Healthcare Trends: November 2015

Thursday, 5 November 2015

Adaptive Licensing Market - Global Industray Analysis and A Holistic Approach to Drug Development and Regulation

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Scope

Adaptive Licensing: Overview
Introduction
A Declining Industry – How AL can tackle issues with the current system
Strengths
Challenges for AL
Proponents
Current Adaptive Licensing
Precursors – Current systems within the traditional drug licensing framework that will act as facilitators to AL
Legality – Feasibility of AL across different jurisdictions
Employing Adaptive Licensing – EMA pilot scheme information, practical strategies
Future Adaptive Licensing
Transformative Strategies – Future utility of AL requiring legislative change
Commercial Considerations
Pricing and Reimbursement with AL
Market Exclusivity
Achieving Value through AL
Value-at-risk

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Key Reasons to Purchase

Adaptive Licensing is a highly current topic. In March 2014, the EMA (European Medicines Agency) began to invite drug developers to apply for involvement in the pilot projects.
Currently, two drug development programs have been accepted by the EMA as pilots. Three were rejected, four are in reserve and 11 are still under consideration.
AL is part of a suite of global initiatives with shared features. These include: Staggered Approval, Progressive
Authorisation, Conditional Licensing and, more recently, Medicines Adaptive Pathways (MAPs) or Medicines
Adaptive Pathways to Patients (MAPPs).
The high level of variance in AL approaches and scarcity of practical information justifies the need for an unbiased report of the strengths, weaknesses and opportunities for this system.
If pilots are successful, AL may become more widely used across all regions, and also play an important role in shaping future regulatory policy, with the potential to affect all healthcare stakeholders.
This new CBR report examines all existing information, and builds on that with conference attendance and new primary research with KOLs and figures central to the movement. It creates a balanced view, and provides an understanding of the current status and potential implications.

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Opioids Market in Western : Europe Industry Analysis, share ,Trends and Forecast 2015

The report provides an estimation of 2013 opioid revenues and forecast consumption and revenues until 2023 in the five major Western European countries: the UK, Germany, France, Italy and Spain. The estimated revenues for 2013 are highest in the UK, which held a share of 52%, followed by Germany with 20%. Spain had the lowest in terms of both consumption (3.3%) and revenues (2.2%).

Their use for medicinal purposes has been highly controversial for several decades. Although recognized as potent painkillers, potential for misuse is high. As a result, all regulatory authorities strive to maintain a fine balance between enforcing strict regulations that will crack down on illicit usage but at the same time ensure accessibility for genuine medical purposes. Amidst concerns regarding inadequate pain management due to low accessibility, there are also concerns regarding a lack of significant clinical evidence of their role in managing chronic pain. However, new abuse-deterrent technologies provide an incentive to prescribe more opioids in pain management by alleviating concerns over misuse potential. The approval of such new drugs and formulations has proved a new impetus to growth in opioid usage in the five major Western European countries.

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Opioids are largely used for two medicinal purposes: pain management and substitution treatment for drug dependence. Several of the recently approved and pipeline opioid analgesics have a strong focus on reducing misuse potential, which is one of the most significant barriers to usage in pain management. However, usage is on the rise following the introduction of new abuse-deterrent formulations of fentanyl and oxycodone, and initiatives that aim to rationalize usage in pain management. Demand is also high in substitution treatment. While both methadone and buprenorphine are approved for substitute treatment, buprenorphine usage increased in Europe after the approval of Suboxone in 2006, in combination with naloxone, a pure opioid antagonist that acts as an abuse-deterrent.

Scope

The report covers the five major Western European countries (the UK, Germany, France, Italy and Spain) and includes -

An overview of opioids in pain management and substitution treatment, and usage constraints for both
Brief analysis of recent approvals of key abuse-deterrent drugs and their impact on consumption and market growth
Country snapshots, comprising key regulations, consumption, market revenues, market forecasts and key drivers and barriers
An overview of new abuse-deterrent technologies and profiles of key pipeline products

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Key Reasons to Purchase

Gain a perspective of the opioids market size and key drivers and challenges that dictate the market trends in each of the five major countries in Western Europe
Gauge the impact of key recently approved abuse-deterrent technologies on opioid usage
Develop an understanding of how the regulatory landscape affects market potential and growth in each country
Identify the key molecules that are currently the leading players in each region and those that hold the highest potential in the forecast period
Scan the pipeline for innovative products with abuse-deterrent technologies that could have an impact on opioid usage in the pain management market.

