.3.2. Development History
8.3.3.3. Phase Of Development, Route Of Administration, And Target Disease Indication
8.3.3.4. Success Protocol Analysis
8.3.4. Darzalex Faspro® / Darzalex® Sc (Halozyme)
8.3.4.1. Overview
8.3.4.2. Development History
8.3.4.3. Phase Of Development, Route Of Administration, And Target Disease Indication
8.3.4.4. Success Protocol Analysis
8.3.5. Dupixent® (Regeneron Pharma)
8.3.5.1. Overview
8.3.5.2. Development History
8.3.5.3. Phase Of Development, Route Of Administration, And Target Disease Indication
8.3.5.4. Success Protocol Analysis
8.3.6. Enbrel® (Amgen)
8.3.6.1. Overview
8.3.6.2. Development History
8.3.6.3. Phase Of Development, Route Of Administration, And Target Disease Indication
8.3.6.4. Success Protocol Analysis
8.3.7. Hemlibra® (Roche)
8.3.7.1. Overview
8.3.7.2. Development History
8.3.7.3. Phase Of Development, Route Of Administration, And Target Disease Indication
8.3.7.4. Success Protocol Analysis
8.3.8. Prolia® / Pralia® (Amgen)
8.3.8.1. Overview
8.3.8.2. Development History
8.3.8.3. Phase Of Development, Route Of Administration, And Target Disease Indication
8.3.8.4. Success Protocol Analysis
8.3.9. Stelara® (Janssen Biotech)
8.3.9.1. Overview
8.3.9.2. Development History
8.3.9.3. Phase Of Development, Route Of Administration, And Target Disease Indication
8.3.9.4. Success Protocol Analysis
8.3.10. Trulicity® (Eli Lilly)
8.3.10.1. Overview
8.3.10.2. Development History
8.3.10.3. Phase Of Development, Route Of Administration, And Target Disease Indication
8.3.10.4. Success Protocol Analysis
8.4. Conclusion
9. Clinical-stage Subcutaneous Biologics: Market Landscape
9.1. Chapter Overview
9.2. Clinical-stage Subcutaneous Biologics: Overall Market Overview
9.2.1. Analysis By Phase Of Development
9.2.2. Analysis By Type Of Biologic
9.2.3. Analysis By Type Of Therapy
9.2.4. Analysis By Mechanism Of Action
9.2.5. Analysis By Dosing Frequency
9.2.6. Analysis By Drug Designation
9.2.7. Analysis By Target Disease Indication
9.2.8. Analysis By Therapeutic Area
9.3. Clinical-stage Subcutaneous Biologics: List Of Developers
9.3.1. Analysis By Year Of Establishment
9.3.2. Analysis By Company Size
9.3.3. Analysis By Location Of Headquarters
9.3.4. Most Active Developers: Analysis By Number Of Clinical-stage Drugs
10. Subcutaneous Formulation: Technology Landscape
10.1. Chapter Overview
10.2. Subcutaneous Formulation: Technology Landscape
10.2.1. Analysis By Fundamental Principle
10.2.2. Analysis By Type Of Molecule
10.2.3. Analysis By Route Of Administration
10.2.4. Analysis By Therapeutic Area
10.2.5. Analysis By Key Characteristics
10.3. Subcutaneous Formulation: Technology Developers Landscape
10.3.1. Analysis By Year Of Establishment
10.3.2. Analysis By Company Size
10.3.3. Analysis By Location Of Headquarters
11. Technology Competitiveness Analysis
11.1. Chapter Overview
11.2. Assumptions And Key Parameters
11.3. Methodology
11.4. Technology Competitiveness Analysis: Subcutaneous Formulation Technology
11.4.1. Subcutaneous Formulation Technology Developed By Companies Based In North America (Peer Group I)
11.4.2. Subcutaneous Formulation Technology Developed By Companies Based In Europe (Peer Group Ii)
11.4.3. Subcutaneous Formulation Technology Developed By Companies Based In Asia-pacific (Peer Group Iii)
12. Subcutaneous Formulation Technology Providers: Company Profiles
12.1. Chapter Overview
12.2. Technology Developers Based In North America
12.2.1. Cd Bioparticles
12.2.1.1. Company Overview
12.2.1.2. Technology Portfolio
12.2.1.3. Recent Developments And Future Outlook
12.2.2. Creative Biolabs
