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Biotechnology, Pharmaceuticals & Genetics OVERVIEW

Biotechnology can be defined as the use of living organisms (such as bacteria), biological processes or biological systems to create a desired end-result or end-product. Primary markets for biotechnology include: 1) Agriculture, where genetically modified seeds are now in wide use in many nations. These seeds deliver plants that have can much higher crop yields per acre, and often have qualities such as disease-resistance, resistance to herbicides and drought-resistance. 2) The manufacture of enzymes, including enzymes used in food processing (such as the making of certain dairy products) and in converting organic matter into ethanol for fuel. 3) Pharmaceuticals, where biotechnology creates such therapies as antibodies, interleukins and vaccines based on living organisms (as opposed to the chemical compounds that make up traditional drugs) that can target specific cellular conditions, often with dramatic results (such as the drug Keytruda that famously fought brain cancer for former U.S. President Jimmy Carter).

Biotechnology is a modern word that describes a very old science. For example, bio-enzymes have always been essential in the production of cheese. The modern difference is that much of the world’s cheese production today utilizes a bio-engineered version of an enzyme called microbial chymosin. This chymosin is made by cloning natural genes into useful bacteria. Another example: For thousands of years, mankind has used naturally-occurring microbes to convert fruit juices into wine.

The Coronavirus (COVID) pandemic is providing a massive boost to the biotech industry. Around the world, biopharmaceutical firms are pouring an immense effort into research that might lead to a greater understanding of the virus, how to prevent it and how to cure it. Much of this research effort has been fueled by emergency injections of government funding. Continuing mutations of the virus, such as the Delta and Lambda variants, will keep Coronavirus research and vaccines at the forefront of the biotech industry for an extended period. While the size of the Coronavirus vaccine market is currently hard to estimate, it is likely at least $40 billion for 2021.

Plunkett Research estimates that combined biotech revenues for publicly held firms headquartered in the U.S. and E.U. were $202 billion during 2020. Genetically-engineered drugs, or “biotech” drugs, represent roughly 16% of the total global prescription drugs market. The U.S. Centers for Medicare & Medicaid Services (CMS) forecast called for prescription drug purchases in the U.S. to total about $378.9 billion during 2020, representing about $1,083 per capita. That projected total is up from only $200 billion in 2005 and a mere $40 billion in 1990.

Estimates of the size of the drugs market vary by source. Plunkett Research estimated the global pharmaceuticals market at $1.25 trillion for 2020. By 2027, American drug purchases alone may top $576.7 billion, according to the CMS, thanks to a rapidly aging U.S. population, increased access to insurance and the continued introduction of expensive new drugs.

Advanced generations of drugs developed through biotechnology continually enter the marketplace. The results may be very promising for patients, as a technology-driven tipping point of medical care is approaching where drugs that target specific genes and proteins may eventually become widespread. However, it continues to be difficult and expensive to introduce a new drug in the U.S.

According to FDA figures, 53 new molecular entities (NMEs) and new biotech drugs (BLAs) were approved in the U.S. during 2020. These NMEs are novel, new active substances that are categorized differently from “NDAs” or New Drug Applications. NDAs may seek approval for drugs based on combinations of substances that have been approved in the past. Also, a large number of generic drug applications are being approved each year. That is, an application to manufacture a drug that was created as a brand name, and has now lost its patent so that competing firms may seek FDA approval to manufacture it.

Dozens of exciting new, biotech drugs that target specific genes are seeking regulatory approval. Many of these drugs are for the treatment of specific forms of cancer. In a few instances, doctors are making treatment decisions based on a patient’s personal genetic makeup. (This strategy is often referred to as personalized medicine.) New breakthroughs in genetically targeted drugs occur regularly. An exciting drug for certain patients who suffer from the skin cancer known as melanoma is a good example. Zelboraf, developed by drug firms Roche Holding and Daiichi Sankyo, will dramatically aid melanoma patients who are shown through genetic tests to have a mutated gene called BRAF. In trials, about 50% of such patients saw their tumors shrink, compared to only 5.5% of patients who received traditional chemotherapy.

New Drug Application Categories

Applications for drug approval by the FDA fall under the following categories:

BLA (Biologics License Application): An application for approval of a drug synthesized from living organisms. That is, they are drugs created using biotechnology. Such drugs are sometimes referred to as biopharmaceuticals.

NME (New Molecular Entity): A new chemical compound that has never before been approved for marketing in any form in the U.S.

NDA (New Drug Application): An application requesting FDA approval, after completion of the all-important Phase III Clinical Trials, to market a new drug for human use in the U.S. The drug may contain active ingredients that were previously approved by the FDA.

Biosimilars (generic biotech drugs): A term used to describe generic versions of drugs that have been created using biotechnology. Because biotech drugs (“biologics”) are made from living cells, a generic version of a drug may not be biochemically identical to the original branded version of the drug. Consequently, they are described as “biosimilars” or “follow-on biologics” to set them apart.

In Europe, their manufacture and sale has been allowed for some time under special guidelines. In February 2012, the FDA created guidelines for biosimilars in the U.S. Manufacturers are now able to rely to a large extent on the clinical trials research previously conducted by the maker of the original version of the drug.