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About Us :
Acute Market Reports is the most sufficient collection of market intelligence services online. It is your only source that can fulfill all your market research requirements. We provide online reports from over 100 best publishers and upgrade our collection regularly to offer you direct online access to the world’s most comprehensive and recent database with expert perceptions on worldwide industries, products,establishments and trends. Our database consists of 200,000+ market research report s with detailed & minute market research.
Contact:
Chris Paul
Office No 01, 1st Floor,
Aditi Mall, Baner, Pune,
MH, 411045 India
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Toll Free(US/CANADA):+1-855-455-8662
Email: sales@acutemarketreports.com
Website: Acute Market Reports

Womens Health Market - Assessing the Need for a Targeted and Specialized Approach, Research

Many of the diseases and conditions that affect mainly women are interlinked with similar root causes; however, placing all of the pieces of the puzzle together to ensure a cohesive management strategy remains a challenge.

Women’s Health is a collection of multi-factorial conditions and diseases that solely affect or are more prevalent in females. Many can have a serious impact on women’s overall long-term health and quality of life. There are a number of causes of Women’s Health diseases, ranging from hormonal fluctuations associated with specific points in a woman’s life through to psychological issues underpinning certain lifestyle disorders. As these causes and the courses and consequences of these diseases become better understood, the importance of targeted, specific treatment is increasingly being recognized, with some female-specific interventions now being investigated. In addition, it is becoming increasingly crucial to understand and act on the interaction between different diseases that primarily affect women, in order to ensure the most effective treatment approaches.

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Female cancers, particularly breast and cervical, have led the way in preventive and therapeutic approaches, creating new paths for the management of other cancers and rendering some previously highly terminal cancers manageable diseases. The advent of personalized therapy for HER2-positive breast cancer was enabled through the identification of the HER2 gene and development of targeted drugs, such as Herceptin (trastuzumab) and Tyverb (lapatinib), and the prevention of cancer through vaccination has become the norm for cervical cancer. However, the same cannot be said for other female cancers, where, in spite of identification of gene mutations, targeted therapy is still in its infancy.

Despite significant advances in Women’s Health, there are still a number of unmet needs, particularly for therapies that address the fundamental causes of many conditions that are specific to or more prevalent in women. The fact that women are living longer means that they are encountering a wider range of health issues. It also means that there are higher expectations in therapies and that factors such as quality of life are playing an increasingly important role. As the Women’s Health environment evolves and expectations in treatment increase, easier and more straightforward therapies will be needed, and there is a particular need for drugs that either address several aspects of Women’s Health or work concomitantly with others to do so. Furthermore, it is recognized that many of the different conditions that affect women are interlinked and have common root causes; however, placing all of the pieces of the puzzle together to ensure a cohesive management strategy remains a challenge. The specialists who can do this are likely to be the main points of care for Women’s Health.

Same Category Report : http://www.acutemarketreports.com/category/healthcare-market

Scope

The report provides an overview of issues and trends in Women’s Health, including analysis of the current market landscape and key issues driving overall treatment decisions. In addition, the report offers a view of how Women’s Health is likely to evolve, including treatment practices and new approaches in the pipeline.

The report covers and includes

A brief introduction to Women’s Health and the key diseases and conditions that affect women, including female cancers, psychological issues, sexual dysfunction and cardiovascular disease
Detailed analysis of why certain diseases affect women in different ways or in larger numbers, the impact that this has on overall health and quality of life, and current approaches to managing these conditions
Analysis of the pipeline for specific women’s diseases including an overview of how personalized medicine is likely to change how certain conditions are treated
An overview of how Women’s Health will be managed in the future, specifically looking at how specialists will adopt a multi-disciplinary approach to ensure the holistic treatment of the “whole woman"

Reasons to buy

Primarily, the report will allow clients to gain a strong understanding of the current landscape in Women’s Health, helping them to identify and clarify market opportunities and the competitive environment. It will also allow clients to
Understand why specific diseases and conditions present differently in women and the implications for treatment and management
Examine developments in Women’s Health and how this has impacted on the incidence and prevalence of certain diseases, along with the overall prognosis and outcomes for women with particular conditions
Assess where the key unmet needs in Women’s Health exist and how these opportunities can be harnessed in future drug development
Understand the different issues and challenges facing companies when developing therapies for Women’s Health conditions and how these can most effectively be addressed to ensure future success

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Mens Health Market - Changing Male Attitudes to Health to Improve Prognosis and Outcomes

Men’s health refers to conditions that specifically affect males, or those that are not gender-specific but have different outcomes in men. Although still dominated by cardiovascular disease, men’s health is increasingly focusing on other conditions and the wellness of the man overall.

