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Key Market Insights
§ Eminent representatives from biopharmaceutical companiesconfirm the rising interest in the concept of subcutaneous drug delivery,highlighting some of the key drivers and upcoming trends in this domain
§ More than 100 subcutaneous biologics have been approved andover 350 such drug candidates are being evaluated in the clinical stages ofdevelopment, for the treatment of a wide variety of disease indications
§ Antibodies and protein therapeutics represent the majorityof subcutaneous biologics that are available / under investigation, designedfor use against various therapeutic areas and having different dosing regimens
§ Advances in drug delivery have led to the development ofnovel technology platforms, enabling the administration of highly viscousformulations, and supporting the development of subcutaneous dosage forms
§ Several technology developers have out-licensed theirproprietary platforms to pharmaceutical companies in order to enable them todevelop subcutaneous formulations of their approved / pipeline products
§ The increasing interest in this field is reflected in theyearly growth in partnership activity, including a number of licensing andproduct development deals related to subcutaneous formulations of various drugcandidates
§ There are several new and innovative drug delivery systemsthat facilitate subcutaneous administration; we identified over 300 such systemsthat are presently available / under development
§ With several self-medication enabling devices, such aswearable injectors and autoinjectors, available in the market, developers areactively differentiating their offerings by incorporating advanced,patient-friendly features
§ The market is anticipated to be worth over USD 180 billionin 2030; the projected opportunity is likely to be distributed across varioustypes of molecules that are developed / being developed for different diseaseindications
§ Pre-filled syringes continue to dominate the current marketof subcutaneous drug delivery systems; technology developers are expected tocontinue relying on licensing agreements as their primary source of revenues333
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Table of Contents
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Types of TherapeuticMolecules
3.3. Biologically DerivedTherapeutics
3.3.1. Types of Products
3.3.2. Routesof Administration and Formulations
3.3.3. Subcutaneous Formulations
3.3.3.1. Approachesin Subcutaneous Delivery of Biologics
3.3.3.1.1. Reformulation
3.3.3.1.2. Differing Potencies
3.3.3.1.3. Novel Technologies
3.3.3.2. Methodof Subcutaneous Administration
3.3.3.3. Advantagesof Subcutaneous Administration
3.3.3.4. Limitationsof Subcutaneous Administration
3.4. Regulatory Considerations
3.4.1. Medical Devices
3.4.2. Drug Device Combination Products
3.5. Future Perspectives
4. SUBCUTANEOUS BIOLOGICS:CURRENT MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Subcutaneous Administration ofBiologics
4.3. Subcutaneous Biologics: Listof Approved Drugs
4.3.1. Analysis by Approval Year
4.3.2. Analysis by Type ofPharmacological Molecule
4.3.3. Analysis by Target TherapeuticArea
4.3.4. Analysis by Type of Formulation
4.3.5. Analysis by Dosing Frequency
4.3.6. Analysis by Dosage Form
4.3.7. Key Players: Analysis by Numberof Drugs Approved
4.4. Subcutaneous Biologics: Listof Clinical-Stage Drug Candidates
4.4.1. Analysis by Phase of Development
