NEW YORK, Nov. 28, 2013 /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#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biopharmaceutical

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 OUTLINESChapter 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 SUMMARY1.1. Scope of the Report1.2. Research Methodology1.3. Chapter Outlines1.4. Key Highlights1.4.1. Oral Protein and Peptide Market Gained Momentum by the Launch of Linzess in 20121.4.2. Diabetes Dominates the Market1.4.3. Around 40% of Molecules are in The Second or Higher Phase of Clinical Development1.4.4. Sandimmune and DDAVP: Two Oral Peptides Available For More Than A Decade1.4.5. GIPET and Axcess are the Most Prominent Technologies

2. INTRODUCTION2.1. Chapter Overview2.2. Comparison Of Protein / Peptide Drugs with Small Molecule Drugs2.3. Route of Administration2.3.1. Injection: intramuscular, intravenous, subcutaneous2.3.2. Transdermal2.3.3. Intranasal2.3.4. Ocular2.3.5. Inhalation2.3.6. Oral2.3.7. Implantation2.4. Development Challenges2.4.1. Instability2.4.2. Complex Purification Process2.4.3. Immunogenicity2.4.4. Side Effects2.5. Oral Proteins and Peptides2.5.1. Synopsis2.5.2. Current Challenges2.5.3. Proposed Solutions

3. OVERVIEW AND MARKET BACKGROUND3.1. Chapter Overview3.2. Oral Protein / Peptides Under Development3.3. Pipeline Analysis3.3.1. Distribution by Companies3.3.2. Distribution by Type of Molecule3.3.3. Distribution by Type of Indication3.3.4. Distribution by Phase of Development3.3.5. Distribution by Technology

4. DRUG PROFILES AND MARKET FORECAST4.1. Introduction4.1.1. Scope and Limitations4.1.2. Assumptions for Market Forecast

4.2. Overall Market

4.3. Linaclotide (Linzess / Constella)4.3.1. Drug Overview4.3.2. Structure and Mechanism of Action4.3.3. From Discovery to Launch4.3.4. Pharmacokinetics4.3.5. Competition4.3.6. Dosage and Cost4.3.7. Patent Portfolio4.3.8. Geographical Presence Through Partnerships4.3.9. Current Status of Development4.3.10. Linzess Sales, 2012 - 20134.3.11. IBS-C and CIC Market4.3.12. Linaclotide (Linzess / Constella) Sales Forecast: Short-Mid Term, 2013-20184.3.13. Linaclotide (Linzess / Constella) Sales Forecast: Long Term, 2018-2024

4.4. IN-1054.4.1. Overview4.4.2. History4.4.3. Structure and Mechanism of Action4.4.4. Characteristics of IN-1054.4.5. Current Status of Development4.4.6. Competition4.4.6.1. Other Non-Injectable Insulin4.4.7. IN-105 Sales Forecast: Short-Mid Term, 2013-20184.4.8. IN-105 Sales Forecast: Long Term, 2018-2024

4.5. Ostora4.5.1. Overview4.5.2. History4.5.3. Structure and Mechanism of Action4.5.4. Current Status of Development4.5.5. Characteristics of Ostora4.5.6. Competition4.5.7. Restriction on the Use of Calcitonin4.5.8. Ostora Sales Forecast: Short-Mid Term, 2013-20184.5.9. Ostora Sales Forecast: Long Term, 2018-2024

4.6. Octreolin4.6.1. Overview4.6.2. Current Treatment Options for Acromegaly4.6.3. Partnership with Roche4.6.4. Structure and Mechanism of Action4.6.5. Current Status of Development4.6.6. Competition4.6.7. Octreolin Sales Forecast: Short-Mid Term, 2013-20184.6.8. Octreolin Sales Forecast: Long Term, 2018-2024

4.7. Plecanatide4.7.1. Overview4.7.2. Structure and Mechanism of Action4.7.3. Patent4.7.4. Current Phase of Development4.7.5. Competition4.7.6. Plecanatide Sales Forecast: Short-Mid Term, 2013-20184.7.7. Plecanatide Sales Forecast: Long Term, 2018-2024

5. CASE STUDIES: LIPROTAMASE, SANDIMMUNE, DDAVP5.1. Liprotamase5.1.1. Overview5.1.2. Structure and Mechanism of Action5.1.3. History5.1.4. Development Stage5.1.5. Competition

