Healthcare Services Industry Overview

Anti-Viral Drug Therapy Market Definition

The anti-viral drug therapy market consists of sales of branded and generic anti-viral drugs and related services by entities (organizations, sole traders and partnerships) that manufacture branded or generic anti-viral drugs to treat microbial infections. The anti-viral drug therapy industry includes establishments that manufacture anti-viral drugs, which are used to treat diseases or illnesses caused by viral infections. Examples of antiviral drugs include idoxuridine, famiciclovir, cidofovir, amantadine, zanamivir, tenofovir, adefovir and ribavirin. Viruses are infective agents comprising of a core of nucleic acids, either RNA or DNA, and are surrounded by a layer of protein. These are not living organisms, and can reproduce only inside a living cell. Anti-viral drugs decrease the ability of viruses to reproduce. These drugs enter the cells infected with virus, and interfere with the ability of the virus to bind to the cell, and stimulate the immune system of the host.

CRISPR Technology Market Definition

The CRISPR technology market consists of sales of CRISPR technology products and related services by entities (organizations, sole traders and partnerships) that produce CRISPR technology products and equipment. CRISPR is a genome-editing tool. It is used by researchers/healthcare professionals to alter DNA sequences and modify gene function. CRISPR is also used for correcting genetic defects, treating human diseases, and to yield better crop varieties. CRISPR stands for Clusters Of Regularly Interspaced Short Palindromic Repeats. The CRISPR-Cas9 system consists of two key molecules, — Cas9 and guide RNA, that introduce a change or mutation into the DNA at the desired position. The Cas9 is an enzyme that acts as a pair of ‘molecular scissors’ and can cut the two strands of DNA at a specific location in the genome so that bits of DNA can then be added or removed. The guide RNA (gRNA is a small piece of pre-designed RNA sequence (about 20 bases long) located within a longer RNA scaffold. The scaffold part binds to DNA and the pre-designed sequence ‘guides’ Cas9 to the right part of the genome. This makes sure that the Cas9 enzyme cuts at the right point in the genome. High orthogonality, versatility, and efficiency of CRISPR technology make it a preferred genome editing technology.

The artificial intelligence (AI) in drug discovery market consists of sales of AI for drug discovery and related services. Artificial Intelligence (AI) for drug discovery is a technology that uses a simulation of human intelligence process by machines to tackle complex problems in the drug discovery process. It helps to find new molecules to identify drug targets and develop personalized medicines in the pharmaceutical industry. The global artificial intelligence (AI) in drug discovery market is expected to decline from $0.37 billion in 2019 to $0.36 million in 2020 at a compound annual growth rate (CAGR) of -1.33%. The decline is mainly due to the COVID-19 outbreak that has led to restrictive containment measures involving social distancing, remote working, and the closure of industries and other commercial activities resulting in operational challenges. The entire supply chain has been disrupted, impacting the market negatively. The market is then expected to recover and reach $1.1 billion in 2023 at a CAGR of 42.9%. North America was the largest region in artificial intelligence (AI) in the drug discovery market in 2019. The rise in demand for a reduction in the overall time taken for the drug discovery process is a key driver propelling the growth of the artificial intelligence (AI) in drug discovery market. Traditionally, it takes three to five years for animal models to identify and optimize molecules before they are evaluated in humans whereas start-ups based on AI have been identifying and designing new drugs in a matter of few days or months. For instance, in 2020, the British startup Exscientia and Japan`s Sumitomo Dainippon Pharma have used artificial intelligence to produce an obsessive-compulsive disorder (OCD) medication, decreasing the development time from four years to less than one year. The reduction in overall time taken for the drug discovery process drives the artificial intelligence (AI) in drug discovery market’s growth. The shortage of skilled professionals is expected to hamper the AI in drug discovery market. The employees have to re-train or learn new skill sets to work efficiently on the complex AI machines to get the desired results for the drug. The shortage of skills acts as a major hindrance to drug discovery through AI, discouraging companies to adopt AI-based machines for drug discovery. According to The Pistoia Alliance, a global non-profit organization that works to encourage innovation in life sciences R&D cited that 44% of respondents agree that lack of skills was the biggest barrier to the adoption of AI and machine learning (ML) in 2019. Major companies operating in the AI drug delivery market are adopting strategic collaborations to research and discover drugs using AI and are gaining significant popularity in the artificial intelligence in drug discovery market. For instance, in September 2019, Atomwise Inc. and Jiangsu Hansoh Pharmaceutical Group Co. Ltd announced the collaboration of $1.5 billion to design and discover the potential drug candidates for up to 11 undisclosed target proteins in cancer and other therapeutic areas. The collaboration is expected to combine Atomwise Inc’s AI technology, protein structure expertise, and medicinal chemistry with Jiangsu Hansoh Pharmaceutical Group Co. Ltd’s manufacturing, research & development, and commercial capabilities in order to improve and accelerate clinical development and drug discovery process. In July 2020, Curi Bio, a leading developer of human iPSC-based platforms for drug discovery, acquired Dana Solutions for an undisclosed amount. This acquisition will give Curi Bio access to Dana`s AI/ML platforms for modeling cell and tissue phenotype, automated platform for contractility analysis of beating cardiomyocyte and platform for predictive safety pharmacology. Dana Solutions is a leading AI solutions provider for the life sciences industry.

