Despite IVDs being at the top of global market attractiveness index, many challenges remain unaddressed.
In vitro diagnostics (IVD) are of utmost importance in the global healthcare industry and comprise the highest revenue generating segment of the medical devices market valued in the multi-billion-dollar range. IVDs are of significant value to the general public as they are deemed not only as indispensable tools for medical diagnoses but also as decision-making aids for disease prevention and timely treatment to enhance well-being and
keep healthcare costs under check. In addition, the IVDs are also one of the vital aids that address the needs of the governments, payers, and patients by delivering optimal, individualized, and affordable treatments.
More than 4000 different diagnostic tests are now possible, and as more IVD tests become compatible with point-of-care (PoC) environments, healthcare providers may take advantage of the benefits of these evolving IVDs for effective treatment of life-threatening illnesses through the optimization of healthcare delivery. IVDs have already tremendously impacted cancer diagnosis and treatment globally by gaining deeper insights into genetic pathways of the disease enabled by human genome sequencing. As a result, identifying faulty genes, personalized risk predictions, and tailored therapies have now become possible. These factors and rapid technological developments should drive the growth of the IVD market in the next 5 years. The market is also expected to be driven by the aging demographics of the developed world, the rising demand and improving healthcare infrastructure in the developing world, and most importantly by the shift from curative to preventive healthcare for both infectious and chronic diseases such as diabetes.
Despite IVDs being at the top of global market attractiveness index, big challenges need to be addressed. The regional and country-wise differences in regulatory aspects, market approvals and entry bottlenecks, affordability issues, reimbursement inadequacies, logistics, and healthcare infrastructure may hold the market back. IVD companies need to look at each country’s market landscape and IVD requirements, and then tailor their entries, launches, and marketing strategies to gain a strong foothold.
Indian market dynamics
The Indian IVD instruments and reagents market is valued at more than Rs. 6000 crore in 2017 and is expected to have a compounded annual growth rate (CAGR) of 20 percent. Reagents constitute around 80 percent share of this market. Increased healthcare awareness, preventive health checkups, and shift from manual to semi-automated (SA) and automated instruments are key drivers. In many segments, 95 percent of fully automated (FA) instruments are placed, and this trend is fast catching up with their SA counterparts too, although this trend is more prevalent in the private sector. Globally automated instruments are steadily replacing their SA counterparts. However, in India the scenario is slightly different. The discerning buyer, generally either the government or the labs in tier 1 cities are upgrading to the FA instruments, albeit the larger facilities with their clout are able to manage to get most of their requirement on a placement/rental basis rather than an outright purchase. The new labs, with stringent budgets in smaller towns are opting for SA instruments, as the number of tests conducted also does not justify large initial investment.
By segment. The Indian immunochemistry market in 2017 is estimated at Rs. 2170 crore. The market for instruments and reagents is estimated at Rs. 1550 crore, ELISA kits at Rs. 330 crore, and rapid tests at Rs. 290 crore. The reagents in 2017 earned revenues of Rs. 1385 crore, and instruments Rs. 165 crore.
In 2017, the Indian biochemistry instruments and reagents market is estimated at Rs. 1540 crore, with reagents continuing to dominate with an 81 percent market share. The Indian market is steadily shifting to reagents sold for open systems; however, system pack reagents continue to hold sway on the market with a 41 percent market share. In the analyzer segment, the market is moving toward FA analyzers, which constituted 53 percent of the market in value terms. In volume terms, the SA segment had an 88 percent share in 2017.
The Indian hematology instruments and reagents market in 2017 is estimated at Rs. 1057 crore, an 11 percent increase over 2016. Reagents constitute 63.4 percent of the market. While, reagents increased by 11.6 percent in 2017 over 2016, and instruments by 9.9 percent in value terms; the increase of 19.1 percent of instruments in quantity terms was larger in the same period. FA 3-part analyzers dominate the instruments market with an 86 percent share in volume terms and 63 percent share in value terms. SA analyzers are gradually exiting the segment, and have a mere 2 percent share in value terms. Within the 5-part FA analyzers, the high-end dominate with a 56 percent share in value terms, whereas the entry level 5-part ones have a 64 percent share in quantity terms.
The Indian coagulation instruments and reagents market in 2016-17 is estimated at Rs. 123 crore, with reagents dominating with an 88 percent share. The FA instruments have a 66 percent market share in the instruments segment. A rough estimate indicates the installed base in 2016 as 3650 instruments, with SA instruments at 3200 units, and FA ones at 450 units. This segment sees an annual growth of about 10–12 percent, with the FA segment growing at 7-8 percent, and private laboratories accounting for 80 percent of the FA instruments sales.
