Amgen (AMGN): The Biotech Pioneer Preparing for Its Next Growth Wave

Initially, the pharmaceutical industry was built on the ability to identify, isolate, and purify chemical compounds with medicinal virtues, for example, how salicylic acid found in tree bark was turned into pure Aspirin, or antibiotics initially produced by microorganisms to kill competing organisms.

Later on, new chemical compounds that did not exist in nature started to be used, giving birth to the modern pharmaceutical industry.

However, for some diseases or some medical targets, chemicals are just not enough. When a pathology is linked to hormones or specific signals inside the body, modifying this through chemical compounds is not enough.

Instead, it requires replicating more complex and much larger biomolecules like DNA, proteins, hormones, etc. And eventually, it can even modify the natural product to improve the efficiency or safety of the treatment.

Source: Amgen

This method is broadly categorized as “biotechnology”, in opposition to the chemical-based pharmaceutical industry, although the two sectors are obviously complementary and can sometimes blend a little into each other.

Fundamental to the creation of the field of biotechnology as a separate segment from pharmaceuticals were a few companies, among which one of the most important was, and it can be argued, still is: Amgen

Amgen Overview

Amgen History: Building The Biotech Industry

At the core of Amgen is the story of its creation in 1980. At this time, insulin was already a widely used treatment for diabetes. However, it was obtained through the processing of animal pancreas, which regularly caused contamination and medical issues.

In 1980, Genentech partnered with Eli Lilly and Company (LLY )  and obtained on October 28, 1982, FDA approval for the first “recombinant” insulin, a pure insulin produced from genetically modified bacteria.

Amgen, too, was created with an initial early focus on recombinant DNA technology and recombinant human insulin. However, it quickly realized that Genentech was ahead, redirected its R&D efforts to another type of protein, and went to IPo in 1983.

This resulted in the creation in 1983 (approved in 1989) of Epoetin alfa/EPOGEN for the treatment of anemia, and in 1985 (approved in 1991) of Filgrastim/NEUPOGEN to help cancer patients fight infections.

Epoetin would prove to be one of the most successful drugs in biotech history, becoming the company’s first “blockbuster”, a molecule and patent so profitable that it can finance all the growth and R&D budget of the company for years. In 1992, epoetin alfa and filgrastim combined generated more than $1B in revenues in just one year.

By 1989, Amgen would quickly establish offices across Europe, including its European headquarters in Lucerne, Switzerland, and a key manufacturing and distribution center in Breda, the Netherlands.

In 1993, Amgen opened a 1.7 million square feet flagship manufacturing site in Puerto Rico, and kept growing its business. Later on in the 1990s, these blockbuster molecules would be improved further into ARANESP/darbepoetin alfa and NEULASTA/pegfilgrastim.

In the 2000s, Amgen (AMGN ) acquired Immunex for $16B, adding a blockbuster drug used to treat inflammatory conditions like rheumatoid arthritis to its portfolio. It also entered the cancer market proper with its first cancer therapeutic, Vectibix, a monoclonal antibody approved for specific types of advanced colorectal cancers.

In the 2010s, Amgen added to its portfolio the next-generation bone health treatments like Prolia and XGEVA. By the end of the decade, Amgen also acquired the immunology medicine Otezla (2019)

Then, the company kept expanding through acquisitions with  Horizon Therapeutics (2023) in a $27.8B deal, to substantially expand its pipeline for high-growth rare disease drugs.

In 2025-2026, Amgen is also entering the highly contested obesity market, with MariTide/maridebart cafraglutide. Contrary to established competitors Ozempic or Mounjaro, MariTide’s monthly or even less frequent dosing could prove a competitive advantage.

Amgen By The Numbers

From its modest origins, Amgen has grown to a company employing 31,500 people, with around half in North America.

Contrary to some other biotech companies, Amgen does a lot of the manufacturing itself, instead of subcontracting, with production and other facilities all over the world, notably in Thousand Oaks, California (HQ & R&D center), Rhode Island (Logistics), Puerto Rico (formulation, fill, finish, and packaging sites), Ireland (Aseptic vial filling and syringe assembly), Singapore (Highly advanced facility equipped with flexible single-use modular bioreactors) and Brazil (local production).

From its initial success with EPO, Amgen has discovered and acquired a large roster of blockbuster drugs, with no less than seven therapies having generated more than $1B in 2025 (see more below).

Among these products, several saw explosive growth in 2026 by more than 1/3rd, notably Repatha, Evenity, and Tezspire.

Source: Amgen

In 2025, the company generated $36.8B in operating revenues, for a net income of $11.8B and a free cash flow of $8.1B.

