• by esalazar@marketresearch.com
  • December 21 2015

Year in Review: Kalorama Information Blog in 2015

Year in Review: Kalorama Information Blog in 2015

Best wishes for a Happy New Year from all of us at Kalorama Information! The events of 2015 in healthcare, biotechnology, IVD and medical device markets provided us frequent opportunities to share analyst insights and findings from our market research reports. We value our readership and look forward to covering key developments in 2016.

Here’s a review of the posts and topics the Kalorama Information blog covered in 2015:

Veterinary Diagnostics - One of the leading applied market opportunities for IVD products, veterinary diagnostics is primarily segmented by tests used for companion animals (pets) or food animals (livestock). The two segments have been affected by different market trends in recent years, and must be evaluated separately by companies looking to enter the veterinary diagnostics space. The strength of the companion animal diagnostics market can be sourced to veterinary practices’ growing emphasis upon “wellness services” including examinations and screening tests. Rising standards of companion animal care led to a boom of in-house analyzer placements, but which have begun to cool in recent years with more extensive market penetration among U.S. veterinary practices.

Molecular Diagnostics - Molecular diagnostics are now used in practically every facet of laboratory medicine including infectious disease, inherited diseases, oncology coagulation, transplant medicine, and prenatal and postnatal screening. The sensitivity, specificity and increasing rapidity of molecular testing provide unparalleled clinical insights in a variety of healthcare settings. With instrument integration of automated test procedures or “sample-to-answer” capabilities, molecular diagnostics can be performed outside of the central lab and at points of care. In 2015, the first CLIA-waived molecular tests able to be performed outside of a laboratory were introduced.

The sophistication of molecular diagnostic technology has resulted not only in the simplification of systems for clinical users, but also a tremendous leap in the capabilities of laboratory medicine. Next-generation sequencing (NGS) is poised for its distribution within healthcare among clinical reference labs and potentially among even hospital labs in the coming years. In 2015, QIAGEN became the latest major sequencing player to introduce its clinical NGS platform, the GeneReader. Commercial labs and biotechnology companies have created a lucrative and increasingly competitive laboratory-developed test (LDT) market in non-invasive prenatal testing (NIPT) using diagnostic technologies including microarrays and NGS. The CFDA is taking an increasingly proactive role in the regulation and approval of NGS LDTs, including NIPTs, that are in high demand in the Chinese market. The technology behind NIPT shows even greater promise in oncology through its application in “liquid biopsy” tests or tests performed using blood-based samples rather than tissue biopsies.

Biomarker and Drug Discovery - Translational medicine has been powered by sequencing in the domain of genomics, but also several technologies and workflows in the domain of proteomics including LC-MS and TOF-MS. In lieu of immunoassays that can be cost-prohibitive in discovery, life science research has utilized a number of mass spectrometry (MS)-based methods to analyze protein differentials between samples and identify candidate biomarkers. Promising alternative or next-generation workflows for protein biomarker discovery include MALDI and DESI imaging of tissue samples using time-of-flight (TOF) instruments, capillary electrophoresis (CE) in lieu of liquid chromatography (LC) for front-end separation, and the production of high-resolution peptide maps using data-independent acquisition on Q-TOF and Orbitrap mass spectrometers.

Cancer and cardiovascular biomarkers claim the predominant share of research dollars in biomarker research, but neurology is closing the gap. Neurodegenerative diseases such as Alzheimer’s disease and Parkinson’s disease have defied development of a definitive antemortem lab diagnostics. Several promising biomarkers have already progressed to incorporation in clinical trial assays or investigational use only (IUO) assays that use MS methods to quantify plasma- or serum-based proteins. Another prospective Alzheimer’s assay uses immunohistohemistry (IHC) of skin biopsies.

Medical research has also found new benefactors within the United States, including Alphabet’s (Google’s) Verily business unit that is attempting to piece together and define baseline healthiness through biomarkers and other clinical parameters.

