Non-Antibody Protein Scaffolds: Drugs and Diagnostics Market, 2017-2030

NEW YORK, Dec. 18, 2017 /PRNewswire/ -- INTRODUCTION
Monoclonal antibodies have been in use for more than two decades. The first product candidate was launched in 1986; since then, they have been used for the treatment of a myriad of diseases, including cancer, inflammatory diseases and infectious diseases. However, despite their clinical and commercial successes, these therapies are known to have certain drawbacks that have had an impact on their overall efficacy, thereby, limiting their therapeutic potential. These drawbacks are related to their inherent structural complexities, high manufacturing costs, difficulties in formulation and insufficient understanding of their precise in vivo mechanisms of action.


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The above-mentioned limitations have prompted researchers to identify alternative protein scaffold based therapeutic strategies. Amongst other novel formats, non-antibody protein scaffolds have emerged as viable alternatives, having the capability to address the existing challenges associated with classical antibody based therapies. Although the concept of non-antibody protein scaffolds was conceived more than a decade ago, this field has gained popularity in recent years. Presently, there is one approved product (Kalbitor®), and several non-antibody protein scaffold based product candidates that are being developed across various clinical and preclinical stages.

SCOPE OF THE REPORT
The 'Non-Antibody Protein Scaffolds: Drugs and Diagnostics Market, 2017-2030' report provides a comprehensive study of the current market landscape of non-antibody protein scaffolds, and related drugs and diagnostics, featuring an elaborate discussion on the likely future potential of this upcoming market. Over the past few years, this burgeoning field of research has captured the interest of several players in the pharmaceutical industry.

Amongst other elements, the report features:
• An overview of the current market landscape, featuring comprehensive list of active industry / non industry players, and detailed analysis of non-antibody protein scaffold based product candidates, based on phase of development (clinical and preclinical / discovery), target therapeutic area(s), end-use (therapeutic agents, diagnostic imaging agents and diagnostic tests), type of scaffold format, route of administration (intravenous, subcutaneous, and intravitreal) and non-antibody protein scaffold technology used.
• A review of the various non-antibody protein scaffolds that are presently available for the development of therapeutics / diagnostics, highlighting information on their developers, and structural and pharmacokinetic features. Specifically, for each scaffold type, we have captured information on size, origin of parent protein, structure, mode of randomization of scaffolds and number of disulfide bonds, type of production system used, method of selection, in vitro half-life and melting temperature.
• A detailed comparative analysis of various non-antibody protein scaffolds, featuring two schematic representations, including [A] an insightful 2 X 2 analysis, to assess the technical strength of the non-antibody protein scaffolds, based on product competitiveness and pipeline strength, and [B] a spider-web analysis, highlighting the popularity of non-antibody protein scaffolds (those that have products in phase I and higher stages of clinical). The analysis was based on various parameters, such as the pipeline strength (number of drugs in both preclinical / clinical stages of development), end-use, number of related publications, target indications and technical strength.
• Comprehensive profiles of marketed and clinical stage (phase I/II and above) non-antibody protein scaffold based drugs / diagnostics, highlighting details of the product, a brief history of development, mechanism of action, non-antibody protein scaffold technology used, manufacturing details, current status of development, information on clinical studies (including key clinical trial results) and target patient population. Each profile also features information on the developer, including an overview of the company, information on its finances and funding (if available), and an informed future outlook.
• An analysis of the partnerships that have been inked between stakeholders in the industry in the recent past, covering R&D collaborations, product / technology licensing agreements, product development / commercialization agreements, mergers / acquisitions, clinical trial collaborations, manufacturing agreements and service agreements.
• An in-depth analysis of the product pipeline, featuring an elaborate funnel analysis, highlighting the most popular targets being considered for therapeutic, as well as diagnostic purposes, along with the formats used and highest phase of development. It includes a grid analysis, representing the distribution of non-antibody protein scaffold based products (on the basis of their end-use) across various target therapeutic areas and different stages of development.
• A detailed analysis of the developer companies, featuring three schematic representations; these include [A] a logo landscape of the various industry and non-industry players involved in the development of non-antibody protein scaffold based products, distributed on the basis of the phase of development of pipeline candidates and size of the companies (small, mid-sized and large companies), [B] a schematic world map representation, highlighting the geographical locations of various industry players, and [C] a bubble analysis comparing the leading players engaged in the generation of drugs / diagnostics, on the basis of parameters such as clinical activity (based on the number of drug candidates developed by a particular company, across different phases of development), number of partnerships established (between 2012 and 2017) and the size of the developer company.

