Category Archives: Biotechnology

Next Generation Sequencing

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Next Generation Sequencing; DNAs double helix structure
On April 25, 1953, molecular biologist James Dewey Watson’s academic paper presenting DNA’s double-helix structure was published in the scientific journal, Nature.
Geographic reference: World
Year: 2020 and 2028
Market size: $3.99 billion and $11.7 billion, respectively

April 25th was National DNA Day. Events and celebrations commemorating the day are organized by the Human Genome Research Institute to encourage “people to learn more about the science that makes them genetically unique.”1 Why April 25th? On April 25, 1953, molecular biologist James Dewey Watson’s academic paper presenting DNA’s double-helix structure was published in the scientific journal, Nature. Francis Crick and Maurice Wilkins were co-authors. Almost 50 years to the day, on April 14, 2003, Human Genome Project scientists announced that the mapping of the human genome was complete.

Today’s market size shows total global revenues for next generation sequencing in 2020 and projected for 2028. Next generation sequencing (NGS), or massively parallel sequencing, describes a number of different modern sequencing techniques to directly determine the nucleic acid sequence of a DNA or cDNA molecule. NGS technology allows for the sequencing of DNA and RNA more quickly and cheaply2 with less DNA or RNA material needed than previous methods. Large-scale whole-genome sequencing can be done in one sequencing experiment. The Human Genome Project, which involved scientists at 20 institutions in France, Germany, Japan, China, the United Kingdom, and the United States, took 13 years to complete using the first-generation technique called Sanger sequencing. Sanger sequencing only sequences a single DNA fragment at a time. NGS sequences millions of fragments simultaneously. As a result, NGS may detect more novel or rare genetic variants.

NGS technology is popular among molecular biologists specializing in functional genomics. Functional genomics involves studying how genes function within a biological system, how genes interact with each other, and how genes interact with the environment. The oncology segment accounted for the largest share of revenues in 2020 at 28%. Leading companies are working toward an NGS-based diagnostics tool to detect cancer and analyze the genomic profiles of tumors to develop treatments for specific types of tumors. Some companies offer genetic testing to identify people who may be at higher risk of developing certain cancers. The development of targeted therapies, therapies targeted toward patients with specific or rare genetic biomarkers, is also increasing. 

The infectious disease segment of the industry is expected to be driven by the use of NGS technology to identify coronavirus strains. The technology is used to study the spread of COVID-19 and to map its evolution. The Covid-19 Genomics U.K. Consortium was formed in March 2020 to use Whole-Genome Sequencing (WGS) to analyze the coronavirus genome. Research is ongoing in the use of NGS technology to develop vaccines and therapies to treat the virus. WGS technology is expected to grow at a significant rate from 2021 to 2028 due to its use in tackling COVID-19.

Targeted sequencing and resequencing had a 73% revenue share in 2020. This is an economical alternative for WGS and allows for the in-depth investigation of genomic regions. RNA-based targeted sequencing is expected to have significant growth through 2028 due to the increasing demand for differential expression analysis. The use of this technology for the diagnosis of schizophrenia and other disorders and the increased availability of expression kits for customized panels are expected to contribute to its growth over this time period also.

Sequencing is a critical step in the genomics workflow. This segment experienced a 54% revenue share in 2020. Revenue in this segment is also expected to have the fastest compound annual growth rate through 2028 as the use of WGS increases. As the use of WGS increases, so too does the amount of data that needs to be analyzed. Increased spending on analysis and management tools for the sequenced data is expected to have a positive effect on revenue share.

Academic research had a 53% share in 2020, followed by clinical research, hospitals and clinics, and then pharmaceutical and biotech companies. Research accomplished at universities and research centers is expected to contribute to growth in the academic research sector through at least 2028. The clinical research segment is expected to grow the fastest from 2021 to 2028 due to the rising use of NGS-based diagnostic tests and the availability of commercial clinical research solutions from various companies. 

