Given the current dynamism in the sector, occasioned by regulatory, market, and technological forces, IVD companies can no longer hold back. This is a time of great opportunity for the industry.
Indian in vitro diagnostics (IVD) has witnessed several changes and additions to its gamut of offerings in the recent past. There has been a paradigm shift from traditional diagnostics to a new-generation diagnostic that works at the gene level. This change was possible only due to the inclusion of advanced technology, such as genetic testing, molecular diagnostics, polymerase chain reaction (PCR), and next-generation sequencing (NGS). Fast turnaround, reliability, user-friendliness, and predictability of predisposed diseases are a few significant qualities that are making these technologies attain their share in major offerings of diagnosis providers around the world.
The Indian IVD market is estimated to grow at a compound annual growth rate (CAGR) of 7 percent during 2019–2023. An increasing demand from more aware patients for more information about their predisposition for serious diseases, and how these potential illnesses can be detected at an early stage are the factors driving the market for IVD. This factor has been posing a significant growth in the market, with the entry of several new technologies that are being adopted by primary end-users, such as hospitals, clinics, laboratories etc. The advantages of these new and upcoming technologies, such as precision, resourcefulness, portability and efficiency, are expected to fuel the market growth further.
Complex reimbursement policies and procedures. The lack of a proper reimbursement system around the globe is a major concern for the IVD market. The process of securing reimbursement and funding for a diagnostic test in India is extremely challenging. Stakeholders need to recognize the awareness required by the payers/purchasers. This fact requires extensive research and interpretation of a very large amount of data. Moreover, international reimbursement structures vary from country to country; hence, interested parties have to come up with new and effective strategies/tactics every now and then. India can take cue from global leaders, like the United States and Germany, to draft a national plan for healthcare insurance and coverage. Therefore, strategies are required to be altered as per the target market, making it a really cumbersome and tedious task. Moreover, the developers and marketers of IVD tests have to go through a time-consuming and resource-intensive regulatory procedure, in order to bring their test to the market. Moreover, they not only have to clear the US FDA hurdles, but also have to gain confidence of the payers to obtain insurance coverage and payment for their devices. As a result, several companies tend to avoid these series of procedure or drop the idea of entering in this market, altogether.
Disposable IVD devices dominate the Indian IVD market. Based on usability of IVD devices, the disposable devices segment led the Indian IVD market with an approximately 70 percent share in 2017. This share is expected to further increase over the next 5 years, due to the emergence of point-of-care testing and the growing demand for portable diagnostic devices.
The global IVD market is expected to reach USD 102.4 billion by 2022 from USD 74.1 billion in 2017 at a CAGR of 6.7 percent. Increase in incidence of chronic and infectious diseases and increase in geriatric population drive the market. In addition, increase in the number of public and private diagnostic centers, and point-of-care centers is expected to fuel the market. Furthermore, rise in investment for the advancement of healthcare sector by government is anticipated to boost the market. However, stringent government regulations for the manufacturing of IVD products and inadequate reimbursement policies are expected to hamper market growth. Ongoing R&D activities related to IVD are anticipated to present new opportunities for the growth of the IVD market.
Based on product type, the IVD market is categorized into reagents, instruments, and software and services. The reagents segment accounted for the highest market share in 2017, and the software and services segment is expected to grow at the highest growth rate during 2017–2022. The growth of the reagents market is attributed to the recent introduction of novel reagents and wide availability of effective and cost-efficient reagents. On the basis of technique, the immunodiagnostics segment captured the highest market share in 2017, owing to the increase in demand for personalized medicines. On the basis of application, the infectious diseases segment captured the highest market share in 2017, owing to the increase in prevalence of infectious diseases and rise in preventive healthcare awareness among the population. Based on end users, the standalone laboratory segment captured the highest market share in 2017, primarily due to non-availability of complex tests in hospitals and commercial clinics.
