Oral Proteins and Peptides Market (3rd Edition), 2018-2030

NEW YORK, May 8, 2018 /PRNewswire/ -- INTRODUCTIONProtein and peptide-based therapeutics have been in use for more than three decades since the approval of recombinant human insulin, the first protein therapy, in 1982. Earlier, most biologic drugs were delivered through the subcutaneous route. However, over time, advances in delivery formulations have enabled the development of orally administrable versions of therapeutic proteins / peptides. Owing to numerous compelling reasons, the concept of oral delivery has gained significant traction. The first oral protein / peptide-based product candidate, Linzess®, was launched in 2012 in the US and EU. Recently, Trulance®, another orally administrable product was approved in the US (January 2017) for the treatment of chronic idiopathic constipation (CIC). In fact, in January 2018, Trulance® was approved for another indication, namely irritable bowel syndrome with constipation (IBS-C).Read the full report: https://www.reportlinker.com/p01902118 The growing popularity of this upcoming class of therapeutics has led to the development of several oral protein / peptide-based product candidates for the treatment of a myriad of diseases. In addition, the need for efficient and patient-friendly treatment options for chronic disorders, such as diabetes, is estimated to boost the demand for oral proteins and peptides in the coming years. Despite their clinical and commercial success, oral formulations of protein / peptide-based drugs have been associated with multiple drawbacks, such as concerns related to unwanted enzymatic degradation, inherent structural complexities, high manufacturing costs and low bioavailability. The aforementioned issues tend to have an impact on the overall efficacy of such products, thereby, limiting their therapeutic potential. This has prompted researchers to develop better technologies in order to improve product stability and therapeutic efficiency. The ongoing innovation has led to the discovery of novel biological targets, strengthening the research pipelines of various companies focused in this domain. Increasing research and development activities, and rising demand for effective drugs with better therapy adherence profiles are anticipated to encourage growth of the global oral proteins and peptides market in the coming years.SCOPE OF THE REPORTThe 'Oral Proteins and Peptides Market (3rd Edition), 2018-2030' report provides an extensive study on the current market landscape of orally administrable protein / peptide-based therapeutics, featuring a comprehensive discussion on the future potential of this evolving market. The field has captured the interest of several drug developers, including both small to mid-sized players and large companies. While more than half of these pipeline candidates are in the discovery / preclinical stages, around 28% of drug candidates are presently in advanced stages of evaluation (phase II and above). Amongst other elements, the report features:• A detailed assessment of the current market landscape of oral proteins / peptides, providing information on various drug developers, phase of development (clinical, preclinical or discovery stage) of product candidates, type of molecule (protein or peptide), biological target, mechanism of action, affiliated technology platform, key therapeutic area(s) and indication(s), and dosage.• An in-depth analysis of the product pipeline and developer companies, featuring three schematic representations; these include [A] a four dimensional grid analysis, representing the distribution of oral proteins / peptides (on the basis of the type of molecule) across various target therapeutic areas and stages of development, [B] a logo landscape of the various industry and non-industry players involved in the development of oral protein / peptide-based drugs, distributed on the basis of phase of development of pipeline candidates and size of developer companies (small-sized, mid-sized and large companies), and [C] a schematic world map representation, highlighting the most active geographies, in terms of the presence of various industry players that are involved in the development of oral proteins / peptides.• Details of recently held / upcoming conferences focused solely / partially on various aspects related to the oral delivery of proteins / peptides.• A detailed analysis identifying the key opinion leaders (KOLs) in the field of oral proteins / peptides. This features a 2X2 analysis to assess the relative experience of certain KOLs, who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field, and a schematic world map representation, highlighting the geographical locations of eminent scientists / researchers involved in the development of already marketed molecules in this domain.• Identification of the most commonly targeted therapeutic indications, and details of the oral proteins / peptides being developed against them. The study presents information on epidemiology, available diagnostic tests, and details of current treatment options and their side effects.• Comprehensive profiles of marketed and phase III drugs, highlighting their history of development, mechanism of action, dosage information (if available), manufacturing information (if available), current status of development, clinical trial information, key clinical trial results, historical sales (if marketed) and information on the developer.