The Indian market for microbiology instruments and reagents in 2016-17 is estimated at Rs. 310 crore, maintaining an annual 5-6 percent growth. Reagents dominate with an 83 percent share. The instruments-based reagents are more popular, and commanded a share of 67 percent in 2016, while the non-instrument based reagents contributed the balance of 33 percent, having declined from 44 percent in 2015-16.
The Indian molecular diagnostics market is estimated at Rs. 111 crore in 2016-17. Reagents contributed Rs. 100 crore and four units of high-throughput extraction analyzers and eight units of low-throughput extraction analyzers contributed the balance Rs. 11 crore. Additionally, 6 units of high-throughput and 4 units of low-throughput extraction analyzers were also placed. Although molecular diagnostics tests are increasingly being preferred and new laboratories and diagnostic centers are being set up, the preference for placements, especially for high-throughput analyzers remains. Reagents continue to be the mainstay and see an increase of about 12–15 percent every year.
The Indian market for urinalysis analyzers and reagents in 2017 is estimated at Rs. 153.82 crore. Reagents continue to dominate with an 81 percent share, estimated at Rs. 125 crore. The FA analyzers segment is estimated at Rs. 13 crore, and the semi-automated instruments comprise the balance share of Rs. 15.82 crore.
The global IVD market is projected to reach USD 87.93 billion by 2023 from USD 68.12 billion in 2018, at a CAGR of 5.2 percent, predicts Research and Markets. The rising demand for early and accurate disease diagnosis, increasing prevalence of infectious diseases, increasing adoption of FA instruments and automation in laboratories, increasing adoption of PoC testing, and growing awareness of personalized medicine are the key factors driving the growth of the market.
On the basis of technology, the market is broadly divided into immunochemistry/immunoassay, clinical chemistry, molecular diagnostics, hematology, microbiology, coagulation & hemostasis, urinalysis, and other technologies. The immunochemistry/immunoassay segment is expected to dominate the market in 2018. The large share of this segment is primarily attributed to the growing preference for these technologies in clinical diagnostics over conventional methods and the ability of immunoassay/immunochemistry technologies to offer faster results with high-sensitivity and accuracy.
On the basis of end user, the market is segmented into laboratories, hospitals, academic institutes, PoC testing, patient self-testing, and other end users. The hospitals segment accounted for the largest share of the IVD market in 2017, owing to the large volume of diagnostic tests carried out in hospitals. However, the PoC testing segment is estimated to grow at the highest CAGR during the forecast period.
North America is expected to command the largest share of the market in 2018 with availability of government funds, growing use of molecular diagnostics in genetic disorders and cancer screening, and the presence of key players in the region. However, Asia-Pacific is expected to register the highest growth rate due to rising healthcare expenditure; increasing number of hospitals and clinical diagnostic laboratories in India and China; increasing incidence of chronic and infectious diseases; rapid development in the healthcare infrastructure of developing countries such as India, China, and South Korea; and increasing per capita income of the middle-class population in the region.
The major factors driving the growth of this market in the North American region include accessibility to advanced technologies, increasing demand for laboratory automation, expansion of molecular diagnostics for genetic disorders and cancer screening, and presence of major leading companies in the United States of America.
The major global players in this market include Roche, Siemens, Abbott, Beckman Coulter (part of Danaher), Alere, Ortho-Clinical Diagnostics, bioMérieux, Thermo Fisher, Sysmex, Biorad, Becton Dickinson, Genprobe, and Bayer, which account for about 75 percent of the total market. Some of the other notable companies playing a key role include Cepheid, Illumina, Qiagen, Quidel, and Sequenom.
Emerging market trends
Several of the same powerful trends reshaping healthcare and clinical laboratory services are having equally significant influence on IVD manufacturers. In particular, the consolidation of hospitals and physicians, as well as the emergence of new sites of service – such as urgent care centers and retail clinics – are motivating IVD companies to tailor new diagnostic systems to the unique needs of these entities. Top trends that will affect IVD in the near future include:
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 7 days before samples are processed and tested for the presence of circulating cell-free DNA.
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. 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. Being a fledgling industry, a number of growing pains are expected before it becomes mainstream.
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 identificaiton (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 PoC settings
Curetis currently has developed the Unyvero Platform. Unyvero cartridges are available for three applications, Unyvero HPN Pneumonia Cartridge, 19 resistance markers and 20 pathogens; Unyvero i60 ITI Cartridge, for implant and tissue infections, for detection of up to 102 analytes; and Unyvero BCU Cartridge, for blood culture, for detection of up to 103 analytes. In addition, an intra-abdominal infection application is under development. In the United States of America, 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.
Some developments of significance 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. Decrease in life science funding in the United States of America has 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.
In-vitro diagnostics 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 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. An increasing demand from the educated public 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 in-vitro diagnostics. 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.