NAT is quickly gaining acceptance and transforming the healthcare industry. The market which is in a nascent stage at present has tremendous growth opportunities in varied application segments.
Nucleic Acid Testing (NAT) was initialized in the year 1999, and presently 33 countries around the world have implemented it for human immunodeficiency virus (HIV) and 27 countries for hepatitis B virus (HBV). Recent years have seen development of highly advanced innovative technologies which have helped in detection and have shown sensitivity and specificity to the viral infections, and this segment is also on a similar upward path.
The next 5 years will witness significant developments in reagent systems and automation, as well as introduction of a wide range of new products that will require innovative marketing approaches. The rate of market penetration into routine clinical laboratories, however, will depend on the introduction of cost-effective and automated systems with amplification methods.
The NAT market is currently underpenetrated and in its nascent stage of development. Although the maximum revenues are generated by the developed countries, it is observed that CAGR in the developing countries is high. Increasing awareness in the latest innovative testing methods, high adoption rate in treatment of chronic wounds and the continuously improving economic conditions is pushing demand for these tests.
In India, mandatory blood screening for HBV, HIV, and HCV is done by serological tests for HBsAg and antibodies to HIV 1/2 and HCV. The screened seronegative donations are still at risk for TTIs and thus, need for a sensitive screening test arises to decrease this residual risk, which has been reduced significantly over the last two to three decades in the western countries where NAT has been implemented. NAT testing has been started in a few centers in India, but it is not a mandatory screening test for TTIs as per the Drug and Cosmetics Act, 1940, and the rules therein. The current mandatory test in India is the enzyme-linked immunosorbent assay or ELISA. The window period for the commonly used third-generation ELISA is around 21 days. The more advanced ELISA IV cuts the window period to about 14 days. The nucleic acid amplification test (NAAT) reduces the window period to 7 days.
Recently, Indian Medical Association (IMA), Cochin, has asked city hospitals to choose NAT over the traditional ELISA test to detect HIV, hepatitis B, and C, especially before blood transfusion. This was after IMA analyzed blood samples of 49,000 persons and found that ELISA test failed to detect several infections, thus increasing the risk of transmitting blood-borne diseases from the donor to the recipient. IMA conducted ELISA test as well as NAT on all 49,000 persons who donated blood to IMA’s blood bank over the past 3 years. The results showed that eight cases of hepatitis B, one HIV, and one case of hepatitis C were not detected by ELISA test. However, it was detected using NAT. IMA’s move is crucial as India has the second-highest pool of HIV persons estimated at 5.7 million and 3–5 percent HBV and 1–2 percent HCV cases reported among a population of almost 1.23 billion. Post-transfusion prevalence of hepatitis has been observed at 1–1.8 percent for hepatitis B and 0.28–0.5 percent for hepatitis C and 0.23–0.47 for HIV.
Major barriers in implementing routine NAT testing in India are its high cost and lack of technical expertise in most of the blood centers. Installation of a NAAT facility costs nearly 2 crore and the cost per test is around 2000. This high price has been cited by several government facilities as one of the main reasons for not using NAAT. Still, states such as Karnataka have implemented the NAAT technology for all their government hospitals. Some others, including Maharashtra, want to follow suit.
Global Market
The global nucleic acid test market is expected to reach USD 4.4 billion by 2025. NAT is gaining preference over traditional diagnostic techniques because of its high efficiency and accuracy. In addition, the potential application of these tests in various life-threatening diseases, including several types of cancer, is attracting a large amount of investment for the purpose of R&D. Increasing number of ongoing studies are expected to ensure higher growth rate in the later part of the forecast period.
These tests are currently being used extensively for screening and diagnosis of a wide range of infectious diseases. Along with known infectious diseases, management of epidemics of new diseases has caused a sudden surge in the demand for advanced diagnostic tests. NAT is currently the most advanced and efficient diagnostic method, which extensively uses technology that helps in reducing procedural time and consumption of reagents.
North America contributes maximum share to the global NAT market. European countries are projected to represent significant growth rates due to the high adoption rate of NAT for detection of various pathogenic infections. Asia-Pacific is expected to grow at a remarkable CAGR for NAT market due to increase in healthcare awareness. Amongst the Asian countries, India and China are more promising due to large population pool and increased prevalence of infectious diseases in these countries.
NAT techniques may be segmented as polymerase chain reaction (PCR), strand displacement amplification (SDA), ligase chain reaction (LCR), transcription-mediated amplification (TMA), nucleic acid sequence-based amplification (NASBA), and whole genome sequencing. The top three revenue-generating technology segments are PCR, SDA, and LCR.
