Increasing incidence rates and the rise of novel therapies
Oncology is the largest therapeutic area in drug development, accounting for up to 45% of the biopharmaceutical industry’s $200 billion annual research and development (R&D) spend. Although the industry has made great strides in recent years in cancer treatment, it is anticipated that new cancer cases will increase to over 35 million in 2050 in comparison to around 20 million cases in 2022. This rise in the global cancer burden is driven by an increasingly aging population along with continued exposure to risk factors, many of which are associated with socioeconomic status. Tobacco use and obesity remain the leading cancer-causing risk factors along with environmental factors such as air pollution. This trend highlights the urgent need for new cost-effective methods of drug development along with novel cancer treatments to improve patient outcomes.
Investment in oncology drug development continues to rise
The average R&D cost of developing an oncology therapy is frequently debated as ranging from US$765 million to US$4.6 billion (in 2020). This variation depends on factors such as the length of clinical trials, complexity of the drug, and the success rate of clinical trials. If we shift the paradigm, however, oncology drugs are estimated to be $1 billion cheaper to develop through a precision approach.
Expediting new oncology drugs through accelerated approval pathways
In addition to the cost, the time it takes to develop new drugs varies significantly with small molecules being faster compared to biotechnology-derived products. The typical development time is estimated to be around 6.7 years. However, some oncology drugs benefit from expedited approval pathways, such as Breakthrough Therapy and Accelerated Approval designations, which can shorten the development time. On average, only about 13% of oncology assets advance from first-in-human studies to market authorization.
Oncology trials are increasing
Both public and private sectors have increased their investment in cancer research. In the past decade, there have been approximately 7,750 oncology clinical trials registered on ClinicalTrials.gov. This reflects the global effort to develop new treatments and improve patient outcomes. According to IQVIA Institute’s Global Oncology Trends 2024, oncology trials comprise 44% of the Phase I-III drug development pipeline across all therapeutic areas and 70% of trial starts in 2023.
Biotech’s growing share of the market
In recent years, many oncology clinical trials have been sponsored by biotech companies. Specifically, small and mid-size biotech companies account for approximately 75% of all drugs currently in development. The dominance of biotech companies underscores their agility and innovation in early-stage drug development. There is also a growing trend towards biotechs holding onto their assets longer—into Phase III and even commercialization.
Continued progress with novel oncology drug modalities
Several novel oncology drug modalities are emerging that have promise in advancing cancer treatment. These new modalities offer alternatives to traditional treatment regimens like chemotherapy and radiation, which have had limited success and significant side effects. The most promising new drug classes being explored include precision medicine, immuno-oncology, and radiopharmaceuticals.
Advancements in precision medicine
Also referred to as personalized medicine or targeted therapy, precision medicine for cancer treatment involves tailoring treatments to an individual’s genetic profile and to the cellular and molecular features of their tumor.
- Antibody drug conjugates (ADCs): ADCs have created a lot of buzz, with significant advances in breast, bladder, and lung cancer treatment in the past few years. They combine the targeting ability of monoclonal antibodies with the cancer-killing power of chemotherapy. They deliver cytotoxic drugs directly to cancer cells, minimizing damage to healthy cells. Fifteen ADCs have been approved globally, and trial starts have increased an average of 22% annually over the last five years.
- Targeted drug therapy: These drugs are designed to attack specific targets on cancer cells. For example, tyrosine kinase inhibitors (TKIs) inhibit specific enzymes involved in cancer cell growth. There are over 70 FDA-approved small molecule kinase inhibitors on the market, with 42 of them approved in five years, from 2018 through 2023.
Innovations in immuno-oncology
Immuno-oncology leverages the body’s own immune system to fight cancer. There are numerous areas of innovation happening in this field.
- Bispecific antibodies (BSABs): BSABs bind to two different antigens simultaneously, allowing more precise targeting of cancer cells. They are predominantly being developed to engage immune cells directly and physically tether them to cancer cells, functioning similar to CAR-T without the logistical and cost complexities of a cellular therapy (see below). Ten bispecific antibodies have been granted marketing approval to date with many more in development.
- Cell therapies: Chimeric antigen receptor T-cell (CAR-T) therapies involve modifying a patient’s T-cells to better recognize and attack cancer cells. Nine CAR T-cell therapies have received market approval for the treatment of several relapsed or refractory hematological cancers. There is a rising number of trials investigating CAR-Ts and other cell therapies, such as tumor infiltrating lymphocytes (TILs) in solid tumors.
- Gene therapies: Gene therapies aim to correct or replace faulty genes responsible for cancer. Recent advances include CRISPR-based gene editing and other gene augmentation techniques.
- Oncolytic viruses: Though there is only one FDA approved treatment to date, great progress is being made in oncolytic virus research. These viruses are engineered to selectively infect and kill cancer cells while stimulating an immune response against the tumor.
The rise of radiopharmaceuticals
Radiopharmaceuticals is a new, evolving class of cancer therapy proving highly effective at treating cancer. Radiopharmaceuticals combine a targeting molecule (e.g., ligand, antibody) that specifically binds to cancer cells with an attached radioactive isotope. The therapy delivers targeted radiation to kill the cancer cells while sparing healthy tissue. Radioligands can be used for both diagnostic and therapeutic purposes. This field is rapidly evolving with new radioligands being developed targeting various cancer-specific markers, such as fibroblast activation protein (FAP) and prostate-specific membrane antigen (PSMA).
In summary, the increasing global incidence of cancer continues to drive the demand for new innovative treatments, leading to a proliferation of oncology clinical trials. The development of targeted therapies and personalized medicine has led to more trials focusing on specific genetic mutations and biomarkers, whereas we also continue to evolve our understanding of how to harness the immune system to attack cancer cells via new immunotherapy approaches. There are many novel modalities emerging which have significant potential—both alone and in combination—to improve patient outcomes.
In future blogs we will continue to explore trends and challenges in oncology drug development, including a deeper dive into some of these new, exciting drug modalities.
We can help
With our exclusive biotech focus and oncology experience, Catalyst Oncology supports early- to late-phase drug development across both solid and hematologic indications. Reach out to learn how we can support the success of your next oncology trial.
