National Bioeconomy Blueprint

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Today, the White House released its National Bioeconomy Blueprint.  The Blueprint defines the bioeconomy as, “economic activity that is fueled by research and innovation in the biological sciences” and identifies the bioeconomy as a priority for the Obama Administration. BIO provided input and submitted ideas to the Administration after it announced the development of the Blueprint last Fall. While the Administration has largely been focused on advancing innovation in areas such as electronic devices, social media and solar energy, we’ve been ringing the bell saying, ‘Don’t forget us.’  The blueprint is a sign that the message has been received.

The Blueprint notes the tremendous potential of the bioeconomy for fostering economic growth as well as for providing critical societal benefits: “It can allow Americans to live longer, healthier lives, reduce our dependence on oil, address key environmental challenges, transform manu­facturing processes, and increase the productivity and scope of the agricultural sector while growing new jobs and industries.” Well said, indeed.

The report also notes that a growing U.S. population requires, “increased health services and more resources such as food, animal feed, fiber for clothing and housing, and sources of energy and chemicals for manufacturing. In short, it needs a new and more potent bioeconomy fueled by innovative ideas and practices that can help address these needs in new, more powerful ways.”

We appreciate the President’s recognition of the need to clear the path for American innovation and ingenuity and unleash the tremendous promise of biotechnology to help solve many of the biggest challenges facing our nation today and foster economic growth throughout the United States.

Already, biotechnology is enabling patients living with debilitating diseases such as cancer, diabetes and Parkinson’s – and all American families – to have a higher quality of life, in a healthy and safe environment. As the new report notes, ‘The U.S. bioeconomy is all around us: new drugs and diagnostics for improved human health, higher-yielding food crops, advanced biofuels to reduce dependency on oil, and biobased chemical intermediates.’

The report’s high-level goals are consistent with many of BIO’s primary goals, including supporting translational research, reducing regulatory barriers for biotech products and emerging technologies, improving coordination across federal agencies, reforming the U.S. Food and Drug Administration, and expanding the bioeconomy workforce.

We look forward to hearing more about specific proposals for accomplishing these goals. And we will challenge the Administration when its policies are inconsistent with this Blueprint.

What do you think about the Blueprint? What is missing that will help drive continued biotech innovation?

Biopharma Industry Enthusiastic About 2012

Posted under biopharma companies, biopharmceutical, Blog, Business and Investments, Business of Biotech, Companies, Diagnostics, economic growth, economy, Funding, industry trends, manufacturing, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

By Eric S. Langer, president and managing partner, BioPlan Associates, Inc.

2012 Annual Study shows budgets, optimism taking a big jump

It looks like the biopharma industry is actually weathering the economic downturn quite comfortably. This year we’ve surveyed hundreds of biomanufacturers and suppliers, and the industry is expressing more raw optimism and confidence than at any time in the past 9 years we’ve been surveying this industry.

More Spending

What this means is that wallets are more open, and investments are being made for the future:

• The firings and hiring freezes that have taken place since 2007, at least within areas that affect productivity, are reversing, and hiring budgets are back up,
• Vendors are spending more on developing new and better technologies,
• Pent-up demand for skilled scientists, and operations staff among biomanufacturers is resulting in more hiring,
• Outsourcing, and off-shoring are being done more rationally, and are no longer a synonym for ‘you’ve just been laid off.’

Our 9th Annual Report and Survey of Biomanufacturing¹ surveys 400 biomanufacturers in 31 countries ever year. And along with the 180 vendors surveyed, we get a good picture of industry trends, problems, and opportunities. This year, we found that both biologics manufacturers and their vendors are spending more, demanding better technologies, and expressing greater optimism for the future than we would expect, given some of the recent gloomy economic trends, and “end-of-world” catastrophe predictions.

Below are just a few of the trends associated with the industry’s buoyant atmosphere. We will continue this discussion during the coming year, and share some of the data from our studies. With a whopping 37.3 percent of suppliers to this industry indicating that their company did either “better” or “much better” than expected in 2011, and with 49.4 percent expecting they will do even better in 2012, I expect this broad optimism will be translating into increased spending, stronger R&D budgets, more capital expenditures, and more hiring.