One of the key objectives of this report was to evaluate the current opportunity and the future potential of the non-antibody protein scaffolds market. Based on various parameters, such as target patient population, 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 2017-2030. In addition, we have provided the likely distribution of the market based on end-use (therapeutic agents and diagnostic agents), key therapeutic areas (genetic disorders, eye disorders, autoimmune disorders, oncology and others), and non-antibody protein scaffold technologies. To account for the uncertainties associated with the development of non-antibody protein scaffold based drugs / diagnostics and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market's evolution.

The opinions and insights presented in the report were also influenced by discussions with senior stakeholders in the industry. These include Alastair Smith (CEO, Avacta), Kyu-Tae-Kim (Director, AbClon), Ratmir Derda (Assistant Professor, University of Alberta) and Aditya Pandey (Postdoctoral Fellow, University of Toronto). 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 METHODOLOGY
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 till 2030, 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 an executive summary of the insights captured during our research. It offers a high-level view on the likely evolution of the non-antibody protein scaffolds based drugs / diagnostics market in the short to mid-term and long term.

Chapter 3 provides a general overview of the evolution of protein based therapeutics over the last several years, featuring a brief discussion on the limitations of antibody based therapeutics and emphasizing on the need for alternative protein scaffolds. It includes a detailed description of non-antibody protein scaffolds, elaborating on their historical evolution, classification and key benefits. It also highlights major types of proteins that are usually tagged with non-antibody protein scaffolds for therapeutic, diagnostic and research purposes. In addition, the chapter features a detailed discussion on different applications of non-antibody protein scaffolds.

Chapter 4 provides a detailed overview of the non-antibody protein scaffold technologies identified during this study. It features a detailed discussion on the impact of various structural and pharmacokinetic features (such as size, origin of the parent protein, structure, mode of randomization and number of disulphide bonds, production system, method of selection, in vitro half-life and melting temperatures) on drug development. The chapter also presents a comparative 2 X 2 matrix analysis of non-antibody protein scaffolds that are presently under preclinical / clinical evaluation. Additionally, it features a spider-web analysis, which highlights the relative popularity of those non-antibody protein scaffolds that have products in clinical stages of development (phase I and above). The parameters considered for this analysis include pipeline strength (based on the number of drugs in both preclinical / clinical stages of development), end-use, number of publications, indication coverage and technical strength of the scaffolds.

Chapter 5 provides a comprehensive overview of the current landscape of the non-antibody protein scaffold based drugs / diagnostics market. It includes information on over 80 non-antibody protein scaffolds based products that are currently in various stages of development (both clinical and preclinical / discovery). It features a comprehensive analysis of the pipeline products on the basis of their phase of development, target therapeutic area(s), end-use, type of scaffold format, route of administration and non-antibody protein scaffold technology. We have also highlighted the key players that are active in this domain.

Chapter 6 presents elaborate profiles of drugs / diagnostic agents that are either marketed or are in advanced stages of clinical development (phase I/II and above). Each profile provides information on the history of development, mechanism of action, non-antibody protein scaffold technology, manufacturing details, current status of development, information on clinical studies, key clinical trial results, target patient population and historical sales of the products (if marketed). It also includes a brief overview of the developer, its financial information, funding details and an informed future outlook.

Chapter 7 presents a comprehensive market forecast analysis, highlighting the future potential of the market till the year 2030. It includes future sales projections of non-antibody protein scaffolds based drugs / diagnostics that are either marketed or are in advanced stages of clinical development (phase II and above). The sales potential and growth opportunity were estimated based on the target patient population, likely adoption rates, existing / future competition from other drug classes and the likely price of products. The chapter also presents a detailed market segmentation on the basis of key therapeutic areas (genetic disorders, eye disorders, autoimmune disorders, oncology and others), end-use (therapeutic agents and diagnostic agents), and non-antibody protein scaffolds technologies.

Chapter 8 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 R&D agreements, product / technology licensing agreements, product development / commercialization agreements, merger / acquisitions and clinical trial collaborations) and the most common forms of deals / agreements that have been established between 2012 and 2017.

Chapter 9 presents the key insights derived from the study. It distinctly highlights the most popular targets that are being investigated for both therapeutic, as well as diagnostic purposes along with their respective types of formats and highest phase of development. The chapter also features a grid analysis, representing the distribution of non-antibody protein scaffold based products (on the basis of their end-use) across target therapeutic areas and stages of development. In addition, it features a logo landscape of industry and non-industry players engaged in the development of non-antibody protein scaffold based products, distributed based on the developmental status of pipeline candidates and size of the companies (small, mid-sized and large companies). We have also mapped the geographical presence of various industry players involved in the development of product candidates in this field. In addition, it includes a comparative analysis, presented in the form of a bubble analysis, to highlight the leading players engaged in the generation of drugs / diagnostics based on these novel non-antibody protein scaffolds. The parameters considered for this analysis include the research activity based on the company's development pipeline (in terms of the number of drugs across different phases of development), number of partnerships established related to each company (between 2012 and 2017) and the size of the developer company.

