Healthcare Services Industry Overview

The pharmaceutical active pharmaceutical ingredients (API) manufacturing market consists of sales of pharmaceutical active pharmaceutical ingredients and related services. Active pharmaceutical ingredients are used to produce drugs which treat various diseases such as cardiovascular diseases, rare genetic disorders, infections, metabolic disorders, cancers, respiratory diseases and others. Active pharmaceutical ingredient is a chemical which is responsible for the pharmacological activity in the living body and are used as a major base for preparation of drugs. The global pharmaceutical api manufacturing market is expected to decline from $174 billion in 2019 to $163.3 billion in 2020 at a compound annual growth rate (CAGR) of -6.2%. The decline is mainly due to the COVID-19 outbreak and the measures to contain it. COVID-19 pandemic is affecting industries across the globe including the pharmaceutical API Manufacturing sector. The disruptions due to lockdowns there has been a slow-down of the production and therefore leading to a shortage of supply causing a hike in prices for essential medicines which are the key factors for this decline. The market is then expected to recover and grow at a CAGR of 6.2% from 2021 and reach $194.1 billion in 2023. North America was the largest region in the pharmaceutical API manufacturing market in 2018. This region is expected to remain the largest during the next five years. The pharmaceutical API manufacturing market in Asia Pacific is forecasted to register the highest CAGR during 2018-2023. The rise in aging population is one of the major drivers of the pharmaceutical API manufacturing market. As the aging population increases, the demand for pharmaceutical drugs also increases. API acts as a specialty drug in these medicines to cure a particular disease. For instance, in 2017, number of people over the age of 60 were 962 million comprising 13% of the global population. This led to increase demand for pharmaceutical drugs, significantly impacting the pharmaceutical API manufacturing market growth. Stringent regulations for approval of pharmaceutical drugs acts as a restraint on the pharmaceutical API manufacturing market. Various regions have their own set of rules, guidelines, and regulations set by their respective drugs regulatory bodies. For example, in Japan, the manufacturers have to register an API with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) through the country’s Drug Master File (DMF) system. Products like APIs and new excipients i.e. inactive substances used in a drug should be registered compulsorily. The API manufacturer is also responsible for DMF registration, even if they don`t have their office in Japan. They should appoint an in-country caretaker (ICC) to apply on their behalf. Also, if there are any changes to be made to DMF products, either an application for change in registration or a minor change notification should be submitted by the ICC to the PMDA. This whole process delays the drugs approvals, thereby negatively affecting the pharmaceuticals API manufacturing market. Many companies use modern technologies such as process control, and powder handling to optimize API manufacturing. These technologies include advances in Lyophilization i.e. freeze-drying process. It is a low-temperature dehydration process which involves freezing the product, lowering pressure and then removing the ice formed. For instance, Telstar, a company that manufactures efficient integrated systems for pharmaceutical and manufacturing processes, developed LyoGistics Zero, an automatic loading and unloading system for freeze dryers to manufacture hazardous products. The system uses a linear magnetic driving mechanism which functions without racks and belts to reduce particle generation and this improves the hygiene in API manufacturing. Also, ILC Dover, a pharmaceutical company, developed JetBreaker system, a semi-automatic powder handling system that separates powdered media and buffers powders so that they can be mixed better in a solution. US FDA`s Current Good Manufacturing Practice (CGMP) regulation contains a minimum requirement that needs to be followed during manufacturing, processing, and packing of any drug products. In September 2016, FDA published the revised Q7 pertaining to the goods manufacturing practices guidance for Active Pharmaceutical Ingredients (API). This guidance includes goods manufacturing practices for quality management system for APIs and ensure that the API quality and purity characteristics are met by the companies. GMP also states a regulation for any imported API from the US, the drug should be listed with the FDA and have an applicable drug labelling in the absence of any exemption. In January 2019, Bristol-Myers Squibb, a US-based company that discovers and manufactures biopharmaceutical products and drugs for cancer and other diseases acquired Celgene Corporation for $74 billion. With this acquisition, Bristol-Myers Squibb led to develop more innovative medicines and also result in a wider portfolio. Celgene Corporation, a US-based company that discovers, develops and commercializes medicines for cancer and inflammatory disorders.

