In 2022, healthcare stakeholders struggled to understand and navigate a number of major issues affecting the healthcare landscape and society more broadly. While COVID-19 shifted from a pandemic to an endemic stage, this complex disease continued to loom large, and  ongoing efforts remained to research the origin of the SARS-CoV-2 pathogen, address new variants, and understand the longer-term impact of the virus as well as prepare to respond more effectively to new potential outbreaks. At the same time, other issues came to the forefront, such as the mental health crisis, the issues around affordability of medicines, and the  impact on biotech ventures of the capital markets slow-down.

More than ever, there is an urgency to advance rigorous research and science-based decision making across the entire healthcare continuum.

As part of our efforts at the IQVIA Institute to help achieve this goal, we undertook new research in 2022 and  published 15 reports, hosted 9 public webinars and 3 forums, convened 3 multi-stakeholder roundtables, and participated in 34 external forums, helping to chart the course for evidence-based research moving forward and inform important conversations about the future of healthcare. We brought together more than 100 external thought-leaders from all major stakeholder groups as well as IQVIA experts to engage in open and provocative discussions. Our research was also cited in nearly 700 scholarly publications, including notable studies published by the OECD¹ , U.S. FDA² , U.S. Congressional Budget Office³ . and Health Affairs⁴ .

Furthermore, the Institute published the weekly Influenza Weekly Tracking Report 2022-23 to bring timely information to the American public on national and regional trends as the biggest  influenza outbreak in more than a decade unfolded.

Multi-Stakeholder Forums

For the first time, the IQVIA Institute convened the IQVIA Life Sciences Innovation Forum: Setting Priorities for Life Sciences Companies to Accelerate Biomedical Innovation and Health System Sustainability for a five day, virtual event September 12-16. The forum, which had a total of 2,713 attendees over the five days representing life sciences companies and other stakeholders, discussed key themes affecting life sciences innovation, including: Addressing and prioritizing unmet healthcare needs and accelerate innovation; Advancing R&D productivity to sustain biomedical innovation; Maximizing the value of medicines to patients through rigorous evidence and new care settings; Advancing health system sustainability; and Rethinking the life sciences business model.

The Institute also hosted the annual IQVIA Research Forum: Exploring the Elusive Nature of Applied Research in National Health Crisis, which took place as a virtual, three day meeting October 10-12 and brought together 491 academic researchers over the three days, along with other stakeholders, to discuss a number of challenges and opportunities facing academic health research, including: Exploring a learning health system approacg in national health crises; Incorporating the impact of social determinants on outcomes in health research; Navigating the complexity and heterogeneity of patient affordability and access; and Elevating the value to patients of academic health research through data sharing and transparency. A bibliography of recently published papers and presentations using IQVIA’s proprietary information was published concurrently with the Research Forum, featuring research focused on: Evaluating the impact of COVID-019 on health systems; Understanding disease and treatment patterns; Providing context for healthcare costs; Assessing policy levers; and Advancing real-world patient-level clinical evidence.

A Patient Advocacy Summit was convened on November 16 in collaboration with the IQVIA Healthcare Solutions team to explore approaches to accelerate advocacy-led research and data initiatives. This invitation-only summit, which convened 153 leaders from patient advocacy organizations, included a patient and caregiver listening session and discussions on Making best bets: prioritizing expenditure for maximizing impact on patient communities; Making patient advances together and faster: a practical guide to life science partnerships; Evolving real-world evidence to elevate the patient voice and more forward toward patient-centricity; Putting patients at the center of innovation in clinical development and patient care; and Looking ahead for patient organizations: how can tech help?

IQVIA Institute Reports

The following 15 reports were published by the IQVIA Institute in 2022, addressing key themes around the use and spending of medicines globally, biopharmaceutical R&D and innovation, improving decision-making in life sciences companies, and global health system resiliency following the COVID-19 pandemic.

Elevating the Knowledge of Medicine Use and Spending

In The Global Use of Medicines 2022, the IQVIA Institute showed how the outlook for global spending on medicines has become clearer as the uncertainties of the last two years in a global pandemic gradually gave way to more predictable challenges and opportunities for healthcare systems and policymakers across developed and emerging economies. According to the report, global medicine spending — the amount spent purchasing medicines from manufacturers before off-invoice discounts and rebates — is expected to reach $1.8 trillion by 2026, increasing at a rate of 3–6% per year. The IQVIA Institute has since published The Global Use of Medicines 2023.

Our deeper dive into The Use of Medicines in the U.S. 2022 provides a grounding in relevant information across a range of issues with both short- and long-term implications. It includes the Health Services Utilization Index, which tracks a range of healthcare activities that affect the use of medicines.The report found that spending on U.S. medicines rose 12% in 2021 due primarily to COVID-19 vaccines and therapies; however, despite the increase in overall spending, costs per prescription on average are flat or slightly declining.

