Intranasal Therapeutics and Drug Delivery Systems Market, 2022-2035

Intranasal Therapeutics and Drug Delivery Systems Market, 2022-2035

Over the past few years, the prevalence of neurological disorders has increased at an annualized rate of 10.9%. Further, the mortality associated with such diseases is projected to account for 12.2% of the global death rate, in 2030. In this context, several research initiatives are underway to identify an approach that allows effective delivery of the target medication directly into the brain. One key challenge currently faced by researchers is the presence of the complex blood brain barrier (BBB), which hinders the entry of the target drug into the CNS, acting as a significant roadblock in the development of effective treatment modalities. It is worth mentioning that the failure of the ongoing research initiatives can incur losses worth USD 2 billion. , As a result, stakeholders in the pharmaceutical domain have shifted their focus towards the use of intranasal treatments, which have demonstrated to be capable of bypassing the blood brain barrier, thereby, delivering the target drug directly into the brain. Clinical studies related to interventional intranasal therapies have increased three-folds over the last decade. Specifically, post the onset of the COVID-19 pandemic, extensive research focused on intranasal therapeutics is being carried out due to their proven pharmacological value and favorable safety profiles. Notable examples of intranasal COVID-19 targeting drugs that are currently being evaluated across different phases of development include (in alphabetical order) COVIDROPS™ (Sorrento Therapeutics) , DEXANEUROSONE™ (Biomed Industries™) and Zavegepant (Biohaven Pharmaceuticals) .

Despite the several advantages offered by the intranasal route of administration, the delivery of therapies via the aforementioned approach is associated with some challenges, such as mucus and epithelial barriers, low bioavailability of drugs, limited drug absorption and shorter residence time. Most of these concerns can be mitigated via the use of appropriate drug delivery systems. Therefore, several pharmaceutical companies are currently focused on the development of novel drug delivery systems for intranasal therapeutics, since conventional pharmaceutical dosage forms are unable to regulate the rate at which these drugs are delivered to the target site. At present, close to 40 intranasal drug delivery systems are available in the market. Additionally, USD 5.5 billion was invested in this domain, during 2016-2021. In the same time frame, multiple partnership agreements were established between various stakeholders. Driven by the increasing patient population and the growing demand for such therapeutics, this market is anticipated to witness steady growth in the coming years.

The “Intranasal Therapeutics and Drug Delivery Systems Market Distribution by Target Indication (Acute Repetitive Clusters, Anaphylaxis, COVID-19, Dry Eye Disease, Hypoglycemia, Influenza, Major Depressive Disorder, Migraine, Nasal Polyps and Prader-Willi Syndrome), Type of Molecule (Biologics and Small Molecule) and Geography (North America, Europe, Asia-Pacific, and Rest of the World): Industry Trends and Global Forecasts, 2022-2035” report features an extensive study of the current market landscape and the likely future potential associated with the intranasal therapeutics and drug delivery systems market. The study also includes an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. Amongst other elements, the report features:

A detailed overview of the overall market landscape of players engaged in providing intranasal drug delivery systems, along with information on several relevant parameters, such as year of establishment, company size, location of headquarters, type of dosage form (liquid, powder and spray) and type of system (unit dose, multi dose and metered dose).

A detailed overview of the overall market landscape of players engaged in providing intranasal therapeutics, along with information on several relevant parameters, such as year of establishment, company size, location of headquarters, phase of development (phase I, phase II, Phase II/III, Phase III and Approved), type of molecule (biologics and small molecule) and therapeutic area (cardiovascular disorders, ear disorders, genetic disorders, infectious disorders, inflammatory disorders, metabolic disorders, neurological disorders, oncological disorders, ophthalmic disorders, respiratory disorders and other disorders)

An in-depth company competitiveness analysis of intranasal drug delivery system providers based on company strength (in terms of experience and company size), and product portfolio strength (such as number of products, type of dosage form, type of system and volume range).