Chapter 10 summarizes the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 11 is a collection of interview transcripts of the discussions that were held with key stakeholders in this field. In this chapter, we have presented the details of our conversations with Alastair Smith (CEO, Avacta), Kyu-Tae-Kim (Director, AbClon), Ratmir Derda (Assistant Professor, University of Alberta) and Aditya Pandey (Postdoctoral Fellow, University of Toronto).

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 the list of companies and organizations mentioned in the report.

EXAMPLE HIGHLIGHTS
1. Over 25 unique non-antibody protein scaffolds have been developed for the generation of different product candidates. Notable examples include (in alphabetical order) Affibody® (Affibody), Affimer® (Avacta), Anticalin® (Pieris Pharmaceuticals), AdnectinTM (BMS), Bicycles® (Bicycle Therapeutics), DARPin® (Molecular Partners), Kunitz Domain (Shire) and Nanofitin® (Affilogic).
2. Around 80 product candidates (drugs / diagnostics) based on non-antibody protein scaffolds are currently under various stages of development for a diverse range of indications. A significant proportion (82%) of these candidates are in preclinical / discovery stages. Specifically, six products are in clinical evaluation (phase I/II and above); these are (in alphabetical order) abicipar pegol (Allergan and Molecular Partners), RG6206 (BMS and Roche), ABY-025 (Affibody), ABY-035 (Affibody), MP0250 (Molecular Partners), PRS-080 (Pieris Pharmaceuticals).
3. The market landscape is well distributed across large-sized (21), mid-sized (5) and small-sized companies (8). Some of the prominent large-sized companies engaged in this domain include (in alphabetical order) Allergan, AstraZeneca, BMS, GSK, Merck, Roche, Sanofi, Servier and Shire. Mid-sized companies that are actively contributing to the development of novel non-antibody scaffold based products include (in alphabetical order) Avacta, ITM Isotopen Technologien München, Molecular Partners, Pieris Pharmaceuticals and ThromboGenics. In addition, small companies, such as (in alphabetical order) Affibody, Affilogic, Bicycle Therapeutics, Complix, Glythera, Navigo Proteins, Nordic Nanovector and Poseida 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. Examples include (in alphabetical order) Cancer Research UK, Chonnam National University, Dartmouth-Hitchcock Medical Center, Harlev Hospital, Memorial Sloan Kettering Cancer Center (MSKCC), National Cancer Institute (NCI) and University of Leeds.
5. Currently, almost 40% of the products in the development pipeline are focused on oncological indications, including hematological cancers and solid tumors. Apart from oncology, autoimmune disorders are the most popular; in fact, close to 17% of product candidates in the pipeline are being developed for such conditions. Products are also being developed for other therapeutic areas, such as eye disorders (7%), blood disorders (6%), inflammatory disorders (5%), respiratory disorders (5%), infectious diseases (4%) and genetic disorders (3%).
6. Nearly 50% of the products are being investigated as stand-alone scaffolds. This is followed by products identified as scaffold-bispecific fusion proteins (17%), scaffold-drug conjugates (14%), radiolabeled scaffolds drugs (7%) and scaffold-fusion drugs (7%).
7. Around 60 partnerships were inked between various stakeholders in the industry between 2012 and October 2017. Of these, approximately 48% were R&D related deals; recent examples include Bicycle Therapeutics and Bioverativ (September 2017), Complix and Merck (July 2017), Avacta and MSKCC (November 2016), Avacta and Glythera (July 2016). Other popular types of collaborations were product / technology licensing agreements (25%), product development / commercialization agreements (13%) and mergers / acquisitions (7%). Avacta (14), Pieris Therapeutics (8), Affibody (7), Molecular Partners (6), Shire (5), Bicycle Therapeutics (4) and Complix (4), emerged as the most active companies in terms of the number of deals signed in the given time period.
8. Our future market outlook is optimistic as we expect several new products to be approved and launched over the coming decade. We expect the market to grow at an annualized rate of ~42% till 2030. In fact, specific products, being developed for indications with very large target patient population, are likely to achieve blockbuster status (sales over USD 1 billion) and become prime contributors to the overall market's evolution.

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