India has been one of the fastest-growing diagnostics markets over the past few years, with a growing share in the global in-vitro diagnostics industry. The IVD market has witnessed a steep incline in recent years on account of increasing number of tests and higher sales of instruments and consumables across an array of segments. The market is comprised of a large number of small-scale manufacturing entities along with large diagnostic products-producing companies, as well as several pathological laboratories. While rising disposable incomes, soaring population with lifestyle diseases, and increase in the number of tests driven by the trend of early detection will lead to an increase in spending on diagnostic tests in India, steep rise in automated and accredited laboratories is expected to augment the revenues from the IVD market in India.
The Indian IVD testing market is estimated at Rs.5000 crore in 2015. Due to recent rapid technological advances and automation, the range and complexity of diagnostic tests have overwhelmingly increased. This has made lab tests much easier to use and less error-prone, with more precise and timelier results, thus transforming medical practice. As a result of these rapid innovations, disease detection has been made possible much before the appearance of symptoms, along with the prediction of beneficial and adverse treatment outcomes. These developments have in turn enabled personalized treatment through the emergence of point-of-care (POC) tests and home-based testing in the form of blood glucose meters for diabetics, pregnancy tests, and cholesterol tests. These tests facilitate more rapid decision-making, especially for management of major chronic diseases such as diabetes, hypertension, or cardiovascular conditions. Instead of a patient having to wait for test results and schedule his or her next visit, test values for key biochemical parameters (such as, for example, HbA1c or lipid profiles), are generated the same day, allowing the doctor to make treatment decisions during one visit. In addition, new tests have become less invasive, easier to perform, and more patient-friendly. Likewise, for critical care, PoC tests enable doctors to make life-saving decisions within minutes, as opposed to waiting for hours for test data that was once available only from a central lab.
The global market for in vitro diagnostics (IVD) products totaled USD 60.3 billion in 2015, poised to be USD 81.1 billion by 2020, at a compound annual growth rate (CAGR) of 6.1 percent. In 2015, the reagents and kits segment accounted for the largest share of approximately 79.3 percent of the IVD product market, expected to grow at a CAGR of 6.4 percent, over the next 5 years. North America, valued at USD 25.3 billion in 2015 leads the market. It is expected to be USD 29.4 billion in 2020, increasing at a CAGR of 3.1 percent. Asia is the fastest-growing region of global IVD market with a CAGR of 12.9 percent from 2015 to 2020. The market is valued at USD 15.3 billion in 2015 and should reach USD 28.2 billion by 2020.
Emerging infectious disease threats, progress on sequencing in clinical medicine, and near-patient DNA testing are among the trends that manufacturers and investors should be on the lookout for in vitro diagnostic (IVD) testing in 2016.
Expect More Acquisitions by Heavyweights
IVD testing is complex now and companies will need to acquire the technology parts they lack to continue to compete. Last year, there were scores of acquisitions, partnership deals, and distribution agreements in IVD. In March 2015, Roche announced a global distribution agreement for kits and enzymes for cellular analysis, proteomics, and conventional PCR applications with Sigma-Aldrich, and in April 2015, became the majority shareholder in Foundation Medicine. Foundation Medicine is a molecular information company dedicated to understanding the genomic changes that contribute to each patient's unique cancer. In March 2015, Qiagen announced an expansion of its portfolio of liquid biopsies through the acquisition of AdnaGen's (Hamburg, Germany) technology from Alere Inc. AdnaGen markets the CE-marked line of AdnaTests that enable enrichment and molecular analysis of CTCs from blood samples including AdnaTest Breast Cancer and AdnaTest Prostate Cancer, which are already marketed in Europe and offer improved treatment monitoring and earlier detection of tumor relapse.
Pragmatic Personalized Medicine
In the area of infectious diseases, personalized medicine (PGx) tests detect therapy-resistance factors in HIV, hepatitis, hospital-acquired infections, and tuberculosis. Tests for hereditary diseases such as cystic fibrosis, multiple sclerosis, Alzheimer's disease, cardiac diseases, and others are helping hone into new therapeutic approaches. Molecular assays in coagulation help treat difficult-to-manage patients and dose drugs such as Coumadin and Plavix. The contribution that personalized medicine has made in oncology is almost beyond measure. The anticipated death sentence associated with cancer has been all but eliminated in some cancers such as breast, colon, and prostate. Technologies such as next-generation sequencing-based gene panels are making the heralded concepts of targeted medicine a reality. 2016 should see more solutions, and it is expected that companies will limit expectation about immediate delivery of exact personalized care and focus on obtainable results. As more gene variants are linked to various forms of cancer and more drugs are targeted to those specific forms of disease, lab professionals claim that the regulatory path for commercial tests does not respond to physicians' need because it takes too long to adjust test panels. In-house-developed lab panels can be updated as soon as validated gene targets are discovered.
The Service Industry Is Here to Stay
The test service model has become a major route for highly sophisticated and specialized molecular tests. At one time, the most successful molecular test services offered cancer diagnostics using in situ hybridization (ISH), sequencing, and PCR analysis of biopsied tissue. More recently, test services have emerged for prenatal chromosome mutation analysis, autism, psychosocial drug metabolism, gastrointestinal autoimmune diseases, and cardiac risk genetics, among others. The service model for molecular tests has been adopted by private reference labs, large hospitals, and company-owned test services. The company-owned test service business model is primarily a phenomenon of the U.S. There is a long history for the commercialization of highly specific assays as test services. Many groundbreaking tests in the areas of viral load testing, anatomical pathology special analyses, and molecular assays were first launched by reference labs in the U.S. This sensitized the medical community to the value of these test services. The first generation of these tests targeted small markets where the financial investment for FDA market clearance - especially the PMA route that would have been required for these unique and first-to-market tests - would have been difficult to recuperate with a commercial test kit.
