After a busy January kicking off new projects, we attended the 2019 Society for Laboratory Automation and Screening (SLAS) in early February right here in our hometown of Washington, DC. More than 300 companies, including many of our clients, were exhibiting and we got to see the tremendous effort they’re making to improve the productivity of their customers.

For example, our friends at Bio-Rad introduced a new API for their ZE5 flow cytometer. The API allows the device to interact directly with an ecosystem of liquid handlers and other components, allowing use in high-throughput screening applications. The API is now available and offered as an upgrade for current as well as newly sold systems.

PerkinElmer was there too with a wide range of instrumentation and consumables to provide labs with a total solution and scalability. At their booth, the company exhibited a number of different systems that can be combined into an automated workflow including the chemagic Prime workstation for DNA and RNA extraction and liquid processing of 96 samples at a time. The Prime has the ability to bundle with other PerkinElmer products, such as reagents and plates.

Tecan also took the opportunity to launch the Tecan NGS DreamPrep system, an automated solution for NGS library preparation, leveraging its Fluent liquid handling automation platform and Infinite plate-reader technology as well as their newly acquired NuGEN Technologies to provide a complete solution for library preparation and online sample QC.

But the big news in February was when Danaher announced its plans to purchase GE Healthcare’s $3.2 billion biopharma business for $21.4 billion. This was Danaher’s largest acquisition to date and in many ways a culmination of Danaher’s commitment to the bioprocessing market. Danaher has emphasized the strategic priority of biopharma manufacturing tools to the company due to the rapidly growing market for biologic drugs and the high percentage of consumables sales, which are also specified into product manufacturing, providing a captive user base. Seventy-five percent of GE BioPharma’s revenues are recurring. According to SDi’s recent market report, Bioprocessing Technologies 2018, GE holds the largest market share in the process chromatography market (defined as systems, aftermarket and service).

In March, a large contingent of us traveled to Philadelphia for Pittcon. More than 700 exhibitors were on the floor. Although Pittcon may not be the hub of press announcements and new products that it once was, the show did mark announcements by Rigaku and Anton Paar. Rigaku debuted a new branding strategy to highlight the unification of the company’s operational units. Anton Paar USA detailed changes to its operational structure, forming four regional organizations in order to be closer to its customer base, provide faster response times and offer more training centers.

Our intrepid reporters from Instrument Business Outlook sat down with senior executives from three major instrument system and lab product suppliers—Shimadzu Scientific Instruments (SSI) (the North American unit of Japanese firm Shimadzu), Thermo Fisher Scientific and Waters. Discussing company priorities, R&D approaches and the current state of informatics development, the companies indicated the influence of major industry themes such as increasing instrument ease of use to growth usage, integrating larger amounts of data and access to them, and providing more tightly integrated workflow solutions

Dan Shine, senior vice president and president of the Analytical Instruments Group told us “[Customers] are under increasing pressure to get more samples analyzed more quickly and make use of the data, so we’re doing a lot on both the front end, with sample prep, and the back end, data analysis and data integrity, to automate that process as best we can and put the pieces together.”

Jeff Mazzeo, PhD, vice president of Marketing at Waters told us that along with new products, Waters plans to enhance its market focus. “We are now trying to focus more on customer input and that’s where the market segment teams really have to understand what do our customers need to be successful with our technology today, and so how do we build the right products for the future.”

Patrick Fromal, vice president of sales at Shimazdu also said this year will include include workflow solutions as well as new markets. “We see our position around HPLC enhancing greatly in pharma, in environmental [and] the emerging markets of cannabis and hemp.”

Then it was off to the American Association of Cancer Research (AACR) annual meeting in Atlanta. Over 500 exhibitors filled AACR 2019’s exhibition hall. Several product announcements presented new imaging solutions designed to address many of the shortcomings of IHC or combined multi-parameter measurements into one system. Single-cell analysis continued to be a major focus for research instrumentation, especially improvements and extensions of current flow cytometry and cell sorting technology. Meanwhile, mass spec exhibitors emphasized new applications specific to cancer research. In addition, many companies debuted product line expansions built upon technology acquisitions.

NanoString Technologies’ used the occasion to unveil the GeoMx Digital Spatial Profiler (DSP) system, which employs NanoString’s digital optical barcodes technology and a microscope for high-plex protein or RNA counting and spatial imaging of FFPE or fresh frozen tissue samples

We also saw Miltenyi Biotec preview its MACSima Imaging Platform for high-content imaging of fixed cell and tissue samples using epifluorescence microscopy. An unlimited number of markers can be detected through repeated sample scanning using up to 3 antibodies and 3 fluorochromes at a time. Applications include target discovery, biomarker discovery and deep phenotyping.

ACEA Biosciences, now a part of Agilent, used AACR as a soft launch for its xCELLigence RTCA eSight, which combines ACEA Biosciences’ real-time, label-free biosensor technology with live-cell imaging for the first time, according to the company, to allow simultaneous visualization of cellular characteristics and activities.

Another product introduction that caught our attention was Bio-Rad’s ddPCR single-cell assay for transposase accessible chromosome sequencing (scATAC- Seq) that maps the epigenetic profile to understand why different gene expressions patterns occur.

Finally we got some vindication for naming Fluidigm the “2019 Company to Watch” at the Life Science Industry Awards last year. Fluidigm launched its Maxpar Direct Immune Profiling System, which can aid in quantifying 37 different immune cell populations from human peripheral blood mononuclear cells as well as whole blood. The Maxpar Direct can allow a researcher to look at 30 different biomarkers (7 of the researcher’s own choice) from the same sample tube and provide results in 5 minutes.

In April, we saw a few niche suppliers unveil some very interesting new products. Jackson ImmunoResearch launched a new range of products for scientists developing single-domain VHH antibodies while Cygnus Technologies, an assay and services provider, introduced the EndonucleaseGTP ELISA Kit for the detection and quantitation of residual endonuclease impurities in recombinant vaccines and viral vectors used for gene therapy.

