Clinical Laboratory Testing Volume 2: Business Strategies

Clinical laboratory testing is generally categorized as either of two general areas--clinical testing and anatomical pathology testing. Clinical and anatomical pathology procedures are frequently ordered as part of regular physician office visits and hospital admissions in connection with the diagnosis and treatment of illnesses. As such, clinical laboratory analysis is one of the most important sections of medical care.

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Booming Clinical Trials Market in India

The clinical trial market in India looks very lucrative. The country promises to be one of the hottest destinations for conducting global clinical trials, owing to a huge patient pool representing both chronic and infectious diseases, easy recruitment of patients, and high cost savings. Moreover, the market is getting boost from improved IPR protection with changed rules and also from reduced taxes and duties.

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Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment

Pharma and biotech companies are attempting to combat escalating R&D costs and lengthy clinical trial timelines by improving patient recruitment and the efficiency of clinical trial analysis/reporting. The biopharmaceutical market has recognized the opportunities and advantages that exist by conducting clinical trials in emerging markets. Although these markets offer a number of significant benefits over traditional clinical trial settings, there remain a variety of challenges and problems associated with conducting trials in emerging regions.

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Emerging Clinical Trial Locations – Eastern Europe: Market dynamics and the changing healthcare and regulatory environment

Over the last decade pharmaceutical and biotechnology companies have entered a period where they have become confronted by a variety of complex issues affecting their operational efficiency and profitability. It has now become generally acknowledged that the current business models have become both economically unsustainable and operationally unsuited to act quickly enough to produce the types of innovative treatments that will be demanded by global markets.

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Emerging Clinical Trial Locations – China: Market dynamics and the changing healthcare and regulatory environment

Over the last decade pharmaceutical and biotechnology companies have entered a period where they have become confronted by a variety of complex issues affecting their operational efficiency and profitability. It has now become generally acknowledged that the current business models have become both economically unsustainable and operationally unsuited to act quickly enough to produce the types of innovative treatments that will be demanded by global markets.

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Emerging Clinical Trial Locations – India: Market dynamics and the changing healthcare and regulatory environment

Over the last decade pharmaceutical and biotechnology companies have entered a period where they have become confronted by a variety of complex issues affecting their operational efficiency and profitability. It has now become generally acknowledged that the current business models have become both economically unsustainable and operationally unsuited to act quickly enough to produce the types of innovative treatments that will be demanded by global markets.

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Emerging Clinical Trial Locations –Latin America: Market dynamics and the changing healthcare and regulatory environment

Over the last decade pharmaceutical and biotechnology companies have entered a period where they have become confronted by a variety of complex issues affecting their operational efficiency and profitability. It has now become generally acknowledged that the current business models have become both economically unsustainable and operationally unsuited to act quickly enough to produce the types of innovative treatments that will be demanded by global markets.

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Clinical Chemistry Analyzers

Clinical chemistry analysis is one of the most important areas within clinical laboratory analysis. The term clinical chemistry usually refers to determining the concentration or activity of a protein, carbohydrate, lipid, electrolyte, enzyme or small molecule in easily-collected bodily fluids such as blood, serum, plasma or urine. However, it is not necessarily limited to these determinations. The analysis of virtually any biologically-active substance—any place in the body—can loosely be defined as clinical chemistry. In fact, traditional specialization barriers such as microbiology, hematology, blood banking, immunology and even anatomical pathology are rapidly fading, both operationally and instrumentally. But for the sake of defining the subject to a reasonable size, the more traditional scope of clinical chemistry will be the subject of this TriMark Publications study. The purpose of this report is to describe the specific segments of the global clinical chemistry instrumentation market. Specifically, this study examines the markets for small lab and highly-automated, large lab platforms, as well as accessory equipment such as reagents, supplies and manufacturers’ original equipment manufacturer (OEM) additional equipment. The emphasis is on those companies and products that are actively developing and marketing chemistry analyzer products for the clinical setting, including hospitals, independent labs, physician’s offices and clinics. Concentration is on the clinical chemistry instrumentation industry market segment in the U.S. and around the world. Particular attention is paid to those areas of the clinical chemistry instrumentation sector that are showing the greatest growth or the most innovation.

