Pharmaceutical Outsourcing, July/August 2015
 

All high-tech industries require constant innovation to achieve growth, and the pharmaceutical business – both small- and large-molecule – is no exception. Advances in technology are required not only to improve manufacturing processes, but to increase the sensitivity and accuracy of analytical systems and enhance productivity and efficiency across all activities from R&D to distribution.

As pressures on drug manufacturers to reduce costs continue to climb, innovation will also be crucial for realizing measurable cost savings without compromising quality and safety. One area where the desire for continued innovation is strongly reflected is the continual introduction of automated laboratory systems as replacements for less efficient and more costly manual operations.

Many Areas Benefit from Innovation

According to the results of Nice Insight’s most recent annual Pharmaceutical and Biotechnology Outsourcing survey of over 2,300 outsourcing-facing pharmaceutical and biotechnology executives, technological innovation has significant potential to benefit many key operations within the pharmaceutical and biopharmaceutical sectors. Survey respondents ranked the activities that would benefit most in the following order: quality control, research and development, manufacturing, distribution and labeling and packaging1.

The survey participants represent big pharma (16%), specialty pharma (20%), emerging, niche, or start-up pharma (9%), large biotech, emerging biotech (14%) medical device (17%), and generics/biosimilar (5%) companies and have positions in c-suite (17%), operations (17%), manufacturing (16%), quality assurance (16%), R&D/formulation (13%), and data/clinical trials management, purchasing, and regulatory affairs (5-8% each).

CROs and CMOs should also take note that a high percentage of respondents to the survey (96%) indicated that they have at least some interest in forming outsourcing partnerships with service providers that adopt state-of-the-art technologies to increase efficiency, safety, quality and traceability. Specifically, 40% of survey participants are interested, 31% have a moderate level of interest, and an additional 25% have some interest in such partnerships.

Specific advances of note include new technologies based on nanoscale solutions and microfluidics, as well as improved sample handling systems and more sensitive optics and detectors.

Furthermore, biotech and pharmaceutical companies looking to outsource to CROs and CMOs consider the level of technological innovation at potential outsourcing partners in a number of key areas. The use of advanced technologies to improve safety was the number one cited category by survey respondents, followed by efficiency, security, regulatory compliance, patient compliance, speed, loyalty and traceability.

Pressures to Increase Efficiencies and Reduce Costs

Pressures from consumers, investors, insurance companies, regulators, and governments to drive down costs and improve product performance (efficacy, ease of use, patient adherence, etc.) are the major trends currently taking place in the pharmaceutical industry, including both the higher levels of merger and acquisition activity and outsourcing. Climbing clinical trial costs are also a concern for the industry. Most drug manufacturers are therefore looking to increase efficiency and productivity while reducing costs and development timelines using a variety of approaches, from streamlining data management to speeding up analyses. Of course, only solutions that provide a positive impact without affecting the quality, safety and efficacy of final drugs products are considered.

Automation Provides Key Opportunities for Cost and Time Reduction

The interest in automated laboratory systems can also be clearly seen in the results of the 2015 Nice Insight Pharmaceutical and Biotechnology Outsourcing survey. Half of respondents to the survey indicated that the use of robotics labs to perform routine tests is an important mechanism for achieving cost and/or time savings when outsourcing to contract research organizations (CROs), second only to the use of cloud-based management services (62%).

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It is also interesting to note that while a similar percentage of respondents from biotech and pharma companies indicated that cloud-based management services will be important for increase cost and time effi ciencies (63% and 61%, respectively), far more survey participants from biotech companies (56%) than from traditional pharmaceutical companies (46%) believe that the use of robotics will provide cost and time savings. This difference may refl ect the fact that many small-molecule analyses have already been automated, or perhaps the greater complexity and longer timelines of analyses required for biologic samples; automation of these processes would have a greater potential to achieve cost and time savings.

