Our latest report finds that digital pathology market is 710 million in 2020. The COVID-19 pandemic, while disrupting healthcare in general, also provides a selling point as many pathologists are now at home and need to work digitally. Kalorama Information’s recent study Digital Pathology Markets, 2020-2025, finds a vibrant market that is pushed by the need for faster cancer detection and the enhancements that IT systems, including artificial intelligence solutions provide.

The COVID-19 pandemic has had a surprising impact for histology and digital pathology. The pandemic has curtailed all but the most serious surgeries and cancer treatments. Thus the histology lab is receiving the most difficult of tissue samples to process. There is also a workforce shortage of pathologists, with more pathologists retiring than those entering the field and with physical distancing many pathologists are staying out of the lab. At the same time new rules allow greater use of digital pathology as well as the reading of the test results from remote locations as long as the test was first performed in an authorized CLIA laboratory.

Leica Biosystems is a leader in this space and its products are used in hospital and reference labs, academic medical centers, and biopharma institutions, worldwide. Roche is a top competitor as well. Ten years ago, Roche reinforced its digital pathology business with the acquisition of a competitor that was integrated into Roche’s Ventana Medical business. Roche recently announced the CE-IVD uPath PD-L1 automatic digital pathology for non-small cell lung cancer (NSCLC).

Applied Spectral Imaging markets PathFusion, a digital pathology solution that combines whole slide imaging, digital FISH analysis and unique digital tissue matching of FISH with H&E/IHC samples. The company reports it has over 3,000 systems installed worldwide.
Visiopharm (Denmark) has been pioneering AI-driven digital precision pathology software since 2001. It works with a number of companies, but the company has recently forged an alliance with Agilent Technologies whereby the companies will co-market Visiopharm’s portfolio of artificial intelligence-driven pathology solutions.

Other companies include Glencoe Systems, Sectra, Epredia and Sunquest. These companies offer a variety of scanner hardware, storage and workflow software solutions and algorithmic based interpretation tools.

Companion diagnostics are rising to the forefront of pharmaceutical development and treatment. Companion diagnostics increase the probability of clinical success by identifying patients with the presence of biomarkers or disease-specific therapeutic targets that can dramatically improve outcomes. The COVID-19 pandemic has gripped the world and continues to be a major area of research and development for diagnostic test developers.

Several approaches continue to evolve, including the use of personalized medicine technologies being adjusted to address the COVID-19 need.

Spartan Bioscience developed its CE and FDA approved DNA analyzer to detect risk of poor treatment choices for patients taking various antiplatelets, antidepressants and PPIs.  People carrying CYP2C19 mutations can impair drug metabolism and alter response to drug therapy.  Over the first-half of 2020, Spartan Bioscience has shifted its technology to focus on detecting COVID-19 and Legionella using its qPCR on-site DNA analyzer.

Our report on companion diagnostics (https://kaloramainformation.com/product/companion-diagnostics-in-the-covid-19-era/), and found that COVID-19 has had a small impact on the market for important cancer test and drug combinations.  But since the oncology therapeutics these tests help facilitate are critically important for patients, that impact was limited.  This was according to informal surveys of companion diagnostic vendors conducted by the authoring analysts of the market report.

Along with new developments, diagnostic service providers are also shifting workloads to address the demand for COVID-19 services.  MiraDx, for example, has opened its CLIA-certified lab to providing COVID-19 test services.  The lab has an analyze capacity of over 9,000 tests with no backlog, reported by MiraDx.  The company also reports test results are available in approximately 48 hours and are being prioritized for hospitals, essential workers and field-based healthcare workers.  MiraDx lists the test at $150 per completed test.
Minimal Ongoing Disruptions

Analysts contacted some oncology treatment centers and others focusing on CDx activity to determine the impact of COVID-19 on laboratory activity.  The analysts of the report found.

• Initial (March 2020) decline in CDx requisitions, yet by April 2020 this was largely resolved;
• Less than 10 percent reduction in test volume reported;
• Budgets largely frozen, no capital expenditures will be initiated in the foreseeable future;
• Some backlog on processing tests due to restructuring of hours and laboratory layout requirements; and
• By appointment only lab draws were in effect beginning around February 2020 for some facilities and ongoing through April 2020 which impacted test volume slightly.

Delaying treatment in patients with overall good prognosis would be detrimental to the outcome in some patients prescribed targeted therapies, primarily cancer therapies.  Therefore, oncologists report only minimal delays in treatment which is often determined case-by-case, dependent on factors such as disease status, cancer type, age of the patients, etc.

For example, systemic therapy may be delayed for a short period in patients aged 50 or older with non-aggressive tumor types; in contrast, delaying treatment in an aggressive tumor could be catastrophic to the patient’s outcome.  The National Institutes of Health (NIH) lists more than 200 clinical trials currently underway for COVID-19 biomarker discovery, development and clinical application.