Biomarker research and drug discovery is responsible for feeding the quickly growing biopharmaceutical pipeline. The increasing use of mammalian cell lines in biopharmaceutical production, including versatile and uniquely capable stem cells, in upstream bioprocessing has imposed specific demands on cell cultures, especially better-defined media. Biopharmaceutical production is also diversifying and facilities require more operational flexibility to efficiently respond to the market. Single-use bioreactors have consequently found growing demand from biopharmaceutical clients.

The fight against cancer is not only enlisting proteomics and specialty biopharmaceuticals, but gene therapies capable of a multifaceted attack against tumor cells using modified viral and plasmid vectors.

Infectious Disease Diagnostics - Infectious disease diagnostics represents a technologically and analyte-diverse market with numerous high-growth opportunities. The leading infectious disease threats in terms of clinical diagnostics sales include respiratory tract infections, HIV, hepatitis, women’s health pathogens and STIs, and healthcare-acquired infections (HAI) and antimicrobial resistance (AMR).

The threat of AMR is not limited to the mounting contemporary loss of life from multidrug-resistant or ‘superbug’ strains, but the potential of a “post-antibiotic age” for medicine characterized by a dearth of effective antimicrobials. The control and elimination of AMR and HAIs requires effective surveillance using highly sensitive tests, which are a chief area of focus in IVD development. Next-generation sequencing, in particular, offers the necessary sensitivity without the downsides of specificity - converting molecular tests from hypothesis-driven or yes/no results to data-rich, more openly interpretable results.

Connected, Patient-Centric Healthcare - While devices and tests often occupy the foreground of market research reports, Kalorama Information also tracks key developments in the practice of healthcare and the increasingly digital interface between individual patients and care. Direct-to-consumer positioning of healthcare services is on the rise, and already most evident through retail clinics. Kalorama Information has tracked the retail clinic market in the United States for several years through a consumer survey. CVS is the market leader in retail clinic services, but the space is attracting more attention from both established and disruptive companies. Controversial Theranos hopes to subvert the traditional model of clinical lab services by offering lab tests directly to consumers while pursuing a more mixed strategy of development with elements in common with POC IVD companies.

The distribution of medical services among new players such as retail clinics and direct-to-consumer labs will require improved electronic consolidation of patient medical records and sharing of results. Behind hospitals, physicians and ambulatory care providers represent the next-phase of electronic medical record (EMR) implementation. Many EMR vendors already offer or plan to offer specialty solutions for their non-hospital client bases. EMR implementation is also expected to rise among nursing home facilities. Initial adopters of EMR systems are also re-entering the market or seeking aftermarket services due to the fast rate of system development.

Laboratories are also active in the digitization of healthcare data, seeking to deliver results faster and improve compatibility with larger connected systems. Acquisitions such as GenoLogics by Illumina and Cartagenia by Agilent Technologies signal the increasing importance of laboratory information management systems (LIMS) to success in clinical markets.

Digital healthcare is also available from the pocket with mHealth applications on connected mobile devices. The market potential for mHealth apps is immense with minimal market penetration among mobile device users and the diverse utility of device apps from daily preventative care through clinical trial recruitment and participant tracking.

With the digitization of healthcare, cybersecurity is an increasingly important safeguard for patient privacy and outcome. A recent FDA warning only formalized rising industry concerns over the IT vulnerabilities of medical devices that had been previously demonstrated on several occasions.

Core Lab and POC IVD Markets - Molecular diagnostics represents a leading front of IVD market expansion, but IVD industry strategies continue to evolve around core lab diagnostics and traditional POC markets. This year, Roche Diagnostics unveiled its core lab hematology platform, the Bloodhound, and Beckman Coulter acquired Siemens’ ID/AST business. Global core lab markets are also supported by ongoing automation of core lab tests in emerging markets such as China.

While the scope of testing able to be performed near patients or at the point of care (POC) continues to widen, a significant number of tests are well-established in their performance outside of clinical laboratories. The next stage of development for POC diagnostics is molecular testing, which may complete molecular diagnostics’ deployment in healthcare.