Beyond Keytruda: The Oncology & Hematology Therapeutics Landscape

Beyond Keytruda: The Oncology & Hematology Therapeutics Landscape

ADCs, Bispecifics, Cell Therapy and Precision Cancer Drugs: How the World's Largest Therapeutic Market Is Being Rebuilt

Mobility Foresights Healthcare & Life Sciences Research | Hub Analysis | September 2026

Oncology is the largest and most innovation-dense segment of the global pharmaceutical market, but the source of its growth is changing faster than at any point in the past decade. Since 2015 the category has been defined by PD-1 and PD-L1 checkpoint inhibitors. Merck's Keytruda alone generated roughly $29.5 billion in 2024 sales and is approved in more than 40 indications. With core U.S. patent protection on pembrolizumab expiring from 2028, the industry is now building the next revenue base on a different set of modalities.

Those modalities fall into four groups:

  • Antibody-drug conjugates (ADCs) and radioligands that deliver cytotoxic payloads with precision.
  • Bispecific and T-cell-engaging antibodies that redirect the immune system to the tumor.
  • Engineered cell therapies that are moving from bespoke manufacturing toward off-the-shelf and in vivo delivery.
  • Precision small molecules and degraders aimed at targets once considered undruggable.

This hub brings together 66 Mobility Foresights market studies across seven segments of oncology and hematology. For each segment we set out:

  • What is driving demand.
  • Where clinical and commercial risk sits.
  • Which of our reports carry the detailed market sizing, segmentation, competitive landscape and forecasts.

Key Takeaways

  • The post-checkpoint transition is the defining commercial theme of the decade. The pembrolizumab loss-of-exclusivity window from 2028 is reshaping pipelines, M&A priorities and combination strategy across every large-cap oncology company.
  • Payload-based modalities have become core franchise strategy. ADCs and radioligand therapies have attracted tens of billions of dollars in acquisitions since 2023, led by Pfizer's $43 billion purchase of Seagen.
  • Bispecific antibodies are the fastest-evolving class. T-cell engagers are now established in multiple myeloma and are expanding into solid tumors, while PD-1/VEGF bispecifics have emerged as the most credible challenger to PD-1 monotherapy.
  • Cell therapy is shifting its operating model. The class is moving from autologous, hospital-intensive manufacturing to tumor-infiltrating lymphocytes (TILs), allogeneic products and in vivo engineering that could extend access beyond specialist centers.
  • Format and treatment-strategy innovation is now a competitive lever. Subcutaneous checkpoint inhibitors, maintenance regimens and treatment guided by minimal residual disease (MRD) shape both lifecycle value and share of market.

How We Segment the Oncology and Hematology Landscape

Oncology market data is often reported by tumor type. That view hides the most important commercial dynamic of the period, which is competition between modalities for the same patients. We therefore organize this hub by therapeutic approach and cross-reference tumor types within each segment.

SegmentWhat is changingReports
1. ADCs & radiopharmaceuticalsTargeted payload delivery displaces untargeted chemotherapy5
2. Checkpoints, combinations & bispecificsFrom PD-1 monotherapy to multi-mechanism regimens17
3. Cell & gene therapyFrom autologous CAR-T to TILs, allogeneic and in vivo engineering7
4. Precision & targeted oncologyBiomarker-defined, tumor-agnostic and degrader-based therapy11
5. Hematologic cancers & myelomaBCMA and GPRC5D targeting; MRD-guided treatment7
6. Tumor microenvironment & immune escapeConverting "cold" tumors and overcoming resistance10
7. Formats, biosimilars & supportive careSubcutaneous dosing, maintenance, biosimilars, bone health9

1. Antibody-Drug Conjugates and Radiopharmaceuticals: The Payload Era

An ADC pairs the specificity of a monoclonal antibody with a cytotoxic payload that is released inside the cancer cell. The concept is decades old, but commercial success arrived only recently. Two advances made the difference: stable, cleavable linkers and potent topoisomerase-I payloads such as deruxtecan. The inflection point was trastuzumab deruxtecan (Enhertu). In 2022 it showed benefit in "HER2-low" breast cancer, a population previously considered ineligible for HER2-directed therapy. Approval of the TROP2-directed datopotamab deruxtecan (Datroway) in January 2025 extended the model to a second validated antigen.

Our antibody-drug conjugates (ADCs) for solid tumor market study tracks this pipeline across breast, lung, gastric and gynecologic cancers, segmented by target antigen (HER2, TROP2, B7-H3, c-MET, CLDN18.2), payload class and linker technology. Over the forecast period the central question is whether next-generation designs can hold efficacy while reducing interstitial lung disease and ocular toxicity, which are the class's main clinical constraints. Novel constructs aim to widen that therapeutic window, including dual-payload ADCs, site-specific conjugation and immune-stimulating ADCs.

Urothelial carcinoma shows how quickly an ADC can reset a standard of care. In the EV-302 trial, enfortumab vedotin plus pembrolizumab nearly doubled median overall survival against platinum chemotherapy (31.5 vs 16.1 months). The combination displaced chemotherapy as first-line treatment for advanced disease. Our bladder cancer immunotherapy and ADC market report quantifies that shift and the parallel development of novel intravesical therapies for non-muscle-invasive disease.