Short Answer: If you haven’t invested in this industry in some way, now’s probably a good time.  Here’s why:

Industry Growth Rate—Sales growth among vendors is a leading indicator of how the overall bio/pharma industry is doing. On average, sales growth to this industry is currently at around 14 percent annually. This compares to 13.0 percent in 2010, and 14.1 percent in 2007.  Most IRAs don’t return growth rates like that.

Budget Trends—Budgets are also a good indicator of industry strength. And budget estimates for 2012 are, once again, up strongly for areas such as acquisition of new technologies, capital equipment, and training. In fact, early returns from respondents to our 9th Annual Report are projecting increases in all 12 areas measured in 2012, except for outsourcing. Spending this year, in particular, is occurring in:

• New technology;
• Capital equipment;
• Process development and optimization; and
• Personnel training and development.

Other Positive Trends:

• Biopharmaceutical markets—The world market for biopharmaceuticals is now about >$140 billion²;  growing at 15-18 percent annually, definitely a very healthy rate.

• Approval-related Innovation and Progress—Good news: In 2011 FDA biopharmaceutical approvals involved genuine innovation and advances, with nearly all products being approved for new indications or for which the last product approval was granted well over a decade ago.

• Biopharmaceutical Approvals—Despite increasing sales, the rate of biopharmaceutical approvals in the U.S. is flat (12 biopharmaceuticals in 2011). (see www.bioplanassociates.com/biopharma).

• Company and country approval trends—A record number, four (33 percent), of newly-approved U.S. biopharmaceuticals are manufactured outside the U.S. — in the United Kingdom, Germany, Mexico and Italy.

• Biosimilars (biobetters / biogenerics)—Patents are expiring and biosimilars are accelerating worldwide. Expect the entrance of many new manufacturers, and multiple biosimilars for each currently successful biopharmaceutical.  Our global facilities analysis³, indicates that biosimilar/biobetter companies are present in virtually every biotechnology-capable region.

• Internationalization—The biopharma industry continues to expand its presence worldwide, particularly in developing countries.

• Internationalization of Manufacturing—Much of the industry growth involves new capacity being added at existing foreign facilities. This is illustrated by BioPlan’s Top 1000 Global Biopharmaceutical Facilities Index, which ranks facilities in terms of capacity, employment, and production.

• Internationalization of R&D—Large international (Big Pharma) companies continue their expansion and off-shoring of R&D.

• Demand for Local Production of Biologics—Companies are developing manufacturing strategies that include local manufacture of vaccines, for example. This contributes to developing countries’ scientific/technical infrastructure and provides continued availability and price stability.

• World Standardization of Manufacturing—As more biopharmaceutical manufacturing is performed worldwide, product developers are working to standardize their products and manufacturing processes.

• Internationalization of Single-use Manufacturing—The increasing adoption of single-use/disposable bioprocessing equipment allows products to be developed, standardized and the same manufacturing systems shipped and installed at multiple facilities; benefitting emerging markets.

• Single-use Bioprocessing Technologies—In 2011, single-use/disposable bioprocessing systems further increased their dominance for the manufacture of biopharmaceuticals for pre-clinical R&D and clinical testing. In 10 years about half of new commercial biopharmaceutical manufacturing systems can be expected to single-use based.

• Microbial manufacturing—Most industry attention in recent years has concentrated on mammalian cell culture-produced recombinant proteins. A confluence of trends is contributing to increased use of microbial (bacteria, yeasts, other fungi, etc.) host cells for recombinant proteins manufacture.

• Outsourcing—Companies of all sizes worldwide continue to increase their outsourcing, particularly R&D, and increase use of CROs, particularly for screening, and clinical research. Based our global survey of biomanufacturing, among 24 areas of outsourcing, the primary outsourced activities included product characterization testing, with 70 percent of biopharmaceutical companies outsourcing at least some activity.

• The Economy—The worldwide economic downturn continues to impact biopharma. Yet, with its underlying sales revenue, the industry has remain insulated.  Financial issues affect most companies; however, demand for new, profitable products, ensures R&D will continue;  ≥$70 billion is being invested by the pharmaceutical industry in R&D.

• Mergers/Acquisitions—The trend for industry mergers, acquisitions will continue.  However, some companies are recognizing that gutting their core competencies such as R&D and manufacturing is counterproductive.