Biosimilars have become a potent force in pharmaceutical markets, and our report on 15+ Years of Biosimilar Experience in Europe analyzed the value provided by the first biosimilar launched in Europe — Omnitrope^®, a human growth hormone, since its launch. In these 15+ years, Omnitrope has also witnessed access and uptake in most European countries and has a 30% share of overall somatropin usage. Based on analysis of IQVIA MIDAS data, the entry of Omnitrope (somatropin) has led to more than $1.9 billion in savings at a list price level across selected European countries between 2006 and 2021, driven by its reduced cost and the increased competitive pressure on reference medicines.

Meanwhile, acceptance and use of biosimilars has also been rising in the U.S. and there are policies currently under discussion in the U.S. to improve access to biosimilars through some sort of shared savings programs (also known as benefit sharing or gain sharing in other countries). Such programs have been implemented in a number of countries in Europe, and while contexts across countries vary, the experience of such programs in other countries can provide lessons for the U.S. In Shared Savings Programs in Europe, five case studies of shared savings/benefit sharing programs from across Europe are examined using secondary research, expert interviews, and IQVIA data. The background to setting up a program is provided for each case study along with the structure of the program and results as stated in secondary literature and as per IQVIA data. Lessons for the U.S. are summarized based on these case studies.

Assessments of the value of new medicines have become more complex as clinical innovation accelerates, and more drugs are obtaining marketing authorization for narrowly defined patient populations and early-stage disease. Real-world evidence (RWE) has the potential to complement and supplement clinical trial evidence, when health technology assessment (HTA) bodies evaluate drugs in the context of reimbursement decisions. According to the report Impact of RWE on HTA Decision-making, an analysis of 16,515 HTA reports across 83 HTA bodies spanning 33 countries, the proportion of records incorporating RWE as part of the submission has risen from just 6% in 2011 to 39% in 2021.

Intellectual property rights for pharmaceuticals that protect medicines from competition – and later permit competition – are critical elements of the drug market landscape and important to understand, especially as regulations and practices evolve. We examined this issue in our report Protection Expiry and Journey Into the Market by analyzing the cohort of medicines in Europe that have lost protection across the past six years. The 118 medicines that lost protection within this study are innovative therapies used by physicians and patients across the EU, which represented ~13% of the total European pharmaceutical expenditure at their peak. The total market value of these molecules and their competitors in the past six years has been more than €100 billion. This cumulative amount represents approximately 10% of the total pharmaceutical expenditure in Europe in the same period.

Access and affordability of medicines are top priority issues for healthcare stakeholders globally as they strive to build and maintain resilient, sustainable health systems. Among those medicines are some that can be considered “essential” on the basis that at least one similar drug in a therapeutic group has been reviewed and received public reimbursement in at least half of the European countries assessed. To date, limited evidence has been presented to show per capita use across countries and for each of the clusters or groups of these Essential Innovative Medicines (EIMs). This evidence gap was filled by our report Defining Essential Innovative Medicines and Measuring Their Use in Europe, which shows that, relative to the European average of 100, per capita use of these essential medicine groups ranged from a high of 236 in Luxembourg and 213 in Austria to a low of 10 in Ukraine and 16 in Bosnia.  While epidemiology is an important explanatory factor in some disease areas, a wider range of underlying drivers of difference in healthcare delivery are also at play and deserving of further research.

We also took a look at how the lack of local data creates barriers to understanding disease burden and the potential impact of therapeutics on patients, caregivers, and society. In the case of Medical Dermatology, we focused on atopic dermatitis and alopecia areata in Latin America, conducting roundtables with experts from various stakeholder groups (payers, patients, caregivers, physicians, and patients advocates) in four countries: Argentina, Brazil, Colombia, and Mexico.  The report found that innovative therapies for these conditions could help address some of the unmet needs in the region, along with creating access to these therapies. Due to the importance of addressing the unmet needs that currently exist in the treatment of these conditions, specific country initiatives are needed to increase disease awareness and improve access to the correct treatments for patients with atopic dermatitis and alopecia areata in Latin America.

Accelerating Biopharmaceutical R&D and Innovation

Understanding key trends in global R&D is critically important for accelerating therapeutic innovation in the future. The report Global Trends in R&D 2022 assesses the trends in new drug approvals and launches, overall pipeline activity in terms of actively researched medicines, and the number of initiated clinical trials. The report demonstrated that the total number of products that are in active development in human trials globally exceeds 6,000, up 68% over the 2016 level, as life sciences companies continue to invest and advance innovative therapeutics and vaccines across a wide range of disease areas, despite the disruptions caused by the COVID-19 pandemic.