Meanwhile, Illumina and BGI filed dueling lawsuits against each other. Illumina’s complaint, filed in Denmark, details infringement of its sequencing-by-synthesis chemistry patent EP 3 002 289 B1. The suit also accuses BGI of trademark infringement of “MGISEQ” under EU Trademark No. 8972127. Illumina also has case pending against BGI in Germany alleging infringement of EP 1 530 578 B1.

In the US, Complete Genomics, a BGI business held by its MGI subsidiary, filed suit against Illumina in Delaware alleging infringement of US Patent No. 9,222,132 (Methods and Compositions for Efficient Base Calling in Sequencing Reactions). The complaint states, “use of Illumina’s ‘two-channel’ sequencing systems in combination with Illumina’s ‘Library Preparation Kits’ and ‘Cluster Generation and Sequencing Kits’ in the United States by Illumina and its customers constitutes direct infringement of at least claims 1–4 of the ’132 patent.” Defining a two-channel system, it states, “On information and belief, during ‘two-channel sequencing,’ the identity of each nucleotide is deduced from two signals.” Two-channel systems include Illumina’s NovaSeq 6000, the NextSeq series and MiniSeq systems. In a press release, MGI called  two-channel sequencing a “key technology in the DNBSEQ sequencing technology.”

Illumina faced a further headache in June when the UK’s Competition and Market Authority (CMA) found that Illumina’s proposed acquisition of Pacific Biosciences could limit competition in the UK sequencer market.

Does the onset of summer make companies more litigious? In July the US District Court for the District of Delaware granted Bio-Rad Laboratories’ motion for a permanent injunction against 10x Genomics’ sale of its single-cell droplet products in the US. In a letter to customers, 10x CEO and Co-founder Serge Saxonov wrote, “We strongly disagree with both this ruling and the jury’s verdict and we will appeal.”

Shortly thereafter, in light of the ongoing CRISPR patent dispute between the University of California (UC) and the Broad Institute, Sigma-Aldrich, part of Merck KGaA, has filed an urgent petition with the US Patent and Trade Office (USPTO) regarding its patent application related to CRISPR-Cas9-based methods in eukaryotic cells. In the petition, Sigma-Aldrich requests a so-called “parallel interference,” or an interference proceeding (an interference is conducted to determine which party is first responsible for invention) between the company and UC that would occur at the same time as current interference between UC and Broad. Sigma-Aldrich emphasized in its filing, “Of critical importance here, Sigma-Aldrich’s benefit applications pre-date the earliest possible benefit applications involved in the UC v. Broad Inst. interference with respect to their respective disclosures of CRISPR-Cas9 in eukaryotic cells.” Sigma-Aldrich also argued that it is being unfairly treated, stating, “Indeed, the USPTO has now granted Broad Inst. over a dozen issued patents. In direct contrast, the USPTO continues to reject Sigma-Aldrich’s CRISPR-Cas9 eukaryotic claims as not patentable over those same UC CRISPR-Cas9 prokaryotic provisional applications that the USPTO has repeatedly found have been successfully overcome by Broad Inst.’s eukaryotic claims.”

Then in August,10x Genomics filed for a public offering of its common stock. As of June 30, the company’s installed base stood at 1,284. Instruments, consumables and services revenues represented 25%, 74% and 1% of 2018 sales, respectively, with a consumable pull-through per instrument of $148,000. In its filing, 10x detailed the effects of Bio-Rad’s 2015 infringement case, which found 10x guilty of patent infringement. To avoid infringement, in the second quarter, 10x launched its Next GEM microfluidic chip for Single Cell Gene Expression, Single Cell Immune Profiling and Single Cell ATAC, but has yet to develop the new chips for its Single Cell CNV and Linked-Read solutions. The company expects the new chips to make up nearly all of its consumables sales by the end of next year. In the third quarter this year, the company anticipates all new Chromium instruments will only use Next GEM solutions. A few weeks later, 10x Genomics disclosed in its September 12 prospectus filing that the US Federal Court of Appeals has granted a partial interim stay of the injunction against the company’s sales of GEM chips. They began trading on the NASDAQ Global Select Market at a price per share of $39.00, raising an estimated $357.5 million in proceeds before expenses.

Also in August, our colleagues at Kalorama released the 12th edition of their highly anticipated report on the Global IVD Market. Kalorama reported that the world market for diagnostics is estimated at $69.2 billion in 2019 and is expected to grow 4% annually to $85.2 billion by 2024. This figure includes all laboratory- and hospital-based products, and over-the-counter (OTC) product sales. Tissue-based testing for cancer and molecular tests for both cancer and infectious diseases are the growth engines among larger market segments, each growing 50% faster than the overall IVD market. Concerns over sepsis and respiratory conditions should ensure that infectious disease will also remain in the fast-growth categories. Specialty immunoassays, continuous glucose tests, MS and inherited diseases are other large and high-growth segments. The IVD market continues to grow, but what the dollars represent is changing. Twenty years ago, clinical chemistry and immunoassays represented most of the testing. Still today, the traditional core lab test segments—chemistry/immunoassay, hematology and coagulation—make up 34% of the dollar value of the IVD market and over 60% of tests run. But as molecular, infectious disease and cancer tests increase in importance, the market share of these core tests will decrease to 29% by 2024.

September saw us launch RateMyProduct – an automated product assessment tool that provides life science suppliers with customer feedback about their product concept, product, or service. RateMyProduct enables life science marketing and product managers to create an online presentation about a lab product or service, have it reviewed by a chosen target market, and get an online report within five days. The automatically generated online report provides feedback from prospective customers and indicates the likelihood of market success. Over the previous several months, our clients had been testing RateMyProduct by deploying it in their own product development cycles. Using this tool, they’ve been able to test different price points and see how well they’re communicating their product’s value. Our clients have been overwhelmingly positive about the outcomes.

