Bispecific Antibody Therapeutics Market (4th Edition), 2019-2030

Overview

The first monoclonal antibody, Orthoclone OKT3®, was approved in 1986 by the FDA. Since then, a number of antibody therapeutics (more than 100) have been marketed for the treatment of patients suffering from various disease indications, primarily malignant tumors and other rare disorders. Despite the success, these drugs are associated with several limitations, such as increased patient resistance and a general lack of understanding of in vivo mechanisms of action. The aforementioned challenges and impending patent expiries of some of the blockbuster monoclonal antibodies have compelled the researchers and pharmaceutical companies to redesign these drugs and / or find new analogues. To further improve the specificity, efficacy and safety of monoclonal antibodies, the focus has gradually shifted towards the development of next generation recombinant antibodies, such as antibody-drug conjugates (ADCs), bispecific and multispecific antibodies, and antibody fragments and antibody-like proteins (ALPs).

Bispecific antibodies are a novel class of antibody therapeutics that act by simultaneously binding two separate and unique antigens (or different epitopes of the same antigen). The primary mechanism of action of these therapeutics involves redirection of immune effector cells for effective killing of cancer cells by antibody-dependent cell mediated cytotoxicity (ADCC) and other cytotoxic mechanisms, such as antibody dependent cellular phagocytosis (ADCP) and complement dependent cytotoxicity (CDC). Having unique biological and pharmacological properties, as well as their availability in different formats, bispecific antibodies have emerged as promising agents for therapeutic use. Advancements related to protein and antibody engineering techniques have led to the production of close to 50 new formats in the recent years.

Till date, two bispecific antibodies, namely Blincyto® (2014) and Hemlibra® (2017), have been approved for therapeutic use. It is worth mentioning that, in 2019 (till September), Blincyto® and Hemlibra® generated revenues worth USD 232 million and USD 930 million, respectively. The growing popularity and therapeutic potential of bispecific antibodies can also be correlated to an exponential increase in the number of clinical trials; the cumulative count of trials has increased from 51 studies in 2014 to over 300 studies in 2019 (till September). More than 300 bispecific drug candidates are currently in clinical/preclinical stages. In fact, multiple licensing agreements, between drug developers and technology providers, have also been inked in the past few years to advance the development of pipeline drug candidates.

Scope of the Report

The “Bispecific Antibody Therapeutics Market (4th Edition), 2019-2030” report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of these therapeutics over the next decade. The study features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. Amongst other elements, the report includes:

• A detailed review of the overall landscape of bispecific antibody therapeutics, including information on drug developers, phase of development (marketed, clinical, and preclinical / discovery) of the pipeline candidates, target antigen, type of antibody format, mechanism of action, target disease indication(s), therapeutic area, broader disease segment, route of administration, mode of administration and patient segment.
• A comprehensive list of novel technology platforms that are either currently available or being developed by various firms for the generation of bispecific antibody therapeutics, along with detailed profiles of key technologies. The chapter also includes an insightful competitiveness analysis, featuring a three-dimensional bubble representation that highlights the key technologies that are being used for the development of bispecific antibodies, taking into consideration the early stage (discovery, preclinical, IND and phase I) and late stage (phase II and above)development activity based on the technology (in terms of the number of drugs across different phases of development), number of partnerships established related to the technology and size of the developer company. In addition, it consists of a schematic world map representation, highlighting the geographical locations of technology developers engaged in this domain.
• Detailed profiles of marketed and clinical stage (phase II and phase III) bispecific antibody therapeutics. Each profile features an overview of the drug, details of the developer, along with its financial performance, mechanism of action and targets, dosage information, current clinical development status, development process, as well as details on annual sales (wherever available).
• Key takeaways from the bispecific antibody therapeutics pipeline, featuring a [A] grid analysis, representing the distribution of the pipeline (on the basis of mechanisms of action of product candidates) across different therapeutic areas and stages of development, [B] a five-dimensional spider-web analysis, highlighting the most popular mechanisms of action based on a number of relevant parameters, including number of bispecific antibodies in early stage (phase I) and late stage of development (phase II and above), number of ongoing clinical trials, target therapeutic areas and the number of companies that are developing these molecules, [C] a two-dimensional scattered plot competitiveness analysis, for the various target combinations for clinical-stage bispecific antibodies and [D] the chapter also includes an insightful summary representation using the logos of different industry stakeholders, highlighting the distribution of companies based on the company size.
• An analysis of the big biopharma players engaged in this domain, featuring a heat map based on various parameters, such as number of bispecific antibody therapeutics under development, target antigen, type of antibody format, mechanism of action and, target therapeutic area.
• An analysis of recent partnerships and collaboration agreements inked in this domain since 2016, covering research collaborations, product and technology licensing agreements, product development and commercialization agreements, manufacturing agreements, mergers / acquisitions, joint ventures, product development agreements and other deals.
• A review on the key steps involved and challenges associated with the manufacturing of bispecific antibodies. In addition, it includes a list of contract manufacturing organizations (CMOs) and contract research organizations (CROs). The chapter also highlights the key considerations for bispecific antibody developers while selecting a suitable CRO / CMO.
• A clinical trial analysis of ongoing and planned studies related to bispecific antibody therapeutics, taking into consideration a number of relevant parameters, including trial registration year, trial recruitment status, trial phase, trial design, disease indication(s), focus therapeutic area, most active industrial and non-industrial players, and geographical location of the trial.
• A review of the key promotional strategies that have been adopted by the developers of the marketed bispecific antibodies, namely Blincyto® and Hemlibra®. It includes a detailed comparison of both the drugs based on the information available on their respective websites, such as patient support offerings, informative downloadable content, and product visibility in scientific conferences.
• A discussion on important, industry-specific trends, key market drivers and challenges, under a SWOT framework, featuring a qualitative Harvey ball analysis that highlights the relative impact of each SWOT parameter on the overall market.

One of the key objectives of the report was to estimate the existing market size and the future opportunity for bispecific antibody therapeutics, for the next decade. Based on multiple parameters, such as target patient population, likely adoption rates and expected pricing, we have provided an informed estimate on the evolution of the market for the period 2019-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] key therapeutic areas (genetic disorders, hematological malignancies, autoimmune disorders, infectious diseases, inflammatory disorders, eye disorders and skin disorders), [B] different mechanisms of action (T-cell retargeting / activation, cytokines retargeting / neutralization, dual ligands blocking and others), [C] key targets (CD3 x CD19, CD30 x CD16A, Factor IXa x Factor X, IL-13 x IL-4, IL-17A x Albumin, IL-17A x IL-17F, IL-1α x IL-1β, Psl x PcrV, TNF-α x HSA and VEGF-A x ANG-2), [D] type of antibody formats (asymmetric, fragments, symmetric and others), [E] key players (AbbVie, Affibody, Affimed, Amgen, AstraZeneca, Merck, Roche, Sanofi and Taisho Pharmaceutical) and [F] key geographical regions (North America, Europe and Asia Pacific). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in the report were also influenced by discussions held with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order):

• Martin Steiner (Chief Executive Officer, Synimmune)
• Ludger Große-Hovest (Chief Scientific Officer, Synimmune)
• Jane Dancer (Chief Business Officer, F-Star)
• Siobhan Pomeroy (Senior Director, Business Development, Cytom X)
• Yinjue Wang (Associate Director, Process Development, Innovent Biologics)

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.