North America had a revenue share of 49.77% in 2020. The market was driven by several clinical laboratories that use NGS technology. Also, the development and launch of several new products using NGS technology are expected to increase market share through 2028. In August 2020, Quest Diagnostics started using the Automated NGS Engine to offer genetic risk screening for blood disorders, colon cancer, breast cancer, and heart diseases as part of AncestryHealth, a consumer genetics product of Ancestry. Although Ancestry decided to discontinue offering such tests in January 2021, Quest is continuing to develop applications that use NGS technology. The Asia Pacific region is expected to experience the fastest revenue growth through 2028 due to the presence of several leading NCS service providers in the region that offer their services to thousands of clinicians and hospitals across South Asia and India. 

The NGS industry is highly competitive. To gain market advantage companies have been focused on launching platforms that are rapid, small in size, and less expensive. In 2020 some companies introduced products to support research and development for COVID-19 vaccine development and products to sequence the complete genomes of viruses. Some leading companies in the NGS market include Illumina, QIAGEN, Thermo Fisher Scientific Inc., F. Hoffman-La Roche Ltd., Oxford Nanopore Technologies, Genomatrix GmbH, PierianDx, DNASTAR Inc., Eurofins GATC Biotech GmbH, Perkin Elmer Inc., BGI Genomics, and Bio-Rad Laboratories Inc.

1 Source: “National DNA Day — April 25, 2021,” National Today available online here.
2 In less than 20 years, the cost of sequencing the human genome dropped from $100 million to less than $1,000.

Sources: “Next Generation Sequencing Market Size, Share & Trends Analysis Report by Technology (Targeted Sequencing & Resequencing), by Application (Oncology, Consumer Genomics), by Workflow, by End-Use, and Segment Forecasts, 2021-2028,” Grand View Research Report Summary, February 2021 available online here; “Next Generation Sequencing Market Size Worth $11.7 Billion by 2028: Grand View Research, Inc.” CISION PR Newswire, February 23, 2021 available online here; “National DNA Day — April 25, 2021,” National Today, February 17, 2020 available online here; “Who Was Involved in the Human Genome Project?” your genome, June 13, 2016 available online here; “Ancestry to Discontinue NGS-Based AncestryHealth Service,” GenomeWeb, January 15, 2021 available online here.
Image source: Gerd Altmann, “dna-genetic-material-helix-proteins-3539309,” Pixabay, July 15, 2018 available online here.

Metabolomics

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laboratory metabolomics
Metabolomics is the comprehensive analysis of metabolites in a biological specimen.
Geographic reference: World
Year: 2020 and 2025
Market size: $1.9 billion and $4.1 billion, respectively

Metabolomics is the “comprehensive analysis of metabolites in biological specimens.”1 Metabolites are substances made when the body breaks down food, drugs, chemicals, or tissue (fat or muscle tissue, for example). These substances create energy and are needed for growth, reproduction, ridding the body of toxic substances, and maintaining health. The process for creating these substances is called metabolism. More than 9,400 metabolites have been detected by scientists to date, according to the Human Metabolome Database, but scientists believe that the human metabolome consists of more than a million compounds. Metabolomics is a relatively new field of study, only coming into existence in the late 1990s.

Scientists use metabolomics to research possible therapies for a variety of illnesses such as cancer, cardiovascular disorders, neurological disorders, and metabolic disorders. The increasing number of people with cancer and higher demand for cancer treatments account for the cancer segment having the largest market share in 2020. This segment of the industry is also expected to have the fastest growing revenues through 2025.

Today’s market size shows the total global revenues for the metabolomics market in 2020 and projected for 2025. Increasing research and development investment in the pharmaceutical and biopharmaceutical segment of the economy, especially at academic and research institutions, along with growing demand for personalized medicine will contribute to growth in this industry. The high costs of instruments and problems with data examination and processing, however, are likely to stifle some growth.2 Even so, the metabolomics instrument market accounted for the largest market share in 2020 as technological advancements, an increasing number of research-related activities, and the shoring up of healthcare infrastructure in developing countries contributed to demand.

