Market Research Logo

Frontier Pharma: Pain - Identifying and Commercializing First-in-Class Innovation

Frontier Pharma: Pain - Identifying and Commercializing First-in-Class Innovation

Summary

Large and Innovative Pipeline

The active pain pipeline is populated by 796 products across all stages of development, which exhibit a highly diverse range of molecular targets. GBI Research’s analyses identified 122 first-in-class programs in active development, constituting 13.6% of the pipeline and acting on 65 first-in-class molecular targets, indicating a high degree of innovation. This is in stark contrast to the pain therapeutics market, which has been largely characterized by only incremental product innovation over the last decade, as most market segments continue to be dominated by long-established active pharmaceutical ingredients and the concomitant mechanisms of action. Moderate-to-severe pain continues to be dominated by opioids that are increasingly being reformulated to offer abuse-resistance, while mild pain is effectively treated with Non-Steroidal Anti-Inflammatory Drugs (NSAID). However, significant unmet needs remain, as chronic pain and some neuropathic pain subtypes do not respond well to existing therapies, which are not adequate to treat associated hypersensitization and do not align to the underlying molecular pathophysiological profile.

Despite being mostly distributed in the early stages of development, first-in-class innovation is particularly concentrated on novel molecular targets that are aligned to the central sensitization associated with neuropathic pain, which is arguably the most debilitating and difficult-to-treat type of chronic pain. This gives them the potential to transform the future market by expanding the range of drug classes.

Highly Diversified Range of Innovative Programs in Early Pipeline and in Granted Patents

Pain is a complex and multifaceted disorder with a complex interplay between different pathological processes, and different pain subtypes exhibit distinct underlying etiologies and pathophysiologies. While technological advances and extensive research efforts have furthered the understanding of these complex underpinnings, gaps remain. However, these insights have translated into the expanding pool of novel therapeutic targets, as reflected by the highly innovative pipeline. GBI Research’s proprietary analysis shows that early-stage, first-in-class programs exhibit a higher level of diversity with respect to novel therapeutic targets. The significant diversity in terms of targets is a reflection of the complex underpinnings of distinct pain subtypes. Although the pipeline continues to feature established therapies, the range of mechanisms of action employed by novel compounds is extremely diverse, with the vast majority residing in the Preclinical stage. This innovation and diversity is maintained throughout the pipeline from early- to late-stage development, although the degree of innovation diminishes from Phase II. Additionally, although NSAIDs and opioids remain the cornerstone of pain treatment, GBI Research analysis indicates a shift towards pain subtypes that are more difficult to treat. Encouragingly, these first-in-class compounds often target molecules which are strongly implicated in pain and its associated signaling pathways. Although there are significant differentiations in the scientific rationale and clinical prospects across these first-in-class products, the majority demonstrate significant Preclinical evidence and alignment to molecular pathophysiological changes.

In addition, GBI Research’s comprehensive and complementary analysis of granted patents highlighted a significant number of first-in-class product technologies, many of which have not been identified in the pain product pipelines or even in pipelines across the industry. The distribution of these products across the molecular target superfamilies and families highlighted that they predominantly align with the proportional distribution observed across the pain pipeline, with G-protein-coupled receptors and enzymes inhibitors constituting the two major categories. However, an array of novel molecular targets within those groups has been identified, which do not present in any pipeline or marketed products across the industry. A significant degree of innovation has also been identified in other molecular target categories.

Active Deals Landscape with Numerous Investment Opportunities

The pain deals landscape has been highly active over the past eight years, with 261 licensing deals and 112 co-development deals. However, despite high levels of investment activity, deals for first-in-class products have been relatively rare.

Overall, more than 50% of deals involving first-in-class targets were settled in the early stages of development, which is a striking contrast with non-first-in-class products, which are more frequently entered into deals in the later stages of development. This reflects companies’ willingness to invest despite the high-risk profile of first-in-class products.

With 107 first-in-class products available for strategic consolidations, a wide variety of investment opportunities are available for licensing deals or co-development deals in pain. This will be encouraged by the growing unmet need for chronic pain therapies, and an increased understanding of the distinct underlying pathophysiologies of distinct pain sub-types, allowed by technological advances. Among these, some first-in-class products have demonstrated promising Preclinical evidence and have significant potential to become game-changing products, representing high-reward investments.

