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Key Inclusions
§
A detailed assessment of the current market landscape of
microbiome therapeutics, providing information on drug / therapy developer(s)
(such as year of establishment, location of headquarters and company size),
clinical study sponsor(s) or collaborators, phase of development (clinical,
preclinical, and discovery stage) of product candidates, type of molecule
(small molecule and biologic), type of therapy (prebiotic, probiotic, and
prescription drug), target indication(s), key therapeutic area(s), molecular /
biological target (if available), mechanism of action (if available), route of
administration, type of drug formulation (tablet, capsule, gel, lotion, cream,
ointment, nasal spray and 4+ categories), dosing frequency (reported for
clinical candidates only), and information on special drug designations (if
any). In addition, the chapter highlights the various technology platforms that
are being actively used for the development of microbiome therapeutics.
§
Elaborate profiles of key players (established after 2005)
that are engaged in the development of microbiome therapeutics (which are
presently in both preclinical and clinical stages of development); each profile
features a brief overview of the company, its financial information (if
available), microbiome-based product portfolio, information on advanced stage
(phase II and above) pipeline candidates (featuring a drug overview, current
status of development, clinical trial information, and clinical trial end-point
analysis) and an informed future outlook.
§
A discussion on the various types of diagnostic tests,
specifically highlighting the importance of next-generation sequencing within
this field of research, along with [A] a detailed review of the current market
landscape of microbiome diagnostic tests, including the information on the
developer(s) (such as year of establishment, location of headquarters and
company size), stage of development (commercialized and under development),
type of sample used (blood, feces, saliva and vaginal swab), target
indication(s), key therapeutic area(s), result turnaround time, and purpose of
diagnosis, [B] brief profiles of popular diagnostic developers, and [C] an
indicative list of screening and profiling test kits, including information on
the developer(s) (such as year of establishment, location of headquarters and
company size), type of sample used (blood, feces, saliva and vaginal swab), key
therapeutic area(s), and result turnaround time.
§
A review of the historical evolution and other relevant
aspects of FMT therapies, including details on the process of donor selection,
therapy procedure, route of administration, important clinical guidelines,
regulatory guidelines and insurance coverage, along with [A] a detailed
assessment of the current market landscape of FMT therapies, providing
information on FMT developer(s) (such as year of establishment, location of
headquarters and company size), status of development (commercialized,
clinical, and preclinical stage), target indication(s), key therapeutic
area(s), and route of administration, [B] a geographical clinical trial
analysis of ongoing / planned / completed studies of FMTs sponsored by
non-industry players, featuring details related to specific FMT therapies and
analysis based on relevant parameters, such as the number of registered trials,
year of registration, current status, phase of development, study design, type
of sponsor(s), target indication(s), key therapeutic area(s), key focus areas,
number of patients enrolled and leading non-industry player(s), and [C]
information on various stool banks (including year of establishment and
location of headquarters), along with brief profiles of the most prominent
stool banks located across the globe.
§
A detailed business portfolio analysis based on an
attractiveness and competitiveness (AC) framework, highlighting the current
market attractiveness and existing competition across the most popular disease
indication(s) for which microbiome therapeutics are under investigation.
§
An analysis of the varied microbiome-focused initiatives of
big pharma players (out of top 20 established pharmaceutical players),
featuring a [A] heat map representation that highlights microbiome therapeutics
under development (in partnership with core microbiome product developers),
along with information on funding, partnership activity, and diversity of product portfolio (in terms
of disease indication(s) being treated and focus therapeutic area(s)), and [B]
a spider web representation of the individual competitiveness of the
initiatives of big pharma players based on multiple relevant parameters.
§
An analysis of the start-ups / small-sized players (established
in the last seven years, with less than 50 employees) engaged in the
development of microbiome therapeutics and diagnostics, featuring heat map
representation based on parameters, such as number of microbiome therapeutics
under development, diversity of product portfolio, funding information
(including funding amount, number of investors and evolution of investment
activity), partnership activity, disease indication(s) being treated and focus
therapeutic area(s), and strength of intellectual property portfolio.
