future of pharmaceutical industry and its product

How will each of these five forces disrupt our current business model? Not unexpectedly, the pharmaceutical industry has aggressively partnered with biotechnology companies to fill their pipeline gaps. The five forces, listed in order of potential disruption to the traditional scope of the biopharma industry, are: Prevention and early detection: Vaccines and improvements in wellness could help prevent disease, making treatment for some diseases no longer necessary. Shifts in how diseases are identified, prevented, treated, or cured may lead to fundamentally different business models for traditional biopharma companies and new entrants. A podcast by our professionals who share a sneak peek at life inside Deloitte. 377–88. We can already see these trends taking shape as the pharma industry is expected to see annual compound growth of over 6% and reach $1.2 trillion in 2024, with R&D spending at 16.9% ofprescription sales in 2024.”, “Pharma will become increasingly reliant on digital tools and data-driven strategies from drug development through commercialization. For example, researchers at the Western University in London, Ontario, successfully used a CRISPR-associated enzyme called Cas9 to eliminate a species of Salmonella using E. coli bacteria. A future marked by greater access to needed Digital therapeutics that reduce the need for pharmaceutical intervention: Digital therapeutics are increasing access to medical providers, which could reduce the need for drug treatments. Digital therapeutics, for example, might use an app-based platform to target modifiable chronic diseases such as diabetes, depression, anxiety, and heart disease. In the face of these five forces, biopharma companies should ask themselves: By 2040, some diseases will be prevented, cured, or managed with nonpharmacological interventions. They include prevention and early detection, custom treatments and personalized medicine, curative therapies, digital therapeutics, and precision intervention. The industry is poised to embrace alternative cell lines that can operate many times faster and cheaper in order to speed up the development and potentially bring down the cost of the end product: medicines for human use. enhancements in the operations of these organizations and patient efficacy. As one interviewee pointed out, “There is no way to determine why some people develop rheumatoid arthritis and some people don’t.” But the groundwork is already being laid for a world with a greater ability to detect and prevent disease. Systematic evaluation of how patients metabolize drugs by evaluating the expression of liver enzymes (CYP450) or kidney function could enable more optimal dosing to get patients into therapeutic ranges. Our interviews confirmed that five forces are beginning to impact biopharma companies but are likely to disrupt the sector more dramatically in the years ahead. Some of our interviewees noted that the ability to use genetic information to identify patients at risk for developing disease could create an opportunity for biopharma companies. Cell therapies: Adoptive cell transfer (ACT) therapy is driving research and development activity among many biopharma companies. Advances in early detection will likely enable interventions that halt diseases in the earliest stages—before they progress to more serious conditions. Gene therapies: The first gene therapy in the United States was approved in 2019, and many more are in the pipeline. Digital therapeutics deliver evidence-based interventions to patients through software programs that help prevent, manage, or treat a medical disorder or disease. Sales volumes for drugs across disease areas are likely to decline due to more effective prevention, greater stratification of disease, better tailoring of drug regimens for patients, an increase in curative therapies, behavioral intervention, and advanced medical procedures. View in article. Our US Health Care practice helps clients transform uncertainty into possibility and rapid change into lasting progress. Amid unprecedented uncertainty and change across the health care industry, stakeholders are looking for new ways to transform the journey of care. Reports indicate that by 2020 the global pharmaceutical market will more than double to around US$1.3 trillion, with Brazil, China, India, Indonesia, Mexico, Russia and Turkey accounting for 1/5th of global pharmaceutical sales.. He cautioned that there are many safety concerns with this approach and said it could be difficult to replace the gene in all of a person’s cancer-causing cells. A therapy that is effective for one patient, might be metabolized differently by another patient and never reach the optimal active concentration, he noted. He suggested that at some point in the future, patients might be presented with multiple options to treat tissue or organ dysfunction. Through her research, she helps inform Deloitte’s health care, life sciences, and government clients about emerging trends, challenges, and opportunities. Emphasis on strategically working with regulators to reduce or at least stabilize prices for vulnerable populations continue to occupy regulators in the U.S. and worldwide.”, “A major focus of Pharma going forward will be a move toward instituting new