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BioJournal - Drug and Market
Development
http://www.bioportfolio.com/cgi-bin/acatalog/Drug_and_Market_Development.html
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D&MD’s Expanding Opportunities in Contract Research and Contract
Manufacture of Biotherapeutics/ Biologics market analysis report is a
comprehensive compilation of CROs, CMOs and their numerous secondary
interconnections. This report traces the funding of the CRO network and
highlights failure points along the chain of the biologic’s production
including the realization that pharmaceutical productivity decline is most
imminent in Phase II failure rates. |
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The pharma industry loses about $20 billion annually to counterfeiters.
Artesunate, a major weapon against malaria, is widely counterfeited.
Researchers have found that up to 33 percent of the artesunate sold in
Thailand, Cambodia and Vietnam contained no active ingredients. Of 30
medicines named in a list of drugs especially susceptible to counterfeiting,
23 are used in treating HIV/AIDS and cancer. |
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Regulatory bodies in the US, Canada, EU and Japan accept the CTD
document format when applying for IND and NDA approval. This multiparty
agreement, led by the ICH Harmonization, facilitates the application process
when multi-nation regulatory approvals are being sought. The ground work and
preparation of the CTD is critical since it serves as the platform for
regulatory filings. Module 3 of the CTD focuses on Chemistry, Manufacturing
and Controls (CMC) documentation relating to substance and product quality.
Providing the correct information in sufficient detail in this section will
reduce delays and costs. |
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D&MD's Transdermal & Transmucosal Delivery of Therapeutics, 2nd Edition
market analysis report estimates the transdermal/transmucosal drug delivery
market is poised for growth through 2010.
Delivering drugs non-invasively through the skin, and particularly through
the mucosa in the oral cavity or nose, has grown from a specialized
application field to a formulation option that is not only convenient for
the patient but also combines sustained or flash delivery with improved
metabolic profile. While transdermal and transmucosal drug delivery had
mainly focused on smoking cessation and cancer pain a few years ago, the
therapeutic scope has since dramatically expanded to include contraception,
sexual dysfunction, alcohol abuse, attention deficit disorder, and
Parkinson's disease, among others. In addition, new chemical entities are
now being specifically tailored for this route of administration as a
competitive marketing strategy. |
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G-protein coupled receptors (GPCRs) have proven to be a highly amenable
target class to successful therapeutic intervention via small-molecule
drugs. There are 324 distinct molecular drug targets for all classes of
approved pharmaceuticals of which 25 percent modulate GPCRs. |
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D&MD's Current Drug Development Market for Cytokines, Chemokines and
Growth Factors focuses primarily on the cytokine market, company pipelines
and trials in the field of cytokine research. This report succinctly details
all the latest advances in the push to market of cytokine-based
therapeutics: which products have evolved, which have failed and new players
on the field. Primary readers will have comprehensive updates on relevant
company pipelines. |
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The Discovery to IND process currently takes an average of 6.5 years and
consumes over 40% of the total R&D budget for a new drug. This critical,
initial phase yields a drug candidate that, with FDA approval of an IND,
will enter Phase 1 clinical trials in healthy human volunteers. The stakes
are high because the initiation of human clinical trials commits a company
to significant additional R&D investment. Consequently, the process of drug
candidate discovery through to IND submission which consists of a series
linear and parallel, steps, procedures and outcomes critical to reducing the
risk of further investment. This initial phase is also governed by the need
to present a cogent case before the FDA in order to gain approval to move
the candidate into clinical trials. |
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Next-generation molecular diagnostics utilize multiplexing platforms
(such as DNA and protein microarrays, or bead-based technologies), to
perform parallel biomarker analyses in order to obtain more comprehensive
clinical information. During 2005 and 2006, the FDA approved the first DNA
microarray instrumentation system for IVD use (Affymetrix's GeneChip System
3000Dx), and the first highly multiplexed diagnostic microarrays: Roche's
AmpliChip CYP450 test, and two cystic fibrosis tests - Tm Bioscience's
Tag-It and Osmetech's eSensor. Although they have not yet been approved by
the FDA, tests based on transcriptomic and proteomic profiling have also
debuted successfully on the market. |
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While the bulk of the business for enzymes is still serving the
industrial market, the growth areas are increasing utilizing biotechnology.