In late September, Illumina and PacBio amended their merger agreement’s expected time for completion, extending it to December 31, with Illumina having the option to further extend it to March 31, 2020. Among the highlights of the CMA’s summary were comments on competitive dynamics, stating that, “Almost all customers said that long-read technologies will be more prevalent in the future, and a large proportion of these said that this will be at the expense of short-read technologies.” Regarding long-read sequencer firm Oxford Nanopore (ONT), the document reads, “Customers often mentioned ONT as a competitor to PacBio, and made comments suggesting that the choice between PacBio and ONT is closely balanced.” Recounting researcher’s opinions of the deal, the document states, “Most customers said that they felt that PacBio’s offering would improve under Illumina, either due to concerns about PacBio’s current financial situation or due to Illumina’s track record of acquiring and improving technology.”

SGI-DNA, a company developing synthetic genomics technologies and DNA data storage solutions, completed a $25 million series A financing round in September, led by Northpond Ventures. Proceeds of the financing will support the global commercial launch of the BioXp 3200 System, which it called the industry’s first fully automated gene synthesis platform.

September wrapped up with Gyros Protein Technologies introducing PurePep Chorus, its next generation automated peptide synthesis platform. The system can be purchased with or lab-upgraded to include, 2, 4 or 6 channels, with independent induction heating, and real-time UV monitoring on 2 or more channels.

In October, Illumina and QIAGEN N.V. announced a 15-year partnership intended to broaden the availability and use of NGS-based in-vitro diagnostic (IVD) kits, including companion diagnostics, for patient management. The agreement grants QIAGEN non-exclusive rights to develop and globally commercialize IVD kits to be used together with Illumina’s MiSeq Dx and NextSeq 550Dx Systems. The agreement also includes rights for expansion of the partnership on future Illumina diagnostic systems. Both companies are also exploring opportunities for QIAGEN to develop and market companion diagnostics based on Illumina’s TruSight Oncology assays that enable comprehensive genomic profiling of tumor samples in immunotherapy.

Our team was on the road again in October for the American Society of Human Genetics (ASHG) annual meeting in Houston. The exhibition hall featured 271 exhibitors and we noted several notable trends among exhibitors. The word “democratize” was prevalent in product ads, flyers and at technology talks. In the context of analytical instrumentation, democratization means to increase accessibility through simplification of operation and analysis. Vendors have come to recognize that specialized skills and training are significant barriers to product use, and ease-of-use is a highly marketable feature.

RNA sequencing products were featured by many exhibitors, with multiple new products showcased for RNA library preparation. RNA-seq is one of the fastest-growing portions of the sequencing market; more information on demand and growth can be found in SDi’s recently published market report, Sample Preparation for Next-Generation Sequencing.

There was a growing presence of data service companies at the conference, with Amazon Web Services presenting its partnership with Illumina, and Microsoft exhibiting its collaboration with the Broad Institute. With the explosive growth of sequencing data generated, large data companies have found opportunities to become increasingly involved in secondary analysis and data storage.

New England Biolabs showcased its recently launched NEBNext Enzymatic Methyl-seq (EM-seq) kit. The EM-seq kit, instead, uses an initial protection step followed by a deamination step to achieve the same conversion as the sodium bisulfite method, while minimizing damage. The higher yields require fewer PCR amplification cycles, provide more uniform coverage and results in more complex libraries.

Inscripta introduced the Onyx Digital Genome Engineering platform, calling it the world’s first fully automated benchtop instrument for genome-scale engineering. The CRISPR-mediated, massively parallel platform enables researchers to engineer microbial libraries containing the full breadth and scope of possible edit types, in their own labs.

As we returned from ASHG, Danaher agreed to divest three businesses—FortéBio label-free biomolecular characterization, chromatography hardware and resins, and SoloHill microcarriers and particle validation—in order to gain regulatory approval of its planned acquisition of GE Healthcare’s biopharma business. Sartorius will acquire the businesses for $750 million. The three businesses had combined 2018 revenues of $140 million and double-digit margins. According to SDi’s 2018 report, “Bioprocessing Technologies 2018.” MilliporeSigma and Pall are the largest vendors of bioprocessing filtration and concentration products, with Sartorius a distant third.

The UK Competition and Markets Authority (CMA) put up another obstacle to the Illumina/Pacbio merger in October when it issues its provisional findings stating, “We provisionally conclude that the adverse effect arising from the identified SLC [substantial lessening of competition] would be that the Merged Entity would have less incentive to complete and that this would result in reduced choice, an increase in prices, deterioration in quality, deterioration in service and/or loss of innovation or refocus their own innovation.”

On the last day of October Mesa Laboratories, which provides instruments and consumables QC applications purchased Gyros Protein Technologies from AP6, Ampersand Capital and individual shareholders for $180 million.

Modern microscope station with tissue section on the screen

November saw us on the road again – this time to Association for Molecular Pathology. Early detection is key to improving treatment outcomes for most cancers, but despite advancements, the challenge of early detection remains. So it came as no surprise that exhibitors showcased innovations designed to improve detection time and testing relevance.

A notable product introduction was Thermo Fisher Scientific’s same-day NGS system, the Ion Torrent Genexus. Thermo Fisher highlighted the durability of the Genexus’ design and IT features, including reporting and documentation of all aspects of the sample run. Andy Felton, vice president of Product Development at Thermo Fisher, spoke with IBO about the system. He said the Genexus is designed to make NGS on par with immunohistochemistry (IHC) systems in terms its influence on oncologists’ decisions. “At the current time, the IHC result comes in a few hours, and the next generation sequencing test is generally outsourced and comes in weeks,” he said. “By then, the treatment recommendation has been made. If you can perform NGS on site, it can also be part of the process.” To do this, Genexus boasts a workflow time of less than 24 hours for some cancer type and same day with most others. This speed, Mr. Felton said, is due to the system’s use of a greatly improved clonal amplification process that reduces processing time from 14 hours to 3 hours.

