Assignment 6-10

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Chapter 14

The Pharmaceutical Industry

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Number and Size Distribution of Sellers

Pharmaceutical companies

A sizeable number of large companies coexist in the drug industry

A multitude of lesser-known, smaller firms exist

Manufacture and retail generic drugs

Little, if any, emphasis on new drug discovery

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Table 14.1 - The Largest Pharmaceutical Companies by U.S. Sales, 2010

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Number and Size Distribution of Sellers

U.S. pharmaceutical industry

763 firms in 2007

Appears to be reasonably competitive from a structural perspective

Therapeutic-market definition offers a more appropriate approach to defining the RPM for drugs

Concentration ratios based on static data on therapeutic markets suggest a more concentrated market environment

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Number and Size Distribution of Sellers

Pharmaceutical industry

Mildly concentrated

A few drug companies tend to dominate most therapeutic markets

Dominant positions may not be very permanent

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Number and Size Distribution of Sellers

Market shares are reasonably close among the top ten drug companies

This cannot by itself identify whether drug companies possess significant market power

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The Buyer Side of the Pharmaceutical Market

Degree of buyer concentration

Number and size distribution of buyers

Market is relatively fragmented

Consumers directly pay for a relatively large percentage of drug costs

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Table 14.2 - Payers for Prescription Drugs, 2010

8

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The Buyer Side of the Pharmaceutical Market

Realized demand for pharmaceutical products

Consumers - not responsible for choosing which specific drug to buy

Demand depends on-

Consumer tastes

Behavior of physicians who prescribe these drugs

Retail and hospital pharmacists who dispense the prescriptions

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The Buyer Side of the Pharmaceutical Market

Classes of drugs

Over-the-counter (OTC)

Available for self-medication

Prescription (Rx)

Available only by a physician’s prescription

Dominant type sold today

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The Buyer Side of the Pharmaceutical Market

Physicians - prescribe medicines

Lack incentive to make cost-effective choices

Result: high-priced, brand-name drug when an equally effective lower-priced generic is available

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The Buyer Side of the Pharmaceutical Market

Third-party influences on the demand for pharmaceutical products

Formularies

Drug utilization review

Required generic substitution

Federal Maximum Allowable Cost (MAC) program

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The Buyer Side of the Pharmaceutical Market

Price controls on drugs sold to Medicaid patients

Omnibus Budget Reconciliation Act of 1990

Veterans Health Care Act of 1992

Pharmacy Benefit Management Companies

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Barriers to Entry

Barriers to entry into the pharmaceutical industry

Government patent

First-mover or brand-loyalty advantage

Control over a key input

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Barriers to Entry

Government patent

Gives the innovating firm the right to be the sole producer of a drug product for a legal maximum of 20 years

Does not guarantee that the company will remain perfectly insulated from competition

Effective duration is often less than 20 years because the FDA takes a number of years to approve a product for commercial introduction

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Barriers to Entry

First-mover or brand-loyalty advantage

Because the quality of a substitute generic product is generally unknown

Generic drugs - experience goods

Confers market power on the innovator of a new product

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Barriers to Entry

Control over a key input

Specific chemical or active ingredient

New competitors require access to the input

Originating firm may sell it to the new entrants only if it is profitable to do so

If replication is difficult or costly

New firms may find it unprofitable to enter the industry

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Consumer Information and the Role of the FDA

Consumers - face 3 risks when directly purchasing pharmaceutical products

Overpaying or receiving a pharmaceutical product of inferior quality

Adverse reaction to a drug may lead to sickness or death

Purchase the wrong drug or take the wrong dosage and therefore fail to recover from an illness or injury

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Consumer Information and the Role of the FDA

FDA - protect consumers from the risks associated with drug purchases

Determining drug status: over-the-counter or prescription status

Must approve a new drug before it can be sold in the marketplace

Correct approval decision means

FDA approves a safe and effective product

FDA rejects an unsafe or ineffective one

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Consumer Information and the Role of the FDA

Uncertainty, FDA - two types of errors

Type 1 error:

FDA rejects the application for a new drug that is truly safe and effective

Less visible

Type 2 error:

FDA approves a drug that is unsafe or ineffective

Highly visible

FDA

Incentive to reject rather than accept a drug

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The Conduct of the Pharmaceutical Industry

Pricing behavior

Potential for noncompetitive pricing

Price drug products above the marginal costs of production and generate economic profits

First-mover advantages

Promotion expenditures

Reinforce the habit-buying practices of many buyers, especially physicians

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Pricing Behavior

Empirical evidence

Prices of brand-name and generic products lower when higher substitutes available

