Affimed N.V. (AFMD): 5 FORCES Analysis [Nov-2025 Updated]

You're trying to size up Affimed N.V.'s competitive footing in the immuno-oncology space, but honestly, that May 2025 insolvency filing changes the whole game we're looking at. Forget standard biotech rivalry for a moment; we are now analyzing a situation where the Bargaining Power of Suppliers is extremely high-they can demand immediate payment or stop supplying critical reagents-and pharma partners hold maximum leverage over assets like acimtamig because the company couldn't fund operations past Q4 2025, despite having about €24.1 million in cash as of Q3 2024. Below, I map out exactly how this financial collapse inverts the standard five forces, showing you where the real pressure points are now, from the threat of well-capitalized acquirers acting as new entrants to the immediate pivot patients will make toward established, stable therapies.

Affimed N.V. (AFMD) - Porter's Five Forces: Bargaining power of suppliers

You're looking at the supplier landscape for Affimed N.V. right after its May 2025 insolvency filing. Honestly, the power dynamic has flipped dramatically; suppliers now hold almost all the cards because Affimed N.V. is officially a high-risk client, having filed for insolvency proceedings with the local court of Mannheim in Germany on May 13, 2025. This event signals to every vendor that payment terms are now a major concern, definitely pushing their bargaining power to an extremely high level.

The financial situation leading up to this confirms the leverage suppliers gained. As of September 30, 2024, Affimed N.V. reported cash, cash equivalents, and investments totaling €24.1 million. Management projected this liquidity, combined with anticipated proceeds from its ATM program and the sale of AbCheck, would only finance operations into Q4 2025. That runway, which looked tight even before the insolvency, means suppliers know the company has limited time and capital to secure critical services or materials, severely weakening Affimed N.V.'s payment leverage.

Here's a quick look at the financial context that suppliers are reacting to:

For a clinical-stage biotech, reliance on specialized external partners is always high, but post-insolvency, this becomes an existential threat. Switching costs are a major factor here, especially for services that require significant setup or knowledge transfer.

The power of specific supplier groups is amplified by these switching costs:

• Contract Research Organizations (CROs) require deep familiarity with ongoing trials.
• Specialized Contract Manufacturing Organizations (CMOs) for biologics have high barriers to entry for new vendors.
• Suppliers of proprietary cell culture media and reagents for the ROCK platform are often single-source.

To be fair, suppliers of essential, non-standard components for the ROCK platform-like specific media or reagents-can effectively demand immediate payment or simply cease supply. They know that halting production or shipment could immediately jeopardize any remaining clinical progress or asset value, giving them maximum leverage over Affimed N.V. in its current state.

Affimed N.V. (AFMD) - Porter's Five Forces: Bargaining power of customers

You're looking at the customer power for Affimed N.V. (AFMD) right around the time of its major financial distress, and honestly, the power dynamic shifted entirely to the customer side. The primary customers, in this case, are the large pharmaceutical and biotech partners who fund and advance the clinical pipeline. Consider the collaboration with Artiva Biotherapeutics on the AFM13/AB-101 combination therapy; the revenue-sharing terms themselves show the structure before the collapse. Under that agreement, Affimed N.V. was slated to receive 67% of the combination therapy revenues, while Artiva was set to receive 33%. Still, the ultimate leverage came from the company's inability to secure necessary capital.

The most telling financial event was the company's filing for insolvency proceedings with the Mannheim court in Germany on May 13, 2025, after attempts to secure additional funding failed. This event immediately gave partners maximum leverage over any in-progress assets or intellectual property. The market reaction was swift, with shares dropping to as low as $0.3299 premarket. Partners could, and likely did, threaten to terminate or renegotiate collaboration agreements, knowing that the risk of clinical trial disruption from insolvency was now a certainty, not a possibility.

Clinical trial sites-the hospitals and investigators running the studies-also hold significant, though different, power. If a sponsor like Affimed N.V. faced insolvency, these sites could halt patient enrollment or pivot to trials run by financially stable sponsors. The cost to keep a trial running is substantial, which is leverage for the site when the sponsor's viability is in question. For instance, industry data suggests the direct daily cost for a Phase II trial is around $23,737, escalating to $55,716 per day for a Phase III trial. A delay or transfer of a complex oncology trial, which was Affimed N.V.'s focus, could easily run into millions of dollars, making site cooperation essential but costly to secure under duress.

