Overview

Substantial progress toward precision medicines and continued innovation across cancer diagnosis & treatment technologies have led to phenomenal spending on cancer care. The global expenditure on cancer medicine development was close to $200 billion in 2022, which is anticipated to surpass $350 billion by 2027. The U.S. has been dominating the global oncology market, followed by major countries in Europe. In the last five years, China’s oncology spending surged by $6.8Bn owing to the expanded access to new therapies, increasing entrants in the market, and offset by lower prices.

How has the oncology sector evolved in the past several years?

During the last decade, the oncology landscape has witnessed a transformative evolution characterized by strides in immunotherapy, precision oncology, and the integration of AI-driven solutions. Some of the key trends driving the oncology segment are explained below:

A) The count of oncology trials started in 2022 remained historically high, up 22% from 2018, and primarily focused on solid tumors and rare cancers

• Phase II trials, including Phase I/II, IIa, and IIb, hold the largest share, with 49% of oncology trials started in 2022 being Phase II compared to 41% accounts for Phase I and 10% for Phase III.
• Although trials related to hematological cancers are significantly low in number, the count increased by 30% from 2017, reaching more than 550 trials started in 2022.

B) Emerging biopharma companies are leading the oncology-related innovation and were responsible for 71% of the oncology pipeline in 2022, up from 45% a decade ago

• The number of products under development in cancer therapeutics has remarkably increased over the last decade, with more than 2,000 products in the pipeline.
• Since the COVID-19 global pandemic, the oncology pipeline growth pattern has become sluggish, with an average growth of just 5% over the last two years. However, 15% growth has been witnessed in the emerging biopharma pipeline compared to a 13% decline across larger companies.

C) Chinese enterprises are gaining traction in the oncology pipeline, accounting for 23% in 2022, up from only 5% a decade ago

• Products from China-headquartered companies represented 23% of the oncology pipeline in 2022, up from 10% five years ago and 3% in 2007.
• The U.S. share of the oncology pipeline has fallen 5% over the past 15 years but remains above 40%. While Europe’s share declined to 21% in 2022, down from 26% five years ago.

D) The initiation of PD-1/PD-L1 inhibitor trials per year grew 54% over the last five years, with 81% of ongoing late-stage trials in single countries

• In 2022, 1,236 trials started globally testing PD-1/PD-L1 inhibitors, which has dropped by 11% from 2021 but is up by 54% from 804 trials that began in 2017.
• Out of over 3,000 ongoing late-stage PD-1/PD-L1 trials in 2022, 81% were being conducted in single countries.
• China has 1,287 ongoing late-state PD-1/PD-L1 trials that are only being conducted domestically and reflect that the drugs being tested in these trials may not be bound for international markets.

E) Six bispecific antibodies are commercialized for oncology, with many in the development phase for rare hematological cancers

• There are currently six approved bispecific antibodies for cancer treatment—three for hematological cancers and three for solid tumors—including the bi-specific T-cell engagers (BiTEs) blinatumomab and tebentafusp.
• More than 130 bispecific antibodies are currently in the development stages for cancer treatment, with 67% of the antibodies being investigated to treat solid tumor cancers, 24% for hematological cancers, and nearly 9% being investigated for both.
• Over 50% of bispecific antibodies are in early clinical development, with only 7% of those under investigation for hematological cancers and 5% of those for solid tumors currently in Phase III trials.

F) The next-generation biotherapeutic pipeline is focused on cell therapies, particularly CAR T in hematological cancers

• In 2022, 194 next-generation biotherapeutics for hematological cancers were under development, up from 14 a decade ago, and 254 for solid tumors, up from 73.
• Across all therapy areas, oncology accounts for 42% of the next-generation biotherapeutic pipeline, highlighting significant research and promise for using these products to improve care for cancer patients.

G) Driven by the success of COVID-19 vaccines, the development of mRNA vaccines for solid tumors has more than doubled since 2017

• The COVID-19 pandemic brought increased interest in mRNA vaccines, and the pace with which these vaccines were developed was largely due to decades of research on mRNA vaccines in oncology.
• While oncology made up the largest proportion of the pre-COVID-19 mRNA vaccine pipeline, the oncology-focused mRNA vaccines have not drastically increased since then and accounted for 8% of the pipeline in 2022.
• Development of mRNA vaccines for cancer treatment is wholly focused on treating solid tumors, with less than 40% of the targeting specific solid tumor indications and most targeting a range of advanced solid tumors.