• A case study, featuring profiles of three of the most popular orally administrable protein / peptide-based drugs belonging to other drug classes, namely cyclic peptides and pancreatic enzyme replacement therapies (PERTs), which are either commercialized or under development. Each profile provides an overview of the drug, history of development, chemical structure and mechanism of action, dosage information (if marketed), clinical trial information (if the product is currently under development), patent portfolio (if available), and information on the other commercially available treatment options.• A review of the various oral drug delivery technology platforms that are being used for the development of product candidates in this domain, highlighting their key features and providing information on their developers. Specifically, for each technology platform, we have captured information on the various components of the technology, approach / system being used, type of formulation and type of molecules(s) that can be delivered using the technology.• Elaborate profiles of the technologies that are presently being used in the development of three or more products / product candidates (in both preclinical and clinical stages of development) with at least one candidate in the clinical stages of development, along with technologies for which the drugs are in advanced clinical stages of development (phase III and above). Each profile features an overview of the developer and technology, mechanism of action, key advantages, pipeline molecules developed using the technology and recent developments specific to the technology (acquisitions / mergers, collaborations and expansions).• An insightful 2X2 analysis of the different oral delivery technology platforms that are presently being utilized for the generation of oral proteins / peptides. The analysis is based on the supplier power (represented in terms of venture funding activity and company size) and product competitiveness (represented in terms of development activity (number of drugs in both preclinical / clinical stages of development), indication coverage, partnerships activity).• An analysis of the partnerships that have been established in the recent past, covering product development / commercialization agreements, R&D collaborations, technology licensing deals, manufacturing agreements, merger / acquisitions, product licensing deals, clinical trial collaborations and others.• An analysis of the investments made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings.• A publication analysis, featuring inputs from close to 90 articles that have been published in 2017, highlighting the key focus areas of the ongoing research activity in this field.• An analysis depicting the prevalent and emerging trends related to this domain as represented on the social media platform, Twitter. In addition to providing information on quarterly trends related to the volume of tweets in 2017, the analysis highlights the most talked about biological targets, drug candidates, active players, technology platforms, disease indications, and therapeutic areas.• A detailed case study on protein / peptide contract manufacturing, featuring a list of over 140 CMOs that are currently offering contract manufacturing services for such products / product candidates.• A discussion on affiliated trends, key drivers and challenges, under a SWOT framework. The analysis features a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall oral proteins / peptides market.One of the key objectives of this study was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. In addition, we have provided the likely distribution of the market based on [A] therapeutic areas (autoimmune disorders, bone disorders, digestive and gastrointestinal disorders, hormonal disorders, infectious diseases, metabolic disorders, urogenital disorders and others), [B] molecule type (protein and peptide), [C] technology platforms, [D] key players, and [E] geography (North America (the US, Canada and Mexico), Europe (EU5 countries), Asia-Pacific and RoW). To account for the uncertainties associated with the growth of the oral proteins / peptides market and to add robustness to our model, we have provided three forecast scenarios, portraying conservative, base and optimistic tracks of the market's evolution.The research, analysis and insights presented in this report is backed by a deep understanding of insights gathered both from secondary and primary sources. This enabled us to solicit inputs on upcoming opportunities and challenges that were considered to develop estimates for a more inclusive growth. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Dinesh Srinivasan (Director, Anthera Pharmaceuticals), Stig K Hansen (Co-founder and CEO, Carmot Therapeutics), Terry Dyck (CEO, IGY Life Sciences and Technology) and Richard Franklin (Director and CEO, Tarix Orphan). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.RESEARCH METHODOLOGYThe 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' viewsWhile the focus has been on forecasting the market till 2030, the report also provides our independent view on various 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 an executive summary of the insights captured in our research. The summary offers a high-level view on the likely evolution of oral proteins / peptides market, in the short-mid term and long term.Chapter 3 provides a comparison of the key characteristics of small molecules and large molecules / biologics. Further, it includes a detailed discussion on proteins / peptides, highlighting their potential as therapeutic agents. It also features a discussion on the various routes of administration used for the delivery of drugs, with special focus on oral route. The chapter elaborates on the likely advantages and challenges associated with the oral route of administration. In addition, it includes a comprehensive discussion on the various approaches developed / under development for the effective oral delivery of proteins / peptides.Chapter 4 includes information on 100 oral proteins / peptides that are currently approved / under development for therapeutic use. It features a comprehensive analysis of pipeline molecules, highlighting the drug developers, phases of development, type of molecule (protein and peptide), biological target, technology platforms, target therapeutic area(s) and disease indication(s). The chapter also highlights the various oral proteins / peptides that have been discontinued over the last few years.Chapter 5 presents the key insights derived from the study. It features a four-dimensional grid analysis, representing the distribution of product candidates (on the basis of type of molecule) across various target therapeutic areas and stages of development. In addition, it features a logo landscape of industry and non-industry players that are engaged in the development of oral proteins / peptides, distributed based on the developmental status of pipeline candidates and size of companies (small-sized, mid-sized and large companies). We have also mapped the geographical presence of various industry players that are involved in the development of product candidates in this field. In addition, the chapter provides a list of recently-held / upcoming conferences focused on various aspects related to the oral delivery of proteins / peptides.Chapter 6 provides an analysis of the KOLs in the field of oral proteins / peptides. It provides a comprehensive list of principal investigators of different clinical trials, along with information related to the affiliated research institutes. The chapter features a schematic representation on a world map, highlighting the geographical locations of the eminent scientists / researchers who are engaged in clinical research activity in this domain. It also features a comparative analysis, highlighting those KOLs who have relatively more experience in this domain.Chapter 7 highlights the potential target indications (segregated by therapeutic areas) that are currently the prime focus of companies developing oral proteins / peptides. These include metabolic disorders, digestive and gastrointestinal disorders, infectious diseases, autoimmune disorders, hormonal disorders and bone disorders. The chapter also provides details on disease epidemiology, available diagnostic tests, and currently available treatment options for each indication and their likely side effects.Chapter 8 contains detailed profiles of drugs that are either marketed or are in phase III of development. Each profile features an overview of the drug, history of development, mechanism of action, dosage information (if available), manufacturing information (if available), current status of development, clinical trial information, key clinical trial results, historical sales (if marketed) and information on the developer.Chapter 9 provides a review of oral proteins / peptides belonging other drug classes, namely cyclic peptides and PERTs, which are either commercialized or still under development. The chapter features detailed profiles of three popular orally administrable, therapeutic proteins / peptides (Minirin®, Sandimmune® and Sollpura®), which were discovered before 2000. Each profile contains an overview of the drug, history of development, chemical structure and mechanism of action, dosage information (if marketed), clinical trial information (if the product is currently under development), patent portfolio (if available) and information on the other commercially available treatment options for the disease indications for which each drug is approved.Chapter 10 provides a list of technology platforms that are either currently available, or being developed by various firms, for the generation of oral proteins / peptides with information on technology composition, approach / system being used, formulation and type of molecules(s) that can be delivered using the technology. In addition, it features detailed profiles of some of the key technologies that have been used to develop (at least three) clinical and / or preclinical product candidates, along with the technologies for which the drugs are in advanced clinical stages of development (phase III and above). Each profile contains details on the technology, including mechanism of action, pipeline molecules developed using the technology, its advantages and the various partnerships that were established related to the technology.Chapter 11 features a 2X2 matrix, comparing product competitiveness and supplier power of the oral drug delivery technology platforms that are presently being utilized for the generation of oral proteins / peptides. The analysis takes into consideration several parameters, such as venture funding activity, company size, development activity (number of drugs