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Pharma Biotech Industry

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Last Updated: 02 July 2021

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General | Latest Info

The pharmaceutical and biotechnology industry produce drugs and other products that help people and animals live healthier lives, recover from injuries, and fight illnesses. From its humble origins in local pharmacies and apothecaries that prepared home remedies during the Middle Ages, pharmaceutical and biotechnology industry has grown into one of the leading industries in the world today. In United States, it is the third most profitable industry in terms of percentage of revenues, is home to cutting - edge biological and chemical research, and offers opportunities for people across a wide spectrum of careers, from scientists, physicians, and engineers to marketing and sales workers and human resources professionals. Pharma / Biotech companies produce three types of products: Prescription Therapeutics and prophylactics, diagnostics, and over - counter consumer products, such as drugs and vitamins. Some experts also place medical technology manufacturing under the umbrella of the pharma / Biotech industry. In a general sense, pharmaceuticals are defined as medicinal drugs that are regulated by the US Food and Drug Administration or other regulatory bodies and are manufactured by pharmaceutical companies. Biotechnology, or Biotech, is the use of biological research techniques to develop products and processes derived from living organisms. Biotechnology techniques are applied at the molecular level and include DNA typing and cloning, genetic manipulation, and gene transfer of plants, animals, and microorganisms. Biotech products, sometimes called biologics, are products that are created using recombinant DNA technology. According to FDA, biological products can be composed of sugars, proteins, or nucleic acids, or a combination of these substances. They may also be living entities, such as cells and tissues. In recent years, pharma and biotech sectors have become closely link. Since the mid 1980s, terms biopharmaceuticals and biopharma have referred to both types of products. In that time, many biopharmaceutical firms have emerge, which are owned by traditional pharmaceutical companies and large drug manufacturers. There are three main types of pharmaceutical companies. Large companies, sometimes know as innovative pharmaceutical companies, produce chemically - derive drugs and have many approved drugs on the market. They run huge research, development, and manufacturing efforts, sometimes with subsidiaries around the globe. Some innovative companies also produce biopharmaceuticals. Next are newer firms that often do have any approved drugs on the market, but that are involved in developing new drugs. Generic Drug Manufacturers, last type, produce drugs developed by other manufacturers after drug patent expires. Some generic companies also do original research and development to produce new drugs. Lines between Innovator and generic companies or between pharmaceutical and biotechnology companies have become increasingly blurred, and most major multinationals now incorporate both biologics and generics subsidiaries in their portfolios, according to 2016 Top Markets Report: Pharmaceuticals, from International trade Administration. As the prevalence of biosimilars grows, high manufacturing and regulatory costs involved in developing these drugs further cloud traditional distinctions between innovative and generic business models and investment cycles. Pharmaceutical companies are scattered throughout the United States, but the greatest concentrations exist in the Middle - Atlantic States and on the West Coast in California.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Overview

The pharmaceutical industry plays a significant role in developing medications and vaccines to reduce the incidence of diseases, to treat diseases and enhance the quality of life of people. Industry's main contribution is engaging in technological advancements through innovative RESEARCH to meet the complex healthcare demands of populations. The global market for pharmaceuticals is expected to grow at an annual rate OF 4. 9% to 1. 3 trillion by 2020. The US pharma market is expected to grow to 320 billion by 2020. Japan market, third largest pharmaceutical market, has forecast growth OF 3% while the US has expected a growth rate OF 5.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Industry Subsectors