Polymerase chain reaction. PCR is an important technique in molecular biology, used for the amplification of genetic material. It is one of the cheapest and most useful tools available for the diagnosis and detection of infectious diseases, paternity disputes, cancer, and other genetic disorders. A wide range of PCR systems like real-time (RT) PCR, quantitative real-time PCR (Q-RT PCR), reverse transcriptase PCR (RT-PCR), multiplex PCR, and nested PCR are available. The several variants of PCR present in the market have contributed in the diagnosis and detection of diseases efficiently. PCR constituted the largest segment of NAT testing market in 2016. Pharmaceutical companies are involved in developing variants for the technology, paving way for better accuracy and cost-effectiveness. This technology is expected to remain dominant over the next 5 years, due to its cost-effectiveness and user-friendly features.
Strand displacement amplification. SDA is a molecular diagnostic technique where isothermal nucleic acid amplification is carried out. This is an in vitro DNA amplification technique, which is performed before the hybridization process. The isothermal nature of the process eliminates the need for thermocyclers, which makes it extremely cost effective. These isothermal NAT processes are extremely fast and are widely adopted in molecular diagnostics.
Some of the isothermal-based amplification processes are loop-mediated isothermal amplification (LAMP), helicase-dependent amplification (HDA) and Nicking enzyme amplification reaction (NEAR). With the growing demand for efficient systems, SDA technology has a wide range of applications in various industries. Pharmaceutical companies are continuously engaged in developing variants for the technology to enable better accuracy and cost effectiveness.
Ligase chain reaction. LCR is a DNA amplification technique in molecular diagnostics, which uses two major enzymes – ligase and polymerase. In each cycle, the target nucleic acid molecule doubles. A thermostable ligase is used to minimize the target-independent ligation, which also helps in avoiding the need for fresh ligase at every step. The amplification time is greatly reduced as there are only two enzymes involved in the process. This makes for a much quicker diagnosis of genes.
LCR technology is widely used for detection of single base mutations, which are responsible for causing genetic diseases. LCR and PCR are used to detect diseases like gonorrhea and chlamydia. When compared to other molecular diagnostic methods, LCR is emerging as the most sensitive method with high specificity for known single nucleotide polymorphism detection. LCR technology is expected to grow at a steady pace in the market, due to the sensitivity and specificity of the amplification process.
Competitive Landscape and Key Vendors
The global NAT market is in a nascent stage and is characterized by the presence of large (Tier-I), medium (Tier-II), and small-sized (Tier-III) companies. Most of the top-tier companies are present in the Americas and Western Europe. However, in APAC there are many local vendors that account for a major share of the market in some areas. Factors such as advances in technology and new product launches also help in increasing the level of competition among vendors.
Major players in the global NAT market include Abbott Laboratories, Roche Molecular Systems, Siemens Healthineers, Hologic, Qiagen, and Grifols, marketed by Hemogenomics in India. Other prominent vendors in this market are Accriva Diagnostics, Acon Laboratories, Affymetrix, Ahram Biosystem, Asuragen, Biocartis, Bio-Rad Laboratories, Cepheid, DiagCor, EKF Diagnostics, Erba Diagnostics, and Randox Laboratories.
Road Ahead
NAT is the most rapidly growing segment of the in vitro diagnostics industry. Major drivers include prevalence of infectious bacterial and viral diseases, cancer, and genetic diseases. About 16 percent of total deaths each year are due to infectious diseases worldwide. According to a WHO report, around one billion people suffer from infectious diseases, which is a major segment of the NAT. Regulatory mechanisms and reforms are directed toward the burgeoning of the market.
In the coming years, NAT will experience innovation and technological advancement specifically in the automation and reagent systems due to the rising demand and growing end-user acceptance of these products. However, cost containment is a major hindrance for the decrease in penetration rate in the clinical laboratories end-user segment, which will be favorable only if cost-effective products are introduced in the market. Also a cut down in reimbursement policies in developed nations and insufficient policies in the developing countries are expected to restrain growth of NAT.
Industry Speak
Want to Go for NAT
Our blood bank is functioning since 2002 at Vijayawada. From the beginning to till date we are doing HIV, HBsAg, and HCV testing with ELISA method only. All these years, we have used 3rd-generation kits. In 2017, we want to go for 4th-generation kits. With 4th-generation ELISA test, the incubation period comes down to 12 to 15 days. If our financial resources allow, we want to go for NAT technique; with this, the incubation period for HIV will come down to 8 days. All these years, we have been doing donor screening perfectly and precisely without giving any chance of missing any important health issues – all these years, our HIV positives are only 0.19 percent.