Scope

The report covers and includes -

  • A brief introduction to pain, including the different subtypes of pain, pathophysiology, and overview of pharmacotherapy and treatment algorithms
  • The changing molecular target landscape between market and pipeline and particular focal points of innovation in the pipeline
  • A comprehensive review of the pipeline for first-in-class therapies, analyzed on the basis of stage of development, molecule type and molecular target
  • Identification and assessment of first-in-class molecular targets with a particular focus on early-stage programs of which clinical utility has yet to be evaluated, as well as literature reviews on novel molecular targets
  • Assessment of the licensing and co-development deal landscape for pain therapies and benchmarking of deals involving first-in-class versus non-first-in-class-products
Reasons to buy

The report will assist business development and enable marketing executives to strategize their product launches, by allowing them to -
  • Understand the focal shifts in molecular targets in the pain therapeutics pipeline
  • Understand the distribution of pipeline programs by phase of development, molecule type and molecular target
  • Access a scientific and clinical analysis of first-in-class developmental programs for pain, benchmarked against non-first-in-class targets.
  • Access a list of the first-in-class therapies potentially open to deal-making opportunities


Big Pharma Drives Innovation in Pain Therapy Development, Despite Declining Patent Applications, says GBI Research

Reference Code: GBIHC356MR

Publication Date: Jan 2015


Patent applications for novel pain therapeutics declined steadily in number from 4,970 in 2008 to 3,492 in 2012, an average annual decrease of 8%, as limited understanding of pain pathophysiology continues to hinder drug development in this arena, says business intelligence provider GBI Research.

The company’s latest report* states that patent applications for pain treatments between 2008 and 2012 were dominated by Big Pharma, including Sanofi, Novartis and Merck & Co. (Merck), which submitted 169, 162 and 142 applications, respectively.

However, according to GBI Research, the global pain treatment market is dominated by opioids and steroidal anti-inflammatory drugs, with no novel products currently able to challenge these products’ efficacy in treating moderate to severe acute pain.

Furthermore, despite the significant unmet needs for more effective therapies in other pain subtypes, such as chronic and neuropathic pain, due to their rising prevalence, the factors underpinning these subtypes are complex and poorly understood.

However, this limited knowledge is being countered by technological advances and significant research efforts, with new insights translating into an expanding pool of novel therapeutic targets.

GBI Research states that the overall pain therapy pipeline is exceptionally large and moderately diverse, with a number of molecules boasting different mechanisms of action to those seen in the current market landscape. This offers a high probability of producing strong market entrants in the near future.

Indeed, among the 111 first-in-class pipeline products available for strategic consolidations, some have shown promising Preclinical evidence and significant potential to become game-changing treatments, representing high-reward investments.

GBI Research believes that such innovation in the pain therapeutics field is being driven primarily by Big Pharma, due to the large number of patent grants awarded to these companies for their treatments between 2008 and 2012.

Merck boasted the highest number of patent grants during this period, with 59, while Boehringer Ingelheim and Allergan achieved 35 and 34, respectively, and Sanofi and Novartis both achieved 30.

*Frontier Pharma: Pain - Identifying and Commercializing First-in-Class Innovation

This report provides a comprehensive review of the pipeline for first-in-class pain therapies, analyzed on the basis of stage of development, molecule type and molecular target. The report also assesses the licensing and co-development deal landscape for pain therapies and the benchmarking of deals involving first-in-class versus non-first-in-class products.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research’s team of industry experts.

