Pharmaceutical Sales Representative Certification (PSC) &
CNPR Exam – Q&A Covering R&D, FDA Regulations,
Managed Care, Formularies, PBMs & Sales Strategies |
INSTANT PDF DOWNLOAD
SECTION 1: Pharmaceutical Industry Overview
1. What percentage of total U.S. healthcare expenditures does prescription drug
spending represent?
Answer: Approximately 8–10%.
*Explanation: Prescription and non-prescription drugs represent about 8–10% of total
U.S. healthcare spending yet are responsible for dramatic reductions in hospitalization,
surgery, and long-term care costs (e.g., statins, biologics for RA, HIV therapies) .*
2. What percentage of global pharmaceutical revenues does the United States
account for?
Answer: Approximately 45–50%.
Explanation: The U.S. captures about 48–50% of global pharmaceutical sales due to
higher pricing, faster adoption of new therapies, and a large insured population, making it
the largest single market for ethical pharmaceuticals .
3. What is the estimated fully capitalized cost to bring a new molecular entity (NME)
to market?
Answer: $2.6–$2.9 billion.
*Explanation: According to the Tufts Center for the Study of Drug Development (2024
update), the out-of-pocket plus capitalized cost is estimated at $2.6–$2.9 billion per
approved new drug, with only about 1 in 5,000–10,000 screened compounds reaching FDA
approval .*
4. For every how many compounds screened, how many receive FDA approval?
Answer: Approximately 1 in 5,000–10,000 compounds screened receives FDA approval.
,Explanation: The drug development process is extremely inefficient; the vast majority
of compounds fail in preclinical or clinical testing due to safety or efficacy issues, making
successful drugs very expensive to develop .
5. What is the single most important driver of pharmaceutical industry revenue
growth from 2015 to 2025?
Answer: Increased life expectancy and the aging population in developed countries.
*Explanation: The aging baby-boomer population (65+ age group) drives demand for
chronic therapies in oncology, cardiology, neurology, rheumatology, and diabetes. This
demographic shift outweighs emerging-market volume growth .*
6. How large will the Medicare-eligible population be by 2035, and what does this
represent in terms of growth?
Answer: Nearly 85 million, up from 65 million in 2025.
*Explanation: Medicare beneficiaries have 3–4 times higher per-capita drug spending
than commercially insured populations. The wave of baby boomers turning 65 continues to
drive spending on high-cost specialty medications .*
7. By 2025, which therapeutic category has overtaken all others to become the #1
driver of U.S. pharmaceutical spending?
Answer: Oncology (cancer drugs).
*Explanation: Oncology overtook immunology in 2023 and continues to dominate in
2025, with spending exceeding $95 billion annually in the U.S., driven by checkpoint
inhibitors, CAR-Ts, ADCs, bispecifics, and targeted oral oncolytics .*
8. What is the single largest contributor to oncology spending growth from 2022–
2025?
Answer: PD-1/PD-L1 inhibitors (Keytruda, Opdivo, Libtayo, etc.).
*Explanation: Pembrolizumab (Keytruda) alone exceeded $25 billion in global sales in
2024 and is on pace for $28+ billion in 2025, making the PD-1/PD-L1 class the largest in
pharmaceutical history .*
9. What is the approximate global market revenue of the pharmaceutical industry?
Answer: Approximately $950 billion to $1 trillion.
, Explanation: The pharmaceutical industry represents one of the largest global markets,
with revenues approaching one trillion dollars annually, driven by both innovative specialty
drugs and established generics. .
10. How many jobs does the pharmaceutical industry directly employ in the United
States?
Answer: Over 650,000 direct employees.
Explanation: According to PhRMA's industry profile, the pharmaceutical sector directly
employs over 650,000 people in the U.S., with additional indirect jobs supported through the
supply chain .
11. What sector provides the major source of funding for business R&D in the United
States?
Answer: The pharmaceutical sector.
Explanation: Pharmaceutical companies invest a higher percentage of sales into
research and development than almost any other industry, driving innovation and drug
discovery .
12. What is the focus of the biotechnology industry in medicine?
Answer: Gene research, genetically-altered drugs, and molecular biology.
Explanation: The biotechnology industry focuses on using living organisms and
biological processes to develop drugs, including gene therapies, monoclonal antibodies,
and genetically engineered proteins that target specific disease mechanisms .
SECTION 2: Research & Development (R&D)
13. What is the average review time for a new drug by the FDA?
Answer: Approximately 18 months.
Explanation: The FDA's review time for a New Drug Application (NDA) or Biologics
License Application (BLA) averages about 18 months, though priority review drugs may be
reviewed in 6 months and breakthrough therapies may receive accelerated timelines
[citation:1, 8].
14. In 2012, how many new drugs were approved by FDA regulators for use in the
United States?