Revolutionary changes in molecular biology are churning out thousands of new
uses of enzyme technology, fueling major growth in this multi-billion-dollar
field.
D&MD's Commercial Opportunities in Enzyme Technologies, 3rd Edition examines
the many current opportunities for enzymes as well as areas targeted for
future growth. Specific attention is paid to the growing and various uses of
enzymes over several industries from industrial uses to therapeutic targets.
In addition, this Report profiles companies designing and producing enzymes,
detailing their technologies and product pipelines. |
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Unprecedented levels of funding reaching tens of billions of dollars
from governments, large corporations and private venture capital during the
last decade, has yet to bear the fruits on the ROI. Optimistic predictions
have slowly given way to the painful reality that the impact of
nanotechnological applications may take one or two decades before
anticipated pay offs become apparent. However, a recent analysis of more
than 200 commercially available products that use nano-based technological
enhancements in the pharmaceutical, medical or healthcare field is
reinforcing the notion that "incremental" modifications of existing drugs,
drug delivery devices and tissue engineering products enhanced by nano
innovations is actually profitable and beginning to harvest revenue. |
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Several new developments have taken place in the Antibody Therapeutics
in the last two years. These developments are primarily in the antibody
market place and in clinical development areas as opposed to in the antibody
discovery field as was observed in the early part of this decade. That the
emphasis in the field has shifted from the discovery area towards product
development is obvious by the fact that many of the companies are now
involved in building product based collaborations and in some cases major
antibody discovery companies have become attractive enough that some of
those have been acquired by large pharma organizations. |
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The kinase-targeted drug market is forecast to reach $58.6 billion in
2010.
D&MD's Kinases: Advanced Strategies for Drug Discovery market analysis
report comprehensively reviews protein kinases and assesses their importance
as drug targets. Approaches to kinase drug discovery are evolving. Small
molecule inhibitors now encompass rationally-designed single-target
inhibitors and multi-target inhibitors developed with the aid of new
screening and profiling assays. Innovative biopharmaceuticals are making
inroads into the market. The range of indications for kinase-targeted drugs
is expanding. |
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This Guide thoroughly evaluates the capabilities, strengths, weaknesses,
and expectations of leading assays and assay technologies.
Assay development is often time consuming and frustrating. But reliable,
robust assays are key to every phase of pharmaceutical development. D&MD's
Assay Development & Technology, 2nd Edition provides critical information to
speed and simplify the development and optimization of most technologies.
This Guide eliminates the tendency to "reinvent the wheel" by providing
valuable tips that incorporate the author's many years of hands-on
experience in the field. |
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About $70 million (20%) of the total R&D costs per drug are spent on
ADME/Tox failures.
Preclinical toxicity is one of the major bottlenecks in drug development. In
particular, the ability to predict the safety of a drug in the preclinical
stage, prior to human testing, has been one of the major bottlenecks in drug
development. Current approaches have serious limitations in their ability to
predict toxicity in humans, and thus invite substantial risk not only in
terms of patient welfare, but also in terms of the cost of late-stage
clinical trial failure. The integration of novel and traditional approaches
to preclinical toxicity assessment will have a major impact on the ability
to predict compound behavior in humans, reduce clinical trial failure, and
cut both risk and cost in drug development. |
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This report focuses on two key pharmaceutical target classes-GPCRs and
Ion Channels. GPCRs and Ion Channels are important targets. They are
associated with a number of disease areas and are currently associated with
blockbuster pharmaceutical sales status. Identifying future direction of
industry growth opportunities in these spaces can be challenging. |
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Recent projections predict a serious shortfall in manufacturing capacity
in the next 3 years.
