LONDON, Oct. 12, 2017 /PRNewswire/
-- INTRODUCTION
A number of monoclonal antibodies (more than 70) have already been
approved for use in humans. These therapeutic products, which
target a particular epitope on an antigen, have become a popular
and robust treatment option for various diseases. However, despite
the success of antibody therapeutics, there are several limitations
associated with the use of mono-specific antibodies. It has been
reported that certain patients treated using these therapeutic
modalities have failed to respond, or have developed resistance to
the therapy.
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Moreover, since the development and progression of several
diseases, such as cancer, are dependent on the cross-talk between
multiple signaling pathways, molecules directed against a single
target may not elicit the desired therapeutic effect.
Bispecific antibodies have demonstrated the capability to address
the existing challenges associated with monoclonal antibodies, such
as high manufacturing costs, limited applicability in assays and
the general lack of understanding of precise in vivo mechanisms of
action. Although the concept of bispecific antibodies was conceived
more than five decades ago, this field has gained significant
popularity in recent years.
These molecules have the potential to be used across a broad range
of application areas; for example, they can be used to redirect
effector cells, simultaneously modulate more than one signaling
pathway, and deliver toxic payloads to target sites in a more
specific manner. It is also important to highlight that advances in
molecular cloning technologies, coupled with a better understanding
of antibody engineering techniques, have led to the discovery and
development of a number of different bispecific antibody formats,
setting them up for use across novel application areas as well.
SCOPE OF THE REPORT
The ‘Bispecific Antibody Therapeutics Market (3rd Edition),
2017-2030’ report provides a comprehensive study of the current
landscape of bispecific antibodies, featuring an elaborate
discussion on the future potential of this upcoming market. The
field has captured the interest of several drug developers,
including both small and large companies. As indicated before, the
applicability of these engineered biomolecules is vast.
Presently, only one bispecific antibody, BLINCYTO® (2014), is
available for therapeutic use. However, the development pipeline of
bispecific antibody based drugs has several promising candidates
that are likely to result in commercial success stories in the
foreseen future. The overall pipeline comprises of over 200
molecules that are under development for the treatment of various
disease indications across different therapeutic areas, including
oncology, autoimmune disorders and infectious diseases. Of these,
more than 60 molecules are currently under clinical evaluation,
while over 140 product candidates are in the discovery /
preclinical stages.
The evolving market has its hopes pinned on multiple start-ups,
small and large-sized companies, which are engaged in this
domain.
Amongst other elements, the report features:
• A review of the current market landscape, featuring a detailed
analysis based on target disease indications / patient segments,
phases of development of product candidates (clinical and
preclinical / discovery), bispecific antibody formats (fragment
based bispecific antibodies, asymmetric bispecific antibodies and
symmetric bispecific antibodies), routes of administration
(intravenous, subcutaneous, and intravitreal) and mechanisms of
action (dual targeting, T-cell engagement, NK-cell engagement,
half-life extension and bispecific antibody drug conjugate).
• Comprehensive profiles of marketed and clinical stage (phase II
and above) bispecific antibody therapeutics, highlighting their
current status of development, clinical trial information and trial
results, and a brief overview, financial performance (if
available), and an informed future outlook of the developer.
• An analysis of the partnerships that have been inked between
stakeholders in the industry in the recent past, covering research
collaborations, licensing agreements, product development /
commercialization agreements, manufacturing agreements, mergers /
acquisitions, product development agreements, clinical trial
collaboration and other deals.
• A grid analysis, representing the distribution of the pipeline
of bispecific antibodies (on the basis of mechanisms of action of
product candidates and antibody formats) across different
therapeutic areas and stages of development.
• A bubble analysis comparing the available technology platforms
on the basis of important parameters, such as clinical activity
(based on the number of drug candidates developed using a
particular technology), number of partnerships established and the
size of the developer company.
• A spider-web analysis highlighting the popularity of different
mechanisms of action of bispecific antibody candidates. The
analysis takes into consideration various parameters, such as
number of bispecific antibodies, number of ongoing clinical trials,
target therapeutic indications, number of publications and the
companies that are developing these molecules.
• An elaborate discussion on a lifecycle management strategy,
depicting how companies are using indication expansion as a tool to
expand their foothold in the field of bispecific antibody
therapeutics.
• A case study on the key promotional strategies adopted for
marketing the approved bispecific antibody, BLINCYTO®, and other
competitive molecules that have been recently approved for the
treatment of relapsed or refractory B-cell acute lymphoblastic
leukemia.