An in-depth analysis of completed, ongoing and planned clinical trials focused on intranasal therapeutics, based on several relevant parameters, such as trial registration year, trial phase, trial recruitment status, enrolled patient population, study design, leading industry sponsors / collaborators (in terms of number of trials conducted), trial focus, target indication, most popular indications and key geographical regions.

An analysis of the recent partnerships inked between various players engaged in the development of intranasal therapeutics, during the period 2016-2021. Additionally, it includes a brief description of the various types of partnership models (such as service agreements, licensing agreements (specific to affiliated technology platforms and product candidates), technology utilization agreements, product manufacturing agreements, product development and commercialization agreements, clinical trial agreements) that have been adopted by stakeholders engaged in this domain.

A detailed analysis of various investments, such as venture capital financing, debt financing, grants / awards, capital raised from IPOs and subsequent offerings that were undertaken by players engaged in this domain, during the period 2016-2021.

An analysis of the start-ups (established between 2011-2020; less than 200 employees) engaged in this domain, based on several parameters, such as number of candidates in discovery, preclinical and clinical phases of development, number of partnerships, number of patents, amount raised, number of investors, types of funding and number of deals inked.

An in-depth analysis of patents related to intranasal therapeutics and drug delivery systems, filed / granted, based on various parameters, such as patent publication year, geographical location / patent jurisdiction, CPC symbols, emerging focus areas, type of applicant, and leading players (in terms of number of patents). In addition, it features a patent valuation analysis, highlighting the qualitative and quantitative aspects of patents.

A detailed discussion on the various steps of the supply chain model, namely concept of development & proof of concept, research and development, regulatory approvals and marketing and sales of the intranasal drug delivery systems and the cost requirements across each of the aforementioned stages.

One of the key objectives of the report was to evaluate the current opportunity and future growth potential within the intranasal therapeutics and drug delivery systems market, over the next decade. We have also provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, over the period 2022-2035. Additionally, the report features the likely distribution of the current and forecasted opportunity across [A] target indication (acute repetitive clusters, anaphylaxis, COVID-19, dry eye disease, hypoglycemia, influenza, major depressive disorder, migraine, nasal polyps and prader-willi syndrome), [B] type of molecule (biologics and small molecules) and [C] key geographical regions (North America, Europe, Asia-Pacific, and Rest of the World). In order to account for future uncertainties and add robustness to our forecast model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

1.1. RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we have conducted interviews with various experts in this domain (academia, industry, medical practice and other associations) in order to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:

Annual reports

Investor presentations

SEC filings

Industry databases

News releases from company websites

Government policy documents

Industry analysts’ views

While the focus has been on forecasting the market till 2035, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

1.2. KEY QUESTIONS ANSWERED

Who are the key players engaged in the development of intranasal therapeutics and drug delivery systems?

What are the major therapeutic areas targeted by intranasal therapeutics?

Which regions represent the maximum research activity related to intranasal therapeutics and drug delivery systems?

What kind of partnership models are most commonly adopted by stakeholders engaged in this industry?

Who are the key investigators in this domain?

How is the current and future market opportunity likely to be distributed across key market segments?

What are the anticipated future trends related to intranasal therapeutics and drug delivery systems?

1.3. CHAPTER OUTLINES

Chapter 2 is an executive summary of key insights captured in our research. It offers a high-level view on the current state of the intranasal therapeutics and drug delivery systems market and its likely evolution in the mid to long-term.

Chapter 3 provides a general introduction to history of intranasal drugs, featuring insights on mechanism of action of intranasal therapeutics. It further includes a brief introduction to intranasal therapeutics and drug delivery systems, along with information on the mechanism of intranasal drug delivery. Further, it highlights key challenges associated with this domain.

Chapter 4 features a detailed overview of the overall market landscape of players engaged in providing intranasal drug delivery systems, along with information on several relevant parameters, such as year of establishment, company size, location of headquarters, type of dosage form (liquid, powder and spray) and type of system (unit dose, multi dose and metered dose).



