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The Changing Face of Analytical InstrumentationTraditional uses for laboratory instruments are being preempted for applications that reflect changes in the economy, political arena, and environment.by Tim Studt
Ten years ago, the U.S. biopharm industry was the envy of the world with large R&D budgets and facilities; today there are a number of empty campuses with the threat of more to come. | A significant part of the advanced instrumentation and equipment in today’s research lab is based on and dedicated to traditional pharmaceutical and biotechnology development methodologies that have evolved over the past 40 to 50 years. The resulting systems developed for these applications include fast sequencing systems, lab-on-a-chip analyzers, spectrometry detection devices, high-speed nano-scale chromatography systems, laser-based cell manipulators, and multiplexed protein and gene expression assays.
Even with all of these sophisticated (and often expensive) tools, large R&D budgets, and extensive research staffs, the current batch of pharmaceutical and biotech companies has not been able to keep up with the phase-changes occurring in their marketplace. These changes include:
• Biopharms’ inability to create enough new “blockbusters” to offset the drugs that have outlived their patent protection and are now being manufactured by generic drug companies and thus sold for a fraction of their original price. Regulation does not appear to be the mitigating factor in this scenario. Instead, the solution to the problem is too complex and not specific enough for the patient.
• A mega-merger mania that has resulted in combined R&D funding and staffing that is significantly smaller than the combined entities—the mergers are primarily a harvesting of other companies’ drug development programs to reinforce the products in the lead company’s inventory artificially (and only temporarily).
• The recent global banking crisis diminishing the venture capital funds that previously were strong supporters of the biotech industry. Biotech firms with equities of less than $1 billion (a very large number of companies) now find themselves struggling to find the monies to operate their businesses.
• A shift in market growth, where drug sales in the U.S. are basically flat, while demand (and hence growth) is increasing in emerging parts of the world.
• A shift in manufacturing and R&D, where both are significantly cheaper to perform in offshore countries than they are in the U.S. or Europe.
• The maturing and increasing availability of offshore skilled researchers, and an overall leveling of the world’s science and technology base.
The net result of these changes is an eroding (both in research spending and staffing) biopharmaceutical industry in the U.S.—and a rapidly growing biopharm industry in Asia. This merger and U.S. downsizing trend started in a small way a couple of years ago as biopharms began to cut costs. In the past, these downsizings or mergers mostly treated R&D as sacred and rarely made reductions in this area. But in the current climate, R&D is no longer protected. Ten years ago, the U.S. biopharm industry was the envy of the world with large R&D budgets and facilities; today there are a number of empty campuses with the threat of more to come.
Instrumentation realities
In light of this inflection point, there are multiple effects on the U.S. analytical instrument market, both technically and economically. In the first case, the situation is not all doom and gloom—the largest likely effect on biopharm R&D for any particular U.S. company is a 10% downsizing. There has been a significant response by the federal government in the form of additional funds for the NIH in the American Recovery and Reinvestment Act (see box below). Also, there is a significant uptick in instrumentation growth for offshore labs as they work to bring their facilities up to the level of U.S. and European labs.
Federal Funding for Science
The American Recovery and Reinvestment Act of 2009 (ARRA) pumped $18.7 billion into the overall U.S. R&D community. Some of this was appropriated in 2009, and most of the remaining will be appropriated in 2010 with much of the actual spending occurring in 2010. The National Institutes of Health (NIH) got the lion’s share of this spending ($10.4 billion, or 56%), increasing its overall federal funding for FY2010 from approximately $30.4 billion to $40.8 billion. This one-year “blip” in spending overcame about five years of flat federal funding for the NIH. But in FY2011, the ARRA funds will be gone, and the NIH will go back to its traditional level of federal funding—President Obama proposed a 3.2% increase to $32.1 billion for FY2011 from FY2010 (non-ARRA) funding of $30.4 billion.
Overall federal funding for R&D for FY2010 was $150.5 billion, an increase of 2% from what was originally requested by Obama. The Administration’s proposal for FY2011 ($147.7 billion) is a scant 0.2% higher than what they proposed for FY2010 and 0.5% more than what was actually spent in FY2009. A lot of shuffling of funds occurred with the FY2011 budget proposal with many basic science programs getting 2% to 3% increases at the expense of defense spending—to keep the overall total basically unchanged. | |
The second situation that should be considered is that the economic forces at work will likely shift instrumentation requirements from one area to another. With tight budgets continuing, researchers will look to increase productivity in their labs and decrease instrumentation-based operating costs. Indeed, a survey by Laboratory Equipment revealed that researchers expect to see the biggest improvements in automation systems (73% of the respondents) over the next 10 years, compared to all other instruments in the lab.
The third point is that many analytical instruments are already being designed to enable their users to be more productive. A recent analysis by Laboratory Equipment editors found that the marketplace for ultrahigh performance liquid chromatography (UHPLC) systems is growing and that suppliers for these systems are expanding. While these systems are generally more expensive than traditional HPLC systems, their output is larger and the data quality is higher.
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Environmental issues, like global warming and pollution, are expected to be the strongest drivers for developing new instruments over the next decade. Life science will still drive new development, but not as strongly. Click to enlarge. | Multiple suppliers are also building on the basic technologies of UHPLC systems to create lower cost “crossover” instruments and enhanced columns that can run on traditional HPLC systems with the equivalent performance of UHPLC systems. As in most economic-based situations, when the number of suppliers for a similar system increases, the cost to the consumer invariably lowers.