12.2.2.1. Company Overview
12.2.2.2. Technology Portfolio
12.2.2.3. Recent Developments And Future Outlook
12.2.3. Creative Biomart
12.2.3.1. Company Overview
12.2.3.2. Technology Portfolio
12.2.3.3. Recent Developments And Future Outlook
12.2.4. Pacira Biosciences
12.2.4.1. Company Overview
12.2.4.2. Financial Information
12.2.4.3. Technology Portfolio
12.2.4.4. Recent Developments And Future Outlook
12.2.5. The Wyss Institute
12.2.5.1. Company Overview
12.2.5.2. Technology Portfolio
12.2.5.3. Recent Developments And Future Outlook
12.2.6. Xeris Biopharma
12.2.6.1. Company Overview
12.2.6.2. Financial Information
12.2.6.3. Technology Portfolio
12.2.6.4. Recent Developments And Future Outlook
12.3. Technology Developers Based In Europe
12.3.1. Adocia
12.3.1.1. Company Overview
12.3.1.2. Financial Information
12.3.1.3. Technology Portfolio
12.3.1.4. Recent Developments And Future Outlook
12.3.2. Ascendis Pharma
12.3.2.1. Company Overview
12.3.2.2. Financial Information
12.3.2.3. Technology Portfolio
12.3.2.4. Recent Developments And Future Outlook
12.4. Technology Developers Based In Asia-pacific
12.4.1. Alteogen
12.4.1.1. Company Overview
12.4.1.2. Technology Portfolio
12.4.1.3. Recent Developments And Future Outlook
12.4.2. Foresee Pharmaceuticals
12.4.2.1. Company Overview
12.4.2.2. Financial Information
12.4.2.3. Technology Portfolio
12.4.2.4. Recent Developments And Future Outlook
13. Subcutaneous Formulation Technologies: Partnerships And Collaborations
13.1. Chapter Overview
13.2. Partnership Models
13.3. Partnerships And Collaborations: Subcutaneous Formulation Technology
13.3.1. Analysis By Year Of Partnership
13.3.2. Analysis By Type Of Partnership
13.3.3. Analysis By Year And Type Of Partnership
13.3.4. Analysis By Type Of Partner
13.3.5. Analysis By Location Of Headquarters Of Partner
13.3.6. Analysis By Therapeutic Area
13.3.7. Most Active Players: Analysis By Number Of Partnerships
13.4. Analysis By Geography
13.4.1. Intracontinental And Intercontinental Agreements
13.4.2. International And Local Agreements
14. Subcutaneous Drug Delivery Systems: Market Landscape
14.1. Chapter Overview
14.2. Types Of Subcutaneous Drug Delivery Systems
14.2.1. Large Volume Wearable Injectors
14.2.1.1. Large Volume Wearable Injectors For Non-insulin Drugs: Market Landscape
14.2.1.1.1. Analysis By Status Of Development
14.2.1.1.2. Analysis By Type Of Device
14.2.1.1.3. Analysis By Usability
14.2.1.1.4. Analysis By Type Of Dose
14.2.1.1.5. Analysis By Type Of Drug Container
14.2.1.1.6. Analysis By Mode Of Drug Filling
14.2.1.1.7. Analysis By Container Volume (Ml)
14.2.1.1.8. Analysis By Route Of Administration
14.2.1.1.9. Analysis By Mode Of Injection
14.2.1.1.10. Analysis By Mechanism Of Action / Driving Force
14.2.1.1.11. Analysis By Type Of Technology
14.2.1.1.12. Analysis By Availability Of Connectivity Feature
14.2.1.1.13. Analysis By Type Of Compatible Drug
14.2.1.1.14. Analysis By Compatibility With High Viscosity Drugs
14.2.1.1.15. Analysis By Therapeutic Area
14.2.1.1.16. Most Active Players: Analysis By Number Of Large Volume Wearable Injectors For Non-insulin Drugs
14.2.1.2. Large Volume Wearable Injectors For Insulin Drugs
14.2.1.2.1. Analysis By Status Of Development
14.2.1.2.2. Analysis By Type Of Device
14.2.1.2.3. Analysis By Usability
14.2.1.2.4. Analysis By Type Of Dose
14.2.1.2.5. Analysis By Mode Of Drug Filling
14.2.1.2.6. Analysis By Container Volume (Ml)
14.2.1.2.7. Analysis By Type Of Diabetes
14.2.1.2.8. Analysis By Type Of Combination Insulin
14.2.1.2.9. Analysis By Period Of Use (Days)
