About the Report
APOL1 gene is a member of APOL gene family, which plays an important role in innate immunity, which is our body’s built-in defense system to fight threats. Some variations in APOL1 gene cause damage to parts within the kidney. Damage to parts that filter blood can lead to severe kidney disease or ultimately kidney failure. An example of such an indication is focal segmental glomerulosclerosis (FSGS), which is a type of kidney disease that can be caused by APOL1 gene variations.
In the current scenario, treatment for APOL1 mediated kidney disease includes only immunosuppressant, which may not always work and can cause severe side effects. Considering this, the demand of drugs that specifically target APOL-1 gene poses both challenge and opportunities for the market players. Higher risk associated with the disease and active clinical pipeline is expected to boost the APOL1 mediated kidney disease market growth.
In its new study, Future Market Insights offers insights about key factors driving demand for APOL1 mediated kidney disease market. The study points toward chronic kidney disease being the most sought-after. North America acquires over three forth of the market share, globally. The report also tracks current available treatments, disease epidemiology and future market potential.
How Historic and Future Outlook for APOL1 Mediated Kidney Disease Market Match Up?
As per some of the key opinion leaders, the APOL1 mediated kidney disease market holds great potential but its trajectory is entirely dependent on the availability and accessibility of APOL1 screening among adults, primarily young adults. Awareness about APOL1 genetic variants and associated diseases will only be a stepping stone towards successful therapy.
If pharmaceutical companies organize free APOL1 screening, they can get real data on the actual prevalence and risk of APOL1 mediated kidney disease. Pharmaceutical companies are expected focus only on populations at greater risk for APOL1 kidney diseases, such as those with African lineage. Targeting a particular population is often intended to save the time required for screening and treatment. Awareness initiatives are therefore undertaken by governments in collaboration with pharmaceutical companies and research institutes. Making diagnostics for APOL1 easily available will widen opportunities for pharmaceutical players. The clinical pipeline potential is expected to be great in terms of value once the product is launched.
All these factors are expected to create opportunities for the expansion of the APOL1 mediated kidney diseases market size over the forecast period. It is analyzed that the current clinical pipeline is expected to hold great potential in terms of value once launched.
What Is the Impact Of Market Consolidation Activities Have On APOL1 Mediated Kidney Diseases Demand?
Consolidation of the market is to an extent caused by key players’ focus on strategic partnerships. This trend is observed among small sized biotech companies for financial support especially for clinical trial funding and expensive drug discovery. Biopharma start-ups often have a panel of efficient scientists however they lack capabilities required to bring the idea from bench to the market. This often compels them to seek collaborations. Even some of the leading companies are collaborating to strengthen their research portfolio. For instance:
- Ionis Pharmaceuticals in partnership with AstraZeneca is investigating an antisense medicine for reduction of APOL1 protein production in CKD. This medicine is in clinical pipeline Phase 1.
- For instance, Ionis Pharmaceuticals has partnered with Novartis for its molecule called Pelacarsen which is in phase 3 clinical trial. This molecule is antisense medicine designed to reduce apolipoprotein(a) in the liver
- For its Neurological pipeline, Ionis Pharmaceuticals is into partnership with Biogen, together they have an antisense molecule in phase 3 clinical trial.
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How are Scientific and Technological Advancements in Drug Discovery Enabling Growth?
Recent advances in three important areas have built a foundation for a whole new era in nephrology research. Bioinformatics and ‘omics have evolved to classify patients and uncover new genetic disease markers and drivers. Improvements in developing models for target validation have made the understanding of disease more clear and relatable. New modalities have widened the treatment portfolio for previously undruggable targets. Advances in genetic testing have substantially helped to correctly diagnose a disease. For instance, genetic testing for APOL1 can determine if a person has inherited two high-risk APOL1 gene variants.
This genetic test not only helps in the diagnosis of APOL1 mediated diseases but can also determine future risks caused by kidney transplants. The pace of scientific progress in this area of APOL1 is immensely exciting. Vertex Pharmaceuticals Incorporated developed an investigational molecule just 10 years after the discovery of APOL1’s association with kidney diseases.