The bioinformatics market consists of sales of bioinformatics and related services. Bioinformatics combines computer programming, information engineering, mathematics, and statistics to analyze biological data for drug discovery and for preclinical studies. The global bioinformatics market is expected to grow from $8.9 billion in 2019 to $10.6 billion in 2020 at a compound annual growth rate (CAGR) of 19.9%. The growth of this market is mainly due to its promising benefits in showcasing the COVID 19 structure. Bioinformatics has helped in understanding the different effects of coronavirus on different people. This virus has created massive levels of uncertainty and knowledge for the virus. The market is then expected to recover and grow at a CAGR of 16.4% from 2021 and reach $16.7 billion in 2023. Increasing demand for protein sequencing is driving growth in the bioinformatics market. Protein sequencing refers to the process of determining the sequence of amino acids in all or part of the proteins present in DNA, based on which specific functions, activities, origin or localization of the protein is determined. Protein sequencing helps analysts to understand the distribution of amino acids along the sequences and the structure of proteins. With bioinformatics methods and databases, capacity, structure and developmental history of proteins can be effectively identified. The demand for protein sequencing is expected to grow on account of factors such as advancements in clinical mass spectrometry and analytical techniques, and significant adoption of target-based drug development by pharmaceutical and biotechnology companies. For instance, in 2015, the total number of protein sequences in UniProtKB, which is a freely accessible database of protein sequence and functional information, increased by over 325% from 2012. Lack of interoperability among various available data formats is acting as a restraint on the bioinformatics market. Various data formats come with differences in structures of data. There are numerous protein databases available through various resources, and each database chooses to represent proteins in a different format. Also, different data models such as object data model or relational data model are used while collecting data. Therefore the problem of interoperability arises when a researcher tries to integrate the results of unique databases present in different data formats. Various data formats available for bioinformatics include Compressed Row Storage (CRS), Sparse Vector, Avro, Parquet and ORC (Optimized Row Compressed). According to a report by Pharmaphorum, an estimated 80% of the researchers’ time is spent on data grooming and only 20% on actual data analysis. This is essentially due to the lack of standardized file types and inconsistent data formatting, which means that every new program results in a new data format. The interoperability issues arising from the use of multiple data formats is affecting market growth. Companies in the bioinformatics market are increasingly investing in the research and development of nanopore sequncing technology. Nanopore sequencing is a single molecule DNA sequencing technology which eliminates the need for Polymerase Chain Reaction or chemical labelling of the sample. This technology passes ionic current through nanopores (a pore of nanometer size) and when the biological molecules pass through the nanopores or near to it then this technology measures the changes in current which can be used to identify the molecule. Nanopore sequencing technology offers high throughput, low cost, longer reads (Sequence of a section of a unique fragment) to the analyst and helps in the collection of data which is an essential part of bioinformatics. For instance, in March 2018, Oxford Nanopore Technologies raised $140 million for commercial expansion and support for further research and development in the area of nanopore technology. Also, in October 2018, biotechnology company Amgen invested $66 million in the company. The bioinformatics market is governed by various regulatory bodies for quality and compliance of bioinformatics platforms. For instance, in India, the Biotechnology Industry Research Assistance Council (BIRAC), set up by Department of Biotechnology (DBT), Government of India, regulates the bioinformatics market. BIRAC introduces Technology Readiness Levels (TRLs) as a measure of estimating the maturity of technology while in the evaluation phases until these technologies are complete to be offered commercially. The TRL scale provides 9 technology readiness levels with TRL1 being the stage when the technology is ideated, and TRL9 being the stage when the technology is ready for commercial use. The manufacturers have to get past TRL9 to have their product available commercially and ready to be marketed. These TRL`s consist of various levels of compliance and processes that the manufacturers must adhere to. The bioinformatics platform is evaluated for quality, feasibility, data privacy and protection as per international standards. In January 2018, bioinformatics company Mind the Byte acquired Intelligent Pharma for an undisclosed amount. Intelligent Pharma, founded in 2007 offers computer-assisted drug discovery services, computational chemistry services and life science informatics. With this acquisition, Mind the Byte aims to become the leading company in Spain and one of the largest companies in Europe in artificial intelligence applied to medicine discovery and development.