4.4.2. Analysis by Type ofPharmacological Molecule
4.4.3. Analysis by Target TherapeuticArea
4.4.4. Analysis by Dosing Frequency
4.4.5. Key Players: Analysis by Numberof Drug Candidates in Trials
5. CASE STUDY: LEADINGSUBCUTANEOUS BIOLOGICS
5.1. Chapter Overview
5.2. Subcutaneous Biologics:Leading Drugs by Annual Sales
5.3. Case Studies
5.3.1. HUMIRA® (AbbVie, Eisai)
5.3.1.1. DrugOverview
5. 3.1.2. Development History
5. 3.1.3. Target Indications and Dosage Forms
5. 3.1.4. Historical Sales
5.3.2. Enbrel® (Amgen, Pfizer, TakedaPharmaceutical)
5.3.2.1. Overview
5. 3.2.2. Development History
5. 3.2.3. Target Indications and Dosage Forms
5. 3.2.4. Historical Sales
5.3.3. RITUXAN® / MabThera® (Biogen,Roche, Chugai Pharmaceutical)
5.3.3.1. Overview
5. 3.3.2. Development History
5. 3.3.3. Target Indications and Dosage Forms
5. 3.3.4. Historical Sales
5. 3.3.5. ENHANZE™ Technology (HalozymeTherapeutics)
5. 3.3.6. Advantagesof Subcutaneous RITUXAN® / MabThera® Over Intravenous RITUXAN® / MabThera®
5.3.4. Herceptin® (Roche, ChugaiPharmaceutical)
5.3.4.1. Overview
5. 3.4.2. Development History
5. 3.4.3. Target Indications and Dosage Forms
5. 3.4.4. Historical Sales
5. 3.4.5. ENHANZE™ Technology (HalozymeTherapeutics)
5. 3.4.6. Advantages of SubcutaneousHerceptin® Over Intravenous Herceptin®
5. 3.4.7. Herceptin® - Large Volume WearableInjector Combination Product
5.3.5. Neulasta® (Amgen, Kyowa HakkoKirin)
5.3.5.1. Overview
5.3.5.2. DevelopmentHistory
5.3.5.3. TargetIndications and Dosage Forms
5.3.5.4. HistoricalSales
6. SUBCUTANEOUSFORMULATION TECHNOLOGIES: CURRENT MARKET LANDSCAPE
6.1. Chapter Overview
6.2. Subcutaneous FormulationTechnologies: List of Technology Developers
6.2.1. Analysis by Year ofEstablishment
6.2.2. Analysis by Company Size
6.2.3. Analysis by GeographicalLocation
6.3. Subcutaneous FormulationTechnologies: List of Technologies
6.3.1. Analysis by Type ofPharmacological Molecule
6.3.2. Analysis by Route ofAdministration
6.3.3. Analysis by Advantage(s) Offered
7. SUBCUTANEOUSFORMULATION TECHNOLOGY DEVELOPERS: COMPANY COMPETITIVENESS ANALYSIS
7.1. Chapter Overview
7.2. Subcutaneous FormulationTechnology Developers: Competitive Landscape
7.2.1. Methodology
7.2.2. Three-DimensionalBubble Analysis based on Supplier Power, Pipeline Strength and Primary Advantage(s)
7.3. Subcutaneous FormulationTechnology Developers: Benchmark Analysis
7.3.1. Methodology
7.3.2. North America
7.3.3. Europe
8. SUBCUTANEOUSFORMULATION TECHNOLOGY DEVELOPERS: COMPANY PROFILES
8.1. Chapter Overview
8.2. Adocia
8.2.1. Company Overview
8.2.2. Technology Overview
8.2.2.1. BioChaperone®Technology
8.2.3. Product Portfolio
8.2.4. Financial Performance
8.2.5. Recent Developments and FutureOutlook
8.3. Ajinomoto Althea
8.3.1. Company Overview
8.3.2. Technology Overview
8.3.2.1. Crystalomics®Formulation Technology
8.3.3. Product Portfolio
8.3.4. Financial Performance
8.3.5. Recent Developments and FutureOutlook
8.4. Arecor
8.4.1. Company Overview
8.4.2. Technology Overview
8.4.2.1. Arestat™Technology
8.4.3. Product Portfolio
8.4.4. Recent Developments and FutureOutlook
8.5. Alteogen
8.5.1. Company Overview
8.5.2. Technology Overview
8.5.2.1. HybrozymeTechnology
8.5.3. Product Portfolio
8.5.4. Recent Developments and FutureOutlook
8.6. Ascendis Pharma
8.6.1. Company Overview
8.6.2. Technology Overview
8.6.2.1. TransConTechnology
8.6.3. Product Portfolio
8.6.4. Financial Performance
8.6.5. Recent Developments and FutureOutlook
8.7. Avadel Pharmaceuticals