5.2. Sandimmune5.2.1. Overview5.2.2. Structure and Mechanism of Action5.2.3. Discovery to Launch5.2.4. Dosage5.2.5. Patents5.2.6. Generics5.2.7. Interactions with Other Drugs5.2.8. Competition5.2.9. Sales

5.3. DDAVP / Minirin (Desmopressin)5.3.1. Overview5.3.2. Structure and Mechanism of Action5.3.3. History5.3.4. Patents5.3.5. Dosage5.3.6. Pharmacokinetics5.3.7. Generics for DDAVP5.3.8. Geographical Presence5.3.9. Competition

6. TECHNOLOGY PLATFORMS6.1. Chapter Overview

6.2. Gastrointestinal Permeation Enhancement Technology, GIPET (Merrion Pharmaceuticals)6.2.1. Overview6.2.2. Patents6.2.3. Acquisition from Elan Biotechnology Research Centre6.2.4. Technology Platform6.2.4.1. Mechanism of Action6.2.5. Advantages of the technology6.2.6. Current Pipeline of Drugs Using GIPET6.2.7. Partner Programmes6.2.7.1. Novo Nordisk6.2.7.2. Other Partners

6.3. Eligen (Emisphere Technologies)6.3.1. Overview6.3.2. In-house Development of Eligen6.3.3. The Technology6.3.3.1. How Eligen Works?6.3.4. Advantages of Technology6.3.5. Molecules in Pipeline6.3.6. Collaborators6.3.6.1. Novo Nordisk6.3.6.2. Novartis6.3.6.3. Genta, Inc.6.3.6.4. Alchemia, Ltd.

6.4. Peptelligence (Enteris Biopharma)6.4.1. Overview6.4.2. Recent Acquisition from Unigene Laboratories, Inc.6.4.3. Patents6.4.4. The Technology6.4.4.1. Tablet Design6.4.4.2. Mechanism of Action6.4.5. Advantages6.4.6. Molecules in Pipeline6.4.7. Partnerships6.4.7.1. Tarsa Therapeutics6.4.7.2. Cara Therapeutics, Inc.6.4.7.3. KeyBioScience6.4.7.4. Other Agreements

6.5. Oral Antibody Platform (Avaxia Biologics)6.5.1. Overview6.5.2. The Technology6.5.3. Advantages6.5.4. Molecules in Pipeline6.5.4.1. AVX-4706.5.4.2. Molecules for Diabetes and Obesity6.5.4.3. Molecules for Gastro Intestinal Acute Radiation Syndrome (GI-ARS)6.5.4.4. Molecules for Celiac Disease6.5.4.5. Molecules for Oral Mucositis6.5.5. Partnerships6.5.5.1. BARDA6.5.5.2. Others

6.6. Axcess (Proxima Concepts)6.6.1. Overview6.6.2. Invention of Axcess6.6.3. Patents6.6.4. Technology6.6.5. Advantages6.6.6. Molecules in Pipeline6.6.7. Partnerships6.6.7.1. Diabetology6.6.7.2. Bone Medical6.6.7.3. Kancer6.6.7.4. Inflexion

6.7. Multi Matrix System (Cosmo Pharmaceuticals)6.7.1. Overview6.7.2. The Technology6.7.3. Patents6.7.4. Mechanism of Action6.7.5. Advantages6.7.6. Product Pipeline6.7.7. Partnerships6.7.7.1. Giuliani S.p.A. and Shire plc.6.7.7.2. Ferring Pharmaceuticals6.7.7.3. Dr. Falk Pharma GmbH6.7.7.4. Santarus, Inc.6.7.7.5. AIMM Therapeutics

6.8. Oramed POD (Protein Oral Delivery) Technology6.8.1. Overview6.8.2. Patents6.8.3. The Technology6.8.3.1. Mechanism of Action6.8.4. Advantages6.8.5. Molecules in Pipeline6.8.6. Collaborations6.8.6.1. Hadasit6.8.6.2. ETI Karle Clinical6.8.6.3. Sanofi Aventis6.8.6.4. Medpace

7. SWOT ANALYSIS7.1. Strengths7.1.1. Improved Patient Compliance7.1.2. Big and Small Pharma Collaboration7.2. Weaknesses7.2.1. Degradation of Peptides in the GI Tract7.2.2. Lower Bioavailability7.3. Opportunities7.3.1. Emergence of Innovative Technologies7.3.2. Rich Pipeline with Drugs in Final Phases7.4. Threats7.4.1. Availability of Self-administered Injections7.4.2. Failure/Discontinuation of Pipeline Drugs

