Oral Proteins and Peptides Market, 2014-2024

NEW YORK, June 4, 2014 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Oral Proteins and Peptides Market, 2014-2024

http://www.reportlinker.com/p01902118/Oral-Proteins-and-Peptides-Market-2014-2024.html

INTRODUCTION

Owing to their complexity and instability, protein and peptide based drugs are mostly delivered by intravenous or subcutaneous routes. Based upon recent developments in R&D processes, scientists have made some progress in other routes of delivery such as transdermal, intranasal, inhalation and oral administration.

Amongst the various modes of administration, oral delivery is the most 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.>Many large and small pharmaceutical companies have led the efforts to develop oral protein / peptides. However, there have been several setbacks. The emergence of more innovative technologies will be the key to achieving success in this field. There are a number of companies doing in-house research for developing new technologies to overcome the existing challenges. Several emerging proteins / peptides are 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.

EXAMPLE HIGHLIGHTS

1. Insulin stands out amongst the various oral proteins and peptides that are being developed. In fact, diabetes accounts for around 39% of all molecules currently in clinical development. Gastric disorders and bone diseases are the two other notable indications which have garnered increased attention.
2. Around 40% of molecules under development are in the second or higher phase of clinical development. Amongst these, five molecules are in late stage clinical trials.
3. New technologies, addressing the challenges posed by oral delivery of peptides, have emerged in the recent past. Some of the prominent technologies include Axcess, GIPET, Peptelligence and Eligen.
4. The overall market for oral delivery of proteins and peptides is huge and likely to tap a significant share of the overall peptide therapeutics multi-billion dollar market.

SCOPE OF THE REPORT

The "Oral Proteins and Peptides Market, 2014-2024" 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 the 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 the oral proteins and peptide drugs market. This is done by analyzing the following:
§ Drugs currently available in the market and those under development
§ Emerging technologies and key developments supporting the development of improved oral peptide delivery
§ Development and likely sales potential of key marketed and pipeline oral proteins and peptides

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. The analysis includes proteins such as antibodies and recombinant proteins including insulin, hormones, interferon etc. The scope of the report doesn't include enzymes. However, we have presented a special analysis on Liprotamase (from Eli Lilly). Liprotamase is a pancreatic enzyme replacement therapy product, which has reached the regulatory review stage. The enzyme has been included as it differs from competing marketed drugs for being non-porcine derived and lacking an enteric coating.

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.

RESEARCH METHODOLOGY

Most of the data presented in this report has been gathered by secondary research. We have also conducted interviews with experts in the area (academia, industry, medical practice and other associations) 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 shape up across different regions and drug 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
§ Other analysts' opinion reports

While the focus has been on forecasting the market over the coming ten years, 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.

CHAPTER OUTLINES
Chapter 2 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 3 provides an overview of the oral protein and peptide market with respect to marketed and pipeline drugs, and companies active in the field. The analysis of the market is also extended to the indications, current phase of development, and the available technologies.

Chapter 4 explores various drug candidates in late stage clinical development. We have presented the market data for base year 2012 (where available) and our forecasts for the period 2013 - 2024. While preparing the forecasts, several factors were taken into consideration, such as, status of development, competition, expected approval and likely adoption rates.

Chapter 5 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 6 reviews, in detail, the major technologies available for oral protein and peptide delivery. We present profiles of seven leading technologies with information about their origin, mechanism, molecules using the technology, and companies involved.

Chapter 7 provides our analysis of the strengths, weaknesses, opportunities and threats in the market, capturing the key elements likely to influence future growth.

Chapter 8 summarizes 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 9 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 10 is an appendix, which provides list of companies mentioned in the report.

Table of Contents

1. EXECUTIVE SUMMARY
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
1.4. Key Highlights
1.4.1. Oral Protein and Peptide Market Gained Momentum by the Launch of Linzess in 2012
1.4.2. Diabetes Dominates the Market
1.4.3. Around 40% of Molecules are in The Second or Higher Phase of Clinical Development
1.4.4. Sandimmune and DDAVP: Two Oral Peptides Available For More Than A Decade
1.4.5. GIPET and Axcess are the Most Prominent Technologies

2. INTRODUCTION
2.1. Chapter Overview
2.2. Comparison Of Protein / Peptide Drugs with Small Molecule Drugs
2.3. Route of Administration
2.3.1. Injection: intramuscular, intravenous, subcutaneous
2.3.2. Transdermal
2.3.3. Intranasal
2.3.4. Ocular
2.3.5. Inhalation
2.3.6. Oral
2.3.7. Implantation
2.4. Development Challenges
2.4.1. Instability
2.4.2. Complex Purification Process
2.4.3. Immunogenicity
2.4.4. Side Effects
2.5. Oral Proteins and Peptides
2.5.1. Synopsis
2.5.2. Current Challenges
2.5.3. Proposed Solutions