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Clinical Immunoanalyzer Markets

Clinical immunoanalyzer analysis is one of the most important functions of clinical laboratory analysis. By all accounts, automated immunoassay testing is the most rapidly developing of the traditional clinical laboratory sectors. Clinical immunoanalyzer analysis usually refers to determining the concentration or activity of protein, carbohydrate, lipid, enzyme or small molecule in easily collected body fluids, such as blood, serum, plasma or urine. However, it is not necessarily limited to these purposes. The analysis of virtually any biologically active substance in any place in the body can generally be defined as clinical immunoassay testing. In fact, traditional specialization barriers, such as microbiology, hematology, blood banking, immunology and even anatomical pathology are fading rapidly, both operationally and instrumentally. This TriMark Publications report deals with the traditional scope of clinical immunoassay, while looking at the emerging technology trends in this sector. The purpose of this study is to describe the specific segments of the global clinical immunoanalyzer instrumentation market. Within this area, the highly-active segments in terms of innovation and growth are covered. Specifically, it examines the markets for small labs and highly-automated large lab platforms, as well as the market for accessory equipment, such as reagents and supplies. Emphasis is on those companies and products that are actively developing and marketing immunoanalyzer products for clinical setting, including hospitals, independent labs, physician’s offices and clinics.

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Pharmacogenomics for Clinical Use and in Drug Development

Pharmacogenomics, the science of individualizing drug therapy based on the genetic makeup of individual patients, offers an unusual opportunity for future market growth. Applying pharmacogenomics would allow doctors to treat specific segments of the population based on their particular responses to a drug. The knowledge of the likely effectiveness of a drug in a patient makes the drug more reliable, and fewer drugs would have to be taken off the market due to adverse reactions in some, but not all, of the patients to whom they were administered. Additionally, reducing the occurrence of adverse effects to a drug effectually reduces the cost of patient care overall. This TriMark Publications study examines the market for diagnostic tests based on this science and the clinical measurement methods, the reagents and supplies being utilized in clinical medicine and the pharmaceutical industry. This report presents an overview of the latest information regarding emerging new products and industry trends and will not only quantify, but also, qualify the pharmacogenomic market segments as an area of research, product development and investment opportunity. Forecasts of the pharmacogenomic market and an analysis of products in the worldwide diagnostics market will provide a basis for understanding the significance of past developments and the immense possibilities of the future.

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Therapeutic Monoclonal Antibodies Markets

Antibodies are proteins in the immune system that help the body defend against foreign invasion, particularly from pathogens and toxins. As such, a human-engineered therapeutic monoclonal antibody (mAb) is protein derived from the immune system through recombinant DNA technology that has the ability to combine specifically with a target protein that plays a role in a disease process.

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Innovations in Protein Kinase Therapies: Company pipelines, therapeutic applications and market forecasts

During the last decade, approvals for several first-in-class kinase inhibitors have resulted in a wider recognition of kinases as an important class of drug targets. In the cancer market, there are now seven launched agents targeting EGFR family kinases, three launched agents targeting ABL family kinases and two launched agents targeting VGFR family kinases. Although the kinase market is still relatively young, 173 kinase-related genes are now being targeted in drug developments.

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Opportunities and Key Players in Clinical Nutrition: The market for enteral, parenteral and infant nutrition in the US and the EU

In both the US and EU, the clinical nutrition industry is undergoing a significant shift as major players re-align their businesses. While some are divesting clinical nutrition operations to focus on prescription medicines, others are building their capabilities to expand their presence in clinical nutrition. This is resulting in some players, such as Novartis, exiting the market while others, like Nestlé, are growing. Demand for clinical nutrition products continues to rise with aging populations that are using more health care products and services, as well as a rising rate of premature births that is fueling increases in infant clinical nutrition. Rising demand, coupled with the introduction of sophisticated new clinical nutrition products, will support market growth over the next five years.

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New Approaches to Pharma R and D: Evolving strategies to rejuvenate R and D efficiency

With industry consolidation, the economic downturn, and an increasing threat from generics, pharma companies are coming under greater pressure to fill their pipelines with innovative drugs. However, despite the costs and risks involved in drug development, the pharma industry is finding new ways to streamline the R&D process in an effort to increase efficiency and output.

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Clinical Trials Market in Russia

The Russian Clinical trials market has always enjoyed good returns since its inception, but its growth has been especially significant over the past few years, and is expected to post major growth in the future says our new report “Clinical Trials Market in Russia”.

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Early Stage Drug Safety Strategies and Risk Management: Maximizing opportunities towards achieving clinical success

Declining industrial productivity has forced companies to urgently address the areas of drug development that are most likely to lead to the failure of a new compound. Innovations are required that can support the earlier termination of drugs which will be toxic in humans and cause rare events that are unlikely to be identified in clinical trials. Major pharma companies have subsequently begun to implement an array of new technologies for drug safety prediction into the discovery phases of research.

