Amgen’s SWOT analysis: biotech giant faces challenges in competitive market

Amgen Inc. (NASDAQ:AMGN), a leading biotechnology company with a substantial market capitalization of $149.37 billion, continues to navigate a complex landscape of opportunities and challenges in the biopharmaceutical industry. With a diverse portfolio of products spanning cardiovascular disease, oncology, bone health, neuroscience, nephrology, and inflammation, Amgen has established itself as a key player in the sector. According to InvestingPro analysis, the company maintains a strong financial health score of "GOOD," reflecting its robust market position. However, recent developments have highlighted both strengths and weaknesses in the company’s strategy, prompting a closer examination of its market position and future prospects.

Recent Financial Performance

Amgen’s financial performance has been a mixed bag in recent quarters. The company reported better-than-expected results for the first quarter of 2025, with revenue and earnings per share (EPS) exceeding consensus estimates. InvestingPro data shows impressive revenue growth of 12.88% over the last twelve months, reaching $34.92 billion. The company’s strong financial position is further evidenced by its attractive dividend yield of 3.49% and a 14-year track record of consecutive dividend increases. This outperformance was primarily driven by strong sales of core products such as Repatha and Prolia, as well as the company’s growing biosimilar portfolio.

Despite the positive top-line results, Amgen has maintained its full-year 2025 guidance, projecting revenue between $34.4 billion and $35.7 billion, with non-GAAP EPS ranging from $20.00 to $21.20. This conservative outlook suggests that the company anticipates potential headwinds in the coming quarters.

One area of concern has been the performance of Amgen’s rare disease segment, which was acquired through the Horizon transaction. Key products in this portfolio, including Krystexxa and Tepezza, have underperformed expectations, raising questions about the long-term value of the acquisition. Analysts have noted that it may be premature to draw definitive conclusions, as more time may be needed for these products to gain traction in the market.

Key Products and Pipeline

Amgen’s core product lineup continues to show strength, with several key drugs driving growth. Repatha, the company’s cholesterol-lowering medication, has demonstrated robust volume growth, with a 41% increase reported in recent data. This performance underscores Repatha’s importance to Amgen’s stable business and its potential for further market penetration.

The company’s bone health franchise, including Evenity and Prolia, has also shown resilience. However, analysts are closely monitoring the potential impact of upcoming biosimilar competition on Prolia and Xgeva, which could affect future sales trajectories.

Amgen’s biosimilar portfolio has emerged as a significant growth driver, contributing 9% of first-quarter revenue in 2025. Notable performers include Pavblu, a biosimilar for Eylea, which has benefited from reduced funding for patient assistance charities for branded anti-VEGF agents. Wezlana, a biosimilar for Stelara, has also shown promise, although its growth potential may be tempered by the presence of other competitors in the market.

In the pipeline, Amgen’s MariTide program for diabetes and obesity treatment has garnered significant attention. The company is set to present 52-week Phase 2 data at the upcoming American Diabetes Association (ADA) conference, with analysts eagerly anticipating updates on the Phase 3 trial design. The potential for improved tolerability through dose escalation protocols could be a key differentiator for MariTide in a competitive market.

Market Position and Competition

Amgen faces intense competition across its various therapeutic areas. In the diabetes and obesity space, the company is up against established players and innovative new entrants. The recent positive Phase III results for Eli Lilly’s oral GLP-1 agonist orforglipron have intensified the competitive landscape, potentially challenging MariTide’s market positioning.

Despite these challenges, some analysts believe that MariTide could still carve out a significant role, particularly among more severely obese patients managed by specialists. The drug’s ultra-long-acting, self-injected modality offers potential advantages in terms of rapid and durable weight loss, as well as improvements in cardiometabolic parameters.

In oncology, Amgen’s Imdelltra, a DLL3-targeting drug, has shown promising results and rapid growth potential. The upcoming presentation of Imdelltra data at the American Society of Clinical Oncology (ASCO) conference is expected to showcase the strength of Amgen’s bispecific platform and could provide further upside to the company’s oncology portfolio.

Future Outlook and Growth Drivers

Amgen’s future growth prospects hinge on several key factors. The successful development and commercialization of MariTide could provide a significant boost to the company’s position in the lucrative diabetes and obesity market. However, the drug’s success will depend on its ability to differentiate itself from both existing treatments and emerging competitors.

The company’s biosimilar portfolio is expected to continue driving growth, with Pavblu and Wezlana leading the charge. As more biosimilars enter the market, Amgen’s early-mover advantage and established presence could prove valuable in capturing market share.

In the rare disease segment, the integration and performance of Horizon assets will be crucial. While initial results have been disappointing, there is potential for improvement as these products progress through their lifecycle and gain broader market acceptance.

Amgen’s pipeline beyond MariTide also holds promise, with bemarituzumab and Imdelltra representing potential catalysts for future growth. Positive clinical trial outcomes for these candidates could provide incremental upside to the company’s valuation.

Bear Case

How might increased competition impact Amgen’s market share?