The fourth point in this evaluation is that the overall healthcare environment is changing, not just the geographical location of research labs and manufacturing facilities. The whole healthcare debate seen in Washington, D.C., over the past six months has brought into focus the value and promise of personalized, predictive, and preventative medicine. Analytical instrumentation manufacturers have the opportunity to create a whole new lineup of devices that address this marketplace.
Agilent Technologies’ 2100 Bioanalyzer was originally developed in 1999 in collaboration with Caliper Life Sciences. Mostly unchanged over the past 11 years, it’s now used primarily to analyze the quality of RNA before being used in expensive and time-consuming array experiments. At the time of its initial development, there was conjecture that it could be expanded to be used in a personalized medicine environment—patients could determine their health status every day by utilizing the lab-on-a-chip devices in a home version of the Bioanalyzer. Obviously, the market and the cost goals of that application never evolved, but they still might.
In a personalized medicine environment, there are also numerous opportunities for manufacturers to create the medical devices and diagnostic instruments to support this application. With the rapidly expanding senior citizen portion of our population (and other countries as well), the market has a built-in growth mechanism.
With all the complexities of an individual—health, genetic makeup, environment, age, physical activity level, food intake—a personalized medicine approach to healthcare may work out to be the most effective (and successful) manner of treating diseases (which by themselves could also mutate). It is also estimated that more than half of the drugs currently prescribed don’t work for patients anyway.
 Industrial-Level Lab Automation
At the recent LabAutomation 2010 Conference in Palm Springs, Calif., Thermo Fisher Scientific introduced its Orbitor microplate mover, which was driven by Thermo’s Momentum 2.0 laboratory workflow software—also introduced at the LabAutomation Conference. This automation solution offers highly advanced user control and standardized real-time data-driven decision-making.
The combination of robotics, analytical instrumentation and intermediary peripherals and scheduling software is ideally suited to small, flexible automated systems or dedicated benchtop applications.
The Orbitor benchtop mover (cylinder shown in the picture above) provides industrial reliability with robust plate motion and control. As a central mover with the ability to rotate 360 degrees, the Orbitor can connect a broad range of scientific devices, making it an extremely versatile platform. With integrated stack and random access storage, as well as re-grip and plate de-lidding, the Orbitor provides an innovative yet low-cost integration solution. Easy-to-use, flexible shelving and a small footprint make the Orbitor ideal for practical online/offline use and rapid instrumentation swap outs.
Extensive vertical reach allows the Orbitor to access virtually any microplate instrument including stacked instruments, and its telescoping arm can reach a variety of distances. The arm can actually travel right through the base, resulting in faster and more efficient movements. Its 360-degree workspace eliminates the need for hard stops and reverse movements.
The Orbitor’s driver software is the Momentum 2.0 software, which facilitates predictive modeling of accelerated dynamic processing schedules, thereby eliminating a common compromise between efficient automation usage and unpredictable system behavior. Equipped with superior error management, as well as simple process design and validation, Momentum 2.0 ensures robust automation control. Compatible with a wide range of third-party instrument drivers, the Momentum 2.0 software also enables an efficient and cost-effective system design.
For additional information, visit www.thermo.com/automate. | |
Performance and ease of use are the top areas where researchers would like analytical instrument developers to focus their efforts over the next 10 years. A similar vendor survey noted that these are exactly the top areas they are working on. Click to enlarge. | The fifth and final point is that there are numerous other applications for analytical instrumentation with many of the same technical and performance requirements. Indeed, the respondents to Laboratory Equipment’s reader survey indicated that the main driver for new instrumentation over the next 10 years would be in environmental testing and analysis (36% of respondents). While biotechnology was ranked third in this list by 30% of respondents, pharmaceutical testing was ranked eighth overall.
User wants and needs
According to the Laboratory Equipment reader survey, the primary instrumentation focus area (64%) desired by researchers is improved instrumentation performance (i.e. accuracy, resolution, speed) followed closely by ease-of-use (60%) and cost of ownership (48%).
Also, the general public will always demand that cures be developed for the great diseases in the world—cancer, heart disease, flu. That is going to involve the development of a biopharmaceutical that is unlikely to be quickly genericized. In the global research community, a drug candidate being developed by Pfizer could have a team approach and attack it with researchers from several of its global R&D centers working together. Most pharmaceutical companies already outsource a significant portion of their drug development activities. This approach is likely to be expanded and optimized to accommodate the pressures of the new pharmaceutical environment.
The U.S., Japan and Germany dominate the development and manufacture of analytical instruments, according to a Laboratory Equipment reader survey. Although a small player, China is expected to challenge Japan for the number two spot by 2020.
Click to enlarge. | The rules for legal protection of these drugs may also need to be changed. Indeed, some very minor modifications have already been discussed to protect the developer and entice new developers to make investments in time and effort.
Little has been said about the computational approach to analytical instrumentation in the life science market. With the implementation of cloud computing in the life sciences, cloud computing could soon embrace personalized medicine applications.
Cloud computing is an inherent component to solving the personalized medicine approach to healthcare. It is the only practical way to manage the genetic predisposition, the options available for treatment, the variety of personalized makeup, the physical modeling, and all the automated online research.
As noted, advanced analytical instrumentation is likely to always be needed in the biopharmaceutical industry. Implementation of a personalized medicine strategy will change those needs in regards to scale—we may not need as many instruments as are currently available. But the generic drugs that will be available to individuals (due to lower cost) will also need those same instruments to verify the quality of their manufacturing processes. As a result, there may be no change in the overall demand for these high-end instruments—they will just find different applications in the same industrial model.
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