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Acromegaly - Market Outlook, Epidemiology, Market Forecast and Competitive Landscape Report -2018 To 2030 -Sample Report

Acromegaly u2013 Market outlook, Epidemiology, Market Fore- cast and Competitive Landscape Report u2013 2020 To 2030 The report provides a comprehensive view of disease events, classi- fication, identified and emerging , Clinical Manifestations, progres- sion, signs & symptoms, risk factors, pathogenesis, genetic basis and treatment guidelines at country level .

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Acromegaly - Market Outlook, Epidemiology, Market Forecast and Competitive Landscape Report -2018 To 2030 -Sample Report

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  1. 2020 Valued Knowledge Partners Valued Knowledge Partners Acromegaly –Market outlook, Epidemiology, Market Fore- cast and Competitive Landscape Report – 2020 To 2030  Disease overview (Classification of Acromegaly)  Approved and Emerging therapies (Pipeline assessment and key clinical trials profile)  Epidemiology (Incidence, prevalence, mortality and survival)  Market share and patient share uptake  KOL’s perspective on current treatment & unmet needs  Market and product event analysis  Market forecast 2020 - 2030 (11 years of future market pro- jections) Market outlook & Insight Report

  2. Report overview Report Summary Thelansis “Acromegaly - Market outlook, Epidemiology, Market Forecast and Competitive Land- scape - 2020 To 2030 ” this re- port provides a comprehensive study of the disease area land- scape and changing market dy- namics with respect to the cur- rent & future market events for the 8 MM countries (USA, EU5, Japan & China)  Key market outlook  11 Year Forecast  08Major Markets  Acromegaly Epidemiology (incidence, prevalence, diag- nosed & treatment eligible patient pool)  Therapies (LoT’s & patient share)  Therapy area landscape (approved and emerging)  Pipeline Assessment  Acromegaly Future  The report provides a comprehensive view of disease events, classi- fication, identified and emerging , Clinical Manifestations, progres- sion, signs & symptoms, risk factors, pathogenesis, genetic basis and treatment guidelines at country level  Acromegaly Market Comprehensive insight on patient segmentation based on Origin (Pituitary Tumor & Non-Pituitary Tumor), Adeno- ma size (Macroadenomas and Microadenomas), responsive to treatment (Surgical & Non-surgical), Clinical Manifestations (osteoarticular manifestation, cardiovascular manifestation, respira- tory manifestation, gastrointestinal manifestation, endocrinological and other manifestations) has been provided into the epidemiology (Incidence and Prevalence) section of the Acromegaly and its treat- ment in the 8 MM countries, covering the United States, EU5 (Germany, Spain, France, Italy, UK), Japan, and China  Drug utilization and analysis on the current clinical practice, KOL perspective on upcoming therapies, estimated TPP for pipeline as- sets, clinical characteristics upcoming therapies and future treat- ment paradigm  Market aggregation on newly diagnosed patient pool, Thelansis esti- mation on persistence, compliance, adherence and a historic view of changing market dynamics and product-level patient flow of Acro- megaly in the 8 MM Countries for the period 2020 - 2030 competition Analysis  Current clinical Practices  Future treatment paradigm  A comprehensive record of both the present and rising disease bur- den with respect to the treatments for Acromegaly are provided, along with impact of the new treatments and the probable patent expiry considering the current market dynamics. A detailed review of 8MM current and forecasted market including the drug outreach at different country level based on their order of entry  Product attribute analysis  Unmet Needs  Market Attractiveness  Emerging Drug Profiles  Market Drivers and Barriers News Update Online support Update 1Qtr Free Forecast model