In the Newtown - Needham area, Camoin Associates is working with a public - private initiative known as N 2 Corridor to position and promote the region as a place for new business attractions and formation. To understand corridors ' competitive advantages, Camoin completes Economic base Analysis that analyzes regions ' existing and potential workforce, current industry presence and demographics. Biotechnology has been identified as a priority industry based upon this work. In developing Economic Development strategies to support continued and future growth of biotech in the region, it become evident through discussions with companies, entrepreneurs, and Economic Development stakeholders that at local level, zoning, land - use regulation, and permitting are where rubber meets road in creating and supporting places with quality infrastructure, amenities and design. Putting research into practice, Needham was recently added to a short list of Massachusetts communities that are designated as BioReady by the Massachusetts Biotechnology Council. This demonstrates that the designee has biotech and Life Sciences friendly zoning, has streamlined permitting system in place and established infrastructure in related biotechnology subsectors. This award will increase areas ' competitive advantage over other locations, especially those elsewhere in the state. 15 battelle / BIO State Bioscience Jobs, Investments and Innovations, June 2014 It should be noted that while progressing Health Care technologies and capabilities is the primary goal of these subsectors, this article excludes activities involved in actual Health Care field like hospitals and physicians, to hone in on Technology and innovation behind Health Care services. Battelle / BIO State Bioscience Jobs, Investments and Innovations, June 2014 IBISWorld Industry Report NN001: Biotechnology in US, March 2016 IBISWorld Industry Report NN001: Biotechnology in US, March 2016 IBISWorld Industry Report NN001: Biotechnology in US, March 2016 National Venture Capital Association, Yearbook, 2016. Ibisworld Industry Report NN001: Biotechnology in US, March 2016 IBISWorld Industry Report 33451b: Medical Device Manufacturing in US, January 2016. Ibisworld Industry Report 42345: Medical Supplies Wholesaling in US, December 2015. Ibis World Industry Report: Diagnostics & Medical Laboratories in US, January 2016. Ibis World Industry Report: Diagnostics & Medical Laboratories in US, January 2016. Modify from work by Catherine Renault and Alyson Slack, Camoin Associates, 2016. Renault, Catherine, Are innovation districts remaking or obsoleting university Research parks?, Camoin Associates Economic Development Navigator, February 2016. Needham certified as BioReady, N 2 Corridor Blog, April 2016.


What Is Biotechnology?

In a nutshell, biotechnology is an industry that focuses on novel drug development and clinical research aimed at treating diseases and medical conditions. Biotechnology companies are almost always unprofitable, and many have no real revenue at all. Biotechnology is also characterized by long development lead times; it can take as much as decade to get a new drug from the test tube to the pharmacy shelf. What's more, there is an overwhelming likelihood of failure, as 90% of all prospective new drugs fail to reach approval. Still, for those that succeed, rewards can be tremendous and daily doubles are not unheard of.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

