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Report Description
Owing to their complexity and instability, proteins and peptides are mostly injected by intravenous or subcutaneous routes. Amongst the various modes of administration, oral delivery is the more preferred route. Although very convenient, there are many challenges which hinder this route of administration. These include enzymatic and pH-dependent degradation of the amino acid based drugs in the gastrointestinal tract, low epithelial permeability and instability during formation. As a result, proteins / peptides administered orally have an extremely low (<1-2%) bioavailability.
Several developments have taken place in the recent past to develop oral formulations of such drugs. Various technologies facilitating oral administration of protein and peptide drugs are under development by a number of large / small companies across the globe. The emergence of more innovative technologies will be the key to achieving success in this field. There are many emerging proteins / peptides which are currently in preclinical / discovery stage. In addition, there are a handful of molecules which are already in late stage clinical development and are likely to become commercially available in the next few years.
The field has attracted several stakeholders including venture capital firms which have led funding rounds of many start-ups. The overall interest continues to rise as is evident from the increasing number of partnerships being forged amongst companies specialising in different areas. Product development and technology licensing agreements have been the most common and are likely to play an active role in industry’s future evolution.
Scope of the Report
The “Oral Proteins and Peptides Market (2nd edition), 2015-2025” report provides a comprehensive analysis of the current state of the market and the likely future evolution over the next ten years. Endogenous peptides are a smart way to utilise body’s own resources to design drugs that are more specific and carry great potential to cure hard-to-treat diseases. The protein and peptide therapeutics market is a multi-billion dollar market and researchers are trying their best to improve the therapy by devising strategies for their oral delivery. The report portrays efforts of various pharmaceutical companies in making the transition towards oral delivery by developing innovative technologies and testing multiple drug candidates based on these technologies. A vast amount of activity is happening in this area as seen by the myriad of discoveries, patents, collaborations and grants.
One of the key objectives of this report is to understand the current and future state of oral proteins and peptide drugs market. This was done by analyzing the following:
The study provides a comprehensive analysis of the competition, partnerships and key players in the market. The research, analysis and insights presented in this report include the sales forecasts of emerging oral proteins / peptides which are currently either marketed or in late stage clinical development. Our study includes proteins such as antibodies and recombinant proteins including insulin, hormones, interferon etc. However, we have excluded enzymes from our analysis. The only enzyme covered in the report is Liprotamase from Eli Lilly. Liprotamase is a pancreatic enzyme replacement therapy product. The enzyme has been presented as it differs from competing marketed drugs for being non-porcine derived and lacking an enteric coating. We have also included a special section on Liprotamase.
One of the interesting features of this report is the inclusion of case studies on two cyclic oral peptides discovered before the year 2000. These two peptides, namely Sandimmune and DDAVP, act as a role model for the biotechnology and pharmaceutical companies for future innovation and development in this field.
Contents
Chapter 2 provides executive summary of major highlights captured in the report. It offers a high level view on the likely future of oral proteins and peptides market.
Chapter 3 provides a general introduction to the protein and peptide therapeutics market. We discuss, in detail, the available modes of administration, advantages over small molecule drugs, current challenges, and proposed solutions.
Chapter 4 provides an overview of oral proteins and peptides market with respect to marketed and pipeline drugs and companies active in the field. The analysis of the market is also extended to indications, current phase of development, and available technologies.
Chapter 5 explores various drug candidates in late stage clinical development. We have presented market data for base year 2014 (where available) and our forecasts for the period 2015 - 2025. While preparing the forecasts, several factors were taken into consideration such as status of development, competition, expected approval and likely adoption rates.
Chapter 6 presents special case studies on three molecules, namely, Liprotamase, Sandimmune and DDAVP. Sandimmune and DDAVP were launched before the year 2000 prior to the oral peptide revolution.
Chapter 7 reviewsthe major technologies available for oral protein and peptide delivery. We have presented profiles of seven leading technologies with information about their origin, mechanism, molecules using the technology and companies involved.