  3. Table of content 1.Acromegaly –Key Findings Summary 1.1.Clinical findings 1.1.1.Disease overview 1.1.2.Therapeutic practices 1.1.3.Future outlook 1.2.Commercial findings 1.2.1.Acromegaly market scenario 2020 1.2.2.Acromegaly market scenario 2025 1.2.3.Acromegaly market scenario 2030 2.Acromegaly Overview 2.1.Disease Introduction 2.2.Pathophysiology 2.3.Signs and Symptoms 2.4.Risk Factors 2.5.Etiology 2.6.Classification 2.7.Pathogenesis 2.8.Diagnosis 2.9.Complications 2.10.Treatment Algorithm 2.10.1.Treatment in US (guidelines) 2.10.2.Treatment in EU-5 (guidelines) 2.10.3.Treatment in Japan (guidelines) 2.10.4.Treatment in China (guidelines) 2.11.Treatment Goals for Acromegaly 2.12.Referral Patterns 2.12.1.Referral Scenario in US 2.12.2.Referral Scenario in EU-5 2.12.3.Referral Scenario in Japan 2.12.4.Referral Scenario in China 2.13.Acromegaly Prognosis 2.14.Healthcare burden 2.14.1.Healthcare burden in US News Update Forecast model Update 1Qtr Free Online support

  4. Table of content 2.14.2.Healthcare burden in EU-5 2.14.3.Healthcare burden in Japan 2.14.4.Healthcare burden in China 2.15. Unmet Needs in Acromegaly management 2.16. Market Opportunity for Acromegaly 2.17.KOL Comments on current and upcoming/expected treatment practices in Acromegaly 3.Acromegaly Epidemiology 3.1.Epidemiology Overview 3.2.Epidemiology by Geography 3.2.1. Acromegaly Epidemiology in US (2015-2030) 3.2.1.1.Incidence of Acromegaly 3.2.1.2.Diagnosed cases 3.2.1.3.Treatable Patient Pool 3.2.1.4.Epidemiology Trends 3.2.2. Acromegaly Epidemiology in EU-5 (2015-2030) 3.2.2.1.Incidence of Acromegaly 3.2.2.2.Diagnosed cases 3.2.2.3.Treatable Patient Pool 3.2.2.4.Epidemiology Trends 3.2.3. Acromegaly Epidemiology in Japan (2015-2030) 3.2.3.1.Incidence of Acromegaly 3.2.3.2.Diagnosed cases 3.2.3.3.Treatable Patient Pool 3.2.3.4.Epidemiology Trends 3.2.4. Acromegaly Epidemiology in China (2015-2030) 3.2.4.1.Incidence of Acromegaly 3.2.4.2.Diagnosed cases 3.2.4.3.Treatable Patient Pool 3.2.4.4.Epidemiology Trends 3.3.Epidemiology Trends (World-wide) 4.Acromegaly Market Outlook 4.1.US Acromegaly Market Forecast 2020-2030 4.1.1.Market Progression (Futuristic) News Update Forecast model Update 1Qtr Free Online support

  5. Table of content 4.1.2.Market Trends and Expectations 4.1.2.1.Worst case scenario 4.1.2.2.Base Case Scenario 4.1.2.3.Best Case Scenario 4.1.3.Drivers and Barriers 4.2.UK Acromegaly Market Forecast 2020-2030 4.2.1.Market Progression (Futuristic) 4.2.2.Market Trends and Expectations 4.2.2.1.Worst case scenario 4.2.2.2.Base Case Scenario 4.2.2.3.Best Case Scenario 4.2.3.Drivers and Barriers 4.3.France Acromegaly Market Forecast 2020-2030 4.3.1.Market Progression (Futuristic) 4.3.2.Market Trends and Expectations 4.3.2.1.Worst case scenario 4.3.2.2.Base Case Scenario 4.3.2.3.Best Case Scenario 4.3.3.Drivers and Barriers 4.4.Germany Acromegaly Market Forecast 2020-2030 4.4.1.Market Progression (Futuristic) 4.4.2.Market Trends and Expectations 4.4.2.1.Worst case scenario 4.4.2.2.Base Case Scenario 4.4.2.3.Best Case Scenario 4.4.3.Drivers and Barriers 4.5.Italy Acromegaly Market Forecast 2020-2030 4.5.1.Market Progression (Futuristic) 4.5.2.Market Trends and Expectations 4.5.2.1.Worst case scenario 4.5.2.2.Base Case Scenario 4.5.2.3.Best Case Scenario 4.5.3.Drivers and Barriers News Update Forecast model Update 1Qtr Free Online support