We are giving utmost importance to quality maintenance, at the same time giving importance to EQAS (external quality assessment schemes). All these years, we have tied up with Bombay Red Cross for this purpose, and have been up to the mark in all aspects of EQAS. In the coming years, we want to concentrate on blood components. With this, we can help more number of patients with limited number of blood donors.
Dr S Madan Mohan, Chief Medical Officer,
Red Cross Blood Bank, Vijayawada
Industry Speak
Technological Advancements and Emerging Trends in Blood Banking
Transfusion medicine, as a branch of medical science, is gaining greater significance more than ever. To ensure that the transfused blood is free of infections of HIV, Hepatitis B & C, an advanced technology called NAT is performed by blood banks across the globe. ID-NAT (Individual Donor – Nucleic Acid Testing) is an international standard blood-screening test that detects the presence of viral RNA/DNA of HIV and Hepatitis B and C in the donated blood units. This test is superior to the conventional serological tests like ELISA, since ID-NAT has a very short window period and is a highly sensitive assay. By detecting infections much earlier than conventional tests, ID-NAT significantly reduces the risk of transfusion-transmitted infections (TTIs).
Most countries with known prevalence of HIV or hepatitis now test each unit of blood individually for NAT. New Zealand, Australia, Egypt, Israel, South Africa, France, Denmark, Greece, Italy, and many countries do ID-NAT to keep their blood supply safe. Almost all of Asia which has high rates of hepatitis B including Japan, S. Korea, Thailand, Singapore, Hong Kong, UAE, Saudi Arabia, Indonesia, Malaysia have moved from pooled NAT to ID-NAT.
Several progressive hospitals and blood banks in India also ensure that their blood supply is safer by screening with ID-NAT technology. These include multiple hospitals of the Karnataka government; AIIMS, Apollo, Fortis Hospitals including Escorts and FMRI, Medanta, Gangaram, RML, AFTC, Artemis, Jaypee, etc., in New Delhi/NCR; PGI Chandigarh; CMC Vellore; Hinduja, KDAH, HN, etc., in Mumbai; SIMS and Global in Chennai; Amrita and Aster in Kochi; CMC and DMCH in Ludhiana; International and Marwari Hospital in Assam, and many more.
Some other sites are pooling six samples, which while providing some cost benefits, may pick up some infections in the serological window period but may also miss some TTIs as experienced in Japan, Thailand, etc. Recent publications show, for example, that Thailand is detecting over five times as many Hepatitis B infections after moving to ID-NAT. Another advancement in blood banking is pathogen inactivation (PI). It is the latest technology that inactivates a broad spectrum of pathogens from donated blood and it components. PI enhances the safety of blood transfusion to the highest possible level possible today by targeting the DNA or RNA of pathogens including bacteria, viruses, spores, etc. Apart from the viruses like HIV, and Hepatitis, PI can also inactivate, dengue, WNV, Zika, most bacteria, and other pathogens.
Hemogenomics has pioneered NAT screening in India by bringing this technology to the country as early as 2004 and is the market leader in this segment. It is now preparing to launch PI from Cerus. As market leaders, Hemogenomics is committed toward the cause of blood safety in India and will continue to bring technologies to ensure that Indian patients, in any part of India have both the right and access to safe blood.
Our blood bank is functioning since 2002 at Vijayawada. From the beginning to till date we are doing HIV, HBsAg, and HCV testing with ELISA method only. All these years, we have used 3rd-generation kits. In 2017, we want to go for 4th-generation kits. With 4th-generation ELISA test, the incubation period comes down to 12 to 15 days. If our financial resources allow, we want to go for NAT technique; with this, the incubation period for HIV will come down to 8 days. All these years, we have been doing donor screening perfectly and precisely without giving any chance of missing any important health issues – all these years, our HIV positives are only 0.19 percent.
Transfusion medicine, as a branch of medical science, is gaining greater significance more than ever. To ensure that the transfused blood is free of infections of HIV, Hepatitis B & C, an advanced technology called NAT is performed by blood banks across the globe. ID-NAT (Individual Donor – Nucleic Acid Testing) is an international standard blood-screening test that detects the presence of viral RNA/DNA of HIV and Hepatitis B and C in the donated blood units. This test is superior to the conventional serological tests like ELISA, since ID-NAT has a very short window period and is a highly sensitive assay. By detecting infections much earlier than conventional tests, ID-NAT significantly reduces the risk of transfusion-transmitted infections (TTIs).
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