Thanks to technological advances, the metabolomics industry has been instrumental in biomarker discovery. Biomarkers are measurable substances in bodily fluids or tissue, the presence of which can be indicative of disease, infection, or environmental exposure. A biomarker can be used to test how well the body responds to treatments for a disease. As an example of biomarker research, George Washington University researchers are studying 5 biomarkers in the blood of those with COVID-19 to see if there is a correlation between having certain biomarkers and the severity of the disease. If there is a correlation, this could lead to a blood test to determine which patients will have a more severe form of the disease and will need to be monitored and/or hospitalized and which can be sent home for quarantining and bed rest.

By region, North America had the highest share of the market in 2020. Thirteen of the top 20 major corporations in the industry are located in the United States. These include Waters Corp., Agilent Technologies, Thermo Fisher Scientific, Danaher Corp., Bruker Corp., PerkinElmer, GE Healthcare, LECO Corp., Metabolon, Inc., Bio-Rad Laboratories, Scion Instruments, SRI Instruments, and JASCO Inc. Other major companies in this industry located elsewhere include Merck KGaA (Germany), Hitachi High Technologies Corp. (Japan), Human Metabolome Technologies Inc. (Japan), DANI Instruments S.p.A. (Italy), GL Sciences (Japan), and Kore Technologies Ltd. (United Kingdom). Revenues in the Asia-Pacific region are expected to grow the fastest through 2025. Several pharmaceutical companies have moved their research, development, and manufacturing operations to the region — especially to India and China where there are large numbers of qualified researchers — to tap into the growing market and to lower the costs of production.

1 Clary B. Clish, “Metabolomics: An Emerging but Powerful Tool for Precision Medicine,” Cold Spring Harbor Molecular Case Studies, October 2015 available online here.
2 Unlike other omics where comprehensive data can be gathered using a single analytic platform, metabolomics relies on a combination of analytical platforms, each with its own advantages and disadvantages. As a result, laboratories have to have a variety of instruments available, each potentially costing in the hundreds of thousands of dollars. In addition, universal procedures for sample preparation, analysis, and interpretation of results are currently few or nonexistent.

Sources: “Metabolomics Market by Product, Application, Indication, End User – Global Forecast to 2025,” ReportLinker Summary, December 2020 available online here; Clary B. Clish, “Metabolomics: An Emerging but Powerful Tool for Precision Medicine,” Cold Spring Harbor Molecular Case Studies, October 2015 available online here; Farhana R. Pinu, et. al., “Translational Metabolomics: Current Challenges and Future Opportunities,” Metabolites, June 2019 available online here; “The Global Metabolomics Market Size is Projected to Reach USD 4.1 Billion by 2025 from USD 1.9 Billion in 2020, at a CAGR of 13.4%,” GlobeNewswire, December 24, 2020 available online here; David S. Wishart, “Metabolomics for Investigating Physiological and Pathophysiological Processes,” Physiological Reviews, August 21, 2019 available online here; “The Human Metabolome Database,” The Metabolomics Innovation Centre available online here; “Blood Test May Point to Patients at Higher Risk for COVID-19 Deterioration, Death,” George Washington School of Medicine and Health Sciences Press Release, August 5, 2020 available online here; Max Roser and Hannah Ritchie, “Cancer,” Our World in Data, July 2015, Revised November 2019 available online here; “Metabolite,” NCI Dictionary of Cancer Terms available online here; “Biomarker,” NCI Dictionary of Cancer Terms available online here.
Image source: Belova59, “laboratory-medical-medicine-hand-3827745,” PIxabay, November 25, 2018 available online here.