3. OVERVIEW AND MARKET BACKGROUND
3.1. Chapter Overview
3.2. Oral Protein / Peptides Under Development
3.3. Pipeline Analysis
3.3.1. Distribution by Companies
3.3.2. Distribution by Type of Molecule
3.3.3. Distribution by Type of Indication
3.3.4. Distribution by Phase of Development
3.3.5. Distribution by Technology

4. DRUG PROFILES AND MARKET FORECAST
4.1. Introduction
4.1.1. Scope and Limitations
4.1.2. Assumptions for Market Forecast

4.2. Overall Market

4.3. Linaclotide (Linzess / Constella)
4.3.1. Drug Overview
4.3.2. Structure and Mechanism of Action
4.3.3. From Discovery to Launch
4.3.4. Pharmacokinetics
4.3.5. Competition
4.3.6. Dosage and Cost
4.3.7. Patent Portfolio
4.3.8. Geographical Presence Through Partnerships
4.3.9. Current Status of Development
4.3.10. Linzess Sales, 2012 - 2013
4.3.11. IBS-C and CIC Market
4.3.12. Linaclotide (Linzess / Constella) Sales Forecast: Short-Mid Term, 2013-2018
4.3.13. Linaclotide (Linzess / Constella) Sales Forecast: Long Term, 2018-2024

4.4. IN-105
4.4.1. Overview
4.4.2. History
4.4.3. Structure and Mechanism of Action
4.4.4. Characteristics of IN-105
4.4.5. Current Status of Development
4.4.6. Competition
4.4.6.1. Other Non-Injectable Insulin
4.4.7. IN-105 Sales Forecast: Short-Mid Term, 2013-2018
4.4.8. IN-105 Sales Forecast: Long Term, 2018-2024

4.5. Ostora
4.5.1. Overview
4.5.2. History
4.5.3. Structure and Mechanism of Action
4.5.4. Current Status of Development
4.5.5. Characteristics of Ostora
4.5.6. Competition
4.5.7. Restriction on the Use of Calcitonin
4.5.8. Ostora Sales Forecast: Short-Mid Term, 2013-2018
4.5.9. Ostora Sales Forecast: Long Term, 2018-2024

4.6. Octreolin
4.6.1. Overview
4.6.2. Current Treatment Options for Acromegaly
4.6.3. Partnership with Roche
4.6.4. Structure and Mechanism of Action
4.6.5. Current Status of Development
4.6.6. Competition
4.6.7. Octreolin Sales Forecast: Short-Mid Term, 2013-2018
4.6.8. Octreolin Sales Forecast: Long Term, 2018-2024

4.7. Plecanatide
4.7.1. Overview
4.7.2. Structure and Mechanism of Action
4.7.3. Patent
4.7.4. Current Phase of Development
4.7.5. Competition
4.7.6. Plecanatide Sales Forecast: Short-Mid Term, 2013-2018
4.7.7. Plecanatide Sales Forecast: Long Term, 2018-2024

5. CASE STUDIES: LIPROTAMASE, SANDIMMUNE, DDAVP
5.1. Liprotamase
5.1.1. Overview
5.1.2. Structure and Mechanism of Action
5.1.3. History
5.1.4. Development Stage
5.1.5. Competition

5.2. Sandimmune
5.2.1. Overview
5.2.2. Structure and Mechanism of Action
5.2.3. Discovery to Launch
5.2.4. Dosage
5.2.5. Patents
5.2.6. Generics
5.2.7. Interactions with Other Drugs
5.2.8. Competition
5.2.9. Sales

5.3. DDAVP / Minirin (Desmopressin)
5.3.1. Overview
5.3.2. Structure and Mechanism of Action
5.3.3. History
5.3.4. Patents
5.3.5. Dosage
5.3.6. Pharmacokinetics
5.3.7. Generics for DDAVP
5.3.8. Geographical Presence
5.3.9. Competition

6. TECHNOLOGY PLATFORMS
6.1. Chapter Overview

6.2. Gastrointestinal Permeation Enhancement Technology, GIPET (Merrion Pharmaceuticals)
6.2.1. Overview
6.2.2. Patents
6.2.3. Acquisition from Elan Biotechnology Research Centre
6.2.4. Technology Platform
6.2.4.1. Mechanism of Action
6.2.5. Advantages of the technology
6.2.6. Current Pipeline of Drugs Using GIPET
6.2.7. Partner Programmes
6.2.7.1. Novo Nordisk
6.2.7.2. Other Partners

6.3. Eligen (Emisphere Technologies)
6.3.1. Overview
6.3.2. In-house Development of Eligen
6.3.3. The Technology
6.3.3.1. How Eligen Works?
6.3.4. Advantages of Technology
6.3.5. Molecules in Pipeline
6.3.6. Collaborators
6.3.6.1. Novo Nordisk
6.3.6.2. Novartis
6.3.6.3. Genta, Inc.
6.3.6.4. Alchemia, Ltd.

