When its blockbuster drug Lipitor lost its patent protection in 2011, sales dropped over 90%, and Pfizer has yet to recover since. The offers that appear in this table are from partnerships from which Investopedia receives compensation. The generic drug is made by Mylan and costs 70% less than Advair. The patent expired in 2011, but Lipitor still lives on for Pfizer as a blockbuster drug, with most of its sales coming from China and overseas markets. That's why certain breakthrough drugs are a real reason for pharma companies and their investors to celebrate -- especially those that wind up being blockbusters. Some of the biggest blockbuster drugs of all time, with lifetime sales of over $100 billion as of 2018, are as follows: Warner-Lambert originally developed Lipitor and it was approved in the U.S. in 1997. Advair is used to treat asthma and breathing from other lung diseases. Drugs that hit the multibillion-dollar sales … The large market segments are saturated, the costs of R&D are rising steeply, and the failure rate has been disappointingly high. Because these drugs come with a patent, the pharmaceutical company is the only company allowed to sell it for a specified period of time, often many years. Phase 1 clinical studies or clinical trials are focused on evaluating the safety aspect of a new drug, rather than how effective it may be. In fact, any sort of blockbuster drug scandal can cause pharmaceutical companies and their investors to lose millions overnight. For companies with blockbuster … Has The Pharmaceutical Blockbuster Model Gone Bust? For this reason, pharma companies often aim to develop a diverse and successful array of products rather than rely on one or two blockbuster drugs to keep themselves profitable. Business Model . Expert Opinion on Orphan Drugs (2013) 1(1):1-3 1. Once a drug's patent expires, competitors can introduce generic versions to the market at lower prices, thus leading to a major loss in market share for the original developer. With the ‘blockbuster bubble’ seemingly burst and patent protection giving way to huge rises in generic competition, the pharma industry would now seek to sustain itself by focusing on niche markets; high … 5 Biggest Blockbuster Drugs of the Future Each of these drugs is forecast to rake in at least $9.5 billion in 2024. A New Bain & Company Study Reveals New Drug Commercialization Costs Have Now Reached $1.7 Billion While ROI Has Plummeted To Just 5%. The ramifications of a blockbuster deficit to the pharmaceutical industry are compounded by the dependence many companies place on blockbuster revenue. A new drug is an original or innovative medication or therapy that has not been used before in clinical practice to treat a disease or condition. Patents are effective for 20 years from the date of filing, which may sound like a decent window, but considering that it can take a decade or more to actually bring a new drug to the market, pharma companies don't actually have all that much time to recoup the money and resources they put into researching and developing their products. Although no one would want to admit it, Blockbuster didn’t make much money from the simple rental of movies. This can result in litigation, high legal fees, and significant monetary compensation to affected users of the drug. The model that we ve based pharmaceutical development on for the last decade is not sustainable, said Dr. David Kessler, who led the FDA from 1990 to 1997. Part of the success of these drugs stems from the fact that they're needed over a long period of time, and that they play a key role in helping doctors manage their patients' conditions. The new blockbuster model has shifted away from primary care to specialty therapies, with specialty blockbusters driving much of the future projected growth. Investopedia uses cookies to provide you with a great user experience. We know the old blockbuster innovation model is unsustainable. Market data powered by FactSet and Web Financial Group. However, this has not impacted Humira sales as yet, which brought in $15 billion in revenues in 2019 for AbbVie. In-text: (WIRE, 2003) Your Bibliography: WIRE, B., 2003. Pharma 2020: Challenging business models 1 Introduction The pharmaceutical marketplace is undergoing huge changes, as we indicated in “Pharma 2020: The vision”, the White Paper PricewaterhouseCoopers* published in June 2007.1 These changes will have a major bearing on the kind of business models pharmaceutical … When a pharmaceutical company creates a drug that works successfully and is approved by the Food and Drug Administration (FDA), they can sell the drug at a high price to recoup the R&D expenses, as well as making a profit. This article is part of The Motley Fool's Knowledge Center, which was created based on the collected wisdom of a fantastic community of investors. Lipitor generated $2 billion in sales for Pfizer in 2019. Advair received its approval in 2001 and has been a big seller since the beginning. AbbVie has also been consistently raising the price of Humira. Cumulative Growth of a $10,000 Investment in Stock Advisor, Copyright, Trademark and Patent Information. Rest in peace. The problem, however, is that when a blockbuster drug's patent expires, the company behind it can start to see a major dip in revenue. Now it is being succeeded by the precision medicine model. Common examples of blockbuster drugs include medications for diabetes, cholesterol, high blood pressure, and cancer. Doctors like Humira’s ability to counteract inflammation caused by several diseases. Blockbuster drugs are those that are typically used to treat chronic or long-term medical problems, as opposed to acute or short-term conditions. So it's not a model that needs to be totally disregarded. When a drug's patent expires, the market is flooded with generic drugs, negatively impacting sales of the blockbuster drug. Value Creation. One such example is Pfizer. However, nothing stays the same. The issue was not the drug but rather the device, which was difficult to reproduce around the FDA's stringent drug-device patent laws. Lipitor would eventually account for one-fourth of Pfizer’s total sales. Visionary thought leaders such as Bernard Munos of InnoThink and the Milken Institute and Paul Stoffels, M.D., vice chairman of the executive committee and chief scientific officer, Johnson & Johnson, have been advocating for years that the blockbuster model is broken and unsustainable. Humira is owned by AbbVie, a 2013 spin-off from Abbott Labs. Founded in 1993 by brothers Tom and David Gardner, The Motley Fool helps millions of people attain financial freedom through our website, podcasts, books, newspaper column, radio show, and premium investing services. But is this picture correct? One of the major issues confronting the pharmaceutical industry is the challenge to, and shifting focus of, the traditional business model. Treats: Ankylosing spondylitis, arthritis, Crohn’s disease, plaque psoriasis, ulcerative colitis. Still, Tagamet ushered in a new era for the pharmaceutical industry, where every drug maker—and investor—was on the lookout for the next blockbuster drug. But your next drug can still be a blockbuster … The expiration date is the date after which a consumable product like food or medicine should not be used because it may be spoiled, or ineffective. European Medicines Agency (EMA) is a government entity that promotes access to and approval of medications in European countries. Blockbuster movie rental retail stores offered a wide selection of movies, but focused mainly on new releases. Pharmaceutical companies spend a significant amount of time and money on the research and development (R&D) of new drugs. How is the blockbuster model shifting, or is it failing? One in which value creation is intrinsically linked to the creation and protection of intellectual property. What is new is the industry’s increased focus on reinventing its commercial strategies, and the nichebuster model has moved front and center of … European Medicines Agency (EMA) Definition. The increasingly favoured specialty model, however, will only provide sufficient returns to biotechnology investors if significant sales volumes are reached. Your input will help us help the world invest, better! It is widely considered that the conventional strategy of pursuing blockbuster medicines (products achieving peak sales of £1bn or more) is in sharp decline, as patents expire on major products and the output of product pipelines diminishes. Now it is being succeeded by the precision medicine model. Pfizer acquired Warner-Lambert in 2000 to gain sole ownership of the drug; a wise investment. in pharma manufacturing Andrew Gonce and Ulf Schrader Change is badly needed in pharma manufacturing. A patent cliff occurs when a company's patents expire, thus losing its monopoly on its associated intellectual property rights,. Jan 12, 2010. Pharma 2020: Challenging business models 1 Introduction The pharmaceutical marketplace is undergoing huge changes, as we indicated in “Pharma 2020: The vision”, the White Paper PricewaterhouseCoopers* published in June 2007.1 These changes will have a major bearing on the kind of business models pharmaceutical companies need to employ. Thanks -- and Fool on! An acquisition adjustment pertains to the premium a business pays to acquire another, which can affect depreciation, net income and taxes. A blockbuster drug can be a major factor in a pharmaceutical company's success. “A bitter pill for Big Pharma: Overdependence on 'blockbuster' drugs is taking a toll on the industry” “Has the Pharmaceutical Blockbuster Model Gone Bust?” Many critics suggest that BIG Pharma must abandon its blockbuster