The gene editing market consists of sales of gene editing technology such as CRISPR/CAS9, zinc finger nucleus, and talens and related services. Gene editing technology allows genetic material to change genetic code at particular location in a genome. It involves cell line engineering, animal genetic engineering and plant genetic engineering. The global gene editing market is expected to grow from $4.1 billion in 2019 to $4.8 billion in 2020 at a compound annual growth rate (CAGR) of 18.2%. The growth of this market is mainly due to its deployment in discovering drugs which could be potential in treating COVID 19. Gene editing can be used to provide with precision medicine for the patients suffering through chronic diseases. The market is then expected to recover and grow at a CAGR of 14.8% from 2021 and reach $7.2 billion in 2023. The rising infectious diseases acts as one of the major drivers of the gene editing market. Gene editing techniques are used for detection of infectious diseases such as HIV. Infectious diseases are caused by microorganisms like bacteria, viruses, fungi, and parasites. Gene therapy treats the infectious diseases by blocking the replication of the infectious agent that causes the disease at the extracellular level. Gene editing introduces new genetic material into the cells of living organisms with the intention of treating the diseases. Infectious diseases are constantly on the rise. For instance, according to the World Health Organization (WHO) report 2018, infectious diseases kill more than 17 million people per year. In addition to that, according to the AP-NORC (a research initiative by the Associated Press and the University of Chicago) survey in 2018, out of 1,067 adults in the US surveyed, 71% are in favor of gene editing for the treatment of incurable, hereditary diseases such as Huntington’s disease and 67% of Americans support the use of gene editing to prevent diseases such as cancer. Ethical issues in general public with respect to gene editing is one of the major restraining factors for the market. Many researchers and ethicist have argued against gene editing due to different reasons such as off-target effect (edits in the wrong place), mosaicism (when only some of the cells carry the edits) and safety concerns. Some even argued that gene editing will lead to the creation of classes of individuals who will be genetically modified to be able to do things that a normal human being is not supposed to do according to the laws of nature. Due to these reasons, gene editing is still not considered to be safe and effective by many nations and international organizations. For instance, in 2019, as per the article published in TIME, scientists from Canada, China, France, Germany, Italy, New Zealand, and the USA have proposed a temporary prohibition on research on gene editing on human eggs, embryos, and sperms. Gene editing (also called genome editing) is a group of technologies that allow the researchers to change an organism`s DNA by adding, removing or altering genetic material at particular locations in the genome. The emergence of advanced genome editing techniques is one of the major trend in the gene editing market. The new techniques in genome editing are relatively inexpensive and can be used in a variety of application areas such as improving the food supply in agriculture, rectifying specific genetic mutations in the human genome and preventing the spread of diseases. For instance, CRISPR-Cas9 is a gene editing technique and stands for Clustered Regularly Interspace Short Palindromic Repeats. The technique uses a strand of DNA as molecular scissors used to make cuts in DNA at specific points to make space to add new genomes. This technique is faster, cheaper, more accurate and efficient than other existing genome editing methods. Companies investing in CRISPR technology are Crispr therapeutics (CRSP), Intellia Therapeutics (NTLA), and Editas medicine. European regulatory framework divided gene therapy into two categories, germline gene therapy, and somatic gene therapy. In germ line gene therapy, modified genes will be passed on to next generations whereas its not the same case with somatic gene therapy. Current regulation by the EU has only allowed somatic gene therapy, therefore, germline gene therapy is banned. The European Medical Association provides guidelines on gene therapy for preparing market authorization application to obtain approval from the authority to carry on research and development activities in gene therapy. For instance, the EU provides guidance note on gene therapy medicinal product which is intended for use in humans, defines scientific principles and provide guidance for development and evaluation of gene therapy products. In May 2018, Novartis AG, a Swiss multinational pharmaceutical company acquired AveXis for $8.7 billion. With this acquisition, Novartis will be able to treat the patients with life threatening neurological genetic diseases, thus the company will be able to expand its services portfolio and market. AveXis is a US based clinical-stage gene therapy biotech company.