Chapter 5 provides a detailed overview of the overall market landscape of players engaged in providing intranasal therapeutics, along with information on several relevant parameters, such as year of establishment, company size, location of headquarters, phase of development (phase I, phase II, Phase II/III, Phase III and Approved), type of molecule (biologics and small molecule) and therapeutic area (cardiovascular disorders, ear disorders, genetic disorders, infectious disorders, inflammatory disorders, metabolic disorders, neurological disorders, oncological disorders, ophthalmic disorders, respiratory disorders and other disorders)

Chapter 6 features an in-depth company competitiveness analysis of intranasal drug delivery systems providers based on company strength (in terms of experience and company size), and product portfolio strength (such as number of products, type of dosage form, type of system and volume range)

Chapter 7 features an in-depth analysis of completed, ongoing and planned clinical trials focused on intranasal therapeutics, based on several relevant parameters, such as trial registration year, trial phase, trial recruitment status, enrolled patient population, study design, leading industry sponsors / collaborators (in terms of number of trials conducted), trial focus, target indication, most popular indications and key geographical regions

Chapter 8 features detailed profiles of the key stakeholders involved in the development of intranasal drug delivery systems. Each profile features a brief overview of the company, its financial information, details on its product portfolio, and recent developments and an informed future outlook.

Chapter 9 provides detailed profiles of phase II / III, phase III and approved intranasal therapeutics. Each drug profile provides information on their current development status, route of administration, primary target indication, dosage, mechanism of action, clinical trials, clinical trial results, collaborations and special drug designation(s) received (if any).

Chapter 10 features an analysis of the recent partnerships inked between various players engaged in the development of intranasal therapeutics, during the period 2016-2021. Additionally, it includes a brief description of the various types of partnership models (such as service agreements, licensing agreements (specific to affiliated technology platforms and product candidates), technology utilization agreements, product manufacturing agreements, product development and commercialization agreements, clinical trial agreements) that have been adopted by stakeholders engaged in this domain

Chapter 11 features a detailed analysis of various investments, such as venture capital financing, debt financing, grants / awards, capital raised from IPOs and subsequent offerings that were undertaken by engaged in this domain, during the period 2016-2021.

Chapter 12 features an analysis of the start-ups (established between 2011-2020; less than 200 employees) engaged in this domain, based on several parameters, such as number of candidates in discovery, preclinical and clinical phases of development, number of partnerships, number of patents, amount raised, number of investors, types of funding and number of deals inked

Chapter 13 provides an in-depth analysis of patents related to intranasal therapeutics and drug delivery systems, filed / granted, based on various parameters, such as patent publication year, geographical location / patent jurisdiction, CPC symbols, emerging focus areas, type of applicant, and leading players (in terms of number of patents). In addition, it features a patent valuation analysis, highlighting the qualitative and quantitative aspects of patents

Chapter 14 features a detailed discussion on the various steps of the supply chain model, namely concept of development & proof of concept, research and development, regulatory approvals and marketing and sales of the intranasal drug delivery systems and the cost requirements across each of the aforementioned stages

Chapter 15 presents an insightful market forecast analysis, highlighting the future potential of intranasal therapeutics and drug delivery systems, till 2035. We have segmented the market on the basis of [A] target indication (acute repetitive clusters, anaphylaxis, COVID-19, dry eye disease, hypoglycemia, influenza, major depressive disorder, migraine, nasal polyps and prader-willi syndrome), [B] type of molecule (biologics and small molecule) and [C] geography (North America, Europe, Asia-Pacific, and Rest of the World).

Chapter 16 is a collection of interview transcripts; these discussions were held with key stakeholders in the industry.

Chapter 17 summarizes the overall report, wherein we have mentioned all the key facts and figures described in the previous chapters. The chapter also highlights important evolutionary trends that were identified during the course of the study and are expected to influence the future of the intranasal therapeutics and drug delivery systems market.

Chapter 18 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 19 is an appendix, which contains a list of companies and organizations mentioned in this report.