6.4. Peptelligence (Enteris Biopharma)
6.4.1. Overview
6.4.2. Recent Acquisition from Unigene Laboratories, Inc.
6.4.3. Patents
6.4.4. The Technology
6.4.4.1. Tablet Design
6.4.4.2. Mechanism of Action
6.4.5. Advantages
6.4.6. Molecules in Pipeline
6.4.7. Partnerships
6.4.7.1. Tarsa Therapeutics
6.4.7.2. Cara Therapeutics, Inc.
6.4.7.3. KeyBioScience
6.4.7.4. Other Agreements

6.5. Oral Antibody Platform (Avaxia Biologics)
6.5.1. Overview
6.5.2. The Technology
6.5.3. Advantages
6.5.4. Molecules in Pipeline
6.5.4.1. AVX-470
6.5.4.2. Molecules for Diabetes and Obesity
6.5.4.3. Molecules for Gastro Intestinal Acute Radiation Syndrome (GI-ARS)
6.5.4.4. Molecules for Celiac Disease
6.5.4.5. Molecules for Oral Mucositis
6.5.5. Partnerships
6.5.5.1. BARDA
6.5.5.2. Others

6.6. Axcess (Proxima Concepts)
6.6.1. Overview
6.6.2. Invention of Axcess
6.6.3. Patents
6.6.4. Technology
6.6.5. Advantages
6.6.6. Molecules in Pipeline
6.6.7. Partnerships
6.6.7.1. Diabetology
6.6.7.2. Bone Medical
6.6.7.3. Kancer
6.6.7.4. Inflexion

6.7. Multi Matrix System (Cosmo Pharmaceuticals)
6.7.1. Overview
6.7.2. The Technology
6.7.3. Patents
6.7.4. Mechanism of Action
6.7.5. Advantages
6.7.6. Product Pipeline
6.7.7. Partnerships
6.7.7.1. Giuliani S.p.A. and Shire plc.
6.7.7.2. Ferring Pharmaceuticals
6.7.7.3. Dr. Falk Pharma GmbH
6.7.7.4. Santarus, Inc.
6.7.7.5. AIMM Therapeutics

6.8. Oramed POD (Protein Oral Delivery) Technology
6.8.1. Overview
6.8.2. Patents
6.8.3. The Technology
6.8.3.1. Mechanism of Action
6.8.4. Advantages
6.8.5. Molecules in Pipeline
6.8.6. Collaborations
6.8.6.1. Hadasit
6.8.6.2. ETI Karle Clinical
6.8.6.3. Sanofi Aventis
6.8.6.4. Medpace

7. SWOT ANALYSIS
7.1. Strengths
7.1.1. Improved Patient Compliance
7.1.2. Big and Small Pharma Collaboration
7.2. Weaknesses
7.2.1. Degradation of Peptides in the GI Tract
7.2.2. Lower Bioavailability
7.3. Opportunities
7.3.1. Emergence of Innovative Technologies
7.3.2. Rich Pipeline with Drugs in Final Phases
7.4. Threats
7.4.1. Availability of Self-administered Injections
7.4.2. Failure/Discontinuation of Pipeline Drugs

8. CONCLUSION
8.1. The Rise of New Technologies
8.2. The Preferred Delivery Mode For a Host Of Indications
8.3. An Emerging Market Close to the Tipping Point
8.4. Challenges Exist, though These can be Surpassed

