PDE Inhibitors Market, 2016-2026

LONDON, Oct. 31, 2016 /PRNewswire/ --

INTRODUCTION
The discovery of the second messengers, cAMP and cGMP, in 1958 led to a deeper understanding of the signal transduction processes behind physiological stimulation and response. Later, the identification of phosphodiesterases (PDEs) and the establishment of their role in diseases led to the development of drugs targeting this class of enzymes. PDEs are a complex superfamily of metallophosphohydrolase enzymes that regulate the activity of second messengers. The superfamily consists of 11 different gene families, ranging from PDE1 to PDE11. These enzymes can be differentiated, in terms of their 3D-structure, modes of regulation, cellular localization and sensitivity to inhibitors.

Until 1998, only non-selective PDE inhibitors were available in the market and were primarily indicated for providing symptomatic relief for respiratory diseases, including COPD and asthma. Post the launch of Viagra® in 1998, several selective PDE inhibitors came into the market. At present, there are 13 PDE inhibitors commercially available in different geographies. Due to the involvement of PDEs in multiple cellular processes, inhibitors against these molecular targets are applicable across a diverse range of disease indications. It is worth mentioning that the introduction of PDE inhibitors brought a radical change in the treatment of erectile dysfunction. Consequently, these molecules now occupy a major share in the erectile dysfunction market. In addition, PDE inhibitors are also being developed to address the current unmet need for pharmacological interventions for the treatment of patients suffering from certain neurological diseases, cardiovascular diseases, respiratory diseases and dermatological diseases. Drug candidates targeting schizophrenia, atopic dermatitis, Huntington's disease, COPD, asthma and Alzheimer's disease are all in various phases of clinical development.

The success of the marketed PDE inhibitors has prompted several industry players to undertake initiatives in this area. The fragmented nature of the market is expected to increase the pace of innovation; as more molecules advance to late stage development and eventually get commercialized, we expect the new entrants to actively monetize this growing opportunity.

SCOPE OF THE REPORT
The PDE Inhibitors Market, 2016-2026 study offers a comprehensive analysis of the current landscape of these therapies and an informed opinion on how the field is likely to evolve over the next decade. The market has gained traction during the last few years with many drug candidates designed to address a wide range of diseases. PDE5, with two blockbuster drugs (Viagra® and Cialis®), is one of the most researched PDE inhibitor subtype. In the recent past, another PDE inhibitor subtype, PDE4, has surfaced to address the unmet needs associated with respiratory diseases and dermatological disorders.

Among other things, the report provides the following information:
- A detailed overview of the PDE inhibitors pipeline covering marketed, clinical and preclinical therapies. We have presented information on the respective phases of development, key players involved, PDE inhibitor subtypes, routes of administration and indications being targeted by specific drug candidates.
- Comprehensive profiles highlighting clinical trial details, key clinical results and future market opportunity for the marketed and late stage (phase II and phase III) PDE inhibitors.
- A list of key opinion leaders (KOLs) who have been involved in the discovery and development of PDE inhibitors.
- A discussion on emerging trends and the popularity of PDE inhibitors as observed on social media platforms, such as Twitter, over the last few years.
- A discussion on the potential side effects and the warnings issued by regulatory authorities, indicating areas of improvement for future drug development.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters such as target consumer segments, likely adoption rates and expected pricing, we have provided an estimate of the size of the market in the short-mid-term and long term. The base year for the report is 2016. To account for the uncertainties associated with the development of novel therapeutic classes and to add robustness to our model, we have provided three forecast scenarios portraying the conservative, base and optimistic tracks of the market's evolution.

The opinions and insights presented in the report were influenced by discussions with experts in the industry. All figures and technical details presented in the report have been sourced and analyzed from publicly available data. All financial figures mentioned in this report are in USD, unless specified otherwise.

RESEARCH METHODOLOGY
Most of the data presented in this report has been gathered through secondary research. We have also conducted interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will shape up across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

- The secondary sources of information include:
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Other analyst's opinion reports

While the focus has been on forecasting the market over the coming decade, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
Chapter 2 provides an executive summary of the report. It offers a high level view on the evolution of PDE inhibitors market in the mid to long term.

Chapter 3 provides an introduction to PDE enzyme superfamily, including details on the historical timeline of this class of therapeutics and information on different PDE isozymes. The chapter highlights the structure of these enzymes and their role in different cellular activities. It also contains comprehensive information about selective and non-selective PDE inhibitors. In addition, the chapter provides details on the design of PDE inhibitors as well as importance of substrate specificity and potency.

Chapter 4 includes information on over 50 molecules that are either approved or are being evaluated in different stages of development (clinical / preclinical). It features a detailed and comprehensive analysis of the pipeline molecules highlighting the key therapeutic indications, PDE subtypes, phases of development, routes of administration and leading players in the field of PDE inhibitors.

