As the pharmaceutical industry evolves, exciting trends are emerging for 2023. Due to the COVID-19 pandemic and scientific advancements, the pharmaceutical industry experienced accelerated change over the past two years. Throughout this evolution, the pharmaceutical industry has remained committed to developing innovative products and improving patient care.

While pharmaceutical companies are often vilified, their research and development efforts have improved healthcare and public health. Pharmaceutical companies continually seek novel approaches for developing drugs, educating healthcare providers (HCPs), and optimizing patient outcomes. Throughout 2023 and beyond, the following five pharma industry trends will continue to shape healthcare.

1. Artificial intelligence will continue to accelerate innovation

Artificial intelligence (AI) continues transforming our lives and the pharmaceutical industry. AI is an umbrella term for any digital technology with the ability to mimic human intelligence. The impact of AI is evident across all healthcare sectors, enhancing drug development, patient diagnosis, treatment, and home healthcare.[1,2]

Within the pharma industry, AI accelerates drug development by predicting drug-target interactions, forecasting toxicity, and streamlining manufacturing procedures.[2] Pharmaceutical companies will increasingly design and implement sophisticated digital tools for faster and more efficient product development and marketing. A pharmaceutical brand's success depends on embracing new digital marketing technologies and digital platforms to reach HCPs and patients.[2]

This era of rapid digital adoption is often called the "Fourth Industrial Revolution."[2] In response to the Fourth Industrial Revolution, the Food and Drug Administration (FDA) created the Digital Health Center of Excellence (DHCoE), empowering digital health stakeholders to form partnerships to advance digital health technologies (DHT). In addition to drug development and marketing, AI and DHTs are transforming clinical trial design, patient recruitment, and patient monitoring.[3]

2. Wearable devices will enhance clinical trials and patient care

Wearable devices will continue to impact clinical trials and patient care. “Wearable devices” are wearable biosensors providing clinicians with digital biomarkers to monitor patients' health.[4,5] According to the FDA, a digital biomarker is a metric derived from DHTs to evaluate biological processes, pathologic processes, and therapy responses.[5] The trend in clinical trials is toward decentralization, a process of collecting trial data remotely rather than at the trial site.[3] Wearable devices make it possible to collect data remotely.

Decentralized clinical trials (DCT) improve trial recruitment, retention, and diversity by allowing patients with socioeconomic or physical barriers to participate in clinical trials.[3,6] Wearable devices provide real-world data (RWD), capturing the heterogeneity of populations more effectively than randomized clinical trials (RCTs).[7] As a result, wearables and DCTs improve health equity and enable researchers to gain greater insights.[3,6,7] By leveraging these insights, pharmaceutical companies can optimize drug development to suit diverse populations.

While consumers have widely adopted wearable devices such as Apple Watches and Fitbits to count calories and steps, healthcare systems and pharmaceutical companies have been slower to adopt them. However, recent studies by Ochsner and Kaiser Permanente health systems highlight the ability of wearable devices to monitor prescription adherence and efficacy.[4]

Ochsner's digital hypertension management program resulted in 71% of patients reaching target blood pressure within 90 days versus 31% under conventional care.[4] Using digital glucose monitoring, Kaiser Permanente minimized the time clinicians devoted to phone calls with patients, increasing the capacity to manage patients effectively.[4] Both programs used readily available devices and integrated the data into their electronic health records (EHRs). The findings of these studies illustrate how wearable devices can empower patients and facilitate precision medicine research in the future.

3. Specialty pharmacies continue to expand and shape the market

As specialty drugs outpace conventional drugs, specialty pharmacies will play an increasingly important role in shaping the pharmaceutical market. Oncology drug development is driving specialty drug spending, which has increased by 316% since 2011.[8] 53% of all drug spending goes toward specialty medicines.[8] Payers control specialty pharmacies, and their decisions shape drug prices and healthcare costs.

Pharmacy benefit managers (PBMs) continue to dominate the specialty pharmacy market. PBMs control three-quarters of the specialty pharmacy market. However, a growing number of specialty pharmacies have emerged due to the increased use of specialty drugs. Hospital-owned specialty pharmacies have grown the fastest, accounting for about one-third of total specialty pharmacies.

The growth of specialty pharmacies shows no signs of slowing down. Research and development (R&D) pipelines in the United States (US) are dominated by specialty drugs, accounting for 70% of drug launches over the last five years.[9] Gene therapy and mRNA vaccines (two types of biologics) have increased from 11 to 21% of the drug development pipeline, a record level of growth. Specialty drugs will depend heavily on genetic testing in the future, but provider education and payer assistance will be essential.