My take

Table2

Product2017 RevenueKey origins
Infliximab (Remicade)$6.3 billionSynthesized at New York University in the 1980s in collaboration with Centocor Ortho Biotech, which was acquired by JJ in 1999
Ustekinumab (Stelara)$4.0 billionCentocor , which licensed Medarexs UltiMAb technology to generate ustekinumab in 1997; Centocor was acquired by JJ in 1999
Paliperidone (Invega Sustenna/Xeplion/Trinza/Trevicta)$2.6 billionJJ
Abiraterone (Zytiga)$2.5 billionUK Institute of Cancer Research in the 1990s, which later assigned rights for the development of abiraterone to British Technology Group International, which licensed abiraterone to Ortho Biotech Oncology Research Development, a unit of Cougar Biotechnology, in 2004. Cougar was acquired by JJ in 2009
Rivaroxaban (Xarelto)$2.5 billionBayer in the 1990s, which later entered into a collaboration with JJ to jointly develop rivaroxaban
Ibrutinib (Imbruvica)$1.9 billionCelera Genomics in 2005, a company founded by a geneticist as a unit of biotechnology company Applera. Pharmacyclis acquired some of Celeras drug discovery programs, including ibrutinib, and entered into an agreement with JJ to jointly develop and market ibrutinib in 2011
Golimumab (Simponi/Simponi Aria)$1.8 billionCentocor , which licensed Medarexs UltiMAb technology to develop golimumab; Centocor was acquired by JJ in 1999
Darunavir (Prezista/Prezcobix/Rezolsta/Symtuza)$1.8 billionUniversity of Illinois at Chicago , in collaboration with the National Institutes of Health and Purdue University, which later licensed darunavir to Tibotec, a pharmaceutical company founded by researchers at the Rega Institute for Medical Research, which was acquired by JJ in 2002
Daratumumab (Darzalex)$1.2 billionGenmab , a European spinoff of U.S.-based Medarex, in collaboration with the University Hospital in Utrecht; Genmab licensed daratumumab to JJ in 2012
Bortezomib (Velcade)$1.1 billionProScript, originally founded as MyoGenics by scientists at Harvard; ProScript later collaborated with the National Cancer Institute to further develop the drug. ProScript merged with LeukoSite, which was acquired by Millennium Pharmaceuticals in 1999. Millennium was acquired by Takeda in 2008, which entered into a co-promotion agreement in JJ in 2010
Canagliflozin (Invokana/Invokamet)$1.1 billionMitsubishi Tanabe Pharm , which later licensed canagliflozin to JJ
Epoetin alfa (Procrit/Eprex)$972 millionAmgen , which later assigned rights for non-dialysis indications in the U.S. and for all indications approved outside the U.S. to JJ
Risperidone (Risperdal Consta)$805 millionJJ in the 1980s
Methylphenidate (Concerta)$791 millionCiba-Geigy in the 1940s. ALZA Corporation, which developed an alternative formulation of methylphenidate, was acquired by JJ in 2001
Rilpivirine (Edurant)$714 millionTibotec , which was acquired by JJ in 2002
Macitentan (Opsumit)$573 millionActelion in 2002, which was acquired by JJ in 2017
Bosentan (Tracleer)$403 millionHoffman-La Roche , which later licensed bosentan to Actelion, which was acquired by JJ in 2017
Selexipag (Uptravi)$263 millionNippon Shinyaku , which later entered into an agreement with Actelion to jointly develop selexipag in 2008, Actelion was acquired by JJ in 2017

My take is all over this article, but it comes down to how pharma performs in the next 12 months. If they look like saviors again, it will be hard to budge from the status quo. However, I believe the mood in Washington is to allow Medicare to begin to negotiate prices. Historically, it hasn't been a partisan issue, as Pharma has courted both parties equally. Can the US get drug prices down to European levels, drop of 75%? Highly unlikely, but new era of reigning in drug companies could have a long - term effect.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

4. Liquid Biopsies

Guardant Health is one of more than a dozen companies with Liquid Biopsies already on the Market. Its test, known as Guardant360, was launched at the 2014 ASCO meeting and looks for alterations in 73 Cancer genes. Guardants CEO, Helmy Eltoukhy, stole concepts from his background in Digital communications to help the company push the sensitivity and specificity of Guardant360 to the point where it can now detect down to a single molecule from a tube of blood in some cases. Right now, Liquid Biopsies are mostly used for treatment selection in patients already diagnosed with cancer, particularly when tissue biopsy is feasible. Gene panel Sequencing, for example, probes for mutations in ctDNA or CTCs and then suggests target treatments match to whichever mutations are present. Treating patients with right therapies should, in many cases, improve response rates. Liquid Biopsies also have particularly powerful implications for managing patient care. Unlike tissue biopsies, which are usually not repeat, Liquid Biopsies can be taken much more easily. With more data points, physicians can see in real time if patients ' cancer has mutated in response to therapy and swap in more effective treatment. Another use of Liquid Biopsies is in clinical trials. As targeted therapies proliferate, pharma companies need to cast a wide net in order to enroll patients who match specific criteria of drug studies. Using Liquid Biopsies to screen patients could greatly accelerate enrollment as well as lower costs. Guardant recently announced a partnership with AstraZeneca, Merck & Co., Merck KGaA and Pfizer to develop a 500 - gene version of Guardant360 for this very purpose. Many companies in space, including Guardant, Market Liquid Biopsies as lab develop tests or LDTs. Unlike other medical devices, LDTs do require FDA approval to be market. Tests can only be done by the original developers. However, companies ca sell LDT to other labs. So far, only one Liquid Biopsy has received FDA approval: Roches cobas EGFR Mutation Test v2, which is use companion diagnostic to Swiss pharmas lung Cancer Drug Tarceva. The Roches Test picks up epidermal Growth factor receptor gene mutations from ctDNA, allowing physicians to determine which patients might benefit most from Tarceva.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

