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Forecast Period
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2024-2028
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Market Size (2022)
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USD 280.51 Million
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CAGR (2023-2028)
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7.84%
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Fastest Growing Segment
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Oral
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Largest Market
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Northeast Region
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Market Overview
United
States Pre-Exposure Prophylaxis (PrEP) Market has valued at USD 280.51
Million in 2022 and is anticipated to project steady growth in the forecast
period with a CAGR of 7.84% through 2028. Pre-Exposure
Prophylaxis (PrEP) is a highly effective and evidence-based strategy for HIV
prevention. It involves the use of antiretroviral drugs by individuals who are
HIV negative but at high risk of acquiring the virus, such as those with
multiple sexual partners or individuals in serodiscordant relationships. When
taken consistently as prescribed, PrEP can significantly reduce the risk of HIV
infection by over 90%. By providing a continuous level of protection against
HIV, PrEP serves as a powerful tool in the global fight against HIV/AIDS. It
complements other prevention strategies like condom use and regular testing,
offering an additional layer of security and peace of mind. The accessibility
and availability of PrEP have expanded in recent years, making it an essential
option for those at risk of HIV transmission.
Moreover, PrEP not only helps prevent HIV infection
but also contributes to reducing stigma and discrimination associated with the
virus. It empowers individuals to take control of their sexual health and make
informed decisions about their well-being. With ongoing advancements in PrEP
research and implementation, it is crucial to raise awareness about this
life-saving intervention. By promoting education and access to PrEP, we can
make significant strides in reducing new HIV infections and moving closer to an
AIDS-free generation.
Key Market Drivers
Growing Rate of Generic Drug Approvals
The rapidly increasing rate of generic drug
approvals in the United States is expected to have a profound impact on the
demand for Pre-Exposure Prophylaxis (PrEP). With generic drugs serving as a
cost-effective alternative to brand-name medications, they play a crucial role
in making healthcare more accessible and affordable for individuals across the
country. As the FDA continues to streamline and enhance the expedited approval
process, we can anticipate an influx of generic versions of PrEP entering the
market. This surge in availability will not only bolster the supply of PrEP,
but also lead to a reduction in its price, making it more affordable and
accessible to a wider population.
Moreover, the rise in generic drug approvals will
foster competition among pharmaceutical companies. This heightened competition
has the potential to spur innovation in drug formulation and delivery
mechanisms, leading to the development of more user-friendly PrEP drugs. These
advancements can further enhance the demand for PrEP by addressing convenience
and ease of use for individuals who rely on this life-saving medication.
The rapid growth rate of generic drug approvals is
poised to catalyze a significant increase in the demand for PrEP in the United
States. By making these life-saving drugs more affordable and accessible, we
can ensure that individuals who need them can access them without financial
barriers. Additionally, the competition and innovation driven by this surge in
generic approvals hold the potential to revolutionize the formulation and
delivery of PrEP, further improving its effectiveness and user experience.
Reduced Cost of Treatment
The anticipated reduction in the cost of
pre-exposure prophylaxis (PrEP) treatment is expected to stimulate demand in
the United States. PrEP, a vital tool in preventing HIV infection, has
previously had its adoption limited by high costs, rendering it inaccessible to
many at-risk individuals. However, with anticipated decreases in price, PrEP is
set to become a more accessible preventative measure.
This affordability will likely have a significant
impact on uninsured populations and those with limited health care benefits, as
they can now consider PrEP as a viable option to protect themselves. With the
cost barriers diminishing, healthcare providers will be more likely to
recommend PrEP to their patients, further promoting its adoption. This
increased recommendation from healthcare providers can help cultivate a more
proactive attitude amongst high-risk individuals towards prevention, thus
elevating the overall adoption of PrEP. Consequently, an increase in demand for
PrEP is anticipated, which, in turn, is expected to contribute to the overall
reduction of new HIV cases in the United States. This cost reduction not only
reflects a significant milestone in public health but also emphasizes the
importance of accessibility in preventative healthcare. By driving the demand
for PrEP through improved affordability, we have the potential to create a
healthier and safer society.