CNPR Exam – Q&A Covering R&D, FDA Regulations,
Managed Care, Formularies, PBMs & Sales Strategies |
INSTANT PDF DOWNLOAD
SECTION 1: Pharmaceutical Industry Overview
1. What percentage of total U.S. healthcare expenditures does prescription drug
spending represent?
Answer: Approximately 8–10%.
*Explanation: Prescription and non-prescription drugs represent about 8–10% of total
U.S. healthcare spending yet are responsible for dramatic reductions in hospitalization,
surgery, and long-term care costs (e.g., statins, biologics for RA, HIV therapies) .*
2. What percentage of global pharmaceutical revenues does the United States
account for?
Answer: Approximately 45–50%.
Explanation: The U.S. captures about 48–50% of global pharmaceutical sales due to
higher pricing, faster adoption of new therapies, and a large insured population, making it
the largest single market for ethical pharmaceuticals .
3. What is the estimated fully capitalized cost to bring a new molecular entity (NME)
to market?
Answer: $2.6–$2.9 billion.
*Explanation: According to the Tufts Center for the Study of Drug Development (2024
update), the out-of-pocket plus capitalized cost is estimated at $2.6–$2.9 billion per
approved new drug, with only about 1 in 5,000–10,000 screened compounds reaching FDA
approval .*
4. For every how many compounds screened, how many receive FDA approval?
Answer: Approximately 1 in 5,000–10,000 compounds screened receives FDA approval.
,Explanation: The drug development process is extremely inefficient; the vast majority
of compounds fail in preclinical or clinical testing due to safety or efficacy issues, making
successful drugs very expensive to develop .
5. What is the single most important driver of pharmaceutical industry revenue
growth from 2015 to 2025?
Answer: Increased life expectancy and the aging population in developed countries.
*Explanation: The aging baby-boomer population (65+ age group) drives demand for
chronic therapies in oncology, cardiology, neurology, rheumatology, and diabetes. This
demographic shift outweighs emerging-market volume growth .*
6. How large will the Medicare-eligible population be by 2035, and what does this
represent in terms of growth?
Answer: Nearly 85 million, up from 65 million in 2025.
*Explanation: Medicare beneficiaries have 3–4 times higher per-capita drug spending
than commercially insured populations. The wave of baby boomers turning 65 continues to
drive spending on high-cost specialty medications .*
7. By 2025, which therapeutic category has overtaken all others to become the #1
driver of U.S. pharmaceutical spending?
Answer: Oncology (cancer drugs).
*Explanation: Oncology overtook immunology in 2023 and continues to dominate in
2025, with spending exceeding $95 billion annually in the U.S., driven by checkpoint
inhibitors, CAR-Ts, ADCs, bispecifics, and targeted oral oncolytics .*
8. What is the single largest contributor to oncology spending growth from 2022–
2025?
Answer: PD-1/PD-L1 inhibitors (Keytruda, Opdivo, Libtayo, etc.).
*Explanation: Pembrolizumab (Keytruda) alone exceeded $25 billion in global sales in
2024 and is on pace for $28+ billion in 2025, making the PD-1/PD-L1 class the largest in
pharmaceutical history .*
9. What is the approximate global market revenue of the pharmaceutical industry?
Answer: Approximately $950 billion to $1 trillion.
, Explanation: The pharmaceutical industry represents one of the largest global markets,
with revenues approaching one trillion dollars annually, driven by both innovative specialty
drugs and established generics. .
10. How many jobs does the pharmaceutical industry directly employ in the United
States?
Answer: Over 650,000 direct employees.
Explanation: According to PhRMA's industry profile, the pharmaceutical sector directly
employs over 650,000 people in the U.S., with additional indirect jobs supported through the
supply chain .
11. What sector provides the major source of funding for business R&D in the United
States?
Answer: The pharmaceutical sector.
Explanation: Pharmaceutical companies invest a higher percentage of sales into
research and development than almost any other industry, driving innovation and drug
discovery .
12. What is the focus of the biotechnology industry in medicine?
Answer: Gene research, genetically-altered drugs, and molecular biology.
Explanation: The biotechnology industry focuses on using living organisms and
biological processes to develop drugs, including gene therapies, monoclonal antibodies,
and genetically engineered proteins that target specific disease mechanisms .
SECTION 2: Research & Development (R&D)
13. What is the average review time for a new drug by the FDA?
Answer: Approximately 18 months.
Explanation: The FDA's review time for a New Drug Application (NDA) or Biologics
License Application (BLA) averages about 18 months, though priority review drugs may be
reviewed in 6 months and breakthrough therapies may receive accelerated timelines
[citation:1, 8].
14. In 2012, how many new drugs were approved by FDA regulators for use in the
United States?
