Subcutaneous Biologics Market, Industry Trends and Global Forecasts to 2035: Subcutaneous Biologics Set to Transform Drug Delivery and Patient Adherence

Dublin, Jan. 16, 2025 (GLOBE NEWSWIRE) — The “Subcutaneous Biologics Market, Industry Trends and Global Forecasts to 2035: Type of Biologic, Type of Therapy, Method of Administration, Fundamental Principle, End User, Payment Method Employed, Therapeutic Area, Drug Delivery Device, Leading Players and Sales Forecast” report has been added to ResearchAndMarkets.com’s offering.

The rising adoption of self-administration devices and technological advancements related to subcutaneous delivery of biologic drugs, is indicative of the growth of subcutaneous biologics market in the next decade. In recent years, the pharmaceutical industry has witnessed an increase in number of biologic drugs, such as gene therapies, blood products, cell products, antibodies, and protein therapeutics. Unlike traditional chemical-based medications, which are generally easier and relatively cheaper to develop, biologics pose unique challenges during the drug development process.

These challenges include high molecular weight, complex chemical structures, susceptibility to degradation after administration, and intricate manufacturing processes. To address these challenges, pharmaceutical companies are utilizing innovative technologies to develop biologics which are capable of treating a wide range of diseases. These technological advancements involve the formulation of subcutaneous biologics based on conjugation, amino acid modification, and encapsulation principles.

Furthermore, novel drug delivery systems such as autoinjectors, pre-filled syringes, and needle-free devices are actively being designed to deliver highly viscous formulations. Notably, a rise in biologic drugs approvals by the US Food and Drug Administration (FDA) was observed in the industry, with nine approvals in the first quarter of 2024. This growing shift towards biologics can be attributed to their potential in offering targeted treatments with minimal drug interactions.

Historically, intravenous administration of biologics was preferred, owing to their rapid systemic circulation and high bioavailability. Although intravenous administration is an effective method for biologics delivery, it requires frequent involvement of healthcare professionals, which can pose a challenge in terms of medication adherence. To circumvent these challenges, subcutaneous administration methods have emerged as suitable alternatives and have gained traction for their effectiveness, tolerability and safety.

Furthermore, the shift towards subcutaneous biologics is driven by the increasing demand for self-administered therapies and the availability of user-friendly devices, such as autoinjectors and pre-filled syringes.

Research Coverage:

• An overview of several systematic research approach utilized to forecast and analyze trends in subcutaneous biologics market. It also explores the key factors influencing the market dynamics and emphasizes the robust quality control framework established to ensure transparency and credibility of our findings.
• An in-depth examination of the key factors affecting market dynamics and the strong quality control framework implemented to guarantee transparency and credibility in the insights provided to the clients.
• A comprehensive view on various economic factors that are anticipated 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 key insights captured during our research, presenting a holistic view of the subcutaneous biologics market. Additionally, it presents information on the most relevant trends, challenges and opportunities that are shaping the industry’s development.
• A general overview of different types of therapeutic molecules comparing their characteristics, such as molecular size, molecular weight, molecular structure, immunogenicity, stability and manufacturing. Further, it also highlights different types of biologically derived products which are currently under development. In addition, this report highlights various challenges associated with the parenteral route of drug delivery, especially those related to the traditional intravenousroute of administration. It further discusses subcutaneous formulations, including different approaches to deliver such biologics, method of administration, advantages and limitations associated with this route, along with the relevant regulatory guidelines.
• An in-depth examination of the current 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 a developer landscape analysis, based on several relevant parameters, such as year of establishment, company size and location of headquarters. The section also highlights the most active developers in this domain.

• A comprehensive success protocol analysis, offering insights on the leading subcutaneous biologics, based on several relevant parameters, such as drug efficacy / success rate, target disease indication burden, global competition, therapy price, geographical reach and disease prevalence.
• An extensive study 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 includes detailed analysis of the developers in this domain, based on several parameters, such as year of establishment, company size, location of headquarters and most active developers.

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• An in-depth analysis 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 the year of establishment, company size and location of headquarters.

