Future Trends in Healthcare
Intro
The pharmaceutical industry has experienced significant growth during the past two decades, and pharma revenues worldwide totalled 1.25 trillion U.S. dollars in 2019[i].
This has attracted investors, created opportunities and brought lifesaving medicines and medical devices to the market.
However, pharmaceutical industry is at the crossroads. The traditional pharmaceutical business models are being constantly challenged in increasingly competitive global markets.
While biopharma companies made significant R&D investments to innovate in the last 10 years, the returns declined significantly during that same period—from 10.1% to 1.8%. This represents an average decline of 0.83% per year[ii].
Governments, regulatory agencies, taxpayers and patient groups demand lower prices of the medicines and expect that pharmaceutical companies demonstrate greater value from their therapies.
These challenges are coming at a time when the broader healthcare universe in which it operates is undergoing a radical change. Patients are changing their attitudes and behaviours and are becoming more open to sharing their data and using new technologies and tools to make decisions about their medical care.
COVID-19 pandemic has highlighted the need for faster development of new medicines and medical devices and switch to digital technologies.
New approaches in how diseases are diagnosed and prevented, personalized medicine, curative therapies, digital therapeutics, and precision intervention could radically alter the current business models.
By preparing for the future now, executives can understand the forces transforming the global economy and prepare for the next wave of growth.
Upcoming changes and Future trends
There are several main change drivers in the upcoming 10-20 years due to the recent discoveries in biomedical sciences, emerging technologies, increased consumer expectations and digital transformation.
Shift from Treatment to Prevention and Early detection
The largest potential direct economic impact in healthcare is likely to come from preventing, diagnosing, and treating diseases. That impact could total between $500 billion and $1.2 trillion a year over the next ten to 20 years, spread across multiple disease areas[iii].
In the near future, it is highly likely that many cancers, metabolic and chronic disease could be detected even before first symptoms appear. Early detection of different types of cancer can and other chronic and debilitating disease eliminate the need for costly therapies.
Early genetic tastings will help to determine who might be genetically predisposed to a disease and introduce preventive measures early, including lifestyle change, frequent monitoring of certain biomarkers and early therapy, if required.
Use of medical health records, machine learning, and anonymized medical databases could help discover patterns of diseases and their formation which would allow early intervention.
Personalized (precision) medicine
The aim of personalized medicine is to tailor medical decisions, interventions and therapies to the individual patients, based on their expected risk of developing a certain disease and predicted response to a therapy, instead of a one‐drug‐fits‐all mode. Also, the term “precision medicine” is being used more often today.
FDA’s (CDER) approved 53 new molecular entities (NMEs) in 2020.
Roughly 40% are personalized medicines as classified by the Personalized Medicine Coalition
Personalized medicines now account for more than a quarter of the new therapeutics approved since 2015
CBER approved Tecartus (brexucabtagene autoleucel) —cell-based therapy, for the treatment of mantle cell lymphoma (MCL)[iv]
The success of precision medicines depends a lot on the accuracy of Next Generation Sequencing (NGS) tests that are capable of rapidly identifying or 'sequencing' large sections of a person's genome and are important advances in the clinical applications of precision medicine.
There are many challenges with the use of personalized medicine that biopharma companies will face in the near future. Given that personalized medicine relies on advances in machine learning, data collection and analysis and population screening, the question of patient privacy, data biases and regulatory oversight is becoming increasingly important.
Intellectual property rights and reimbursement policies will certainly influence investment in personalized medicine.
Biomachine interfaces
In the near future, computers will be connected to human central nervous system and will help humans restore lost bodily functions or will be used for diagnosis, monitoring and analysis.
Neuroprosthetics will be used by people who have lost their limbs and by people who have lost control over their limbs due to nervous system damage.
One example of the myoelectric prosthesis is the Hero Arm from Open Bionics.
The future will bring commercial devices that can be directly implanted in the brain or interpret brain signals. Various combinations of myoelectric devices, exoskeletons, prosthetic limbs and neural implants will be used to restore the control of the limbs.
Deep brain stimulation involves implanting electrodes within certain areas of your brain. It is being studied as a potential treatment for addiction, chronic pain, depression, multiple sclerosis and many other diseases[v].
In the future, wearable devices that can recognize different emotions and read brain signal-could be used as a therapeutical aid. An example of a wearable device in the wellness industry is the Muse headband that interprets EEG signals to track sleeping patterns.
Digital Healthcare
In September 2020 FDA launched the Digital Health Center of Excellence[vi] with a goal to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation. This includes the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.
Digital tools should empower patients and give them a more holistic view of their health through access to data and more control.
An example of app is MyDose Coach - a smartphone app designed for patients with type 2 diabetes who take once-daily insulin. Eko Digital Stethoscope is a device that connects a stethoscope to the cloud and analyze the data using artificial intelligence with aim to detect cardiac anomalies easier.
The global mobile health apps market size was valued at USD 40.05 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 17.7% from 2021 to 2028[vii]
In the future, a more streamlined and efficient regulatory oversight of software as a medical device (SaMD) is needed. FDA established the Software Precertification (Pre-Cert) Pilot Program together with a selection of pharmaceutical and IT companies. This pilot program will help establish a new regulatory framework and provide a better oversight of SaMD.
In addition, in January 20201, FDA issued Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. AI and ML can derive new and important insight from the huge amount of health-related data.