§
An assessment of the most commonly targeted therapeutic
indications and details of microbiome-based drugs that are being developed
against them, highlighting key epidemiological facts about specific diseases,
available methods of diagnosis, and currently available treatment options and
their side effects.
§
An analysis of the investments made, including seed
financing, venture capital financing, debt financing, grants, capital raised
from IPOs and subsequent offerings, at various stages of development in
start-ups / small-sized companies (established in last seven years, with less
than 50 employees) that are focused on developing microbiome therapeutics and
diagnostics.
§
An elaborate discussion on the various steps involved in
the development and manufacturing of microbiome therapeutics, along with [A] an
indicative list of contract manufacturers, along with details on year of
establishment, location of headquarters, company size, scale of operation, facility
location and microbiome production capacity, [B] an indicative list of
companies with in-house manufacturing facilities for microbiome therapeutics,
along with details on year of establishment, location of headquarters, and
company size, [C] an indicative list of CROs that currently claim to have the
necessary capabilities to offer various research services (such as screening,
sequencing, characterization, analytical), along with details on year of
establishment, location of headquarters, company size, and service portfolio
details, and [D] an insightful Harvey ball analysis of key considerations that
need to be taken into account by industry stakeholders while selecting a
suitable CMO / CRO partner.
§
An assessment of the emerging role of big data, highlighting
efforts focused on the development and implementation of various algorithms /
tools to analyze data generated from microbiome research along with [A] an
insightful google trends analysis to demonstrate the rising interest of
stakeholders in using big data tools to support microbiome research over the
past decade, [B] a list of companies offering big data-related services / tools
to support microbiome research, and [C] brief profiles of some of the popular
companies that are engaged in this field of research.
§
An informative case study on the various other applications
of microbiome products, such as agriculture, animal health, plant health, food
products, featuring a list of nearly 80 products, including probiotic
supplements, cosmetics, and over-the-counter (OTC) products that are being used
as dietary supplements.
The USD 4 billion (by 2030) financial opportunity
within the microbiome therapeutics (Tx) market and diagnostics (Dx) markets, has
been analyzed across the following segments:
§ Type
of Therapy (Tx)
§ Prescription
Drug
§ Prebiotics
§ Probiotics
§ Type
of Molecule (Tx)
§ Small
Molecules
§ Biologics
§ Target
Indication (Tx+Dx)
§ Acne
Vulgaris
§ Atopic
Dermatitis
§ Clostridium
difficile Infection
§ Colorectal
Cancer
§ Crohn’s
Disease
§ Diabetes
§ Irritable
Bowel Syndrome
§ Lactose
Intolerance
§ Lung
Cancer
§ Nonalcoholic
steatohepatitis (NASH)
§ Obesity
§ Ulcerative
colitis
§ Therapeutic
Area (Tx+Dx)
§ Autoimmune
Disorders
§ Dental
Disorders
§ Digestive
and Gastrointestinal Disorders
§ Dermatological
Disorders
§ Infectious
Disease
§ Metabolic
Disorders
§ Oncology
Others
§ Key
Geographical Regions (Tx+Dx)
§ North
America
§
Europe
§
Asia-Pacific and Rest
of the World
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Key Questions Answered
§
Who are the leading developers of microbiome therapeutics
and diagnostic tests?
§ What
are the key technology platforms (available / under development) for
microbiome-related therapies and diagnostics?
§ What
are the disease indications against which microbiome-based therapeutics are
being evaluated?
§ Which
companies are targeting gut-brain axis for the development of microbiome
therapies?
§ Who
are the leading (industry and non-industry) players involved in the development
of FMT products?
§ Who
are the key contract research / manufacturing service providers in this domain?
§ What
is the trend in capital investments in microbiome-related R&D?
§ What
are the contributions of big pharma players in this domain?
§ Which
are the popular players offering big data-related services / tools to support
microbiome research?
§
How is the current and future market opportunity for
microbiome-based therapeutics and diagnostics is likely to be distributed
across key market segments?
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Contact:
Gaurav Chaudhary
+1
(415) 800 3415
Gaurav.Chaudhary@rootsanalysis.com