There are many different factors that impact on men’s health, making it a unique therapy area; these include biological, social, psychological and economic factors. In addition, men are exposed to a number of risk factors that make specific diseases and conditions more prevalent in the male population, such a behavioural risk and work-related risk factors. Lifestyle factors are also known to be at the root cause of many diseases and conditions that affect men, and while some changes can help reduce the overall risk, many men find it difficult to persist with these changes. Male behavior has historically been recognized as a major contributor to health issues, with men more likely to participate in risky activities, suffer from work-related health issues and have unhealthy lifestyles, particularly in relation to alcohol, smoking and diet. Men are also more reluctant to actively seek health advice and undertake treatment, due to a number of factors including social taboos, a perception that it is not manly to see the doctor, and a feeling that HCPs tend to be focused on women rather than men.

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The sensitive nature of male-specific cancers mean many men tend to ignore symptoms, failing to self-examine and only presenting to physicians at a late stage. Prostate cancer is the most common male-specific cancer, with testicular and penile cancer being relatively uncommon. Prostate cancer has experienced advances in treatment in recent years, although unmet needs still exist with potential solutions being studied. Indeed, if diagnosed and treated in its early stages, prostate cancer has a very good prognosis, with 100% of patients living beyond five years. However, if the cancer has spread it becomes more difficult treat and there remains a need for effective therapies for metastatic prostate cancer and castrate-resistant prostate cancer. Other male cancers tend be relatively rare, which makes them less of a priority for research and development. Indeed, compared with many female cancers, male cancers receive less attention and lower levels of funding, being seen as the poor relation.

Changing attitudes and encouraging more health-aware behavior is critical to ensure traditional failures in addressing men’s health issues are overcome in the future. It is commonly recognized that men tend to hide anxiety and concern about their health and only visit the doctor when symptoms become unmanageable. As such, small changes in the way in which healthcare can be accessed in order to recognize the different pressures and priorities exerting an influence on men will help increase the number of men seeking HCP advice and the frequency with which this occurs. To this end, the concept of treating the whole man is gaining traction and becoming the standard of care for many. Going forward, it is expected that this will change the management of men’s health, with primary care taking greater control of the overall care, and specialists having a role where needed for specific conditions and diseases. Furthermore, physicians and healthcare providers are recognizing that specific measures need to be put in place to ensure that men feel comfortable seeking medical advice and are adapting their approach accordingly to ensure more beneficial management of men’s health issues.

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Scope

The report provides an overview of issues and trends in Men’s Health, including an analysis of the current market landscape and key issues driving overall treatment decisions. In addition, the report offers a view of how Men’s Health is likely to evolve in the future including treatment practices and new approaches coming through the pipeline.

The report covers and includes:

A brief introduction to Men’s Health, including key diseases and conditions that affect women, such as male cancers, sexual dysfunction and cardiovascular disease
Detailed analysis of the reasons why certain diseases affect men in different ways or in larger numbers compared to women, the impact that this has on overall health and quality of life and current approaches to managing these conditions
Analysis of the pipeline for specific men’s diseases including an overview of how personalized medicine is likely to change how certain conditions are treated
An overview of how Men’s Health will be managed in the future, specifically looking at how specialists will adopt a multi-disciplinary approach to ensure complete treatment of the whole man and all underlying causes of disease

Reasons To Buy

Primarily, the report will allow clients to gain a strong understanding of the current landscape in Men’s Health, helping to identify and clarify market opportunities and the competitive environment. It will also allow you to:

Understand why specific diseases and conditions present differently in men and the implications for treatment and management
Examine developments in Men’s Health and how this has impacted on the incidence and prevalence of certain diseases, along with the overall prognosis and outcomes for men with particular conditions
Assess where the key unmet needs in Men’s Health exist and how these opportunities can be harnessed in future drug development
Understand the different issues and challenges facing companies when developing therapies for Men’s Health conditions and how these can most effectively be addressed to ensure future success

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Biosimilars Market - Regulatory Framework and Pipeline Analysis

Biosimilars are copied versions of biologics that offer a 20-50% reduction in cost compared with innovative biologic products. Biosimilars are getting the world wide attention as the cost of the innovative biologics are enormously high and even minimal reduction in price will reduce the healthcare spending substantially. All the countries are focusing on reducing the healthcare expenditure and biosimilars compliments to this goal. Biologic products are complex in structure and follow a complex manufacturing process thus, some variation exists between the reference product and its biosimilar.