Amgen’s Products

Current Portfolio

Amgen’s biotech product portfolio is centered around four main therapeutic axes: rare diseases, oncology, inflammation, and general medicine, each with a wide array of products.

Source: Amgen

Rare Diseases

The rare disease segment has recently grown thanks to the acquisition of Horizon Therapeutics. It mostly concerns poorly understood or untreated diseases that, while not concerning millions of patients, are often very serious. As such, these therapies are well reimbursed by insurance despite high prices and are often given a fast track to approval by regulatory agencies like the FDA and its equivalent in other countries and regions.

This notably includes blood autoimmune diseases (B-cell depletion, vasculitis) and thyroid eye disease.

Source: Amgen

Overall, the rare disease segment has been growing by 21% year-to-year in Q3 2026, and should be annualized at around $5B in revenues.

Oncology

The oncology segment is one where Amgen has been for two decades, and even longer if we consider support treatments. Two products in particular should be mentioned for their recent growth:

• Imdelltra, a treatment for small cell lung cancer, which is already a “half-blockbuster” with half a billion in annualized sales.
• Blincyto, an immunotherapy medication for relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL), to be used alongside or alternating with multiphase chemotherapy.

Overall, the “innovative oncology” segment has been growing by 18% year-to-year in Q3 2026.

Source: Amgen

Inflammation

Inflammation is increasingly considered a new frontier of medicine, as many hard-to-treat diseases are ultimately linked to chronic inflammation. In the case of Amgen, this overlaps well with its deep expertise regarding rare autoimmune diseases, as the process of inflammation is also mediated by the immune system.

One such example is joint inflammation, which can be caused by gout, triggered by unhealthy diets and lifestyles, and quickly growing into a global medical issue, but also by rheumatoid arthritis, an autoimmune disease.

Among the major Amgen drugs in this category are:

• Otezla/apremilastfor plaque psoriasis and psoriatic arthritis, one of Amgen’s blockbuster drugs.
• Enbrel/etanercept: Amgen’s historic flagship anti-TNF therapy for rheumatoid arthritis and plaque psoriasis.

General Medicine

This category covers a wide variety of medical fields. This includes several of Amgen’s blockbuster products like:

• Repatha to reduce cholesterol, with sales up 37% year-to-year.
• Evenity for reducing bone fracture risk in up to two million women in the US alone, with sales up 38% year-to-year.
• Tezspire, providing new therapeutic options for patients with severe asthma, with sales up 42% year-to-year.

Biosimilars

While not yet described as a major for Amgen, biosimilars are also growing. This is a category equivalent for biotech products to what generic drugs are to chemical drugs: essentially a copy of an existing product from a competitor when it is no longer protected by a patent.

What makes biosimilars unique is that, while replicating a chemical formula is relatively speaking easy, replicating with the exact same properties a biotech therapy is harder, due to the complex nature of the protein or other biomolecules used. So only companies with extensive experience in producing biotech therapies can achieve an efficiency & safety profile satisfactory enough to the FDA to approve a biosimilar.

As such, the market dynamics for biosimilars are different than for generic drugs:

• Drugs falling off patent often see several, if not dozens of new generic competitors arrive on the market in less than a year, often causing price collapse >90%.
• Biotech therapies exposed to biosimilars can sometimes see no new competitors for years, and then turn more into an oligopoly with two or three producers, helping hold prices higher.

Since entering this market in 2018, Amgen’s biosimilars have generated $13B in cumulative sales through two waves of launches, with $42B in sales growth driven by the second wave of product launches.

Source: Amgen

A third wave of product launches is getting ready, tackling some of the world’s most profitable biotech therapies, including:

• Opdivo/nivolumab, the flagship cancer immunotherapy from Bristol Myers Squibb, which generated $10B in revenues in 2025.
• Merck’s Keytruda, another flagship cancer immunotherapy, which generated $31.7B in revenues in 2025.
• Roche’s Ocrevus, a multiple sclerosis medication, generated $5.9B in revenues in 2025.

Even assuming conservative market share capture for these massive blockbuster biosimilars and a reduction in the value of their global sales from falling off-patent, it is reasonable to assume that this segment will become a major pillar of Amgen revenues moving forward, with potential for multi-billion-dollar revenues at play.

R&D Pipeline

Besides the existing portfolio, investors in biotech and pharmaceutical companies need to pay attention to the R&D pipeline, as these companies need to constantly renew their portfolio to compensate for the current one seeing patent expiration.

