US Breast Cancer Therapeutics Market Analysis

US Breast Cancer Therapeutics Market Executive Summary

The US breast cancer therapeutics market size is projected to grow to $ 17.48 Bn by 2030 from $7.64 Bn in 2022, exhibiting a CAGR of 10.9% during the forecast period (2022-2030). Breast cancer is a common diagnosis of cancer among US women followed by lung cancer. White women had the greatest incidence rates of breast cancer (133.7 per 100,000), while Black women come in second (127.8 per 100,000), and Hispanic and Asia Pacific Islander (API) women have the lowest incidence rates. In the US as of January 2022, there were about 4.1 Mn women were reported to be living with breast cancer. More than 4% of these survivors have a metastatic form of cancer and 48% received the initial diagnosis of early-stage (I-III) cancers. A lifetime diagnosis of invasive breast cancer is estimated to occur in 13% of women (1 in 8), and 3% (1 in 39) are prone to mortality, according to the American Cancer Society (US) Statistics 2020.

The increase in breast cancer incidence during the most recent time period largely reflects a rise in local-stage disease which increased from 75 per 100,000 in 2004 to 86 per 100,000 in 2020. The incidence rates increased across all racial/ethnic groups, although they were slower among White (0.5% per year) and Black (0.7% per year) women than among Hispanic (1.4% per year), AIAN (2.0% per year), and API (2.1% per year) women. Reasons for the divergent trends are unknown but likely reflect changes in subtype-specific breast cancer risk factors. For example, parity is associated with a lower risk of HR-positive breast cancer and a higher risk of triple-negative breast cancer, although women who breastfeed reduce their risk of triple-negative disease. In the US, the fertility rate, which was once as high as 118 births per 1000 women aged 15 to 44 years, declined from 69.4 births per 1000 women in 2007 to an all-time low of 56.6 per 1000 women in 2021. In addition, there has been a shift to later age at first birth, which is also associated with an increased risk of HR-positive breast cancer.

From 1975 to 1989, the overall breast cancer death rate grew by 0.4% per year but has since decreased by 43% through 2020. Between 1989 and 2020, 460,000 breast cancer deaths in women in the US were avoided as a result of this drop. Breast cancer mortality has decreased due to better and more targeted therapy, as well as early detection with screening mammography. However, the fall in breast cancer mortality has slowed recently, from an annual decrease of 1.9% from 1998 to 2011 to 1.3% from 2011 to 2020, possibly reflecting the constant growth in breast cancer incidence and consistent screening mammography prevalence. The health outcomes measured in this report are in terms of Disease-Free Survival (DFS), Breast Cancer-Specific Survival (BCSS), and Overall Survival (OS).

Market Dynamics

Market Growth Drivers

There are several key factors that are driving the market for breast cancer therapeutics like the increasing incidence of breast cancer, advances in treatment options, growing awareness and early detection, increase in healthcare expenditure, growing interest in biologics and immuno-oncology and advancement in precision medicine methodologies

Market Restraints

Breast cancer treatments can be expensive, and may not be affordable for all patients. This can be a barrier to access to care, particularly for uninsured or underinsured individuals. Reimbursement policies for breast cancer treatments vary by state and insurer, and some treatments may not be covered. The process of bringing a new drug to market is long and costly, with many regulatory hurdles to be cleared. This can make it difficult for new therapies to enter the market. As patents on brand-name drugs expire, they may be replaced by cheaper generic alternatives. This can lead to a decline in revenue for the companies that manufacture brand-name drugs. Not all patients respond well to standard breast cancer treatments, and for some, the treatments may not be effective this may impede the market for treatments with less effectiveness rate. Overall, these factors are likely to have a negative impact on the growth of the market for breast cancer therapeutics in the US and may lead to a decline in revenue for companies that manufacture and market these drugs.

Competitive Landscape

Key Players

• Genentech (US)
• Novartis (US)
• Pfizer (US)
• Bristol-Myers Squibb (US)
• Eli Lilly and Co. (US)
• AstraZeneca

Notable Recent Deals

August 2022: AstraZeneca and Daiichi Sankyo come together for a strategic alliance for the metastatic breast cancer drug Enhertu. The newly FDA approved promises a sizable market for the drug due to meeting 60% of the criteria for HER2-low. According to data from the National Cancer Institute, approximately 80% to 85% of the 287,850 new instances of breast cancer that will be diagnosed in the US this year are HER2-negative by the old definition. By 2023, Enhertu could generate $4.6 Bn in revenues from HER2-low patients thanks to that sizable patient pool.

August 2022: The potential Merck & Co. acquisition of Seattle-based biotech firm Seagen would be the largest pharmaceutical acquisition since 2020 if it were to go through. A $32 Bn cancer-focused biotech company Seagen Inc., has four patented medications available for the treatment of various tumours. For Merck's oncology division, which mostly depends on Keytruda, a medication whose patent exclusivity expires in 2028, the acquisition of a young, cancer-focused pharmaceutical company is essential.

Healthcare Policies and Regulatory Landscape

The American Society of Clinical Oncology is the regulatory body in the United States that has recently produced recommendations to governing the use of neoadjuvant systemic therapy, including endocrine therapy, in women with breast cancer. Additional systemic drugs have been discovered in clinical trials to improve outcomes for triple-negative (HR-negative/HER2-negative) and HER2-positive tumours in women who do not achieve a complete pathologic response following neoadjuvant therapy. The majority of stage IV breast cancer patients (60%) get non-curative radiation and/or chemotherapy. The study looked at the 5-year relative survival rates of breast cancer molecular subtypes. Triple-negative breast cancers have a worse prognosis than other subtypes because they are more likely to be discovered at an advanced stage and have less effective treatment choices. Inequitable access to timely, high-quality treatment explains much of the survival gap, however, differences in tumour biology, comorbidities, and other factors also play a major role.

Reimbursement Scenario

Medicaid provides prescription pharmaceutical coverage to people who cannot afford it through other means. Manufacturers of branded pharmaceuticals who want to distribute drugs through Medicaid have been required to pay a rebate on the price of each drug sold since 1990. The Patient Protection and Affordable Care Act, first adopted in 2010, increased the compulsory Medicaid rebate from 15.1% to 23.1%, expanded the rebate to Medicaid Managed Care use, and enlarged the types of companies eligible for the federal 340B Drug Pricing Program. Insurance status was indicated as one reason for the variance in treatment availability and outcomes in unequal DFS among Black (72%) versus White (79%) patients in a study based on a large national sample of non-elderly patients with early-stage breast cancer.