Evaluating the Breast Cancer Therapeutics Market

October 24, 2023 - As breast cancer awareness month continues, gathering a comprehensive understanding of the breast cancer therapeutics market is critical, including current trends and market players, gaps, and predictions for the coming year. Understanding the therapeutics market and market dynamics can help companies position themselves for prompt regulatory approval or successful market entry.

According to the World Health Organization (WHO), in 2020, there were approximately 2.3 million breast cancer diagnoses worldwide. Additionally, the global prevalence of breast cancer mortality was nearly 700,000.

The organization explained, "Breast cancer cells begin inside the milk ducts and/or the milk-producing lobules of the breast. The earliest form (in situ) is not life-threatening. Cancer cells can spread into nearby breast tissue (invasion). This creates tumors that cause lumps or thickening.”

Therapeutic interventions for breast cancer may include surgical tumor removal, radiation therapy, or medications, including hormonal therapies, chemotherapy, and targeted biologic therapies.

PharmaNewsIntelligence sat down with Millie Gray, Healthcare Analyst at Citeline, a Norstella company, to discuss the market for breast cancer therapies and treatments.

Breast Cancer Therapeutics Market

A recent market report published by Precedence Research, which analyzed from the base year 2022 to the forecast period of 2023–2032, revealed that in 2022 the breast cancer market size was estimated to be $28.8 billion (USD). Research projections anticipate the market will be valued at $73.68 billion (USD) by 2032 with a compound annual growth rate (CAGR) of 9.9%.

The report revealed that the largest breast cancer market is in North America (US, Canada, and Mexico), with Asia Pacific (Japan, China, Australia, India, South Korea, etc.) in second place. However, researchers also explored other regions, including Europe (Germany, France, United Kingdom, Italy, Spain, etc.), Latin America, the Middle East, and Africa (Brazil, South Africa, Saudi Arabia, etc.).

Analysts segmented the breast cancer market by distribution channel, cancer type, and therapy, evaluating trends in each segment.

According to the report, key players in the breast cancer market include Merck & Co., Bristol Myers Squibb, Kyowa Kirin, Eisai Co. Ltd, Sanofi, Pfizer Inc, AstraZeneca PLC, Novartis AG, Eli Lilly and Company, Genentech, Mylan Laboratories, Celltrion, Fresenius Kabi, Baxter Healthcare Corporation, Halozyme Inc., and GlaxoSmithKline.

In a 2021 Nature market research article, analysts divided breast cancer treatments depending on cancer subtypes, which included the following:

• HER2-positive
• HR-positive/HER2-negative
• Triple-negative breast cancer

Key Market Focuses

PharmaNewsIntelligence asked Gray to provide insights into the key market focuses in breast cancer.

“Last year and the year before, the focus was more on the metastatic setting,” she revealed.

According to Gray, there have been significant advancements in metastatic breast cancer, especially triple-negative breast cancer (TNBC), over the past year.

“TNBC is a subtype of breast cancer, which, before these approvals, essentially was a hundred percent treated by chemotherapy. There was very little use of targeted therapy for TNBC. So that's a huge area of focus and development there,” explained Gray.

Considering the limited options, companies saw the potential for market growth and pursued treatments focused on this aggressive breast cancer subtype.

Early-Stage Focus

Beyond targeting TNBC, Gray noted increasing therapeutic interventions intended to treat breast cancer in its early stages.

“Pharma companies are now focusing on getting their drugs approved in the earlier stages of breast cancer,” she added. “Now, quite a few therapies are approved across all the subtypes of breast cancer. They're focusing on the early stage setting because it is the largest among all breast cancers. Approximately 90% of breast cancers get diagnosed at the early stages.”

Gray explains that targeting early-stage breast cancer allows pharmaceutical companies to reach the greatest portion of patients — meaning that they can make significant revenues even if they comprise a small market share.

Beyond the financial incentives to focus on early-stage breast cancers, Gray adds that early stages are the only stage where physicians could potentially cure the condition.

“In the metastatic setting, patients aren't treated with curative intent; they're treated with palliative attempts to manage the symptoms and potentially keep the patient alive longer,” she explained. “The development of better therapies, in the early-stage setting, is looking at being able to cure these patients or, at the very least, extend their life longer than the chemotherapies and endocrine therapies approved there before.”

Regulatory Approval and Competitive Landscape

In addition to describing therapeutic goals and target changes, Gray explored the competitive landscape and how increased competition and market saturation may impact regulatory approval. As more breast cancer therapies are researched, approved, and launched, market growth may disadvantage new researchers seeking regulatory approval. Companies and scientists are entering a saturated market.

“There can be issues with the approval of drugs. If there are a lot of therapies approved in one setting, there isn't a need for more,” noted Gray. “First of all, physicians probably aren't going to use it even if it does get improved.”

It is increasingly essential for companies to have an intelligent trial methodology to get approval. She explained that trials need a comparator arm showing clinically meaningful data that the experimental treatment is beneficial over the current standard of care. Researchers would submit trial data to the US Food and Drug Administration (FDA) in the US.

“There are already so many options; it's difficult for physicians to differentiate between them. If it's not addressing an unmet need — either by being better than what is currently approved or finding its niche, such as a strong benefit in a certain biomarker population — there's almost no point in getting it approved.”