One of the most significant contributions by R&D has been the development of COVID-19 vaccines that became available for public use seven months from the start of clinical trials.  This was a record-breaking, cross-stakeholder response, and in our report Lessons Learned from COVID-19 Vaccine Trials, we zeroed in on the model changes that allowed for clinical trial efficiencies to be realized.  We took the perspective of the contract research organization (CRO) and based this research on a set of workshops with COVID-19 vaccine clinical delivery teams.

Oncology is the leading therapy area for innovation in terms of the level of clinical trial activity, number of companies investing in therapeutics, size of the pipeline of therapies in clinical development, novel active substances being launched, and the level of expenditure on these drugs. In 2021 and during a global pandemic, as demonstrated in the annual report Global Oncology Trends 2022, cancer care continued to be delivered, although a backlog in treatment and screenings raised worrying questions. In a record-setting year, oncology trial starts reached historically high levels in 2021, up 56% from 2016 and mostly focused on rare cancer indications.

The majority of biomedical innovation is developed by emerging biopharma (EBP) companies, many of which have never marketed a therapy before. EBPs are responsible for a record 65% of the molecules in the R&D pipeline without a larger company involved, up from less than 50% in 2016 and 34% in 2001. Our research included in Emerging Biopharma’s Contribution to Innovation examined these companies that are at the root of early-stage drug development and their performance, the environment in which they operate, their relationship to other stakeholders in the health system, and their role in determining the future of many novel therapies and health technologies.

The call for achieving representative diversity in clinical trials and development programs has been amplified over the course of the COVID-19 pandemic as the striking disparities in health outcomes among diverse populations became evident. The report Advancing Diversity in Clinical Development through Cross-Stakeholder Commitment and Action measures the progress that has been made in increasing participation by racial and ethnic groups – with a principal focus on Black/African Americans and Hispanics – in clinical trials. The report demonstrates that a dramatic increase in diversity data reporting has occurred in the past five years, peaking in 2018. Yet reported diversity data from the past decade shows both Black/African American and Hispanic participation in Phase II and Phase III trials fall short of the 2020 U.S. demographics levels of 13.6% and 18.9% respectively. We also showcase success cases where sites, patient organizations, CROs and sponsors have overcome some of the known barriers to clinical trial participation by Black/African Americans and Hispanics.

Improving Decision-Making in Life Sciences Companies

The report Improving Decision-Making through Connected Intelligence examines the fundamental elements of connected intelligence that feed into decision-making at life sciences companies: building meaningful connections in data and technology, elevating skills to generate insights, and shaping the organizational structure and culture to share, link and utilize those insights. With an eye to what lies ahead for life sciences organizations, the report examines how connected intelligence can generate better insights to guide decision-making at various levels, including at critical points along a molecule’s lifecycle and at the enterprise level, and can also enable evidence-sharing and dissemination in support of multi-stakeholder decisions.

Building Resilient Global Health Systems Post COVID-19

Over the past decade, a new wave of pioneer healthcare initiatives has emerged in low- and middle-income countries by building commercially viable and scalable enterprises to solve patient pain points by making use of mobile and digital technologies, offering financing and insurance solutions, and improving access to preventative and primary care. This report Scaling Up Healthcare Inclusive Initiatives in Low- and Middle-Income Countries reviews the preliminary findings of a study performed by the IQVIA Institute for Human Data Science, together with Hystra – a consultancy specialized in inclusive business solutions – to learn from pioneer organizations what underlies their early successes and what is limiting them from reaching further scale or impact.

Acknowledgements

A majority of our research activities in 2022 were undertaken as a public service, without external funding. We are grateful for the research funding received for some of our research, as disclosed in those reports. All of our research is undertaken independently, often with support from IQVIA data sources and experts, whose collaboration is much appreciated.

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¹Morgan, D. and F. Xiang (2022), "Improving data on pharmaceutical expenditure in hospitals and other health care settings", OECD Health Working Papers, No. 139, OECD Publishing, Paris, https://doi.org/10.1787/6c0d64a2-en.

²U.S. FDA. Office of Generic Drugs. 2021 Annual Report. https://www.fda.gov/drugs/generic-drugs/office-generic-drugs-2021-annual-report

³Congressional Budget Office Report. Prescription Drugs. Janunary 19, 2022. https://www.cbo.gov/publication/57050

⁴Poisal JA et al. National Health Expenditure Projections, 2021–30: Growth To Moderate As COVID-19 Impacts Wane. Health Affairs, 41. March 28, 2022. https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2022.00113