manufacturing technologies to produce biologic drugs and vaccines. Some manufacturers might forge partnerships directly with health systems or consortiums to supply them with products. View in article, Express Scripts, “Innovation page,” accessed February 25, 2020. Company leaders should develop strategies to counter potential threats and take advantage of the short- and long-term opportunities that emerge in this changing environment. View in article, Livongo, “Case study: Livongo demonstrates cost savings,” accessed February 25, 2020. The forces of change highlighted in this paper are likely to reshape, if not shrink, the market for biopharma products. Smaller-volume therapies could require new manufacturing capabilities—not just for branded manufacturers, but all generics (see the sidebar, “The future of generic drug manufacturing”). Organizations that ignore these forces and maintain the status quo could wind up shrinking in parallel to the demand for drug interventions to manage symptomatic diseases. If more diseases are cured or prevented, the need for generic drugs that treat chronic diseases could be reduced significantly, which could disrupt the volume-based model. We look forward to reporting about innovative approaches and lessons learned from this situation. Biopharma companies might be able to develop or target therapies to the unique characteristics of each subpopulation. Instead, the biopharma sector is on the fringe of an era where hypertailored therapies are developed to cure or prevent disease rather than treat symptoms. Taking action against systemic bias, racism, and unequal treatment, Key opportunities, trends, and challenges, Go straight to smart with daily updates on your mobile device, See what's happening this week and the impact on your business. It is too early to opine on the timing and impact of those activities and how the forces we describe in this paper might accelerate or change how biopharma responds to pandemics in the future. It's here. Many fewer people would have long-term conditions with continued need for medication to treat symptoms.1. Share your feedback and we'll consider adding it to the piece! Since the outbreak, retail of over-the-counter drugs spiked before lockdowns in March 2020 as consumers stockpiled these drugs. Parkinson’s disease, for example, has a number of clear genetic subsets and various mutations. Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee ("DTTL"), its network of member firms, and their related entities. During December 2019, on moving annual total (MAT) basis, industry growth was at 9.8%, with price growth at 5.3%, new product growth at 2.7%, while volume growth at 2% y-o-y. How can we continue to monitor the landscape for future disruption. Based on emerging technology, we can be reasonably certain that digital transformation—enabled by radically interoperable data, AI, and open, secure platforms—will drive much of this change. View in article, Sriram Renganathan, “The battle against drugs—3D printing drugs: The latest advancements,” All3DP, February 23, 2019. “If pharma wants to survive, they should broaden themselves significantly,” said one former executive of a global pharmaceutical company. “We’ll be able to fix it, regenerate tissue, or grow replacements, perhaps through xenotransplantation,” he predicted. For example, airway splints for babies with tracheobronchomalacia (a rare condition where the tracheal or windpipe cartilage is soft) can be created by a 3D printer.26, Tissue engineering—in combination with additive manufacturing—could be used to restore damaged tissues. The way individuals express disease and respond to treatment varies greatly. Tailored drug regimens: Clinicians of the future might be able to examine a range of biomarkers and genetic information—as well as clinical and behavioral digital health data—to determine the appropriate drug combinations for a patient. The innovative pharmaceutical industry is driven by, and drives, medical progress. Global Regulatory Affairs, Allergan, Irvine, CA, USA . For example, data on how a patient metabolizes a drug could be used to ensure he/she gets the precise dose that will optimize effectiveness and minimize toxicity. ALL RIGHTS RESERVED. See Terms of Use for more information. View in article, Amy Dockser Marcus, “A genetic test led seven women in one family to have major surgery. These forces represent both opportunities and threats to incumbents. In recent times the industry has been less successful at discovering innovative new molecules. The company said it detected strong signals for 12 cancers with a 99 percent specificity rate.6, Nutrition and microbiome: Everyone has a unique microbiome, and researchers are just beginning to understand the relationship between these tiny organisms and how they influence mental and physical health. 2: Personalized or customized treatment. 