By geography, North America accounted for the highest share of the market in 2017, followed by Europe. However, Asia-Pacific is anticipated to witness the highest growth rate during the forecast period. In addition, this region is expected to emerge as the area with maximum growth potential due to the focus of key players in the emerging economies and improvement in the healthcare infrastructure.
In the past 50 years, IVD technologies were used only in clinical labs. Initially, pregnancy tests were undertaken in laboratories; however, these days, one can take the tests at home by placing urine samples on test sticks. These tests are accurate, less time-consuming, and can be easily performed. Similarly, the blood glucose levels testing can be done using point-of-care testing devices such as glucometers. The HIV test too can be conducted at home using a mouth swab that is inbuilt in the diagnosis device and provides results in 20–40 minutes. Previously, these tests were carried out in clinical laboratories, where blood sample of the individual was taken. As there are various advancements in the conventional technologies of IVD, there is increase in demand for IVD in the market. These advancements contribute in driving the global IVD market.
Major companies operating in the IVD market adopted product launch as their key development strategy. Companies operating in the global market include Thermo Fisher Scientific Inc., Alere Inc., BioMérieux, Danaher Corporation, F. Hoffmann-La Roche AG, Becton Dickinson and Company, Bio-Rad Laboratories, Bayer AG, Sysmex Corporation, and Johnson & Johnson among others.
Trends to Watch in 2018
Five clinical testing trends are most likely to see further development in 2018.
Liquid biopsy and multi-target liquid biopsy. Non-invasive cancer testing will continue to trend in 2018. Qiagen has been pioneering the use of liquid biopsy-based companion diagnostics as a less-invasive option to complement surgical biopsies for genomic profiling of cancers. Qiagen is expanding its industry-leading portfolio of liquid biopsy solutions addressing all major technologies: cell free DNA, exosomal analytes, and circulating tumor cells. Qiagen’s leading portfolio of liquid biopsy technologies also includes the QIAamp Circulating Nucleic Acid Kit, which is considered to be the gold standard sample technology for the processing of free circulating DNA and RNA, as well as the REPLI-g product line, which enables genomic analysis from single cells.
PAXgene technology offers automated solutions for the collection, stabilization, and purification of circulating cell-free DNA from blood samples. It allows whole blood to be drawn and stored at cooled and ambient temperatures for up to seven days before samples are processed and tested for the presence of circulating cell-free DNA.
At the JP Morgan healthcare conference, Guardant Health CEO Helmy Eltoukhy said during the liquid biopsy company’s presentation that it plans to submit to the US Food and Drug Administration a liquid biopsy assay, Guardant360IVD, by the end of 2018. The firm has also developed a liquid biopsy assay that analyzes more than 500 genes, GuardantOMNI, which it launched in the second half of 2017 and which has so far seen higher than anticipated demand. GuardantOMNI is the firm’s second product after Guardant360, a liquid biopsy assay it launched in 2014 which analyzes 73 genes.
The consumer rules. In some cases, the consumer is seeking out testing directly. The global direct-to-consumer (DTC) genetic health testing market totaled USD 99 million in 2017. With average 25.6 percent growth, the market will grow to USD 310 million in 2022. Kalorama Information said growth of the DTC genetic testing market is born out of a paradigm shift among consumers who are seeking greater control over their own healthcare. Ethical dilemmas are also a concern for the industry. This involves the interpretation and use of the genetic test results. To address this concern, many DTC genetic testing companies have employed onsite genetic counselors. Because this is a fledgling industry, there will be a number of growing pains before this industry is mainstream.
A growing segment in clinical laboratory testing is provided as a service by walk-in style clinics in pharmacies and retail food outlets. Retail clinics, also known as convenience clinics, have become a quickly growing segment of the U.S. healthcare marketplace. Retail patient service centers have grown in number since they first came on the scene in the mid-2000s. In 2010, there were 1200 retail clinics operating in 32 states in the United States of America, according to the Convenient Care Association. Accenture Consulting estimates the number of U.S. retail health clinics would reach more than 2800 in 2017. In 2016, total U.S. retail clinic sales are estimated at more than USD 1.4 billion, an increase of 20.3 percent per year from USD 518 million in 2010. Through 2020, sales are expected to continue expanding.