  • Executive Summary
    • Large and Innovative Pipeline
    • Highly Diversified Range of Innovative Programs in Early Pipeline and in Granted Patents
    • Active Deals landscape with Numerous Investment Oppertunities
  • The Case for Innovation
    • Table Figure 1: Innovation Trends in Product Approvals, 1987-2012
    • Growing Opportunities for Biologic Products
    • Diversification of Molecular Targets
    • Innovative First-in-Class Product Development Remains Attractive
      • Table Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006-2013
      • Table Figure 3: Sales Performance of Central Nervous System First-in-Class and Non-First-in-Class Products post Marketing Approval, 2006-2013
    • Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation
    • Sustained Innovation
    • GBI Research Report Guidance
  • Clinical and Commercial Landscape
    • Disease Overview
      • Chronic and Neuropathic Pain
      • Disease Pathophysiology
      • Diagnosis
      • Treatment Option
      • Treatment Algorithm
        • Table Figure 4: Treatment Algorithm
    • Overview of Marketed Products for Pain
      • Table Figure 5: WHO Analgesic Ladder
      • Analgesic Product Categories
      • Molecular Type Analysis
        • Table Figure 6: Molecule Types in Marketed Products
      • Molecular Target Analysis
        • Table Figure 7: Marketed Products, Part 2
      • Current Unmet Needs
  • Assessment of Pipeline Product Innovation
    • Pain Pipeline by Molecule Type, Phase and Therapeutic Targets
      • Table Figure 8: Developmental Pipeline Overview
      • Table Figure 9: Developmental Pipeline Molecular Target Categories
    • Comparative Distribution of Programs between the Pain Market and Pipeline by Therapeutic Target Family
      • Table Figure 10: Molecular Target Category Comparison, Pipeline and Marketed Products
    • First-in-Class Pipeline Programs
      • Table Figure 11: Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets
    • First-in-Class Targets by Pain Subtype
      • Table Figure 12: Total Pipeline Targets by Pain Subtype
      • Table Figure 13: First-in-Class Pipeline Targets by Pain Subtypes
      • Table Figure 14: First-in-Class Products in the Pipeline
  • Pain Patent Analysis
    • Table Figure 15: Patent Families Filed and Granted by Year
    • Table Figure 16: Organizations Frequently Applying for Pain-Related Patent Families, (2008-2012)
    • Table Figure 17: Granted Patents by Mechanism of Action
    • Table Figure 18: Granted Patent Families by Molecular Target Family, 2009-2012
    • Table Figure 19: Molecular Targets Identified in Patents(Part 1), 2008-2012
    • Table Figure 20: Molecular Targets Identified in Patents(Part 2), 2008-2012
    • Table Figure 21: Molecular Targets Identified in Patents(Part 3), 2008-2012
    • Table Figure 22: Molecular Targets Identified in Patents(Part 4), 2008-2012
  • First-in-Class Target and Pipeline Program Evaluation
    • Pipeline Programs Targeting Fatty Acid Amide Hydrolase
      • Table Figure 23: Data and Evidence for Fatty Acid Amide Hydrolase as a Therapeutic Target
      • Table Figure 24: Pipeline Programs Targeting FAAH
    • Pipeline Programs Targeting Purinoceptor 3
      • Table Figure 25: Data and Evidence for P2X3 as a Therapeutic Target
      • Table Figure 26: Pipeline Programs Targeting P2X3
    • Pipeline Programs Targeting Purinoceptor 7
      • Table Figure 27: Data and Evidence for P2X7 as a Therapeutic Target
      • Table Figure 28: Pipeline Programs Targeting P2X7
    • Pipeline Programs Targeting Purinoceptor 4
      • Table Figure 29: Pipeline Programs Targeting P2X4
    • Pipeline Programs Targeting Orexin Receptor Type 1
      • Table Figure 30: Pipeline Programs Targeting Orexin Receptor Type 1
      • Table Figure 31: Pipeline Programs Targeting Orexin Receptor Type 1
    • Pipeline Programs Targeting Neuronal Nitric Oxide Synthase
      • Table Figure 32: Data and Evidence for Neuronal Nitric Oxide Synthase as a Therapeutic Target