Along with new developments, diagnostic service providers are also shifting workloads to address the demand for COVID-19 services.  MiraDx, for example, has opened its CLIA-certified lab to providing COVID-19 test services.  The lab has an analyze capacity of over 9,000 tests with no backlog, reported by MiraDx.  The company also reports test results are available in approximately 48 hours and are being prioritized for hospitals, essential workers and field-based healthcare workers.  MiraDx lists the test at $150 per completed test.

There is also a growing trend for treatment centers, specifically cancer treatment centers, and research hospitals to get involved in the COVID-19 recovery plan.  The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University (Baltimore, Maryland, United States) is gearing up to commence a Phase II trial to promote recovery from COVID-19 with ivermectin or bicalutamide endocrine therapy.  The study is an interventional trial with an estimated enrollment of 60 participants that have had a confirmed PCR test of COVID-19 infection and require inpatient hospitalization due to COVID-19 with minimal or no respiratory symptoms. Estimated start date is June 2020 with estimated completion in June 2021.

 

Cell therapy involves the modification of human cell which are used to replace or repair damaged tissues or cells. Two areas with growing development and commercialization include chimeric antigen receptor (CAR)-T therapies and stem cell therapies.

According to a recent report from Kalorama Information, the global market for cell and gene therapy in 2020 is estimated to reach $3,866 million And most of the market is for the treatment of cancer. Dermatological, Cardiovascular – Blood, Oncology, Ophthalmic, Musculoskeletal and other conditions.

With the COVID-19 crisis, there are some efforts to adapt this promising technology to the treatment and prevention of the disease. There are a number of companies that are responding to the call to develop a therapeutic or vaccine for the coronavirus including:

Vitro Biopharma offers its umbilical cord derived stem cells AlloRx stem cells and has a patent-pending and scalable manufacturing platform to provide stem cell
therapies to COVID-19 patients.

Celularity and Sorrento Therapeutics entered into collaboration for CYNK-001, an allogeneic, off the shelf, placental-derived NK cell therapy. The companies on January 30, 2020, launched a clinical and manufacturing collaboration designed to expand the therapeutic use of Celularity’s CYNK-001 to COVID-19. Sorrento and Celularity agreed to assess CYNK-001 as a potential novel therapy for coronaviruses, specifically SARS-CoV-2

It’s even possible CAR-T, currently used for types of cancer with limited therapeutics, could be used for COVID-19. CAR-T involves using modified versions of the patient’s own cells for treatment. The engineering of specific virus-targeting receptors onto a patient’s own immune cells is now being explored by scientists from Duke-National University of Singapore (Duke-NUS) Medical School (Duke-NUS), as a potential therapy for controlling infectious diseases, including the COVID-19-causing virus, SARS-CoV-2. This therapy that has revolutionized the treatment of patients with cancer has also been used in the treatment of other infectious diseases such as Hepatitis B virus (HBV), as discussed by the School’s researchers in a commentary published in the Journal of Experimental Medicine.

According to the university, this type of immunotherapy requires specialized personnel and equipment, and it needs to be administered indefinitely. This makes it cost-prohibitive for treating most types of viral infections. However, in the case of HBV infections, for example, current anti-viral treatments merely suppress viral replication and cure less than 5% of patients. Treating these patients with a combination of anti-virals and CAR/TCR T cells could be a viable option. The team’s approach using mRNA electroporation to engineer CAR/TCR T cells limits their functional activity to a short period of time, and hence provides enhanced safety features suited for its deployment in patients with

Despite these efforts, the majority of the market currently is and is expected to represent treatments for cancer.  Kalorama’s report breaks down the market by types of cancer including Blood cancers, Prostate cancer, Melanoma, Other cancers. Oncology drugs Kymriah, Provenge, and Yescarta are primarily responsible for generating sales in the segment.

Prognostic and Other Evaluative Tests Kits Join Companion Diagnostics in U.S. Cancer Diagnostics.  Kalorama Information covers molecular in vitro diagnostics (IVD) markets for cancer and blood disorders inThe World Molecular Diagnostics Market, 7th Ed.

The U.S. Food and Drug Administration (FDA) recently cleared Qiagen’s ipsogen JAK2 RGQ PCR Kit for detection of the V617F mutation on the JAK2 gene associated with the myeloproliferative disorder polycythemia vera. The cancer test kit assists patient evaluation for the particular form of leukemia and is routinely tested in myeloproliferative neoplasms (MPNs) negative for mutation in the BCR-ABL gene. Kit availability for JAK2 testing will make the test more widely available to health systems for the implementation of personalized medicine for leukemia patients. Qiagen’s incremental market opportunity with the test kit is less than $10 million, but the molecular cancer diagnostics heavyweight has built its global 20% market share on just such individually small product markets.

Companion diagnostics are Qiagen’s core products in molecular cancer diagnostics, including co-labeled kits for EGFR, KRAS and BRAF mutations. While companion assays will continue to grow the molecular cancer diagnostics market, industry development activities are also focused on liquid biopsy tests that can broadly address cancer testing – from early cancer detection and multiplex profiling of cancer cells through non-invasive tumor monitoring. Panel tests performed using PCR or next-generation sequencing (NGS) are expected to become an increasingly significant element in the U.S. molecular cancer diagnostics market. The recent clearance of Qiagen’s JAK2 test kit can be interpreted as a step by the company in preparation for the submission of other non-pharmacodiagnostic tests or a leukemia panel.

