(Health-NewsWire.Net, May 21, 2016 ) Obesity is a major growing health concern around the world. In most markets, a person is considered obese if their Body Mass Index (BMI) exceeds 30 kilograms per square meter (kg/m2), calculated by dividing body mass in kilograms by height in meters squared.
With the global prevalence continuing to rise, the disease has placed significant burden on healthcare expenditure, as it is also a major risk factor for cardiovascular diseases, diabetes and cancer. Anti-obesity pharmacotherapy can be used as an adjunct lifestyle modification to improve weight loss in order to significantly reduce obesity-associated health risks in obese patients. However, the use of currently available anti-obesity drugs is largely limited by poor long-term safety and a modest weight loss effect. Despite substantial clinical and regulatory challenges, the early-stage obesity pipeline remains robust, containing a high level of first-in-class innovation that has the potential to be translated into effective and safe weight loss treatments.
Other Key Points in Report:
Historically, the obesity market has suffered from long-term safety concerns and modest efficacy with current treatments, both of which contribute to the low prescription rate and limited widespread use. -What are the main safety concerns that lead to significant challenges in gaining drug approval in obesity? -Why is sustainable weight loss difficult to achieve, and what is the implication for future drug development? Analysis reveals a high level of innovation and diversity in the pipeline, with 75 first-in-class programs identified to act on 60 unique molecular targets. -What is the dominant target family across these first-in-class pipeline products? -How well do they align with the underlying signaling pathways governing the central and peripheral regulation of food intake, and energy expenditure? Some first-in-class targets are deemed more likely to be developed into marketable treatments than others, having demonstrated substantial body weight reduction in Preclinical studies and addressing multiple mechanisms underpinning the development of obesity. -What is the scientific rationale behind these targets? How are they likely to surpass existing treatment?
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Table of Content: An Overview
2 Executive Summary 4 2.1 High Unmet Need Remains in the Obesity Market 4 2.2 Highly Innovative and Diverse Pipeline 4 2.3 Deals Landscape Presents Substantial Investment Opportunities 4
3 The Case for Innovation 5 3.1 Growing Opportunities for Biologic Products 6 3.2 Diversification of Molecular Targets 6 3.3 Innovative First-in-Class Product Developments Remain Attractive 6 3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 7 3.5 Sustained Innovation 7 3.6 GBI Research Report Guidance 8
4 Clinical and Commercial Landscape 9 4.1 Disease Overview 9 4.2 Disease Etiology 9 4.2.1 Genetics 9 4.3 Disease Pathophysiology 10 4.3.1 Central Regulation of Energy Homeostasis 10 4.3.2 Endocrine Regulation in Energy Balance 11 4.3.3 Adipose Tissue and Regulation of Energy Expenditure 11 4.3.4 Dysregulation of Adipokines and Contribution to Obesity and Related Metabolic Disorders 12 4.4 Epidemiology 13 4.5 Classification and Diagnosis 13
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4.6 Co-morbidities 14 4.6.1 Type 2 Diabetes 14 4.6.2 Hypertension 14 4.6.3 Dyslipidemia and Cardiovascular Diseases 14 4.6.4 Respiratory Complications 14 4.6.5 Osteoarthritis 14 4.6.6 Cancer Risk 14 4.7 Prognosis 15 4.8 Treatment Algorithm and Options 15 4.8.1 Lifestyle and Behavioral Modification 15 4.8.2 Bariatric Surgery 15 4.8.3 Pharmacotherapy 16 4.9 Overview of Marketed Products 18 4.9.1 Molecule Type and Target Analysis 19 4.9.2 Major Drug Withdrawals in the Obesity Market 20 4.9.3 Significant Challenges with Reimbursement in the Obesity Market 20 4.10 Current Unmet Needs 21
5 Assessment of Pipeline Product Innovation 22 5.1 Obesity Pipeline by Molecule Type, Phase and Therapeutic Target 22 5.2 Comparative Distribution of Programs between Obesity Market and Pipeline by Therapeutic Target Family 26 5.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets 27
6 Signaling Pathways, Genetics and Innovation Alignment 31 6.1 The Complexity of Signaling Networks in Obesity 31 6.2 Signaling Pathways, Genetic Risk Factors and First-in-Class Molecular Target Integration 32 6.3 First-in-Class Target Matrix Assessment 34
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