With the Theranos (Palo Alto, CA) debacle in 2016, the allure of retail clinic ventures had faded somewhat. But, in 2017, Quest Diagnostics and Laboratory Corporation of America (LabCorp) have become more active and have been opening more patient service centers in grocery stores and retail pharmacies. In 2017, Quest announced plans to open patient services centers with several retailers, particularly in the states of Texas and Florida. Similarly, LabCorp disclosed an agreement with Walgreens Boots Alliance. Walgreens and LabCorp announced a collaboration through which LabCorp will develop and operate patient service centers within select Walgreens stores. The centers, which will be co-branded LabCorp at Walgreens, will offer LabCorp patient services in a secure, comfortable environment for specimen collection, located near the pharmacy area inside the store. Tests on specimens collected at the Walgreens locations will be performed through LabCorp’s network of primary and specialty laboratories.
Quest has been a leader in the movement for consumer empowerment in healthcare. The company has been a strong advocate of the effort to provide patients with direct access to lab testing through its Sonora Quest Laboratories joint venture. Nearly three million patients track and access their lab results and health data through its myQuest by Care360 patient portal and mobile app. Other consumer offerings include Blueprint for Wellness, a growing wellness business, and Blueprint for Athletes, a DTC biomarker monitoring service for amateur and professional athletes. In June 2017, Quest and Wal-Mart Stores announced they will open retail clinics. They will launch with a select number of locations (approximately 15) in Wal-Mart stores in Florida and Texas by the end of 2017. These co-branded sites will initially provide laboratory test services. Over time, offerings are expected to expand to include other basic healthcare services. This is in addition to Quest’s collaboration with Safeway grocery stores. Seven LabCorp centers at Walgreens locations will begin seeing patients in 2017, with five patient service centers in Denver and one in Morrisville, North Carolina expected to open later in 2017. The initial Walgreens sites will be in addition to LabCorp’s approximately 1750 existing patient service centers, providing even more options for patients to access LabCorp’s menu of over 4800 tests, including offerings in important areas such as women’s health, genomics, oncology, and companion diagnostics.
Skipping the pathogen: syndromic testing. Infectious disease tests most companies produce detect a single pathogen, or an antibiotic resistance gene. However, if a patient presents with general symptoms of a respiratory infection, or with symptoms of a gastrointestinal infection or some other type of infection, there are several different pathogens that may have caused the infection. This has led to the development of syndromic panels that include a panel of pathogens and often also resistance genes commonly found with the targeted type of syndromic infection.
- BioFire Diagnostics (a bioMérieux company) has commercialized the FilmArray platform. Four syndromic panels are currently available: respiratory panel, meningitis/encephilitis (ME) panel, gastrointestinal (GI) panel, and blood culture identification (BCID) panel. BioFire Diagnostics also offers the FilmArray respiratory panel EZ on the FilmArray EZ Configuration platform. This is a CLIA waived test designed for point-of-care settings
- Curetis currently has developed the Unyvero Platform. Unyvero cartridges are available for three applications: (1) Unyvero HPN pneumonia cartridge – 19 resistance markers and 20 pathogens, (2) Unyvero i60 ITI cartridge – for implant and tissue infections; for detection of up to 102 analytes, and (3) unyvero BCU cartridge – for blood culture; for detection of up to 103 analytes. In addition, an intra-abdominal infection application is in development. In the United States, Curetis has conducted clinical trials and submitted to the FDA, seeking clearance of the Unyvero Platform and lower respiratory tract infection (LRT) application cartridge
- GenMark Diagnostics has developed the ePlex system. A respiratory panel is currently available
- In addition to the single disease tests, Luminex is developing tests on the company’s Verigene platform. Luminex showcased the Verigene respiratory pathogen’s flex test at the San Diego AACC Annual Meeting in 2017. Luminex has also developed two gastrointestinal infection tests
Microbiome. The continuous search for the etiology of diseases as part of the body’s systemic response to change has led to a consideration of the gut microbiome as part of disease processes. While still in the early phase of development a number of companies have developed assays for the study of the microbiome and there is a proliferation of microbiome related therapeutics.