Companion diagnostics are rising to the forefront of pharmaceutical development and treatment. Companion diagnostics increase the probability of clinical success by identifying patients with the presence of biomarkers or disease-specific therapeutic targets that can dramatically improve outcomes. Companion diagnostics can also decrease costs by identifying the patient population that will most likely benefit from the therapy, and ruling out therapies that are not likely to be effective. This is especially critical given the cost of many new cancer therapies. Companion diagnostics also improve patient outcomes by selectively determining which patients will respond to therapy.
The emergence of new technology has opened doors for companion diagnostic research, discovery, development and commercialization. This has resulted in a huge increase in exploratory studies, diagnostic developments, and clinical usefulness in the pursuit of personalized medicine.
The growing interest in companion diagnostics is fueling many novel partnerships between big pharma and diagnostic companies. In the past, each individual company would develop its own product, many times at great risk and expense. In many cases, it was viewed by industry participants as too risky to devote resources towards the development of a test that may never be used. This has opened the door for co-development and partnership deals to take center stage. In 2010 there were approximately 25 big pharma and diagnostic companies’ deals, up from 19 in 2009 and only 7 in 2008. That number has increased to over 50 since 2011 with oncology as the primary area of companion diagnostic licensing/partnership deals in recent years.
Following is a list of recent companion deal etched in the first half of the year.

Produced from information included in Kalorama Information’s study Companion Diagnostic Markets
FULL MARKET REPORT WITH DETAILED MARKET SIZEING AND FORECASTS AVAILABLE.

Companion DX Partnerships, First Half 2014
Diagnostic Company Pharmaceutical Company CDx Area Date Roche/Ventana Merck Cancer July 2014 Roche/Ventana Ferring Infertility June 2014 Qiagen Eli Lilly Undisclosed June 2014 Sysmex Inostics Merck Colon cancer June 2014 Roche/Ventana MedImmune NSCLC June 2014 Nanostring Celgene Lymphoma June 2014 Qiagen Eli Lilly Cancer June 2014 Dako Merck Cancer May 2014 Foundation Medical Clovis Cancer May 2014 Abbott Diagnostics Iderra B-cell Lymphoma May 2014 Roche/Ventana Genmab Cancer April 2014 20/20 Gene Systems NIH Kidney cancer February 2014 Dako Amgen Cancer February 2014 Theradig Splicos HIV/obesity January 2014 Illumina Amgen Colon cancer January 2014 Dako Merck Cancer January 2014 Lab Corp Arca biopharma Atrial Fibrillation January 2014 Leica Arno Cancer January 2014

The majority of partnerships have been with established diagnostic players such as Roche and Abbott but there seems to be a shift recently moving toward specialized diagnostic companies as seen in the Eli Lilly and PrimeraDx partnership. Most of the partnerships have been exclusive for a limited time period.
There are at least four current business models for the development of companion diagnostics.
The first of these models is in-house development. This usually is seen in large pharmaceutical companies with many divisions. The company uses internal expertise to develop a companion diagnostic usually for its own research and development projects in clinical trials.
A second model is the partnership/licensing approach. This seems to be the most popular approach and one that is the most cost effective for the pharmaceutical company and the diagnostic company alike.
The third approach is the acquisition model where the pharmaceutical company acquires the companion diagnostic company to provide in house development. Eli Lilly’s acquisition of Avid Radiopharmaceuticals to
develop a diagnostic for Alzheimer’s disease and advance diagnostics development platform is just one of many examples of this approach.
A fourth model is the hybrid approach where pharmaceutical company collaborate with companion diagnostic companies to develop products, while also developing internal capabilities as well. Novartis established an internal molecular diagnostics unit but it also collaborates with other companies for companion diagnostic development.
Cancer is the driver of companion diagnostic products. With the advent of gene sequencing, treatment for cancer began to move to a more personalized approach. . There are more than 41 oncology-focused biomarker/companion diagnostic products.
The majority of competitive participation for companion diagnostics is in the United States and Europe. However, competition is steadily escalating in the United States and Europe, which is encouraging more participation in other areas such as Asia and Latin America. There are numerous companies in the market which include large multiproduct companies such as Roche and Abbott and small niche developers such as 20/20 GeneSystems. Other companies include:
 20/20 GeneSystems
 Affymetrix
 Agendia
 Alere
 Beckman Coulter
 Becton Dickinson
 Biocartis SA
 Biodesix
 bioMerieux
 BioReference Laboratory
 bioTheranostics
 CardioDX
 Celera Alameda
 Clarient
 deCODE Genetics
 DiaGenic
 Genomic Health
 Genoptix Medical Laboratory
 Illumina
 Johnson & Johnson
 Life Techologies
 Memory Dx
 Myriad Genetics
 Nanostring Technologies
 OPKO Health
 Provista Dx
 Qiagen
 Seimens Healthcare
 Singulex
 Thermo Fisher Scientific
Produced