Large Molecules, Larger Impact

The biopharma industry remains one of the most robust and healthy of industries, not only in the states, but also around the world

By Steven E. Kuehn, Editor in Chief

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If there’s a bright spot in Pharma these days, it’s the light shining from the biopharmaceuticals sector. Most professionals observing this aspect of pharmacopeia agree that the biopharmaceutical industry remains one of the most robust and healthy of industries, not only in the U.S., but arguably around the world. The global market for biopharmaceuticals is quite large; north of $165 billion and growing at some 15 percent annually. Sources say of the top 100 prescription products, by 2018, biologics will account for 50% of sales.

Accenture analyzed the 16 largest pure biopharmaceutical companies and found that collectively at some $487 billion in aggregate 2011 revenue, these companies represented 54 percent of the global pharmaceutical market. That’s pretty impressive and reveals the dominance the sector is creating for itself even in the face of patent expiry, which Accenture says hit its peak in 2012. In its overview of market trends, Bioplan Associates Inc.’s 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity, finds that the biopharmaceutical industry did more than survive the downturn. “In fact,” says the report, “the industry has done rather well for itself during this period — not contracting or losing much at all in recent years — and is now showing clear signs of full recovery and growth.” Clearly the industry’s momentum shows little sign of doing anything but accelerating.

As an industry, biopharmaceuticals have become a significant economic driver, especially in the United States. In its 2013 Profile report, The Pharmaceutical Research and Manufacturers of America, (PhRMA), notes that the biopharmaceutical industry continues to make major contributions to the U.S. economy. “The U.S. biopharmaceutical sector employs more than 810,000 workers, supports a total of 3.4 million jobs across the country and contributes nearly $790 billion in economic output on an annual basis …” According to PhRMA, those workers earned a collective $89.9 billion in pay, averaging slightly more than $110,000 in wages and benefits per worker. Those kinds of wages buy a lot of toasters and SUVs as well as health care.

The industry’s growth, the effectiveness of its therapies, and its continued health and vitality are linked very directly to the industry’s growing investments in R&D and technology. In 2012 the industry invested $8.5 billion in R&D, says PhRMA’s report, representing more than 20% of sales when it comes to domestic R&D spending and defines the largest R&D investment of any sector of the U.S. economy. Since 2000, PhRMA members spent $500 billion in R&D and it is paying off. Fostering a decade of innovation that produced the first anti-angiogenic medicine for cancer (2004), the first new kidney cancer Rx in a decade, three new diabetes therapies (2005), first once-a-day HIV medicine (2006), first fibromyalgia treatment (2007), the first new Rx for gout in 40 years (2009), two new multiple sclerosis drugs (2010), first lupis drug in 50 years (2011), 43 new approvals (2012) and as of 2013, more than 5,000 medicines in development globally.

This robust activity provides real testimony to the efforts of the industry, but it’s not all a bed of roses. As John Castellani, president and CEO of PhRMA notes in his intro letter to the report, “Researchers continue to work toward these goals in spite of many barriers. The science and technology of drug development are increasingly complex, and the length and cost of research and development have continued to grow. Regulatory and business environments add uncertainty to the process.”

Adding to CFO heartburn is the advance of biosimilars. In its recent report Shaping the Biosimilars Opportunity: A Global Perspective on the Evolving Biosimilars Landscape, research firm IMS says: “By 2015, sales of biosimilars are expected to reach between $1.9 to $2.6 billion, up from $378 million for the year to the first half of 2011. Potentially, this market could be the single fastest-growing biologics sector in the next five years — albeit from a small base — spurred by the convergence of major dynamics that will see new biosimilars enter the U.S. market by 2014, bring additional molecules to Europe through 2015, and open up oncology and autoimmune disease areas to biosimilars for the first time ever.” The IMS report finds that society is putting pressure on Pharma to continue to lower the cost of drugs and increase access to effective but expensive biologic therapies. What’s going to be tricky for the biopharmaceutical industry is how to answer that demand for generic therapies without going broke; one prominent analyst noted that the costs to commercially develop and produce biosimilars is, well, similar to that of its branded counterparts.

In spite of the complexities and costs associated with biopharmaceutical drug development, the expense associated with clinical trials, etc., the biopharmaceutical industry is fueling its growth and financial success by investing heavily in the process and analytical technologies that support innovative, cost-effective cGMP-based manufacturing environments. In fact, the industry is demanding effective technologies to drive efficiency and productivity in and costs out of biopharmaceutical processing. They’re looking for increased manufacturing performance, especially in clinical-scale scenarios.

To that end, the editors of Pharmaceutical Manufacturing and PharmaManufacturing.com have compiled this special issue to hopefully provide readers fresh technological insight as well as a few best practices to help better understand biopharma processes and generate the manufacturing performance the industry is demanding. Welcome to Pharmaceutical Manufacturing’s Biopharmaceutical Technical Resource Guide.

Published in the November 2013 edition of Pharmaceutical Manufacturing magazine

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