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It is very important to assess the variations in biosimilars by comparing with reference product to ensure quality, non-clinical, and clinical properties, which has given rise to the regulatory requirements for biosimilars. Regulatory requirement for approving biosimilars varies across different regulatory bodies. However, all the countries have derived the basic theme from EMA and WHO guidelines for framing their regulatory structure. There is a need to harmonize the nomenclature of biosimilars, extrapolation of indications, and interchangeability of biosimilars with reference products across the regulatory bodies. Biosimilars market is developing and it could be well established with the pipeline that is poised to deliver a wave of biosimilars in the market in the near future

Same Category Reports : http://www.acutemarketreports.com/category/pharmaceutical-market

Scope
The scope of the report includes:

Introduction
Market dynamics: Trends, Drivers, and Barriers
WHO guidance for biosimilars
Regulatory overview, biosimilar guidelines, regulatory framework for biosimilars, and market outlook for:
Europe
USA
India
South Korea
Japan
China
Key players
Pipeline Analysis

Overview

By Stage of Development / Molecule / Therapy Area / Indication
Late-Stage / Phase II / Phase I Pipeline Biosimilars

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Reasons To Buy

The report will enhance your decision-making capability by allowing you to:

Understand the regulatory requirement and regulatory framework that facilitates effective product development strategy as biosimilars industry is currently highly focused, growing, and outpacing the growth rate of small molecule pharmaceutical market

Targeting geographies would be easy by comparing different regulatory frameworks; this would also provide a base for designing a strategy to enter the developed markets. Biosimilars are of interest in developed countries to reduce the healthcare expenditure
With the recent approvals of biosimilars by USFDA, the biosimilars market is going to grow and this report examines the post approval market landscape
Examine the biosimilars pipeline and specifies the products that are highly targeted, it also includes analysis of highly focused indications, mechanism of actions, and therapy areas in the pipeline
Analyze the details of the clinical pipeline that includes late stage products, Phase II, and Phase I products. Detailed understanding of the pipeline will help in targeting the products for development, rate the current products and predict the competition

Clinical Development and Trial Design Market - Global Industry Analysis and Developing a Coherent Approach From Beginning to End

A good clinical development plan will ensure success throughout the product lifecycle.
In todays cost constrained environment, the clinical development plan can help refine the trial process, encouraging cost and time efficiencies and ensuring a streamlined process throughout.
The clinical development plan ties together all aspects of product development, enabling an incorporated approach to the clinical and commercial rationale of product development.
A variety of approaches should be adopted to ensure a robust clinical development plan is developed. Early initiation of the clinical development plan is critical for the execution of a successful product development process.

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A proactive approach to the processes and objectives encompassed in the clinical development plan must be adopted..

The report, Clinical Development and Trial Design - Developing a Coherent Approach From Beginning to End, was written to provide insights & analysis to teams and companies to support getting a product to market quickly and successfully. This report will help ensure development teams are on top of all necessary components of product development while providing suggestions which enable them speed the process to a successful launch.

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Scope

Devising a clinical development plan key considerations
Review of clinical trial design stages protocol, objectives, patient population selection, endpoints, site selection and issues
Recent developments

Key Reasons to Purchase

Understand what a clinical development plan consists of and how creating one at an early stage of new pharmaceutical product development will contribute to the overall success of the trial program and eventual commercial launch
Provides an overview of the recommended approaches to the range of activities that should be undertaken to ensure all aspects of clinical development are addressed
Enables you to understand the interaction between the commercial and scientific members of the clinical development team and how to ensure clear communication and ongoing cooperation throughout the clinical trial process
The report provides in-depth analysis of key aspects of clinical trial design, examining how the right endpoints, objectives and design are critical to guarantee eventual regulatory and reimbursement approvals
Benefit from up-to-date case studies and analysis examining changes in clinical studies, in particular in the fast-moving oncology therapy area, and how new initiatives are breathing life into the stagnant antibacterials market

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R&D Productivity Market - The State of Research and Development in the BioPharmaceutical Industry

As Blockbusters go off patent and the pool of marketed products supporting pharmaceutical Research & Development (R&D) decline, questions about the future of R&D in the pharmaceutical and biotech industry arise. Where will funding come from? Is spend decreasing? If spend is decreasing, what impact is this having on R&D? What can be done to encourage innovation in the biotech and pharmaceutical industry? Is the biotech model of R&D better for innovation than the traditional pharmaceutical model?

