The good news for the pharmaceutical industry is that, short-term, it may emerge as a winner in the health care reform battle as new customers enter the system and price protections remain in force.

The bad news is that while big pharma has used increasingly large megamergers to support its reliance on huge-selling blockbuster products, it still faces the long-term need to develop fundamentally new business models to cope with its most significant problem — a failure to come up with innovative new treatments, according to Wharton faculty.

Once a powerful profit-machine, big pharma is stumbling up against dry product pipelines, fierce competition from generic manufacturers, consumer concerns about safety, and false marketing claims — along with the threat of a larger government role in drug purchases and pricing. “The old model is dead, and big pharma is struggling to come to terms with what new model is going to work,” says Wharton management professor John Kimberly. “What is clear is that scale is not going to do it.”

IMS Health, the drug industry forecasting firm, reports that the global pharmaceutical industry will grow 4% to 6% in 2010, up to $825 billion — the lowest levels of growth in a decade.

While health care reform has dominated headlines, drug companies have come through the debate relatively untouched, according to Mark Pauly, a Wharton health care management professor. Early in the health care reform negotiations, the drug industry promised the Obama administration it would contribute $80 billion in savings to help finance proposed reform over the next 10 years. In return, the industry’s basic pricing structure would remain intact under the reform proposals being considered by legislators in Washington. “In the short run, they fought off strong pressure. They dodged the bullet,” says Pauly. “They are already far down in revenue growth but they are lucky because a lot of people in Congress would like to kick them more.”

In addition, Pauly notes that the expansion of coverage to more than 40 million uninsured would give the industry a larger customer base. The revenue growth would translate to pure profit because the cost of creating a medication is not in the production of the pill itself, but the research that goes into discovering a new therapy. Over time, however, Pauly says the industry could face government pressure on pricing. “In the long run, if we are serious about cost containment, they are in the cross-hairs.”

Looking ahead, Pauly adds, the introduction of new products — such as expensive anti-cancer drugs — will be subject to more scrutiny based on cost either through Medicare, another form of public insurance or exchanges as proposed in some of the reform proposals. “It’s going to be more of a regulated industry. After reform gets passed [the drug industry] is one of the primary candidates for regulation.”

Marketing Practices Come under the Microscope

In addition to government involvement in pricing and sales, the industry is also facing new scrutiny of its marketing practices at the state and federal levels, according to David Grande, a senior fellow at the Leonard Davis Institute of Health Economics at the University of Pennsylvania.

This fall, Pfizer agreed to pay the largest U.S. criminal fine in history — $1.2 billion — to settle U.S. Justice Department claims that the firm had violated marketing regulations by promoting its painkiller Bextra (which has since been removed from the market) and other drugs for uses that had not been approved by the U.S. Food and Drug Administration.

According to Grande, states are increasingly adding restrictions to how drug marketers can interact with doctors and limiting the value of gifts and other subtle, non-financial inducements to prescribe one company’s product over another. Federal legislation has been proposed that would require disclosure of gifts at varying levels, ranging from $10 to $500. “Many gifts would fly under the radar at the $500 level,” he says, adding, “There does seem to be some traction to include that type of provision in the health care reform bill [although] I haven’t seen anything that would ban or prohibit certain types of exchanges or interactions.”

Some states are developing so-called “academic detailing” programs in which educators — those without a financial stake in one particular product over another — would meet with doctors to keep them up-to-date on new treatments, Grande says. “In the last decade, we have seen much more scrutiny of physicians prescribing in high profile cases where drugs were pulled off the market. And with the high cost of drugs and cost pressures — particularly in the public sector — legislators are more aware of these practices and are more engaged.”

While marketing to physicians still dwarfs drug company outreach to consumers, he notes, the explosion in so-called direct-to-consumer (DTC) advertising since regulations were eased in the late 1990s has brought more attention to drug marketing. Indeed, says Grande, federal officials seem actively engaged in monitoring the industry as a result of the safety problems. However, it is too soon to say whether the Obama Administration is going to come down harder on the industry than prior administrations.

On another front, the industry faces continued pressure from cheaper generic drugs that can come onto the market once a branded product loses its 20-year patent protection. According to the IMS report, generic competition will be the major factor bringing global pharmaceutical growth to the mid-single digits through 2013. In the next five years, drugs generating $137 billion in sales — including the widely prescribed cholesterol medicine Lipitor — will confront generic competition.

Kimberly notes that generic drug manufacturers are growing increasingly sophisticated in their ability to produce generic versions of a medication as soon as it loses patent protection. Large pharmaceutical companies, which have viewed generic producers as their sworn enemies, are now wondering whether it would be a successful strategy to get into the generic market, he says.

In response to declining research productivity, many large drug firms have acquired or formed partnerships with small, innovative biotech firms producing biologically based products. As of now, those types of products have no generic competition because there is no mechanism to prove they are equivalent to the original product, as is possible with chemical-based entities. The FDA and industry are exploring the creation of bioequivalency standards that could eventually lead to generic competition in this product category.

For years, the industry’s response to its many challenges has been to double down and acquire competitors to bring in new products and create synergies by reducing overhead and focusing on selling major blockbuster drugs. The most recent examples of this strategy are Pfizer’s $68 billion acquisition of Wyeth and Merck’s $41 billion purchase of Schering-Plough.