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Insurance Coverage of HIV drugs
U.S. insurance companies have recognized the
importance of providing coverage for HIV drugs and have taken steps to include
them in their new therapeutics. This change has led to a significant increase
in the utilization of PrEP, a preventive medication for HIV. As an example, in
May 2019, the U.S. government announced an agreement with Gilead Sciences Inc.
to supply Truvada to 200,000 individuals annually for up to 11 years, or until
a generic version becomes available. Consequently, the U.S. government assumes
the cost for the distribution of this drug, ensuring its accessibility to those
who need it.
The Affordable Care Act (ACA), implemented in 2010,
has played a crucial role in enhancing healthcare coverage and quality throughout
the United States. Under the ACA, prEP drugs are covered by health insurance
policies, making them accessible to all individuals. The inclusion of PrEP
coverage in these policies has simplified the provision of PrEP and raised
hopes for significant advancements in access, particularly in areas heavily
affected by HIV. The government's commitment to providing essential medicines
and services has not only improved public health but also stimulated market
growth in the United States.
Increasing Prevalence of HIV
The increasing prevalence of HIV (Human
Immunodeficiency Virus) infections in the United States has brought the demand
for Pre-Exposure Prophylaxis (PrEP) to the forefront. PrEP is a powerful HIV
prevention tool and when taken consistently, it can significantly reduce the
risk of HIV infection in people who are at substantial risk. With over a
million people in the U.S. at high risk for HIV infection, the demand for PrEP
is poised to grow considerably. As more people become aware of their risk and the
efficacy of PrEP in HIV prevention, its usage is expected to escalate.
Additionally, healthcare providers are progressively recommending PrEP to
patients at risk, as a preventative measure which is also driving demand.
Government initiatives are also playing a role, with policies implemented to
increase the accessibility and affordability of PrEP, thus encouraging its
uptake. Overall, the interplay of HIV prevalence, increased awareness,
healthcare recommendations, and supportive policies is expected to bolster the
demand for PrEP in the U.S. significantly.
Key Market Challenges
Accessibility And Affordability Constraints
In the United States, the demand for Pre-Exposure
Prophylaxis (PrEP), a preventive measure against HIV infection, is projected to
decline due to constraints in accessibility and affordability. Despite the
proven efficacy of PrEP, its adoption remains hindered by its high cost and
limited availability. Many people who are at high risk of HIV infection, including
marginalized communities and those with low income, often find the cost of PrEP
prohibitive. Without insurance, a month's supply can cost up to $2000, making
it unaffordable for many. Additionally, access to PrEP is often limited in
rural areas and among healthcare providers who lack the requisite knowledge and
training to prescribe it. Furthermore, systemic injustices and socio-economic
disparities compound these barriers, preventing those who need PrEP the most
from obtaining it. These factors, combined with the stigmatization and
discrimination associated with HIV and PrEP, are expected to decrease its
demand. Thus, addressing these accessibility and affordability issues is
critical to increasing the uptake of PrEP and reducing the HIV incidence in the
United States.
Potential Side Effects and Adherence to Prep
Medication
The anticipated decrease in the demand for
Pre-Exposure Prophylaxis (PrEP) medication in the United States could largely
be attributed to two key factors: potential side effects and adherence to the
drug regimen. PrEP, although highly effective in preventing HIV infection, has
been associated with some adverse side effects. These range from mild symptoms
such as nausea, headaches, and weight loss, to severe ones like kidney dysfunction
and bone density reduction. Such side effects may deter potential users,
especially those who perceive their risk of contracting HIV as low.
Additionally, for PrEP to be effective, it requires daily administration and
regular follow-ups with healthcare providers, which can be seen as a
considerable commitment. Non-adherence to the medication regimen significantly
reduces PrEP’s efficacy, which might discourage potential users. Moreover,
sustained adherence is often challenging due to various reasons, including pill
fatigue, fear of stigma, forgetfulness, and access to healthcare services.