model. The best-selling: Humira In its 2011 report, Progressions: Building Pharma 3.0Ernst and Young outlines the evolution of the pharmaceutical industry from Pharma 1.0 (vertically integrated blockbuster model) through Pharma 2.0 (the current model characterized by diversification, flexible R&D, specializations, partnerships) to 3.0, where “companies will succeed based … on their ability to improve health outcomes.” Yet Blockbuster’s model had a weakness that wasn’t clear at the time. It’s 9,000 stores allowed customers to easily … While Big Pharma’s fully-integrated business model generated huge profits for stockholders for many years – the market value for top companies grew 85-fold from 1985 to 2000, the report notes—by 2020, that model will not work. It earned an enormous amount of money by charging its customers late fees, which had become an important part … By Suraj Mathew, Partner, Tefen USA. In essence, the pharma company has a monopoly on this drug and can charge any price. With the ‘blockbuster bubble’ seemingly burst and patent protection giving way to huge rises in generic competition, the pharma industry appears to be focusing on high value drugs for rare diseases of low prevalence for which there is a potential for rich return on investment. During this transition, the pharmaceutical industry may worry about losing … The drug lost patent protection in 2018 and the FDA has approved five generic versions. The research and development process can take years and cost hundreds of millions of dollars. Tech transfer as usual. Common blockbuster drugs are Vioxx, Lipitor, and Zoloft. If a blockbuster drug is discovered to have major side effects or is subjected to a recall, the financial losses can be catastrophic. “Big Pharma” has reached out for a new model and found that orphan drugs may be the answer. Building a New Tech Transfer Model As blockbuster and generic business models merge, tech transfer must change. Today, there are 116 so-called blockbuster medicines, providing 36% of the global pharmaceutical market’s 2011 value, up from 51 products and 25% of the global pharmaceutical … 25 million patients. It is expected that sales of Advair will significantly decrease. Blockbuster therapies are manufactured in centralised biomanufacturing plants configured to produce large quantities of a single therapy in each batch. Download : Download full-size image; Fig. But although the blockbuster model has worked for decades, it is now facing disruption from multiple developments occurring in the pharma … A blockbuster drug is a very popular drug that generates annual sales of $1 billion or more for the company that sells it. While the blockbuster model has served Pharma well, it is unable to build in a higher level of predictability in developing safe and effective treatments for patients with specific disease subtypes. The blockbuster model But because drug companies need to file for patents while their products are still in development, patents only give them a limited window of exclusivity in practice. This is a significant decrease, however, when compared to sales in 2011, the last year Pfizer had the patent. Treats: Chronic obstructive pulmonary disease, asthma. The experiences of other disrupted industries may be relevant to pharma, such as: Continuing ‘business as usual’ and failing to innovate – for example, Blockbuster Video, Kodak and Borders; Financial challenges – for example, 11 of the top 13 companies have more debt on their balance sheet than cash (AstraZeneca especially). While it's true that many pharmaceutical companies are extremely profitable, there's also a lot of time, work, and money that goes into the development of new drugs. It’s 9,000 stores allowed customers to easily walk through aisles of movies advertised with their DVD cases in order to make a selection. Long Term Strategies: I • Many pharmaceutical companies locked into the blockbuster model of drug development are witnessing diminishing returns in sales and marketing II • As research in personalised drugs becomes more advanced, portfolios are starting to shift towards therapies that target genotype specific patient populations III • Disease management is taking pharma companies towards … For the past 20 years, the blockbuster model has dominated the pharmaceutical industry. It s the notion of the blockbuster, the idea that we ll be able to come up with drugs that millions of … The Blockbuster Model Is Broken Unlike most industries where a handful of winning strategic models often prevail side by side, the pharmaceutical industry majors have all converged over the last decade on one strategic model. You can see novel compounds still coming out of the traditional model that will benefit a general population on a global basis. Blockbuster drugs are used for common ailments, such as diabetes, cholesterol, high