Chapter 5 contains information on various genitourinary and cardiovascular diseases targeted by different PDE inhibitors. In addition to other elements, we have provided details on disease epidemiology and information on specific PDE inhibitors that are involved in the treatment of a particular indication. The chapter also provides comprehensive profiles of drug candidates in development (phase II or higher) for the treatment of genitourinary and cardiovascular diseases. Each profile presents an overview of the drug developer, portfolio of PDE inhibitors, details on clinical trials, current status of development and key clinical results. In addition, the chapter highlights the emerging trends on social media related to PDE inhibitors. It presents an overview of the popularity of the keywords phosphodiesterase inhibitor and PDE inhibitor on Twitter over the last five years.

Chapter 6 contains information on various neurological diseases being targeted by different PDE inhibitors. In addition to other elements, we have provided details on disease epidemiology and information on specific PDE inhibitors that are involved in the treatment of a particular indication. The chapter also provides comprehensive profiles of drug candidates in development (phase II or higher) for the treatment of neurological diseases. Each profile presents an overview of the drug developer, portfolio of PDE inhibitors, details on clinical trials, current status of development and key clinical results.

Chapter 7 contains information on various dermatological diseases being targeted by different PDE inhibitors. In addition to other elements, we have covered details on disease epidemiology and information on specific PDE inhibitors that are involved in the treatment of a particular indication. The chapter also provides detailed profiles of the molecules in development (phase II or higher) for the treatment of dermatological diseases. Each profile presents an overview of the drug developer, portfolio of PDE inhibitors, details on clinical trials, current status of development and key clinical results.

Chapter 8 contains information on various respiratory diseases and other key indications targeted by different PDE inhibitors. In addition to other elements, we have covered details on disease epidemiology and information on specific PDE inhibitors that are involved in the treatment of a particular indication. The chapter also provides detailed profiles of the molecules in development (phase II or higher) for the treatment of respiratory diseases and other key indications. Each profile presents an overview of the drug developer, portfolio of PDE inhibitors, details on clinical trials, current status of development and key clinical results.

Chapter 9 presents an analysis of the key opinion leaders (KOLs) in this domain. It contains schematic representations of world maps highlighting the geographical locations of these eminent scientists / researchers. The chapter presents a detailed 2X2 analysis to assess the relative experience of certain KOLs based on the number of clinical studies and the highest phase of development of a clinical trial investigated by them.

Chapter 10 presents a detailed market forecast of PDE inhibitors and a discussion on the overall financial opportunity in this domain. It includes future sales projections for 13 molecules in advanced stages of development. These estimates take into account the target patient population, the existing competition, likely adoption rate and the expected price of each therapy.

Chapter 11 focusses on the various side effects reported by patients treated using these drugs. In addition, the chapter lists the PDE inhibitors that have been terminated during development due to various reasons.

Chapter 12 provides a summary of the overall report. In this chapter, we present a list of key takeaways from the report and our independent opinion on the nature and potential of the PDE inhibitors market. The insights presented in this chapter are based on the research and analysis described in previous chapters.

Chapter 13 contains a collection of interview transcripts of discussions held with some of the key players in the industry.

Chapters 14 and 15 are appendices, which provide tabulated data and a list of companies mentioned in the report, respectively.

EXAMPLE HIGHLIGHTS
1. Around 40 PDE inhibitors are currently in various stages of clinical / preclinical development. PDE4 and PDE5 inhibitors, each occupying over 30% share of the pipeline, have emerged as the most prominent PDE inhibitor subtypes.
2. Several molecules are under development for the treatment of neurological diseases (36%), such as schizophrenia, Alzheimer's disease and Huntington's disease; most of these molecules are in early development phases. Other key therapeutic areas include genitourinary diseases (25%) and cardiovascular diseases (11%).
3. Although the market was initially led by large-size pharma players (such as AstraZeneca, Bayer, Celgene, Eli Lilly, Pfizer), the current market is characterized by the presence of several small / mid-sized pharma players. Notable examples of small firms and start-ups include (in alphabetical order) BioCrea, Dart NeuroScience, Carinopharm, CTC Bio, FORUM Pharmaceuticals, Intra-Cellular Therapies, Omeros Corporation, Medimetriks Pharmaceuticals, NuSirt Biopharma, Palobiopharma, Roivant Sciences, Sagene Pharmaceuticals, Tetra Discovery Partners, Tritechbiopharm, VIVUS, Verona Pharma, and vtv Therapeutics.
4. Several research institutes, companies and organizations have made significant contribution to the overall development of these therapeutics. During our research, we identified over 400 key opinion leaders who have played critical role in the development of PDE inhibitors. Lee Zane (Anacor Pharmaceuticals / Pfizer), Sae Woong Kim (Catholic University Medical College), Dave Singh (Medicines Evaluation Unit) and Min-Gul Kim (Chonbuk National University Hospital) are some of the well-known researchers who have done exemplary work in this field.
5. With the presence of already approved PDE inhibitors such as Viagra® and Cialis®, trends on social media platform have indicated growing trend. In fact, we were able to capture around 2.7 million tweets of relevant keywords over last five years on Twitter.
6. It is important to highlight that the impending patent expiries of currently approved drugs is expected to negatively impact the market's growth in the short-term. However, it is poised to gain momentum post 2021 after the anticipated approval of a number of late stage product candidates. By 2026, we expect that the overall PDE inhibitors market could be worth over USD 10 billion.
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