Clinical Trials

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clinical trial laboratory
Geographic reference: World
Year: 2019 and 2027
Market size: $46.8 billion and $69.8 billion, respectively

Clinical trials are carefully designed studies that test the benefits and risks of new medical treatments and devices. Each clinical trial is led by a principal investigator, usually a doctor, along with a team of nurses and researchers. In the United States, once scientists have completed laboratory research and pre-clinical testing and achieved a successful result—work that can involve years of experiments on animal and human cells—the pharmaceutical or device company submits its data to the Food and Drug Administration (FDA) for approval to begin testing on human volunteers.

Before an investigational medication1 can be sold to the public, it must successfully pass through 3 clinical trial phases. Phase I trials last several months and involve small numbers of volunteers, 20 to 100. This study determines the effects of the drug on humans and the side effects as dosages are increased. About 70% of experimental drugs pass this phase of clinical trials.

Phase II trials typically last several months to two years. They test the efficacy of a drug. Several hundred volunteers participate in randomized trials where one group receives the experimental drug and another either receives a standard treatment or a placebo. Often neither the patient nor the researchers know who is receiving the experimental drug. This allows investigators to compare information about relative safety and effectiveness. About 33% of experimental drugs pass these first two phases.

Phase III trials are also randomized, blind studies but involve several hundred to several thousand patients. This stage can last several years and provides the pharmaceutical company and the FDA a more complete picture of the drug’s effectiveness, benefits, and adverse reactions. Between 70% and 90% of drugs that enter Phase III successfully complete this level of testing. Phase III trials garnered a 53% revenue share in 2019, followed by Phase II with a 19.8% share. Phase III trials are the most expensive because they involve a large number of patients and a long treatment period.

After a successful Phase III completion, the pharmaceutical company can request FDA approval to market the product. According to PhRMA, less than 12% of drugs that enter Phase I trials go on to be approved by the FDA. Over the past decade, the average research and development cost to bring a new FDA-approved medication to market was $2.6 billion, the development process taking an average of 10-15 years.

With COVID-19 affecting the lives and livelihoods of millions of people around the world and causing hundreds of thousands of deaths, currently more than 150,000 in the United States alone, President Donald Trump announced Operation Warp Speed on May 15, 2020. This is a public-private initiative to “accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.” One of its goals is to “have substantial quantities of a safe and effective vaccine available for Americans by January 2021,” a mere 7 months in the future, although researchers had been working on a vaccine since January 2020. As of July 30, 2020, there were 42 potential vaccines in various stages of development around the world according to the Regulatory Affairs Professionals Society COVID-19 Vaccine Tracker.2 Earlier in 2020, the World Health Organization announced an international clinical trial launch, called Solidarity, to find effective treatments for this virus. In May 2020, as a part of Solidarity, it announced an international alliance for simultaneously developing a number of vaccines for COVID-19. In addition, regulatory agencies across the globe issued guidelines related to conducting clinical trials during the COVID-19 pandemic, restricting face-to-face interactions and supporting the incorporation of virtual services, including performing decentralized clinical trials in which many trial functions are done remotely and researchers rely on help from the patients, their family members, and other caregivers instead of healthcare professionals.

Today’s market size shows the revenues for clinical trials worldwide in 2019 and projected for 2027. Funding for clinical trials comes from government agencies such as the National Institutes of Health and the Department of Defense in the United States, pharmaceutical and biotechnology companies, medical institutes, and foundations. Predicted revenue growth during this time period will be due to many factors: the increasing prevalence of chronic diseases, the rising number of biologics, the need for personalized medicines and orphan drugs, as well as increasing demand for clinical trials in developing countries. The globalization of clinical trials, increased use of technology to meet stringent regulations, and increased use of contract research organizations by pharmaceutical companies to organize and conduct clinical trials are additional factors contributing to future growth. In 2019, oncology clinical trials accounted for the largest share of revenue, 23.2%, followed by trials for drugs to treat central nervous system conditions, autoimmune diseases/inflammation, and diabetes. As of August 4, 2020, there were more than 347,000 studies registered at ClinicalTrials.gov, located in all 50 states and 216 countries. Recruiting studies totaled 52,249.

