Global spending on oncology drugs, the industry’s largest therapeutic sector, is projected to reach $409 billion by 2028. What product innovation, trends, and commercialization strategies are at play?

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

Strong market growth
The outlook for the oncology drug market is strong. Global spending on cancer medicines increased to $223 billion in 2023, $25 billion more than in 2022, and is projected to rise to $409 billion by 2028, according to a recent analysis, Global Oncology Trends 2024: Outlook to 2028., from the IQVIA Institute for Human Data Science. This growth is attributed to the volume of protected brands and the introduction of new products in the past five years despite losses of exclusivity for some treatments, including the introduction of some biosimilars in major markets.

On a product basis, notably, six major tumor categories experienced double-digit growth in spending due to breakthrough medicines and improved patient access, according to the IQVIA Institute analysis. PD 1/PD-L1 inhibitors, which are widely used in solid tumor treatments, accounted for $52 billion in spending in 2023, with expectations to increase to more than $90 billion by 2028. In new products, the future of next-generation biotherapeutics in oncology is marked by clinical and commercial uncertainties, yet annual spending could still potentially rise from $4 billion to $23 billion by 2028.

“The global oncology ecosystem is operating near peak levels to address increasing challenges. New therapies for advanced cancers, including some of the most advanced novel science in the industry, are under development or have been recently launched,” said Murray Aitken, Executive Director, the IQVIA Institute for Human Data Science, in commenting on the firm’s recent analysis. “These therapies represent the largest area of collective research and drug spending across all of healthcare.”

Demand for oncology drugs is based on the growing and large unmet need for treatments. Cancer incidence is expected to rise significantly through 2050, particularly in lower-income countries, to 32 million new cases annually, a potential increase of more than 12 million new annual cases, according to the IQVIA Institute analysis.

The total number of cancer treatment regimens provided globally—defined as the number of patients treated with a regimen in a time period, whether one cycle or multiple—has increased by an average of 9% annually since 2019 due to higher cancer rates and better access to care, according to the IQVIA Institute analysis. Despite this growth, the pace of novel cancer therapies arriving to patients is uneven across countries, with differences in biomarker testing rates, adoption of novel therapies, and the lack of infrastructure capacity to deliver some of the most advanced therapies. Treatment of women’s cancers, prostate cancer and late-stage multiple myeloma has advanced in recent years as novel modalities, including antibody-drug conjugates (ADCs), radiopharmaceuticals, bispecifc antibodies, and CAR T-cell therapies, have been introduced  to provide better patient outcomes.

Product innovation in oncology
In 2023, 25 oncology new active substances (NASs) were launched globally, reaching a total of 193 since 2014, bringing the average annual new launches from 2019–2023 to 25 compared to an average of 13 annually in the five years prior, according to the IQVIA Institute analysis. However, large geographic variations exist in the availability of these medicines.

In looking NAS launches on a geographic basis, 18 new cancer medicines were introduced in the US in 2023, and these new drugs are largely targeting rare cancers, are recombinant, and are often approved based on a single clinical trial. The European Medicines Agency approved eight NASs for hematological cancers and five for solid tumors in 2023, fewer than the 14 approved in 2022. New medicine launches in Europe have slowed, resulting in delays in the availability of innovative medicines compared to the US; 38% of US oncology NASs in the past 10 years are not yet available in Europe. In China, the second largest bio/pharmaceutical market globally, the  number of NAS launches in oncology over the last five years exceeded those in the US. While many of these new medicines in China are driven by domestic innovation, most have previously launched globally, according to the IQVIA Institute analysis.

R&D activity in oncology
Given the strong potential of the oncology drug market, research and development (R&D) activity is also high. In 2023, more than 2,000 oncology trials started, fewer than the past two years of rebounding from the COVID-19 pandemic and 11% higher than in 2019, according to the IQVIA Institute analysis. On a company basis, Emerging Bio/Pharma companies accounted for 60% of these trials, a significant increase from 33% in 2013.

On a product basis, novel modalities, including cell and gene therapies, ADCs and multispecific antibodies, show significant promise for cancer treatment and represent a growing share of clinical research, according to the IQVIA Institute analysis. Trials involving PD-1/PD-L1 inhibitors grew 29% over the last five years, investigating across more tumors and in earlier lines of therapy. However, PD-1/PD-L1 checkpoint inhibitors, which saw significant growth over the last decade, have begun to taper off in recent years, indicating a crowded market and switch to even newer targeted molecules. In 2023, 1,141 trials started globally by both industry and non-industry sponsors testing PD-1/PD-L1 inhibitors, down 7% from 2021 but up 53% from the 746 in 2018. More than 80% of clinical trials involving PD-1/PD-L1 inhibitors are currently in Phase II, with an emphasis on solid cancers such as non-small cell lung cancer (NSCLC), esophageal cancer, liver cancer, and head and neck cancer, according to the IQVIA Institute analysis.

More than 250 trials testing CAR T-cell therapies in oncology started in 2023 and while the majority investigated for hematological cancers, the therapies were increasingly viewed across a range of solid tumors. Cell and gene therapy trials have increased across both solid tumors and hematological cancers over the last decade, now accounting for 25% of hematological cancer trial activity, according to the IQVIA Institute analysis.

Fifteen ADCs have been approved globally and the number of ADC trials grew 26% from 2022 to 2023 as more companies invested in these targeted chemotherapeutics, according to the IQVIA Institute analysis. ADC-based R&D is primarily focused on solid tumors, with 80% growth over the last two years in solid tumor development. The development of ADCs has grown significantly in recent years with nearly 200 trials started in 2023, more than five times the number a decade ago and up 26% from 2022, according to the IQVIA Institute analysis.

Among more niche therapeutics, 10 bispecific antibodies are marketed for oncology and many more in late-stage development,primarily for solid tumors. Multispecific antibody development for cancer treatment has grown significantly, now representing 4% to 5% of both hematological cancer and solid tumors. In 2023, the US Food and Drug Administration approved four bispecific antibodies—epcoritamab, elranatamab, glofitamab, and talquetamab—and all were approved for hematological cancers. However, more than 150 bispecific antibodies trials are ongoing for cancer treatment, with 82% being conducted in solid tumor cancers.

An important measure of R&D activity and the potential of product innovation is the success rate of such clinical trials. The oncology composite success rate increased to 10% in 2023 from 4% the year prior, with improvements across all phases, especially in rare oncology and solid tumor research, according to the IQVIA Institute analysis. While oncology trials remain complex, their level of complexity—a comparison of a number of factors, including the number of countries, sites, patients, eligibility criteria, and clinical endpoints—has decreased by 8% since 2019, in contrast to a 2% increase in complexity for other disease areas. The number of subjects enrolled in oncology trials is down 11% in 2023 from the peak in 2021. Western European countries are included in trials the most often although China and North American country inclusion has increased significantly in recent years. Despite a reduction in trial durations, the overall length of all oncology programs was only shortened by an average of five months due to an increase in the time between trial completion and starting the next phase. Overall, improved success and declining complexity resulted in a 23% improvement in productivity in oncology clinical development in 2023, according to the IQVIA Institute analysis.