Emerging Disease Threats
A number of emerging diseases are making their global presence a public health problem. Once thought to be limited geographically to the tropics or developing countries, they continue to show up all over the world and are among the most complex and dangerous infectious diseases to prevent and control. The Ebola threat has awakened the American public to pandemic disease threats and created an opportunity for elevated approvals on related test devices. But Ebola is by no means the only emerging disease threat, nor is it the most likely to find cases in the United States. The rise of global transportation, trade, and climate change allows insects to easily carry disease organisms across borders, infecting animals as well as humans. Because of increased global travel, there is the fear that diseases usually found only in the developing world can be transported, unwittingly, to countries of the developed world as well. Furthermore, developed nations are no longer safe from diseases such as malaria. Chagas and Dengue fever were once thought to be a developing-world problem alone. Today, infectious diseases can travel in a matter of hours to any part of the globe. A number of natural and human actions influence the introduction and spread of these diseases.
Near-Patient Molecular Diagnostics
To test for infectious diseases where time is of great concern, 2016 will see more developments in PoC molecular diagnostics. In 2015, Alere announced its i Influenza A & B, that provides molecular flu results in less than 15 minutes. Cepheid announced its 9-inch tall GeneXpert Omni, the world's most portable molecular diagnostics system enabling unprecedented access to accurate and fast diagnosis for patients suspected of TB, HIV, and Ebola. Such products also push infectious disease testing into the point-of-care (POC) and near-patient testing arena, allowing providers to initiate care during the same visit or day. These announcements built on previous developments in near-patient molecular last year.
Cancer: Immunotherapy and More
Immunotherapy for cancer exploded in 2015. It is already used in many cancer treatments, but it tends to be a second-line approach or reserved for advanced disease. In 2016, industry will see more immunotherapy treatments approved and they will likely become the first-line choice in many cancers.
Industry can also expect to see more cell-mediated therapies - engineering a patient's own immune cells to attack cancer - added to the cancer armamentarium. And expect to hear more about epigenetics - using the cancer cell's genetic programming to push it back toward normalcy.
Recently, the American Association for Cancer Research convened an international immunotherapy conference, which completely sold out. One of the biggest stories to emerge was how chemotherapy resistance can be overcome using engineered proteins. Resistance is an all-too-common problem that dampens the hopes of precision medicine. These proteins, which are smaller than antibodies, will bring immunotherapy to new levels in 2016.
New drug combinations, combining traditional chemotherapy with immunotherapy, will also blossom in 2016. Such approaches are already showing promise in lung cancer, prostate cancer, and melanoma. And one can expect new vaccines against cancer to emerge in 2016.
A New Approach to Clinical Trials
Traditional drug trials test a drug against a known cancer type. With the precision medicine revolution upon us, it has become evident that many cancers, regardless of type, often share the same genetic mutations. 2015 saw the first trials of using a drug in an off-label manner to target common mutations across cancers of many different organs. Such basket trials will explode in popularity in 2016 in an effort to bring greater patient access to drugs. This new clinical trial paradigm will become commonplace in 2016. Already the American Society of Clinical Oncology is sponsoring its first-ever basket trial, partnering with five drug companies. Expect preliminary results in 2016.
Leveraging Gut Microbes
The bacteria in the gut have long been known to play a role in the immune system and metabolism. Now, new research is showing that many diseases may be caused in part by gut microbes, and it is expected that the coming year will bring a flurry of new uses for these microbes.
One of the fast-growing applications is the use of fecal transplants to treat the deadly Clostridium difficile infection. Other diseases such as inflammatory bowel disease, irritable bowel syndrome, autoimmune diseases, and allergic diseases will likely see bacteria-based treatment advances in 2016.
Recently, gut microbes have even been shown to reduce the side effects of chemotherapy. Perhaps most exciting are the ways in which these bacteria are detected. Traditional methods of bacterial culture will be replaced by genetic sequencing of bacterial DNA. Such powerful information is already showing early promise in helping to stem transmission of drug-resistant bacteria within and between hospitals, a major cause of illness and death.
Lab on a Chip: Miniaturizing the Lab
Recent advances have revolutionized lab-testing technology. Miniaturizing the complex and grand scale of lab testing down to a microchip will allow healthcare providers in 2016 to do more with smaller samples, and more cheaply. One such company, Theranos, has already gained FDA clearance for herpes testing this year. More such tests will inevitably follow in 2016 if this new technology holds up to peer review. 2016 will see an explosion in this minimally invasive lab-testing technology. The traditional site of care will further shift outside the lab, clinic, or hospital to the consumer.
Consumers can expect to see a rise in wearable health-tracking technology in 2016, and providers can expect an explosion of mobile diagnostics. Point-of-care handheld mobile devices will expand access to care throughout the world. Whether in remote areas of rural or the jungles and deserts of the Third World, this next generation of diagnostics may transform access to care in 2016. Smartphones can be easily retrofitted to microscopes and other types of analyzers.
The Road Ahead
Today, more than 4000 different diagnostic tests have become available, and as more IVD tests become compatible with PoC environments, healthcare providers should take advantage of the benefits of these evolving IVDs for effective treatment of life-threatening illnesses through 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.
Big challenges need to be addressed, however, despite IVDs being at the top of global market attractiveness index. The regional and country-wise differences in regulatory aspects, market approvals, entry bottlenecks, affordability issues, reimbursement inadequacies, logistics, and healthcare infrastructure may hold the market back. Due to these factors, the 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 foot hold.