Prostate Cancer (Metastatic Castrate-Resistant): The Late-Stage Pipeline Is Rich in Novel, Promising Drug Candidates, but What Will It Take to Unseat Abiraterone?

Tue, 01 May 2012 00:00:00 -0400

Significant drug development activity in metastatic castrate-resistant prostate cancer is coming to fruition. Since 2010, three therapies have launched in this setting based on survival benefits and have reshaped clinical practice for this difficult to treat disease. Despite these approvals, significant clinical and commercial opportunities remain for therapies that can improve overall survival. The late-stage pipeline is buoyant, and, going forward, the market will become increasingly crowded and competitive as multiple emerging therapies fight for a share of this lucrative opportunity.

Human Immunodeficiency Virus (HIV) (Event Driven)

Last Updated 24 May 2012
The HIV market is highly dynamic, continually evolving in terms of new treatment options and practices. Major-market sales for HIV antiretrovirals reached $11.8 billion in 2010, and we expect sales to exceed $18 billion in 2020. Among the most promising products in the pipeline are Gilead’s Quad (elvitegravir/cobicistat/emtricitabine/tenofovir) and Shionogi/ViiV’s 572-Tri (dolutegravir/abacavir/lamivudine). Both drugs are complete fixed-dose regimens in a once-daily pill with blockbuster potential. Introduction of Gilead’s blockbuster drug Atripla (efavirenz/emtricitabine/tenofovir) raised the bar for other HIV drug developers. The launch of Quad and two new fixed-dose combinations codeveloped with BMS and Janssen, atazanavir/cobicistat and darunavir/cobicistat, respectively, will further solidify Gilead as the dominant force in HIV treatment.

Breast Cancer (Event Driven)

Last Updated 24 May 2012
Despite the availability of numerous effective therapies from many different drug classes to treat breast cancer (CaB), significant unmet need and commercial opportunity remain. The high incidence of CaB means that it is the second-leading cause of cancer-related death among women in the markets under study (United States, France, Germany, Italy, Spain, United Kingdom, and Japan). The treatment of distinct subpopulations of CaB is addressed by numerous agents including hormonal agents, chemotherapeutics, and targeted therapies; there remains, however, a distinct dearth of therapies to treat triple-negative disease, where drug development has struggled and current therapies have little impact on patient prognosis.

Turkey: Market Access Tracker

Last Updated 24 May 2012
The Turkish pharmaceutical market is the 6th largest in Europe and the 16th largest in the world and has experienced rapid growth since 2003. A substantial increase in national investment in healthcare and the creation of a universal health insurance system have boosted demand for healthcare services, including prescription drugs. However, a tough pricing and reimbursement environment and restrictions on market access for new imported drugs present serious challenges for multinational pharmaceutical companies (MNCs) interested in this emerging market. New cost-containment measures unveiled in November 2011 have added to the industry’s woes.

Brazil: Market Access Tracker

Last Updated 23 May 2012
The Brazilian pharmaceutical market now ranks among the seven largest in the world and experienced sales growth of 20% in 2010, with further strong growth forecast for the coming years. Growing affluence and increasing life expectancy will boost demand for pharmaceuticals, but manufacturers will also have to contend with pressures such as limited reimbursement of drugs, strict price controls, and weak intellectual property protection.

Snapshot: Tofacitinib 2012 - Despite Tofacitinib’s Convenience and Strong Efficacy Against RA, Rheumatologists Expect Most Patients Initially Treated with Tofacitinib will be Biologic-Refractory

Tue, 01 May 2012 00:00:00 -0400

Pfizer’s oral Janus kinase (Jak) inhibitor tofacitinib is poised to become the first oral kinase inhibitor approved for the treatment of rheumatoid arthritis (RA), a market currently dominated by parentally-administered biologic agents. The FDA Arthritis Advisory Committee (FDA AAC) meeting evaluating tofacitinib as a possible therapeutic for RA was held on May 9, 2012. The most detailed analysis of tofacitinib’s efficacy in slowing structural progression and the most detailed information on the drug’s safety profile from Phase III and long-term extension trials were reported at this meeting. While tofacitinib has strong advantages with the convenience of its formulation and robust efficacy in treating the signs and symptoms of RA, the drug’s safety profile is likely to be a critical determinant of its uptake. Safety events observed with tofacitinib treatment include risk of serious and/or opportunistic infection, malignancy, and hyperlipidemia. This Snapshot report provides a survey assessment based on responses from 52 U.S. rheumatologists, all of whom prescribe biologics and have at least moderate familiarity with tofacitinib, of physician reaction to key efficacy and safety data reported at the drug’s FDA AAC meeting. Surveyed physicians also identify key factors that are likely to constrain their prescribing of tofacitinib, and an estimate, based on its clinical factors, of how they expect to prescribe the drug within its first year of marketing.

