Frontier Pharma: Pain - Identifying and Commercializing First-in-Class Innovation
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.
The report covers and includes -
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.
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