  6. Table of content 4.6.Spain Acromegaly Market Forecast 2020-2030 4.6.1.Market Progression (Futuristic) 4.6.2.Market Trends and Expectations 4.6.2.1.Worst case scenario 4.6.2.2.Base Case Scenario 4.6.2.3.Best Case Scenario 4.6.3.Drivers and Barriers 4.7.Japan Acromegaly Market Forecast 2020-2030 4.7.1.Market Progression (Futuristic) 4.7.2.Market Trends and Expectations 4.7.2.1.Worst case scenario 4.7.2.2.Base Case Scenario 4.7.2.3.Best Case Scenario 4.7.3.Drivers and Barriers 4.8.China Acromegaly Market Forecast 2020-2030 4.8.1.Market Progression (Futuristic) 4.8.2.Market Trends and Expectations 4.8.2.1.Worst case scenario 4.8.2.2.Base Case Scenario 4.8.2.3.Best Case Scenario 4.8.3.Drivers and Barriers 4.9.Key Expected Milestones (world-wide) Impacting the Market 5.Acromegaly Competitive Landscape 5.1.On Market Therapies 5.1.1. Sandostatin (Novartis) 5.1.1.1.Current Status 5.1.1.2.Status in Acromegaly 5.1.1.3.Drug Positioning 5.1.1.4.Market Forecast –Till 2030 5.1.2.Sandostatin LAR (Novartis) 5.1.2.1.Current Status 5.1.2.2.Status in Acromegaly 5.1.2.3.Drug Positioning News Update Forecast model Update 1Qtr Free Online support

  7. Table of content 5.1.2.4.Market Forecast –Till 2030 5.1.3.Signifor (Recordati SpA) 5.1.3.1.Current Status 5.1.3.2.Status in ACROMEGALY 5.1.3.3.Drug Positioning 5.1.3.4.Market Forecast –Till 2030 5.1.4.Somatuline Autogel (Ipsen SA) 5.1.4.1.Current Status 5.1.4.2.Status in ACROMEGALY 5.1.4.3.Drug Positioning 5.1.4.4.Market Forecast –Till 2030 5.1.5.Somavert (Nektar Therapeutics) 5.1.5.1.Current Status 5.1.5.2.Status in Acromegaly 5.1.5.3.Drug Positioning 5.1.5.4.Market Forecast –Till 2030 5.1.6.All Other Marketed Therapies World-Wide… 5.2.Pipeline Therapies Overview 5.2.1.Phase III Therapies 5.2.1.1.CAM2029 (Novartis) Profile 5.2.1.1.1.Current Status 5.2.1.1.2.Trial details, results 5.2.1.1.3.Approval Timeline 5.2.1.1.4.Likelihood of approval 5.2.1.1.5.Expected Product Positioning 5.2.1.2.Mycapssa (Chiasma, Inc) 5.2.1.2.1.Current Status 5.2.1.2.2.Trial details, results 5.2.1.2.3.Approval Timeline 5.2.1.2.4.Likelihood of approval 5.2.1.2.5.Expected Product Positioning 5.2.1.3.All other Phase III Therapies ….. 5.2.1.4.Attribute Analysis of Phase III molecules News Update Forecast model Update 1Qtr Free Online support

  8. Table of content 5.2.2. Phase II Therapies 5.2.2.1.COR-005 (Strongbridge Biopharma plc) Profile 5.2.2.1.1.Current Status 5.2.2.1.2.Trial details, results 5.2.2.1.3.Approval Timelines 5.2.2.2.CRN00808 (Crinetics Pharmaceuticals, Inc.) Profile 5.2.2.2.1.Current Status 5.2.2.2.2.Trial details, results 5.2.2.2.3.Approval Timelines 5.2.2.3.IONIS-GHR-LRx (Ionis Pharmaceuticals, Inc.) Profile 5.2.2.3.1.Current Status 5.2.2.3.2.Trial details, results 5.2.2.3.3.Approval Timelines 5.2.2.4.ITF-2984 (Italfarmaco S.p.A.) Profile 5.2.2.4.1.Current Status 5.2.2.4.2.Trial details, results 5.2.2.4.3.Approval Timelines 5.2.2.5.All Other Phase II Therapies 5.2.2.6.Attribute Analysis of all Phase II Therapies 5.2.3.Phase I Therapies 5.2.3.1.DP1038 (Dauntless Pharmaceuticals, Inc.) Profile 5.2.3.1.1.Current Status 5.2.3.1.2.Trial details, results 5.2.3.1.3.Approval Timelines 5.2.3.2.Glide Octreotide (Enesi Pharma Limited) Profile 5.2.3.2.1.Current Status 5.2.3.2.2.Trial details, results 5.2.3.2.3.Approval Timelines 5.2.3.3.ONO-5788 (Ono Pharmaceutical Company, Ltd.) Profile 5.2.3.3.1.Current Status 5.2.3.3.2.Trial details, results 5.2.3.3.3.Approval Timelines 5.2.3.4.Q-Octreotide (Midatech Pharma PLC) Profile News Update Forecast model Update 1Qtr Free Online support

