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Peptide Therapeutics in Metabolic Disorders, 2016 - 2025

  • February 2016
  • 436 pages
  • Roots Analysis Private Ltd.
Report ID: 3677259

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INTRODUCTION
Peptide therapeutics, due to their numerous advantages such as high selectivity, stability, efficacy, safety, bioavailability and tolerability offer a number of benefits over other therapeutic classes. In addition, peptides (when compared to proteins) are much smaller in size and can be easily synthesized, optimized and evaluated as viable therapeutic solutions for a number of diseases. These highly favourable and intrinsic characteristics of peptides have caused an evident shift in the interest of pharmaceutical / life science companies towards developing peptide based drugs during the last decade. The number of marketing approvals granted to such molecules has increased recently. Researchers have continued to develop novel strategies to synthesize customized peptides to elicit desired biological responses.

Metabolic disorders have gained significant attention for the development of peptide based therapies. Some of the marketed drugs in this space, including BYETTA®/ BYDUREON® and Victoza®, have already emerged as blockbusters with over USD 1 billion annual sales. It is worth highlighting that the evolution of peptides into potent therapeutic solutions has been facilitated by a variety of novel technologies that have been developed by drug / technology developers. Technologies designed to enhance the stability, increase the bioavailability and facilitate the effective delivery of peptides have acted as key enablers to the market’s growth. Specifically, technologies that offer alternative routes of administration (oral / intranasal / transdermal) and sustained drug delivery over a longer time duration are expected to significantly improve patient compliance. In fact, companies have actively entered into collaboration with other stakeholders to either acquire or develop peptide therapies. There have also been a growing number of partnerships related to technology licensing.

SCOPE OF THE REPORT
The “Peptide Therapeutics in Metabolic Disorders, 2016-2025” report provides a comprehensive analysis of the current market landscape and future outlook of peptide therapeutics targeting metabolic disorders. Novartis’ Miacalcin, a calcitonin analogue, was the first peptide therapeutic approved for the treatment of post-menopausal osteoporosis in 1986. Following Miacalcin, several more peptide based therapies targeting various metabolic diseases have been approved so far. The overall pipeline is rich and continues to grow at a healthy pace. These therapies hold the potential to capture a significant share of the pharmaceutical market in the foreseen future.

A majority of peptide therapeutics that we identified during our research are being developed for the treatment of diabetes, obesity, osteoporosis and acromegaly. In addition, there are several peptide therapeutics targeting other metabolic disorders such as Cushing’s disease, hypoglycemia, cystic fibrosis and achondroplasia.

One of the key objectives of the study is to review and quantify the opportunities laid by the development programs of both small and big pharma firms. Amongst other elements, the report elaborates on the following key areas:
- The current state of the market with respect to key players, developmental stage of pipeline products (both clinical / pre-clinical), route of administration and metabolic indications being targeted.
- The innovative technology platforms and delivery systems being offered to eliminate the challenges associated with the administration of peptide therapeutics.
- Partnerships that have taken place in the recent past covering research and development collaborations, manufacturing agreements, license agreements specific to technology platforms or product, co-development and co-commercialization of promising candidates.
- Recently approved and mid / late stage peptide therapeutics in terms of their history of development, available formulations, associated patents, key clinical trials and results.
- The epidemiology and patient population for each key metabolic indication.

The report provides sales forecast for the overall peptide therapeutics market targeting metabolic disorders for the period 2016 - 2025. We have provided three market forecast scenarios to add robustness to our model. Accordingly, the conservative, base and optimistic scenarios represent three different tracks of industry evolution. For the purposes of the study, we interviewed important stakeholders to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth. All actual figures have been sourced and analyzed from publicly available information.

RESEARCH METHODOLOGY
Most of the data presented in this report has been gathered via secondary and primary research. For all our projects, we 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 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 over the coming ten years, the report also provides our independent view on various 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.

1.1. CHAPTER OUTLINES
Chapter 2 presents an executive summary of the report. It offers a high level view on the current scenario of the peptide therapeutics market for metabolic disorders and where it is headed in the mid-long term.

Chapter 3 provides a general introduction to peptide therapeutics. In this section, we have discussed the structure, chemistry and other fundamental aspects of peptides. In addition, we have also discussed the methods of synthesis, purification strategies and stabilization methods for peptides, along with relevant advantages and disadvantages.

Chapter 4 provides a general introduction to metabolic disorders. It includes a comprehensive classification of the various types of metabolic disorders and detailed description of the most common metabolic disorders, along with their respective causes and symptoms.

Chapter 5 provides a comprehensive overview on the landscape of peptide therapeutics for metabolic disorders. It includes information on over 80 different peptide therapeutics that are currently in various stages of development (both clinical and preclinical / discovery). It also contains a detailed analysis of the development pipeline highlighting the different types of peptides and peptide analogues used, their targeted metabolic indications, the current phase of development of each molecule, various routes of administration and the dosage frequency of drugs. In addition, we have presented a detailed ten year forecast, based on primary and secondary research, for the overall market of peptide therapeutics in metabolic disorders.

Chapter 6 focuses on peptide therapeutics that have been / are being developed to specifically target diabetes. It presents an overview of the current market scenario and provides our likely future growth outlook. It includes detailed drug profiles of marketed drugs and drugs in late stages of development. The profiles cover information on several aspects of these therapeutics such as their history of development, clinical trial results, manufacturing, product costs and related collaborations.