The coronavirus pandemic has disrupted clinical trials for a variety of disease treatments. The number of patients enrolled in clinical trials in March 2020 dropped 65% worldwide from a year earlier. Some studies have halted altogether as medical center resources are diverted to treating patients with COVID-19 and biotechnology firms divert resources to develop therapeutics and vaccines to treat and prevent the spread of the virus.

As of May 2020, interventional design studies accounted for 79% of all registered studies, the majority being for drugs and biologics. Expanded access trials, also known as compassionate use trials, are predicted to grow at the fastest rate, a compound annual growth rate (CAGR) of 5.2%, through 2027. These trials are a way for patients with serious diseases to obtain treatment outside of clinical trials when other treatments prove ineffectual. For example, many oncology drugs considered as a part of expanded access trials are administered to patients before getting FDA approval. As of May 2020, there were 20 therapeutics for COVID-19 in Phase II and Phase III expanded access trials.

North America accounted for 51.2% of the market in 2019 and is expected to maintain its majority share due to increasing research and development and adoption of new technologies. The Asia-Pacific region is expected to grow the fastest, at a CAGR of 6.1%. A growing number of biotechnology firms are seeking to recruit patients for their COVID-19 trials in this region due to its large patient pool and fast-track trial procedures.

Some major companies in the clinical trial market include ICON Plc, Wuxi AppTec, PRA Health Sciences, SGS SA, Syneos Health, Eli Lilly and Company, Novo Nordisk A/S, Pfizer, Clinipace, IQVIA, PAREXEL International Corp., Pharmaceutical Product Development LLC, and Charles River Laboratory.

1 We concentrate on investigational medications in the text, but the market size figures include revenue for all types of clinical trials: drug, biologic, behavioral, clinical procedure, and device studies.
2 According to a June 16, 2020 U.S. Department of Health & Human Services press release, there are more than 100 COVID-19 vaccines in development.

Sources: “Clinical Trials Market Size, Share & Trends Analysis Report by Phase (Phase I, Phase II, Phase III, Phase IV), by Study Design (Interventional, Observational, Expanded Access), by Indication, and Segment Forecasts, 2020 – 2027,” Grand View Research Report Summary, May 2020 available online here; “Clinical Trials Market Size Worth $69.8 Billion by 2027 | CAGR: 5.1%: Grand View Research, Inc.,” CISION PR Newswire, February 18, 2020 available online here; “What is Clinical Research?” WCG CenterWatch available online here; “Clinical Trials,” PhRMA available online here; “Trends, Charts, and Maps,” ClinicalTrials.gov, National Institutes of Health, U.S. National Library of Medicine, August 4, 2020 available online here; “The Impact of Industry Sponsored Clinical Trials,” PhRMA available online here; Jeff Craven, “COVID-19 Vaccine Tracker,” Regulatory Focus, Regulatory Affairs Professionals Society, July 30, 2020 available online here; “Trump Administration Announces Framework and Leadership for ‘Operation Warp Speed,'” U.S. Department of Health & Human Services Press Release, May 15, 2020 available online here; “Fact Sheet: Explaining Operation Warp Speed,” U.S. Department of Health & Human Services Press Release, June 16, 2020 available online here; Bryan Hill, Pratik Maroo, Venu Mallarapu, and Vidya Viswanathan, “Reinventing Clinical Trials for a Stay-at-Home World,” Perspectives, June 22, 2020 available online here; Ben Fidler, “A Guide to Clinical Trials Disrupted by the Coronavirus Pandemic,” BioPharma Dive, May 15, 2020 available online here.
Image source: Belova59, “laboratory-medical-medicine-hand-3827745,” Pixabay, November 15, 2018 available online here.