Gauging the overall growth of R&D in the pharmaceutical and biotech industry proves challenging in regards to stipulating the appropriate definition of variables by which this is measured. Public companies may release overall expenses, yet allocations to specific products or franchises may be more difficult to assess. On a related note, information may be available about specific research projects and molecules under development, yet tying those back to the overall R&D expenses can also be challenging. To that end, we are focused on general estimations in this report which address a high level analysis of the overall industry and a basic formulaic approach to understanding growth and productivity within R&D. The methods used for assessing these variables are suppo 180-180

rted by literature in the field.

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Research & Development (R&D) in the Pharmaceutical and Biotech Industry has experienced a major shift from the blockbuster era of the last decade. Pharmaceutical manufacturers are operating with thinner margins and smaller pipelines, the success rates of early stage research projects have decreased, and overall the complexity of efficient and productive R&D in the pharmaceutical industry has increased. This report provides an overview of the current situation in pharmaceutical and biotech R&D.

Scope

Current scenario of R&D
Review of the pipeline and key issues affecting R&D efforts
Approvals by year and by sponsor (established vs. new companies)
Trends in R&D spending
Analysis of R&D productivity
Company snapshots

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Key Reasons to Purchase

Understand the current state of R&D in the biopharmaceutical industry and the key issues that are affecting companys efforts
Assess the strategies being used to strengthen R&D productivity and relate them to what is taking place within your organization
Evaluate how the top pharmaceutical and biotech companies have structured their pipeline
Analyze the trends being seen in R&D spend and how different forms of collaboration could support a stronger R&D organization
Examine the R&D landscape and identify the key disease areas seeing the greatest activity
Benefit from CBRs insights & case study analysis to support a better understanding of different influencers of R&D productivity and the strategies which can be used within your organization

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The Politics of Pharma - Washington, States and the Courts Impact on the Industry

Politics have a greater direct effect on the pharmaceutical industry than almost any other in the US, and correspondingly, pharma makes considerable investments in election campaigns. The November elections kept the face of Washington the same, with the re-election of President Obama, Democratic control of the Senate and Republican control of the House. However, the outcome of the elections will still impact the industry in a variety of ways.

The Medical Device Excise Tax, a component of the 2010 health care reform legislation, survived a pre-election Congressional effort at repeal, but a coalition of House Republicans and Democrats from key states are looking to try again. Post-election, another bi-partisan congressional group is pushing for the FDA to impose stricter regulations on certain painkillers. Meanwhile, the Administrations prioritization of generics at the FDA remains controversial.

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The budget impasse and resulting sequestration are election fall-outs that may impact the pharmaceutical industry in a number of ways: decreased vaccine sales, reduced research funding and potential cuts at the FDA that could dramatically raise time to market. Medicare reform also looms out as an issue un-resolved in November, with the possibility of playing a role in the mid-term elections 180-180

The report, The Politics of Pharma - Washington, States and the Courts Impact on the Industry was written to provide companies with an update and future outlook of how the political atmosphere within the United States will impact the pharmaceutical industry in both the near and long term. This report should be used by both large and small organizations alike, as well as branded and generics manufacturers.
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Scope

November Election Results
Health Care Reform
State Politics
The courts
The Political Outlook
Key Reasons to Purchase
Understand the current pharmaceutical related issues before the Supreme Court
Assess the impact of the November elections on the political issues that affect pharma now and in the future
Evaluate where pharmaceutical companies should turn their political focus
Analyze why state politics are increasingly important to pharmaceutical companies and the impact they could have on future revenues
Examine the potential impact from the current budget impasse
Benefit from accessing CBRs view on the outlook for the pharmaceutical industry as a result of the political climate in the United States

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About Us :

Acute Market Reports is the most sufficient collection of market intelligence services online. It is your only source that can fulfill all your market research requirements. We provide online reports from over 100 best publishers and upgrade our collection regularly to offer you direct online access to the world’s most comprehensive and recent database with expert perceptions on worldwide industries, products,establishments and trends. Our database consists of 200,000+ market research report s with detailed & minute market research.

Immunotherapy Development Strategies Market ,An Evolving Industry with Significant Potential : AMR

Although Immunotherapy was first recognized over 100 years ago, it has only become an important therapeutic tool in recent decades. The immune system can be harnessed in one of several ways to tackle various diseases such as cancer, infection, auto-immune disease and inflammatory diseases.
The complexity of the immune system has led to some intrinsic obstacles with clinical research, particularly in relation to targeting the right genes, identifying the appropriate patient population and accessing internal tissues for testing.
Market access presents a significant hurdle for immunotherapeutics, as many are high cost and do not deliver the measurements required for traditional cost-effectiveness assessments.