Although there is approval potential for drugs that can be used down the line, Gray explains that the market for these therapies is slim.

“As patients progress down the lines, they will get sicker and sicker. Fewer patients are going to be treated. So the treatment rates in fourth or fifth lines will be minimal,” she explained.

Companies generally do not intend to be fourth- or fifth-line treatments because of the small market size and limited revenue options. Late-stage breast cancer patients are most commonly treated with generic chemotherapies.

Beyond that, Gray adds, “Payers will have less of an issue treating these patients with these chemotherapies. The issue is that these patients are incredibly sick and would rather be treated with these cheaper, already-established chemotherapies this far down the line. The majority of them will eventually stop being treated.”

Gaps In the Market

Despite a relatively saturated market in some areas, Gray explained that the currently approved drugs do not meet all needs. She explored existing gaps in the market, identifying areas where new companies or research can address unmet needs.

TNBC

“Triple-negative breast cancer is the area of breast cancer that has the biggest gaps in the market right now,” emphasized Gray.

So far, Keytruda (Merck & Co.), Lynparza (AstraZeneca and Merck), and Talzenna (Pfizer Oncology) have been approved for triple-negative breast cancer.

“They are all approved for specific biomarker populations. So, Keytruda is only approved for PD-1-positive patients. Talzenna and Lynparza are approved for BRCA-mutated patients. There isn't a targeted therapy in triple-negative breast cancer that has applicability across the population that isn't biomarker-limited, except famously toxic chemotherapies,” Gray added.

According to the American Society of Clinical Oncology (ASCO), , including fatigue, nausea, diarrhea, mouth sores, hair loss, and anemia. The Centers for Disease Control and Prevention (CDC) also describes emotional and neurological impacts, including depression, anxiety, stress, sleep disturbances, and cognitive issues.

Gray identifies this as a critical unmet need in the breast cancer drug market: finding breast cancer treatments beyond chemotherapy that can address a broad range of triple-negative breast cancer cases.

“In the same vein, efficacy in TNBC is an issue,” she continued.

Although she notes that Keytruda and Lynparaza have generally strong efficacy data, Gray also emphasizes that TNBC is a highly aggressive form of breast cancer.

“Patients still don't live in the metastatic setting of TNBC longer than a year, which isn't necessarily the case in the other two breast cancer subtypes.”

HR-Positive/HER2-Negative

Additionally, Gray told PharmaNewsIntelligence that another unmet need is pre-treated metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, another highly aggressive form. Beyond developing new and efficacious therapeutics, researchers should work toward developing less painful treatments.

Currently, researchers are exploring oral selective estrogen receptor degraders (SERDs), a hormonal therapy similar to Fulvestrant, as an alternative to the standard of care.

However, Gray explains, “Fulvestrant is off-patent; it's cheap, and it's been a standard of care for over 10 years. So, physicians’ familiarity is solid there. Oral SERDs must have impressive trial results to replace that.”

HER2-Positive

One of the most significant unmet needs in HER2-positive breast cancer is a therapeutic intervention to address brain metastasis, a substantial issue in this subtype. An article in Nature revealed that nearly 20% of all breast cancers are HER2-positive breast cancer.

Gray revealed that Herceptin (trastuzumab), manufactured by Roche, has been the standard of care across nearly every HER2-positive breast cancer setting. The drug was the first targeted treatment for this subtype, with the approval in 1998. However, the US patent expired in 2019, introducing pricing pressures on the market.

“There are now far cheaper biosimilars. Herceptin's market share has dropped rapidly, meaning that it is going to be far harder to get approval for a novel therapy in this market, given that patients and insurers are going to prefer using this cheaper biosimilar that's available,” noted Gray, when asked to provide an example of how patent expiration may impact market entry.

Market Predictions

PharmaNewsIntelligence asked Gray to provide insights into the three biggest trends coming to the breast cancer market. She touched on multiple areas of focus, including a focus on early-stage therapeutics, increased segmentation of patients, and slowed development.

She explained that five years ago, few breast cancer therapies targeted early treatment stages, especially in HR-positive and triple-negative breast cancer.

“It’s a very lucrative area with so many patients. So, pharma companies are increasingly targeting this area to maximize profit.”

Another trend she predicted is increased market segmentation as research advances. For example, Keytruda targets PD-1-positive patients, while capivasertib and Piqray target patients with PI3K mutations.

“There are increasing numbers of trials looking at smaller and smaller subsets of patients with certain biomarkers. For example, in non-small cell lung cancer, [treatment] is heavily divided by the types of mutations a patient will have. That is going to happen in breast cancer,” predicted Gray. “All these different biomarkers are going to emerge, and it's going to be a far more segmented indication than it is now.”

Companies may do additional market research to understand segments with unmet needs and how new products could fit into the global market.

Finally, Gray emphasized that the saturated market will prompt slower development as companies navigate regulatory approval and product differentiation challenges.

“Particularly for HER2-positive and HR-positive, development will slow down over the next 10 years. They are relatively crowded at the moment. It will become increasingly difficult to show a strong efficacy benefit over what's currently approved. And, as patents start to expire, it'll be more difficult to justify the pricing of a novel therapeutic, which generally will be high,” she concluded.

Editor's Note: This article has been edited to correctly reference capivasertib.