The opportunity: Biopharma goes mainstream

With the year drawing to close, this is time to look back, summarize industry trends, and ruminate about what to expect in the coming year. The most important trend, predicted by BioPlan Associates year ago, was continue, consistent expansion of revenues among industry suppliers, driven by increasing global demand for biologics. Industry as a whole has shown surprising resilience and consistency, emerging relatively unscathed from recession at the beginning of the past decade. Capacity and expansion were relatively unaffected and continue to draw investors seeking healthy returns and recession - resistant risk profile. 1 there have been challenges, including increasing criticism of exceptionally high prices, general worldwide economic concerns, and the emergence of biosimilars and biogenerics as they compete for the same markets. 10 000 or more therapeutics in the R & D pipeline include both low molecular weight drugs and biopharmaceuticals, with nearly 40 000 ongoing or recently Report clinical trials. Among these, 40 percent or more are biopharmaceutical products. A significant portion, now more than 1 700 products in the development pipeline, are follow - on biopharmaceuticals, mostly biosimilars and biobetters in major markets, with a large number of biogenerics proliferating in developing countries with looser regulatory structures. Despite the positive picture describing the last 12 months, we do see concern over the trend for companies, especially Big Pharma, to cut back on expenses by consolidating R & D, with truncated companies often ending up with a shrunken pipeline of new offerings. Most every merger or acquisition invariably includes acquirer claiming the new company will have a larger and healthier pipeline, increased capacity, and more adept expertise. However, it also seems that this rarely happen, and after merger and acquisition activity, new, bigger post - merger / acquisition companies tend to consolidate and cut back R & D, close facilities, and outsource tasks previously considered better done in - house. This trend is slowing, but any decreases in existing company R & D are likely to be more than counterbalanced by established companies and new entrants worldwide jumping in to fill the R & D gap. This increasingly includes large number of new entrants moving into cellular and gene therapy areas and expansion geographically in Asia, China in particular. The final outcome is that the biopharmaceuticals industry keep expanding at a steady pace. As biopharmaceuticals become ever more significant and lucrative component of the healthcare industry, they are driving new chapter in the industry. With all sectors entering their development, including big pharma, small companies, and foreign participants, demand for resources, including staffing, is growing. As a result, year after year, hiring the right people is creating real bottlenecks. For example, over 45 percent of facilities are having trouble hiring downstream process development staff, critical position in development of biologic. These problems have existed since at least 2010 and are continuing to grow. Budgets are equally expanding to address these staff shortages. And troubles may only be beginning. When promising new technologies, such as cell and gene therapies, move into clinical or commercial development, they will pull staff from existing companies, which will exacerbate shortages.