      • Table Figure 33: Pipeline Programs Targeting Neuronal Nitric Oxide Synthase
    • Pipeline Programs that Target Tropomyosin-Related Kinase A
      • Table Figure 34: Data and Evidence for Tropomyosin-Related Kinase A as a Therapeutic Target
      • Table Figure 35: Pipeline Programs Targeting Tropomyosin-Related Kinase A
    • Pipeline Programs that Target C-C Chemokine Receptor 2
      • Table Figure 36: Data and Evidence for C-C Chemokine Receptor 2 as a Therapeutic Target
      • Table Figure 37: Pipeline Programs Targeting C-C Chemokine Receptor 2
    • Pipeline Programs that Target Endomorphin 2
      • Table Figure 38: Data and Evidence for Endomorphin 2 as a Therapeutic Target
      • Table Figure 39: Pipeline Programs Targeting Endomorphin 2
    • Pipeline Programs that Target Protein Kinase Ca
      • Table Figure 40: Data and Evidence for Protein Kinase C a as a Therapeutic Target
      • Table Figure 41: Pipeline Programs Targeting Protein Kinase C a
    • Pipeline Programs that Target Opioid Receptor-Like-1 Receptor
      • Table Figure 42: Data and Evidence for Opioid Receptor-Like-1 Receptor as a Therapeutic Target (Part 1)
      • Table Figure 43: Data and Evidence for Opioid Receptor-Like-1 Receptor as a Therapeutic Target (Part 2)
      • Table Figure 44: Pipeline Programs Targeting Opioid Receptor-Like-1 Receptor
    • Pipeline Programs that Target Bradykinin B1 Receptor
      • Table Figure 45: Data and Evidence for Bradykinin B1 Receptor as a Therapeutic Target (Part 1)
      • Table Figure 46: Data and Evidence for Bradykinin B1 Receptor as a Therapeutic Target (Part 2)
      • Table Figure 47: Data and Evidence for Bradykinin B1 Receptor as a Therapeutic Target (Part 3)
      • Table Figure 48: Pipeline Programs Targeting Bradykinin B1 Receptor
    • Pipeline Programs Targeting Galanin Receptor 2
      • Table Figure 49: Data and Evidence for Galanin Receptor 2 as a Therapeutic Target
      • Table Figure 50: Pipeline Programs Targeting Galanin Receptor 2
    • Pipeline Programs Targeting Nerve Growth Factor
      • Table Figure 51: Data and Evidence for Nerve Growth Factor as a Therapeutic Target
      • Table Figure 52: Pipeline Programs Targeting Nerve Growth Factor
  • Deals and Strategic Consolidations
    • Industry Industry-wide First-in-Class Deals
      • Table Figure 53: Industry-wide Deals by Stage of Development, 2006-2014
      • Table Figure 54: Industry Licensing Deal Values by Stage of Development, 2006-2014
    • Pain Deals Landscape
    • Licensing Deals
      • Table Figure 55: Licensing Deals, 2006-2015
      • Table Figure 56: Regional Network of Licensing Deals, 2006-2015
      • Molecule Type
        • Table Figure 57: Licensing Deals by Molecule Type and Phase, 2006-2015
      • Mechanism of Action
        • Table Figure 58: Licensing Deals by Target, 2006-2015
        • Table Figure 59: Summary of Licensing Deals, 2006-2015 (Part1)
        • Table Figure 60: Summary of Licensing Deals, 2006-2015 (Part 2)
        • Table Figure 61: Summary of Licensing Deals, 2006-2015 (Part 3)
    • Co-development Deals
      • Table Figure 62: Co-development Deals, 2006-2015
      • Table Figure 63: Regional Network of Co-development Deals, 2006-2015
      • Molecule Type
        • Table Figure 64: Co-Development Deals by Molecule Type and Phase, 2006-2015
      • Mechanism of Action
        • Table Figure 65: Co-Development Deals by Target, 2006-2015
        • Table Figure 66: Summary of Co-development Deals, 2006-2015 (Part 1)
        • Table Figure 67: Summary of Co-development Deals, 2006-2015 (Part 2)
    • First-in-Class Programs Not Involved in Licensing or Co-Development Deals
      • Table Figure 68: First-in-Class Products not Involved in Prior Deals
  • Appendix
    • Abbreviations
    • References
    • Contact Us
    • Disclaimer

Download our eBook: How to Succeed Using Market Research

Learn how to effectively navigate the market research process to help guide your organization on the journey to success.

Download eBook

Share this report