Prices of branded drugs sometimes rise upon generic entry

Goodwill established during the patent period allows established firms to maintain a large market share despite generics

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Pricing Behavior

Empirical evidence

Price accounts for most of the variation in a generic company’s market share

Therapeutic novelty of a drug influences pricing strategy over time

High brand-name profit margin at the time of generic entry increases the number of entrants fairly quickly

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Promotion of Pharmaceutical Products

Pharmaceutical promotion strategies

Leffler (1981), Hurwitz and Caves (1988), and Caves et al. (1991)

Support both the informational and persuasion effects of pharmaceutical promotion

Informational effect

Advertising intensity is greater for newer and more important pharmaceutical products

New entrants’ promotion expenditures helped them expand their market shares

Increased generic competition results in less advertising by the innovator

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Promotion of Pharmaceutical Products

Pharmaceutical promotion strategies

Empirical evidence, Leffler (1981), Hurwitz and Caves (1988), and Caves et al. (1991)

Persuasion effect

Detailed targeting of younger physicians occurs for older products

Leading firms’ promotion expenditures preserved their market share from new generic entrants

Generic firms gain relatively small shares despite their huge discounts

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Product Innovation

New drug development is a sequential process

Review development status of a drug; decide to continue or abandon the project

Expected revenues depend on

Therapeutic properties of the drug, the size of the target market, and the number of substitute drugs

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Product Innovation

Anticipated costs depend on

The frequency and severity of adverse reactions to the drug and the projected additional development, marketing, distribution, and production costs

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Figure 14.1 – R&D Intensity of Major Pharmaceutical Companies, 1970-2009

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Product Innovation

Grabowski and Vernon (1981), Vernon (2005), and Lichtenberg (2004)

Determinants of R&D Spending

The amount of expected economic profits T

The difference between the expected future streams of revenues and costs.

The contemporary profit rate

Past R&D success

Market value of the firm as a measure of expected revenues

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Product Innovation

Firm Size and Innovation

Larger firms tend to face a greater incentive to undertake successful R&D activities than smaller firms:

Resource capability

Risk absorption

Research economies

Larger firms also face greater bureaucratic red tape - stifles creativity

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Product Innovation

Acs and Audretsch (1988)

Larger firms have an innovative advantage:

Capital intensive, advertising intensive, and relatively concentrated industries

Smaller firms have an innovative advantage:

Industries with total innovation and the use of skilled labor

Some, but not many, large firms exist

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Product Innovation

Pharmaceutical innovation

Mixture of firm sizes foster innovation

Innovativeness of smaller firms is greatest when large firms dominate in an industry

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The Relative Price Inflation Rate of Pharmaceutical Products

1970s

General price inflation rate - outpaced the prescription drug inflation rate

Real or relative drug prices declined

1980s

Quick rise of real drug prices

1990s

Drug price inflation rate tended to track the general price inflation rate during 1993–1996

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The Relative Price Inflation Rate of Pharmaceutical Products

1997 to 2005

Drug prices increased faster than the general price level

The difference in inflation rates was slight in 2003, 2004, and 2005

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The Relative Price Inflation Rate of Pharmaceutical Products

2006-2007

General price inflation rate exceeded the drug price inflation rate

Quality-adjusted price inflation rates may be lower than the BLS reported rates

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Figure 14.2 – Drug and General Price Inflation Rates, 1996-2011

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Output of New Pharmaceutical Products

New chemical entities, NCEs

Improve quality of life by relieving pain

Significantly reduced deaths from many diseases

Tuberculosis, kidney infection, and hypertension

Virtually eliminated diseases such as whooping cough and polio

New drug cost offset theory

Reduce the cost of treating diseases

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Output of New Pharmaceutical Products

Lichtenberg (2005)

New drugs have a strong positive impact on the probability of survival

People can expect to live one week longer each year because of new drugs

Produce an additional life-year at an incremental cost of about $6,750

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Figure 14.3 – Annual Number of New Molecular Entities, 1980-2010

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Table 14.3 – Return on Assets and Stockholder Equity for Drugs and all Manufacturing Companies, Various Years

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Profits in the Pharmaceutical Industry

High profits

Patents, brand loyalty, and an inelastic demand for drugs

Profitability of drug firms is twice that of the manufacturing industry average:

Unusually high R&D risks and marketing outlays

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Provisions of the Patient Protection and Affordable Care Act (PPACA) of 2010 Relating to the Pharmaceutical Industry

Health insurance mandate should increase the demand for all type of drugs

Firms manufacturing or importing branded drugs will be taxed on branded-drug sales

A generic drug can be approved despite last-minute changes to the labeling of the listed drug

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