Amgen faces significant competitive pressures across its product portfolio. In the diabetes and obesity space, the emergence of new oral treatments like Eli Lilly’s orforglipron could challenge MariTide’s market potential. The convenience of daily oral medications may be preferred by some patients over injectable therapies, potentially limiting MariTide’s adoption.

In the biosimilar market, while Amgen has gained an early advantage with products like Pavblu and Wezlana, the entry of additional competitors could erode market share and pricing power. As more biosimilars become available, payers may exert pressure to reduce costs, potentially impacting Amgen’s revenue from this segment.

Furthermore, the company’s established products, such as Prolia and Xgeva, face the threat of biosimilar competition in the near future. This could lead to market share erosion and price pressure, affecting a significant portion of Amgen’s current revenue base.

What risks does Amgen face in its rare disease segment?

The underperformance of Amgen’s rare disease portfolio, acquired through the Horizon transaction, presents a significant risk to the company’s growth strategy. Key products like Krystexxa and Tepezza have fallen short of expectations, raising concerns about the value of the acquisition and the potential for future growth in this segment.

Rare disease treatments often face challenges in market adoption due to small patient populations and the need for specialized care. If Amgen struggles to gain traction with these products, it could impact the company’s ability to diversify its revenue streams and reduce its reliance on core products facing patent expirations.

Additionally, the high costs associated with rare disease treatments may face increasing scrutiny from payers and regulators, potentially limiting pricing power and market access. This could further constrain the growth potential of Amgen’s rare disease portfolio.

Bull Case

How could MariTide’s success drive Amgen’s growth?

MariTide represents a significant opportunity for Amgen to establish a strong presence in the rapidly growing diabetes and obesity market. If the Phase 3 trials demonstrate improved tolerability through dose escalation protocols, MariTide could differentiate itself from competitors and gain widespread adoption.

The drug’s ultra-long-acting formulation and potential for significant weight loss and cardiometabolic improvements could make it an attractive option for patients and healthcare providers. Success in this market could drive substantial revenue growth for Amgen, given the large and expanding patient population seeking effective weight management solutions.

Furthermore, positive results from MariTide could bolster Amgen’s reputation in metabolic diseases, potentially opening doors for future developments in related therapeutic areas. This could lead to a more diversified product portfolio and reduced reliance on the company’s current core products.

What potential does Amgen’s biosimilar portfolio have?

Amgen’s growing biosimilar portfolio has already demonstrated its value, contributing significantly to the company’s recent revenue growth. As healthcare systems worldwide seek to reduce costs, the demand for high-quality biosimilars is likely to increase.

Amgen’s early-mover advantage in certain biosimilar markets, such as Pavblu for Eylea, positions the company well to capture market share and establish brand recognition. As more of Amgen’s biosimilars gain approval and enter the market, they could provide a steady stream of revenue growth.

Moreover, the experience and infrastructure developed through its biosimilar program could give Amgen a competitive edge in bringing future biosimilars to market more efficiently. This could create a sustainable growth engine for the company, helping to offset potential losses from patent expirations of its branded products.

SWOT Analysis

Strengths:

• Strong portfolio of established products (Repatha, Prolia, Evenity)
• Growing biosimilar business with early-mover advantages
• Robust pipeline with potential high-impact candidates (MariTide, Imdelltra)
• Expertise in biologic drug development and manufacturing

Weaknesses:

• Underperformance in recently acquired rare disease segment
• Dependence on a few key products for significant portion of revenue
• Challenges in differentiating new products in competitive markets

Opportunities:

• Expansion into diabetes and obesity market with MariTide
• Further growth in biosimilar market as more products launch
• Potential for successful clinical trial outcomes in oncology and other areas
• Increasing global demand for cost-effective biologic treatments

Threats:

• Intense competition in key therapeutic areas
• Upcoming biosimilar threats to established products (Prolia, Xgeva)
• Pricing pressures from payers and regulators
• Potential for clinical trial failures or regulatory setbacks

Analysts Targets

• Cantor Fitzgerald (May 2nd, 2025): Neutral, Price Target $305.00
• BMO Capital Markets (May 2nd, 2025): Outperform, Price Target $346.00
• Piper Sandler (May 5th, 2025): Overweight, Price Target $329.00
• RBC Capital Markets (May 2nd, 2025): Outperform, Price Target $320.00
• Piper Sandler (April 21st, 2025): Overweight, Price Target $329.00

Amgen continues to navigate a complex and competitive biopharmaceutical landscape, balancing the strengths of its established products with the potential of its pipeline and biosimilar portfolio. While challenges remain, particularly in the rare disease segment and with increasing competition, the company’s diverse product lineup and innovative pipeline provide opportunities for future growth. Investors and industry observers will be closely watching the development of key programs like MariTide and the performance of Amgen’s biosimilars as indicators of the company’s long-term prospects.

This analysis is based on information available up to September 17, 2025, and reflects the most recent data and analyst perspectives provided in the context. For the most comprehensive and up-to-date analysis of Amgen, including detailed financial metrics, Fair Value estimates, and expert insights, explore the full Pro Research Report available exclusively on InvestingPro, covering what really matters for smarter investment decisions.

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