Chapter 8 covers details on the recent partnerships which have taken place in the industry. We have discussed the various partnerships models in existence and the most common forms of deals / agreements which have evolved over time.
Chapter 9 provides information on several funding instances which have driven research in the area of oral proteins and peptides. The analysis reveals interesting insights on the growing interest from venture capitalists and other stakeholders.
Chapter 10 provides our analysis of the strengths, weaknesses, opportunities and threats in the market, capturing the key elements likely to influence future growth.
Chapter 11 summarises the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.
Chapter 12 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 13 is an appendix, which provides list of companies mentioned in the report.
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. Comparison of Protein / Peptide Drugs with Small Molecule Drugs
3.3. Route of Administration
3.3.1. Injection: Intramuscular, Intravenous, Subcutaneous
3.3.2. Transdermal
3.3.3. Intranasal
3.3.4. Ocular
3.3.5. Inhalation
3.3.6. Oral
3.3.7. Implantation
3.4. Development Challenges
3.4.1. Instability
3.4.2. Complex Purification Process
3.4.3. Immunogenicity
3.4.4. Side Effects
3.5. Oral Proteins and Peptides
3.5.1. Synopsis
3.5.2. Current Challenges
3.5.3. Proposed Solutions
4. OVERVIEW AND MARKET BACKGROUND
4.1. Chapter Overview
4.2. Oral Protein / Peptides Under Development
4.3. Pipeline Analysis
4.3.1. Distribution by Companies
4.3.2. Distribution by Type of Molecule
4.3.3. Distribution by Type of Indication
4.3.4. Distribution by Phase of Development
4.3.5. Distribution by Technology
5. DRUG PROFILES AND MARKET FORECAST
5.1. Introduction
5.1.1. Scope and Limitations
5.1.2. Assumptions for Market Forecast
5.2. Overall Market
5.3. Linaclotide (Linzess / Constella)
5.3.1. Drug Overview
5.3.2. Structure and Mechanism of Action
5.3.3. From Discovery to Launch
5.3.4. Pharmacokinetics
5.3.5. Competition
5.3.6. Dosage and Cost
5.3.7. Patent Portfolio
5.3.8. Geographical Presence Through Partnerships
5.3.9. Current Status of Development
5.3.10. Linzess Sales, 2012 - 2013
5.3.11. IBS-C and CIC Market
5.3.12. Linaclotide (Linzess / Constella) Sales Forecast: Short-Mid Term, 2014-2019
5.3.13. Linaclotide (Linzess / Constella) Sales Forecast: Long Term, 2019-2025
5.4. Plecanatide
5.4.1. Overview
5.4.2. Structure and Mechanism of Action
5.4.3. Patent
5.4.4. Current Phase of Development
5.4.5. Competition
5.4.6. Plecanatide Sales Forecast: Short-Mid Term, 2014-2019
5.4.7. Plecanatide Sales Forecast: Long Term, 2019-2025
5.5. Octreolin
5.5.1. Overview
5.5.2. Current Treatment Options for Acromegaly
5.5.3. Partnership with Roche
5.5.4. Structure and Mechanism of Action
5.5.5. Current Status of Development
5.5.6. Competition
5.5.7. Octreolin Sales Forecast: Short-Mid Term, 2014-2019
5.5.8. Octreolin Sales Forecast: Long Term, 2019-2025
5.6. Ostora
5.6.1. Overview
5.6.2. History
5.6.3. Structure and Mechanism of Action
5.6.4. Current Status of Development
5.6.5. Competition
5.6.6. Restriction on the Use of Calcitonin