The global life science and chemical instrumentation market, including chromatography, spectroscopy electrophoresis, DNA sequencing, lab automation systems (automated liquid handling, microplate readers, robots, automated storage & retrieval systems, software & informatics, and others), immunoassays, microarrays, flow cytometers, incubators, fume hoods, centrifuges, etc., is growing at a compound annual growth rate (CAGR) of 6.9% and expected to reach $48.84 billion by 2019, according to Markets and Markets. The market research fi rm notes that technological advancements in analytical instrumentation, rising government spending on pharmaceutical R&D in emerging nations, increasing public and private life science research and development expenditures, growing food safety concerns, and progress in the drug discovery and clinical diagnostics fi elds are key factors driving this growth2.

More specifi cally, in 2012, the market for laboratory automation used in the biotechnology, pharmaceutical, and clinical diagnostics industries, for food and agricultural research and forensics, and in academic science, was worth nearly $2.8 billion and growing at a 6.3% CAGR, with expectations that it would reach a value of $3.8 billion in 2017, according to BCC Research. Key drivers include the vital need to reduce laboratory operating costs through the use of new technologies, particularly for proteomics and small-molecule chemistry applications. The market research fi rm also noted that the increased importance of liquid chromatography and mass spectrometry and the new technologies needed to support such methods is contributing to revenue growth3.

Key Trends in Automated Lab Systems for CROs/ CMOs

As drug manufacturers rely increasingly on outsourcing and simul-taneously demand more rapid development cycles to keep costs down and often to meet the shorter timelines required for Fast Track and other special drug designations, the increased effi ciency, productivity and reliability afforded by automated systems are becoming a necessity to remain competitive.

Automated systems are performing an ever growing range of laboratory operations today, many of which it was thought even just a few years ago that no robotic system could achieve. Robots now routinely perform most repetitive and manually labor-intensive tasks, allowing for increased throughput. At the same time, the risk of human error is signifi cantly reduced and results are more consistent and reliable due to exact repetition.

For instance, automated cell culture workstations with integrated advanced readers can serve as mini-bioreactors. These systems can process many cell lines in parallel and perform such tasks as cloning, transfection, cell maintenance, routine subculturing, and adherent cell harvesting and collect data on cell counts, confl uency, viability and other properties, allowing much more effi cient generation of data for process development and scale-up.

Initially, automated laboratory systems were used only by larger biotechnology and pharmaceutical companies that could afford the investment in such advanced technology. Today, however, in addition to producing large, customized systems for these customers, equipment manufacturers now off er a whole host of aff ordable benchtop systems with very small footprints for use in smaller companies and academic research laboratories.

With the ability to screen more parameters in parallel, drug developers can choose to speed up the development process using a similar number of data points or increase the number of data points to obtain a more comprehensive data set in a similar amount of time as was possible without access to automated systems. In addition, because the generated data is all recorded online, automated systems also facilitate regulatory requirements for data management and reporting, including for sample tracking as samples move from one analysis to another(typically achieved through the use of a laboratory information management system, or LIMS).

Specific advances of note include new technologies based on nanoscale solutions and microfluidics, as well as improved sample handling systems and more sensitive optics and detectors. In addition, laboratory activities that were once considered unrelated are now being integrated into comprehensive automated systems to create multifunctional yet easy-to-operate automated workstations. When coupled with cloud-based data management, such technologies are changing the way research and development is taking place in the pharmaceutical industry.

Other Benefits of Automation

While cost savings can be a clear benefit of automation, overall respondents to the 2015 Nice Insight Pharmaceutical and Biotechnology Outsourcing survey identified the ability to perform analysis around the clock to provide faster turnaround times as the most important attribute of CROs that use robotics, followed by the reduced risk for human error and greater reproducibility due to precise task repletion.