Bacteria in the gut, mouth, and plaque (biofilms) have been implicated in a number of diseases including: diabetes, obesity, autoimmune, cancer, diarrhea, and mental disorders. Thousands of species of microbes – bacteria, viruses, fungi, and protozoa – inhabit every internal and external surface of the human body. The microbiome’s complicated relationship with its human host is increasingly considered crucial to health. Imbalances in the microbiome’s diverse microbial communities, which interact constantly with cells in the human body, may contribute to chronic health conditions, including diabetes, asthma and allergies, obesity and the metabolic syndrome, digestive disorders including irritable bowel syndrome (IBS), and autoimmune disorders like multiple sclerosis and rheumatoid arthritis.
Researchers also evaluated specific diseases associated with disturbances in the microbiome, including gastrointestinal diseases such as Crohn’s disease, ulcerative colitis, IBSs, and obesity, as well as urogenital conditions, those that involve the reproductive system, and skin diseases like eczema, psoriasis, and acne, diabetes, autoimmune disorder, acute diarrhea, cancer, mental disorder, and others.
Some of the significant developments include:
- May 2016, the U.S. Office of Science and Technology Policy (OSTP) announced the formation of a National Microbiome Initiative (NMI), a collaboration of government agencies and private companies to research microbiomes across different ecosystems. The NMI will launch with an investment of more than USD 121 million from various federal agencies for 2016 and 2017, including USD 20 million from the National Institutes of Health, USD 16 million from the National Science Foundation, USD 10 million from the Department of Energy, USD 12.5 million from the National Aeronautics and Space Administration, and more than USD 15.9 million from the Department of Agriculture
- The University of Pittsburgh Schools of the Health Sciences and the University of Pittsburgh Medical Center announced they are taking part in the NMI by collaborating on a joint venture dedicated to better understanding the human microbiome. The university’s Center for Medicine and the Microbiome will bring clinicians and researchers together to explore how the microbiome affects health and disease, and to find new therapies for diseases affected by the microbiome. The center will receive more than USD 5 million from the university’s Department of Medicine, UPMC, UPMC Enterprises, the Pitt School of Dental Medicine, and uBiome, a microbial genomics company based in San Francisco, CA
- November 2016, Bio-Rad Laboratories announced a partnership with Genetic Analysis whereby Bio-Rad received commercialization rights in certain undisclosed territories for Genetic Analysis’ CE-marked GA-map technology to detect microbial imbalances, also known as gut dysbiosis
Merging, mixing, matching in IVD: still the rule. A number of totally disparate phenomena have come together to paint the IVD industry with a fresh and refreshing coat of paint. Human genome research is providing areas of expansion for molecular testing. Decreases in life science funding in the United States of America have encouraged companies active in this space to migrate their technologies for clinical applications. The result is the entry of companies such as Illumina, Thermo Fisher Scientific, PerkinElmer, and Affymetrix (now part of Thermo Fisher Scientific) to the diagnostics market. They have tweaked their research products to accommodate the needs of clinical lab medicine. These companies have made investments to become clinical companies. These companies join expansion activity into new market segments by companies already involved in the IVD industry.
There are several reasons for the conservatism of the IVD industry. But given the current dynamism in the sector, occasioned by regulatory, market, and technological forces, IVD companies can no longer hold back. This is a time of great opportunity, albeit with some challenges, for the industry. As the industry looks to grow while managing existing investments, it must adopt a dual strategic approach toward technology-renewal existing systems and process for greater efficiency while adopting completely new technologies and practices for value creation.