Illumina made news with the debut of a liquid biopsy NGS offering for oncology. As of 2019, over 40 companies are active in the global market for liquid biopsy diagnostics and monitoring tests. The market is expected to surpass $1.5 billion by 2023, according to a recent Kalorama Information report, with a CAGR of 27.9% over the next five years. Illumina’s TruSight Oncology 500 ctDNA is its first liquid biopsy solution for detecting cancer biomarkers. According to the company, TruSight provides labs with the flexibility to analyze both tissue and liquid biopsy samples. Consequently, it can uncover biomarkers using liquid biopsy when tissue samples are limited or unavailable, or it can complement tissue results by detecting biomarkers in circulating tumor DNA (ctDNA).

Agena Bioscience showcased its combined RT-PCR and mass spec system. The company’s UltraSeek chemistry is designed to be an economical method for validating mutations of interest identified through NGS and RT-PCR, to confirm or rule out borderline results. The company said that following whole-exome sequencing, targeted detection on its MassARRAY system has been proved to confirm low-threshold mutations.

Promega announced at AMP a global collaboration with Merck for companion diagnostics (CDx). The collaboration will develop Promega’s MSI technology as an on-label, solid tumor CDx for use with Merck’s anti-PD-1 therapy, KEYTRUDA. The presence of MSI represents phenotypic evidence that DNA mismatch repair (MMR) is not functioning normally. Cells with abnormally functioning MMR are unable to correct errors that occur during DNA replication and consequently accumulate errors.

Mission Bio displayed its Tapestri Platform, which the company calls the first and only single-cell multi-omics platform that is capable of simultaneously providing both genotype and phenotype data from the same cell, across thousands of cells. The system can directly assess the clonal architecture of a sample and uncover the true distribution of genotypes and their segregation patterns across subclones. These subclonal mutations can escape current treatments, and NGS alone can miss what is happening in rare cell within a population.

The Illumina saga took a new twist when the company submitted its response to the UK Competition and Market Authority’s if Illumina were to acquire Pacbio. In its first response to the CMA, Illumina proposed granting Oxford Nanopore Technologies a perpetual, royalty-free license to certain PacBio patents for use in nanopore sequencing, or alternatively granting this license to any third party. But Oxford Nanopore responded, “The Parties’ proposal is egregiously misleading. It includes offering patents that have been revoked, while also excluding substantially relevant patents and applications from PacBio’s intellectual property (IP) portfolio and pipeline. In addition, the offer does not include any of the relevant Illumina patents and/or patent applications.”

In a second proposed remedy document submitted eight days after the first, Illumina removed specific references to Oxford Nanopore stating “A perpetual, royalty-free, irrevocable, license of PacBio’s and Illumina’s patents to any interested third-party undertaking for use in the field of single-molecule, native long-read sequencing systems and associated sequencing chemistries would be a fully effective, reasonable and proportionate undertaking to remedy the SLC provisionally identified by the CMA.” Oxford Nanopore wasn’t impressed, “As an IP package, the offer has serious limitations and appears to be confined to a very restricted field of use: ‘single-molecule, native long-read sequencing and associated sequencing chemistries.’ As of this writing, the CMA has moved its timeline for its revised statutory decision to February 5, 2020 from the previous date of December 31.

Since 2002, the Life Science Industry Awards have recognized the innovative manufacturers of the “tools of science” that help advance biological research and drug discovery. Traditionally, the Life Science Industry Awards have been a biennial event where thousands of life scientists nominate and vote for the best performing supplier in 10 distinct customer support, service and communications categories. Beginning in 2019, the Life Science Industry Awards have expanded to include three new categories to recognize the most innovative new products released this year. The editors of Instrument Business Outlook and the scientists who comprise BioInformatics’ market insights team will select winners.

This year, the LSIAs were awarded in three categories: cell biology, genomics and protein analysis. Speaking about the Awards, BioInformatics Inc. CEO Craig Overpeck enthused, “The amazing life transformations from a therapy often overshadows the fact that these discoveries resulted from the labors of small groups of dedicated scientists who themselves are supported by the relatively small number of companies that produce the ‘tools of science.’”

2019 LSIA Award Winners for Most Innovative New Product

Towards the end of November, private equity firms Astorg and Cinven, leading a consortium of buyers, agreed to purchase LGC from KKR for an undisclosed amount. LGC is a provider of genomics reagents, standards for supply chain assurance, proficiency testing schemes, among other products, to end-markets that include the health care, agri-food and environment sectors.

So here we are in December. Inscripta announced an early holiday present in the form of $125 million in a Series D round. Inscripta will use the funding to commercialize and develop new applications for its Onyx Digital Genome Engineering platform. Twist Bioscience reported that revenues for its fiscal fourth quarter 2019 rose 87 percent year over year. Dolomite Bio and S2 Genomics just announced they were joining forces to automate library preparation of tissue samples for single-cell RNA sequencing.

Like I said, it’s been a busy year! 2019 marked our 25th year in business delivering market insights and Voice of Customer to our clients in the life science and analytical instrument market. On behalf of everyone here at BioInformatics, we wish you a happy and peaceful holiday season and we look forward to working with you in 2020.

If you liked this article, you’ll love Instrument Business Outlook. Download a free sample issue here!

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Multi-photon microscopy, also called two-photon excitation microscopy, makes use of nonlinear optics to provide finely localized, three-dimensional imaging. Instead of using optics to control the light returning to the detector, multi-photon optics ensure that the stimulated part of the sample is restricted to a small point, which reduces the risk of photobleaching effects.