The protein expression market consists of sales of protein expression vectors, competent cells, reagents, equipment and related services. Protein expression is a process in which proteins are synthesized, modified, regulated and controlled in living organisms according to the host cell. Protein expression included yeast expression, insect expression, and bacterial expression, algal expression and mammalian cell expression. The global protein expression market is expected to grow from $2 billion in 2019 to $2.3 billion in 2020 at a compound annual growth rate (CAGR) of 14.3%. The growth of this market is mainly due to the increased research activities for covid 19 vaccines which is aiding in the growth of protein expression market as they are used for studying the effect of drugs on the virus through an in-vitro setup. The market is then expected to recover and grow at a CAGR of 11% from 2021 and reach $3.1 billion in 2023. North America was the largest region in the protein expression market in 2018. The protein expression market in Asia Pacific is forecasted to register the highest CAGR during 2018-2023. Increase in demand for biologics to counter various genetic disorders and chronic diseases is one the major factors driving the research and sales of protein expression market. Biologics is a medicine produced from living organisms or contains components of living organisms such as protein, tissue, genes, allergens, cells, blood components, blood, and vaccines. The increasing use of biologics (therapeutic protein and others) to cure chronic diseases such as cancer, cardiovascular conditions and genetic disorders, is increasing the demand for protein expression devices and equipment. According to the World Health Organization, chronic disease prevalence is expected to rise by 57% globally, by the year 2020. Hence the rising demand for biologics is driving the protein expression market. For instance, according to an article published by Chemistry World in the year 2018, analysts expect the biologics market to hold a market share of more than a quarter of the entire pharmaceutical market by 2020. The global biologics market is expected to grow at 9.9% during 2018-2024. Government regulations related to protein therapeutics and production of biologics may hinder the protein expression market growth. Government regulations on biologics to undergo rigorous preclinical and clinical trials prior to regulatory approval, and time consuming process for approval of biologics with regards to health and the safety of any individual are restraining the market growth. Marketing and distribution of biologics including insulin, hormones, therapeutic antibodies, and vaccines depends upon the successful completion of clinical trials, which is a long, expensive, and uncertain process. According to FDA, for an approval of new biologic, Under the regulations (21 CFR 314.81(b)(2)(vii) and 601.70, a clinical trial approval usually takes 10- 12 months where firms are required to submit a report annually on the status of clinical safety, clinical efficiency, clinical pharmacology, and nonclinical toxicology study. Companies in the industry are increasingly adopting Microfluidics technology to enhance protein expression tests in order to reduce the time, cost, labor, and increase the accuracy and performance. The microfluidics technology effectively analyzes biological samples than the traditional (macroscale) instruments. Microfluidics technology is used to measure the expression of proteins on cells and optimizes the output to generate results regarding protein expression. Therapeutics-on-a-chip (TOC) uses microfluidic platform and is able to synthesize proteins in a point of care setting to reduce cost associated with storage and transportation of therapeutic proteins. For instance, companies such as MissionBio, NanoCellect Biomedical, RainDance Technologies and Sphere fluidics have implemented this technology in protein expression test. The Protein Expression market in the U.S. is governed by Food and Drug Administration (FDA) that lays down a series of guidelines for the manufacturers and retailers of this industry. Within FDA, Center for Drug Evaluation and research (CDER) regulates biological products under FDA 101 which includes gene therapy products and vaccines. These regulations ensure quality, safety and efficacy of biological therapeutics products, and speed up innovations that make these products safer, and effective. In May 2014, the US’s FDA announced a fast-track initiative to review its drugs and biologics policy to speed the availability of therapies to patients with serious conditions, orphan drugs for rare disease, while preserving the safety and efficacy standards. In 2016, FDA also removed a rule (Section 610.21 of the FDA code) which specified minimal potency limits for certain antibodies and antigens. The European Medicines Agency has also introduced policies which include a provision to waive the scientific advice fee, which encourage more academic groups and small companies to propose candidates for biologics.

