US Brain Cancer Therapeutics Market

US Brain Cancer Therapeutics Market Executive Summary

US Brain Cancer Therapeutics Market valued at $966 Mn in 2022, projected to reach $1,869 Mn by 2030 with a 8.6% CAGR.

The abnormal multiplication of brain cells serves as an indicator of brain cancer, with these cells manifesting as either cancerous (malignant) or non-cancerous (benign). Despite the exact cause of brain cancer remaining elusive, identified risk factors encompass exposure to ionizing radiation and a family history of brain tumors. Symptoms commonly associated with a brain tumor involve headaches, gradual sensory decline, issues with balance, speech impediments, and hearing difficulties. The manifestation of these symptoms varies based on factors such as the tumor’s size, location, and growth rate. The treatment options for brain cancer are influenced by the type, location, and size of the tumor. Commonly employed treatments include radiosurgery, chemotherapy, radiotherapy, surgery, and the utilization of carmustine implants.

In 2023, 25,400 malignant tumors affecting the brain or spinal cord were diagnosed, equating to an average of approximately 70 diagnoses per day. This statistic encompasses both adults and children. Among adults aged 40 and above, around 79,340 individuals were diagnosed with a primary brain tumor, while approximately 5,230 children under the age of 20 were diagnosed with a central nervous system (CNS) tumor. Notably, meningiomas are identified as the most prevalent primary brain tumor type in adults, representing about 46.1% of cases, followed by the highly aggressive glioblastoma, constituting 16.4% of adult diagnoses. Pituitary tumors account for approximately 14.5% of primary brain tumors in adults. The impact of brain cancer is underscored by its ranking as the 10th most common cancer diagnosed in the US, with a particularly poignant note as the leading cause of cancer-related deaths in children under the age of 15. The overall 5-year survival rate for all malignant brain tumors remains relatively low, hovering around 35.7%.

The combination of Opdivo (nivolumab) and Yervoy (ipilimumab) was given accelerated clearance by the FDA in December 2023 to treat recurrent glioblastoma, giving patients in the US access to a new therapy option. Furthermore, the FDA authorized Venclexta (venetoclax) in November 2023 for the treatment of adult patients with mantle cell lymphoma (MCL) who have relapsed or are not responding to two or more previous lines of therapy. This medication is used in conjunction with rituximab and cyclophosphamide. Venclexta was originally designed to treat MCL, but it may also be used in the future to treat other types of brain cancer. This approval highlights the potential for wider uses of Venclexta in the field of oncology and represents improvements in treatment choices for such diseases.

Market Dynamics

Market Growth Drivers

Rising Prevalence and Increased Awareness: The incidence of brain cancer diagnoses is regrettably escalating, averaging approximately 70 new cases daily in the US. The increased need for therapeutic options is being driven by this increased prevalence. The greater accessibility of information and the success of public awareness efforts are two more factors driving the market's rise.

Technological Advancements: Swift progress in fields such as immunotherapy, targeted therapies, and precision medicine provides enhanced and individualized treatment alternatives. Contemporary diagnostic technologies, including AI-enhanced imaging and liquid biopsies, enable earlier and more precise identification, leading to prompt interventions and heightened market demand.

Evolving Regulatory Landscape: The FDA's increased focus on hastening the approval process for innovative therapies, demonstrated through methods such as accelerated approval, speeds up the availability of promising medications for patients. In December 2023, the FDA granted accelerated approval to the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for treating recurrent glioblastoma. This expedited regulatory strategy holds the promise of encouraging market growth by motivating companies to commit to and progress the creation of new and innovative treatment options.

Market Restraints

High Treatment Costs and Limited Access: The cost of medications for brain cancer treatment is frequently exorbitant, often amounting to hundreds of thousands or even millions of dollars annually. This financial burden poses a substantial challenge for patients and their families, even when covered by insurance. While the healthcare system in the US provides coverage for essential medical costs, stringent reimbursement policies and high deductibles may limit access to newer or specialized drugs. This restricted availability consequently hampers the broader adoption of certain therapeutic options in the market.

Adverse Side Effects and Limited Efficacy: Various medications, including radiation therapy and chemotherapy, are used for brain cancer treatment, but they bring significant side effects like fatigue, nausea, vomiting, hair loss, and cognitive impairment. These adverse effects can impact patient adherence to treatment plans and overall quality of life. Current therapeutic approaches, especially for aggressive glioblastoma multiforme (GBM), have limited effectiveness, with a 6% 5-year survival rate, potentially causing patient discouragement and hindering market expansion in the medical field.

Ethical Considerations and Concerns: The exploitation of desperation and elevated medication costs for a profoundly debilitating illness may give rise to ethical considerations, eliciting negative societal perceptions that could influence public opinion and market dynamics.

Notable Recent Updates

• June 2023, Erasca, Inc., a company focused on precision oncology in the clinical stage, has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for ERAS-801 in the treatment of malignant glioma, encompassing glioblastoma (GBM). ERAS-801, an orally bioavailable small-molecule EGFR inhibitor, demonstrated significant penetration into the central nervous system (CNS) in preclinical animal studies.
• January 2023, Stanford University partnered with the investment firm Invus Group to work on treatments for glioblastoma. Invus provided funding for two initiatives within the Stanford Innovative Medicines Accelerator (IMA) aimed at creating a prototype for a drug, either in the form of a small molecule or a protein, to address this disease.

Healthcare Policies and Regulatory Landscape

In the US, the regulatory landscape and healthcare policies governing treatment drugs are overseen by several key authorities. The Food and Drug Administration (FDA) is a government organization that is responsible for rigorous pre-market assessments, post-market safety monitoring, and approval of new pharmaceuticals. An FDA division called the Centre for Drug Evaluation and Research (CDER) is primarily responsible for pre-market reviews, drug regulation, and the establishment of guidelines for drug development. Under the U.S. Department of Justice, the Drug Enforcement Administration (DEA) is responsible for enforcing regulations on prohibited narcotics to prevent abuse and diversion. A sizable population's access to pharmaceuticals is influenced by the Centres for Medicare & Medicaid Services (CMS), which oversees the reimbursement policies for medications covered by Medicare and Medicaid.

Competitive Landscape

Key Players

• Roche
• Novartis
• Merck
• Pfizer
• BMS
• Bayer
• Celgene
• AbbVie
• Teva Pharmaceuticals
• Spectrum Pharmaceuticals