Light sheet microscopy, also called single plane illumination microscopy, illuminates only a thin plane of just a few micrometers at a time using a laser. As the sample is moved through the light sheet, three-dimensional images are generated. Since only a thin slice of the sample is exposed at a time, light sheet microscopy is a relatively gentle technique for live cell imaging, and can be used to image cells in living animals.

Both techniques have seen substantial growth over the past five years. Multi-photon and light sheet microscopes have become increasingly used in labs worldwide conducting research on cellular processes and dynamics. These instruments are ideally suited for imaging sensitive living cells due to their reduced phototoxicity effects. The majority of these instruments have been purchased and used by university research and government-sponsored labs.

Over the next five years, strong growth rates of these advanced microscopy techniques are expected to continue. Additionally, increased adoption of these instruments from the pharma/bio industry for drug development research can be anticipated. More vendors continue to innovate their advanced microscopy pipeline of instruments. Multi-photon microscopy is the more mature market, while the market for light sheet instruments is more emerging. As these technologies continue to evolve, their value will grow to labs conducting live cell imaging.

Download the free report brochure to see the full table of contents and key takeaways for the important and timely report!

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Here are the 2019 Winners of the Life Science Industry Awards – Innovation:

Most Innovative New Product – Cell Biology

Fluidigm (Gold Award) for its Maxpar Direct Immune Profiling System

Tecan (Silver Award) for its Spark Cyto plate reader with real-time image cytometry

Agilent Technologies (Bronze Award) for its xCELLigence RTCA eSight

Most Innovative New Product – Genomics

Pacific Biosciences (Gold Award) for its Sequel II System

Agilent Technologies (Silver Award) for its Magnis NGS Prep System

Thermo Fisher Scientific (Bronze Award) for its QuantStudio 6 and 7 Pro Real-Time PCR Systems

Most Innovative New Product – Protein Analysis

Thermo Scientific (Gold Award) for its Orbitrap Exploris 480 Mass Spectrometer

Gyros Protein Technologies for its PurePep Chorus

Bruker for its TimsTOF FleX

“With their in-depth understanding of customer needs, each of these innovative companies establishes differentiation and improves their competitiveness in every phase of their products’ lifecycle — from the actual design and manufacture of the product to its pricing, delivery and post-sale support, said Craig Overpeck, chief executive office of Science and Medicine Group, parent company of BioInformatics. “Through our countless surveys, interviews, focus groups and hundreds of reports, we’re proud to have played a role in our clients’ successes by helping them see their markets and themselves through the eyes of their customers.”

Since 2002, the Life Science Industry Awards have recognized manufacturers of the “tools of science” that help advance biological research and drug discovery. Beginning in 2019, the Life Science Industry Awards have expanded to include three new categories to recognize the most innovative new products released this year. The editors of Instrument Business Outlook and the scientists who comprise BioInformatics’ market insights team selected the winners.

For more information please visit http://www.LifeScienceIndustryAwards.com

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The shift to precision medicine has driven major changes in how we think about the structure of the pharma/bio sector. Traditionally, relatively large companies that develop small molecule drugs were thought of as “pharma” companies, while companies developing biotherapeutics, which often conjured the image of scrappy little startups, were thought of as “biotech” companies. However, this dichotomy never truly existed in the sector, and is not very useful in classifying participants. The advance of biotherapeutics as a focus of development among players of all sizes and stages of business development has thoroughly erased the distinction between “pharma” and “biotech” at the company level.

The nature of biotherapeutics and their role in precision medicine is fundamentally changing the model of drug development and marketing. Because biotherapeutics are so highly targeted to specific disease and patient types, the patient pool for each drug is much smaller, compared to the old pharmaceutical model of developing “blockbuster drugs” that could treat large portions of the population. This has led to development pipelines involving a greater number of drugs, and an overall proliferation in the number of laboratories in the pharma/bio space. However, because resources are spread across the development of more therapeutics, the R&D infrastructures for individual labs are growing leaner.

SDi’s newly published report, titled Lab Instrumentation Markets for Pharmaceuticals, Biopharmaceuticals, & CROs, is an in-depth analysis of how these trends and challenges are shaping the demand for analytical instrumentation and lab equipment in the pharma/bio space. With demand exceeding $19 billion in 2018, the pharma/bio sector is the largest source of demand for laboratory instrumentation, representing 30% of the overall market for laboratory and life science instrumentation. Trends in pharma/bio development involving 64 technologies in 10 categories are examined though historic market growth and forecasts for demand over the next five years, while end-user perspectives gained through a survey completed by 120 pharma/bio researchers provide further insights into development pipelines, laboratory budget, and challenges being faced in therapeutics development.

Companies we covered include: 

• Agilent
• Becton Dickinson
• Bio-Rad
• Bruker
• Danaher
• GE Healthcare
• Illumina
• Mettler Toledo
• MilliporeSigma
• PerkinElmer
• QIAGEN
• Shimadzu
• Thermo Fisher
• Waters

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Kalorama’s report, The Worldwide Market for In Vitro Diagnostics Tests is a comprehensive global report designed to track those activities. The report finds that IVD testing is driven by disease incidence, aging population, new technologies, new entrants, and demand from consumers and providers for better care. Tissue-based testing for cancer and molecular tests for both cancer and infectious diseases are the growth engine; growing at rate 50% higher than the overall market. Concern over sepsis and respiratory conditions should ensure that infectious disease will remain in the fast-growth categories. Early detection and linking of therapy to patient should drive cancer diagnostics.

Specialty immunoassays, continuous glucose tests, mass spectrometry and inherited diseases are other large and high-growth segments.

Developed markets still make up the bulk of revenue in IVD (N.America, Europe, Japan are 72% of market), but vendors compete globally and seek out emerging markets to thrive. Key nations are China, India, Korea, Turkey, and Brazil, but IVD vendors are finding new emergent nations. These nations are not new markets for established IVD vendors, most have had offices or distribution in these countries for decades. But the role these nations play in market growth has become more prominent.