  9. Table of content 5.2.3.4.1.Current Status 5.2.3.4.2.Trial details, results 5.2.3.4.3.Approval Timelines 5.2.3.5.All Other Phase I Therapies 5.2.4.Attribute Analysis of Phase I molecules 5.2.5.List of active Pre-clinical Therapies 5.2.5.1.AP102 (Amryt Pharma plc) 5.2.5.1.1.Status in Acromegaly 5.2.5.1.2.Company positioning 5.2.5.2.AQST-305 (Aquestive Therapeutics, Inc) 5.2.5.2.1.Status in Acromegaly 5.2.5.2.2.Company positioning 5.2.5.3.All other pre-clinical therapies 5.2.6.List of Inactive/discontinued assets 5.2.6.1.Business impact of discontinuations on current pipeline 5.2.7.Potential winners from Acromegaly Pipeline 5.2.7.1.Winners from current Phase III assets 5.2.7.2.Winners from current Phase II assets 5.2.7.3.Winners from current Phase I assets 5.2.7.4.Potential Blockbusters across the pipeline 6.Regulatory/Approval Scenario 6.1.Regulatory/Approval Framework in US 6.1.1.Policy Framework 6.1.2.Payer Expectations 6.2.Regulatory/Approval Framework in UK 6.2.1.Policy Framework 6.2.2.Payer Expectations 6.3.Regulatory/Approval Framework in France 6.3.1.Policy Framework 6.3.2.Payer Expectations 6.4.Regulatory/Approval Framework in Germany 6.4.1.Policy Framework 6.4.2.Payer Expectations News Update Forecast model Update 1Qtr Free Online support

  10. Table of content 6.5.Regulatory/Approval Framework in Italy 6.5.1.Policy Framework 6.5.2.Payer Expectations 6.6.Regulatory/Approval Framework in Spain 6.6.1.Policy Framework 6.6.2.Payer Expectations 6.7.Regulatory/Approval Framework in Japan 6.7.1.Policy Framework 6.7.2.Payer Expectations 6.8.Regulatory/Approval Framework in China 6.8.1.Policy Framework 6.8.2.Payer Expectations 7.Acromegaly Clinical Trial Assessment –Current and Future Paradigm 7.1.Distribution of Primary Endpoints across trials 7.2.Distribution of Secondary Endpoints across trials 7.3.Evolution and acceptance of surrogate endpoints 7.4.Key Investigator initiated trials 7.5.Attrition analysis 7.5.1.Suspended/Discontinued Assets 7.5.2.Failed Trials, Reasons and Business Impact 7.5.3.Terminated Trials, Reasons and Business Impact 7.5.4.Withdrawn Trials, Reasons and Business Impact 7.6.Trial enrollment scenario and challenges 7.7.Clinical Trial Guidance (across geographies) 8.Thelansis Commentary 8.1.Key Unmet needs in Acromegaly 8.2.Possible Best-case Clinical Trial Strategies 8.3.Possible Best Case Targeted Product Profile (TPP) 8.4.Possible Best-case Market positioning strategies 8.5.Possible Best-case Market Access Strategies 8.6.Possible Best-case LCM Strategies 8.7.Overall View on Acromegaly Market in Dollar Value 9.Report Methodology News Update Forecast model Update 1Qtr Free Online support

