"The
Report Frontier Pharma: Pain - Identifying and Commercializing
First-in-Class Innovation provides information on pricing, market
analysis, shares, forecast, and company profiles for key industry
participants. - MarketResearchReports.biz"
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.
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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.
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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
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Table
of Contents
1 Table of Contents
1.1 List of Figures
2 Executive Summary
2.1 Large and Innovative
Pipeline
2.2 Highly Diversified Range of
Innovative Programs in Early Pipeline and in Granted Patents
2.3 Active Deals landscape with
Numerous Investment Oppertunities
3 The Case for Innovation
3.1 Growing Opportunities for
Biologic Products
3.2 Diversification of
Molecular Targets
3.3 Innovative First-in-Class
Product Development Remains Attractive
3.4 Regulatory and
Reimbursement Policy Shifts Favor First-in-Class Product Innovation
3.5 Sustained Innovation
3.6 GBI Research Report
Guidance
4 Clinical and Commercial
Landscape
4.1 Disease Overview
4.1.1 Chronic and Neuropathic
Pain
4.1.2 Disease Pathophysiology
4.1.3 Diagnosis
4.1.4 Treatment Option
4.1.5 Treatment Algorithm
4.2 Overview of Marketed
Products for Pain
4.2.1 Analgesic Product
Categories
4.2.2 Molecular Type Analysis
4.2.3 Molecular Target Analysis
4.2.4 Current Unmet Needs
5 Assessment of Pipeline
Product Innovation
5.1 Pain Pipeline by Molecule
Type, Phase and Therapeutic Targets
5.2 Comparative Distribution of
Programs between the Pain Market and Pipeline by Therapeutic Target
Family
5.3 First-in-Class Pipeline
Programs
5.4 First-in-Class Targets by
Pain Subtype
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