One of the key objectives of the report was to understand the
primary growth drivers and estimate the future size of the market.
Based on 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 mid to long term, for the period 2017-2030.
The research, analysis and insights presented in this report
include potential sales of bispecific antibody therapeutics that
are currently marketed or are in the late stages of development. To
account for the uncertainties associated with the development of
novel bispecific antibody therapeutics 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 held with senior stakeholders in the
industry. The study includes detailed transcripts of discussions
held with Jane Dancer (CBO, F-star),
Ludge Gro•e-Hovest (Founder and CSO, Synimmune), Siobhan Pomeroy (Senior Director, Business
Development, CytomX Therapeutics) and 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 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 over the coming
10-15 years, 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 bispecific antibody therapeutics market in the mid
to long term.
Chapter 3 provides a general overview of antibodies covering their
historical background, structure, and the 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 includes information on over 200 bispecific antibody
therapeutics that are currently in different stages of development.
It features a comprehensive analysis of the pipeline molecules,
highlighting the target therapeutic areas, phases of development,
antibody formats, routes of administration and the corresponding
mechanisms of action.
Chapter 5 provides a list of technologies that are either currently
available, or being developed by various firms, for the generation
of bispecific antibody therapeutics. In addition, it features
detailed profiles of some of the key technologies that have been
used to develop at least four clinical and / or preclinical
bispecific antibody candidates. Each profile contains details on
the technology, such as the structure of bispecific antibody,
pipeline molecules developed using the technology, its advantages
and partnerships established related to the technology.
Chapter 6 contains detailed profiles of drugs that are in advanced
stages of clinical development (phase II, filed and marketed). Each
profile provides information on the mechanism of action, current
status of development, dosage form and treatment regimen,
information on clinical studies and key clinical trial results of
the drug. It also includes an overview of the developer, its
financial 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 bispecific antibody
therapeutics that are either marketed or are in advanced stages of
clinical development (phase II and preregistration). 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 (oncology, autoimmune
disorders, inflammatory disorders, eye disorders and others) and
mechanisms of action (T-cell engagement, NK-cell engagement, dual
targeting, blocking cytokines and others).
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 and the most common forms of deals /
agreements that have been established between 2012 and 2017.
Chapter 9 is a compilation of key insights derived from the study.
It presents a detailed logo landscape of the companies engaged in
developing bispecific antibody based products, distributed based on
the developmental status of pipeline candidates and size of the
companies (small, mid-sized and large companies). The chapter also
features a grid analysis, representing the distribution of
bispecific antibody candidates (on the basis of their mechanisms of
action and formats) across target therapeutic areas and stages of
development. It also features a comparative study, presented in the
form of a bubble analysis, of the different platforms that are
being utilized for the generation of bispecific antibodies. The
parameters considered for this analysis include the 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 the size of the developer
company. Additionally, the chapter features a spider-web analysis,
which highlights the activity of bispecific antibodies based on
their mechanisms of action. The parameters considered for this
analysis include number of drug candidates, active clinical trials,
publications, target indications and the companies that are
involved in this domain.
Chapter 10 includes a detailed discussion on product life cycle
management strategies. It primarily focuses on the indication
expansion strategy, which is being used extensively by the
developers of bispecific antibody based therapeutics.
Chapter 11 highlights the key promotional strategies that are being
implemented by the developer (Amgen) of the marketed bispecific
antibody, BLINCYTO® (approved for the treatment of relapsed or
refractory B-cell precursor acute lymphoblastic leukemia). For the
purpose of this analysis, we also studied the promotional
activities of two other drugs, namely Iclusig® and Marqibo®,
which are approved for the treatment of the same indication. The
promotional aspects covered in the chapter include details provided
on the product website (covering key messages for patients and
healthcare professionals), patient support offerings and
informative downloadable content, and product visibility in
scientific conferences.
Chapter 12 provides a detailed analysis capturing the key
parameters and trends that are likely to influence the future of
the bispecific antibodies market within the biopharmaceutical
industry, under a comprehensive SWOT framework.
Chapter 13 is a summary of 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 14 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 Jane Dancer (CBO, F-star), Ludge Gro•e-Hovest
(Founder and CSO, Synimmune), Siobhan
Pomeroy (Senior Director, Business Development, CytomX
Therapeutics) and Yinjue Wang (Associate Director, Process
Development, Innovent Biologics).
Chapter 15 is an appendix, which provides tabulated data and
numbers for all the figures included in the report.
Chapter 16 is an appendix, which provides the list of companies and
organizations mentioned in the report.