  11. Table of content 9.1.Secondary research 9.2.Primary research 9.3.Data collation 9.4.Insight Generation 10.About Thelansis 10.1. Our Capabilities 10.2. Our Services 10.3. Our Contacts 10.4. Disclaimer News Update Forecast model Update 1Qtr Free Online support

  12. Forecast Model - Snapshot Acromegaly Patient based forecast model 2020 - 2030 (Snapshot - 1.1) Acromegaly Patient based forecast model 2020 - 2030 (Snapshot - 1.2) News Update Forecast model Update 1Qtr Free Online support

  13. Sample Diagrams Epidemiology Disease overview:  Acromegaly is a hormonal disorder that results from the availability of too much growth hormone (GH) in the body. The pituitary, a small gland in the brain, makes GH. In acromegaly, the pituitary produces excessive amounts of GH. Usually, the excess GH comes from benign, or noncancer- ous, tumors on the pituitary. These benign tumors are called Adenomas.  When GH is secreted into the bloodstream, it triggers the liver to produce a hormone called insulin-like growth factor-I (IGF-I). In turn, IGF-I stimu- lates the growth of bones and other tissues. If the pituitary gland makes too much GH, excessive amounts of IGF-I can result. Too much IGF-I can cause abnormal growth of soft tissues, skeleton and, other signs and symptoms characteristic of Acromegaly and Gigantism.  Clinical manifestations in each patient depend on the levels of GH and IGF -I, age, tumor size, and the delay in diagnosis. The clinical manifestation of Acromegaly includes an osteoarticular manifestation, cardiovascular man- ifestation, respiratory manifestation, gastrointestinal manifestation, en- docrinological and other manifestations. Epidemiology:  "Incidence and prevalence of acromegaly in a large US health plan data- base” the overall annual incidence rate of Acromegaly was relatively con- stant with 11 cases per million person-years (PMPY). The objective of this study was to estimate the annual incidence and prevalence of Acromegaly in the large US managed care population, overall and stratified by age, sex, and geographic region, using data from 2008 to 2012.  An equal number of males and females being affected with Acromegaly each with approximately 77 cases per million each year. Whereas, the overall annual prevalence of Acromegaly was relatively constant across 5 years from 2008 to 2012 with approximately 78 cases per million each year. Both the Incidence and prevalence increase by age and those did not differ for either of the sexes.  According to Thelansis, the incident population of Acromegaly will signifi- cantly increase at a CAGR of X% during the period 2020-2030 in 8 MM markets  Over the course of 11 years till 2030, Thelansis expects the number of prevalent cases to increase at the CAGR of X.XX% in the US. The preva- lence may reach X,XXX patients by 2030 in the US. In the EU-5 market(s), the prevalence is expected to reach X,XXX patients by 2030 whereas in Japan the rate of CAGR is relatively less with X.XX%. It is expected that in Japan, the prevalence pool will reach X,XXX in 2030 2020 - 2030 Potential patient tower Number of Acromegaly patients on supportive and off-label therapies Treated patients forecast by region/ country 2020 - 2030 Acromegaly Diagnosed incidence Vs. Treated Key patient segmentation Acromegaly Market Trends: Key Takeaways News Update Online support Update 1Qtr Free Forecast model Illustrative sample