14.2.1.2.10. Analysis By Type Of Device Control Feature
14.2.1.2.11. Analysis By Availability Of Interoperable Device
14.2.1.2.12. Analysis By Availability Of Continuous Glucose Monitoring (Cgm) / Blood Glucose Meters (Bgm) System
14.2.1.2.13. Analysis By Availability Of Automatic Insulin Delivery (Aid) / Artificial Pancreas
14.2.1.2.14. Analysis By Type Of Automated Insulin Delivery (Aid) Feature
14.2.1.2.15. Analysis By Availability Of Connectivity Feature
14.2.1.2.16. Analysis By Waterproof Capabilities
14.2.1.2.17. Most Active Players: Analysis By Number Of Large Volume Wearable Injectors For Insulin Drugs
14.2.1.3. Large Volume Drug Device Combinations For Non-insulin Drugs: Market Landscape
14.2.1.3.1. Analysis By Status Of Development
14.2.1.3.2. Analysis By Type Of Device
14.2.1.3.3. Analysis By Usability
14.2.1.3.4. Analysis By Type Of Dose
14.2.1.3.5. Analysis By Type Of Drug Container
14.2.1.3.6. Analysis By Mode Of Drug Filling
14.2.1.3.7. Analysis By Container Volume (Ml)
14.2.1.3.8. Analysis By Route Of Administration
14.2.1.3.9. Analysis By Mode Of Injection
14.2.1.3.10. Analysis By Type Of Compatible Drug
14.2.1.3.11. Analysis By Mechanism Of Action / Driving Force
14.2.1.3.12. Analysis By Type Of Technology
14.2.1.3.13. Analysis By Therapeutic Area
14.2.1.3.14. Leading Players: Analysis By Number Of Drug Device Combinations For Non-insulin Drugs
14.2.2. Autoinjectors
14.2.2.1. Current Market Landscape
14.2.2.1.1. Analysis By Stage Of Development
14.2.2.1.2. Analysis By Usability
14.2.2.1.3. Analysis By Type Of Primary Drug Container
14.2.2.1.4. Analysis By Requirement Of Needle
14.2.2.1.5. Analysis By Volume Of Container
14.2.2.1.6. Analysis By Type Of Dose Delivered
14.2.2.1.7. Analysis By Route Of Administration
14.2.2.1.8. Analysis By Type Of Actuation Mechanism
14.2.2.1.9. Analysis By Type Of Feedback Mechanism
14.2.2.1.10. Analysis By Availability Of Connectivity Feature
14.2.2.1.11. Analysis By Target Indication
14.2.2.1.12. Analysis By Type Of Molecule Delivered
14.2.2.1.13. Analysis By End User
14.2.2.1.14. Most Active Players: Analysis By Number Of Autoinjectors
14.2.3. Pen Injectors
14.2.3.1. Current Market Landscape
14.2.3.1.1. Analysis By Type Of Dose
14.2.3.1.2. Analysis By Storage Volume / Capacity
14.2.3.1.3. Analysis By Usability
14.2.3.1.4. Most Active Players: Analysis By Number Of Devices
14.2.3.2. Drug Device Combination Products
14.2.4. Needle Free Injection System
14.2.4.1. Current Market Landscape
14.2.4.1.1. Analysis By Actuation Mechanism
14.2.4.1.2. Analysis By Route Of Administration
14.2.4.1.3. Analysis By Type Of Formulation Administered
14.2.4.1.4. Analysis By Type Of Drug Delivered
14.2.4.1.5. Analysis By Therapeutic Area
14.2.4.1.6. Analysis By Usability
14.2.4.1.7. Analysis By Type Of Formulation Administered And Actuation Mechanism
14.2.5. Novel Drug Reconstitution Delivery Systems
14.2.5.1. Current Market Landscape
14.2.5.1.1. Analysis By Type Of Device
14.2.5.1.2. Analysis By Type Of Chamber
14.2.5.1.3. Analysis By Type Of Device And Type Of Chamber
14.2.5.1.4. Analysis By Physical State Of Drug
14.2.5.1.5. Analysis By Container Fabrication Material
14.2.5.1.6. Analysis By Volume Of Container
14.2.5.1.7. Analysis By Drug Class
14.2.5.1.8. Analysis By Device Usability
14.2.5.1.9. Analysis By Container Fabrication Material And Device Usability
14.2.5.1.10. Analysis By Type Of Pre-sterilized Devices
14.2.5.1.11. Analysis By Type Of User-sterilized Devices
14.2.5.1.12. Analysis By Type Of Sterilization Equipment Used
14.2.5.1.13. Most Active Players: Analysis By Number Of Novel Drug Reconstitution Systems Manufactured