There are new technologies in the market. It was once uncommon to see mass spectrometry’s use in clinical decisions. Now it has arrived, enough that it is a category in the market, especially in developed markets. A particular use is for the identification of bacteria, fungi, and mycobacteria. The MALDI-TOF market has exploded in recent years in microbiology labs thanks largely to the IVD regulatory approval of the VITEK MS and MALDI Biotyper. Histopathology is a new area of interest. Throughput and operational complexity are limits despite this fast growth in usage.

Companion testing is the segment with the most buzz and attention, due to its role in bringing about precision treatment and personalized care. Kalorama reports these tests in the molecular and histology segments of its report. FoundationOne CDx’s approval as the first FDA approved companion diagnostic test for solid tumors is a positive signal to companies developing companion diagnostics for oncology indications. Companion testing has expanded since the commercial success of Herceptin (trastuzumab) and Gleevec (imatinib), both of which required testing with companion diagnostics before they could be prescribed.

In the more mature segments, there is no lack of activity: Major core lab vendors such as Siemens, Roche, OrthoClinical and Abbott Diagnostics are developing improved models selling their existing on staying with them. They do preserve and expand revenue, as well as create barrier entry against other vendors in a shrinking lab environment. Footprint improvements, IT enhancements, EMR, automation, and expanded menus are part of this change. While this is not part of traditional IVD commercialization, web-based and TV marketing has helped in a few categories and usage of such mechanisms would boost this category. Analytes that would normally be found only on dedicated immunoanalyzers, have migrated to consolidated workstations including: vitamin D, HbA1c, NGAL, D-dimer, anti-CCP, hsTroponin, hsCRP, cystatin, procalcitonin, HE4 cancer marker and markers for Graves’ disease.

Blood screening markets are boosted by better global collection of blood and the globalization of tropical diseases, which need to be detected.

Kalorama Information’s report captures all these trends, makes forecasts and estimates sizes for scores of test categories. The report can be found here: https://kaloramainformation.com/product/the-world-market-for-in-vitro-diagnostic-tests-12th-edition/

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 “The pace of science, technology, and medicine is moving faster than ever, and we have built a qualitative offering to match the new speed of business today. Our Experts-on-Demand consultants are profiled and responsive to meet the increasing needs of our clients,” said Craig Overpeck, chief executive officer of Science and Medicine Group.

The experts are drawn from The Science Advisory Board®, an expert network formed in 1997. Tens of thousands of laboratory professionals representing basic and translational life science research, drug discovery, and clinical diagnostics routinely participate in BioInformatics’ quantitative and qualitative global market research projects. The proprietary global network encompasses more than 25 market segments and includes scientists and clinicians with profiled expertise in 80 different research and diagnostic techniques.

“Experts-on-Demand facilitates direct communication between those on the cutting edge of science and medicine with those companies who must support them with ever more innovative technologies,” said Overpeck.

More information on Experts-on-Demand can be found here.

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Here at BioInfo, we have been studying these patterns and changes for over three years. Our newest report Benchmarking for 2019: Life Science Customer Experience, evaluates the complete customer journey (pre-purchase, purchase, post-purchase) at each touchpoint for 27 leading life science suppliers and trends this data over 2016, 2018, and 2019. Our report can help you better understand how you are doing amongst your competitors as well as understand what a great customer experience really means to life scientists. Here, we share a few insights from the report, as well as from the interviews we conducted, to help you understand what customer experience for life scientists means.

Of the touchpoints shown above, life scientists particularly value the quality of customer service and technical support. When a customer experiences a problem, outstanding, “beyond-the-call-of-duty” service can generate corporate goodwill. But it is not possible to build loyalty solely on the basis of a talent for narrowly escaping disaster. Life scientists define as “valuable” any product or service that elevates their performance or lowers their costs. Responsive service and support contributes to both of these objectives. Individual or laboratory performance is heightened when ordering and delivery problems are avoided, or technical issues are resolved quickly. Lowering costs does not simply refer to the price of the product, but also reflects time and convenience costs. In a market where technological differentiation is becoming so difficult to achieve, providing quality service and support an exceedingly important element of creating a branded customer experience.

But what are some other areas of importance? Here we jump back to the beginning of the customer experience journey — awareness, product knowledge, and product selection. Unfortunately, scientists take some of these corporate activities for granted or see them as secondary despite the impact they have on their overall customer experience. For example, overall the industry averages for the pre-purchase phase are lower than any other phase of the customer experience. This is ironic because scientists curious and are happy to explore instrumentation for themselves and listen to their colleagues and peers to learn more about products. This suggests suppliers must continue to invest in resources to fulfill this need for information, a need that is especially acute during the pre-purchase phase of the purchasing cycle. These investments range from user-friendly and intuitive website design, search engine optimization, and the development of comprehensive website content. This will also assist in the Product Selection touchpoint where the industry is clearly under-performing.For some products such as instrumentation, an empowered sales force is essential to facilitating the transition from lead to customer.

In addition to these factors, taken as a whole, our analysts found that scientists also genuinely want to build better and closer relationships with their suppliers. We interviewed members of The Science Advisory Board and learned that scientists feel that suppliers seem to lack the perspective of what a lab scientist (academic or industrial) may truly need at any given touchpoint of the customer experience. This frustration can be heard in comments on touchpoints as simple as poor web design, advertising that scientists feel is misleading, and even technical support that doesn’t understand the product that it is supporting. It is important to carefully consider how your customer experience can build and nurture customer relationships.

Our report, Benchmarking for 2019: Life Science Customer Experience explores, in depth, customer perspectives of each touchpoint within the journey, your overall rating, and how your customers’ views have changed over the last three years. The full report contains detailed profiles and comparisons of 27 leading suppliers. In addition, a companion interactive report gives you the ability to filter the data by company, market segment, region and touchpoint to conduct your own analysis and presentations.