8.7.1. Company Overview
8.7.2. Technology Overview
8.7.2.1. Medusa™Technology
8.7.3. Product Portfolio
8.7.4. Financial Performance
8.7.5. Recent Developments and FutureOutlook
8.8. Camurus
8.8.1. Company Overview
8.8.2. Technology Overview
8.8.2.1. FluidCrystal®Injection Depot Technology
8.8.3. Product Portfolio
8.8.4. Financial Performance
8.8.5. Recent Developments and FutureOutlook
8.9. Creative BioMart
8.9.1. Company Overview
8.9.2. Technology Overview
8.9.2.1. HighConcentration Formulation Technology
8.9.3. Product Portfolio
8.9.4. Recent Developments and FutureOutlook
8.10. Creative Biolabs
8.10.1. Company Overview
8.10.2. Technology Overview
8.10.2.1. Long-Acting Injectable Technology
8.10.3. Product Portfolio
8.10.4. Recent Developments and FutureOutlook
8.11. DURECT
8.11.1. Company Overview
8.11.2. Technology Overview
8.11.2.1. SABER® Platform
8.11.2.2. CLOUD™ PLATFORM
8.11.3. Product Portfolio
8.11.4. Financial Performance
8.11.5. Recent Developments and FutureOutlook
8.12. Eagle Pharmaceuticals
8.12.1. Company Overview
8.12.2. Technology Overview
8.12.2.1. Unnamed Technology
8.12.3. Product Portfolio
8.12.4. Financial Performance
8.12.5. Recent Developments and FutureOutlook
8.13. Halozyme Therapeutics
8.13.1. Company Overview
8.13.2. Technology Overview
8.13.2.1. ENHANZE® Technology
8.13.3. Product Portfolio
8.13.4. Financial Performance
8.13.5. Recent Developments and FutureOutlook
8.14. MedinCell
8.14.1. Company Overview
8.14.2. TechnologyOverview
8.14.2.1. BEPO® Technology
8.14.3. Product Portfolio
8.14.4. Recent Developments and FutureOutlook
8.15. Xeris Pharmaceuticals
8.15.1. Company Overview
8.15.2. Technology Overview
8.15.2.1. XeriJect™ Technology
8.15.2.2. XeriSol™ Technology
8.15.3. Product Portfolio
8.15.4. Recent Developments and FutureOutlook
8.16. Serina Therapeutics
8.16.1. Company Overview
8.16.2. Technology Overview
8.16.2.1. POZ™ Drug Delivery Technology
8.16.3. Product Portfolio
8.16.4. Recent Developments and FutureOutlook
9. PARTNERSHIPS ANDCOLLABORATIONS
9.1. Chapter Overview
9.2. Partnership Models
9.3. SubcutaneousFormulation Technologies: Partnerships and Collaborations
9.3.1. Analysis by Year of Partnership
9.3.2. Analysis by Type of Partnership
9.3.3. Most Active Players: Analysis byNumber of Partnerships
9.3.4. Regional Analysis
9.3.5. Intercontinental andIntracontinental Agreements
10. SUBCUTANEOUS DRUG DELIVERYSYSTEMS: CURRENT MARKET LANDSCAPE
10.1. Chapter Overview
10.2. Different Types of SubcutaneousDrug Delivery Systems
10.3. Subcutaneous Drug DeliverySystems: Overall Market Landscape
10.3.1. Large Volume Wearable Injectors
10.3.1.1. Overview
10.3.1.2. Current Market Landscape of Devicesfor Non-insulin Biologics
10.3.1.2.1. Analysis by Stage of Development
10.3.1.2.2. Analysis by Type of Device
10.3.1.2.3. Analysis by Type of Dose Administered
10.3.1.2.4. Analysis by Volume / Storage Capacity
10.3.1.2.5. Analysis by Usability
10.3.1.2.6. Analysis by Mode of Injection
10.3.1.2.7. Analysis by Mechanism of Action
10.3.1.2.8. Most Active Players: Analysis by Numberof Devices
10.3.1.2.9. Product Competitiveness Analysis
10.3.1.3. CurrentMarket Landscape of Devices for Insulin
10.3.1.3.1. Analysisby Stage of Development
10.3.1.3.2. Analysis by Type of Device
10.3.1.3.3. Analysis by Volume / Storage Capacity
10.3.1.3.4. Analysis by Usability
10.3.1.3.5. Analysis by Availability of IntegratedCGM / BGM System
10.3.1.3.6. Most Active Players: Analysis by Numberof Devices
