Industry and competitive analysis MCQs With Answer

Industry and competitive analysis MCQs With Answer equips B. Pharm students with practical knowledge of pharmaceutical market dynamics, competitor profiling, regulatory influence, and strategic tools like Porter’s Five Forces, SWOT, PESTLE, value chain and pharmacoeconomics. This focused introduction links industry analysis to drug lifecycle, patent cliffs, generics, biosimilars, market access, pricing, reimbursement, HTA and R&D pipeline evaluation. Understanding market share, barriers to entry, supply chain and clinical trial implications helps future pharmacists contribute to strategy, product planning and regulatory affairs. Clear, pharma-specific examples and MCQs build analytical skills needed for industry roles. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of industry analysis in the pharmaceutical sector?

• To optimize laboratory protocols
• To understand market forces, competitor position and industry structure
• To train pharmacists for clinical practice
• To increase prescription writing

Correct Answer: To understand market forces, competitor position and industry structure

Q2. Which of the following is included in Porter’s Five Forces framework?

• Supplier power
• Threat of new entrants
• Bargaining power of buyers
• All of the above

Correct Answer: All of the above

Q3. Which factor most increases barriers to entry in the pharmaceutical industry?

• High R&D and clinical development costs
• Low regulatory oversight
• Abundant low-cost manufacturers
• Short product development timelines

Correct Answer: High R&D and clinical development costs

Q4. What does the term “patent cliff” refer to in pharma?

• A period of increased patent filings
• Loss of exclusivity leading to generic competition and revenue decline
• Regulatory rejection of a patent
• Expiration of manufacturing permits

Correct Answer: Loss of exclusivity leading to generic competition and revenue decline

Q5. Which is the central drug regulatory authority in India?

• FDA (Food and Drug Administration)
• EMA (European Medicines Agency)
• CDSCO (Central Drugs Standard Control Organization)
• WHO (World Health Organization)

Correct Answer: CDSCO (Central Drugs Standard Control Organization)

Q6. How is a biosimilar best defined?

• An identical chemical copy of a small-molecule drug
• A closely similar biological product to an approved biologic, with no clinically meaningful differences
• A brand new biologic with different mechanism
• A dietary supplement

Correct Answer: A closely similar biological product to an approved biologic, with no clinically meaningful differences

Q7. Market share is commonly expressed as:

• Total number of patents held
• Percentage of total sales or units in a defined market
• Number of R&D employees
• Average selling price across products

Correct Answer: Percentage of total sales or units in a defined market

Q8. SWOT analysis includes which four components?

• Sales, Warranties, Offers, Targets
• Strengths, Weaknesses, Opportunities, Threats
• Strategy, Workload, Operations, Tactics
• Suppliers, Workforce, Outputs, Trends

Correct Answer: Strengths, Weaknesses, Opportunities, Threats

Q9. PESTLE analysis examines which external factors?

• Product, Equity, Sales, Technology
• Political, Economic, Social, Technological, Legal, Environmental
• Pricing, Efficacy, Safety, Trials
• Production, Export, Supply, Trade

Correct Answer: Political, Economic, Social, Technological, Legal, Environmental

Q10. HTA in pharmaceutical competitive analysis stands for:

• Health Technology Assessment
• High Throughput Analysis
• Health Treatment Authorization
• Hospital Therapeutic Audit

Correct Answer: Health Technology Assessment

Q11. What is the main goal of bioequivalence studies for generics?

• To improve manufacturing yield
• To demonstrate similar bioavailability to the reference product
• To compare pricing strategies
• To evaluate environmental impact

Correct Answer: To demonstrate similar bioavailability to the reference product

Q12. Which activities are part of the pharmaceutical value chain?

• R&D, manufacturing, distribution, marketing and post-marketing surveillance
• Only manufacturing and sales
• Only clinical trials
• Only regulatory filing

Correct Answer: R&D, manufacturing, distribution, marketing and post-marketing surveillance

Q13. Competitive intelligence in pharma is best described as:

• Illicitly stealing competitor data
• Gathering lawful, structured data on competitors to inform strategy
• Designing competitor lab equipment
• Trading manufacturing secrets

Correct Answer: Gathering lawful, structured data on competitors to inform strategy

Q14. Market segmentation in pharmaceuticals commonly uses which criteria?