The metabolomics market consists of sales of metabolomics analytical tools, equipment and related services. Metabolomics is the field of bio-analytics for quantification and identification of metabolic small molecules such as cell, tissue, organ and biological fluid. Metabolomics includes analytical instruments such as liquid chromatography, gas chromatography, capillary electrophoresis, mass spectrometry and nuclear magnetic resonance spectroscopy. The global metabolomics market is expected to grow from $2 billion in 2019 to $2.3 billion in 2020 at a compound annual growth rate (CAGR) of 17%. The growth of this market is mainly due to outbreak of COVID 19 leading to deployment of predictive antiviral drug efficacy in COVID 19. Metabolomics are used in identifying biomarkers of COVID 19. The market is then expected to recover and grow at a CAGR of 13.6% from 2021 and reach $3.4 billion in 2023. North America accounted for about 42% of the metabolomics market in 2016, this region is expected to account for about 45% in 2019. Increasing prevalence rate of cancer drives the metabolomics market growth. Metabolomics screens the potential biomarkers (specific cells, molecules, or genes, gene products, enzymes, or hormones) to measure the cancer drug responsiveness aiding early diagnosis. For instance, according to a report by American Cancer Society in 2018, approximately 1,735,350 new cancer cases were diagnosed in the United States of which the most common cancers are lung cancer, breast cancer, prostate cancer and others. In 2018, according to American Lung Association, lung cancer is the leading cancer killer in both men and women in the USA, there were 2.1 million new cancer cases and 1.8 million deaths. Metabolomics approaches such as nuclear magnetic resonance (NMR) technique and mass spectrometry (MS) techniques have been used to study cancer. Companies like Metabolon Inc., Bruker Corp, and others have adopted metabolomics as a tool for early detection and cure for cancer. The increasing complexity in interpreting data act as a restraint hindering the metabolomics market growth. Metabolomics tools generate huge quantum of data through metabolomics techniques and the generated data keeps changing not static, hence increasing the difficultly in interpretation of data. For instance, data generated by nuclear magnetic resonance (NMR) Spectroscopy, an analytical technique used for metabolic profiling (a method to measure and interpret various low molecular weight and other intermediates), is difficult to process and interpret. High-level statistical techniques are required for classification and analysis of this data to uncover the biological knowledge which is time-consuming and expensive, restraining the metabolomics market growth. Machine learning is increasing its popularity in the field of metabolomics due to improve efficiency in interpretation of data generated from metabolomics techniques. Machine learning enabled technologies help in automation of risky and complex processes, avoid repetitive and time taking processes, provide quick and error-free services. Companies in the industry are preferring machine learning techniques for metabolism analysis to solve problems, automate processes and execute tasks. Some of the machine learning algorithms aid in metabolism data analysis and metabolic pathway modeling. Some of the companies such as Bio-Rad Laboratories, Metabolon Inc and others have started using machine learning algorithms for better understanding and prediction in metabolomics study. For instance, MeltDB 2.0, a machine learning software used as a tool for the analysis and integration of metabolomics experiment data that aids research, store experimental data sets. Such machine learning software offer comprehensive analysis and visualization features for the proper representation of the large complex data. In January 2018, Biocrates Life Sciences AG, an Austria-based biotechnology company, acquired Metanomics Health GmbH, for an undisclosed amount. This acquisition would strengthen and improve Biocrates Life market share in early disease detection by leveraging the capabilities of Metanomics. Metanomics Health GmbH is a biotechnology company offering metabolomics in life sciences, providing analytical services of metabolite profiling, involved in marketing and developing tools to carry out research and development in healthcare sector. The company was founded in 2002 and is headquartered in Berlin, Germany.