blood pressure, and cancer, that many individuals face. When the patent expires, many companies flood the market with generic versions of the drug at a significantly reduced price than the original, wiping away the monopoly and creating a competitive market. Another problem with blockbuster drugs is that companies rely on them heavily to generate revenue, so when a blockbuster product fails, it can spell disaster. Blockbuster movie rental retail stores offered a wide selection of movies, but focused mainly on new releases. Examples of blockbuster drugs include Vioxx, Lipitor, and Zoloft. We will have to see whether the new open innovation model will work for the pharmaceutical industry in the next 10 years. By using Investopedia, you accept our. 5. Blockbuster therapies are manufactured in centralised biomanufacturing plants configured to produce large quantities of a single therapy in each batch. Value Creation. It discusses the key forces reshaping the pharmaceutical marketplace, including the growing power of healthcare payers, During this transition, the pharmaceutical industry may worry about losing the blockbuster model’s strengths—broad, simple indications and large, steady revenues.” “Pharma 2020: Marketing the future” is the third in this series of papers on the future of the pharmaceutical industry published by PricewaterhouseCoopers. The blockbuster business model-challenges • Pharmaceutical companies are finding that the blockbuster drug business model is becoming prohibitively expensive. Those paradigms have led to enormous successes. Open innovation model. Wherein, the earlier blockbuster business model is focused on more diversified global R&D clusters. It has generated tremendous value for companies and shareholders and will likely continue to do so well into the future. Netflix could completely “A bitter pill for Big Pharma: Overdependence on 'blockbuster' drugs is taking a toll on the industry” “Has the Pharmaceutical Blockbuster Model Gone Bust?” Many critics suggest that BIG Pharma must abandon its blockbuster model. “The blockbuster drug model once reigned supreme. Based on the currently applied cost of capital for pharmaceutical and biotechnology companies the attractiveness of the so-called blockbuster model is clearly supported. Blockbuster drugs are those that generate at least $1 billion in revenue a year for the pharmaceutical companies that produce them. Returns as of 01/14/2021. Now it is being succeeded by the precision medicine model. The top drug on the list of potential blockbuster drugs is Ultomiris, Alexion's next-generation version of Soliris. In order to retain exclusive rights to sell a drug, a pharmaceutical company must obtain a patent. A blockbuster drug is an extremely popular drug that generates annual sales of at least $1 billion for the company that sells it. The problem, however, is that due to patent laws, the success of blockbuster drugs is often short-lived. The drug's U.S. patent expired in 2010 and its inhaler pattern expired in 2016, but no successful generic competitor surfaced until 2019. The model isn’t new; companies have been looking to smaller targeted indications, sometimes as added indications for their blockbuster drugs, for more than 10 years. But although the blockbuster model has worked for decades, it is now facing disruption from multiple developments occurring in the pharma … With the ‘blockbuster bubble’ seemingly burst and patent protection giving way to huge rises in generic competition, the pharma industry would now seek to sustain itself by focusing on niche markets; high value drugs for rare diseases of low prevalence, but for which a rich return on investment could be reaped. It has since been joined by popular drugs such as Lipitor, which treats high cholesterol, Advair, an asthma treatment, and Nexium, which treats gastroesophageal reflux disease (GERD ). The blockbuster drug model once reigned supreme. Now I see the model as a combination model. Business Model . Cimetidine (marketed as Tagamet), a heartburn and stomach acid treatment, was the first drug to generate over $1 billion a year in sales and, as such, has gone down in history as the first ever blockbuster drug on the market. However, it can also cause major problems for a company if the drug is discovered to have problematic side effects or is recalled after being released. Pharmaceutical companies spend a lot of money on research and development (R&D) and sell a successful drug at a high price to recoup losses and earn a profit. This in concert with the advent of personalised medicine and the demise of the therapeutic drug Blockbuster Model has necessitated a re-evaluation of the pharmaceutical business model. The blockbuster model that traditionally drove the pharmaceutical industry seems to have lost its relevance. Email us at knowledgecenter@fool.com.