• Therapeutic area, patient demographics, prescribing behaviour and payor type
• Only company size
• Only geographic longitude
• Random patient lists

Correct Answer: Therapeutic area, patient demographics, prescribing behaviour and payor type

Q15. A common pricing strategy for launching a low-cost generic is:

• Price skimming
• Penetration pricing
• Premium pricing
• Cost-plus monopoly pricing

Correct Answer: Penetration pricing

Q16. Which metric best describes historical market growth over time?

• Compound Annual Growth Rate (CAGR)
• Patent expiration date
• Number of clinical sites
• Batch failure rate

Correct Answer: Compound Annual Growth Rate (CAGR)

Q17. Orphan drug designation is given to drugs that treat:

• Common colds
• Rare diseases with small patient populations
• Topical cosmetic conditions
• All over-the-counter medicines

Correct Answer: Rare diseases with small patient populations

Q18. One strategic reason for mergers and acquisitions in pharma is to:

• Reduce the number of pharmacists in hospitals
• Expand the product pipeline and acquire new technologies
• Increase local retail pharmacy count
• Eliminate clinical trials

Correct Answer: Expand the product pipeline and acquire new technologies

Q19. API in pharmaceutical manufacturing stands for:

• Automated Production Interface
• Active Pharmaceutical Ingredient
• Authorized Product Information
• Analytical Purity Index

Correct Answer: Active Pharmaceutical Ingredient

Q20. Pharmacoeconomics primarily evaluates:

• Drug marketing slogans
• Cost-effectiveness and value of therapies relative to outcomes
• Lab equipment maintenance costs
• Physician hiring practices

Correct Answer: Cost-effectiveness and value of therapies relative to outcomes

Q21. Therapeutic area analysis focuses on:

• The logistics of packaging only
• The market dynamics, unmet needs, competitors and pipeline within a specific disease area
• Hospital interior design
• Generic tablet color preferences

Correct Answer: The market dynamics, unmet needs, competitors and pipeline within a specific disease area

Q22. Which of the following is NOT one of Porter’s Five Forces?

• Threat of substitutes
• Bargaining power of suppliers
• Government regulation
• Competitive rivalry

Correct Answer: Government regulation

Q23. Phase III clinical trials are primarily designed to:

• Assess long-term manufacturing stability
• Evaluate efficacy and safety in large patient populations
• Test chemical synthesis routes
• Monitor environmental impacts of drugs

Correct Answer: Evaluate efficacy and safety in large patient populations

Q24. Why are biosimilars more complex to develop than small-molecule generics?

• Biologics have simple chemical structures
• Biologics are large, variable molecules produced in living systems and require complex characterization
• Biosimilars bypass regulatory review
• Small-molecules require living cells for production

Correct Answer: Biologics are large, variable molecules produced in living systems and require complex characterization

Q25. Which of the following is an example of an opportunity in a SWOT analysis for a pharmaceutical firm?

• Declining product quality
• Entering an emerging market with unmet therapeutic need
• Loss of key personnel
• Manufacturing shutdown

Correct Answer: Entering an emerging market with unmet therapeutic need

Q26. Primary market research in pharma involves:

• Collecting existing published sales reports
• Gathering new, original data through surveys, interviews or clinical investigator feedback
• Only reviewing patents
• Analyzing competitor logos

Correct Answer: Gathering new, original data through surveys, interviews or clinical investigator feedback

Q27. Market access strategies address which key areas?

• Storage temperature control only
• Pricing, reimbursement, formulary inclusion and health economics evidence
• Packaging design colors
• Clinical trial randomization methods

Correct Answer: Pricing, reimbursement, formulary inclusion and health economics evidence

Q28. Which factor most influences physician prescribing behaviour and thus competitive positioning?

• Office interior lighting
• Clinical evidence, safety, guideline recommendations and peer influence
• Tablet shape only
• Country GDP per capita

Correct Answer: Clinical evidence, safety, guideline recommendations and peer influence

Q29. A “pay-for-delay” agreement is considered:

• An innovation incentive program
• An anticompetitive practice where originator pays generics to delay entry
• A clinical collaboration for trials
• A regulatory approval pathway

Correct Answer: An anticompetitive practice where originator pays generics to delay entry

Q30. A strong pharmaceutical value proposition typically emphasizes:

• Only the number of patents
• Clinical benefit, safety profile, cost-effectiveness and unmet needs addressed
• Complex chemical names
• Packaging weight

Correct Answer: Clinical benefit, safety profile, cost-effectiveness and unmet needs addressed

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