5.6.7. Ostora Sales Forecast: Short-Mid Term, 2014-2019
5.6.8. Ostora Sales Forecast: Long Term, 2019-2025
5.7. IN-105
5.7.1. Overview
5.7.2. History
5.7.3. Structure and Mechanism of Action
5.7.4. Characteristics of IN-105
5.7.5. Current Status of Development
5.7.6. Competition
5.7.7. IN-105 Sales Forecast: Long Term, 2019-2025
6. CASE STUDIES: LIPROTAMASE, SANDIMMUNE, DDAVP
6.1. Liprotamase
6.1.1. Overview
6.1.2. Structure and Mechanism of Action
6.1.3. History
6.1.4. Development Stage
6.1.5. Competition
6.2. Sandimmune
6.2.1. Overview
6.2.2. Structure and Mechanism of Action
6.2.3. Discovery to Launch
6.2.4. Dosage
6.2.5. Patents
6.2.6. Generics
6.2.7. Interactions with Other Drugs
6.2.8. Competition
6.2.9. Sales
6.3. DDAVP/Minirin (Desmopressin)
6.3.1. Overview
6.3.2. Structure and Mechanism of Action
6.3.3. History
6.3.4. Patents
6.3.5. Dosage
6.3.6. Pharmacokinetics
6.3.7. Generics for DDAVP
6.3.8. Geographical Presence
6.3.9. Competition
7. TECHNOLOGY PLATFORMS
7.1. Chapter Overview
7.2. Axcess (Proxima Concepts)
7.2.1. Overview
7.2.2. Invention of Axcess
7.2.3. Patents
7.2.4. Technology
7.2.5. Advantages
7.2.6. Molecules in Pipeline
7.2.7. Partnerships
7.3. Peptelligence (Enteris Biopharma)
7.3.1. Overview
7.3.2. Recent Acquisition from Unigene Laboratories, Inc.
7.3.3. Patents
7.3.4. The Technology
7.3.5. Advantages
7.3.6. Molecules in Pipeline
7.3.7. Partnerships
7.4. Gastrointestinal Permeation Enhancement Technology, GIPET (Merrion Pharmaceuticals)
7.4.1. Overview
7.4.2. Patents
7.4.3. Acquisition from Elan Biotechnology Research Centre
7.4.4. Technology Platform
7.4.5. Advantages of the technology
7.4.6. Current Pipeline of Drugs Using GIPET
7.4.7. Partner Programmes
7.5. POD (Protein Oral Delivery) Technology (Oramed Pharmaceuticals)
7.5.1. Overview
7.5.2. Patents
7.5.3. The Technology
7.5.4. Advantages
7.5.5. Molecules in Pipeline
7.5.6. Collaborations
7.6. Multi Matrix System (Cosmo Pharmaceuticals)
7.6.1. Overview
7.6.2. The Technology
7.6.3. Patents
7.6.4. Mechanism of Action
7.6.5. Advantages
7.6.6. Product Pipeline
7.6.7. Partnerships
7.7. Oral Antibody Platform (Avaxia Biologics)
7.7.1. Overview
7.7.2. The Technology
7.7.3. Advantages
7.7.4. Molecules in Pipeline
7.7.5. Partnerships
7.8. Eligen (Emisphere Technologies)
7.8.1. Overview
7.8.2. In-house Development of Eligen
7.8.3. The Technology
7.8.4. Advantages of Technology
7.8.5. Molecules in Pipeline
7.8.6. Collaborators
8. RECENT PARTNERSHIPS
8.1. Chapter Overview
8.2. Partnership Models / Agreements
8.3. Collaborations Amongst Stakeholders are on a Rise
8.4. Product Development, Technology Licensing and Product Licensing Models Are Preferred Modes of Collaboration
8.5. Most Active Companies in Oral Proteins and Peptides Area
9. VENTURE CAPITAL SUPPORT
9.1. Chapter Overview
9.2. Instances of Investments / Grants in Oral Protein and Peptide Drugs Market
9.3. Growing Venture Capitalist Interest
9.4. Funding Instances: Distribution by Type of Funding
9.5. Funding Amount: Distribution by Type of Funding
10. SWOT ANALYSIS
10.1. Chapter Overview
10.2. Strengths
10.3. Weaknesses
10.4. Opportunities
10.5. Threats