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Oncology has been a primary area of focus for immunotherapeutics, largely due to the potential offered by this market but also due to the critical role the immune system plays in the proliferation of cancer throughout the body. Auto-immune and inflammatory diseases are also attractive targets for immunotherapy, with several different approaches being investigated.
The report, Immunotherapy Development Strategies - An Evolving Market with Significant Potential but with Challenging Hurdles to Overcome was written to support executives within both the commercial and R&D sides of the biopharmaceutical industry. It provides key insights through the analysis of issues, trends, and the future outlook of immunological therapies to support executive decision making for both biotech and pharmaceuticals companies alike.

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Scope

Immunotherapy Overview
Immunotherapeutic Development and Launch Strategies
Trends in the Development of Immunotherapeutics
The Immunotherapeutics Market
Key Companies Involved in Immunotherapeutics
Case Studies
Future outlook

Key Reasons to Purchase

Access CBRs insights and analysis on the opportunities which exist within this complicated and fast moving market
Better understand where both the main opportunities and challenges exist to successfully developing an immunotherapeutic product and what it will take to get there
Gain a more complete picture of the where the trends in development are taking the future of immunotherapeutics
Utilize CBRs case study analysis to help support key business decisions
Benefit from CBRs identification and discussion on the lessons learned when developing an immunotherapeutic product and our outlook on the future of the market

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Biosimilars Market - Global Industry Outlook ,Trends and Forecast by AMR

The Biosimilars market is undergoing rapid change with developments such as the recent approvals of infliximab and trastuzumab heralding a new era. In order to keep up with the pace of change in the marketplace, regulatory agencies have been developing updated guidance around the development and approval of biosimilars, but there is still a lack of consistency, particularly between the two leading agencies – the FDA and EMA.
Moreover, there are some concerns around biosimilar use, for example with physicians worried about how similar certain drugs are and whether they can safely be used in particular patient populations such as transplant, due to the potential for variance in efficacy and tolerability. Despite this, it is expected that the biosimilar market will continue to experience significant growth in the next five to ten years, being driven by the extensive pipeline and the number of companies becoming involved in this area – including some big pharma who are seizing the opportunity to develop biosimilar versions of competitor products in order to ensure they are able to compete at all levels.

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Scope :

The report covers the following key areas -

An overview and background about biosimilars – what they are and a timeline of their development
Key concerns regarding the development and use of biosimilars
An overview of the issues around automatic substitution with biosimilars
The regulatory landscape for biosimilars, including a comparison of FDA and EMA guidelines
Recent developments in the biosimilars market including the anticipated patent expiries of key biologic products and launches of new biosimilar products
The position of HTA and P&R agencies on biosimilars
Industry perspective on the expected impact of biosimilars
The biosimilars pipeline and key future developments
Key companies involved in biosimilars
The way forward for industry

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Key Reasons to Purchase

The report will Provide an in-depth insight into recent biosimilar regulatory developments including a comparison of the processes used in different markets and the guidance being implemented
Assess the biosimilars pipeline including where development is currently focused and the potential impact new biosimilars will have on the marketplace
Highlight industry opinions towards biosimilars and their expected impact in different therapy areas and how industry can meet the challenges being presented by biosimilar development and launches
Provide an understanding about the key concerns around biosimilar development and use, including manufacturing concerns and issues around automatic substitution
Provide an overview of the key companies involved in the biosimilar market including an analysis of where the majority of biosimilar companies are located, the markets in which they operate and the future outlook

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Vaccine Development Strategies Market - Refocusing Efforts to Address New Challenges

Vaccines are one of the most important healthcare advances and have saved millions of lives through immunizing against some of the most deadly diseases. With protection against a number of key viral and bacterial diseases now effectively generated, vaccine R&D is turning to areas of unmet need. Preventative vaccination in adults and against pathogens that affect the developing world is increasingly becoming a focus. Research into therapeutic vaccination for patients already affected by a disease is also gathering pace. There are several different approaches to preventative vaccination, most of which have been effectively employed to reduce the incidence of certain diseases or, in some cases, eradicate them completely.

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Scope

This report providers readers with an understanding of the key developing trends in the vaccines market and how these are expected to impact on the overall competitive landscape, the major players and forecasted growth
This report provides an overview of the preventative vaccines market, including insights into clinical development strategies, recommendations for maximizing potential for development of preventative vaccines and discussion about potential areas of growth in the near term
The report provides in-depth analysis of the developing landscape for therapeutic vaccines, including recent activities of major pharmaceutical companies, insight into the challenges being faced by companies developing therapeutic vaccines and recommendations on clinical development strategies to overcome these potential obstacles and hurdles
The report assesses the evolving competitive vaccines landscape, profiling the major pharmaceutical players and providing information into the emerging vaccines companies and assessing how the vaccines market is expected to develop in the short to medium term.