9. APPENDIX 1: TABLES
10. APPENDIX 2: LIST OF COMPANIES


LIST OF FIGURES
Figure 2.1 Paracellular Transport of Drugs
Figure 2.2 Transcellular Transport of Drugs
Figure 3.1 Molecules Under Development: Distribution by Companies
Figure 3.2 Molecules Under Development: Distribution by Type of Molecule
Figure 3.3 Molecules Under Development: Distribution by Type of Indication
Figure 3.4 Molecules Under Development: Distribution by Phase of Development
Figure 3.5 Molecules Under Development: Distribution by Technology
Figure 4.1 Overall Market of Emerging Oral Proteins / Peptides (USD MM): Short-Midterm Forecast, 2013 – 2018
Figure 4.2 Overall Market of Emerging Oral Proteins / Peptides (USD MM): Long Term Forecast, 2018 – 2024 (USD MM)
Figure 4.3 Structure of Linzess
Figure 4.4 Linzess Quarterly US Sales, 2012 - 2013 (USD MM)
Figure 4.5 US Market for IBS-C and CIC, by Drug Class, 2012 (USD BN)
Figure 4.6 Linaclotide (Linzess / Constella) Sales Forecast (USD MM): Short-Mid Term, 2013-2018
Figure 4.7 Linaclotide (Linzess / Constella) Sales Forecast (USD MM): Long Term, 2018-2024
Figure 4.8 IN-105 Sales Forecast (USD MM): Short-Mid Term, 2013-2018
Figure 4.9 IN-105 Sales Forecast (USD MM): Long Term, 2018-2024
Figure 4.10 Structure of Salmon Calcitonin
Figure 4.11 Ostora Sales Forecast (USD MM): Short-Mid Term, 2013-2018
Figure 4.12 Ostora Sales Forecast (USD MM): Long Term, 2018-2024
Figure 4.13 Structure of Octreolin
Figure 4.14 Octreolin Sales Forecast (USD MM): Short-Mid Term, 2013-2018
Figure 4.15 Octreolin Sales Forecast (USD MM): Long Term, 2018-2024
Figure 4.16 Structure of Plecanatide
Figure 4.17 Plecanatide Sales Forecast (USD MM): Short-Mid Term, 2013-2018
Figure 4.18 Plecanatide Sales Forecast (USD MM): Long Term, 2018-2024
Figure 5.1 Sandimmune Worldwide Sales (USD MM), 2002 - 2012
Figure 5.2 DDAVP Structure
Figure 6.1 Multifunctional Role of Absorption Enhancer in GIPET
Figure 6.2 Role of Ingredients and Excipients Used in Peptelligence Technology
Figure 6.3 MMX Technology Platform
Figure 8.1 Overall Market of Emerging Oral Proteins / Peptides (USD MM)

LIST OF TABLES
Table 3.1 Oral Proteins / Peptides Under Development
Table 4.1 Emerging Oral Proteins / Peptides: Expected Launch Year of Phase III molecules
Table 4.2 Marketed Drugs for IBS-C and CIC
Table 4.3 Linzess: Dosage and Cost
Table 4.4 Linzess: List of Patents
Table 4.5 Ironwood Partnerships for Linaclotide
Table 4.6 Linaclotide: Current State of Development
Table 4.7 IN-105: Status of Clinical Trials
Table 4.8 Oral Insulin: Molecules Under Development
Table 4.9 Ostora: Phase III Clinical Trials
Table 4.10 Ostora: Competitive Landscape
Table 4.11 Octreolin: Current State of Development
Table 4.12 Octreolin: Phase III Clinical Trial
Table 4.13 Octreolin: Competitive Landscape (Marketed Drugs)
Table 4.14 Octreolin: Competitive Landscape (Pipeline Drugs)
Table 4.15 Plecanatide: Patent Details
Table 4.16 Plecanatide: Current State of Development
Table 4.17 Plecanatide: Phase IIb/III Clinical Trials for CIC
Table 4.18 Plecanatide: Phase II Clinical Trials for IBS-C