The situation crystallized the customer power dynamic into clear financial and operational risks for Affimed N.V. The leverage points for these partners were direct and immediate:

• Threat of immediate contract termination post-insolvency filing.
• Control over clinical data transfer and asset rights.
• Ability to halt patient enrollment in ongoing studies.
• Negotiating asset acquisition at distressed values.

Here's a quick look at the financial stakes involved in the partnership structure and the general cost of running the trials that partners controlled:

The insolvency filing on May 13, 2025, effectively transferred maximum negotiating power to the partners, as they were dealing with a company whose ability to fund future obligations, including covering its share of clinical costs, was zero. The partners were in the driver's seat to secure continuity for their own programs or acquire assets from the insolvency estate, which was the ultimate expression of customer bargaining power.

Affimed N.V. (AFMD) - Porter's Five Forces: Competitive rivalry

You're looking at the competitive landscape for Affimed N.V. (AFMD) right now, late in 2025, and honestly, the rivalry is fierce. The environment for immuno-oncology (I-O) and specifically for bispecific/trispecific antibodies is seeing explosive innovation, which means Affimed N.V. is fighting for every inch of ground.

The sheer size of the market underscores the intensity. The global immuno-oncology drugs market was calculated at US$ 109.39 billion in 2025, and that's just one segment of the broader fight. The bispecific antibodies market itself was projected to hit USD 17.24 billion in 2025, growing from USD 11.97 billion in 2024. With over 5,000 I-O drug candidates in development as of May 2025, the pipeline is crowded. This means competition isn't just about approved drugs; it's about who gets the next breakthrough data point.

Direct rivals developing NK cell engagers or other bispecifics are definitely competing for the same clinical trial patients. You see this pressure in indications like Hodgkin Lymphoma (HL) and Non-Small Cell Lung Cancer (NSCLC). For instance, Affimed N.V.'s Phase 2 LuminICE-203 study, which uses acimtamig (AFM13) in combination with AlloNK, is vying for patients who might otherwise be enrolled in trials for competing NK cell engagers or other novel mechanisms. The competition for intellectual property is just as critical; securing strong data early is key to establishing platform dominance.

Affimed N.V.'s lead asset, acimtamig (AFM13), faces a tough gauntlet against entrenched standards of care. Established therapies like checkpoint inhibitors still dominate the I-O market, holding a 72% market share as of May 2025. Furthermore, cell therapies like CAR-T are seeing the fastest projected growth in the I-O segment. This means any new data from Affimed N.V. must show a significant step-change in efficacy or safety to displace these established players.

The clinical data Affimed N.V. has generated is certainly promising, but it also makes them a target. Data from the prior AFM13-104 trial showed an Overall Response Rate (ORR) of 94% in heavily pretreated patients, and specifically in 31 r/r HL patients, the ORR was 97% and the Complete Response (CR) rate was 77%. This level of efficacy in a refractory setting is what makes rivals interested. Given that Affimed N.V. announced the Filing for the Opening of Insolvency Proceedings on May 13, 2025, and their cash position was only €24.1 million as of September 30, 2024 with runway into Q4 2025, the pressure to secure a partnership or be acquired is high. Rivals are positioned to potentially acquire this promising clinical data or entire programs at a discount, knowing the company's precarious financial standing. It's a classic biotech dynamic.

Here is a quick look at the competitive environment metrics we are tracking:

The competitive forces are clearly defined by market size, pipeline density, and the financial vulnerability of the target. You need to watch the next data readout from the LuminICE-203 trial very closely.

• Immuno-oncology pipeline has over 5,000 agents in development.
• There are 12 key competitors with I-O revenue over $1 billion.
• The I-O market is projected to grow at a 16.34% CAGR through 2034.
• AFM13 monotherapy ORR in cutaneous lymphoma was 42% (6/14).

Finance: draft 13-week cash view by Friday.

Affimed N.V. (AFMD) - Porter's Five Forces: Threat of substitutes

Threat of substitutes is high, as the innovative innate cell engagers (ICE®) developed by Affimed N.V. (AFMD) are substitutes for existing standard-of-care treatments, but the reverse is now true, with established therapies substituting for Affimed N.V.'s pipeline candidates.