1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Historical Evolution of Intranasal Therapies
3.3. Mechanism of Intranasal Drug Delivery
3.3.1. Intracellular Pathway
3.3.2. Extracellular Pathway
3.4. Types of Intranasal Drug Formulations
3.5. Types of Intranasal Drug Delivery Systems
3.5.1. Droppers
3.5.2. Unit / Bi-dose Systems
3.5.3. Spray Tips
3.5.4. Dry powder Systems
3.5.5. Multi-dose Systems
3.6. Regulatory Landscape for Intranasal Therapies
3.7. Future Perspectives
4. MARKET LANDSCAPE (DRUG DELIVERY SYSTEMS)
4.1. Chapter Overview
4.2. Intranasal Drug Delivery Systems: Developer Landscape
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Location of Headquarters
4.2.4. Analysis By Year of Establishment, Company Size and Location of Headquarters
4.2.5. Most Active Players: Analysis by Number of Products
4.3. Intranasal Drug Delivery Systems: Product Landscape
4.3.1. Analysis by Type of Dosage Form
4.3.2. Analysis by Type of System
4.3.3. Analysis by Dosage Volume Range
5. MARKET LANDSCAPE (DRUG PIPELINE)
5.1. Chapter Overview
5.2. Intranasal Therapeutics: Developer Landscape
5.2.1. Analysis by Year of Establishment
5.2.2. Analysis by Company Size
5.2.3. Analysis by Location of Headquarters
5.2.4. Analysis by Company Size and Location of Headquarter
5.2.5. Most Active Players: Analysis by Number of Therapeutics
5.3. Intranasal Therapeutics: Pipeline Review
5.3.1. Analysis by Phase of Development
5.3.2. Analysis by Type of Molecule
5.3.3. Analysis by Target Therapeutic Area
5.3.4. Analysis by Type of Molecule and Phase of Development
5.3.5. Analysis by Type of Molecule and Company Size
5.3.6. Most Active Players: Analysis by Phase of Development
6. COMPANY COMPETITIVENESS ANALYSIS (DRUG DELIVERY SYSTEMS)
6.1. Chapter Overview
6.2. Key Assumptions and Parameters
6.3. Methodology
6.3.1. Company Competitiveness Analysis: Drug Delivery Systems
6.4. Company Competitiveness: Benchmarking the Capabilities of Leading Players
7. CLINICAL TRIAL ANALYSIS
7.1. Chapter Overview
7.2. Scope and Methodology
7.3. Intranasal therapeutics: Clinical Trials Analysis
7.3.1. Analysis by Trial Registration Year
7.3.2. Analysis by Trial Status
7.3.3. Analysis by Trial Phase
7.3.4. Analysis by Trial Registration Year and Trial Status
7.3.5. Analysis by Enrolled Patient Population and Trial Phase
7.3.6. Analysis by Type of Sponsor / Collaborator
7.3.7. Analysis by Target Patient Group
7.3.8. Analysis by Target Therapeutic Area
7.3.9. Analysis by Study Design
7.3.10. Most Active Players: Analysis by Number of Registered Trials
7.3.11. Analysis by Number of Trials and Geographical Location
7.3.12. Analysis by Number of Trials, Trial Status and Geographical Location
7.3.13. Analysis by Enrolled Patient Population, Trial Status and Geographical Location
8. COMPANY PROFILES
8.1. Chapter Overview
8.2. Aptar Pharma
8.2.1. Company Overview
8.2.2. Financial Information
8.2.3. Product Portfolio
8.2.4. Recent Developments and Future Outlook
8.3. Nemera
8.3.1. Company Overview
8.3.2. Product Portfolio
8.3.3. Recent Developments and Future Outlook
8.4. Teleflex
8.4.1. Company Overview