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The winners are:

Gold Award: Inventia Life Science’s RASTRUM 3D Bioprinter

Silver Award: Axcend’s Focus LC

Bronze Award: Thermo Fisher Scientific’s HAAKE Viscotester 3 Rotational Viscometer

To be eligible for an IBO Design Award, a product must have begun shipping between August 2018 and July 2019. Award candidates are chosen from new products that IBO monitors through trade shows and conferences, trade publications, and press releases. Award winners are selected based on both their industrial and technical design. Criteria include innovation, aesthetics, functionality and ease of use.

About Instrument Business Outlook

Instrument Business Outlook (IBO) is the leading source for news, data and analysis on the $50 billion analytical instrument and laboratory products industry, and is published twice monthly by Strategic Directions International, Inc. (SDi), part of the Science and Medicine Group.

To download a free sample copy of IBO, visit: https://instrumentbusinessoutlook.com/learn-more/#freeissue

For more information, visit www.instrumentbusinessoutlook.com or contact:

Tanya Samazan, Managing Editor
Strategic Directions International, Inc.
6242 Westchester Parkway, Suite 100
Los Angeles, CA 90045­-4820
Tel: (323) 336-8788
Email: tsamazan@strategic-directions.com

Gold Award

Inventia Life Science’s RASTRUM 3D bioprinter

Silver Award

Axcend’s Focus LC

Bronze Award

Thermo Fisher Scientific’s HAAKE Viscotester 3 Rotational Viscometer

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The biomarker market is extremely large, reflecting the large market for diagnostic tests based on these biomarkers, and also the ongoing efforts to discovery, validate, and commercialize new biomarkers. This market is fueled by factors that are supporting growth of both the research and the diagnostics markets, including:

• Aging of the population
• Rising rates of obesity
• Growing number of cancer therapies
• Longer lifespans of cancer patients
• Advances in technology, improving our ability to analyze the increasing number of biomarkers
• Advances in bioinformatics

In addition, market growth is being fueled by the identification, validation, and introduction of new biomarkers, and products based on these new biomarkers. These include safety and efficacy biomarkers being used in drug discovery and development, and other applications in addition to diagnostics.

The large and growing biomarker market has attracted a lot of attention, and new players are entering the market. For biomarkers that have already been commercialized and for which many diagnostic companies offer tests, this is a very competitive field. However, even for companies that have developed their own, proprietary biomarkers, this can be a very competitive market as different companies or laboratories work to convince clinicians to use their proprietary biomarker or panel for a specific disease application, rather than use a biomarker or panel offered by a competing company.

Many different technologies have been developed and are used in biomarker discovery, and also for detection and analysis of known biomarkers. These include traditional technologies, some of which have been used for decades. In addition, many new technologies developed for other applications are now being applied in this field. These include mass spectrometry and next generation DNA sequencing. Many tests performed using newer technologies are currently being done primarily as laboratory developed tests (LDTs) or by organizations performing clinical tests for pharmaceutical companies developing new drugs; however, some companies plan to eventually develop IVD test kits based on their laboratory assays. Selected examples of companies using these various technologies are discussed in this report, including key players in the market:

• Companies Using Immunoassays for Detection and Analysis of Biomarkers
• Companies with Immunohistochemistry Tests for Detection of Biomarkers
• Companies Using In Situ Hybridization for Detection and Analysis of Biomarkers
• Companies Using PCR or Other Nucleic Acid Amplification-Based Technologies for Biomarker Assays
• Companies Analyzing Gene Signatures
• Companies Using Microarrays to Detect and Analyze Biomarkers
• Diagnostics Companies and Clinical Laboratories with Sequencing-Based Biomarkers
• Companies Using Mass Spectrometry

Companies, clinical laboratories, researchers, and others do not generally purchase “biomarkers.” One exception is in settings in which companies or clinical laboratories acquired rights to use specific biomarkers for certain applications. The application may be development of reagents or assays that can be sold to researchers who are studying the biomarker, or who are using the biomarker in their research. These research applications could include using the biomarker as a safety marker, or as a surrogate marker for clinical efficacy, or a different research application. Alternatively, applications of new biomarkers may be to develop diagnostic assays that will be used in clinical setting for diagnosis, predicting prognosis, monitoring, determining the optimal therapy, or other clinical application. In addition, some biomarkers may prove valuable as potential targets for novel new therapies.

In our report, the market for biomarkers focuses on the applications of biomarkers. This includes both research and diagnostic applications of biomarkers. The potential market for biomarkers being evaluated as potential drug targets is not included in this market analysis, as that therapeutic market would be determined by the potential market for new therapies targeting the biomarker drug target. Key biomarker categories with 2019-2024 market estimates include the following:

• Cardiac Markers [cTn, HscTn, Acute CK-MB/BNP, Others]
• Tumor Markers [PSA, CEA, CA 125, AFP, PSA Rapid, Others]
• Coagulation Markers [PT/INR, D-dimer]
• Infectious Disease Markers [including Sepsis]
• Immunological Disease [Autoimmune/Allergy]
• Neurological Markers
• C-Reactive Protein and Other Markers

The World Market for Biomarkers estimates the world markets for biomarkers and biomarker tests from 2014 to 2024, with 2019 as the base year, providing global biomarker market forecasts for the total biomarker market, the market by application (clinical diagnostic biomarker market, research biomarker market), and the market by geographical distribution:

• Total Global Biomarker Market by Application, 2014 – 2024, in $Millions (Clinical Diagnostic, Research, Total)
• Biomarker Market Segments by Application, 2014, 2019, 2024, by Share (%) (Clinical Diagnostic, Research)
• Total Global Biomarker Market by Region 2014 – 2024, in $Millions (North America, European Union, Japan, China, India, ROW, Total)
• Global Market Segments by Region, 2014, 2019, 2024, by Share (%) (North America, European Union, Japan, China, India, ROW)