14.2.6. Prefilled Syringes
14.2.6.1. Current Market Landscape
14.2.6.1.1. Analysis By Type Of Barrel Fabrication Material
14.2.6.1.2. Analysis By Number Of Barrel Chambers
14.2.6.1.3. Analysis By Type Of Needle System
14.2.6.1.4. Analysis By Volume Of Syringe
14.2.6.1.5. Most Active Players: Analysis By Number Of Prefilled Syringes
14.2.6.2. Drug Device Combination Products
14.2.7. Implants
14.2.7.1. Current Market Landscape
14.2.7.1.1. Analysis By Phase Of Development
14.2.7.1.2. Analysis By Therapeutic Area
14.2.7.1.3. Analysis By Implant Material
14.2.7.1.4. Analysis By Treatment Duration
14.2.7.1.5. Analysis By Type Of Delivery System
14.2.7.1.6. Most Active Players: Analysis By Number Of Implants
14.2.7.2. Subcutaneous Implants Eluting Small Molecules
15. Subcutaneous Drug Delivery Systems: Product Competitiveness Analysis
15.1. Chapter Overview
15.2. Large Volume Wearable Injectors
15.2.1. Assumptions And Key Parameters
15.2.2. Methodology
15.2.3. Product Competitiveness Analysis: Large Volume Wearable Injectors For Non-insulin Drugs
15.2.3.1. Products Developed By Players In North America
15.2.3.2. Products Developed By Players In Europe
15.2.3.3. Products Developed By Players In Asia And Middle East And North Africa
15.2.4. Product Competitiveness Analysis: Large Volume Wearable Injectors For Insulin Drugs
15.2.4.1. Products Developed By Players In North America
15.2.4.2. Products Developed By Players In Europe
15.2.4.3. Products Developed By Players In Asia And Middle East And North Africa
15.2.5. Product Competitiveness Analysis: Large Volume Drug Device Combinations For Non-insulin Drugs
15.2.5.1. Products Developed By Players In North America
15.2.5.2. Products Developed By Players In Europe
15.2.5.3. Products Developed By Players In Middle East And North Africa
15.3. Autoinjectors
15.3.1. Assumptions And Key Parameters
15.3.2. Methodology
15.3.3. Product Competitiveness Analysis: Autoinjectors
15.3.3.1. Disposable Autoinjectors
15.3.3.2. Reusable Autoinjectors
15.4. Needle-free Injection Systems
15.4.1. Assumptions And Key Parameters
15.4.2. Methodology
15.4.3. Product Competitiveness Analysis: Needle-free Injection Systems
15.4.3.1. Spring-based Needle-free Injection Systems
15.4.3.2. Gas-powered Needle-free Injection Systems
15.4.3.3. Other Needle-free Injection Systems
15.5. Prefilled Syringes
15.5.1. Assumptions And Key Parameters
15.5.2. Methodology
15.5.3. Product Competitiveness Analysis: Prefilled Syringes
15.5.3.1. Glass Barrel Prefilled Syringes
15.5.3.2. Plastic Barrel Prefilled Syringes
16. Swot Analysis
16.1. Chapter Overview
16.2. Comparison Of Swot Factors
16.2.1. Strengths
16.2.2. Weaknesses
16.2.3. Opportunities
16.2.4. Threats
17. Global Approved Subcutaneous Biologics Market
17.1. Chapter Overview
17.2. Key Assumptions And Methodology
17.3. Global Approved Subcutaneous Biologics Market, Till 2035
17.3.1. Roots Analysis Perspective On Market Growth
17.3.2. Scenario Analysis
17.3.2.1. Conservative Scenario
17.3.2.2. Optimistic Scenario
17.4. Key Market Segmentations
18. Approved Subcutaneous Biologics Market, By Type Of Biologic
18.1. Chapter Overview
18.2. Key Assumptions And Methodology
18.3. Approved Subcutaneous Biologics Market: Distribution By Type Of Biologic, Current Year And 2035
18.3.1. Approved Subcutaneous Biologics Market For Antibodies, Till 2035
18.3.2. Approved Subcutaneous Biologics Market For Proteins, Till 2035
18.3.3. Approved Subcutaneous Biologics Market For Nucleotides, Till 2035
18.4. Data Triangulation And Validation
19. Approved Subcutaneous Biologics Market, By Type Of Therapy
