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Oral Proteins and Peptides Market (2nd Edition), 2015-2025

  • January 2015
  • 175 pages
  • Roots Analysis Private Ltd.
Report ID: 1902118


Table of Contents

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.

The “Oral Proteins and Peptides Market, 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 oforal proteins and peptide drugs market. This was 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. 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.

1. The market is characterized by the presence of 76 molecules in different phases of development.Four molecules are in the late stage clinical trials (phase III); of these, Oral Octreolin, Ostora and Plecanatide are likely to be made commercially available in 2016.
2. Diabetes stands out among the indication groups for which various molecules are in investigational studies. Nearly 37% of the total molecules under research are being developed for diabetic disorders. Other prominent areas include gastric disorders andbone diseases.
3. The market is not dominated by the presence of a big company or a group of companies. Several start-ups have led research efforts by developing the technologies that facilitate oral formulation of proteins and peptides.
4. Prominent technologies include Axcess, GIPET, Peptelligence and Disulfide Rich Peptides; a number of oral proteins and peptides are based on one of these technologies.
5. One of the primary drivers for growth in the industry is the rising venture capital interest and available funding from other avenues. In total, over the last 10 years, we identified total investment of close to USD 0.9 billion.
6. The current crop of oral proteins and peptides is likely to benefit from early success of Linzess; combined, we expect it to be a multi-billion dollar market growing at an annualised rate of 30% over the coming decade.

Most of the data presented in this report has been gathered by secondary research. For specific studies, we also conduct 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
- Industry analysts’ views

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 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.

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