The World Market for Biomarkers includes profiles of companies active in the discovery and/or commercialization of biomarkers. This includes companies commercializing in vitro diagnostic tests for detection and analysis of biomarkers, selected diagnostic companies commercializing diagnostic tests in their own CLIA certified laboratories for detection and analysis of biomarkers, and selected other players. The report’s focus is on companies with commercialized products and/or very advanced development programs. The diagnostics market is a highly competitive market, and there are many additional diagnostic companies that offer tests based on biomarkers discussed in this report. Companies profiled in the report range from large, multinational companies to smaller companies in or entering this market, including the following:

• 20/20 Genesystems
• Abacus Diagnostica
• Abbott Laboratories
• Act Genomics
• Adaptive Biotechnologies
• Admera Health
• Agena Bioscience
• Agendia
• Agilent Technologies
• Alpco
• Ambry Genetics
• Athena Diagnostics /Quest
• Banyan Biomarkers
• Beckman Coulter
• Becton, Dickinson
• Biofire Diagnostics/Biomerieux
• Biohit
• Biomérieux
• Bio-Rad Laboratories
• Cancer Genetics
• Caris Life Sciences
• Cepheid
• Curetis
• Exact Sciences
• Foundation Medicine
• Fujirebio
• Genomic Health
• Hologic
• Illumina
• Myriad Genetics
• Neogenomics
• Ortho-Clinical Diagnostics
• Qiagen N.V.
• Roche
• Siemens Healthineers
• Sysmex Corp.
• Thermo Fisher Scientific
• Ventana Medical Systems/Roche
• Zeus Scientific

The large and growing biomarker market has attracted a lot of attention, and new players are entering the market. For biomarkers that have already been commercialized and for which many diagnostic companies offer tests, this is a very competitive field. However, even for companies that have developed their own, proprietary biomarkers, this can be a very competitive market as different companies or laboratories work to convince clinicians to use their proprietary biomarker or panel for a specific disease application, rather than use a biomarker or panel offered by a competing company.

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Clinical laboratory customers have become increasingly sophisticated and typically have multiple suppliers in every product category from which to choose. Leading diagnostics suppliers seek to differentiate themselves by improving both the tangible and intangible ways they interact with their customers. With the high cost of customer acquisition, the easiest way to increase profitability is to develop one’s current customer accounts. Improving the customer experience through innovation, mass customization and customer intimacy programs is a key strategy many life science companies are pursuing.

Innovation is not limited to developing revolutionary new products. Innovation can also be incorporated in the ways customers find, buy and use your products.

Smart companies continually evaluate customer reactions to multiple touchpoints so that they can offer the kind of experience that inspires customers to want to come back. Diagnostics suppliers will be challenged as to how to get beyond “better sameness” to create truly memorable customer experiences. The question becomes one of how to best to enhance the quality of the customer experience in a remarkably homogenous marketplace.

In our latest report, Benchmarking for 2019: Understanding the Clinical Diagnostics Customer Experience, we asked more than 300 clinical lab professionals to evaluate 21 different diagnostics companies on 18 critical customer touchpoints. Here at Kalorama Information, we have developed a customer experience model for the diagnostics market. Every time a laboratory professional interacts with a supplier in any way, that moment is a customer experience touchpoint and as such, a branding opportunity. The scope of our report spans the pre-purchase, product-usage and post-purchase customer experience over the course of the purchasing life cycle. It is summarized in the following graphic:

The questions we developed to cover each touchpoint were designed to capture the attributes that are valued by clinical lab professionals. Touchpoints encompass the time spent researching products, the selection process and after the sale is made. Within each touchpoint, we asked customers multiple questions to capture the attributes valued by clinical diagnostics customers. These touchpoints encompass the experiences that lead to repurchase and recommendation of clinical diagnostic equipment and consumables.

Purchasing life cycle questions were asked on an 11-point scale (some with a not applicable option) where “Positive” is a rating of 9-10 and “Negative” is a rating of 0 to 6. Performance is calculated using a Net Promoter Score (NPS)-like methodology; that is, Performance = percentage of Positive responses minus the percentage of Negative responses. This provides a respondent-level view of touchpoint performance. Values for every vendor at each touchpoint are compared to an industry-specific average to provide an understanding as to how each supplier is perceived compared to this average. An awareness of the importance assigned to each touchpoint allowed us to create a weighted overall Customer Experience Score for each supplier, as well as establish an industry-specific standard that is used as a benchmark throughout this report.

Awareness of the breadth of a supplier’s product line has the lowest industry average value. This suggests suppliers must continue to invest in resources to fulfill this need for information, a need that is especially acute during the pre-purchase phase of the purchasing cycle. These investments range from user-friendly and intuitive website design, search engine optimization, and the development of comprehensive website content. This will also assist in the Product Selection touchpoint where the industry is clearly under-performing.

Suppliers who focus their customer experience efforts on outperforming the industry’s averages are those who will achieve the competitive advantage and differentiation they seek.

The suppliers evaluated in our report are:

• Abbott
• Agilent
• BD Biosciences
• Beckman Coulter
• Bio-Rad
• bioMerieux
• Bruker
• Cepheid
• DiaSorin
• GenMark Diagnostics
• Illumina
• Luminex
• Ortho Clinical Diagnostics
• Quidel
• Roche
• Sekisui Diagnostics
• Siemens Healthineers
• Sysmex
• Thermo Fisher Scientific

How did your company compare to the industry average at each touchpoint? The full report contains detailed profiles and comparisons of 21 leading suppliers. In addition, a companion interactive report gives you the ability to filter the data by company, market segment, region and touchpoint to conduct your own analysis and presentations.

Please download our complimentary report summary.

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