The five forces

Curative therapiestime - limited treatments that remove symptoms of disease through permanent correction of underlying conditionhave potential to reduce incidence and prevalence of many diseases. Several of our interviewees predict that diseases driven by single genetic mutations are likely to be among the first ones treated by curative therapies. At the end of 2019, more than 1 000 clinical trials were being executed worldwide for cell and gene therapies. 13 these trials are targeting a breadth of diseases including cancer, musculoskeletal disorders, and neurodegenerative diseases. While biopharma is at the forefront of developing these treatments, keeping pace with the rapidly changing environment will likely require new business models. Gene therapies: first gene therapy in the United States was approved in 2019, and many more are in the pipeline. Most of these therapies target diseases driven by single or few genetic mutations. One interviewee said he expected to see cures for diseases that are well - defined by genetic mutations based on better gene therapy. Such diseases could include cystic fibrosis, sickle cell disease, Fragile X syndrome, muscular dystrophy, and Huntingtons disease. One academic researcher told the US that we might be able to cure cancer subtypes that are caused by specific oncogenes passed down in families, such as BRCA. Gene replacement, for example, could replace prophylactic mastectomies. He cautioned that there are many safety concerns with this approach and said it could be difficult to replace genes in all people's cancer - causing cells. Diseases that are cell nonautonomous might be more attractive, he add. Another interviewee told the US that CRISPR has been used to destroy viruses and bacterial infections. He also said that CRISPR can be used to program bacteria to guard against other bacteria. For example, researchers at Western University in London, Ontario, successfully used CRISPR - associate enzyme called Cas9 to eliminate species of Salmonella using E. Coli bacteria. Scientists at Broad Institute also recently published a study that demonstrates that another enzyme called Cas13 could be program to kill three different kinds of single - strand RNA viruses. 14 However, one CRISPR leader points out that gene editing might only address part of the problem for multifactor diseases. Drug therapy might still be required to manage other variables that drive disease expression. Cell therapies: Adoptive cell transfer therapy is driving research and development activity among many biopharma companies. The most publicized form of ACT uses patients ' own immune system to destroy cancer cells. Two therapies using this technology have been approved in the United States, and many more are in development. 15 these therapies could treat previously difficult - to - treat late - stage cancers and have led to high rates of remission. As researchers reduce the cost of making and delivering these therapies, and reduce or better manage toxicities, they could move upstream in treatment plans to become the standard of care. One interviewee suggested that applications of this technology could expand beyond oncology into autoimmune diseases. Well, better understand where the immune system has been program up and learn to program it down using CAR - T, he say.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

1. Increased regulatory demands.

While patients demand the latter, businesses and sometimes patients alike often complain about the former, feeling that regulations are an impediment to drug development. They maintain that these Regulations often keep medical improvements and life - saving drugs from reaching needy patients, since too much time is taken by FDA to conduct thorough premarket Evaluation. It has been claimed that the 1962 Kefauver - Harris Amendments alone created an additional decade of regulatory delay. These delays were also blamed for the greatly increasing cost of Drug Development. One economist WHO compared pre - and post - 1962 drug market estimated that since the acquisition of FDA new powers, the number of new drugs had been reduced by 60%, so the rate of new drug development was decreasing. Actually, new drugs are getting to market, but while the number of new drugs approximately doubles each year, pharmaceutical R & D costs grow by a factor of 20. As an example of response to bad decision, Miller recalled one incident early in his career where canner of beets labelled them as baby beets, Upon inspection of the canning facility, it was noted that canner was using a small device to scoop out little balls of beets from mature beets and labeling them baby beets, not very serious infraction and not even very fraudulent since they were pack in glass jar and one could easily tell they were not baby beets. Nevertheless, FDA seized the product as being mislabeled and took canner to court. Canner went to his congressman, named Taber, WHO happened to head up the appropriations Committee of which FDA was part. Taber was so incensed he said that if the FDA had time to spend on things like this, they have too much money. He cut their funding by 25%, ie, millions of dollars. Miller learn lesson that seemingly minor regulatory decisions in terms of product quality and marketing can have major impact on FDA with serious budgetary consequences, emphasizing dictum that Congress pronounces. Experiences like this can set the tone for being more deliberate in the decision - making process. During the period following the Kefauver - Harris Amendments of 1962, there was increasingly greater pharmaceutical innovation and, at same time, increasing regulatory oversight. As noted above, effect was that the number of NDAs decreased while the time to get them reviewed and approved increase. One of the problems, according to the FDA, was that with the ever - greater number of drugs to review, they just didnt have adequate staff to get the job done more quickly. Yet, Congress would not increase FDA budgets sufficiently to provide enough funds to turn this around. In an effort to find some way to increase the FDA's ability to evaluate and approve more safe drugs in an era of expanding pharmaceutical discovery but limited regulatory resources, Prescription Drug User Fee Act was enacted in 1992.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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