in both preclinical / clinical stages of development), indication coverage and partnerships activity.Chapter 12 presents details on various investments received by companies that are engaged in this domain. It also includes an analysis of the funding instances that have taken place in the period between 1996 and January 2018, highlighting the growing interest of the venture capital community and other strategic investors in this market.Chapter 13 features an elaborate discussion and analysis of the various collaborations and partnerships that have been inked amongst players in this market. We have also discussed the different partnership models (including product development / commercialization agreements, R&D agreements, technology licensing, manufacturing agreement, mergers / acquisitions, product licensing, clinical trial collaborations and others) and the most common forms of deals / agreements that have been established between stakeholders in this domain between 2000 and 2018 (till January).Chapter 14 provides a comprehensive publication analysis, highlighting the recent trends in published literature related to oral proteins / peptides. It presents information such as the year of publication, type of study, the key targets and the publication journals. The chapter provides details on novel methods, and also highlights the various attempts that are being made to add value to the ongoing R&D efforts within this domain.Chapter 15 provides insights on the popularity of oral proteins / peptides on the social media platform, Twitter. The section highlights the yearly distribution of tweets posted on the platform in the time period 2013-2017, and the most significant events responsible for increase in the volume of tweets each year. Additionally, the chapter showcases the most frequently mentioned words, therapeutic areas, biological targets, drug candidates, and the key players that post frequent updates related to their drugs and technologies, as observed on social media.Chapter 16 presents a comprehensive market forecast analysis, highlighting the future potential of the market till the year 2030. It includes future sales projections of drugs that are either marketed or in advanced stages of clinical development (phase II and above). Further, sales potential and growth opportunity were estimated based on target patient population, likely adoption rates, existing / future competition from other drugs and the likely price of products. The chapter also presents a detailed market segmentation on the basis of therapeutic areas (autoimmune disorders, bone disorders, digestive and gastrointestinal disorders, hormonal disorders, infectious diseases, metabolic disorders, urogenital disorders and others), molecule type (protein and peptide), technology platforms, key players, and geography (North America (the US, Canada and Mexico), Europe (EU5 countries), Asia-Pacific and RoW).Chapter 17 features a case study on the role of CMOs in the field of oral proteins / peptides. It provides details on the various factors that need to be considered while selecting the right CMO partner for the pharmaceutical companies. In addition, it includes a list of over 140 contract manufacturers that claim to have the necessary capabilities for protein / peptide manufacturing.Chapter 18 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of the oral proteins / peptides market, under a comprehensive SWOT framework. The chapter also features a schematic Harvey ball analysis to highlight the relative impact of each SWOT parameter on the overall oral proteins / peptides market.Chapter 19 is a summary of the overall report. In this chapter, we have provided a list of the key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.Chapter 20 is a collection of interview transcripts of discussions held with key stakeholders in this market. In this chapter, we have presented the details of our conversations with Dinesh Srinivasan (Director, Anthera Pharmaceuticals), Stig K Hansen (Co-founder and CEO, Carmot Therapeutics), Terry Dyck (CEO, IGY Life Sciences and Technology) and Richard Franklin (Director and CEO, Tarix Orphan).Chapter 21 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.Chapter 22 is an appendix, which provides the list of companies and organizations mentioned in the report.EXAMPLE HIGHLIGHTS1. Around 100 oral protein / peptide therapeutics are currently being developed across various preclinical / clinical stages for a diverse range of indications. Two products, namely Linzess® (Ironwood Pharmaceuticals) and Trulance® (Synergy Pharmaceuticals), are commercially available; of these, Trulance® was approved in January 2017. Nearly 41% of the pipeline molecules are under clinical development; of these, 5 molecules are being investigated in phase III and phase II/III, 18 molecules in phase II, 5 molecules in phase II (planned), 1 in phase I/II, and 9 molecules in phase I and phase I (planned) clinical trials. However, majority (57%) of the product candidates in the pipeline are still in the preclinical and discovery stages.2. 