Second-Line Metastatic Colorectal Cancer: Decision Resources' Market Forecast and Opportunity Analysis

Tue, 01 May 2012 00:00:00 -0400

Second-Line Metastatic Colorectal Cancer: Decision Resources' Market Forecast and Opportunity Analysis is an Executive Summary presentation of key insights drawn from Decision Resources’ Pharmacor Advisory Service and DecisionBase report on this indication for clients that have purchased both products. By weaving together key findings from Pharmacor and DecisionBase, this presentation provides a high-level summary of the most important issues pertinent to this market, including:

- Disease etiology and pathophysiology

- Patient population

- Current medical practice

- Current competitive landscape

- Factors influencing physicians’ prescribing behavior and payers’ formulary decisions

- Comparative assessment of key current and emerging therapies using DecisionBase’s proprietary Drug Comparator Model

- Unmet need, from the perspective of interviewed thought leaders, surveyed physicians, and surveyed payers

- Prescription patterns, patient share and market potential of two physician-built target product profiles of a drug fulfilling a key unmet need

- Patient share and prescription patterns of emerging product profiles

- Market Forecast

More detailed analysis can be found in the Pharmacor and DecisionBase source products.

Schizophrenia (Negative Symptoms): Payer and Physician Receptivity to Treatments for Negative Symptoms Presents a Lucrative Opportunity

Tue, 01 May 2012 00:00:00 -0400

The negative symptoms of schizophrenia (e.g., diminished motivation, social connection, and feelings of pleasure) are highly disabling and pervasive in schizophrenia, yet they are often overlooked clinically and are unaddressed by current therapies. We estimate that more than 4 million people in the seven major pharmaceutical markets we cover (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) suffer from some degree of negative symptoms of schizophrenia and that more than 3 million of these people have significant negative symptoms (i.e., scoring greater than 18 on the Positive and Negative Syndrome Scale [PANSS] negative subscale). As the current atypical antipsychotic market, which is targeted toward treating positive symptoms, becomes increasingly generic, drug developers are focusing on treating negative symptoms, in particular through new mechanisms of action. Given that payers report that a drug’s effect on negative symptoms is a top influence in their reimbursement decisions and that interviewed experts report that no current agents are substantially efficacious, the treatment of negative symptoms represents a significant opportunity in the schizophrenia therapy market.

Colorectal Cancer in Russia

Tue, 01 May 2012 00:00:00 -0400

The incidence of colorectal cancer (CRC) in Russia is the highest among the BRIC (Brazil, Russia, India, China) markets and is comparable to that of the United Kingdom and the United States. Changes in medical practice and a growing incident population offer significant opportunity to multinational companies (MNCs) with emerging therapies in this indication. In this report, we examine the trends within Russia’s CRC therapy market, which is characterized by the growing use of molecular testing, increasing government spending on healthcare, gradually increasing use of higher-priced chemotherapies, and the introduction of several premium-priced agents.

Hepatitis C Virus (Event Driven)

Last Updated 17 May 2012
Hepatitis C virus (HCV) is marked by a relatively large prevalent population and high unmet medical need due to the suboptimal efficacy of current therapy. This high unmet need makes HCV one of the most active areas of drug development within infectious diseases. The protease and polymerase inhibitors are the most promising classes in development, and we anticipate these agents will change the standard of care soon after they are introduced into the market. We expect the HCV market to greatly expand in the coming years due, in large measure, to the entry of novel drugs and their impact on both treatment rates and the re-treatment of nonresponders.