The isothermal nucleic acid amplification technology (INAAT) market consists of sales of isothermal nucleic acid amplification technologies and related services. The services include only installation and maintenance services offered by equipment manufacturers. Isothermal nucleic acid amplification technologies are used to amplify DNA sequence from two different nucleic acids segments at the constant temperature. The global isothermal nucleic acid amplification technology (inaat) market is expected to grow from $2.1 billion in 2019 to $2.4 billion in 2020 at a compound annual growth rate (CAGR) of 15.7%. The growth of this market is mainly due to positive effect of COVID 19 on healthcare industry. Isothermal nucleic acid amplification technology (INAAT) is used in the detection of coronavirus because of its similar sensitivity as RT-PCR and rapid diagnosis of virus. The market is then expected to recover and grow at a CAGR of 12.3% from 2021 and reach $3.4 billion in 2023. North America was the largest region in the isothermal nucleic acid amplification technology (INAAT) market in 2018. The isothermal nucleic acid amplification technology (INAAT) market in Asia Pacific is forecasted to register the highest CAGR during 2018-2023. The incidence of infectious diseases such as H. influenzae, S. pneumonia (respiratory tract infections), N. gonorrhoeae, C. trachomatis (genital infections), and TB are increasing and require isothermal nucleic acid amplification technology (INAAT) to diagnose them. For instance, according to World Health Organization 17 million people lose their lives to infectious diseases every year. Another report by Centers for Disease Control show that number of diseases from mosquitoes, ticks and fleas like West Nile, Zika, Malaria and Lyme disease increased three times between 2004 and 2016. Similarly, as per a survey done by NCBI in 2018, around 50% of the population in the United States (approx. 133 million) was suffering from at least one chronic disease and this is expected to increase to 157 million by 2020. Increase in infectious or chronic disease drives the demand for diagnosing through isothermal nucleic acid amplification technology. The market for isothermal nucleic acid amplification technology is strictly regulated by stringent regulatory policies that govern the functioning, approvals and standards set for the manufacturers of this market. These regulations discourage companies to invest in new products for research and development or enter new markets. For example, the administration of US food and drugs (USFDA) requires multi-laboratory validation of a loop-mediating isothermal amplification which takes twice as much time as the Commission for European regulatory to review the process. Long regulatory procedures delay the scope for further study of the safety and efficacy of devices and affects the operating cycle of the vendors thereby adversely affecting the growth of the market. Nanostructures are being incorporated to in vitro diagnostics and in vitro rapid diagnostic tests (RDT) in order to improve existing tests and make them more effective or create innovative diagnostic test approaches that are incorporated in point-of-care applications. Nanostructures/nanotechnology uses nanoparticles to enhance the action of the drug in treatment and nanotechnology is the design, characterization, production, and application of devices, structures and systems by controlled manipulation of size and shape at the nanometer scale. For instance, a range of RDTs have been developed to diagnose syphilis such as AccuBioTech (Accu-Tell Rapid Syphilis Test), Alere, Inc. (Alere Determine), Alere/Standard Diagnostics (SD Syphilis 3.0), The Tulip Group/Qualpro (Syphicheck - WB), Cypress Diagnostics (Syphilis Rapid Test), and Omega Diagnostics (Visitect Syphilis). These RDTs allow patients to be diagnosed at the point-of-care (POC). The isothermal nucleic acid amplification technology market is regulated by government agencies such as European Medicines Agency (EMA), USFDA (the US food and drug ministration), and others. For instance, according to USFDA, each medical device is classified into three groups which is class 1, class 2 & class 3. Class 1 devices require less regulatory control and class 3 requires the most. However, devices which are not been marketed before as in the case of INAAT devices, will fall under class 3 devices as per the medical device amendment of 1976. Such devices require approval of a Pre Market Application (PMA) under the federal law. Premarket approval (PMA) is the scientific and regulatory review process of the FDA to assess the safety and efficacy of medical devices of Class 3. In 2018, Tecan, a laboratory instruments and solutions provider acquired Nugen Technologies for $54.5 million. The acquisition helps Tecan expand into new market segment of next-generation sequencing (NGS) reagents. Nugen Technologies is a biotech company founded in the year 2000. The U.S. based company having its headquarters in California, manufactures molecular biology reagents for next-generation sequencing genomic analysis.