11. CONCLUSION
11.1. Growing Interest from Several Stakeholders
11.2. Rise of New Technologies
11.3. The Preferred Delivery Mode For a Host Of Indications
11.4. An Emerging Market Close to the Tipping Point
11.5. Challenges Exist, Though These can be Surpassed
12. APPENDIX 1: Tabulated Data
13. APPENDIX 2: List of Companies
Figure 3.1 Paracellular Transport of Drugs
Figure 3.2 Transcellular Transport of Drugs
Figure 4.1 Molecules Under Development: Distribution by Companies
Figure 4.2 Molecules Under Development: Distribution by Type of Molecule
Figure 4.3 Molecules Under Development: Distribution by Type of Indication
Figure 4.4 Molecules Under Development: Distribution by Phase of Development
Figure 4.5 Molecules Under Development: Distribution by Technology
Figure 5.1 Overall Market of Emerging Oral Proteins / Peptides (USD Million): Short-Mid Term Forecast, 2014 – 2019 (Base Scenario)
Figure 5.2 Overall Market of Emerging Oral Proteins / Peptides (USD Million): Long Term Forecast, 2019 – 2025 (Base Scenario)
Figure 5.3 Structure of Linzess
Figure 5.4 Linzess Quarterly US Sales, 2013 - 2014 (USD Million)
Figure 5.5 US Market for IBS-C and CIC, by Drug Class, 2012 (USD Billion)
Figure 5.6 Linaclotide (Linzess / Constella) Sales Forecast (USD Million): Short-Mid Term, 2014-2019 (Base Scenario)
Figure 5.7 Linaclotide (Linzess / Constella) Sales Forecast (USD Million): Long Term, 2019-2025 (Base Scenario)
Figure 5.8 Structure of Plecanatide
Figure 5.9 Plecanatide Sales Forecast (USD Million): Short-Mid Term, 2014-2019 (Base Scenario)
Figure 5.10 Plecanatide Sales Forecast (USD Million): Long Term, 2019-2025 (Base Scenario)
Figure 5.11 Structure of Octreolin
Figure 5.12 Octreolin Sales Forecast (USD Million): Short-Mid Term, 2014-2019 (Base Scenario)
Figure 5.13 Octreolin Sales Forecast (USD Million): Long Term, 2019-2025 (Base Scenario)
Figure 5.14 Structure of Salmon Calcitonin
Figure 5.15 Ostora Sales Forecast (USD Million): Short-Mid Term, 2014-2019 (Base Scenario)
Figure 5.16 Ostora Sales Forecast (USD Million): Long Term, 2019-2025 (Base Scenario)
Figure 5.17 IN-105 Sales Forecast (USD Million): Long Term, 2019-2025 (Base Scenario)
Figure 6.1 Sandimmune Worldwide Sales (USD Million), 2002 - 2013
Figure 6.2 DDAVP Structure
Figure 7.1 Role of Ingredients and Excipients Used in Peptelligence Technology
Figure 7.2 Multifunctional Role of Absorption Enhancer in GIPET
Figure 7.3 MMX Technology Platform
Figure 8.1 Cumulative Partnerships by Year, 2006-2014
Figure 8.2 Oral Proteins and Peptide Partnerships: Distribution by Type of Partnership
Figure 8.3 Oral Proteins and Peptides Partnerships: Major Stakeholders
Figure 9.1 Cumulative Funding Instances by Year, 2005 onwards
Figure 9.2 Funding Instances: Distribution by Type of Funding
Figure 9.3 Funding Amount: Distribution by Type of Funding, USD Million
Figure 11.1 Overall Market of Emerging Oral Proteins / Peptides: Comparative Market Scenarios, 2014, 2019 and 2025 (USD Billion)
Table 4.1 Oral Proteins / Peptides Under Development
Table 5.1 Emerging Oral Proteins / Peptides: Expected Launch Year of Molecules
Table 5.2 Marketed Drugs for IBS-C and CIC