Irritable Bowel Syndrome: Decision Resources' Market Forecast and Opportunity Analysis

Tue, 01 May 2012 00:00:00 -0400

Irritable Bowel Syndrome: Decision Resources' Market Forecast and Opportunity Analysis is an Executive Summary presentation of key insights drawn from Decision Resources’ Pharmacor Advisory Service and DecisionBase report on this indication for clients that have purchased both products. By weaving together key findings from Pharmacor and DecisionBase, this presentation provides a high-level summary of the most important issues pertinent to this market, including:

- Disease etiology and pathophysiology

- Patient population

- Current medical practice

- Current competitive landscape

- Factors influencing physicians’ prescribing behavior and payers’ formulary decisions

- Comparative assessment of key current and emerging therapies using DecisionBase’s proprietary Drug Comparator Model

- Unmet need, from the perspective of interviewed thought leaders, surveyed physicians, and surveyed payers

- Prescription patterns, patient share and market potential of two physician-built target product profiles of a drug fulfilling a key unmet need

- Patient share and prescription patterns of emerging product profiles

- Market Forecast

More detailed analysis can be found in the Pharmacor and DecisionBase source products.

Alzheimer's Disease (Event Driven)

Last Updated 15 May 2012
The Alzheimer’s disease (AD) patient population is large and growing rapidly as the global population ages. Despite a large patient pool, treatment options for AD are at present limited to symptomatic therapies with only modest efficacy of limited duration. Disease-modifying therapies that could slow or halt the progression of the disease are a critical need in this market. Three agents with disease-modifying potential are expected to launch during our ten-year forecast period, resulting in a dramatic expansion of the AD therapy market. Uptake of these drugs will be aided by the availability of improved diagnostics, particularly the amyloid-binding agents for use with PET imaging, leading to identification of patients earlier in the disease course.

Rheumatoid Arthritis: Rheumatologists Will Accept Trade-Offs in Safety for an Oral Agent That Is as Efficacious as Humira and Priced at a Significant Discount

Tue, 01 May 2012 00:00:00 -0400

Over the last several years, the rheumatoid arthritis (RA) therapy market has become saturated with biologics. Although these agents are the most efficacious disease-modifying drugs for the treatment of RA, they are expensive and require parenteral administration. Because of the suboptimal efficacies of the significantly more affordable oral conventional disease-modifying antirheumatic drugs (DMARDs), both physicians and patients would welcome less-expensive oral therapies that demonstrate efficacy comparable (or nearly comparable) to that of current biological agents. Several key agents in development for RA are oral therapies, but their commercial success is likely to depend on their long-term safety and efficacy profiles.

Ulcerative Colitis: Decision Resources' Market Forecast and Opportunity Analysis

Tue, 01 May 2012 00:00:00 -0400

Ulcerative Colitis: Decision Resources' Market Forecast and Opportunity Analysis is an Executive Summary presentation of key insights drawn from Decision Resources’ Pharmacor Advisory Service and DecisionBase report on this indication for clients that have purchased both products. By weaving together key findings from Pharmacor and DecisionBase, this presentation provides a high-level summary of the most important issues pertinent to this market, including:

- Disease etiology and pathophysiology

- Patient population

- Current medical practice

- Current competitive landscape

- Factors influencing physicians’ prescribing behavior and payers’ formulary decisions

- Comparative assessment of key current and emerging therapies using DecisionBase’s proprietary Drug Comparator Model

- Unmet need, from the perspective of interviewed thought leaders, surveyed physicians, and surveyed payers

- Prescription patterns, patient share and market potential of two physician-built target product profiles of a drug fulfilling a key unmet need

- Patient share and prescription patterns of emerging product profiles

- Market Forecast

More detailed analysis can be found in the Pharmacor and DecisionBase source products.

Moderate to Severe Psoriasis: Decision Resources' Market Forecast and Opportunity Analysis

Tue, 01 May 2012 00:00:00 -0400

Moderate to Severe Psoriasis: Decision Resources' Market Forecast and Opportunity Analysis is an Executive Summary presentation of key insights drawn from Decision Resources’ Pharmacor Advisory Service and DecisionBase report on this indication for clients that have purchased both products. By weaving together key findings from Pharmacor and DecisionBase, this presentation provides a high-level summary of the most important issues pertinent to this market, including:

- Disease etiology and pathophysiology

- Patient population

- Current medical practice

- Current competitive landscape

- Factors influencing physicians’ prescribing behavior and payers’ formulary decisions

- Comparative assessment of key current and emerging therapies using DecisionBase’s proprietary Drug Comparator Model

- Unmet need, from the perspective of interviewed thought leaders, surveyed physicians, and surveyed payers

- Prescription patterns, patient share and market potential of two physician-built target product profiles of a drug fulfilling a key unmet need

- Patient share and prescription patterns of emerging product profiles

- Market Forecast

More detailed analysis can be found in the Pharmacor and DecisionBase source products.