19.1. Chapter Overview
19.2. Key Assumptions And Methodology
19.3. Approved Subcutaneous Biologics Market: Distribution By Type Of Therapy, Current Year And 2035
19.3.1. Approved Subcutaneous Biologics Market For Monotherapy, Till 2035
19.3.2. Approved Subcutaneous Biologics Market For Combination Therapy, Till 2035
19.3.3. Approved Subcutaneous Biologics Market For Both Monotherapy And Combination Therapies, Till 2035
19.4. Data Triangulation And Validation
20. Approved Subcutaneous Biologics Market, By Method Of Administration
20.1. Chapter Overview
20.2. Key Assumptions And Methodology
20.3. Approved Subcutaneous Biologics Market: Distribution By Method Of Administration, Current Year And 2035
20.3.1. Approved Subcutaneous Biologics Market For Administration Via Injection, Till 2035
20.3.2. Approved Subcutaneous Biologics Market For Administration Via Infusion, Till 2035
20.3.3. Approved Subcutaneous Biologics Market For Administration Via Both Injection And Infusion, Till 2035
20.4. Data Triangulation And Validation
21. Approved Subcutaneous Biologics Market, By Therapeutic Area
21.1. Chapter Overview
21.2. Key Assumptions And Methodology
21.3. Approved Subcutaneous Biologics Market: Distribution By Therapeutic Area, Current Year And 2035
21.3.1. Approved Subcutaneous Biologics Market For Autoimmune Disorders, Till 2035
21.3.2. Approved Subcutaneous Biologics Market For Metabolic Disorders, Till 2035
21.3.3. Approved Subcutaneous Biologics Market For Oncological Disorders, Till 2035
21.3.4. Approved Subcutaneous Biologics Market For Hematological Disorders, Till 2035
21.3.5. Approved Subcutaneous Biologics Market For Inflammatory Disorders, Till 2035
21.3.6. Approved Subcutaneous Biologics Market For Neurological Disorders, Till 2035
21.3.7. Approved Subcutaneous Biologics Market For Bone Disorders, Till 2035
21.3.8. Approved Subcutaneous Biologics Market For Other Disorders, Till 2035
21.4. Data Triangulation And Validation
22. Approved Subcutaneous Biologics Market, By Geographical Regions
22.1. Chapter Overview
22.2. Key Assumptions And Methodology
22.3. Approved Subcutaneous Biologics Market: Distribution By Geographical Regions, Current Year And 2035
22.3.1. Approved Subcutaneous Biologics Market In North America, Till 2035
22.3.2. Approved Subcutaneous Biologics Market In Europe, Till 2035
22.3.3. Approved Subcutaneous Biologics Market In Asia-pacific, Till 2035
22.3.4. Approved Subcutaneous Biologics Market In Middle East And North Africa, Till 2035
22.3.5. Approved Subcutaneous Biologics Market In Latin America, Till 2035
22.4. Penetration-growth (P-g) Matrix
22.5. Data Triangulation And Validation
23. Approved Subcutaneous Biologics Market, Sales Forecast Of Drugs
23.1. Chapter Overview
23.2. Key Assumptions And Methodology
23.3. Drug-wise Sales Forecast
23.3.1. Actemra® / Roactemra®
23.3.2. Acthar® Gel / Acthar
23.3.3. Aimovig®
23.3.4. Ajovy®
23.3.5. Amvuttra®
23.3.6. Aranesp® / Nesp®
23.3.7. Basaglar® / Abasaglar
23.3.8. Benlysta®
23.3.9. Betaseron® / Betaferon® / Extavia®
23.3.10. Cablivi®
23.3.11. Cimzia®
23.3.12. Cosentyx®
23.3.13. Crysvita®
23.3.14. Darzalex Faspro® / Darzalex® Sc
23.3.15. Dupixent®
23.3.16. Emgality®
23.3.17. Enbrel®
23.3.18. Enspryng®
23.3.19. Entyvio®
23.3.20. Epogen® / Procrit® / Eprex®
23.3.21. Evenity®
23.3.22. Fasenra®
23.3.23. Fiasp®
23.3.24. Forteo® / Forsteo®
23.3.25. Gattex® / Revestive®
23.3.26. Genotropin®
23.3.27. Givlaari®
23.3.28. G-lasta® / Peglasta® / Neulasta® / Gran®
23.3.29. Gonal-f®
23.3.30. Haegarda®
23.3.31. Hemlibra®
23.3.32. Herceptin® Sc / Herceptin™ Hylecta
