Improved Diagnostics Drive Market Growth; Thriving Oncology Therapeutics Complements High Growth Rate
The National Cancer Institute estimated around 1,806,590 new cancer cases diagnosed in the US alone and roughly 606,520 deaths due to the disease recorded in 2020. However, over the past five decades, cancer survival rates (five-year survival) have improved to 70% from 50% (in 1970). This transformation has been possible because of trifecta - improved healthcare systems (e.g., advanced diagnostics), public health measures (such as drug abuse awareness), and rise of novel pharmaceutical therapies. Oncology therapeutics accounted for ~1/5th of the global branded pharmaceuticals sales, growing in double digits since quite a long time.
Oncology Remains a Highly Competitive and Largest Therapeutic Area
Global oncology therapy sales are forecasted to be more than US$ 300 Bn by 2026. Oncology will contribute 21.7% to the total pharmaceutical sales in 2026. The top 10 pharmaceutical companies of the world have declared oncology as their key focus area. On top of the organic R&D, there is also a growing trend of multibillion-dollar oncology-focused M&A deals and strategic collaborations. Pfizer has acquired Array BioPharma for US$11 Bn in 2019, while AbbVie has entered a strategic partnership with Genmab for a bispecific antibody development deal worth US$3 Bn. Oncology thus remains the largest therapeutic area, pushing the oncology drugs market ahead in the growth curve.
High Incidence Rates of Diverse Indications Raise Demand for Oncology Drugs
Oncology represents more than 20 different indications but a major chunk of the revenue stems from only five of them. In 2020, breast cancer, multiple myeloma, non-small-cell lung carcinoma (NSCLC), prostate cancer, and non-Hodgkin's lymphoma (NHL) accounted for ~65% of the market. These five have large incidence rates and unmet need. 6 out of 10 biggest sales generating drugs are the treatments for various cancers, and three of these are anti-PD(L1) antibodies. Some other common cancer types are brain, head & neck, skin, thyroid, pancreatic, bladder, kidney and renal pelvis, and soft tissue. The three most common cancers in women are of breast, lung, and colorectal, expected to be collectively accounting for ~50% of all new cancer diagnoses by 2026.
Disruptive Trends to Shape Long-term Innovation Platform in Oncology Drugs Landscape
Cell therapy, RNA therapy, viral vectors, and stem cell therapy have been creating a buzz in the oncology drugs market recently. Cell and gene therapies create significant disruptions with more complex manufacturing and supply chain processes, especially for autologous therapies. Two CAR-T cell therapies were approved recently, Kymriah and Yescarta, for acute lymphocytic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL) respectively. The diagnostics and treatment regimen are progressing rapidly with the help of precision medicine. More than 160 oncology biomarkers were approved by 2019, and more than 90% of pivotal trials are against molecular targets. ~80% of novel clinical assets are aimed at marketed targets or with four or more clinical competitors. The increase in competition has resulted in lesser developmental cycles, leading to faster initial launches, followed by competitor therapies.
Oncology Continues to be Main R&D Area with Highest Clinical Development Expenditure
Innovation in oncology is accelerating and the highest number of novel FDA approvals are predicted in the current US pipeline. The projected total clinical development spend is US$ 82.0 Bn, over triple that of any other therapy area 103 new molecular entities in phase III development in the US. Oncology holds the largest share of clinical development spending, with 37.4% of total pipeline expenditure, and 28.7% of total pipeline FDA approvals. Moreover, it is one of the most expensive areas witnessing extensive therapeutic developments. As per the experts, ~US$ 0.7-0.8 Bn of the total clinical development is spent per approval of an oncology drug.
Cancer Screening Took a Back Seat amid COVID-19 Outbreak
Oncology is one of the worst hit therapeutic areas amid the COVID-19 pandemic. Sales of products in oncology and blood disease areas have declined in the near-term as a result of inadequate availability of physicians. Most of the top 15 companies have experienced decreased demand for physician-administered products. Emergency hospitalisation of COVID-19 patients has also been the factor pulling the oncology drug sales down. The Lancet article recently published suggests ~60% decrease in new clinical trials for cancer drugs and biological therapies during the pandemic. In the US, only 15,453 people underwent cancer screening tests between March and June 2020, compared to 60,344 in the same four months of 2019. Cancer drug supply also witnessed disruption throughout 2020.
Immuno-oncology Crucial in Positioning Oncology as Largest Therapy Area
Immuno-oncology sales are expected to increase to ~US$ 95 Bn by 2026. Immuno-oncology agents and protein kinase inhibitors are set to make up ~65% of sales by 2026. Continued momentum and innovations for immuno-oncology treatments are expected, and more than 550 active cell- and gene-therapy agents are under clinical development. Companies have increased their investments in immuno-oncology combination studies, with more than 200 mechanisms now being investigated as PD-(L)1 or CTLA-4 combination partners and immuno-oncology assets estimated to represent approximately half of the top 10 company pipelines.
Roche Remains Global Leader; Keytruda Set to be King of Oncology Drugs
The global oncology drugs market is a highly concentrated landscape where the top 10 companies capture more than 75% of the market value, including F. Hoffmann-La Roche AG (Roche), Celgene, Bristol-Myers Squibb, Johnson & Johnson, Pfizer, AstraZeneca, Merck & Co., Novartis, AbbVie, and Astellas Pharma. Roche is the world leader in oncology space and set to hold its leading position throughout the forecast period. In 2020, Roche held more than 25% of the market but there is likely be a decline in its market share by 2026, mainly due to biosimilar erosion of its key products - Avastin, Rituxan, Herceptin, and late entry in the PD-1/PDL-1 space with Tecentriq.
On the other hand, Keytruda (Merck & Co.) is set to become the world’s top selling oncology drug by 2026, a forecast almost double that of its closest rival, Humira (AbbVie). Keytruda received seven FDA approvals in 2019, allowing it to continue to pull away from fellow PD-1 antibody Opdivo (Bristol-Myers Squibb) that would rank second in 2026. Some other products enjoying significant sales include Tagrisso (AstraZeneca), Tecentriq (Roche), Darzalex (JNJ), and Ibrance (Pfizer).