10.3.1.3.7 Product Competitiveness Analysis
10.3.2. Autoinjectors
10.3.2.1. Overview
10.3.2.2. Current Market Landscape
10.3.2.2.1. Analysis by Usability
10.3.2.2.2. Analysis by Type of Primary Container
10.3.2.2.3. Analysis by Volume / Storage Capacity
10.3.2.2.4. Analysis by Type of Dose
10.3.2.2.5. Analysis by Actuation Mechanism
10.3.2.2.6. Most Active Players: Analysis by Numberof Devices
10.3.2.2.7. Product Competitiveness Analysis
10.3.2.3. Drug Device Combination Products
10.3.3. Pen Injectors
10.3.3.1. Overview
10.3.3.2. Current Market Landscape
10.3.3.2.1. Analysis by Usability
10.3.3.2.2. Analysis by Volume / Storage Capacity
10.3.3.2.3. Analysis by Type of Dose
10.3.3.2.4. Most Active Players: Analysis by Numberof Devices
10.3.3.3. Drug Device Combination Products
10.3.4. Needle-Free Injection Systems
10.3.4.1. Overview
10.3.4.2. Current Market Landscape
10.3.4.2.1. Analysis by Stage of Development
10.3.4.2.2. Analysis by Volume / Storage Capacity
10.3.4.2.3. Analysis by Usability
10.3.4.2.4. Analysis by Actuation Mechanism
10.3.4.2.5. Most Active Players: Analysis by Numberof Devices
10.3.4.2.6. Product Competitiveness Analysis
10.3.5. Drug Reconstitution DeliverySystems
10.3.5.1. Overview
10.3.5.2. Current Market Landscape
10.3.5.2.1. Analysis by Usability
10.3.5.2.2. Analysis by Type of Device
10.3.5.2.3. Analysis by Type of Drug Container
10.3.5.2.4. Most Active Players: Analysis by Numberof Devices
10.3.6. Prefilled Syringes
10.3.6.1. Overview
10.3.6.2. Current Market Landscape
10.3.6.2.1. Analysis by Barrel Fabrication Material
10.3.6.2.2. Analysis by Number of Barrel Chambers
10.3.6.2.3. Analysis by Type of Needle System
10.3.6.2.4. Analysis by Volume / Storage Capacity
10.3.6.3.5. Most Active Players: Analysis by Numberof Devices
10.3.6.3. Product Competitiveness Analysis
10.3.6.4. Drug Device Combination Products
10.3.7. Implants
10.3.7.1. Overview
10.3.7.2. Current Market Landscape
10.3.7.2.1. Analysis by Stage of Development
10.3.7.2.2. Analysis by Target Therapeutic Area
10.3.7.2.3. Analysis by Implant Material
10.3.7.2.4. Analysis by Treatment Duration
10.3.7.2.5. Most Active Players: Analysis by Numberof Devices
11. SWOT ANALYSIS
11.1. Chapter Overview
11.2. Comparisonof SWOT Factors
11.2.1. Strengths
11.2.2. Weaknesses
11.2.3. Opportunities
11.2.4. Threats
12. MARKET FORECAST ANDOPPORTUNITY ANALYSIS
12.1. Chapter Overview
12.2. Subcutaneous Biologics Market
12.2.1. Forecast Methodology and Key Assumptions
12.2.2. Overall Subcutaneous BiologicsMarket, 2020-2030
12.2.2.1. Subcutaneous Biologics Market,2020-2030:Distribution by Phase of Development
12.2.2.2. SubcutaneousBiologics Market, 2020-2030:Distribution by Type of Pharmacological Molecule
12.2.2.3. Subcutaneous Biologics Market,2020-2030:Distribution by Target Therapeutic Area
12.2.2.4. Subcutaneous Biologics Market,2020-2030:Distribution by Key Geographical Regions
12.3. Subcutaneous Drug DeliverySystems Market
12.3.1. Device Type 1: Large VolumeWearable Injectors
12.3.1.1. Forecast Methodology and KeyAssumptions
12.3.1.2. Global Large Volume WearableInjectors Market for Non-Insulin Drugs, 2020-2030
12.3.1.2.1. GlobalLarge Volume Wearable Injectors Market for Non-Insulin Drugs: Distribution byType of Device, 2020-2030
12.3.1.2.2. GlobalLarge Volume Wearable Injectors Market for Non-Insulin Drugs: Distribution byUsability, 2020-2030
12.3.1.2.3. GlobalLarge Volume Wearable Injectors Market for Non-Insulin Drugs: Distribution byTarget Therapeutic Area, 2020-2030