4. Genetic and genomic testing will become more widespread

Specialty medications, such as biologics, will increasingly rely on genomic data for designing clinical trials and optimizing patient care.[10,11] Genetic and genomic tests identify biomarkers (e.g., genes) that predict therapy response, adverse reactions, and prognoses. Genetics will play an increasingly significant role in healthcare in the future, so knowing its language is essential.

Genetics refers to the study of genes and their effects on inheritance, while genomics refers to the study of all of a person's genes.[13] A somatic genomic test detects all of a tumor's mutations, allowing HCPs to prescribe the most appropriate targeted treatment. Any genetic testing which predicts a response to medications is called pharmacogenomic (PGx) testing.

Over the last twenty years, the number of new drugs approved with PGx labeling has doubled, and 75% are oncology drugs.[11] Among all patients, regardless of diagnosis, germline genetic testing identifies patients' inherited mutations, which can predict adverse drug reactions (ADRs).[12] Genetic variability contributes to about 20% of ADRs, and PGx testing can reduce ADRs by approximately 50%.[14] Despite the benefits of genetic and genomic testing, adoption is slow due to a lack of education among payers and HCPs.[15]

A growing number of publicly available genome databases and guidelines are helping HCPs and payers better understand how scientists identify and translate genetic variants into actionable biomarkers. Common resources include:

1. Clinical Pharmacogenetics Implementation Consortium (CPIC®): CPIC's purpose is to create, curate, and post freely available, evidence-based gene/drug clinical practice guidelines.

2.PharmGKB: PharmGKB collects, curates, and disseminates knowledge about genotype-phenotype relationships and how human genetic variation affects medication response.

3. OncoKB: precision oncology knowledge base developed at Memorial Sloan Kettering Cancer Center that contains biological and clinical information about cancer-related genomic alterations.

These databases will help genetic and genomic testing become more widespread. Pharmaceutical companies will use genetic and genomic testing to streamline clinical development in the future. Payers and HCPs will increasingly recognize the value of genetic and genomic testing for reducing healthcare costs and optimizing patient care.

5. Credentialing and regulation will continue to gain importance

Pharma companies will need to train and certify their medical science liaisons (MSLs) and pharmaceutical sales reps to standardize employee training and ensure compliance. Due to the popularity of virtual programs, HCP education is shifting to digital platforms.[16] A heightened regulatory environment necessitates training and credentials for life science professionals to adapt to the current and future digital environment.[16] As a result, the need for accredited certifications will become more widespread.

Healthcare will become increasingly complex due to rapid technological advancements. Adapting to the future will require understanding biologics, which dominate R&D pipelines. The pharmaceutical industry will continue to shape healthcare trends as new technologies, medications, and regulations emerge.

References

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3.Thomas KA, Kidziński Ł. Artificial intelligence can improve patients’ experience in decentralized clinical trials. Nature Medicine. 2022. doi:10.1038/s41591-022-02034-4.

4. Smuck M, Odonkor CA, Wilt JK, Schmidt N, Swiernik MA. The emerging clinical role of wearables: factors for successful implementation in healthcare. npj Digital Medicine. 2021;4(1). doi:10.1038/s41746-021-00418-3.

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8. The Use of Medicines in the US. IQVIA Institute for Human Data Science. May 27, 2021. Accessed December 18, 2022. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/the-use-of-medicines-in-the-us/iqi-the-use-of-medicines-in-the-us-05-21-forweb.pdf

9. Global Trends inR&D. IQVIA Institute for Human Data Science. Feb 10, 2022. Accessed December 18, 2022.https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/global-trends-in-r-and-d-2022/iqvia-institute-global-trends-in-randd-to-2021.pdf

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11. Kim JA, Ceccarelli R, Lu CY. Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000-2020). J Pers Med. 2021;11(3):179. Published 2021 Mar 4. doi:10.3390/jpm11030179.

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13. Genetics vs. Genomics fact sheet. Genome.gov. Published March 9, 2019. Accessed December 19, 2022.https://www.genome.gov/about-genomics/fact-sheets/Genetics-vs-Genomics

14. Malki MA, Pearson ER. Drug–drug–gene interactions and adverse drug reactions. The Pharmacogenomics Journal. 2020;20(3):355-366. doi:10.1038/s41397-019-0122-0.

15. Pinzón-Espinosa J, Van Der Horst M, Zinkstok J, et al.. Barriers to genetic testing in clinical psychiatry and ways to overcome them: from clinicians’ attitudes to sociocultural differences between patients across the globe. Translational Psychiatry. 2022;12(1). doi:10.1038/s41398-022-02203-6.

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