Global Dyslipidemia Disease Analysis Report 2020-2027 – ResearchAndMarkets.com

Global Dyslipidemia Disease Analysis Report 2020-2027 – ResearchAndMarkets.com




Global Dyslipidemia Disease Analysis Report 2020-2027 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Disease Analysis: Dyslipidemia” report has been added to ResearchAndMarkets.com’s offering.

The report estimates that in 2018, there were approximately 1.5 billion prevalent cases of dyslipidemia in adults aged 20 years and older worldwide, and forecasts that number to increase to 1.7 billion prevalent cases by 2027.

The dyslipidemia market is well established, and the branded segment has seen declining sales due to generics. However, the market is poised to resume steady growth due to the introduction of novel agents, improved access with price competition, and new CV outcomes data with label expansions.

In the hypercholesterolemia segment, the injectable PCSK9 inhibitors from Amgen and Regeneron have struggled due to payer restrictions. While declining net pricing in the US has improved access and growth somewhat, combined sales may only reach $1.3bn in 2020 despite a large potential market, hindered by prior authorization, even though only physician attestation may be needed.

The siRNA inclisiran, injected every six months, is slated to be approved in late 2020 and is likely to dominate the segment. Novartis plans to use inclisiran’s more convenient maintenance dosing to pursue administration in healthcare provider offices, with medical rather than pharmacy benefit coverage, including Medicare Part B.

Success will depend on whether the drug can avoid prior authorization, how comfortable physicians feel about such prolonged dosing, and to what extent physicians are willing to adopt the buy-and-bill approach, which may be more suited to larger integrated delivery networks.

Inclisiran’s cardiovascular outcomes trial (CVOT) is also designed to show a numerically stronger top-line benefit, though the drug may well gain popularity prior to these results. The company is also open to innovative collaborations with healthcare systems outside the US, and has initiated one in the UK.

The overall likelihood of approval of a Phase I dyslipidemia asset is 8.9%, and the average probability a drug advances from Phase III is 62.1%. Dyslipidemia drugs, on average, take 7.6 years from Phase I to approval, compared to 10.0 years in the overall CV space.

Key Topics Covered:

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Patient segmentation

TREATMENT

  • Treatment guidelines vary across regions
  • Treatment recommendations focus on risk groups
  • Recommendations on specific classes

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • Daiichi Sankyo Enters Europe’s Cholesterol Market
  • Amarin Seeks EU Fast-Track For Potential Cardiovascular Blockbuster
  • YouTube Video Suggesting Livalo Is Safer Than Other Statins Is Dinged By US FDA

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Deal Watch: NewAmsterdam To Take On Amgen’s Stalled CETP Inhibitor
  • Alnylam Secures $2bn Financing From Blackstone By Monetizing Inclisiran Royalties
  • Novartis To Pay $9.7bn For The Medicines Company
  • Pfizer Reaffirms CV Disease Commitment With Deal For Akcea’s ANGPTL3 Drug

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Published on 06 November 2020
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

  • Cholesterol-lowering drugs
  • Triglyceride-lowering drugs
  • Lp(a)-lowering drugs
  • HDL-increasing drugs

MARKET DYNAMICS

FUTURE TRENDS

  • New launches and CVOT data will drive growth in the dyslipidemia market over the forecast period
  • Novel reimbursement strategy for inclisiran could salvage the PCSK9 segment
  • Price pressures and affordability will continue to be major factors limiting growth

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • CaPre for Dyslipidemia (August 31, 2020)
  • Multiple Drugs for Dyslipidemia (August 31, 2020 and August 29, 2020)
  • Nexletol for Dyslipidemia (June 14, 2020)
  • Vupanorsen for Dyslipidemia (January 28, 2020)
  • Dalcetrapib for Dyslipidemia (January 27, 2020)
  • CaPre for Dyslipidemia (January 13, 2020)
  • Inclisiran for Dyslipidemia (November 16, 2019 and November 18, 2019)
  • Vascepa for Dyslipidemia (November 18, 2019)
  • Vascepa for Dyslipidemia (November 14, 2019)
  • Vascepa for Dyslipidemia (November 12, 2019)
  • ARO-ANG3 for Dyslipidemia and ARO-APOC3 for Lipoprotein Lipase Deficiency (September 16, 2019)
  • Inclisiran for Dyslipidemia (September 2, 2019)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

  • Interviews with physicians at the ADA conference regarding Vascepa
  • Interview regarding PCSK9 reimbursement with a KOL from a large US payer

UNMET NEEDS

  • Improved options for statin-intolerant patients
  • A well-tolerated oral drug with LDL-C lowering as good as the current injectable PCSK9 inhibitors when added to a statin
  • Addressing the residual risk remaining in higher-risk patients despite well-controlled LDL-C levels
  • A way to motivate patients to stick with treatment if their lipid levels are elevated

BIBLIOGRAPHY

  • Prescription information

APPENDIX

For more information about this report visit https://www.researchandmarkets.com/r/vaga4i

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