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

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

  • January 2020 •
  • 363 pages •
  • Report ID: 2530816 •
  • Format: PDF
INTRODUCTION
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-1? x IL-1?, Psl x PcrV, TNF-? 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 Gro•e-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.

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 may evolve across different regions and technology segments. Wherever 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 period 2019-2030, 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 key insights captured in our research. It offers a high-level view on the current state of the market for bispecific antibody therapeutics and its likely evolution in the mid to long term.

Chapter 3 provides a general overview of antibodies, including their historical background, structure, and the different types of antibodies available, along with their mechanisms of action. In addition, the chapter highlights the evolution of antibody-based therapeutics over the last few years. It also features a discussion on bispecific antibodies, elaborating on the different bispecific formats that are currently available, mechanisms of action of various products / product candidates and their applications.

Chapter 4 provides information on over 300 bispecific antibody drug candidates that are either approved or in different stages of development (clinical and preclinical / discovery). It features an analysis of drug developers on basis of various parameters, such as year of establishment, company size and geographical location, phase of development (marketed, clinical, and preclinical / discovery stage) of the pipeline molecules, target antigens, type of antibody format (symmetric antibody format, asymmetric antibody format, fragments and others), mechanism of action, target disease indication(s), therapeutic area, broader disease segment (oncology / non-oncology), route of administration and patient segment.

Chapter 5 includes a list of innovative 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. Each profile contains details on the technology, including the pipeline molecules being developed using the technology, its advantages and partnerships established related to the technology. 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) and the size of the developer company. In addition, it features a schematic world map representation, highlighting the geographical locations of technology developers, along with the symbol representation for drug portfolio for each technology.

Chapter 6 provides detailed profiles of marketed drugs and mid to late stage (phase II and phase III) candidates. Each profile provides information on the drug overview, including route of administration, developer, highest phase of development, primary indication, therapeutic area, special designation (if any), key targets, mechanism of action, technology used, current status of development, information on clinical studies and key clinical trial results of the drug, antibody format (if available) and construct (if available). It also includes an overview of the developer, its financial details and annual sales of the drug, in case of approved drugs.

Chapter 7 is a compilation of key insights featuring a grid analysis, representing the distribution of pipeline (on the basis of mechanisms of action of product candidates) across different therapeutic areas and stages of development, 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 and a two-dimensional scattered plot competitiveness analysis, for the various target combinations for clinical-stage bispecific antibodies. It also presents a detailed logo landscape of the companies engaged in the development of bispecific antibody-based products, distributed based on the status of development of their pipeline candidates and size of the company (small, mid-sized and large companies).

Chapter 8 highlights 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.

Chapter 9 features the different partnership models and the most common forms of deals / agreements that have been inked amongst players in this market between 2016 and 2019 (till September). It also presents an analysis of the various collaboration agreements signed in this domain, based on the year of partnership, type of partnership, therapeutic area, most active developers (in terms of number of partnerships), most active contract manufacturers (in terms of number of manufacturing agreements) and regional analysis.

Chapter 10 highlights the key manufacturing steps involved, and challenges associated with the manufacturing of bispecific antibodies. In addition, it consists a list of CMOs and CROs involved in this domain along with the details on their headquarters, year of establishment and other specific information, such as scale of operation of CMOs and research services offered by CROs. The chapter also highlights the key points that bispecific antibody developers need to consider while or selecting a suitable CRO / CMO.

Chapter 11 presents an analysis of the various clinical trials of bispecific antibodies registered across the world (which have last update of 2019). The analysis was done for clinical trials across various parameters, such as 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 based on the number of trails and number of patients enrolled.

Chapter 12 is a review of regulatory guidelines issued by the ICH, WHO and FDA related to the development of bispecific antibodies. In addition, it provides details related to the responses of the various pharmaceutical industries to the FDA guidelines.

Chapter 13 highlights the key promotional strategies that are being implemented by the developers of the marketed bispecific antibodies, namely Blincyto® and Hemlibra®, and comparison of both the drugs based on the information available on their respective websites. The promotional aspects covered in the chapter include the drug overview, details provided on the product website (covering key messages for patients and healthcare professionals), patient support offerings, informative downloadable content, and product visibility in scientific conferences.

Chapter 14 provides 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 bispecific antibody therapeutic market.

Chapter 15 presents a comprehensive market forecast analysis, highlighting the future potential of the market till the year 2030. It includes future sales projections of bispecific antibody therapeutics that are either marketed or in advanced stages of clinical development (phase II and phase III). 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, hematological malignancies, autoimmune disorders, infectious diseases, inflammatory disorders, eye disorders and skin disorders), key 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-1? x IL-1?, Psl x PcrV, TNF-? x HSA and VEGF-A x ANG-2), [D] type of antibody format (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).

Chapter 16 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it captures the evolutionary trends that are likely to determine the future of this segment of the bispecific antibody therapeutics industry.

Chapter 17 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. The chapter provides details of interviews held with Martin Steiner (Chief Executive Officer, Synimmune), Ludge Gro•e-Hovest (Founder and Chief Scientific Officer, Synimmune), Jane Dancer (Chief Business Officer, F-Star), Siobhan Pomeroy (Senior Director, Business Development, Cytom X) and Yinjue Wang (Associate Director, Process Development, Innovent Biologics).

Chapter 18 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 19 is an appendix, which provides the list of companies and organizations mentioned in the report.