  14. Sample Diagrams Competitive landscape Acromegaly Market Scenario:  There are three dimension treatment pattern are being under practice such as; surgery, medical therapy and radiotherapy. Pitu- itary surgery is recommended as the primary treatment in pa- tients with microadenomas and in patients with macroadenomas that are associated with local mass effects or are enclosed and potentially curable surgically because surgery can lead to durable control of the tumor mass and associated biochemical effects. Key targets mutations  The role of primary medical therapy, especially with somatostatin analogs (SSAs), has been suggested in patients with macroadeno- mas who have no local mass effects and have a minimal chance of surgical cure. A role of primary medical therapy, especially with somatostatin analogs (SSAs), has been suggested in patients with macroadenomas who have no local mass effects and have a mini- mal chance of surgical cure. Key assets on different phases of  RT is recommended as an adjuvant treatment in patients with active disease despite surgery and medical therapy or in patients who prefer RT in light of the cost of long-term medical treatment. Acromegaly Competitive Landscape:  In terms of pharmacologic therapies, Several drug candidates are in Phase II and II/ III stages of development by various companies. Key assets among these are, CAM2029; Novartis, Mycapssa; Chi- asma, ATL1103; Antisense Therapeutics, COR-005 (Veldoreotide); Strongbridge Biopharma, CRN00808; Crinetics Pharmaceuticals, IONIS-GHR-LRx; Ionis Pharmaceuticals. Among these key assets, some of the assets are being designated as an orphan drug and EMA and US FDA. The launch of key assets will positively impact the overall market during 2020 to 2030 in 8 MM countries. Key players in the Acromegaly space, with assets under development  While there is a lot of competitive activity going on in pipeline for Acromegaly, companies like Dauntless Pharmaceuticals, Enesi Pharma, Ono Pharmaceutical, Midatech Pharma are having their assets in the early stage of development. Emerging patient share and uptake; 2020 - 20130  Apart from the above development Evotec , Camurus (Partner with Novartis) and Novartis has received orphan designation for their pipeline assets. Unmet needs News Update Online support Update 1Qtr Free Forecast model

  15. Sample Diagrams Market forecast Acromegaly Market Forecasting:  Thelansis’ research team expects the Acromegaly market poten- tial for 2030 at $X.XXB in 8MM countries. Out of this market, 52.5% sales are expected to be contributed from the US market whereas XX.X% is expected to come from EU-5. Japan and China are expected to contribute XX.X% and X.X% respectively. Acromegaly Future market - 2020 To 2030  Acromegaly current market stands at $XXXX.XM which is ex- pected to grow from 2019 to 2024 at a CAGR of X.X%. Majorly this is expected because of expected approvals of pharmacotherapies in the space. The market is expected to grow exponentially post 2024 at a CAGR of XX.X% (for the period 2024-2030). The most substantial increase in the market will be witnessed by the US market. Country-wise revenue estimation  Major Milestone of market growth is the entry of Orphan desig- nated products like Somatostatin analog , and endogenous pep- tide hormone somatostatin will command a premium pricing and can offer long term cost burden reduction for the patients. How- ever, targeted therapies do carry a high attrition rate across the orphan indication space and this can be a key catalyst in deter- mining market value for 2030. Patient share and market uptake Acromegaly Products Pricing Scenario:  Upcoming therapy probably transform the treatment paradigm of Acromegaly in the near future. Clinical trials some level of promising results like proportion of patients maintaining their baseline and in most of the patients, without causing significant safety concerns. Of course, some questions about targeted therapy still remain un- solved.  Based on the KOL Insights gathered from Primary Market Research (PMR) of Acromegaly market Thelansis expects upcoming therapies may raise significant concerns with respect to the treatment cost as much as USD 85,000 to USD 124,000 per patient . Disease burden matrix  To control the cost research have developed algorithm for tiered testing guide to enhance the clinical diagnosis of Acromegaly, in the other hand it is hard to distinguish genetic variations such as pin- pointing the phenotype and exact biomarker. Market Access News Update Online support Update 1Qtr Free Forecast model

  16. Contact Us About Thelansis: - As the name depicts Thelansis is specialized in “Therapy Area Landscape Analy- sis” along with market intelligence and consultancy that supports pharmaceutical, biotechnology, and diagnostics companies to successfully prepare, launch, and commercialize their products. Our Syndicated research reports include Market Insight, Pipeline Insight, Product Insight, Specialized Re- ports, Indication Outlook and Market Access Reports. Our focused therapeutic approach provides our clients with clinical and disease area expertise from an integrated team of academic, medical, and industry specialists of our panel, Ask for our report offerings, and Indication specific sample pages by sharing your email ID with us at, p.potdar@thelansis.com Peeyush Potdar Delivery Head Email: p.potdar@thelansis.com www.thelansis.com Delivery office Delivery office Sales office Sales office B-1030, C Wing Vrindavan tech village Marathahalli Outer ring road Bangalore- 560037 183-Asylum Street Hartfort, CT-06103, USA Email Email Telephone Telephone clientsupport@thelansis.com sales@thelansis.com USA +1-302-380-3552 India +91-9899921259 News Update Update 1Qtr Free Online support Forecast model

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