Chapter 7 focuses on peptide therapeutics that have been / are being developed to specifically target acromegaly. It presents an overview of the current market scenario and provides our likely future growth outlook. Similar to the previous chapter, this chapter also includes detailed drug profiles of marketed drugs and drugs in late stage of development covering information on several aspects such as their history of development, clinical trial results, manufacturing, product costs and related collaborations.

Chapter 8 focuses on peptide therapeutics that have been / are being developed to specifically target obesity. It presents an overview of the current market scenario and provides our likely future growth outlook. Similar to the earlier chapters, this chapter also includes detailed drug profiles of marketed drugs and drugs in late stage of development covering information on several aspects such as their history of development, clinical trial results, manufacturing, product costs and related collaborations.

Chapter 9 focuses on peptide therapeutics that have been / are being developed to specifically target osteoporosis. It presents an overview of the current market scenario and provides our likely future growth outlook. Similar to the earlier chapters, this chapter also includes detailed drug profiles of marketed drugs and drugs in late stage of development covering information on several aspects such as their history of development, clinical trial results, manufacturing, product costs and related collaborations.

Chapter 10 focuses on peptide therapeutics that have been / are being developed for metabolic disorders other than diabetes, obesity, osteoporosis and acromegaly. Similar to the earlier chapters, this chapter also includes detailed drug profiles of marketed drugs and drugs in late stage of development covering information on several aspects such as their history of development, clinical trial results, manufacturing, product costs and related collaborations.

Chapter 11 highlights the various technologies that are currently being utilized for the development of peptide therapeutics. It includes detailed profiles of the relatively more popular technologies covering their key features and advantages.
Chapter 12 is a collection of interview transcripts of the discussions that we held with key stakeholders in this market. These include Andrew Mallon (CEO, Calista Therapeutics), Andrew Parker (CEO, ArisGen), John Dodd (VP Discovery and Research, Palatin Technologies) and Dennis Goldberg (President, LipimetiX Development).

Chapter 13 summarizes the overall report. In this chapter, we provide a recap of the key takeaways and also present our independent opinion based on the research and analysis described in the previous chapters.

Chapter 14 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 15 is an appendix, which provides the list of companies and organizations that have been mentioned in the report.

EXAMPLE HIGHLIGHTS
1. During our research, we identified over 20 approved formulations of peptide therapeutics for various metabolic disorders. The pipeline is rich with several molecules in clinical / preclinical / discovery stage. In our research, we came across ~90 peptide based drugs that are currently under development; a significant proportion (~50%) is in early stages of development.
2. GLP-1 analogues, with 35% share, are the most common. This is followed by somatostatin analogues (14%), PTH analogues (7%), glucagon analogues (5%) and calcitonin analogues (4%). Companies are also developing novel peptide analogues such as Apolipoprotein E mimetic peptide analogues, angiotensin (1-7) analogues, unacylated ghrelin analogues, C-type natriuretic peptide analogues, oxyntomodulin analogues¸ Human proIslet peptide analogues, Glucose-Dependent Insulinotropic peptide analogues, melanocortin receptor analogues and vasoactive intestinal peptide analogues.
3. Diabetes, obesity, osteoporosis and acromegaly have gained significant traction so far; peptide therapeutics being developed for these indications are likely to be the primary revenue drivers in near future. In addition, peptide based drugs are also being evaluated as treatment solutions for other metabolic disorders such as erythropoietic protoporphyria, lipodystrophy-HIV related, homozygous familial hypercholesterolemia, achondroplasia, Cushing’s disease, hypercalcemia and growth hormone deficiency.
4. Discovery and implementation of novel technologies to enhance specific properties such as stability, half-life and bioavailability have led the research efforts. Technologies such as ArisGen’s ArisCrown technology, Biolaxy’s NOD technology, Chiasma’s TPE® technology, Emisphere’s Eligen® formulation technology, Merrion’s GIPET®, Oramed’s POD™ technology, Proxima’s Axcess™ technology and Unigene/Enteris’ Peptelligence™ technology provide oral peptide delivery. Technologies such as Zosano’s ZP transdermal microneedle patch system and 3M’s microneedle drug delivery technology offer transdermal delivery of peptides. Sustained / extended delivery of peptides is being made possible through the biodegradable polymer implant technology (SurModics), ELP platform technology (PhaseBio Pharmaceuticals), FluidCrystal® injection depot technology (Camurus Pharmaceuticals), Intarcia Platform Technology (Intarcia Therapeutics), LAPSCOVERY™ platform technology (Hanmi Pharmaceuticals), Medisorb® microsphere technology (Alkermes), SIF platform technology (Foresee Pharmaceuticals) and SmartDepot™ technology (Peptron).
5. Pharmaceutical giants including Novo Nordisk, Novartis, Elli Lilly, AstraZeneca and Sanofi dominate this market while other companies such as Intarcia Therapeutics, Chiasma, Zealand Pharma and Radius Health are actively trying to gain a foothold. Several start-ups/ small companies such as Amunix, APEPTICO, Apitope, ArisGen, Calista Therapeutics, Clinuvel, ConjuChem Biotechnologies, CureDM, LipimetiX Development, Longevity Biotech, Oramed Pharmaceuticals, Palatin Technologies, Rani Therapeutics, Tarsa Therapeutics and Zosano Pharma are also emerging and have one or multiple peptides in early stages of development.
6. Overall, we expect the peptide therapeutics market for metabolic disorders to witness a steady growth rate over the coming decade and be worth over USD 10 billion by 2025. As expected, diabetes will account for a majority share. Ongoing technological developments and research in other metabolic disorders will fuel growth in the long term.

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