EXAMPLE HIGHLIGHTS
1. Close to 68% of bispecific antibody based therapeutic products
are in the early stages of development (preclinical / discovery),
while one bispecific antibody therapeutic (BLINCYTO®) is approved
for the treatment of acute lymphoblastic leukemia. 11 products are
in advanced clinical evaluation (phase II and above); these include
(in alphabetical order) ABT-981 (AbbVie), AFM13 (Affimed), Anti-CD3
MUC1 bispecific antibody (Benhealth Biopharmaceutical), emicizumab
(Chugai Pharmaceutical), HER2Bi-Armed Activated T Cells (Barbara
Ann Karmanos Cancer Institute), istiratumab (Merrimack
Pharmaceuticals), MEDI3902 (MedImmune), ozoralizumab (Ablynx),
RG7716 (Roche), SAR156597 (Sanofi)
and vobarilizumab (Ablynx).
2. The market landscape is well distributed across small (33),
large (30) and mid-sized (25) companies. Some of the prominent
small-sized companies engaged in this domain include (in
alphabetical order) Affimed, Avillion, Amphivena Therapeutics,
Benhealth Biopharmaceutical, EngeneIC and Oxis Biotech. In
addition, well established companies, such as (in alphabetical
order) Amgen, AstraZeneca, Boehringer Ingelheim, Bayer, Emergent
BioSolutions, Merck, Pfizer, Roche and Sanofi, are also actively
involved in this domain. It is worth mentioning that several
universities / research organizations have also contributed to the
development of bispecific antibody therapeutics; examples include
(in alphabetical order), Barbara Ann Karmanos Cancer Institute,
California Institute for Biomedical Research, Duke NeuroSurgery,
Fraunhofer Institute of Molecular Biology and Applied Ecology, Sun
Yat-Sen University, The First Affiliated Hospital with Nanjing
Medical University, The Scripps Research
Institute and Vanderbilt Vaccine Center.
3. Bispecific antibodies are capable of simultaneously targeting
more than one target and are, therefore, capable of treating
clinical conditions that are characterized by cross-talk between
multiple disease related pathways. Currently, almost 80% of the
development programs are focused on oncological indications,
including hematological cancers and solid tumors. Apart from
oncology, autoimmune disorders are the most popular; close to 9% of
candidate drugs in the pipeline are being developed for such
clinical conditions. It is also worth highlighting that the
bispecific antibody products are being developed for other
therapeutic areas, such as infectious diseases, blood disorders and
eye disorders.
4. The market features the presence of a diverse range of
bispecific antibody generation platforms, which is indicative of
the ongoing innovation in this domain. During our research, we
identified around 50 unique platforms that have been developed /
are being developed for the generation of different bispecific
antibody therapeutics. Of these, we observed that 11 technology
platforms are being extensively used; these include (in
alphabetical order) Dual Affinity Re-targeting (DART)
(MacroGenics), Bispecific T-cell Engager (BiTE) (Amgen), CrossMAb
(Roche) and Nanobody (Ablynx)
5. Close to 100 partnerships were inked between various
stakeholders in the industry during the period between 2012 and
July 2017. Of these, approximately
43% were early R&D related deals; recent examples include
Ablynx and Sanofi (July 2017), Numab
and Kaken Pharmaceutical (June 2017),
and Merus and Institute for Research in Biomedicine, Barcelona (January
2017). Other popular types of collaborations were product /
technology licensing agreements (23%), product development and
commercialization agreements (16%), manufacturing agreements (4%)
and merger / acquisitions (4%). Some of the acquisitions that we
came across include Celgene Corporation and EngMab (October 2016), and Aduro Biotech and BioNovion
(September 2015).
6. Our future market outlook is highly optimistic as we expect
several new drugs to be approved and launched over the coming
decade. Examples of drugs in late stages of development include
emicizumab, ABT-981, SAR156597,
vobarilizumab, istiratumab, AFM13, MEDI3902 and RG7716. In fact, by
2030, we expect the market to grow at an annualized rate of ~34%.
Specifically, we believe that emicizumab, istriatumab, ABT-981 and
AFM13 will attain blockbuster status and become prime contributors
to the market’s revenue.
7. Majority of product candidates are T-cell engagers; molecules
using this particular mechanism of action are estimated to capture
58% share of the market by 2023. However, in the long term (by
2030), molecules belonging to other product classes having
different mechanisms of action, such as blocking cytokines, dual
targeting, and half-life extension, are collectively projected to
capture almost 75% of the market.
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