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Clinical Laboratory Testing Volume 1: Reagents and Instruments

Clinical laboratory analysis for in vitro diagnostic (IVD) testing is one of the most important sectors of medical care. By all accounts, it is very mature, large and diverse--crossing the $39 billion mark in 2008--and employing over 100,000 laboratory workers, and spawning an industry for reagents and instruments comprised of thousands of companies worldwide. The term clinical laboratory analysis usually refers to determining the concentration or activity of a protein, carbohydrate, lipid, electrolyte, enzyme or small molecule in easily collected body fluids such as blood, serum, plasma or urine. However, it is not necessarily limited to these determinations.

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Companion Biomarkers in Drug Development

The term “companion biomarker” means that a particular diagnostic test is specifically linked to a therapeutic drug either in drug development or in the clinic. Biomarkers of disease have long played an important role in diagnostic medicine as evidenced by the intense use of specific clinical laboratory tests in the diagnosis of disease.

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Trends in Clinical Trials: Strategies to enhance clinical trial design

Pharma is experiencing tough times, facing both economic and regulatory pressures, with increasing demands for improved safety data and comparative efficacy studies. Consequently, the duration, size, complexity and ultimately cost of clinical trials is on the increase, while simultaneously, the success of late-stage clinical trials is declining.

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Global Clinical Trial Business Report and Analysis 2008-2018

The global clinical trials business is worth an estimated $50bn in 2008, with a growth of rate of 10%. The market will show considerable growth in the future, as this visiongain report, Global Clinical Trial Business 2008-2018, explains in detail. In recent years, the nature of clinical trials has changed considerably. An increased emphasis has been placed on cost-effectiveness of pharmaceutical R&D, as well as increased productivity to maintain the high output of recent years. Consequently, the pharmaceutical industry has witnessed rapid expansion of outsourced clinical services in both the West and in developing nations, most notably India and China. Importantly, pharmaceutical and biotechnological companies are increasingly delegating the responsibility of clinical trials to contract research organisations (CROs).

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Streamlining Clinical Trials

Streamlining Clinical Trials examines industry benchmarks for clinical trial spending, staffing and performance measurement. Clinical operations executives, trial managers and other clinical function executives will find innovative solutions for eliminating bottlenecks from the clinical development process. The report also outlines strategies and tactics for accelerating clinical trials and increasing efficiency from study design to study close out.

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The Emerging Role of Postmarketing Clinical Research:
Regulatory issues, strategic drivers and overall trends

‘Emerging Role of Postmarketing Clinical Research’ is a new report published by Business Insights that uses detailed case studies and market scenarios to examine the latest issues surrounding phase IV trial applications. The potential to leverage competitive advantage with postmarketing research is assessed by measuring the implications for formulary access, product marketing, indication expansion and reimbursement coverage. This report also explores the regulatory issues and requirements affecting mandatory postmarketing trial conduct and identifies the key components of effective phase IV trial design and completion.

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Innovative Clinical Trial Design and Management:
Trends, success stories and impact upon R and D budgets

‘Innovative Clinical Trial Design and Management’ is a new report published by Business Insights that explores the major types of adaptive design and their role in dose-finding. The report investigates seamless Phase 2/3 trials and adaptive trials in pharmacogenomics, assesses the logistical implications of adaptive trial implementations and reviews the current regulatory standpoints of the FDA and EMEA. Detailed case studies of recent adaptive clinical trials are provided and the companies offering statistical expertise in this area are profiled. This report also includes a breakdown of the potential cost and time savings that innovative trial designs can offer throughout the clinical development process.

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Investigator-Initiated Trials: Building Superior IIT Capabilities

Investigator-Initiated Trials examines the structures, processes and resources used by companies to better manage their IIT opportunities. The report analyzes efforts to centralize the collection and evaluation of IIT proposals, oversee ongoing studies and use IIT findings to advance company and brand strategies.

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Live-Licensing and In-life testing: R and D Processes and Regulation for New Drugs, 2008-2020

Visiongain predict that the current phase I to IV clinical testing process will eventually be selectively or wholly replaced by a system known as “in-life” testing or “live” licensing. Those proposals involve cumulative testing of the drug throughout its lifecycle. The industry would continually test drugs with smaller, more focused clinical trials. If a trial shows efficacy and safety, a live license would be given, allowing the company to market the drug in a limited manner. Already, the FDA and the EMEA have shown favourable interest in such developments - amongst other amendments to current practice.

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Mastering Phase IV Clinical Trials

Mastering Phase IV Clinical Trials examines industry benchmarks for post-marketing trial spending, staffing and performance measurement. Medical affairs' executives, Phase 4 research managers, and marketing executives will also find innovative solutions for recruiting patients in a competitive environment, building or refining their post-marketing study management structures, and removing process bottlenecks to accelerate trials.

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