The digital diabetes management market consists of sales of digital diabetes management devices and related services. Digital diabetes management includes devices, apps, and software that manage blood glucose levels in the human body. These devices play a vital role in the care of diabetes patients with the management of patient’s blood glucose levels and controlling their conditions. The global digital diabetes management market is expected to decline from $6.09 billion in 2019 to $6.03 billion in 2020 at a compound annual growth rate (CAGR) of -1.02%. The decline is mainly due to the COVID-19 outbreak that has led to restrictive containment measures involving social distancing, remote working, and the closure of industries and other commercial activities resulting in operational challenges. The entire supply chain has been disrupted, impacting the market negatively. The market is then expected to recover and reach $12.13 billion in 2023 at a CAGR of 26.27%. North America was the largest region in the digital diabetes management market in 2019. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The increasing prevalence of diabetes is projected to propel the demand for digital diabetes management devices and related services, thereby increasing the demand for the market. Diabetes is a leading cause of death with 30% of loss of life expectancy from diagnosis of diabetes. According to the European Society of Cardiology’s (ESC) global statistics on diabetes published in April 2019, approximately 4 million people under the age of 60 years die from diabetes every year. The prevalence of diabetes for the age group 20-79 years is predicted to increase to 9.9% to reach 628.6 million people with an expected growth of 48% by the end of 2045, globally. Digital diabetes management devices provide continuous care for diabetic patients and provide relevant data for further analysis. Data security is a major challenge limiting the growth of the digital diabetes management market. Data safety is necessary to maintain integrity and confidentiality. Lack of accurate flow of information and commands is likely to compromise the function of digital diabetes devices and may put patients or users at the risk of health complications. According to the Global Application and Network Security Report, 2019–2020 published by Radware, a cybersecurity company, data security and service & application availability are the top two concerns of the healthcare industry. Moreover, according to the 2019 HIPAA Journal, the data breaches are occurring more than once a day with the average breach size of 18,208 records, growing by 30.1% in November 2019. Thus, data security is a key challenge for the growth of the digital diabetes management market in the coming years. Several companies are increasing attention on developing design-focused and AI-powered connected apps to enhance the user experience, which is gaining significant popularity in the digital diabetes management market. Key companies operating in the digital diabetes management market including OneDrop, Ascencia, and Dario are increasing their focus on developing their products as stylish gadgets rather than medical devices. In June 2018, Medtronic plc and IBM Watson Health announced the launch of AI-powered Sugar.IQ smart diabetes management app, designed to improve and simplify daily diabetes management. In April 2020, OneDrop, a consumer diabetes management platform, announced the acquisition of assets, IP, and certain staff of Sano Intelligence Inc., an innovator in health sensing technology for an undisclosed amount. OneDrop and Sano Intelligence shared a vision of transforming traditional healthcare into preventive and proactive self-care. The companies are expected to integrate Sano’s silicon sensing technology into a painless silicon-based health sensing platform for use across multiple conditions, which is a personalized solution for a rapidly growing health issue. Sano Intelligence, Inc. was founded in 2011 and is a manufacturer of non-invasive connected CGM patch.

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.