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• An insightful technology competitiveness analysis of the subcutaneous formulation technologies, based on various parameters, such as company strength and technology strength.
• 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 their location of headquarters, year of establishment, number of employees, leadership team, contact details, financial information, technology portfolio, and recent developments and an informed future outlook.
• A thorough examination of 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.

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• An overview of 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.

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Key Topics Covered:

APPROVED SUBCUTANEOUS BIOLOGICS: MARKET LANDSCAPE

• Approved Subcutaneous Biologics: Overall Market Overview
• Approved Subcutaneous Biologics: List of Developers

APPROVED SUBCUTANEOUS BIOLOGICS: SUCCESS PROTOCOL ANALYSIS

Success Protocol Analysis of Top Approved Subcutaneous Biologics

• BENLYSTA (Human Genome Sciences)
• BESREMi (PharmaEssentia)
• COSENTYX (Novartis)
• DARZALEX FASPRO / DARZALEX SC (Halozyme)
• DUPIXENT (Regeneron Pharma)
• Enbrel (Amgen)
• HEMLIBRA (Roche)
• Prolia / Pralia (Amgen)
• STELARA (Janssen Biotech)
• Trulicity (Eli Lilly)

CLINICAL-STAGE SUBCUTANEOUS BIOLOGICS: MARKET LANDSCAPE

• Clinical-stage Subcutaneous Biologics: Overall Market Overview
• Clinical-stage Subcutaneous Biologics: List of Developers

SUBCUTANEOUS FORMULATION: TECHNOLOGY LANDSCAPE

• Subcutaneous Formulation: Technology Landscape
• Subcutaneous Formulation: Technology Developers Landscape

SUBCUTANEOUS FORMULATION TECHNOLOGY PROVIDERS: COMPANY PROFILES

Technology Developers Based in North America

• CD Bioparticles
• Creative Biolabs
• Creative BioMart
• Pacira BioSciences
• The Wyss Institute
• Xeris Biopharma

Technology Developers Based in Europe

Technology Developers Based in Asia-Pacific

• Alteogen
• Foresee Pharmaceuticals

SUBCUTANEOUS FORMULATION TECHNOLOGIES: PARTNERSHIPS AND COLLABORATIONS

• Partnership Models
• Partnerships and Collaborations: Subcutaneous Formulation Technology
• Analysis by Geography

SUBCUTANEOUS DRUG DELIVERY SYSTEMS: MARKET LANDSCAPE

Types of Subcutaneous Drug Delivery Systems

• Large Volume Wearable Injectors
• Autoinjectors
• Pen Injectors
• Needle Free Injection System
• Novel Drug Reconstitution Delivery Systems
• Prefilled Syringes
• Implants

SUBCUTANEOUS DRUG DELIVERY SYSTEMS: PRODUCT COMPETITIVENESS ANALYSIS

• Large Volume Wearable Injectors
  • Autoinjectors
  • Needle-free Injection Systems
  • Prefilled Syringes

SWOT ANALYSIS

GLOBAL APPROVED SUBCUTANEOUS BIOLOGICS MARKET

• Global Approved Subcutaneous Biologics Market, till 2035

APPROVED SUBCUTANEOUS BIOLOGICS MARKET, BY TYPE OF BIOLOGIC

• Approved Subcutaneous Biologics Market: Distribution by Type of Biologic, Current year and 2035

APPROVED SUBCUTANEOUS BIOLOGICS MARKET, BY TYPE OF THERAPY

• Approved Subcutaneous Biologics Market: Distribution by Type of Therapy, Current year and 2035

APPROVED SUBCUTANEOUS BIOLOGICS MARKET, BY METHOD OF ADMINISTRATION

• Approved Subcutaneous Biologics Market: Distribution by Method of Administration, Current year and 2035

APPROVED SUBCUTANEOUS BIOLOGICS MARKET, BY THERAPEUTIC AREA

• Approved Subcutaneous Biologics Market: Distribution by Therapeutic Area, Current year and 2035