Priority Reviews: The FDA places some drug applications that appear to promise “significant improvements” over existing drugs for priority approval, with a goal of returning approval within six months.

Accelerated Approval: A process at the FDA for reducing the clinical trial length for drugs designed for certain serious or life-threatening diseases.

Fast Track Development: An enhanced process for rapid approval of drugs that treat certain life-threatening or extremely serious conditions. Fast Track is independent of Priority Review and Accelerated Approval.

Personal genetic codes are becoming less expensive and more widely attainable. Today, the cost of decoding the most important sections of the human genome for an individual patient has dropped dramatically.

Although total drug expenditures are relatively small in developing nations such as India and Brazil, they have tremendous potential over the mid-term. This means that major international drug makers will be expanding their presence in these nations. However, it also means that local drug manufacturers have tremendous incentive to invest in domestic research and marketing.

The Coming BioIndustrial Era:

Some of the most exciting developments in the world of technology today are occurring in the biotech sector. These include advances in agricultural biotechnology, the convergence of nanotechnology and information technology with biotech and breakthroughs in synthetic biotechnology.

The rapidly growing worldwide base of biotechnology knowledge has the potential to create a new “bioindustrial era.” For example, scientists’ ability to capture refinable-oils from algae and other organisms (organisms that remove carbon from the atmosphere as they grow) may eventually create a new source of transportation fuel. Oil industry giant ExxonMobil has backed research in this regard at Synthetic Genomics, Inc. with hundreds of millions of dollars.

The use of enzymes in industrial processes may enable us to bio-engineer a long list of highly desirable substances at modest cost. The result could easily be a lower carbon footprint for many industrial processes, less industrial and residential waste to deal with and a significant increase in yields in chemicals, coatings, food and other vital sectors. DuPont’s acquisition of global enzyme leader Danisco is a good indicator of the looming era of bioindustrial advancements, as DuPont made a $5.8 billion bet that it can help a vast variety of manufacturers to achieve significant product enhancements and efficiencies.

Source: Plunkett Research, Ltd.

Significant ethical issues face the biotech industry as it moves forward. They include, for example, the ability to determine an individual’s likelihood to develop a disease in the future, based on his or her genetic makeup today; the potential to harvest replacement organs and tissues from animals or from cloned human genetic material; and the ability to genetically alter the basic foods that we eat. These are only a handful of the powers of biotechnology that must be dealt with by society. Watch for intense, impassioned discussion of such issues and a raft of governmental regulation as new technologies and therapies emerge.

Another breakthrough in gene therapy is CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats). The technology focuses on the use of a DNA-cutting protein that is guided by an RNA molecule, targeted at a specific gene. This technology enables a scientist to quickly and easily edit or re-engineer specific bits of DNA. A defective gene can be precisely edited within the laboratory, and then reintroduced to a patient's body as a form of gene therapy with far more accuracy than previous gene therapies. CRISPR is sometimes referred to as “genetic editing,” and it is considered to be a very significant breakthrough. Practical applications may include treatments or even cures for sickle-cell anemia, HIV and cystic fibrosis. Libraries of CRISPRs have been created by researchers at MIT that account for nearly all human genes. CRISPR is also being utilized to modify seeds and plants for agricultural use.

The biggest single issue may be privacy. Who should have access to your personal genetic records? Where should they be stored? How should they be accessed? Can you be denied employment or insurance coverage due to your genetic makeup?

Global Factors Boosting Biotech Today:

1) A rapid aging of the population in nations including the EU, much of Asia and the U.S., such as tens of millions of Baby Boomers in America who are entering senior years in rising numbers and require a growing level of health care. A significant portion of that care may be in the form of biotech drugs.

2) The Coronavirus pandemic creates immense demand for vaccines, boosting research, manufacturing and distribution.

3) Major pharmaceuticals firms paying top prices to acquire young biotech drug companies that own promising drugs.

4) A very significant market for genetically engineered agricultural seeds (“Agribio”), with farmers in dozens of nations planting genetically modified seeds.

5) Aggressive investment in biotechnology research in Singapore, S. Korea, China and India, often with government sponsorship—for example, Singapore’s massive Biopolis project.

6) Very promising research into synthetic biology.

7) Dramatic decreases in the cost of personal genetic studies, which can be a big boost to personalized medicine.

8) Highly advanced biotech technologies known as gene therapies are slowly beginning to prove their ability to cure patients.

9) An increased focus on the discovery and manufacture of new drugs (“orphan drugs”) that impact rare diseases or relatively small portions of the population.

10) The advent of the genetic engineering process known as CRISPR, enabling scientists to alter cells and repair defective cells. This has profound potential in both human and animal health therapies.

11) CRISPR also has major potential to modify agricultural seeds and plants through gene editing.

Source: Plunkett Research, Ltd.

Internet Research Tip:

For the latest biotech developments check out www.biospace.com, a private sector portal for the biotech community, and www.bio.org, the web site of the highly regarded Biotechnology Industry Organization.