The use of computers, smartphones and wearables to gather and store huge amounts of health-related data has been rapidly accelerating. This will allow the use of real-world data (RWD) and real-world evidence (RWE) to better design and conduct clinical trials.
Biological advances
In order to answer the challenges of the 21st century biology, scientists will need to work with new tools and generate, have access to, interpret, and archive more information than ever before.
Some of these tools already exist like genetic sequencing, while others like artificial intelligence are being perfected and complement already existing technologies.
DNA sequencing is becoming cheaper and huge volumes of data is being created daily.
In 2003, mapping the human genome cost about $3 billion; by 2019, it was less than $1,000. Within a decade or even sooner, the cost could be less than $100[viii].
Genomics – the study of the genome, is the most talked about of all “omics”- collective name used for various disciplines in biology like proteomics, epigenomics, lipidomics etc…
In 2019 FDA approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children with spinal muscular atrophy (SMA). This milestone opened a new chapter in treatment of genetic diseases and provided hope to many patients and their families worldwide.
The genetic basis of cancers has been studies for decades. Primary methods for treating cancers were chemotherapy, surgery and radiation.
In the near future, it is expected that various cell and gene will be developed and used in treatment of cancer. Adoptive cell transfer (transfer of ceils into a patient) is used in cancer immunotherapy. In CAR-T cell therapy (chimeric antigen receptor) T-cells are extracted from a patient, genetically modified in a lab and then returned into a patient.
In essence, this therapy uses patient’s own immune system to destroy cancer cells. Future will bring similar therapies for other types of cancers. Currently new approached are being tested in clinical trials. Clinicians are considering using stem cells to create a limitless source of off-the-shelf CAR T cells. This approach may have some limitations, like being feasible only in certain settings but it would allow timely application of the medication[ix].
Therapies for monogenic diseases are likely to be adopted first, followed by polygenic disease therapies.
There are more than 10.000 monogenic disease, for most of them adequate diagnosis and treatment are not available, even when the exact mechanisms of the diseases are known. The advances in gene sequencing will lower the cost of diagnosis and reinforce screening for these disorders.
Genome-wide association studies or GWAS will help us understand the connection between the genes and disease pathways. This understanding could help us understand which genes could be targeted to threat a disease. For example, Verve Therapeutics are pioneering medicines to safely edit the adult genome and threat cardiovascular disease.
Genomics and AI can help identify infectious agents, diagnose or threat infectious diseases.
The Karius Test is a blood test based on next-generation sequencing of microbial cell-free DNA. It can identify and quantify over 1,000 clinically relevant pathogens including bacteria, DNA viruses, fungi, and parasites. Proprietary technology efficiently extracts microbial cell-free DNA (mcfDNA) circulating in the bloodstream from pathogens causing an acute infection and advanced machine learning algorithms allow analysis of complex genomic data in real-time.
Regenerative medicine hold promises for treatments that still don’t exist today. Stem cells could stimulate growth or repair of damaged tissues and organs.
Robotics, nanotechnology
Robotic surgery is now the standard of care for many diseases. However, there are still many hard-to-reach places in the body that prevent efficient use of robotics in removing and treating different tumors. It is expected that progress in robotics would enable sophisticated and precise interventions that are not possible today.
Nanotechnology can be used to deliver the drugs to specific tissues or to remove certain inflammatory molecules from the body.
Together with the 3D printing these technologies could remove the need for the chronic use of certain drugs or even classes of drugs that are regularly prescribed today.
Conclusion
It is expected that the current model of developing drugs that treat symptoms and prevent the progress of chronic diseases will be challenged in the future by regulators, patients and competitors.
Pharmaceutical executives should prepare for the new reality in which many diseases will be discovered even before symptoms emerge and even when they emerge, the therapies and procedures will be expected to be cheaper and personalized. Wearable devices and apps will significantly help identify diseases early and provide real-world data that could further reduce the need for expensive therapies of chronic diseases.
Many diseases will also be discovered, prevented and managed by non-pharmacological means.
Pharmaceutical executives must identify new opportunities and threats to their business models, plan and when necessary, adapt. Companies that are able to adapt their current business practices to a world built around early prevention and detection, extensive use of real-world data and digitalization of healthcare will be able to capitalize on the upcoming opportunities.
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Sources/References:
[i] https://www.statista.com/topics/1764/global-pharmaceutical-industry/ [ii] https://www2.deloitte.com/us/en/insights/industry/life-sciences/pharmaceutical-industry-trends.html [iii] McKinsey Global Institute “The Bio Revolution” May 2020 [iv] Personalized Medicine at FDA: The Scope & Significance of Progress in 2020 [v] https://www.mayoclinic.org/tests-procedures/deep-brain-stimulation/about/pac-20384562 [vi] https://www.fda.gov/medical-devices/digital-health-center-excellence/what-digital-health [vii] https://www.grandviewresearch.com/industry-analysis/mhealth-app-market [viii] Kristen V. Brown, “A $100 genome is within reach, Illumina CEO asks if world is ready,” Bloomberg, February 27, 2019; Antonio Regalado, “China’s BGI says it can sequence a genome for just $100,” MIT Technology Review, February 26, 2020. [ix] https://www.cancerresearch.org/immunotherapy/treatment-types/adoptive-cell-therapy
