Posted On: Jun-2023 | Categories : Healthcare
The area of oncology has expanded significantly in recent years and has emerged as the largest therapy to treat cancer. The sales of oncology medications are increasing due to rising regulatory approvals, intense competition, and an aging population. The frequency of the disease increases with the rising aging population because age is a significant risk factor for cancer, leading to a larger patient population in need of treatment. According to the American Cancer Society, people 65 and older account for about 60% of cancer cases.
As per the Centers for disease control and Prevention, In the United States, 1,603,844 new instances of cancer were reported in 2020, and 602,347 cancer-related deaths were recorded. 403 new cases of cancer and 144 cancer-related deaths were recorded for every 100,000 persons.
The market for oncology drugs in 2021 was USD 177.54 billion, and by 2030 it will reach USD 474.06 billion, growing at 11.53% CAGR during 2021-2030.
The five-year survival rates for glioblastoma, non-small-cell lung cancer (NSCLC), and pancreatic cancer in patients who are getting therapy are still less than 50%. More than 250,000 new cases of these three malignancies are diagnosed annually in the United States alone. Response rates remain under 50% despite the significant, well-founded excitement surrounding the use of PD-(L) treatments in NSCLC.
Mesothelioma (7.2%), pancreatic cancer (7.3%), and brain cancer (12.8%) have the lowest five-year survival rates. The three cancers with the highest five-year survival rates are testicular cancer (97%), cutaneous melanoma (92.3%), and prostate cancer (88%).
Patient outcomes have greatly improved thanks to oncology advancements. With an estimated 1,700 clinical compounds under development (about one-third of the worldwide clinical pipeline across all therapeutic areas), oncology is a declared focus area for the top 10 pharmaceutical corporations. There are about 100 ongoing Phase III studies for NSCLC in the US, which include about 75,000 patients. More than 32,000 patients must join in clinical trials for acute lymphocytic leukemia research, which is more than the number of new diagnoses in a single year.
There has been an upsurge of multi-billion dollar oncology-focused acquisitions (like Pfizer's 2019 acquisition of Array BioPharma for $11 billion) and partnerships (like a $3 billion collaboration on bispecific antibodies between AbbVie and Genmab). These acquisitions have occurred in addition to a lot of organic R&D at both large pharmaceutical companies and numerous clinical-stage biotech.
Oncology now has success rates of about 13%, with an average development length of 9.5 years. More than half of the goods introduced during the past five years will produce less than $500 million per year, while seven products with revenues of more than $5 billion account for 39% of 2019 revenues. Although there are many interesting prospects in the clinical pipeline, only a small percentage of them will have revolutionary benefit-to-risk profiles that will support return on investment.
Merck & Co.'s Keytruda, which treats cancer, produced over 17 billion dollars in revenue in 2021, making it the most profitable cancer medicine in the world. Revlimid, Opdivo, and Imbruvica were among the top ten cancer products.
According to EUROCARE-5 findings, there are differences in the non-Hodgkin lymphoma (NHL) five-year survival rates—63% in Northern Europe and 50% in Eastern Europe—as well as the ten-year breast cancer survival rates—76% in Northern Europe and 66% in Eastern Europe. Chinese outcomes have significantly improved, although they still lag behind those in developed markets. China still has a lot of room to improve healthcare for its four million newly diagnosed patients each year.
Oncology trial starts increased by 22% from 2018 to 2022, remaining at historically high levels.
Over the previous five years, there has been an average 5% annual growth in the number of patients treated worldwide.
By 2027, global spending on cancer medications will increase to $375 billion from $196 billion.
Black/African American and Hispanic patients were represented in oncology clinical trials at rates that were 80% and 61%, respectively, lower than the 2019 U.S. cancer incidence.
In 2022, emerging biopharma firms drove cancer innovation, accounting for 71% of the pipeline.
Over 2,000 drugs are now being developed in the field of cancer, a significant increase over the previous ten years.
71% of the cancer-related drugs now under development are from emerging biopharma businesses with annual sales of less than $500 million and R&D expenditures of less than $200 million. This is an increase from 51% in 2017.
Large pharmaceutical companies (annual revenues of $10 billion or more) have seen their portion of the oncology pipeline decline, accounting for 21% of the drugs now in development, down from 36% in 2017.
In the past 20 years, 237 NASs have been developed worldwide to treat cancer, 115 of which have been launched in the previous five years. With 189 oncology NAS releases in the last 20 years and 78 in the last five years, the United States has regularly launched the bulk of novel cancer medications first globally.
Over the past ten years, significant advancements in non-small cell lung cancer medicines have improved patient outcomes with first-line therapy.
A total of 53% of all oncology sales are attributable to the top five tumor types: prostate cancer, non-small cell lung cancer, breast cancer, multiple myeloma, prostate cancer, and kidney cancer.
The rise of PD-1/PD-L1 Inhibitors in patient populations can be due to the significant value growth seen in NSCLC, renal cancer, and SCLC.