These factors combined could diminish the demand for PrEP, thereby affecting
its role in HIV prevention strategies in the United States.
Key Market Trends
Advancements in Pharmaceutical Sector
The pharmaceutical sector in the United States has
been witnessing significant advancements, which is expected to boost the demand
for Pre-Exposure Prophylaxis (PrEP). PrEP, a medication used to prevent the
contraction of HIV in high-risk individuals, has been increasingly recognized
for its effectiveness. As pharmaceutical innovations continue to improve drug
formulations and delivery methods, the accessibility and usability of PrEP are
set to increase. Enhanced focus on research and development is leading to more
efficient and patient-friendly versions of PrEP, which can contribute to higher
adoption rates. Furthermore, healthcare policies encouraging preventive
medicine coupled with initiatives to increase awareness about HIV are contributing
factors to the anticipated demand surge in PrEP adoption. The increasing
prevalence of HIV and the growing need for its prevention underscores the
importance of these pharmaceutical advancements. With the promise of better
tolerability, lower side-effects, and improved delivery systems, these
advancements are poised to significantly increase PrEP usage in the United
States, revolutionizing HIV prevention strategies.
Improvements in Healthcare Infrastructure
Improvements in healthcare infrastructure in the
United States are anticipated to significantly amplify the demand for
Pre-Exposure Prophylaxis (PrEP), a preventative measure for individuals at high
risk for HIV. These advancements primarily encompass efficient distribution
systems, increased availability of healthcare resources, and enhanced patient
education. The robust distribution network ensures that PrEP is readily
accessible, even in remote areas. The existence of modern clinics and hospitals
equipped with state-of-the-art facilities enables more people to receive PrEP
treatment, thereby contributing to the increased demand. Additionally, the rise
in telehealth services due to the recent pandemic has played a pivotal role in
making PrEP available to a broader population. These telehealth services, as
part of the improved healthcare infrastructure, provide convenience and
privacy, which are key factors in increasing PrEP uptake. The strengthened
healthcare system also focuses on patient education, spreading awareness about
the effectiveness of PrEP in preventing HIV infection. Given the stigma
surrounding HIV, this education is crucial in encouraging more people to
consider PrEP. Therefore, as the U.S. continues to invest in its healthcare
infrastructure, a proportional increase in the demand for Pre-Exposure
Prophylaxis is expected.
Segmental Insights
Drug Type Insights
Based on the Drug Type, Descovy
is anticipated to command a progressively larger share of the United States
Pre-Exposure Prophylaxis (PrEP) market, gradually surpassing Truvada. This
expectation is primarily based on Descovy's demonstrated superior safety
profile, particularly in terms of renal and bone density side effects, which
positions it as a more favorable choice for long-term usage compared to
Truvada. Descovy's favorable safety profile not only ensures a higher level of
patient well-being but also contributes to improved treatment adherence. The
reduced incidence of renal and bone density side effects in Descovy users
minimizes the potential long-term health risks associated with PrEP medication.
This advantage is crucial for individuals who require long-term usage of PrEP
to prevent HIV transmission.
However, it is important to
note that the dynamics of the market could potentially be influenced by various
factors, including potential revisions in guidelines, pricing considerations,
and the emergence of generic versions. These factors have the potential to
impact market trends and competition, making it necessary for stakeholders to closely
monitor and evaluate the evolving landscape. Given the evolving nature of the
PrEP market, continuous monitoring and evaluation are crucial to gain a
comprehensive understanding of the changing dynamics. This will enable
stakeholders to adapt their strategies accordingly and ensure the most
effective and safe options are available to individuals seeking HIV prevention
through Pre-Exposure Prophylaxis.