8.4.2. Financial Information
8.4.3. Product Portfolio
8.4.4. Recent Development and Future Outlook
8.5. Mystic Pharmaceuticals
8.5.1. Company Overview
8.5.2. Product Portfolio
8.5.3. Recent Development and Future Outlook
8.6. Zeteo Medical
8.6.1. Company Overview
8.6.2. Product Portfolio
8.6.3. Recent development and Future Outlook
9. DRUG PROFILES
9.1 Chapter Overview
9.2. TrudhesaTM
9.3. Tyrvaya
9.4. VALTOCO®
9.5. SPRAVATO®
9.6. BAQSIMITM
9.7. NAYZILAM®
9.8. Tosymra®
9.9. XHANCETM
9.10. SINUVA
9.11. NeffyTM
9.12. ZAVEGEPANT (BHV-3500)
9.13. LV-101
9.14. MEDI3250
9.15. DEXANEUROSONE™
10. PARTNERSHIPS AND COLLABORATIONS
10.1. Chapter Overview
10.2. Partnership Models
10.3. Intranasal Therapeutics and Drug Delivery Systems: Recent Partnerships and Collaborations
10.3.1. Analysis by Year of Partnership
10.3.2. Analysis by Type of Partnership
10.3.3. Analysis by Year and Type of Partnership
10.3.4. Analysis by Focus Area
10.3.5. Analysis by Therapeutic Area
10.4. Most Active Players: Analysis by Number of Partnerships
10.5. Analysis by Geography
10.5.1. Country-wise Distribution
10.5.2. Intercontinental and Intracontinental Distribution
11. FUNDING AND INVESTMENT ANALYSIS
11.1. Chapter Overview
11.2 Types of Funding
11.3. Intranasal Therapeutics and Drug Delivery Systems: Funding and Investments
11.3.1. Analysis of Number of Funding Instances by Year
11.3.2. Analysis of Amount Invested by Year
11.3.3. Analysis by Number of funding Instances and Type of Funding
11.3.4. Analysis by Amount Invested and Type of Funding
11.3.5. Analysis by Year and Type of Funding
11.3.6. Analysis by Focus Area and Amount Invested
11.3.7. Analysis by Therapeutic Area and Amount Invested
11.3.8. Analysis by Type of Molecule and Amount Invested
11.3.9. Analysis by Geography
11.3.10. Most Active Players: Analysis by Number of Funding Instances
11.3.11. Most Active Investors: Analysis by Amount Invested
11.4. Concluding Remarks
12. START-UP HEALTH INDEXING (DRUG PIPELINE)
12.1. Chapter Overview
12.2. Start-ups in Intranasal Therapeutics
12.2.1. Analysis by Location of Headquarters
12.3. Benchmarking of Start-ups
12.4. Startup-Health Indexing
12.4.1. Analysis by Supplier Strength
12.4.1. Analysis by Pipeline Strength
12.4.2. Analysis by Pipeline Maturity
12.4.4. Analysis by Financial Investments
12.4.5. Analysis by Partnership Activity
12.4.6. Start-ups Health Indexing: Roots Analysis Perspective
13. PATENT ANALYSIS
13.1. Chapter Overview
13.2. Scope and Methodology
13.3. Intranasal Therapeutics and Drug Delivery Systems: Patent Analysis
13.3.1. Analysis by Publication Year
13.3.2. Analysis by Geography
13.3.3. Analysis by CPC Symbols
13.3.4. Emerging Focus Areas
13.3.5. Analysis by Type of Applicant
13.3.6. Leading Players: Analysis by Number of Patents
13.4. Intranasal Therapeutics and Drug Delivery Systems: Patent Valuation Analysis
13.5. Leading Patents: Analysis by Number of Citations
14. VALUE CHAIN ANALYSIS
14.1. Chapter Overview
14.2. Intranasal Drug Delivery Devices Value Chain
14.3. Cost Distribution Across the Value Chain
14.3.1. Costs Associated with Concept Development and Proof of Concept