Summary

Most of the fundamental indications are pointing to a positive, healthy industry; and bio/pharma is emerging from the current global economic situation by spending more, becoming more efficient, and, perhaps most importantly, showing great optimism.

I welcome comments on these trends and their impact on the industry.

References:

1. 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production:  A Survey of Biotherapeutic Developers and Contract Manufacturing Organizations, BioPlan Associates, April 2011, 490 pages.
2. Rader, R.A., Biopharmaceutical Products in the U.S. and European Markets (database), BioPlan Associates, www.bioplanassociates.com/publications/pub_bpuseu.htm
3. See BioPlan’s Top 1000 Global Biopharmaceutical Facilities Index™, http://www.top1000bio.com/index.asp Accessed June 20, 2011
4. Biopharmaceutical Expression Systems and Genetic Engineering Technology: Current and Future Manufacturing Platforms, BioPlan Associates, Inc. 2008]

Eric S. Langer is president and managing partner at BioPlan Associates, Inc., a biotechnology and life sciences marketing research and publishing firm established in Rockville, MD in 1989. He is editor of numerous studies, including “Biopharmaceutical Technology in China,” “Advances in Large-scale Biopharmaceutical Manufacturing”, and many other industry reports. You can contact him at: elanger@bioplanassociates.com or 301-921-5979.

“America Speaks” Poll Shows Health Research is Key to Economic Recovery

Posted under biotech jobs, Blog, Companies, Diagnostics, economic growth, economy, Funding, Health, Health Care, jobs, Medical Devices, Medical Supply, Pharmaceuticals, public health, research, Startups, STEM, STEM Education, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

By Mary Woolley, President of Research!America

Research!America’s 12th edition of America Speaks, an annual summary of our public opinion polls, shows that Americans are deeply concerned about our country’s ability to create jobs and compete globally. In fact, 77 percent of those polled say that the U.S. is losing its competitive edge in science, technology and innovation and more than half of Americans (58 percent) do not believe we are making enough progress in medical research. Furthermore, the majority of Americans believe investing in health research (86 percent) is important to job creation and economic recovery.

So much is at stake right now: our economic future, U.S. jobs and our global leadership. In this election year, we must make advancing health research a priority and part of the national dialogue.

As federal funding tightens, we are compromising discovery and the development of new products, which is important to patients and businesses alike. Incentives for industries to conduct research, including efforts to make the research and development tax credit permanent, are supported by many Americans. And most are willing to support higher taxes for research. Half of those surveyed said they would be willing to pay $1 per week more in taxes if they were certain their money would be spent for additional medical research.

Our public opinion polls indicate that Americans want viable solutions to improve our health, health care system and the economy. They see research as part the solution to rising health care costs and would like to see more of the health dollar dedicated toward research.

Similarly, careers in science, technology, engineering and math (STEM) continue to receive broad support among Americans who believe the federal government should place more emphasis on increasing the number of young Americans who pursue these fields.

Other findings in America Speaks show:

• 91 percent of Americans believe that research and development are important to their state’s economy;
• 84 percent of Americans think it is important to invest in regulatory science to ensure the safety and efficiency of the drug and device development process; and
• 87 percent of Americans think it is important that elected officials at all levels listen to advice from scientists and public health professionals;

These findings provide validation that Americans do not want to settle, and see their country fall behind in research and innovation. They want their country to remain resolute in its commitment toward advancing science and innovation.

As we face more budgetary challenges for health research in 2012, the community of stakeholders in research must continue to make the case that investing in health research will not only support the health of our nation, but also the prosperity of our country for years to come. Your voice from the front lines of science is essential in conveying what we could gain or lose with a robust or flat federal health budget and a sound and globally-competitive policy structure.

I invite you to take a look at our poll data summary, America Speaks, Volume 12 and to join the conversation about making research a priority this election season. Candidates who are running for office this year must hear from scientists and other stakeholders in the science enterprise; those who are elected without hearing from scientists are unlikely to become champions for science once they take office! Tell candidates why science is the key to better, more affordable health, and is key to driving the US economy. Please visit: http://www.researchamerica.org/uploads/AmericaSpeaksV12.pdf

Mary Woolley is the president of Research!America, the nation’s largest nonprofit public education and advocacy alliance working to make research to improve health a higher national priority.