Several ongoing and new trends that will likely elevate the oncology sector to new peaks

1. Novel modalities and emerging targets:

• An extensive pipeline of multi-specific antibodies (e.g., TrAb, quad-specific) is engineered to enhance the antitumor effect by redirecting immune cells, such as T and NK cells, to specific tumor antigens. While targeting multiple antigens results in significant immune responses against tumors; optimization is still needed to mitigate the challenges, such as in vivo durability and off-target effects.
• Non-coding RNAs are being explored as potential targets (e.g., piRNA in lung and breast cancer) and as diagnostic markers to guide risk stratification. This may open new RNA-related therapeutic opportunities once optimal drug delivery, tolerability, and specificity are realized.

2. Novel modalities, targeted therapies and their use in earlier LoT:

• ADCs, BsAbs, and CAR-Ts have succeeded in late-stage disease and are anticipated to continue advancing into earlier line of therapies (LoT) [e.g., CAR T approval in 2L DLBCL; CAR T expansion into 1L DLBCL].
• PD-1/PD-L1 inhibitors and targeted therapy are also shifting towards earlier LoT [e.g., nivolumab + chemo in resectable non-small-cell lung cancer (NSCLC); osimertinib in EGFR+ adjuvant NSCLC]. Also, additional immunotherapies are anticipated to enter earlier lines to become SOC.
• Recently announced regulatory programs, such as Project Frontrunner—an initiative to enable drug approval in earlier LoT to help accelerate innovation in oncology—is anticipated to encourage stakeholders to reimagine oncology R&D.

3. Novel combinations to target drug resistance:

• Given the eventual leapfrogging of novel modalities into earlier lines, a wide pool of treatment-resistant population is anticipated to emerge. It will require creative therapeutic combinations to provide patients with therapy options with a durable response. Mixed progress to date in successfully combining therapies (e.g., failure of pembrolizumab + lenvatinib in melanoma; pembrolizumab + mRNA-4157/V940 demonstrated successful signal in melanoma).

4. Next wave of IO targets beyond PD-1/PD-L1:

• Immune checkpoint targets such as LAG-3 and TIM-3 have emerged with positive results in melanoma and others, paving the way for innovation in immunotherapy beyond PD-1/PD-L1. This will enable potential combination therapies with existing PD-1/PD-L1 to provide enhanced immunomodulating effects.

5. Clinical progress of mRNA cancer vaccines:

• COVID-19 mRNA vaccine success accelerated interest in the potential of mRNA vaccines to target tumors enabling exciting combination studies [e.g., BNT 122 + atezolizumab (PDAC), BNT 111 + cemiplimab (melanoma)] that are anticipated to advance to late-stage clinical trials.

6. Disease/patient segmentation based on biomarkers identification:

• There will be continued disease fragmentation based on novel biomarkers (e.g., Trop-2, CEACAM5) supporting innovation in targeted therapy.
• Technologies that enable sequencing accuracy from solid and liquid biopsies to identify biomarkers will drive biomarker use for predictive and prognostic purposes.

7. Integration of ctDNA use in clinical care:

• ctDNA will increasingly be used at different steps of the patient journey, ranging from early disease detection to understanding disease resistance mechanisms.
• Advancement of sequencing accuracy will ensure a multitude of ctDNA/MRD usage, including the potential to be used as a surrogate endpoint in clinical trials.

Conclusion:

After witnessing a remarkable evolution in the oncology sector marked by significant advancements in precision treatments, immunotherapy, and AI integration; IeB experts precisely anticipate the potential opportunities and challenges in the cancer care field. Based on the ongoing and emerging trends, we assist biopharma enterprises in efficiently developing drugs and equipment for cancer care through technology benchmarking, market foresighting, competitive intelligence, opportunity landscaping, Go-to-market strategy, and other key services.

To gather deeper insights that can remarkably thrive your business operations, connect with seasoned IeB healthcare experts by emailing them at contact@iebrain.com.

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