14.3.2. Costs Associated with Research and Development
14.3.3. Costs Associated with Regulatory Approvals
14.3.4. Costs Associated Marketing and Sales
15. MARKET FORECAST AND OPPORTUNITY ANALYSIS
15.1. Chapter Overview
15.2. Scope and Limitations
15.3. Key Assumptions and Forecast Methodology
15.4. Global Intranasal Therapeutics and Drug Delivery Systems Market, 2022-2035
15.5. Global Intranasal Therapeutics and Drug Delivery Systems Market: Analysis by Target Indication, 2022 and 2035
15.6. Global Intranasal Therapeutics and Drug Delivery Systems Market: Analysis by Type of Molecule, 2022 and 2035
15.7. Global Intranasal Therapeutics and Drug Delivery Systems Market: Analysis by Key Players, 2022 and 2035
15.8. Global Intranasal Therapeutics and Drug Delivery Systems Market: Analysis by Geography, 2022 and 2035
15.9. Intranasal Therapeutics and Drug Delivery Systems: Product-wise Sales Forecast
15.9.1. TRUDHESA (Impel NeuroPharma)
15.9.1.1. Target Patient Population
15.9.1.2. Sales Forecast
15.9.1.3. Net Present Value
15.9.2. VALTOCO (Neurelis)
15.9.2.1. Target Patient Population
15.9.2.2. Sales Forecast
15.9.2.3. Net Present Value
15.9.3. Tyrvaya (Oyster Point Pharma)
15.9.3.1. Target Patient Population
15.9.3.2. Sales Forecast
15.9.3.3. Net Present Value
15.9.4. SPRAVATO (Janssen Pharmaceuticals)
15.9.4.1. Target Patient Population
15.9.4.2. Sales Forecast
15.9.4.3. Net Present Value
15.9.5. BAQSIMI (Eli Lilly)
15.9.5.1. Target Patient Population
15.9.5.2. Sales Forecast
15.9.5.3. Net Present Value
15.9.6. NAYZILAM (UCB)
15.9.6.1. Target Patient Population
15.9.6.2. Sales Forecast
15.9.6.3. Net Present Value
15.9.7. Tosymra (Dr. Reddy’s Laboratories)
15.9.7.1. Target Patient Population
15.9.7.2. Sales Forecast
15.9.7.3. Net Present Value
15.9.8. XHANCE (OptiNose)
15.9.8.1. Target Patient Population
15.9.8.2. Sales Forecast
15.9.8.3. Net Present Value
15.9.9. ONZETRA Xsail (OptiNose)
15.9.9.1. Target Patient Population
15.9.9.2. Sales Forecast
15.9.9.3. Net Present Value
15.9.10. SINUVA (Intersect ENT)
15.9.10.1. Target Patient Population
15.9.10.2. Sales Forecast
15.9.10.3. Net Present Value
15.9.11. Neffy (ARS Pharmaceuticals)
15.9.11.1. Target Patient Population
15.9.11.2. Sales Forecast
15.9.11.3. Net Present Value
15.9.12. MEDI3250 (Daiichi Sankyo)
15.9.12.1. Target Patient Population
15.9.12.2. Sales Forecast
15.9.12.3. Net Present Value
15.9.13. BHV3500 (Biohaven Pharmaceuticals)
15.9.13.1. Target Patient Population
15.9.13.2. Sales Forecast
15.9.13.3. Net Present Value
15.9.14. LV-101 (Levo Therapeutics)
15.9.14.1. Target Patient Population
15.9.14.2. Sales Forecast
15.9.14.3. Net Present Value
15.9.15. BHV-3500 (Biohaven Pharmaceuticals)
15.9.15.1. Target Patient Population
15.9.15.2. Sales Forecast
15.9.15.3. Net Present Value
15.9.16. DEXANEUROSONE (Biomed Industries)
15.9.16.1. Target Patient Population
15.9.16.2. Sales Forecast
15.9.16.3. Net Present Value
16. EXECUTIVE INSIGHTS
16.1. Chapter Overview
17. CONCLUDING REMARKS
18. APPENDIX I: TABULATED DATA
19. APPENDIX II: LIST OF COMPANIES AND ORGANIZATION

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