The primary factor promoting the growth of various malignancies is the ongoing release of novel medications.
In industrialized economies, the prevalence of cancer treatment is steadily increasing due to aging populations and good access to healthcare.
With treatment regimens rising internationally on an average of 5% annually over the previous five years, more patients are receiving treatment every year due to increased access to care in lower-income countries and longer treatment durations.
Numerous therapies like immunotherapy, cell therapy, chemotherapy, gene therapy, targeted therapy, radiation therapy, and nanotechnology have effectively treated cancer.
Since the 1990s, the age-related total cancer death rate in the United States has been consistently falling; between 1991 and 2019, the declines prevented over 3.5 million cancer deaths.
In 2022, there were 18 million cancer survivors in the United States, an increase of more than a million over the previous three years.
In 2022, 1,918,030 new instances of cancer were diagnosed in the United States alone, and 609,360 individuals died.
By 2040, over 2.3 million additional cancer will be diagnosed annually in the United States alone. This is largely because cancer is primarily an aging disease; 80 percent of cancer diagnoses in the United States occur in people 55 and older, and 57 percent of diagnoses occur in people 65 and older. Additionally, this population segment in the United States will increase from 54.1 million in 2019 to nearly 81 million in 2040.
As incidence rates continue to rise by roughly 0.5% annually, 287,850 women received new diagnosis of invasive breast cancer in 2022. The American Cancer Society (ACS) predicts that there will be 236,740 new lung cancer cases.
Despite smoking rates declining over the past 20 years, smoking remains the leading cause of over 80% of deaths related to lung cancer and 30% of all cancer deaths in the US.
At least 42% of cancers that are newly diagnosed in the United States (or roughly 805,600 cases in 2022) may be prevented, including at least 18% of cancers that are caused by a combination of being overweight, drinking alcohol, eating poorly, and not exercising, and 19% of cancers that are caused by smoking.
Compared to White women, Black women experience a 41% greater mortality from breast cancer.
More than any other racial or ethnic group, black males had the highest overall cancer mortality rate (221 per 100000 person).
Hispanics are 30% more likely to have cervical cancer and are twice as likely to develop liver and stomach cancer than white women.
The overall incidence and mortality rates of cancer are lowest among Asian and Pacific Islander men and women, but their rates of stomach and liver cancer are highest—roughly twice as high as those of White people.
In the UK, there are currently 3 million cancer survivors. By 2025, 4 million survivors will exist, followed by 5.3 million survivors by 2030.
In the UK, cancer claimed the lives of over 167,000 individuals in 2019, or 460 people on average per day.
According to an estimate by Macmillan, the disruption caused by the COVID-19 pandemic resulted in more than 43,000 patients "missing" a cancer diagnosis as of December 2021. Two years after the epidemic began, in March 2022, the number of people in the UK beginning cancer treatment was still at least 37,000 lower than anticipated.
Cost
By 2026, global spending on oncology drugs will increase to $307 billion from $185 billion in 2021. Growth in the U.S. is anticipated to occur at a rate of 9–12%, with biosimilars, targeted therapies, and novel drugs for uncommon cancer types all contributing to a slightly slower sales uptake than anticipated in 2022.
71% of the cancer-related drugs now under development are from emerging biopharma businesses (annual sales of less than $500 million) and R&D expenditures of less than $200 million. This is an increase from 51% in 2017.
Some patients may be unable to afford expensive therapies due to declining insurance reimbursements, rising out-of-pocket expenses, and financial
hardships unless they obtain additional support. The average deductible for an individual plan is currently $1,763, while the average premium for family coverage has increased by 20% over the past five years, according to the Kaiser Family Foundation.
People with Cancer will still struggle to afford treatment due to record-high inflation and rising costs of living. Unusual for a change, consumer prices now exceed those for healthcare. Prices for medical treatment rose by 5% in October 2022 than 2021, while overall prices jumped by over 8%. This comparatively high rate of inflation could signal even heavier inflation. Nearly 61% of patients who are currently unable to pay for their cancer medicine due to health care expenses will require the greatest amount of assistance in the future in order to receive and pay for treatment.
Drug Shortage
Due to the widespread shortages of cancer medications, doctors are required to make difficult decisions about managing their patients, including restricting doses and switching to other treatments that could have worse adverse effects.
According to a March study from the Senate Committee on Homeland Security and Governmental Affairs, Drug shortages are at all-time highs. Between 2021 and 2022, there was an almost 30% increase in new medicine shortages.
One well-known technique is to categorize tumors mostly according to the part of the body where they first appear (for example, lung cancer). This is currently changing as malignancies are divided into subgroups based on the underlying biology or genetic causes.
As genetic sequencing technology advances, a wide variety of cancer cell subpopulations inside specific patients are being revealed. As a result, the use of biomarkers assists in the more accurate definition of cancer, resulting in more targeted therapy and changing how medications are developed. Patients and payers are greatly affected by this.