The biotechnology industry has been growing at a rapid rate, currently
topping $35 billion worldwide. The industry most affected by this impressive
growth is the bioprocessing industry, which provides the means for the
fabrication, and testing of biopharmaceutical products. The bioprocessing
industry is under constant pressure to increase efficiency, reduce
production costs, and speed time to market. To meet these heavy demands,
bioprocessing companies are adapting and innovating faster than ever. |
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D&MD's updated Good Manufacturing Practices professional development
guide provides pharmaceutical and biological companies of all sizes with
assistance in regulatory compliance. The guide examines the new FDA Guidance
for Industry documents and a new amendment covering an exemption for
investigational drugs in Phase 1 studies. The guide is addressed
particularly to smaller sized companies, perhaps those with their first new
drug, working on this extra challenge to their capabilities. |
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D&MD’s High-Growth Diagnostics: Technology and Market Analyses of
Segments experiencing Robust Growth in the Various Diagnostics Spaces market
analysis report focuses on the market segments within the diagnostics
industry that are currently experiencing robust growth. This also analyzes
the technologies, markets (both qualitatively and quantitatively), and key
companies within this space. |
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D&MD’s new Pain Therapeutics market analysis report focuses on new
advances in drug discovery and development. The report provides a background
on pain, current therapies and research and development in the area.
Profiles of companies with major pain programs include Abbott Laboratories,
AstraZeneca, GlaxoSmithKline, GW Pharmaceuticals, Johnson & Johnson, Merck &
Co., Neuromed Pharmaceuticals, Novartis, Pfizer, Vernalis, VistaGen
Therapeutics, Xenome and more. In-depth interviews with industry leaders
provide specific case studies from both biotech and academia that give a
sense of what’s really going on in the trenches. |
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The transporter-targeted drug market is forecast to reach $153.8 billion
in 2010 and more than 100 transporter drug targets are under commercial
investigation.
Transporters represent a highly druggable class of targets and are addressed
by many successful drugs on the market. Of the 957 or so human transporter
genes, around 10 percent are being targeted for therapeutic effects, which
leaves a large number of potential targets unexplored. As additional
transporters are characterized and their structures are elucidated
competition in this field is likely to increase. |
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Five years after the historic completion of the Human Genome Sequencing
Project, personalized nutrition and medicine are fields evolving with an
emphasis on discovering and researching biomarkers to aid diagnoses.
Specifically, clinical pharmacogenomics, theranostics, and nutrigenomics are
all examples of areas where diagnostic have entered the arena of being used
in conjunction with drug treatments and nutrition recommendations. The
availability of genome sequences and biotechnology developments, such as
clinical microarrays during the last year, are driving the development of
diagnostics. At the same time, the technology is progressing, regulatory
issues have to keep up with the changes. The FDA approval of Affymetrix's
AmpliChip at the end of 2004 and beginning of 2005 as a 510K device rather
than analyte specific reagents reflects the changing landscape of genetic
testing regulation. Therefore, having examples and cases studies of business
strategies, business models, regulatory, and reimbursement issues are
extremely useful for learning and understanding the commercialization
process of diagnostics that are to be used in conjunction with therapeutics. |
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D&MD's Growth and Technological Advances of the Biodisposables Market is
valuable tool. The report details and reviews the implementation,
cost-effectiveness, utility and applications, including advances in specific
apparatus, for disposable biotechnology equipment including filters, mixers,
dispensers, connectors, storage bags and bioreactors. |
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Chronic Obstructive Pulmonary Disease (COPD) has been a much neglected
area in drug development for several decades but now is the fifth leading
cause of death worldwide.