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Key Reasons to Purchase

The report will enable you to understand how key factors such as the emerging markets, new therapeutic targets and innovative technologies are becoming increasingly important to profitability and commercial return for vaccine companies as traditional targets and populations become satisfied
Gain insights on the key challenges that exist to further vaccine development
Compare considerations in both therapeutic and preventive vaccines markets

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Tuesday, 3 November 2015

Geriatric Medicine Development Market - Global Industry Analysis and Carving out New Opportunities to Treat Age-related Diseases

More than 50% of prescriptions is written for people aged 65 years and older. Many older people suffer from comorbid conditions and one in three takes at least five drugs or more on a daily basis. This significantly increases the risk of Adverse Drug Events (ADEs) and hospitalization. Up to one third of emergency admissions in elderly people is drug-related.

There remains a lack of clinical data to support prescription decisions as relatively few medicines have been clinically evaluated in age-appropriate patients. In addition, many drugs are not available in formulations that are suitable for the elderly, leading to non-compliance and lack of therapeutic efficacy. In 2011, the EMA introduced its Geriatric Medicines Strategy to ensure that the medical requirements of older people are identified earlier in the drug development process. In 2012, the ICH E7 guidelines were revised to include a greater focus on involving more geriatric patients in drug trials.

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Scope
Reviews the current regulatory landscape and helps sponsors to understand the potential impact of recent guidelines.
Assesses the barriers to entry in geriatric medicines and identifies potential ways to overcome them and improve clinical decision making.
Evaluates the importance of establishing Target Quality Product Profiles (TQPP) to help sponsors determine the target patient population earlier on in drug development.
Identifies treatment gaps and commercial opportunities based on primary care real-time data and KOL insights.
Analyses different strategies to develop age-appropriate medicines in niche therapeutic fields and discusses methods to encourage the smarter prescription of medicines.

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Key Reasons to Purchase

Utilize the insights from this study to analyze the barriers facing the geriatrics market

Understand the impact of drug development in this market now and in the future

Find out why regulators are paying more attention to unnecessary “exclusion criteria” and encouraging the inclusion of older people to ensure trials are age-appropriate and more representative of the real world setting.

Assess the opportunities available for companies to develop age-appropriate dosages and formulations for existing drug classes that are currently widely associated with ADEs in the elderly as well as new therapeutic prospects.

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Acute Market Reports is the most sufficient collection of market intelligence services online. It is your only source that can fulfill all your market research requirements. We provide online reports from over 100 best publishers and upgrade our collection regularly to offer you direct online access to the world’s most comprehensive and recent database with expert perceptions on worldwide industries, products,establishments and trends. Our database consists of 200,000+ market research report s with detailed & minute market research.

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Adaptive Licensing Market - Global Industray Analysis and A Holistic Approach to Drug Development and Regulation

Adaptive Licensing (AL) is a flexible approach to drug development and regulation, with two live pilot schemes accepted by the European Medicines Agency (EMA). The system acknowledges that levels of uncertainty will always surround innovative treatments. An initial license is granted at an earlier stage than possible under the traditional system, with less clinical information from Randomized Controlled Trials (RCTs). After the initial license is granted, the entry to market is heavily restricted, and the patient population is carefully monitored through observational studies, electronic devices and registries. Data from ongoing RCTs, and the more robust data from post-license surveillance studies are used to determine full license permission. By improving the alignment of stakeholder needs in a fluid system, overall costs and patient access times can be reduced. However, uncertainty still exists around the approach, and it is clear that cultural and political changes will be necessary to realize the full potential of AL.

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Scope

Adaptive Licensing: Overview
Introduction
A Declining Industry – How AL can tackle issues with the current system
Strengths
Challenges for AL
Proponents
Current Adaptive Licensing
Precursors – Current systems within the traditional drug licensing framework that will act as facilitators to AL
Legality – Feasibility of AL across different jurisdictions
Employing Adaptive Licensing – EMA pilot scheme information, practical strategies
Future Adaptive Licensing
Transformative Strategies – Future utility of AL requiring legislative change
Commercial Considerations
Pricing and Reimbursement with AL
Market Exclusivity
Achieving Value through AL
Value-at-risk