As such, it should also be noted that while it can obviously contribute to growth, a significant part of the R&D budget in such companies should be considered as part of operating expenses, with constant innovation a requirement for the company’s survival in the same way that regular mineral deposit exploration is for mining companies, or industrial building capex for heavy industries.

Currently, Amgen is conducting a total of 298 clinical trials, with 43,000+ patients participating.

In general, while potentially, the eventual future revenues from promising drugs in preclinical or early stage (1 & 2) should be taken with a grain of salt, as around 90% of preclinical drugs never gain FDA approval. So when it comes to the effects on the company and its stock price, drugs in phase 3 of clinical trials are the ones most likely to have a significant impact in the upcoming five years.

In general medicine, Amgen’s R&D pipeline is heavily oriented toward cardiovascular diseases with MariTide, with the angle of weight management/obesity treatment another important topic to watch for this molecule, as GLP-1-related drugs have quickly become some of the world’s most profitable drugs since the release of Ozempic a few years ago. It could also make MariTide the first monthly therapy for Type 2 diabetes.

Source: Amgen

In rare diseases, Amgen has a wide array of drugs in phase 3, each targeting a different rare pathology. In this segment, the expertise of Amgen in getting quick approval and commercialization once the clinical trials are over is an important competitive advantage.

Source: Amgen

In oncology (cancer), Amgen has five different molecules in phase 3 of clinical trials. As mentioned, the development of biosimilars for this segment will also likely contribute to the company’s growth in oncology in the coming years.

Source: Amgen

In inflammation, the largest potential future market is atopic dermatitis with Rocatinlimab. Expansion of the already approved Tezepelumab to new applications, if approved, will help both increase drug sales and extend its total patent life.

Amgen Competitive Position

Amgen has historically been built on groundbreaking innovation building from scratch new blockbuster drug markets, combined with strategic acquisitions. These acquisitions did not just give the company existing products and its R&D pipeline, but also expanded sales channels and key talent in its fields of focus of inflammation/immunology, rare diseases, and oncology.

This has led to today, where the company is highly profitable, with many blockbuster drugs each generating billions of revenue every year.

The next important stage for Amgen will be to expand its model from R&D-driven to market- and manufacturing-driven.

This starts with aggressive moves into making biosimilars for some of the world’s most profitable biotech therapies in cancer treatment, like Keytruda, currently around half of the total sales of the other pharmaceutical industry giant Merck.

It also means entering the fray in the obesity/weight loss market, with a serious competitor to Ozempic and Mounjaro, which have been the largest surprise success story in the pharmaceutical industry in the 2020s.

To support this shift to intense competition on biosimilars and large-scale demand for obesity therapies, Amgen has been heavily investing in its manufacturing capacities. It has invested as much as $40B in new manufacturing infrastructure since 2018.

This focus on supply chain localization has resulted in the production of new modular, flexible, and environmentally sustainable biomanufacturing systems and has leveraged legislative frameworks encouraging reindustrialization and manufacturing in the USA.

Investing In Amgen

For investors, it can always be difficult to fully understand biotechnology companies, as they are dealing with complex diseases, difficult-to-manufacture and research biomolecules, and extremely regulated business environments. This can result in ultra-volatile stock prices depending on the fortune of almost unpredictable clinical trials and FDA decisions.

So it can make sense to prefer getting exposure to this sector through a more mature actor, with steady income from blockbuster drugs built from decades of steady accumulation of key patents, medical data, research personnel, and advanced manufacturing facilities.

An investment in Amgen will take into account these currently existing assets, but should also remember that they are most likely already priced into the company’s current stock value.

So future gains will likely have to come from the upcoming growth in revenue streams. Three main segments will be of special interest:

• Expansion of existing therapies into new applications and afferent pathologies, as well as growth in sales for currently approved applications through stronger adoption from medical practitioners.
• Expansion into biosimilars, aggressively attacking market share of 10-digit market blockbuster therapies, especially in oncology.
• Eventual success or failure in the obesity market with GLP-1 type drugs, which has grown from zero (around 2021) to a $79B market in 2025 and expected to grow to $190B by 2035. Here, Amgen’s advantage will be a rarer monthly dose or less frequent dosing, although other companies are working on a similar medical profile for their own competing products and improvements. Still, even a relatively modest 5-10% market penetration in 2035 could result in $9B-$18B in additional revenues, or around half of Amgen’s 2025 revenues.

All in all, Amgen takes its place in a portfolio as a mixed growth and defensive position, with the existing portfolio and the pharmaceutical sector’s tendency to work as a defensive investment combining with the potential for multi-billion-dollar new segments from multiple new biomolecules.

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