8. CONCLUSION8.1. The Rise of New Technologies8.2. The Preferred Delivery Mode For a Host Of Indications8.3. An Emerging Market Close to the Tipping Point8.4. Challenges Exist, though These can be Surpassed

9. APPENDIX 1: TABLES10. APPENDIX 2: LIST OF COMPANIES

LIST OF FIGURESFigure 2.1 Paracellular Transport of DrugsFigure 2.2 Transcellular Transport of DrugsFigure 3.1 Molecules Under Development: Distribution by CompaniesFigure 3.2 Molecules Under Development: Distribution by Type of MoleculeFigure 3.3 Molecules Under Development: Distribution by Type of IndicationFigure 3.4 Molecules Under Development: Distribution by Phase of DevelopmentFigure 3.5 Molecules Under Development: Distribution by TechnologyFigure 4.1 Overall Market of Emerging Oral Proteins / Peptides (USD MM): Short-Midterm Forecast, 2013 – 2018Figure 4.2 Overall Market of Emerging Oral Proteins / Peptides (USD MM): Long Term Forecast, 2018 – 2024 (USD MM)Figure 4.3 Structure of LinzessFigure 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, 2013-2018Figure 4.7 Linaclotide (Linzess / Constella) Sales Forecast (USD MM): Long Term, 2018-2024Figure 4.8 IN-105 Sales Forecast (USD MM): Short-Mid Term, 2013-2018Figure 4.9 IN-105 Sales Forecast (USD MM): Long Term, 2018-2024Figure 4.10 Structure of Salmon CalcitoninFigure 4.11 Ostora Sales Forecast (USD MM): Short-Mid Term, 2013-2018Figure 4.12 Ostora Sales Forecast (USD MM): Long Term, 2018-2024Figure 4.13 Structure of OctreolinFigure 4.14 Octreolin Sales Forecast (USD MM): Short-Mid Term, 2013-2018Figure 4.15 Octreolin Sales Forecast (USD MM): Long Term, 2018-2024Figure 4.16 Structure of PlecanatideFigure 4.17 Plecanatide Sales Forecast (USD MM): Short-Mid Term, 2013-2018Figure 4.18 Plecanatide Sales Forecast (USD MM): Long Term, 2018-2024Figure 5.1 Sandimmune Worldwide Sales (USD MM), 2002 - 2012Figure 5.2 DDAVP StructureFigure 6.1 Multifunctional Role of Absorption Enhancer in GIPETFigure 6.2 Role of Ingredients and Excipients Used in Peptelligence TechnologyFigure 6.3 MMX Technology PlatformFigure 8.1 Overall Market of Emerging Oral Proteins / Peptides (USD MM)