12.3.1.2.4. GlobalLarge Volume Wearable Injectors Market for Non-Insulin Drugs: Distribution byKey Geographical Regions, 2020-2030
12.3.1.3. Global Large Volume WearableInjectors Market for Insulin , 2020-2030
12.3.1.3.1. GlobalLarge Volume Wearable Injectors Market for Insulin: Distribution by Type ofDevice, 2020-2030
12.3.1.3.2. GlobalLarge Volume Wearable Injectors Market for Insulin: Distribution by Usability,2020-2030
12.3.1.3.3. GlobalLarge Volume Wearable Injectors Market for Insulin: Distribution by KeyGeographical Regions, 2020-2030
12.3.2. Device Type 2: Autoinjectors
12.3.2.1. Forecast Methodology and KeyAssumptions
12.3.2.2. Global Autoinjectors Market,2020-2030
12.3.2.2.1. Global Autoinjectors Market:Distribution by Usability, 2020-2030
12.3.2.2.2. GlobalAutoinjectors Market: Distribution by Type of Pharmacological Molecule,2020-2030
12.3.2.2.3. Global Autoinjectors Market:Distribution by Key Geographical Regions, 2020-2030
12.3.3. Device Type 3: Prefilled Syringes
12.3.3.1. Forecast Methodology and KeyAssumptions
12.3.3.2. Global Prefilled Syringes Market,2020-2030
12.3.3.2.1. GlobalPrefilled Syringes Market: Distribution by Type of Syringe Barrel Material,2020-2030
12.3.3.2.2. Global Prefilled Syringes Market:Distribution by Type of Chamber System, 2020-2030
12.3.3.2.3. GlobalPrefilled Syringes Market: Distribution by Type of Pharmacological Molecule,2020-2030
12.3.3.2.4. Global Prefilled Syringes Market:Distribution by Target Therapeutic Area, 2020-2030
12.3.3.2.5. Global Prefilled Syringes Market:Distribution by Key Geographical Regions, 2020-2030
12.3.4. Device Type 4: Needle-FreeInjection Systems
12.3.4.1. Forecast Methodology and KeyAssumptions
12.3.4.2. Global Needle-Free Injection SystemsMarket, 2020-2030
12.3.4.2.1. Global Needle-Free Injection SystemsMarket: Distribution by Usability, 2020-2030
12.3.4.2.2. GlobalNeedle-Free Injection Systems Market: Distribution by Actuation Mechanism,2020-2030
12.3.4.2.3. GlobalNeedle-Free Injection Systems Market: Distribution by Target Therapeutic Area,2020-2030
12.3.4.2.4. GlobalNeedle-Free Injection Systems Market: Distribution by Key Geographical Regions,2020-2030
12.3.5. Device Type 5: Novel DrugReconstitution Systems
12.3.5.1. Forecast Methodology and KeyAssumptions
12.3.5.2. Global Novel Drug ReconstitutionSystems Market, 2020-2030
12.4. Subcutaneous Formulation TechnologiesMarket
12.4.1. SubcutaneousFormulation Technologies Market: Distribution by Upfront and MilestonePayments, 2020-2030
13. CONCLUDING REMARKS
14. EXECUTIVE INSIGHTS
14.1. Chapter Overview
14.2. LindyBiosciences
14.2.1. CompanySnapshot
14.2.2. InterviewTranscript: Deborah Bitterfield, Chief Executive Officer and Founder
14.3. OvalMedical Technologies
14.3.1. CompanySnapshot
14.3.2. InterviewTranscript: Matthew Young, Chief Technology Officer and Founder
14.4. XerisPharmaceuticals
14.4.1. CompanySnapshot
14.4.2. InterviewTranscript: Steve Prestrelski, Chief Scientific Officer and Founder; Hong Qi,Vice President, Product Development; and Scott Coleman, Sr. ScientistFormulation)
14.5. DALIMedical Devices
14.5.1. CompanySnapshot
14.5.2. InterviewTranscript: David Daily, Chief Executive Officer and Co-Founder
14.6. ExcelseBio
14.6.1. CompanySnapshot
14.6.2. InterviewTranscript: Michael Reilly, Chief Executive Officer and Co-Founder
14.7. i-novion
14.7.1. CompanySnapshot
14.7.2. InterviewTranscript: Poonam R Velagaleti, Co-Founder
14.8. EnableInjections
14.8.1. CompanySnapshot
14.8.2. &nbs