The extensively expanding tool kit for therapeutics such as small molecule, gene modification, and nucleic acid therapies is a hopeful sign for the future.
How a Thin Pipeline of APOL1 Mediated Kidney Disease Market Can be a Golden Opportunity for Drug Developers?
A less competitive market offers a huge opportunity for other players to invest in novel drug discoveries for such unmet targets. APOL1 mutations generate a different category of kidney disease that occurs in younger people, especially those of African ancestry. The higher rate of kidney failure associated with APOL1 is anticipated to increase the focus on these diseases.
Increasing risk associated with APOL1 is a major cause of concern. This situation can be controlled by dialysis or a transplant. Both dialysis and transplant have their own drawbacks and are not cost-effective. Current treatments such as steroids have severe side effects and do not assure recovery.
The current clinical pipeline of APOL1 mediated kidney disease treatment is very slim, with only two pharmaceutical companies working on it. Vertex Pharmaceuticals Incorporated has its small molecule inhibitor VX-147 in clinical trial Phase 2 and AstraZeneca is working with Ionis Pharmaceuticals for APOL1-associated chronic kidney disease. However, this investigational molecule is still in Phase 1. Slim pipeline presents attractive opportunities for research within the market.
Increasing Spending On Pharmaceutical R&D Propelling APOL1 Mediated Kidney Diseases Market Growth
The pharmaceutical industry’s actions have significant socio-economic impact in terms of investments in both research and development (R&D) and manufacturing. R&D is the key pillar for success for any drug discovery project. Pharmaceutical R&D spending by companies serves as a vital metric to showcase any company’s commitment towards novel discoveries.
The global R&D spending increase between 2016 and 2017 was 3.9%. Some of the prominent pharma companies spent a total of around $97.2 billion in 2017 on R&D. Notably, R&D investment is consistently highest in the U.S. from the past few years. More than half of the global R&D expenditure comes from US pharma players.
The rewards of this investment are visible in terms of the rising number of new food and drug administration (FDA) approvals, rising from 27 new molecular entities in 2016 to more than 50 in 2018. Rising research spending will therefore create attractive opportunities for the growth of the market.
Why Does the U.S. Remain A Leading Market for APOL1 Mediated Kidney Disease?
The U.S. market value for symptomatic treatment accounted for over US$ 2.0 Bn in 2020 and is expected to grow at an impressive momentum. The APOL1 associated kidney diseases are highly prevalent among black Americans as these mutations are proven to get inherited among the African origin.
As per the United States Census, around 13% of the US population consists of African Americans. The APOL1 disease prevalence among African origin population is the highest compared to any other region. Hypertension-attributable kidney disease prevalence rate accounts for 12% among these people. Moreover the current therapeutic pipeline is targeted for launch in the U.S. market only. All these factors make the US, prominent player in the APOL1 mediated kidney diseases market.
How Will Increasing Awareness Drive Growth in Africa?
The African origin population is at the highest risk of developing APOL1 mediated kidney diseases and subsequent clinical complications. The genetic testing can play a significant role in the diagnosis of accurate APOL1 mediated kidney diseases. More the diagnosis more will be the patient pool requiring treatment. This whole idea of developing cost effective and easily accessible testing kits will boost the treatment market in African countries.
Several scientific studies have shown that the APOL1 mediated kidney diseases remain either undiagnosed or misdiagnosed. This may lead to mistreatment and early end stage kidney failure.
The prominent players in the genetic and molecular diagnosis industry are investigating several innovative pathways and methodologies to early diagnose APOL1 mediated kidney diseases.
Focus on the diagnostic innovation is expected to increase in the coming years to uncover the disease prevalence more precisely.
For instances, Duke University is developing genetic diagnostic test for APOL1 positive patient to assess the population with high risk of APOL1 mediated kidney diseases. This can change the trend of the APOL1 high risk diagnostic in the future with simple, affordable and easy to perform genetic test.
How Will Improved Funding In Nephrology Research Benefit APOL1 Mediated Diseases Market?