The synthetic biology market consists of sales of synthetic compound, technology and related services. Synthetic biology is a field of biology science which involve engineering principles. The global synthetic biology market is expected to grow from $8.2 billion in 2019 to $11.3 billion in 2020 at a compound annual growth rate (CAGR) of 38%. The growth of this market is due to its implication in diagnosis and vaccine development for COVID 19. The market is then expected to recover and grow at a CAGR of 33.9% from 2021 and reach $27 billion in 2023. The synthetic biology market has been geographically segmented into North America, Western Europe, APAC, Eastern Europe, South America and Middle East & Africa. The North American market is the largest market for synthetic biology and is expected to continue to be the largest market during the forecast period. DNA sequencing is important in development of the synthetic biology in many ways. The DNA sequencing finds its use in many synthetic biology applications, therefore the availability of the DNA sequencing technique at low cost drives the production of products based on the applications of synthetic biology. DNA sequencing allows the researchers to determine the DNA sequences in genes and helps a researcher to create a repository of entire genomes. These repositories form the basis for the implementation of synthetic biology applications such as protein expression, directed evolution, and metabolic engineering. For instance, in 2018, according to the article by Dante labs, the first whole human genome sequencing cost about $2.4 billion (2.2 billion euros) in 2003. In 2006, the cost decreased to $0.28 million (250,000 euros). In 2016, the cost decreased to about $1,000 (900 euros). The bio-safety risks involved in synthetic biology restrains the synthetic biology market. Synthetic biology involves researches on micro-organism to perform the desired function or produce a biological desired substance. Such processes possess health risks such as illness, allergies in humans as well as environmental risks such as toxicity and risk of new micro-organisms affecting living creatures in the ecosystem. Such potential risks pose as a deterrent to possible innovative research that could be done in certain fields such as combating epidemics such as Ebola and life-threatening diseases such as cancer. The new technological advances in the field of DNA sequencing has enabled the researchers to use DNA to store non-genetic information. With the rise in the demand to store quantum of data, DNA data storage offers a solution where one DNA strand can store about 455 Exabyte of data (455 billion gigabytes). Thus, the concept has received huge investments from the entities in the market. The binary data (data coded in 0O and 1) is converted into DNA strings of four potential base units of unique sequences of A, G, C, T (DNA is made up of four base components: Adenine, Guanine, Cytosine, and Thymine (known as AGCT)). The information coded in DNA lasts for thousands of years when compared to the data in traditional hard drives which gets corrupted or damaged within 30 years. For instance, according to a journal published by Nature Publishing Group, in February 2018, Microsoft and University of Washington researchers stored 35 distinct digital files in DNA—more than 200 megabytes of data and plans to increase future investment to improve the technology. In March 2018, Danaher Corporation, a technology conglomerate acquired Integrated DNA technologies (IDT) for $1.9 billion. With this acquisition, Danaher acquired the oligonucleotides research expertise of IDT which is a very vital part of DNA sequencing research. Integrated DNA technologies, a US-based manufacturer of custom DNA and RNA oligonucleotides for academic and pharmaceutical genomics research.