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Key Reasons to Purchase

Adaptive Licensing is a highly current topic. In March 2014, the EMA (European Medicines Agency) began to invite drug developers to apply for involvement in the pilot projects.
Currently, two drug development programs have been accepted by the EMA as pilots. Three were rejected, four are in reserve and 11 are still under consideration.
AL is part of a suite of global initiatives with shared features. These include: Staggered Approval, Progressive Authorisation, Conditional Licensing and, more recently, Medicines Adaptive Pathways (MAPs) or Medicines Adaptive Pathways to Patients (MAPPs).
The high level of variance in AL approaches and scarcity of practical information justifies the need for an unbiased report of the strengths, weaknesses and opportunities for this system.
If pilots are successful, AL may become more widely used across all regions, and also play an important role in shaping future regulatory policy, with the potential to affect all healthcare stakeholders.
This new CBR report examines all existing information, and builds on that with conference attendance and new primary research with KOLs and figures central to the movement. It creates a balanced view, and provides an understanding of the current status and potential implications.

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Acute Market Reports is the most sufficient collection of market intelligence services online. It is your only source that can fulfill all your market research requirements. We provide online reports from over 100 best publishers and upgrade our collection regularly to offer you direct online access to the world’s most comprehensive and recent database with expert perceptions on worldwide industries, products,establishments and trends. Our database consists of 200,000+ market research report s with detailed & minute market research.

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Pediatric Drug Development Market - Global Industry Analysis, Regulatory challenges and commercial opportunities 2023

Although pediatrics represent around two-fifths of the global population the market for pediatric medicines remains relatively small (accounting for <10% of global pharmaceutical sales). Until pediatric legislation was introduced in the US (1997) and EU (2007) there has been little incentive for the pharma industry to evaluate drugs in children due to the low medical need of chronic illnesses and the high off-label use of generic drugs (Milne & Bruss, 2008).
Since the introduction of pediatric legislation there has been a substantial investment in pediatric research and the number of clinical trials performed in children has increased significantly. In the US more than 350 product labels include new pediatric information and more than 130 products have undergone a pediatric focused post-labelling safety review. In Europe there has been 221 changes regarding the safety and efficacy of medicines from the submission of old or new studies in children and 89 additions of dosing information for children as a direct consequence of Paediatric Investigation Plans (PIPs).

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Despite the apparent success of the pediatric regulation, the submission of pediatric information is complex and the incentives are often insufficient to encourage industry innovation (Rose & Della Pasqua, 2011). No new drugs can be registered in the EU without a detailed PIP being approved by the EMA’s Pediatric Committee (PDCO) (Rose, 2014). Without a PIP, the registration process for a new drug can be blocked. In the US, the FDA has adopted a more pragmatic approach to pediatric drug development, providing voluntary and mandatory routes for pediatric evaluation.

Many experts agree that there is significant room to improve the EU pediatric regulations and a revision of the legislation is scheduled to take place in 2018. In the meantime, there is considerable potential for the industry to develop pediatric formulations and doses of approved and generic medicines, particularly for use in transition countries where access to high quality pediatric formulation is improving. In addition, new commercial opportunities exist to develop medicines that target pediatric specific conditions in neonates as well as rare and neglected diseases and pediatric vaccines.

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Scope
Pediatric medicines: an overview
The pediatric population
Underlying/key issues for pediatric drug development
Unmet clinical needs
Current landscape
Regulation and legislation
Global harmonization
Strategic considerations for developing pediatric medicines
Clinical trial considerations
Pediatric formulation issues
Pediatric networks
Patient access
Commercial opportunities
Generic formulations and dosage forms
Rare and neglected diseases
Pediatric vaccines

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Key Reasons to Purchase

Reviews the current regulatory landscape and helps sponsors to understand the potential impact of FDA SIA regulations and the variations between EU regulation on global pediatric plans;

Identifies the key challenges associated with pediatric drug development and the ways to overcome these hurdles;

Assesses what issues need to be addressed in order to improve access to pediatric medicines and commercial opportunities in transition countries based on KOL insights;

Analyses different strategies to develop age-appropriate medicines in niche therapeutic fields in neonates, rare and neglected pediatric diseases and pediatric vaccines.

About Us :

Acute Market Reports is the most sufficient collection of market intelligence services online. It is your only source that can fulfill all your market research requirements. We provide online reports from over 100 best publishers and upgrade our collection regularly to offer you direct online access to the world’s most comprehensive and recent database with expert perceptions on worldwide industries, products,establishments and trends. Our database consists of 200,000+ market research report s with detailed & minute market research.

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Chris Paul
Office No 01, 1st Floor,
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MH, 411045 India
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