Table 5.3 Linzess: Dosage and Cost
Table 5.4 Linzess: List of Patents
Table 5.5 Ironwood Partnerships for Linaclotide
Table 5.6 Linaclotide: Current State of Development
Table 5.7 Plecanatide: Patent Details
Table 5.8 Plecanatide: Phase IIb Clinical Trials for CIC
Table 5.9 Plecanatide: Phase II Clinical Trials for IBS-C
Table 5.10 Plecanatide vs. Linaclotide
Table 5.11 Plecanatide: Competitive Landscape
Table 5.12 Octreolin: Current State of Development
Table 5.13 Octreolin: Phase III Clinical Trial for Acromegaly
Table 5.14 Octreolin: Competitive Landscape (Approved / Marketed Drugs)
Table 5.15 Octreolin: Competitive Landscape (Pipeline Drugs)
Table 5.16 Ostora: Phase III Clinical Trials
Table 5.17 Ostora: Competitive Landscape
Table 5.18 IN-105: Status of Clinical Trials
Table 5.19 Oral Insulin: Molecules Under Clinical Development
Table 6.1 Liprotamase: Mechanism of Action
Table 6.2 Liprotamase: Phase III Short-term Efficacy Study
Table 6.3 Liprotamase: Long-term Safety Studies
Table 6.4 Liprotamase: Competitive Landscape
Table 6.5 Sandimmune: Dosage Details
Table 6.6 Neoral: Patent Portfolio
Table 6.7 Sandimmune and Neoral: List of Generic Drugs
Table 6.8 Sandimmune: Competitive Landscape
Table 6.9 DDAVP: Patent Portfolio
Table 6.10 DDAVP: Tablet and Oral Melts
Table 6.11 DDAVP: Cost of Tablets and Melts
Table 6.12 DDAVP Generic Versions
Table 6.13 DDAVP: Major Markets and Trade Names
Table 6.14 DDAVP: Competitive Landscape
Table 7.1 Axcess Patent Family
Table 7.2 Drugs Under Development Based on Axcess
Table 7.3 Bone Medical: Pipeline Drugs
Table 7.4 Peptelligence: Pipeline of Drugs
Table 7.5 GIPET Platforms
Table 7.6 GIPET: Pipeline of Drugs
Table 7.7 POD Patent Status
Table 7.8 POD: Molecules in Pipeline
Table 7.9 Drugs Based on MMX Technology
Table 7.10 Eligen: Pipeline of Drugs
Table 8.1 List of Partnerships
Table 9.1 List of Funding Rounds / Grants and Investors Involved
Table 10.1 SWOT Analysis
Table 12.1 Molecules Under Development: Distribution by Companies
Table 12.2 Molecules Under Development: Distribution by Type of Molecule
Table 12.3 Molecules Under Development: Distribution by Type of Indication
Table 12.4 Molecules Under Development: Distribution by Phase of Development
Table 12.5 Molecules Under Development: Distribution by Technology
Table 12.6 Overall Market of Emerging Oral Proteins/Peptides (USD Million): Short-Midterm Forecast, 2014-2019 (Conservative Scenario)
Table 12.7 Overall Market of Emerging Oral Proteins/Peptides (USD Million): Short-Midterm Forecast, 2014-2019 (Base Scenario)
Table 12.8 Overall Market of Emerging Oral Proteins/Peptides (USD Million): Short-Midterm Forecast, 2014-2019 (Optimistic Scenario)
Table 12.9 Overall Market of Emerging Oral Proteins/Peptides (USD Million): Long Term Forecast, 2019-2025 (Conservative Scenario)
Table 12.10 Overall Market of Emerging Oral Proteins/Peptides (USD Million): Long Term Forecast, 2019-2025 (Base Scenario)
Table 12.11 Overall Market of Emerging Oral Proteins/Peptides (USD Million): Long Term Forecast, 2019-2025 (Optimistic Scenario)
Table 12.12 Linzess Sales (USD Million): Short-Midterm Forecast, 2014-2019 (Conservative Scenario)