1 (2019): pp. One physician interviewee predicted, “We will be giving patients one pill with everything rather than a number of pills.” She noted that this a common patient pain point that physicians often don’t see. The future of the pharmaceutical industry 1. Prior to Deloitte, Sonal worked in the biopharma industry. Sonal has a Master of Business Administration in health care management from the Wharton School, and a Doctor of Pharmacy from the Rutgers University Ernest Mario School of Pharmacy. Unlike today, we believe care will be organized around the consumer, rather than around the institutions that drive our existing health care system. With unlimited access to information, patients are more knowledgeable than ever before, making healthcare providers more informed, and therefore better equipped to manage a disease or even avoid it altogether. Considerations: These technologies could be highly disruptive to biopharmaceutical companies by eliminating the need for drug therapy. The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered (or self-administered) to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms. There must be a biological component taken into consideration in pharma advancements. Unlike some high-cost therapies that treat a small portion of the population, the generic-drug business model is based entirely on high-volume treatments that target large populations. Microbes found in the guts of children, for example, could be related to childhood diseases, such as Type 1 diabetes.9 Recent research also suggests that the microbiome could influence how susceptible a patient might be to certain types of cancer, or how a patient is likely to respond to immunotherapy.10. Case in point: In December 2019, the Wall Street Journal reported that seven women from the same family underwent major surgeries after a genetic test determined they all had an elevated risk of developing breast cancer.5 Since then, we’ve learned the increased risk associated with this particular gene is not quite as high as previously thought. Interviewees noted that disruption is already taking place in the industry, and they tried to project where those threats might lead over the next 20 years. Life at Deloitte Blog. By 2040, health is likely to revolve around preventing some diseases from happening, and curing others. Pharmaceutical R&D productivity has been steadily falling for over 50 years: this is what is known within the industry as “Eroom’s Law”—Moore’s Law in reverse. Some digital therapeutics are empowering patients to take charge of their symptoms for complex chronic diseases, including autoimmune diseases (see the sidebar, “New digital therapeutics help patients manage their chronic diseases”). Express Scripts, for example, has established a digital formulary that evaluates digital interventions based on clinical research, usability, and financial value.16 Livongo’s digital therapeutics for diabetes, prediabetes, and hypertension have received preferred formulary status (see the sidebar, “New digital therapeutics help patients manage their chronic diseases”). View in article, Philip D. Greenberg, “How cellular immunotherapies are changing the outlook for cancer patients,” Cancer Research Institute, accessed February 25, 2020. Developing, marketing, and pricing these curative treatments could require the biopharma sector to adopt new capabilities. For example, the increasing use of advanced data analytics and deep learning will allow Pharma to more effectively design and implement clinical trials that result in more personalized and consumable therapies that benefit patients and providers. Innovation starts with insight and seeing challenges in a new way. View in article, Colin A. Espie et al., “A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application,” Sleep 35, no. For example, the home bathroom of the future might include a smart toilet that uses always-on sensors to test nitrites, glucose, protein, and pH for possible infections or disease. In 2017, Livongo presented at the Annual American Diabetes Association’s Scientific Sessions showing that it decreased costs by 5.8 percent compared to non-Livongo users, helping save US$83 per participant per month.23. If the future of health emerges in the way we expect it will, we could see some consolidation among generic-drug manufacturers. In some applications, 3D printing offers solutions where none existed. Given the need for data, we envision that the early advances in personalized treatments will be seen with generic and late–life cycle medications, which have a wealth of RWE available to inform the stratification of the disease, tailored dosing, and tailored regimens. There was also some discussion that our ever-growing knowledge of genetic risks could lead to under- or over-treatment. One of our interviewees said, “We will have an active nanomechanical system that can go through and do different things in the body, like replace tissues and cell types.” Case in point: A team of scientists at the University of California, San Diego, created “nanosponges” that can go through the body and remove toxins from bacterial pathogens and inflammatory conditions.24 Nanotechnology might even evolve to include living cells. Curative therapies: As with prevention, treatments that cure disease could reduce or eliminate the demand for some prescription medicines. Twenty years from now, rather than picking up a prescription at the pharmacy, personalized therapies based on a diverse set of a patient’s characteristics including their genomics, metabolome, microbiome, and other clinical information might be manufactured or compounded just in time through additive manufacturing. 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