Snapshot: AAN 2012 - Physician Insight on Recent Developments in Multiple Sclerosis and New Data Presented at the 64th Annual Meeting of the American Academy of Neurology

Tue, 01 May 2012 00:00:00 -0400

Starting with the U.S. launch of Novartis’s fingolimod (Gilenya) in 2010, the market for disease-modifying therapies (DMTs) for the treatment of multiple sclerosis (MS) has entered a period of dramatic transformation. A wave of new and promising products is in advanced stages of development, moving closer to launch. In this ever-changing arena, important developments arise frequently that can materially impact neurologists’ evolving view of current and anticipated future medical practice in MS. This Snapshot report offers a rapid survey assessment of 50 U.S. neurologists’ opinions of recent news and developments in MS, including new insights presented at the 64^th annual meeting of the American Academy of Neurology (AAN) in April 2012.

Industry Opportunity Platform: PatientBase

Tue, 01 May 2012 00:00:00 -0400

PatientBase is the premier epidemiology database that provides robust coverage of more than 120 disease indications and more than 2300 patient populations. With a rich data set and easy-to-use Web interface, PatientBase allows users to:

Identify disease growth trends over a 20-year outlook period (10-year outlook for emerging markets coverage and select indications)
Understand undiagnosed and untreated populations—key areas of opportunity and growth
Address business questions using continuously updated epi data

This comprehensive analysis includes stratification of the patient population by:

Diagnosed and drug-treated status
Relevant clinical variables such as stage of disease at diagnosis and severity
Urban and rural status (for China and India)

Features & Benefits

Wide breadth of coverage: more than 2300 patient populations
Transparent methodologies and sources, and access to Decision Resources’ epidemiologists to help address key business questions
Intuitive navigation and the ability to quickly download and integrate data into user’s own models and presentations
View and compare epi data for the seven largest mature markets and key emerging markets under one platform
Create, chart and export epidemiological projections of key patient segments

Sample questions PatientBase can help answer:

What is the size and growth rate of a specific patient population across various geographies?
What factors will drive growth in a specific patient population?
How many patients in a particular market are diagnosed and drug-treated?
How will prevalence, diagnosis and drug-treated percentages change over the next 10-20 years?
How many of the patients with cancer are diagnosed with early stages of the disease versus later stages?
How does disease burden vary by country and by indication?

Industry Opportunity Platform: Pharmaview

Tue, 01 May 2012 00:00:00 -0400

Pharmaview offers all the insight you need to understand how the leading players in the biopharmaceutical industry function.

Company strategies, pipelines and deals, drug profiles and forecasts, examination of major market events—all are included in a subscription to Pharmaview. With itswealth of industry experience and independent objective insight, Decision Resources’ Pharmaview offers you the information you need to make the right decisions for your business.

Features
Regular Updating—Analysis is updated and reviewed regularly. Decision Resources’ analysts cover a range of therapy area conferences, company R&D days, annual general meetings and quarterly earnings conference calls, providing analysis and insight updated directly onto the Pharmaview platform.

Competitive Assessment Calls—The Pharmaview team conducts regular analyst calls on the current issues and drivers within the industry, including opinion and insight on key company deals, evolving therapeutic dynamics and the macroenviromental changes taking place within the drug industry.

Market Analyzer—A quantitative tool that allows users to track market sizes, assess barriers to market entry, quickly benchmark internal forecasts and analyze the potential of a licensing candidate. Data is updated three times a year based on company-reported net sales.

Macroviews—Using a consistent and concise report structure designed to quickly inform the busy executive on some of today’s leading issues, these reports analyze major events and trends, and assess their potential impact on the global industry.