Enzymes

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enzymes in laundry detergent
Laundry detergent. Enzymes in laundry detergent allow clothes to be washed in cold water.
Geographic reference: World
Year: 2019 and 2027
Market size: $9.9 billion and $17.2 billion, respectively
Sources: “Enzymes Market Size, Share & Trends Analysis Report by Application (Industrial Enzymes, Specialty Enzymes), by Product (Carbohydrase, Proteases, Lipases), by Source, by Region, and Segment Forecasts, 2020 – 2027,” Grand View Research Report Summary, March 2020 available online here; “Enzymes Market Size Worth $17.2 Billion by 2027 | CAGR 7.1%: Grand View Research, Inc.,” CISION PR Newswire, March 16, 2020 available online here; Sindhu Raveendran, et. al., “Applications of Microbial Enzymes in Food Industry,” Food Technology & Biotechnology, March 2018 available online at the U.S. National Library of Medicine, National Institutes of Health here; JanMaarten van Dijl and Michael Hecker, “Bacillus Subtilis: From Soil Bacterium to Super-secreting Cell Factory,” Microbial Cell Factories, January 14, 2013 available online here; “A Global Fermentation Approach,” Leaf by Lesaffre available online here; “Specialty Enzymes Market Worth $6.6 Billion by 2025,” MarketsandMarkets Press Release, April 20, 2020 available online here.
Image source: habelfrank, “washing-powder-detergent-1500058,” PIxabay, July 7, 2016 available online here.

Enzymes are proteins that act as catalysts. Enzymes in the body run cellular processes and convert food to energy and to building blocks for proteins, lipids, nucleic acids, and some carbohydrates. Industrial enzymes such as proteases, amylases, lipases, and others are used in various applications: in the food and beverage industry, in detergents, animal feed, biofuels, textiles, pulp and paper, nutraceuticals, personal care products and cosmetics, wastewater treatment, and medications. In 2018, 60% of industrial enzymes on the market were proteases. In Europe, 900 tons of protease enzymes are used for detergents alone every year.

Today’s market size shows the global enzyme revenues for 2019 and projected for 2027. Microorganism-based enzymes comprised the vast majority of the industrial enzyme market in 2019, about 85%, followed by animal-based and plant-based enzymes. Microorganisms are preferred as a source due to their more predictable and controllable enzyme content. This type of enzyme can also be produced in a cost-effective manner with less space and time necessary than animal-based or plant-based enzymes. There are three types of microorganism-based enzymes: bacterial, fungal, and yeast. Bacterial enzymes are mostly sourced from Bacillus. They’re used in food and detergent and in pharmaceutical applications to diagnose diseases, promote wound healing, and kill disease-causing microorganisms. Fungal enzymes are used in the preparation and production of soy sauce, beer, baked goods, processed fruits, and dairy products. Yeast is used in beer, baked goods, and industrial ethanol production.

Increased investment in biotechnology research for the development of specialty enzymes for medicinal and diagnostic purposes is one of the main factors driving product demand globally. Increasing demand from the food and beverage, biofuel, animal feed, and home cleaning sectors along with the growing consumption of functional foods will contribute to the growth in the market through 2027. By region, growing biofuel production in North America and Europe, as well as increasing meat production in Europe and the Russian Federation, are expected to contribute to growth in these regions. Enzymes are used extensively in meat processing to improve the tenderness of the meat. Europe was third behind China and North America in meat production in 2018. The top three companies in this industry—Novozymes, DuPont Danisco, and DSM— claimed more than 75% of the market in 2019.1 Other major companies in this industry include BASF SE, Associated British Foods PLC, Chr. Hansen Holding A/S, and Advanced Enzyme Technologies.

1 Source: Grand View Research. The press release from CISION PR Newswire mentioning the same Grand View Research report states that the top 3 companies are Novozymes, DuPont Danisco, and BASF SE.