There were, however, interesting differences amongst the participants representing different types of companies. Those from specialty/ mid-sized and emerging/niche traditional pharmaceutical firms and generics/biosimilar companies ranked the reduced possibility for human error as the number-one benefit, while respondents from both big and emerging biotech and big pharma consider the ability to have a 24/7 workflow as most important. In addition, the latter companies also cared more about enabling scientists to focus on interpretation of results than specialty/medium-sized and emerging/niche pharma, medical device and generics/biosimilar manufacturers.

Wide Range of Experiments

The 2015 Nice Insight Pharmaceutical and Biotechnology Outsourcing survey also revealed that biopharmaceutical and conventional pharmaceutical companies have varying interests in the use of robotics for different types of experiments, but in general they find automated systems suitable for a wide range of applications.

Overall, the most cited experiments sent to robotics labs included cell growth assays, protein quantitation, molecular cloning, cDNA library generation, protein expression/purification, cell viability assays, fluorescence reporter assays and flow cytometry antibody screening, with cell growth assays the clear top choice for participants from all of the different types of companies.

Perhaps not surprisingly given the types of experiments listed, respondents from biotech companies indicated that they would use robotics labs for a much larger number of experiments than participants from the other types of firms.

In addition, while in general most of top experiment choices were the same, the order of preference varied by company type beyond the top choice of cell growth assays. Big biotech companies use robotics labs for protein quantitation, followed by molecular cloning, flow cytometry antibody screening, fluorescent reporter assays, cDNA library generation and protein expression/purification, while emerging biotech firms prefer robotics for molecular cloning, cDNA library generation, protein quantitation, fluorescent reporter assays, tagman assays, flow cytometry antibody screening and protein expression/purification.

For survey participants from mid-sized and big pharma companies, quantitation and molecular cloning were the second and third most popular experiments for sending to robotics labs. Mid-sized pharma companies also used automated systems for protein expression/ purification, while big pharma firms use robotics labs for cDNA library generation and in vitro transcription. Meanwhile, emerging pharma and medical device companies use robotics labs for molecular cloning, protein expression/purification and cell viability assays, and generics/ biosimilar manufacturers prefer to use automated systems for protein expression/purification, molecular cloning, cDNA library generation and cell viability assays. 

References

  1. 2015 Pharmaceutical and Biotechnology Outsourcing Survey, Nice Insight, January 2015
  2. Markets and Markets, Life Science and Chemical Instrumentation Market (Chromatography, Electrophoresis, DNA Sequencer, PCR, Microplate Reader, Robotics, Spectroscopy, Immunoassay, Microarray, Flow Cytometer, Incubator, Fume Hood, Centrifuge) - Global Forecast to 2019, March 15, 2015, http://www.marketsandmarkets.com/Market-Reports/ life-science-chemical-biotech-instrumentation-market-38.html
  3. BCC Research, Laboratory Automation: Technologies and Global Markets, June 2013,http://www.bccresearch.com/blog/instrumentation-sensors/global-market-for-laboratory- automation-to-reach-three-point-eight-billion-in-2017.html

If you want to learn more about Nice Insight, the report or about how to participate, please contact Guy Tiene by sending an email to guy@thatsnice.com

Survey Methodology

The Nice Insight Pharmaceutical and Biotechnology Survey is deployed to outsourcing-facing pharmaceutical and biotechnology executives on an annual basis. The 2014-2015 report includes responses from 2,303 participants. The survey is comprised of 240+ questions and randomly presents ~35 questions to each respondent in order to collect baseline information with respect to customer awareness and customer perceptions of the top ~125 CMOs and ~75 CROs servicing the drug development cycle. Five levels of awareness, from “I’ve never heard of them” to “I’ve worked with them,” factor into the overall customer awareness score. The customer perception score is based on six drivers in outsourcing: Quality, Innovation, Regulatory Track Record, Affordability, Productivity, and Reliability. In addition to measuring customer awareness and perception information on specifi c companies, the survey collects data on general outsourcing practices and preferences as well as barriers to strategic partnerships among buyers of outsourced services.