Funding for kidney research is unimpressive compared to oncology research. The number of people diagnosed with kidney disorders each year is more than cancer. Despite this, research activities are tremendously focused on new oncology drug discovery. Till the second quarter of 2019, there was only one late stage nephrology study, while there were 39 studies for cancer.
The funding provided by the National Institutes of Health (NIH) for cancer was 10 times more than that for kidney disorders. It is reported that around 20 percent of people above 60 years of age have chronic kidney disease (CKD). Despite this, pipelines of 10 prominent pharmaceutical companies contain less than 30 active nephrology molecules, while the number for cancer stands at 1,300. According to the American Society of Nephrology (ASN) Research Advocacy Committee, NIH spending stood at more than $500 per cancer patient and $30 per CKD patient every year. Limited activity in kidney research has impacted the healthcare industry. There have been many costly phase III trials in kidney research that failed to achieve improved outcomes, further shortening the industry’s interest
The APOL1 mediated kidney disease market has only two biopharmaceutical players. Till date, there is no medicine available to inhibit APOL1 mediated kidney disease directly. The only management options are immunosuppressant, kidney transplant, and dialysis, and people receiving treatment may still suffer from kidney failure. Kidney failure leaves the patient with no option other than transplant and dialysis, both of which require lifelong treatment and follow-ups. The two companies with pipeline molecules are
- Vertex Pharmaceuticals Incorporated: The company is investigating its small molecule inhibitor VX-147 and others against APOL1 for the probable treatment of
- The company is investigating its small molecule inhibitor VX-147 and others against APOL1 for the probable treatment of APOL1-mediated kidney diseases.
- Ionis Pharmaceuticals in partnership with AstraZeneca plc, are developing ION532, also known as AZD2373, is an investigational antisense medicine under development for reduction of APOL1 protein production in Chronic Kidney Disease. This medicine is in clinical pipeline Phase 1.
Scope of Report
Historical Data Analysis
USD Million for Value
Key Regions Covered
North America, Europe, and Middle East & Africa
Key Countries Covered
Key Segments Covered
Indication and Region
Key Companies Profiled
Market Forecast, Company Share Analysis, Competition Intelligence, DROT Analysis, Market Dynamics and Challenges, and Strategic Growth Initiatives
Customization & Pricing
Key Questions Answered in Report
Which is the most prevalent indication among APOL1 mediated kidney diseases?
Hypertension-associated kidney disease is very common type of APOL1 mediated kidney disease. In the U.S., hypertension-attributed kidney disease cases in 2019 were around 7,01,476.
Which drug modality looks promising for the treatment?
At present the clinical pipeline includes small molecule inhibitor and antisense technology based medicine. However according to market experts, small molecules will be more promising. Antisense medicines are slower in development and the one under development is still in Phase I. The complexity associated with antisense therapeutics, make them less promising as treatment option.
Which are the leading companies offering treatment for APOL1 mediated kidney diseases?
The active pipeline of APOL1 mediated kidney diseases include Ionis Pharmaceuticals Inc. and Vertex Pharmaceuticals Incorporated.
What are the challenges associated with APOL1 mediated kidney diseases market?
Investment in drug discovery and development has always remained a risky and prolonged process. It begins with the lengthy process of API development, with failure anticipated in each step forward. API development and preclinical studies take up more of the drug development budget than the combined cost of filings and clinical trials. New chemistry is mandatory and crucial for every single project, which is challenging, extremely time consuming, and very expensive.
Regulatory stringency for early drug development is increasing day by day. Another factor that pushes early development costs is the complexity of molecules. This high cost associated with drug development is challenging, especially for rare and unmet targets like APOL1.
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APOL1 mediated kidney diseases (Symptomatic Treatment) Market By
- Chronic Kidney Disease
- Focal segmental glomerulosclerosis (FSGS)
- Human immunodeficiency virus (HIV)-associated Nephropathy
- Hypertension-associated Kidney Disease
- End-Stage Kidney Disease
- North America (U.S.)