APPROVED SUBCUTANEOUS BIOLOGICS MARKET, BY GEOGRAPHICAL REGIONS

• Approved Subcutaneous Biologics Market: Distribution by Geographical Regions, Current year and 2035

APPROVED SUBCUTANEOUS BIOLOGICS MARKET, SALES FORECAST OF DRUGS

Drug-wise Sales Forecast

• Actemra / RoActemra
• Acthar Gel / ACTHar
• AIMOVIG
• AJOVY
• AMVUTTRA
• Aranesp / NESP
• Basaglar / Abasaglar
• BENLYSTA
• Betaseron / Betaferon / EXTAVIA
• CABLIVI
• CIMZIA
• COSENTYX
• CRYSVITA
• DARZALEX FASPRO / DARZALEX SC
• DUPIXENT
• EMGALITY
• Enbrel
• ENSPRYNG
• ENTYVIO
• Epogen / Procrit / Eprex
• EVENITY
• FASENRA
• FIASP
• Forteo / Forsteo
• GATTEX / Revestive
• Genotropin
• GIVLAARI
• G-LASTA / Peglasta / Neulasta / GRAN
• Gonal-F
• HAEGARDA
• HEMLIBRA
• Herceptin SC / HERCEPTINT HYLECTA
• Hizentra
• Humalog
• HUMIRA
• Humulin
• ILARIS
• Kesimpta
• KEVZARA
• KINERET
• LANTUS
• LEQVIO
• Mircera
• MOUNJARO
• NPLATE
• Nucala
• ORENCIA
• OXLUMO
• PALYNZIQ
• Phesgo
• PLEGRIDY
• PRALUENT
• Prolia / Pralia
• Rebif
• REBLOZYL
• REKOVELLE
• Repatha
• RITUXAN HYCELA / MabThera SC
• RYZODEG 70/30 SC
• Saizen
• Saxenda
• SIMPONI
• Skyrizi
• SOLIQUA 100/33
• STELARA
• Strensiq
• TAKHZYRO
• Taltz
• Tecentriq
• TEGSEDI
• TEZSPIRE
• Toujeo
• TREMFYA
• TRESIBA
• Trulicity
• Tysabri
• Ultomiris
• Victoza
• Voxzogo
• VYVGART Hytrulo
• WAINUAT
• Xgeva / RANMARK
• XOLAIR
• XULTOPHY
• ZEPBOUND

APPROVED SUBCUTANEOUS BIOLOGICS MARKET, BY LEADING PLAYERS

GLOBAL SUBCUTANEOUS BIOLOGICS FORMULATION TECHNOLOGIES MARKET

• Global Subcutaneous Biologics Formulation Technologies Market, till 2035

SUBCUTANEOUS BIOLOGICS FORMULATION TECHNOLOGIES MARKET, BY FUNDAMENTAL PRINCIPLE

• Subcutaneous Biologics Formulation Technologies Market: Distribution by Fundamental Principle, Current year and 2035

SUBCUTANEOUS BIOLOGICS FORMULATION TECHNOLOGIES MARKET, BY END USER

• Subcutaneous Biologics Formulation Technologies Market: Distribution by Type of End User, Current year and 2035

SUBCUTANEOUS BIOLOGICS FORMULATION TECHNOLOGIES MARKET, BY THERAPEUTIC AREA

• Subcutaneous Biologics Formulation Technologies Market: Distribution by Therapeutic Area, Current year and 2035

SUBCUTANEOUS BIOLOGICS FORMULATION TECHNOLOGIES MARKET, BY KEY GEOGRAPHICAL REGIONS

• Subcutaneous Biologics Formulation Technologies Market: Distribution by Key Geographical Regions, Current year and 2035

SUBCUTANEOUS BIOLOGICS FORMULATION TECHNOLOGIES MARKET, BY TYPE OF PAYMENT METHOD EMPLOYED

• Subcutaneous Biologics Formulation Technologies Market: Distribution by Type of Payment Method Employed, Current year and 2035

SUBCUTANEOUS BIOLOGICS FORMULATION TECHNOLOGIES MARKET, BY LEADING PLAYERS

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