42% of the products in the development pipeline are designed to treat various metabolic disorders, including (in decreasing order of number of pipeline products) diabetes, obesity and non-alcoholic steatohepatitis (NASH). Nearly 15% of therapy candidates are being developed for the treatment of digestive and gastrointestinal disorders, including (in decreasing order of number of pipeline products) chronic idiopathic constipation (CIC), irritable bowel syndrome with constipation (IBS-C), inflammatory bowel disease (IBD) (Crohn's disease and ulcerative colitis), opioid-induced constipation (OIC) and short bowel syndrome (SBS). Products are also being developed for other therapeutic areas, such as autoimmune disorders (9), infectious diseases (9), hormonal disorders (5), bone disorders (4), blood disorders (3), various oncological indications (2), respiratory disorders (2), urogenital disorders (2), genetic disorders (1) and neurodegenerative disorders (1).3. The market landscape is characterized by the presence of large (13, with more than 200 employees), mid-sized (12, with 50-200 employees) and small-sized companies (33, with less than 50 employees). Some of the prominent large companies engaged in this domain include (in alphabetical order) Chiasma Pharma, Ferring Pharmaceuticals, Ironwood Pharmaceuticals, Novo Nordisk and Sanofi Aventis. Similarly, mid-sized companies that are actively contributing to the development of oral protein / peptide-based product candidates include (in alphabetical order) Emisphere Technologies, Protagonist Therapeutics, Synergy Pharmaceuticals and Transgene Biotek. In addition, small companies, such as (in alphabetical order) Allena Pharmaceuticals, Biolingus, Enteris BioPharma, Longevity Biotech, Oramed Pharmaceuticals, Proxima Concepts and Rani Therapeutics, are also actively involved in this domain.4. Several universities / research organizations, either independently or in collaboration with industry players, have also contributed to the development of products in both preclinical and clinical studies. Examples include (in alphabetical order) Medical University of South Carolina, Monash University, National Institute of Diabetes and Digestive and Kidney Diseases, Niagara University and University of Montreal.5. To overcome the challenges related to the effective administration of oral biologics, several innovative technologies to formulate and deliver oral biologics are being developed. Notable examples of advanced drug delivery technologies include (in decreasing order of number of pipeline products) Robotic Pill Maker technology (Rani Therapeutics), Peptelligence® (Enteris BioPharma), AxcessTM oral drug delivery technology (Proxima Concepts), Oral Peptide Utility System (OPUS) technology (Biolingus), Sublingual Immunotherapy (SLIT) technology (Biolingus), and Oramed Protein Oral Delivery (PODTM) technology (Oramed Pharmaceuticals).6. Over 195 funding instances, amounting to USD 5.4 billion worth of capital, have taken place in this field in the last decade. Cherrystone Angel Group, Novartis Venture Fund, Third Security, MVM Life Science Partners, Venrock, ARCH Venture Partners, Ascent Biomedical Ventures, Boston Harbor Angels, F2 Ventures, Google Ventures, MPM Capital and Pharmstandard International have emerged as some of the prominent investors (in terms of number of funding instances).7. Since 2008, around 100 partnerships have been inked between various stakeholders within the industry; of these, 44 collaborations have been established since 2012. Approximately 39% of the deals were product development / commercialization agreements; recent examples include agreements between Carmot Therapeutics and Amgen (December 2017), Eli Lilly and KeyBioscience (June 2017), Protagonist Therapeutics and Janssen Biotech (May 2017), Enteris BioPharma and Sanofi (January 2017), Ironwood Pharmaceuticals and Allergan (January 2017), and Takeda Pharmaceuticals and PvP Biologics (January 2017). Other popular types of collaborations were R&D deals (25%), technology licensing agreements (9%), manufacturing agreements (8%), mergers / acquisitions (7%), product licensing agreements (6%) and clinical trial collaborations (5%). In terms of the number of deals signed in the given time period, Oramed Pharmaceuticals (8), Ironwood Pharmaceuticals (8), Merrion Pharmaceuticals (7), Enteris BioPharma (7) and Novo Nordisk (7), have emerged as the most active companies.8. With many candidates in late stages of development and increase in technological advancements, the market is likely to grow at a steady pace over the coming decade. North America and the EU5 presently dominate the market share and are expected to retain the leading position over the next decade. Within Asia-Pacific and RoW regions, India, Japan, Russia, Israel and Australia are expected to garner a growing share of the market by 2030.9. The two currently marketed drugs target digestive and gastrointestinal disorders, including CIC and IBS-C. With the anticipated approval of close to 20 additional drugs by 2030, the market is likely to be driven by five therapeutic areas, namely digestive and gastrointestinal disorders (31%), metabolic disorders (30%), bone disorders (10%), infectious diseases (6%) and urogenital disorders (5.5%). In fact, specific products, being developed for indications with very large target patient populations, are anticipated to achieve blockbuster status (with sales over USD 1 billion) and become prime contributors to future revenues in the coming decade.Read the full report: https://www.reportlinker.com/p01902118 About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. __________________________ Contact Clare: [email protected] US: (339)-368-6001 Intl: +1 339-368-6001

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