23.3.33. Hizentra®
23.3.34. Humalog®
23.3.35. Humira®
23.3.36. Humulin®
23.3.37. Ilaris®
23.3.38. Kesimpta®
23.3.39. Kevzara®
23.3.40. Kineret®
23.3.41. Lantus®
23.3.42. Leqvio®
23.3.43. Mircera®
23.3.44. Mounjaro®
23.3.45. Nplate®
23.3.46. Nucala®
23.3.47. Orencia®
23.3.48. Oxlumo®
23.3.49. Palynziq®
23.3.50. Phesgo®
23.3.51. Plegridy®
23.3.52. Praluent®
23.3.53. Prolia® / Pralia®
23.3.54. Rebif®
23.3.55. Reblozyl®
23.3.56. Rekovelle®
23.3.57. Repatha®
23.3.58. Rituxan Hycela® / Mabthera® Sc
23.3.59. Ryzodeg® 70/30 Sc
23.3.60. Saizen®
23.3.61. Saxenda®
23.3.62. Simponi®
23.3.63. Skyrizi®
23.3.64. Soliqua® 100/33
23.3.65. Stelara®
23.3.66. Strensiq®
23.3.67. Takhzyro®
23.3.68. Taltz®
23.3.69. Tecentriq®
23.3.70. Tegsedi®
23.3.71. Tezspire®
23.3.72. Toujeo®
23.3.73. Tremfya®
23.3.74. Tresiba®
23.3.75. Trulicity®
23.3.76. Tysabri®
23.3.77. Ultomiris®
23.3.78. Victoza®
23.3.79. Voxzogo®
23.3.80. Vyvgart® Hytrulo
23.3.81. Wainua™
23.3.82. Xgeva® / Ranmark®
23.3.83. Xolair®
23.3.84. Xultophy®
23.3.85. Zepbound®
24. Approved Subcutaneous Biologics Market, By Leading Players
25. Global Subcutaneous Biologics Formulation Technologies Market
25.1. Chapter Overview
25.2. Key Assumptions And Methodology
25.3. Global Subcutaneous Biologics Formulation Technologies Market, Till 2035
25.3.1. Roots Analysis Perspective On Market Growth
25.3.2. Scenario Analysis
25.3.2.1. Conservative Scenario
25.3.2.2. Optimistic Scenario
25.4. Key Market Segmentations
26. Subcutaneous Biologics Formulation Technologies Market, By Fundamental Principle
26.1. Chapter Overview
26.2. Key Assumptions And Methodology
26.3. Subcutaneous Biologics Formulation Technologies Market: Distribution By Fundamental Principle, Current Year And 2035
26.3.1. Subcutaneous Biologics Formulation Technologies Market For Encapsulation Principle, Till 2035
26.3.2. Subcutaneous Biologics Formulation Technologies Market For Complex Formation Principle, Till 2035
26.3.3. Subcutaneous Biologics Formulation Technologies Market For Conjugation Principle, Till 2035
26.3.4. Subcutaneous Biologics Formulation Technologies Market For Amino Acid Interaction Principle, Till 2035
26.3.5. Subcutaneous Biologics Formulation Technologies Market For Other Principles, Till 2035
26.4. Data Triangulation And Validation
27. Subcutaneous Biologics Formulation Technologies Market, By End User
27.1. Chapter Overview
27.2. Key Assumptions And Methodology
27.3. Subcutaneous Biologics Formulation Technologies Market: Distribution By Type Of End User, Current Year And 2035
27.3.1. Subcutaneous Biologics Formulation Technologies For Pharmaceutical And Biopharmaceutical Companies, Till 2035
27.3.2. Subcutaneous Biologics Formulation Technologies For Biotechnology Companies, Till 2035
27.3.3. Subcutaneous Biologics Formulation Technologies For Medtech Companies, Till 2035
27.3.4. Subcutaneous Biologics Formulation Technologies For Contract Drug Manufacturing Organizations, Till 2035
27.3.5. Subcutaneous Biologics Formulation Technologies For Educational Institutes, Till 2035
27.3.6. Subcutaneous Biologics Formulation Technologies For Medical Equipment Manufacturers, Till 2035
27.3.7. Subcutaneous Biologics Formulation Technologies For Other End Users, Till 2035
27.4. Data Triangulation And Validation
28. Subcutaneous Biologics Formulation Technologies Market, By Therapeutic Area
28.1. Chapter Overview
28.2. Key Assumptions And Methodology
28.3. Subcutaneous Biologics Formulation Technologies Market: Distribution By Therapeutic Area, Current Year And 2035
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