RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Global research and development activity in oncology remained at historically high levels in 2022, up 22% from 2018, and the global number of patients treated with approved medicines increased at an average of 5% annually over the same period, according to a new report from the IQVIA Institute for Human Data Science on Global Oncology Trends 2023. Over the last five years, a total of 115 novel active substances in oncology have launched globally; simultaneously, clinical development productivity — defined as trial complexity factored by duration and divided by the probability of success — in oncology has been trending down. Diversity and inclusion of Black/African American and Hispanic patient populations in oncology clinical trials lag behind trials in all other top therapeutic areas.
“Global oncology continues to discover, develop and deliver important novel treatments that benefit more patients,” says Murray Aitken, Executive Director, the IQVIA Institute for Human Data Science. “And even though there are challenges – with a decline in clinical success rates and ongoing disparities in clinical trial inclusion along racial and ethnic lines – the ongoing pursuit of novel treatments is a testament to the ingenuity and innovative power that are moving cancer treatments forward.”
A few key highlights of the report include:
- Research and development: Oncology trial starts remained at historically high levels in 2022, up 22% from 2018 and primarily focused on rare cancers. Oncology development is focused on solid tumors, with next-generation biotherapeutics growing across all cancers. Among the various classes of oncology drugs, trials started for PD-1/PD-L1 inhibitors grew 54% over the last five years, accounting for 81% of ongoing single-country late-stage trials. Antibody-drug conjugates are also emerging with significant efficacy across a broad range of targets, with varying commercial success. There is a growing interest for bispecific antibodies, including six compounds marketed globally for oncology and many in development for rare hematological cancers. While mRNA vaccines for cancer were in development prior to the COVID-19 pandemic, the technology received an investment boost from successes during the pandemic; trial starts have more than doubled since 2017, with a focus on solid tumors.
- Spending on oncology medicines: The spending on cancer medicines rose to $196Bn globally in 2022, growing an average 12% annually over the last five years. The growth in major markets is driven by new products and brand volume, and offset by losses of exclusivity, including biosimilar impact. In the U.S. in the past five years, 79% of oncology launches had annual costs above $100K, up from 52% in the prior five years. In the same period, China oncology spending grew by $6.8Bn, driven by new therapies, brand volume, and generics. The uptake of biosimilars in oncology saved payers $5.5Bn in 2022, with the biosimilars exceeding 50% molecule share of the originator molecules across major markets. Seven of the top 10 tumors by spending level have double-digit spending growth over the last five years. Much of the growth has been driven by PD-1/PD-L1 inhibitors, which are used across most solid tumors and contributed nearly 50% of spending for lung and kidney cancer in 2022. Spending on oncology medicine is expected to reach $375Bn by 2027.
- Novel active substances in oncology: A total of 115 oncology novel active substances (NASs) have launched globally in the past five years and 237 over the last 20 years, with large geographic variations. There were 10 new cancer medicines launched in the U.S. in 2022, and nine were orphan designated. In the U.S., 53 unique new hematological cancer medicines have been launched since 2013, with 89 to treat solid tumors. New launches in the U.S. in 2022 provide significant clinical benefits to patients across a range of tumors and mechanisms. The European Medicines Agency (EMA) approved six small molecules and eight biologic NASs for oncology in 2022, compared to the 10 total approved in 2021. Since 2013, 27% of U.S. oncology NASs have not launched in Europe, while 2% of Europe launches have not reached the U.S. In China, 121 NASs were launched in oncology in the period from 2003 to 2022. 75 of these were launched in the last five years.
- Emerging biopharma companies (EBPs) are leading innovation: EBPs originated 70% of new U.S. oncology drugs in 2022 and launched 71% of their own products. EBPs were also responsible for 71% of the oncology pipeline in 2022, up from 45% a decade ago.
- Cell and gene therapies: The next-generation biotherapeutic pipeline is focused on cell therapies, particularly CAR T in hematological cancers. Nearly 250 trials testing CAR T-cell therapies in oncology started in 2022, with a growing number across a range of solid tumors. There were 532 hospitals accredited with international standards for administering CAR T therapies globally, up 38% from 2020. While the number of CAR T-cell centers is growing, not all centers have all approved products available, potentially creating challenges for patients to access specific novel treatments.
- Clinical development productivity: Composite success rates in oncology have been trending down since 2015, falling to 3.5% in 2022, with clinical development productivity indices for oncology extending a decade-long trend as lowest of all disease areas. Hematological cancers maintain the highest level of clinical productivity compared to other cancer disease areas. The overall decline in productivity is largely due to oncology trials being substantially more complex than other disease areas, even though they are often able to accommodate fewer trial subjects. The number of subjects in oncology clinical trials fell 3% in 2022. Oncology trials have significantly less “white space” - the difference between the duration of clinical trials and the duration of time between trial phases when administrative activities often take place – than other therapy areas but longer trial durations. Further, oncology trials more frequently use novel trial designs than trials for other diseases.
- Diversity and inclusivity in oncology: There are significant disparities in oncology along racial and ethnic lines, linked to socioeconomic inequities such as less awareness of and access to healthcare and novel therapies via clinical trials. Diversity in oncology clinical trials lags behind all other top therapeutic areas, with Black/African American and Hispanic patient inclusion lagging compared to cancer incidence through the last decade. Key operational decisions regarding inclusion/exclusion criteria, site geography and site density impact trial diversity and offer opportunities for improvement. Despite these disparities in disease outcomes, only 2.8% Black/African American and 5.9% Hispanic patients in trials completed 2020–2022, 80% and 61% below their 2019 U.S. cancer incidences of 13.8% and 15.3%, respectively.
- Cancer patient access: The global numbers of treated patients have increased annually at an average 5% over the past five years. Despite the growth, the pace of novel therapies getting to patients varies, with large differences in adoption across countries. Generally, per capita use of Essential Innovative Medicines is correlated with GDP, but there are notable outliers. In particular, the use of checkpoint inhibitors has risen rapidly in major markets but there are significant variations across countries on a per capita basis. Fewer patients are being treated for non-small cell lung cancer than three years ago, while treatment has shifted to novel kinase inhibitors and PD-1/PD-L1 combination regimens, which have significantly better outcomes than previously available therapies.
The full version of the report, including a detailed description of the methodology, is available at www.IQVIAInstitute.org. The study was produced independently as a public service, without industry or government funding.
About the IQVIA Institute for Human Data Science
The IQVIA Institute for Human Data Science contributes to the advancement of human health globally through timely research, insightful analysis and scientific expertise applied to granular non-identified patient-level data.
Fulfilling an essential need within healthcare, the Institute delivers objective, relevant insights and research that accelerate understanding and innovation critical to sound decision making and improved human outcomes. With access to IQVIA’s institutional knowledge, advanced analytics, technology and unparalleled data, the Institute works in tandem with a broad set of healthcare stakeholders to drive a research agenda focused on Human Data Science, including government agencies, academic institutions, the life sciences industry, and payers. More information about the IQVIA Institute can be found at www.IQVIAInstitute.org.
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