Easy-to-navigate Interface—Search functionality allows users to quickly find relevant information across the entire research suite while hyperlinks allow users to quickly view relevant content.

Analogue Tool—search for product analogues based on a range of metrics.

Therapy Area Analysis
With all relevant information grouped by therapy area, our Therapy Area Analysis provides access to our in-depth analysis at the drug group and drug class levels. Our therapeutic area-aligned insight includes coverage of:

Key therapeutic events, including analysis of major conferences
Deals by therapy area that can be filtered by company, deal type and year (2001-present)
Company and drug rankings by therapeutic area
R&D analysis and pipelines
Therapeutic forecasts broken out by drug class, brand or company, with a 7-year forecast window, and 5-years of historical sales and market share data
Historical and forecasted therapy area sales rankings

Drug Analysis
Product analysis and sales forecasts can be viewed by brand, therapy area, drug group, drug class or by individual company. Included in our Drug Analysis:

Insightful and in-depth qualitative analysis on more than 3,000 drugs from more than 300 companies
Transparent forecasts and assumptions for more than 1,500 drugs, in 167 product classes, across 14 therapy areas
Historical and forecasted drug sales rankings

Company Analysis
Updated on an ongoing basis with the latest news and analysis, our Company Analysis provides independent and objective insight into the strategy and business development activities of the leading biopharmaceutical companies. This includes:

Corporate, geographic, therapeutic and business development strategies
Coverage of major strategic moves and deals by company that can be filtered by therapy area, deal type and year (2001-present)
Details of leading marketed products including historic sales data and independent 7-year forecasts by company
In-depth franchise analysis including benchmarking against peers and gap analysis
Coverage of key R&D candidates and pipeline analysis
Insight into factors affecting the future prospects for specific products and R&D candidates
Monthly updates tracking and analyzing major company events
Historical and forecasted company rankings

Industry Analysis
Providing up-to-date analysis and insight into the industry-wide and territory-specific issues shaping the pharmaceutical industry, our Industry Analysis helps busy executives cut through the news flow and understand the impact of key events. This includes:

Concise and comparable analysis, together with key reference data and ready-to-use graphics, focusing on the healthcare/pharmaceutical business environment in the G7 and emerging markets
Monthly Macroview reports covering key industry developments and their potential impact on the global pharmaceutical and biotechnology markets
Background reports provide summaries of the structure and key features of each country’s healthcare and pharmaceutical market
Thought leadership from a team of career experienced analysts—delivering intelligent and objective viewpoints on the issues that matter

Pseudomonas Aeruginosa Infections: The Emergence of Multidrug-Resistant Strains Creates Untapped Market Opportunity for Novel Antipseudomonals

Tue, 01 May 2012 00:00:00 -0400

Pseudomonas aeruginosa infections (PAIs) account for a significant proportion of hospital-treated infections, especially those acquired in the hospital setting. Because of inherent baseline resistance of Pseudomonas spp. to antibiotics and growing rates of resistance due to additional mechanisms, PAIs tend to be difficult to treat. Thus, they represent an important area of unmet need and significant opportunity for new agents with activity against multidrug-resistant Pseudomonas spp. The near-term pipeline for antipseudomonals is lean, but three key agents are in late-stage development: Cubist’s CXA-201, AstraZeneca/Forest’s CAZ-AVI (formerly CAZ-104), and Achaogen’s plazomicin (formerly ACHN-490). Each of these agents uses a distinct strategy to elicit high clinical cure rates in gram-negative infections, including infections caused by Pseudomonas spp., and may become formidable competitors in the PAI market.

Osteoarthritic Pain: Will Anti-NGF Therapies Still Be Able to Revolutionize This Market by Addressing Unmet Needs?

Tue, 01 May 2012 00:00:00 -0400

Osteoarthritic (OA) pain is the second largest segment of the chronic pain market after chronic back pain—yet a truly novel therapy has not been made available for this indication in more than a decade. Because nonsteroidal anti-inflammatory drugs (NSAIDs) and opioid analgesics are predominantly used to manage OA pain, there is a significant unmet need for therapies that lack the severe gastrointestinal, cardiovascular, and abuse risks associated with the current standard of care. Only one emerging class of agents—monoclonal antibodies against nerve growth factor (anti-NGFs)—has demonstrated the potential to improve on the efficacy, safety, and tolerability problems that plague the current therapies used to treat OA pain. However, the commercial success of the anti-NGFs in OA pain will ultimately hinge on safety concerns unique to this class of agents and on their accessibility in an overwhelmingly genericized market.