LIST OF TABLESTable 3.1 Oral Proteins / Peptides Under DevelopmentTable 4.1 Emerging Oral Proteins / Peptides: Expected Launch Year of Phase III moleculesTable 4.2 Marketed Drugs for IBS-C and CICTable 4.3 Linzess: Dosage and CostTable 4.4 Linzess: List of PatentsTable 4.5 Ironwood Partnerships for LinaclotideTable 4.6 Linaclotide: Current State of DevelopmentTable 4.7 IN-105: Status of Clinical TrialsTable 4.8 Oral Insulin: Molecules Under DevelopmentTable 4.9 Ostora: Phase III Clinical TrialsTable 4.10 Ostora: Competitive LandscapeTable 4.11 Octreolin: Current State of DevelopmentTable 4.12 Octreolin: Phase III Clinical TrialTable 4.13 Octreolin: Competitive Landscape (Marketed Drugs)Table 4.14 Octreolin: Competitive Landscape (Pipeline Drugs)Table 4.15 Plecanatide: Patent DetailsTable 4.16 Plecanatide: Current State of DevelopmentTable 4.17 Plecanatide: Phase IIb/III Clinical Trials for CICTable 4.18 Plecanatide: Phase II Clinical Trials for IBS-CTable 4.19 Plecanatide vs. LinaclotideTable 4.20 Plecanatide: Competitive LandscapeTable 5.1 Liprotamase: Mechanism of ActionTable 5.2 Liprotamase: Clinical StudiesTable 5.3 Liprotamase: Phase III Short-term Efficacy StudyTable 5.4 Liprotamase: Long-term Safety StudiesTable 5.5 Liprotamase: Competitive LandscapeTable 5.6 Sandimmune: Dosage DetailsTable 5.7 Neoral: Patent PortfolioTable 5.8 Sandimmune and Neoral: List of Generic DrugsTable 5.9 Sandimmune: Competitive LandscapeTable 5.10 DDAVP: Patent PortfolioTable 5.11 DDAVP: Tablet and Oral MeltsTable 5.12 DDAVP: Cost of Tablets and MeltsTable 5.13 DDAVP Generic VersionsTable 5.14 DDAVP: Major Markets and Trade NamesTable 5.15 DDAVP: Competitive LandscapeTable 6.1 GIPET PlatformsTable 6.2 GIPET: Pipeline of DrugsTable 6.3 Eligen: Pipeline of DrugsTable 6.4 Peptelligence: Pipeline of DrugsTable 6.5 Axcess Patent Family,Table 6.6 Drugs Under Development Based on AxcessTable 6.7 Drugs Based on MMX TechnologyTable 6.8 POD Patent StatusTable 6.9 POD: Molecules in PipelineTable 7.1 SWOT AnalysisTable 9.1 Overall Market of Emerging Oral Proteins / Peptides, Short-Midterm Forecast: 2013 - 2018Table 9.2 Overall Market of Emerging Oral Proteins / Peptides, Long Term Forecast: 2018 - 2024Table 9.3 Linaclotide (Linzess / Constella) Sales Forecast (USD MM): Short-Mid Term, 2013-2018Table 9.4 Linaclotide (Linzess / Constella) Sales Forecast (USD MM): Long Term, 2018-2024Table 9.5 IN-105 Sales Forecast (USD MM): Short-Mid Term, 2013-2018Table 9.6 IN-105 Sales Forecast (USD MM): Long Term, 2018-2024Table 9.7 Ostora Sales Forecast (USD MM): Short-Mid Term, 2013-2018Table 9.8 Ostora Sales Forecast (USD MM): Long Term, 2018-2024Table 9.9 Octreolin Sales Forecast (USD MM): Short-Mid Term, 2013-2018Table 9.10 Octreolin Sales Forecast (USD MM): Long Term, 2018-2024Table 9.11 Plecanatide Sales Forecast (USD MM): Short-Mid Term, 2013-2018Table 9.12 Plecanatide Sales Forecast (USD MM): Long Term, 2018-2024

The following companies have been mentioned in the report:1. Abbott Laboratories2. AbbVie3. Access Pharma4. Affilogic5. AIMM Therapeutics6. Alchemia7. Almirall S.A.8. Alnara Pharmaceuticals9. Altus Pharmaceuticals10. Amarillo Biosciences11. Antisense Therapeutics12. Apollo Life Sciences13. Apotex14. Aptalis Pharma15. Astellas Pharma16. AstraZeneca17. Avaxia Biologics18. Barr Pharmaceuticals19. Biocon20. Biodel21. Bone Medical22. Bristol-Myers Squibb23. Cara Therapeutics24. Chiasma25. Cosmo Pharmaceuticals26. Diabetology27. Diasome Pharma28. Digestive Care29. Dr. Falk Pharma GmBH30. Eli Lilly31. Emisphere32. Enteris Biopharma33. Ferring Pharmaceuticals34. Forest Laboratories35. Generex Biotechnology36. Genta37. Giuliani38. GSK39. Hemispherx Biosciences40. Hepasome41. Heptares Therapeutics42. Igy, Inc.43. Inflexion44. Ipsen45. Ironwood Pharmaceuticals46. Ivax47. Janssen Pharmaceuticals48. Johnson & Johnson49. Kancer50. KeyBioScience51. Mankind Corporation52. Merck53. Merrion Pharmaceuticals54. NanoMega Medical55. NasVax56. Nektar Therapeutics57. Nobex Corporation58. Nod Pharma59. Novartis60. Novex61. Novo Nordisk62. Oramed63. Pfizer64. Pliva65. Protagonist Therapeutics66. Proxima Concepts67. QS Pharma68. Rani Therapeutics69. Rebel Pharmaceuticals70. Roche71. Sandoz72. Sanofi Aventis73. Santarus74. Schering-Plough75. Shire 76. Shreya Life Sciences77. Stealth Peptides78. Synergy Pharma79. Syntaxin80. Synthetic Biologics81. Takeda82. Tamarisk Technologies83. Tarix Pharma84. Tarsa Therapeutics85. Teva Pharmaceuticals86. TNT Pharma87. Transgene Biotek Limited88. Unigene89. Upsher-Smith Laboratories90. Ventria Bioscience91. Watson Laboratories92. Zydus Cadila

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