How is the Emergence of Generic Drugs Reshaping the Familial Hypercholesterolemia Treatment Market 2031?

Familial hypercholesterolemia is a genetic condition caused due to increased levels to LDL i.e. low-density lipoprotein into the blood vessels. Population suffering from familial hypercholesterolemia is expected to be at higher risk of developing cardiac risk and later stage. Increasing diagnosis and treatment adoption rate is projected to grow familial hypercholesterolemia treatment market in the coming decade.

According to the National Institutes of Health, for every 100 people there is 0.3% prevalence of a heterozygous form of familial hypercholesterolemia. On the other hand, a homozygous form of familial hypercholesterolemia occurs in 1 in million population.

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Leading biopharmaceutical players are focused on expanding their product portfolio with increasing adoption rate for familial hypercholesterolemia treatment to cope up with the demand. For instance, in the year 2020 there were approximately 10 active clinical trials for drug involved in the familial hypercholesterolemia treatment.

What are the Key Trends Impacting Growth of the Familial Hypercholesterolemia Treatment Market?

Increasing use of combination therapy with the availability of high-level manufacturing technology has boosted the familial hypercholesterolemia treatment market growth. Leading biopharmaceutical players spend the large capital amount on the research and development activities to expand its product portfolio and sustain the competition.

For instance, according to the U. S. Food and Drug Administration (FDA) in 2020, 53 drugs received approval for manufacturing and commercialization out of which one Nexletol is used for treatment of familial hypercholesterolemia. Hence, the demand for more and more accurate therapeutics for familial hypercholesterolemia will have a positive impact on familial hypercholesterolemia treatment market growth.

According to several studies, PCSK9 inhibitor or pure EPA fish oil with given in combination with statins can reduce cholesterol at a higher rate and by great extent as compared to statin alone.

Increasing Adoption of Statins: How a Statin Became Most Commonly Prescribed Medication

Statin, cholesterol-lowering drug is expected to observe the exponential rise of demand in familial hypercholesterolemia treatment market. Familial hypercholesterolemia can sometimes lead to atherosclerotic cardiovascular diseases that are caused due to build-up of high cholesterol levels.

Statin being advantageous and highly effective for reducing LDL levels in familial hypercholesterolemia treatment market will lead to a high growth rate as compared to other drugs. For instance, in the February 2020 Esperion Therapeutics Inc. announced the approval of its NEXLIZET, statin therapy for heterozygous familial hypercholesterolemia treatment by U.S Food and Drug Administration (FDA).

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On the other hand, the low cost of statin in also one of the key factor for increasing the demand in the market.

How is the Emergence of Generic Drugs Reshaping the Familial Hypercholesterolemia Treatment Market?

Generic drugs are experiencing increasing demand with time as more and more patents expire in the familial hypercholesterolemia treatment market. The generic drug is bioequivalent to the branded drug but much cheaper. A generic drug can lead to increasing adoption of familial hypercholesterolemia treatment drugs among the lower-income population.

On comparison, branded Atorvastin costs between US$ 5 – US$ 6 and generic drug costs between US$ 2 – US$ 3. Thus, the emergence of generic drugs has led to a decrease in sales of branded drugs in familial hypercholesterolemia treatment market resulting in a reduction in market growth rate with patent expiry.

What are the Key Challenges that may Restrain Growth of the Familial Hypercholesterolemia Treatment Market?

Familial hypercholesterolemia treatment market growth is expected to be hindered by stringent regulatory requirements for drug manufacturing and commercialization process. On the other hand, side effects associated with currently prescribed drugs is expected to challenge familial hypercholesterolemia treatment market growth.

Less diagnosis rate in the region like the Middle East & Africa and Latin America also acts as a restraining factor for familial hypercholesterolemia treatment market growth.

Key Segments of Familial Hypercholesterolemia Treatment Market Covered in the Report

  • Based on indication type, the Familial Hypercholesterolemia Treatment Market has been segmented as
    • Heterozygous familial hypercholesterolemia
    • Homozygous familial hypercholesterolemia

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  • Based on the drug, the Familial Hypercholesterolemia Treatment Market has been segmented as
    • Statins
    • Bile-acid-binding resins
    • Cholesterol absorption inhibitors
    • Combination cholesterol absorption inhibitor and statin
    • Fibrates
    • Niacin
    • Omega-3 fatty acid supplements
  • Based on the route of administration, the Familial Hypercholesterolemia Treatment Market has been segmented as
    • Oral
    • Injectable
  • Based on the distribution channel, the Familial Hypercholesterolemia Treatment Market has been segmented as
    • Institutional Sales
    • Hospitals
    • Speciality Clinics
    • Research Institutes
    • Retail Sales
      • Retail Pharmacies
      • Online Pharmacies
  • Based on the region, the Familial Hypercholesterolemia Treatment Market has been segmented as
    • North America
    • Latin America
    • Europe
    • South Asia
    • East Asia
    • Oceania
    • Middle East & Africa

Competitive Landscape

Key players such as:

  • AbbVie Inc.
  • Aegerion Pharmaceuticals
  • Novartis AG
  • AstraZeneca Plc.
  • Merck Company
  • Pfizer Inc.
  • Sanofi S.A.
  • Amgen Inc.
  • Daiichi Sankyo Company Limited
  • Esperion Therapeutics
  • CJ Healthcare
  • others are actively involved in offering Familial Hypercholesterolemia for different applications.

What strategies are the Key Players adopting for Increasing their Market Share in the Familial Hypercholesterolemia Treatment Market?

The manufacturers involved in the production of familial hypercholesterolemia treatment drugs are carrying out different product portfolio expansion strategies for increasing their market share in the global familial hypercholesterolemia treatment market.

Key players are expanding their manufacturing facilities to serve the increasing demand for Familial Hypercholesterolemia Treatment. Key players are focussed towards development and launch of new products into familial hypercholesterolemia treatment market.

  • In January 2020, Novartis AG announced its acquisition of The Medicines Company through Medusa Merger Corporation. The Medicines Company has further become an indirect wholly-owned subsidiary of Novartis.
  • The acquisition of The Medicines Company into Novartis Pharmaceuticals has led to its product portfolio expansion with atherosclerotic cardiovascular disease or familial hypercholesterolemia therapeutic drugs segment.
  • On the other hand, in July 2016 Madrigal Pharmaceuticals and Synta Pharmaceutical Corporation entered into a collaboration for developing drugs used in cardiovascular, metabolic and liver diseases along with NASH and heterozygous/homozygous familial hypercholesterolemia with a total of US$ 40 million capital dedicated for research and development activities.
  • For instance, in October 2020 Novartis International AG announced it received positive response from European Medicines Agency (EMA) for marketing of its drug Leqvio (inclisiran) which is used in treatment of adults suffering from hypercholesterolemia or mixed dyslipidemia. Inclisiran is based on small interfering RNA (siRNA) and makes it a potential drug for European Market.

The report answers important questions which include:

Why is player leading the in region?

Which factors pose a negative impact on the growth?

What was the value registered in 2018?

What challenges do the players face during R&D stages?

Which countries contribute a significant share to the total revenue in region?

Key findings of the market report:

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