Colorectal Cancer (Second-Line Metastatic): Promising Antiangiogenic Agents Are on the Horizon, but What Attributes Do They Need to Displace Bevacizumab?

Tue, 01 May 2012 00:00:00 -0400

Despite the availability of targeted therapies that, when used in combination with chemotherapy, have yielded significant improvements in the treatment of second-line metastatic colorectal cancer (mCRC), the primary goal remains to prolong survival and/or delay tumor progression, as well as to relieve disease symptoms and improve quality of life. Decision Resources anticipates the approval of three new regimens for second-line mCRC over the next ten years, including the launches of two new antiangiogenic agents. The entry of a third antiangiogenic agent in the third-line setting is also expected, which will receive some off-label use in the second line. It is anticipated that only one of these regimens will increase efficacy outcomes in patients. A significant clinical and commercial opportunity awaits a regimen that can provide greater survival benefits than current treatments.

Systemic Lupus Erythematosus: Decision Resources' Market Forecast and Opportunity Analysis

Tue, 01 May 2012 00:00:00 -0400

Systemic Lupus Erythematosus: Decision Resources' Market Forecast and Opportunity Analysis is an Executive Summary presentation of key insights drawn from Decision Resources’ Pharmacor Advisory Service and DecisionBase report on this indication for clients that have purchased both products. By weaving together key findings from Pharmacor and DecisionBase, this presentation provides a high-level summary of the most important issues pertinent to this market, including:

- Disease etiology and pathophysiology

- Patient population

- Current medical practice

- Current competitive landscape

- Factors influencing physicians’ prescribing behavior and payers’ formulary decisions

- Comparative assessment of key current and emerging therapies using DecisionBase’s proprietary Drug Comparator Model

- Unmet need, from the perspective of interviewed thought leaders, surveyed physicians, and surveyed payers

- Prescription patterns, patient share and market potential of two physician-built target product profiles of a drug fulfilling a key unmet need

- Patient share and prescription patterns of emerging product profiles

- Market Forecast

More detailed analysis can be found in the Pharmacor and DecisionBase source products.

Asia Pacific: Market Access Tracker

Last Updated 2 May 2012
Decision Resources’ Market Access Tracker service for the Asia Pacific region explains the challenges and opportunities to gaining and maintaining favorable market access terms in the mature and emerging markets of Australia, China, India, Japan and South Korea. Timely analysis of key events, regular webinar update presentations, and access to our team of experts will equip biopharmaceutical companies with the insight needed to evaluate the implications of the latest changes for their business and to assess the commercial outlook in each market.

Schizophrenia (Event Driven)

Last Updated 26 April 2012
Total major-market sales of schizophrenia therapies will fall from $6.4 billion in 2010 to $6.0 billion in 2020. The launch, and continued uptake, of several atypical depot formulations early in the forecast period will be among the strongest market drivers, but they will not fully offset significant losses from the generic erosion of many top-selling atypical antipsychotics. The market will experience a slight increase late in the forecast period owing to the launch of two emerging therapies with novel mechanisms of action, which will gain significant adjunctive use to current therapies. Although the schizophrenia market is crowded and will meet with extensive genericization, the need for better tolerated and more effective antipsychotic therapies, particularly for long-term maintenance and treatment-resistant schizophrenia, continues to fuel drug development. In addition, negative symptoms and cognitive impairment associated with schizophrenia (CIAS) are increasingly being recognized as important aspects of the disease.

Epilepsy (Event Driven)

Last Updated 25 April 2012
Epilepsy is one of the world’s most common neurological disorders. In addition to its effect on patients’ quality of life, its considerable direct and indirect costs place a heavy socioeconomic burden on patients, their families, healthcare institutions, and society as a whole. Despite the widespread availability and uptake of first-, second-, and third-generation antiepileptic drugs (AEDs), approximately one-third of patients with epilepsy suffer from refractory disease, leaving significant commercial opportunity for new and emerging drugs.