Route Of Administration Insights
Based on the route of
administration, the oral method is expected to dominate the United States
Pre-Exposure Prophylaxis (PrEP) market. This can be attributed to several
factors. Firstly, the oral method is highly convenient for users, as it
involves taking medication orally without the need for injections or other invasive
procedures. This ease of use contributes to its widespread acceptance among
individuals seeking PrEP. Secondly, the majority of available PrEP medications
are currently formulated for oral administration, further solidifying its
position as the most common method of delivery. The availability and
accessibility of these oral medications play a significant role in shaping the
market dynamics. Consequently, the oral method is anticipated to continue its
dominance in the United States PrEP market, ensuring that individuals have a
convenient and widely accepted option for HIV prevention.
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Regional Insights
The United States Pre-Exposure Prophylaxis (PrEP)
market is predominantly dominated by the region of the Northeast. This can be
attributed to several factors, including the higher prevalence of HIV in
densely populated cities such as New York and Boston. These cities not only
have a higher concentration of individuals at risk of HIV transmission but also
boast comprehensive healthcare facilities that specialize in HIV prevention and
treatment. Moreover, the Northeast region exhibits higher levels of awareness
regarding HIV prevention strategies, including the use of PrEP, which further
contributes to its market dominance.
It is worth mentioning that the local health
departments in these areas have taken proactive measures to promote and
increase PrEP usage. These initiatives include targeted awareness campaigns,
education programs, and collaborations with healthcare providers to ensure
widespread access to PrEP medications. The combined efforts of various
stakeholders have significantly influenced the market dominance of PrEP in the
Northeast region, making it a focal point for HIV prevention and treatment
initiatives in the United States.
Recent Development
- In August 2021, Gilead Sciences, Inc. discovered
tampered and counterfeit versions of Biktarvy (Bictegravir 50 mg, Emtricitabine
200 mg, and Tenofovir Alafenamide 25 mg tablets) and Descovy (Emtricitabine 200
mg and Tenofovir Alafenamide 25 mg tablets) within US drug distribution
networks. Genuine Gilead bottles were found to have been altered with
counterfeit foil induction seals or labels, containing incorrect tablets.
Unauthorized distributors have been selling these counterfeits to pharmacies,
where genuine Gilead bottles have been tampered with, also using counterfeit
foil induction seals or labels and containing incorrect tablets.
- In July 2021, Gilead Sciences, Inc. received
encouraging results from the AMBITION clinical trial, which were presented on
21 July 2021 at the 11th International AIDS Society (IAS) Conference on HIV
Science. The study demonstrated that a single dose of AmBisome (liposomal
amphotericin B), administered along with 14 days of flucytosine, showed
non-inferiority to 14 days of conventional dose L-AmB in terms of reducing
fungal burden in the treatment of HIV-associated cryptococcal meningitis.
Key Market Players
- Gilead Sciences, Inc.
- Teva Pharmaceuticals USA, Inc.
- Merck & Co., Inc.
- Bristol-Myers Squibb Company
- Genentech, Inc.
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By Drug
Type
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By Route of Administration
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By Region
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- North-east
- Mid-west
- West
- South
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Report Scope:
In this report, the United States Pre-Exposure
Prophylaxis (PrEP) Market has been segmented into the following categories, in
addition to the industry trends which have also been detailed below:
- United States Pre-Exposure
Prophylaxis (PrEP) Market, By Drug Type:
o Truvada
o Descovy
- United States Pre-Exposure
Prophylaxis (PrEP) Market, By Route of Administration:
o Oral
o Topical
- United States Pre-Exposure
Prophylaxis (PrEP) Market, By Region:
o Northeast Region
o Midwest Region
o West Region
o South Region
Competitive Landscape
Company Profiles: Detailed analysis of the major companies
present in the United States Pre-Exposure Prophylaxis (PrEP) Market.
Available Customizations:
United States Pre-Exposure Prophylaxis (PrEP) Market
report with the given market data, TechSci Research offers customizations
according to a company's specific needs. The following customization options
are available for the report:
Company Information
- Detailed analysis and
profiling of additional market players (up to five).
United States Pre-Exposure Prophylaxis (PrEP) Market
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