Table 4.19 Plecanatide vs. Linaclotide
Table 4.20 Plecanatide: Competitive Landscape
Table 5.1 Liprotamase: Mechanism of Action
Table 5.2 Liprotamase: Clinical Studies
Table 5.3 Liprotamase: Phase III Short-term Efficacy Study
Table 5.4 Liprotamase: Long-term Safety Studies
Table 5.5 Liprotamase: Competitive Landscape
Table 5.6 Sandimmune: Dosage Details
Table 5.7 Neoral: Patent Portfolio
Table 5.8 Sandimmune and Neoral: List of Generic Drugs
Table 5.9 Sandimmune: Competitive Landscape
Table 5.10 DDAVP: Patent Portfolio
Table 5.11 DDAVP: Tablet and Oral Melts
Table 5.12 DDAVP: Cost of Tablets and Melts
Table 5.13 DDAVP Generic Versions
Table 5.14 DDAVP: Major Markets and Trade Names
Table 5.15 DDAVP: Competitive Landscape
Table 6.1 GIPET Platforms
Table 6.2 GIPET: Pipeline of Drugs
Table 6.3 Eligen: Pipeline of Drugs
Table 6.4 Peptelligence: Pipeline of Drugs
Table 6.5 Axcess Patent Family,
Table 6.6 Drugs Under Development Based on Axcess
Table 6.7 Drugs Based on MMX Technology
Table 6.8 POD Patent Status
Table 6.9 POD: Molecules in Pipeline
Table 7.1 SWOT Analysis
Table 9.1 Overall Market of Emerging Oral Proteins / Peptides, Short-Midterm Forecast: 2013 - 2018
Table 9.2 Overall Market of Emerging Oral Proteins / Peptides, Long Term Forecast: 2018 - 2024
Table 9.3 Linaclotide (Linzess / Constella) Sales Forecast (USD MM): Short-Mid Term, 2013-2018
Table 9.4 Linaclotide (Linzess / Constella) Sales Forecast (USD MM): Long Term, 2018-2024
Table 9.5 IN-105 Sales Forecast (USD MM): Short-Mid Term, 2013-2018
Table 9.6 IN-105 Sales Forecast (USD MM): Long Term, 2018-2024
Table 9.7 Ostora Sales Forecast (USD MM): Short-Mid Term, 2013-2018
Table 9.8 Ostora Sales Forecast (USD MM): Long Term, 2018-2024
Table 9.9 Octreolin Sales Forecast (USD MM): Short-Mid Term, 2013-2018
Table 9.10 Octreolin Sales Forecast (USD MM): Long Term, 2018-2024
Table 9.11 Plecanatide Sales Forecast (USD MM): Short-Mid Term, 2013-2018
Table 9.12 Plecanatide Sales Forecast (USD MM): Long Term, 2018-2024

The following companies have been mentioned in the report:
1. Abbott Laboratories
2. AbbVie
3. Access Pharma
4. Affilogic
5. AIMM Therapeutics
6. Alchemia
7. Almirall S.A.
8. Alnara Pharmaceuticals
9. Altus Pharmaceuticals
10. Amarillo Biosciences
11. Antisense Therapeutics
12. Apollo Life Sciences
13. Apotex
14. Aptalis Pharma

15. Astellas Pharma
16. AstraZeneca
17. Avaxia Biologics
18. Barr Pharmaceuticals
19. Biocon
20. Biodel
21. Bone Medical
22. Bristol-Myers Squibb
23. Cara Therapeutics
24. Chiasma
25. Cosmo Pharmaceuticals
26. Diabetology
27. Diasome Pharma
28. Digestive Care
29. Dr. Falk Pharma GmBH
30. Eli Lilly
31. Emisphere
32. Enteris Biopharma
33. Ferring Pharmaceuticals
34. Forest Laboratories
35. Generex Biotechnology
36. Genta
37. Giuliani
38. GSK
39. Hemispherx Biosciences
40. Hepasome
41. Heptares Therapeutics
42. Igy, Inc.
43. Inflexion
44. Ipsen
45. Ironwood Pharmaceuticals

46. Ivax
47. Janssen Pharmaceuticals
48. Johnson & Johnson
49. Kancer
50. KeyBioScience
51. Mankind Corporation
52. Merck
53. Merrion Pharmaceuticals
54. NanoMega Medical
55. NasVax
56. Nektar Therapeutics
57. Nobex Corporation
58. Nod Pharma
59. Novartis
60. Novex
61. Novo Nordisk
62. Oramed
63. Pfizer
64. Pliva
65. Protagonist Therapeutics
66. Proxima Concepts
67. QS Pharma
68. Rani Therapeutics
69. Rebel Pharmaceuticals
70. Roche
71. Sandoz
72. Sanofi Aventis
73. Santarus

74. Schering-Plough
75. Shire
76. Shreya Life Sciences
77. Stealth Peptides
78. Synergy Pharma
79. Syntaxin
80. Synthetic Biologics
81. Takeda
82. Tamarisk Technologies
83. Tarix Pharma
84. Tarsa Therapeutics
85. Teva Pharmaceuticals
86. TNT Pharma
87. Transgene Biotek Limited
88. Unigene
89. Upsher-Smith Laboratories
90. Ventria Bioscience
91. Watson Laboratories
92. Zydus Cadila



To order this report: Oral Proteins and Peptides Market, 2014-2024
http://www.reportlinker.com/p01902118/Oral-Proteins-and-Peptides-Market-2014-2024.html

__________________________
Contact Clare: [email protected]
US: (339)-368-6001
Intl: +1 339-368-6001

SOURCE Reportlinker