Widely recognized as self-inflicted by smoking, COPD has often had low
priority in respiratory programs. It is now realized that at least 600
million people, worldwide, suffer from COPD-numbers indicative of epidemic
proportions. Governments, healthcare workers and pharmaceutical companies
have recently prioritized and raised awareness of this disease area as one
of major unmet medical need. Indicative of prioritization of this disease is
the widespread occurrence of COPD-specific drug discovery in respiratory R&D
in pharmaceutical companies. It is evident that a paradigm shift is taking
place in COPD drug discovery. Rather than the traditional approach of
symptom relief; new generation pharmaceuticals are beginning to target
underlying disease. |
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To date, three types of molecules have been developed for the treatment
of human diseases. These major classes of molecules are 1) small molecules,
2) antibodies, and 3) peptides. Currently, the majority of the therapeutic
molecules developed and marketed are small molecules. However, with the
recent development in several technologies in the areas of peptide
synthesis, screening, stability, and modifications, peptides are now
recognized as lead molecules for therapeutics. |
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Securing FDA approval or clearance is not a guarantee of payer coverage
or payment for your novel drug or device. D&MD's Guide to US Reimbursement
for Drugs, Medical Devices, and Diagnostics is a comprehensive review of how
medical technologies secure payment from private and public payers. The
Guide examines coverage, coding, and payment issues from private payer (HMO,
PPO) and public payer (Medicare, Medicaid) perspectives. The Guide is
indispensable for life science technology executives who are responsible for
reimbursement strategy, securing reimbursement, or assessing the value of a
new technology with reimbursement in mind. D&MD's Guide to US Reimbursement
for Drugs, Medical Devices, and Diagnostics will provide insight to a wide
audience of product managers, reimbursement planners, business development
executives, and CEOs. |
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D&MD’s Life Sciences Mergers & Acquisitions (M&A): A Reference Guide
Illustrating Recent Trends in Life Science M&A market analysis report
focuses on mergers & acquisitions (M&A) in the general life sciences space.
This report is an excellent reference guide for the life sciences audience
engaged primarily in drug discovery and development. The report includes
information on the latest industry statistics on recent life sciences merger
and acquisition transactions in biotechnology and medical devices, latest
industry statistics on initial public offerings (IPOs) and venture capital
investing. Specifically, key merger and acquisition transactions within the
last 18 months in the life sciences tools space are presented and
characterized in this report to help readers spot growth trends or define
exit strategies.
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High-content Screening (HCS) is a focused term referring to the
re-screening process-referred to sometimes as secondary screening-whereby
the use of different types of assays enables a number of different
parameters of a system to be assessed, in the presence of given lead
compounds (in this manner, the effect of lead compounds on the biological
system can be studied and those leads that display significant toxicity, for
instance, can be eliminated early in the process-thereby enabling triage of
the sub-optimal leads). |
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The bio-outsourcing trend is being influenced by recent developments such as
dwindling biopharmaceutical financial support, increasing costs associated
with building biomanufacturing facilities, increasing regulatory complexity
surrounding biomanufacturing, shortages of qualified manufacturing and
technical personnel, and the advent of disposable technologies. |
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Breast Cancer treatment is undergoing major transition. New targeted
therapies are emerging that target cancer cells and spare healthy cells,
resulting in reduced side effects. These developments have arisen following
at least two decades of research into the molecular mechanisms that underlie
cancer phenotypes. |
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Traditionally, treatment of human diseases is carried out by small or
large molecules that modulate specific cell types. In the majority of the
cases, such as cancer, the aim of the treatment is to kill cancer cells,
leading to the physiological benefit of the organism. In other
circumstances, the disease cells are manipulated to perform a specific
function that they normally do not. A variety of therapeutic molecules have
been utilized to carry out for treatment leading to therapeutic benefit.
These include small molecules, peptides, proteins, antibodies, anti-sense
RNAs, and ribozymes. In the case of cell therapy, as the name indicates,
treatment is carried out with cells instead of small molecules, as mentioned
above. In cell therapy, cells are given to the patient as the therapeutic
delivery system for a specific disease to achieve therapeutic benefit. |
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The application of pharmacogenomics in drug development is widespread
today in differing degrees of intensity. Pharmacogenomics has recently seen
an inflection point that pharmaceutical and biotechnology companies need and
want to understand. Given recent issues with Cox-2 inhibitors and
anti-depressants, the FDA is increasingly focused on bringing personalized
medicine to this area. Advances in patents and technology are occurring at a
faster rate than ever before. The first FDA approved test in this area was
for the Roche and Affymetrix 2D6 GeneChip. |
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