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Key Inclusions
§ A detailed review of the overall landscape of bispecificantibody therapeutics, including information on drug developers, phase ofdevelopment (marketed, clinical, and preclinical / discovery) of the pipelinecandidates, target antigen, type of antibody format, mechanism of action,target disease indication(s), therapeutic area, broader disease segment, routeof administration, mode of administration and patient segment.
§ A comprehensive list of novel technology platforms that areeither currently available or being developed by various firms for thegeneration of bispecific antibody therapeutics, along with detailed profiles ofkey technologies. The chapter also includes an insightful competitivenessanalysis, featuring a three-dimensional bubble representation that highlightsthe key technologies that are being used for the development of bispecificantibodies, taking into consideration the early stage (discovery, preclinical,IND and phase I) and late stage (phaseII and above) development activity based on the technology (in terms of thenumber of drugs across different phases of development), number of partnershipsestablished related to the technology and size of the developer company. In addition,it consists of a schematic world map representation, highlighting thegeographical locations of technology developers engaged in this domain.
§ Detailed profiles of marketed and clinical stage (phase IIand phase III) bispecific antibody therapeutics. Each profile features anoverview of the drug, details of the developer, along with its financialperformance, mechanism of action and targets, dosage information, currentclinical development status, development process, as well as details on annual sales(wherever available).
§ Key takeaways from the bispecific antibody therapeuticspipeline, featuring a [A] grid analysis, representing the distribution of thepipeline (on the basis of mechanisms of action of product candidates) acrossdifferent therapeutic areas and stages of development, [B] a five-dimensionalspider-web analysis, highlighting the most popular mechanisms of action basedon a number of relevant parameters, including number of bispecific antibodiesin early stage (phase I) and late stage of development (phase II and above),number of ongoing clinical trials, target therapeutic areas and the number ofcompanies that are developing these molecules, [C] a two-dimensional scatteredplot competitiveness analysis, for the various target combinations forclinical-stage bispecific antibodies and [D] the chapter also includes aninsightful summary representation using the logos of different industrystakeholders, highlighting the distribution of companies based on the companysize.
§ An analysis of the big biopharma players engaged in thisdomain, featuring a heat map based on various parameters, such as number ofbispecific antibody therapeutics under development, target antigen, type ofantibody format, mechanism of action and target therapeutic area.
§ An analysis of recent partnerships and collaborationagreements inked in this domain since 2016, covering research collaborations,product and technology licensing agreements, product development andcommercialization agreements, manufacturing agreements, mergers / acquisitions,joint ventures, product development agreements and other deals.
§ A review on the key steps involved and challengesassociated with the manufacturing of bispecific antibodies. In addition, itincludes a list of contract manufacturing organizations (CMOs) and contractresearch organizations (CROs). The chapter also highlights the keyconsiderations for bispecific antibody developers while selecting a suitableCRO / CMO.
§ A clinical trial analysis of ongoing and planned studiesrelated to bispecific antibody therapeutics, taking into consideration a numberof relevant parameters, including trial registration year, trial recruitmentstatus, trial phase, trial design, disease indication(s), focus therapeuticarea, most active industrial and non-industrial players, and geographicallocation of the trial.
§ A review of the key promotional strategies that have beenadopted by the developers of the marketed bispecific antibodies, namelyBlincyto® and Hemlibra®. It includes a detailed comparison of both the drugsbased on the information available on their respective websites, such aspatient support offerings, informative downloadable content, and productvisibility in scientific conferences.
§ A discussion on important, industry-specific trends, keymarket drivers and challenges, under a SWOT framework, featuring a qualitativeHarvey ball analysis that highlights the relative impact of each SWOT parameteron the overall market.
The report alsofeatures the likely distribution of the current and forecasted opportunityacross important market segments, mentioned below:
- Therapeutic Area
§ Autoimmune Disorders
§ Eye Disorders
§ Genetic Disorders
§ HematologicalMalignancies
§ Infectious Diseases
§ InflammatoryDisorders
§ Skin Disorders
- Mechanism of Action
§ Cytokines Retargeting/ Neutralization
§ Dual Ligands Blocking
§ T-cell Retargeting /Activation
§ Others
- Target Antigens
§ CD3 x CD19
§ CD30 x CD16A
§ Factor IXa x Factor X
§ IL-1α x IL-1β
§ IL-13 x IL-4
§ IL-17A x Albumin
§ IL-17A x IL-17F
§ Psl x PcrV
§ VEGF-A x ANG2
§ Others
- Key Players
§ Astra Zeneca
§ Amgen
§ AbbVie
§ Affirmed
§ Affibody
§ Merck
§ Roche
§ Sanofi
§ Taisho Pharmaceutical
- Key Geographical Regions
§ North America
§ Europe
§ Asia-Pacific
Thereport features inputs from eminent industry stakeholders, according to whomthis relatively novel class of antibody therapeutics is likely to garnersignificant interest among therapy developers and end users alike. The reportincludes detailed transcripts of discussions held with the following experts:
§ Martin Steiner (ChiefExecutive Officer, Synimmune)
§ Ludger Große-Hovest(Chief Scientific Officer, Synimmune)
§ Jane Dancer (ChiefBusiness Officer, F-Star)
§ Siobhan Pomeroy(Senior Director, Business Development, Cytom X)
§ Yinjue Wang(Associate Director, Process Development, Innovent Biologics)
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Key QuestionsAnswered
§ What are the key technologies used for the development ofbispecific antibodies?
§ What are the key biological target combinations andantibody formats that are being explored for bispecific antibody development?
§ Who are the leading industry and non-industry playersengaged in this market?
§ What kind of partnership models are commonly adopted bybispecific antibody developers?
§ Which CMOs offer services for manufacturing bispecificantibodies?
§ What are the regulatory guidelines issued by differentorganizations related to the development of bispecific antibodies?
§ What kind of promotional strategies are being used bydevelopers of marketed bispecific antibody developers?
§ How is the current and future market opportunity (relatedto bispecific antibodies) likely to be distributed across key market segments?
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