Table 12.13 Linzess Sales (USD Million): Short-Midterm Forecast, 2014-2019 (Base Scenario)
Table 12.14 Linzess Sales (USD Million): Short-Midterm Forecast, 2014-2019 (Optimistic Scenario)
Table 12.15 Linzess Sales (USD Million): Long Term Forecast, 2019-2025 (Conservative Scenario)
Table 12.16 Linzess Sales (USD Million): Long Term Forecast, 2019-2025 (Base Scenario)
Table 12.17 Linzess Sales (USD Million): Long Term Forecast, 2019-2025 (Optimistic Scenario)
Table 12.18 Plecanatide Sales (USD Million): Short-Midterm Forecast, 2014-2019 (Conservative Scenario)
Table 12.19 Plecanatide Sales (USD Million): Short-Midterm Forecast, 2014-2019 (Base Scenario)
Table 12.20 Plecanatide Sales (USD Million): Short-Midterm Forecast, 2014-2019 (Optimistic Scenario)
Table 12.21 Plecanatide Sales (USD Million): Long Term Forecast, 2019-2025 (Conservative Scenario)
Table 12.22 Plecanatide Sales (USD Million): Long Term Forecast, 2019-2025 (Base Scenario)
Table 12.23 Plecanatide Sales (USD Million): Long Term Forecast, 2019-2025 (Optimistic Scenario)
Table 12.24 Octreolin Sales (USD Million): Short-Midterm Forecast, 2014-2019 (Conservative Scenario)
Table 12.25 Octreolin Sales (USD Million): Short-Midterm Forecast, 2014-2019 (Base Scenario)
Table 12.26 Octreolin Sales (USD Million): Short-Midterm Forecast, 2014-2019 (Optimistic Scenario)
Table 12.27 Octreolin Sales (USD Million): Long Term Forecast, 2014-2019 (Conservative Scenario)
Table 12.28 Octreolin Sales (USD Million): Long Term Forecast, 2019-2025 (Base Scenario)
Table 12.29 Octreolin Sales (USD Million): Long Term Forecast, 2019-2025 (Optimistic Scenario)
Table 12.30 Ostora Sales (USD Million): Short-Midterm Forecast, 2014-2019 (Conservative Scenario)
Table 12.31 Ostora Sales (USD Million): Short-Midterm Forecast, 2014-2019 (Base Scenario)
Table 12.32 Ostora Sales (USD Million): Short-Midterm Forecast, 2014-2019 (Optimistic Scenario)
Table 12.33 Ostora Sales (USD Million): Long Term Forecast, 2019-2025 (Conservative Scenario)
Table 12.34 Ostora Sales (USD Million): Long Term Forecast, 2019-2025 (Base Scenario)
Table 12.35 Ostora Sales (USD Million): Long Term Forecast, 2019-2025 (Optimistic Scenario)
Table 12.36 IN-105 Sales (USD Million): Long Term Forecast, 2019-2025 (Conservative Scenario)
Table 12.37 IN-105 Sales (USD Million): Long Term Forecast, 2019-2025 (Base Scenario)
Table 12.38 IN-105 Sales (USD Million): Long Term Forecast, 2019-2025 (Optimistic Scenario)
Table 12.39 Oral Proteins and Peptides: Cumulative Partnerships by Year, 2006-2014
Table 12.40 Oral Proteins and Peptides Partnerships: Distribution by Type of Partnerships
Table 12.41 Oral Proteins and Peptides: Major Stakeholders
Table 12.42 Cumulative Funding Instances by Year, 2005 Onwards
Table 12.43 Funding Instances: Distribution by Type of Funding
Table 12.44 Funding Amount: Distribution by Type of Funding, USD Million
Following companies have been mentioned in the report:
Following Universities / Research Centres have been mentioned in this report:
Following Venture Capital firms have been mentioned in this report:
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