Kimberly says Pfizer’s move is designed to quickly fill its product portfolio when Lipitor, which accounted for a quarter of the company’s sales before the Wyeth merger, loses patent protection in 2011. Indeed, Pfizer bought Warner Lambert in 2000, largely to acquire Lipitor. “They have to do something to plug the revenue gap,” Kimberly states, adding that Pfizer has painted the merger as an attempt to build a diverse product base and wean itself off dependence on a single product. However, Kimberly notes, that would have happened anyway once the company lost patent exclusivity on Lipitor.

Merck’s merger with Schering-Plough, he says, is interesting because Merck had traditionally resisted the urge to combine with competitors, remaining staunchly independent during a long series of industry mega-mergers. “This is deep in Merck’s genes. The fact that they are acquiring Schering-Plough is a signal to me that big pharma is struggling to come to terms with what new model is going to work.”

New Ideas, New Trends

Kimberly points to a few indications of new ideas that are hatching in the industry that could eventually form the basis for fundamental change. One notable trend, he says, is that pharmaceutical companies are acquiring or partnering with biotech companies that make more sophisticated products. Biotech medications, which must typically be delivered by infusion in a physician’s office, tend to be more expensive and highly targeted to patients compared to the traditional chemical-based compounds that the pharmaceutical industry usually manufacturers.

Biotech companies tend to be small, science-based operations, often run by a founding entrepreneur. As a result, Kimberly says, they are likely to be more innovative than the big pharmaceutical companies that have attempted to drive discovery through mass screenings of chemical entities hoping to hit on a compound that might show promise against disease.

Now, he says, many large drug companies are investing in pieces of many companies that usually are focused on one product. The best example of this strategy, he says, is Eli Lilly, which is participating with more than 200 small companies working on novel treatments. “It’s only in the early stages, and there’s no guarantee it will pay off,” he says.

Kimberly also predicts that in the next five to 10 years, big pharmaceutical firms will increase their level of investment in small research-based start-ups with promising products, and cut back on the vast research and marketing operations they have spent billions to amass. This emerging model poses challenges to pharmaceutical management that is used to working in a highly centralized framework. “How do you manage a portfolio of companies with their own idiosyncrasies and their own history?” he asks. “It’s a fascinating management challenge.”

According to Wharton health care management professor Guy David, changes in marketing practices could staunch the backlash developing over drug safety. He notes that the industry now spends $5 billion in advertising aimed directly at consumers — a tactic that has eroded doctors’ roles as gatekeepers in the prescription process. The result has been a rash of expensive settlements with injured patients, fines and costly withdrawals of products that might now create problems for patients who need the drugs most.

Direct-to-consumer advertising has been good for patients — those with clear-cut medical needs — by raising awareness of treatments, according to David. For example, Lipitor is an effective drug in helping prevent heart disease and is easy for doctors to prescribe because cholesterol levels are simple to verify, he notes. On the other hand, drugs for pain or depression are more difficult for doctors to target. As a result, larger numbers of patients clamor for high-powered medications with little regard to the relationship between the potential benefit and the risk of side effects. Once that relationship erodes, higher incidences of safety problems are bound to be recorded, potentially leading to the withdrawal of a drug from the market that would be beneficial for certain patients.

“Direct-to-consumer advertising, from the firm’s perspective, is a double-edged sword,” says David. “In one sense, it is like any other advertising, but you are, in an indirect way, increasing the likelihood of an adverse reaction.”

Brian Strom, another senior fellow at the Leonard Davis Institute, suggests that pharmaceutical firms focus on developing products with a strong value proposition to fend off any future demands for lower prices. In recent years, the drug industry’s blockbuster model has led drug makers to focus on tweaking another company’s product to create “me too” medications. Then they rely heavily on marketing to generate enough revenue to support the organization’s large research and marketing overhead.

Companies should emphasize “comparative effectiveness” as they select promising drug candidates and usher them through clinical trials and government approvals, says Strom. Comparative effectiveness emphasizes the benefits of one drug over others in treating a condition. A few firms have used this to market products, but it requires significant investment in producing clinical data, and there is the risk that the data might show the drug is no better than others — or worse, he notes.

“They would rather compete on marketing expertise. That’s the model we have now,” says Strom, arguing that research geared toward comparative effectiveness could help bring down health care costs, while continuing to provide innovative new treatments. 

An overemphasis on marketing, along with high-profile withdrawals of drugs once trumpeted through elaborate media campaigns — such as the arthritis drug Vioxx — has led to growing consumer distrust of pharmaceutical manufacturers, according to Strom. “The industry shouldn’t be afraid of comparative effectiveness. They would be better off embracing it, and trying to use it rationally, rather than fighting it. The solution isn’t marketing. They should be focusing on innovation.”

As the industry struggles against these challenges, one bright spot is growing sales abroad. IMS refers to seven countries, including China, Mexico and Russia, as “pharmerging markets,” and predicts sales in those nations will grow by 12% to 14% in 2010 and 13% to 16% over the next five years. China alone is expected to contribute 21% of overall growth through 2013.

In the meantime, Pauly says the drug industry remains in search of new guidance. “They may save themselves if they come up with a wonderful product at a wonderful price,” he says, “but they may need to light a votive candle.”