Patients and physicians will default to approved, financially stable therapies like PD-1/PD-L1 inhibitors or brentuximab vedotin for R/R cHL. The global PD-1 and PD-L1 Inhibitors Market was valued at USD 62.23 Bn in 2025, with PD-1 inhibitors expected to account for more than three-fifths of the market share in 2025. The North America segment alone was expected to be valued at around USD 27.56 Bn by 2025.

Other bispecific T-cell engagers (BiTEs) and allogeneic NK cell therapies from well-funded companies are direct, viable substitutes. Affimed N.V. has treated over 500 patients with its proprietary ICE® molecules to date, but competitors with larger capital bases present a significant substitution risk.

The risk of an uncompleted trial pushes the market toward established, commercialized therapies with a clear path to approval. Affimed N.V.'s cash position was €24.1 million as of September 30, 2024, with a projected cash runway into Q4 2025, contrasting sharply with the scale of the established market.

The contrast between the potential efficacy of Affimed N.V.'s lead asset and the market reality underscores the substitution pressure:

The reliance on continued clinical success is a major factor in substitution risk. For instance, the AFM13 + NK cells combination showed a 71% complete response rate in a specific late-stage trial cohort.

Key factors driving physicians toward established substitutes include:

• Approved status for standard-of-care treatments.
• Established safety profiles in broad patient populations.
• Financial stability of the sponsoring companies.
• Clear reimbursement pathways for commercialized drugs.

The Q3 2024 revenue for Affimed N.V. was €0.2 million, compared to R&D expenses of €10.1 million in the same period, highlighting the need for rapid clinical validation against established, multi-billion dollar substitutes.

Affimed N.V. (AFMD) - Porter's Five Forces: Threat of new entrants

You're looking at the threat of new entrants for Affimed N.V. (AFMD) in late 2025, and honestly, the situation is starkly defined by the company's own recent history. For a brand-new, de novo entrant-a company starting from scratch-the threat level remains low, primarily due to the massive capital requirements and the stringent regulatory hurdles inherent in clinical-stage oncology development. Developing a therapy through Phase 1, 2, and 3 trials requires hundreds of millions, if not billions, of dollars over many years. Affimed N.V., despite having a proprietary platform, could not secure the necessary runway, which signals just how high those capital walls really are.

The company's failure, culminating in the insolvency filing on May 13, 2025, definitely signals a high-risk environment for its specific technology niche-innate cell engagers (ICE®). While the technology itself might be attractive, the market has just witnessed a clinical-stage player with assets like AFM13, AFM24, and AFM28 collapse due to insufficient funding. This outcome can deter new investment in similar platforms, as investors see the direct consequence of capital exhaustion.

High barriers to entry definitely exist, centered around intellectual property and financial muscle. Affimed N.V.'s proprietary ROCK® platform technology is a significant barrier, as replicating that specific engineering would take years and substantial R&D spend. Furthermore, the need for significant capital proved insurmountable for Affimed N.V., leading directly to the insolvency filing with the local court of Mannheim in Germany. Before this event, the company reported cash of €120 million with a runway into 2025, yet this proved insufficient to sustain operations.

Here's a quick look at the financial context surrounding the insolvency event:

The real, immediate threat isn't a de novo startup; it's a well-capitalized competitor acquiring Affimed N.V.'s assets out of insolvency. When a company enters formal insolvency proceedings, its valuable pipeline assets, including the ROCK® platform technology and its clinical candidates, become available for purchase, often at a significant discount. A large pharmaceutical or biotech firm with deep pockets can step in, acquire the assets, and effectively become a new, mature entrant overnight, bypassing years of early-stage R&D risk.

The barriers that keep out smaller players are substantial:

• Massive, multi-year capital burn rates.
• Lengthy, complex FDA/EMA clinical trial pathways.
• Need for specialized, proprietary platform technology like ROCK®.
• Regulatory scrutiny evidenced by the minimum bid price non-compliance notice on April 15, 2025.

The market has shifted from one where a small, innovative company could potentially bootstrap its way to a major partnership to one where only well-funded entities can survive the clinical valley of death.