Targeted medicines are effective because doctors can now examine a patient's body fluids, blood, or tissue for biomarkers to better understand the cancer they are trying to treat. One in five cases of breast cancer is caused by a gene mutation resulting in an overabundance of the HER2 protein, which encourages the proliferation of cancer cells. Finding out the mutation can help choose highly efficient treatments that precisely target HER2.
Strength, appetite, and hair are all things that chemotherapy treatments remove from cancer patients. However, time is one of the most significant and possibly underappreciated things cancer patients lose while undergoing treatment.
"Time toxicity" is a new phrase that has evolved in recent years to highlight the detrimental effects of the time patients spend receiving cancer therapy.
Time toxicity is any interaction a patient has with the healthcare system. This includes visits to the doctor's office, picking up prescription drugs, receiving care at home, going to the ER, speaking with insurance providers, and more.
Clinicians "might asses about the benefits and drawbacks of treatment options" by informing patients about the potential length of time they may spend receiving medical attention.
A 2021 study of 298 randomized studies found that the average survival benefit of current cancer medication therapies was only a few months. Time spent dealing with the health system is one of the data points that inform patients about the possible time burden associated with new treatments.
Patients now have more therapy options thanks to the approval of new anticancer treatments.
The FDA approved a new treatment called Glofitamab-exam on June 15. It is designed for patients who have relapsed or refractory diffuse large B-cell lymphoma or large B-cell lymphoma (LBCL) due to follicular lymphoma after having undergone two or more systemic therapies.
Epcoritamab-bysp (Epkinly, Genmab US, Inc.) received accelerated approval from the Food and Drug Administration on May 19 for the treatment of high-grade B-cell lymphoma and diffuse large B-cell lymphoma that has relapsed or become resistant to two or more lines of systemic therapy.
On March 16, the FDA authorized the use of the drugs dabrafenib and trametinib in young patients with low-grade glioma, the most typical form of pediatric brain cancer, who are at least one year old.
Retifanlimab-down (Zynyz), a new ICI, received approval from the FDA on March 22 for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma, a rare but aggressive non-melanoma skin cancer type that carries a high risk of recurrence and metastasis.
On April 17, FDA granted omidubicel-onlv (Omisirge, Gamida Cell Ltd.) approval for use in adult & pediatric patients with hematologic malignancies scheduled to receive an umbilical cord blood transplant after undergoing myeloablative conditioning. This approval is intended to shorten the time it takes for neutrophils to recover and to lower the risk of infection.
On March 16, FDA approved trametinib (Mekinist, Novartis) and dabrafenib (Tafinlar, Novartis) to treat pediatric children with low-grade glioma who need systemic therapy and are at least one year old. These kids have a BRAF V600E mutation. Additionally, the FDA approved new oral versions of both medications for patients who cannot swallow pills.
New Cell and Gene Therapy
Treatments like cell therapy, viral vectors, RNA therapy, and stem-cell therapies have grown during the past five years. Two CAR-T cell treatments, Kymriah and Yescarta, have been licensed to treat acute lymphocytic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL). While only a few hundred active agents are now selling CAR-T, sales will reach $6 billion by 2024. Cell and gene therapies complicate manufacturing and supply-chain procedures and cause major disruptions to conventional healthcare paradigms. Due to the fact that many of these medicines have a one-time curative potential, they also have longer lead times, more difficult treatment procedures, and more complicated market-access issues.
Precision Medicine
Precision medicine is advancing quickly and involves giving the correct medication to the right patient at the right time. More than 160 oncology biomarkers were authorized by 2019, and over 90% of major trials are directed at molecular targets. Driving the use of patient mapping and discovery technologies will become a key competitive advantage as more medicines target specific subpopulations. For instance, a variety of less frequent mutations account for fewer than 3% of patients combined, outside of the three NSCLC mutations that are most prevalent. Additionally, it will be crucial to investigate new clinical trials and business models when pharmaceutical companies develop treatments for smaller patient populations to ensure that prices are reasonable given the prospective patient population.
Accelerating Development Timelines
Oncology-focused pharmaceutical businesses are becoming more prevalent, and there is growing rivalry for important targets. Shorter development times are a result of increased competition, as rival therapies quickly take over after an initial launch. In order to succeed in this environment, new development paradigms must be investigated, including a greater emphasis on earlier trials.
Immuno-Oncology Combination Therapies
With more than 200 mechanisms currently being examined as PD-(L) or CTLA-4 combination partners and immuno-oncology assets will make up around half of the top ten business pipelines, companies have boosted their investment in immuno-oncology combination studies. However, the frequent use of combination medicines makes the trial design more challenging, especially when neither combination partner is currently approved or when the additional expenses of the combination partner must be incurred for clinical investigations. These combination medicines will result in higher treatment costs, necessitating new approaches to collaborating with payers and proving cost-effectiveness.