The flow cytometry market consists of sales of flow cytometry instruments, software and chemicals and related services. Flow cytometry is used to analyze characteristics of a biological cell such as cell size, cell count and cell complexity using laser optics. In the flow cytometry technique, cells are added to a fluid medium which is then passed through a pulsating laser beam. The cell then scatters the beam in different directions towards receptors that capture the light and translate it to data displayed on a monitor. The global flow cytometry market is expected to grow from $4 billion in 2019 to $4.5 billion in 2020 at a compound annual growth rate (CAGR) of 11.4%. The growth of this market is due to deployment of flow cytometery in studying the virus for vaccine development and in-vitro diagnosis. The market is then expected to recover and grow at a CAGR of 8.1% from 2021 and reach $5.7 billion in 2023. The flow cytometry market has been geographically segmented into North America, Western Europe, APAC, Eastern Europe, South America and Middle East & Africa. The North American market is the largest market for flow cytometry and is expected to continue to be the largest market during the forecast period. The increasing number of HIV cases globally is an important driver for the flow cytometry market. This is because the flow cytometry technique has its direct application in HIV diagnosis. Flow cytometry uses light scattering to determine the identity of cells. These cells are given certain markers called CDs (clusters of differentiation), based on the type of scattering. For the HIV virus cell, the clusters of differentiation is called CD4, and based on the number of CD4s in a medium, flow cytometry can be used to diagnose HIV. As the global HIV population continues to grow, the demand for diagnosis techniques such as flow cytometry is also increasing. The availability of cheaper and better substitutes for flow cytometry is a major restrain on the flow cytometry market. These substitutes include ELISA (enzyme-linked immunosorbent assay) and radioimmunoassay. While flow cytometry, ELISA and radioimmunoassay are all methods that help in HIV diagnosis by detecting “problem cells” in a group of cells, ELISA and radioimmunoassay are cheaper and easier methods than flow cytometry. In ELISA, colour changes in reagents are used to detect problematic cells. While in radioimmunoassay, cells are given certain radioactive markers which are used to detect problematic cells. Both ELISA and radioimmunoassay can be implemented using cheap, traditional laboratory equipment and reagents with a higher throughput rate. However, flow cytometry involves high setup costs and costs of interpreting data along with a very low throughput. High-throughput flow cytometry is an emerging trend in the flow cytometry market. This is due to high speed of cell parameter processing and capability to analyze several heterogeneous cell groups at once, using this technique. Traditional cytometry methods are very slow, especially when several cells need to be tested within a day. Using high-throughput flow cytometry methods such as fluorescence-activated cell-sorting (FACS), multiple cells can be allotted fluorescent markers which can be used to analyze their parameters in quick time. Examples of companies that offer high-throughput flow cytometry solutions include AstraZeneca and Novartis. The US FDA`s code of federal regulations (CFR) includes regulations related to a flow cytometry device called the automated differential cell counter (ADCC). An ADCC is a device used in the study of blood cells, mainly for the detection of faulty blood cells and low blood cell counts. This device comes under the purview of the class 2 special controls guidance document which outlines requirements such as the methods for accurate and precise reporting of results, the statistical linearity conditions of graph-based cytometry results and the types of specimens to be used. Flow cytometry device manufacturers must conform to these guidelines, which address the specific health risks associated with ADCC devices. Hence, this is expected to maintain a vigil on flow cytometry companies involved in manufacturing ADCC. In February 2019, Danaher acquired the biopharma business of GE Life Sciences for $21.4 billion. This acquisition will help Danaher to improve its existing bioprocessing capabilities. The biopharma division of GE Life Sciences is involved in the development and production of biologic drugs, vaccines and cell therapies. It develops products and solutions that facilitate research into fundamental cell and protein biology. GE Life Sciences is a division of GE Healthcare, which was founded in 1994 and has its headquarters in Illinois, the USA.