Radiopharmaceuticals are following a similar trajectory, one step behind. Lutathera (somatostatin receptor) and Pluvicto (PSMA) validated targeted radioligand therapy commercially. A wave of strategic acquisitions followed: Bristol Myers Squibb bought RayzeBio (about $4.1 billion), AstraZeneca bought Fusion Pharmaceuticals (about $2.4 billion) and Eli Lilly bought POINT Biopharma (about $1.4 billion).

Three reports cover the space from different angles:

Analyst view: In radiopharmaceuticals, competitive advantage is shifting from the targeting molecule to isotope supply and manufacturing footprint. Lutetium-177 production capacity, actinium-225 scarcity and the logistics of short half-life products favor companies with vertically integrated or regionally distributed supply.

2. Beyond PD-1: Checkpoint Inhibitors, Combinations and Bispecific Antibodies

2.1 The checkpoint franchise and the 2028 cliff

PD-1, PD-L1 and CTLA-4 inhibitors remain the backbone of modern cancer treatment. Our checkpoint inhibitor oncology drugs market report sizes the class by target, indication and line of therapy, and models the impact of loss of exclusivity on leading brands. The wider immuno-oncology therapeutics market study adds the adjacent categories that compete for the same immunotherapy budget, including cytokine therapies, cancer vaccines, oncolytic viruses and emerging checkpoint targets.

The most consequential question in oncology commercial planning is what happens to pembrolizumab revenue after 2028. Our post-Keytruda oncology market analysis models how that revenue redistributes across four destinations:

  • Subcutaneous reformulations.
  • Biosimilar entrants.
  • Next-generation PD-1-based combinations.
  • Entirely new classes that aim to replace PD-1 monotherapy as the standard backbone.

In our view, no single asset inherits the Keytruda franchise. Instead, the value fragments across modalities, and that fragmentation is what makes the segments below attractive to new entrants.

2.2 Combination regimens

Most patients do not respond durably to PD-1 monotherapy, so the majority of immuno-oncology development is now combination-based. The track record is mixed. The LAG-3/PD-1 combination Opdualag reached approval in melanoma in 2022, while several TIGIT programs failed in Phase 3. The lesson is that combinations need a clear mechanistic rationale and biomarker selection rather than a "layer on another checkpoint" strategy.

We cover this space at four levels:

Pricing is a recurring constraint across all four. Regimens that stack two or three branded agents test payer tolerance, especially in European markets.

2.3 T-cell engagers and bispecific antibodies

Bispecific antibodies bind two targets at once. The most commercially important subgroup, T-cell engagers, links CD3 on T cells to a tumor antigen, redirecting the patient's own immune cells to kill the cancer. The class stretches back to blinatumomab (2014). It reached critical mass with teclistamab and elranatamab (BCMA) and talquetamab (GPRC5D) in multiple myeloma. It then crossed into solid tumors with tebentafusp in uveal melanoma (2022) and tarlatamab, a DLL3-directed engager for small-cell lung cancer (2024).

Our bispecific antibody market report sizes the class across all therapeutic areas, and the bispecific antibody oncology therapies market study isolates the cancer segment. Within that segment, four reports examine the mechanism in detail:

Solid tumors remain the harder frontier. On-target, off-tumor toxicity and poor tumor penetration limit many CD3 engagers outside hematology. Our solid tumor bispecific immunotherapies market report tracks the programs working through these barriers, including conditionally active and masked designs. Next-generation formats add further mechanisms: the bifunctional and trispecific antibodies market study covers molecules that add a co-stimulatory signal (CD28 or 4-1BB) or target two tumor antigens to reduce escape. The bispecific antibody combination therapeutics market report tracks bispecifics dosed with other agents, including dual-bispecific regimens in myeloma.

2.4 PD-1/VEGF bispecifics: the most watched challenger

The sharpest recent disruption came from a bispecific that pairs PD-1 blockade with VEGF inhibition. In the HARMONi-2 Phase 3 trial in China, Akeso's ivonescimab roughly doubled median progression-free survival versus pembrolizumab in PD-L1-positive non-small cell lung cancer (11.1 vs 5.8 months). It was the first head-to-head Phase 3 win against Keytruda. The result triggered a licensing wave that included Bristol Myers Squibb's multibillion-dollar partnership with BioNTech on BNT327, Pfizer's licensing of SSGJ-707 from 3SBio and Merck's LM-299 deal with LaNova.

Our PD-1/VEGF bispecific immuno-oncology market report tracks these assets, their trial programs and the scenarios under which the class captures first-line share. The decisive uncertainty is whether China-generated efficacy translates into overall survival benefit in global trials. It is also a reminder that China has become a primary source of in-licensed oncology innovation.

3. Cell and Gene Therapy: From Autologous CAR-T to In Vivo Engineering

Chimeric antigen receptor (CAR) T-cell therapy transformed the treatment of B-cell lymphomas, leukemias and multiple myeloma. The FDA has now approved seven CAR-T products, including the BCMA-directed Abecma and Carvykti. Our CAR-T cell therapies for hematologic cancers market report sizes the approved portfolio and the pipeline by target, indication and line of therapy.

The commercial constraint has never been efficacy but the operating model: weeks-long vein-to-vein times, individualized manufacturing and treatment limited to specialist centers. Regulators have begun to ease part of that burden. In 2025 the FDA removed the risk evaluation and mitigation strategy (REMS) requirements for approved autologous CAR-T products, an important step toward community-setting delivery, although the 2024 boxed warning for secondary T-cell malignancies remains.

Four reports frame the rest of the landscape:

The most disruptive development is in vivo CAR-T. Instead of harvesting and re-engineering a patient's cells, a lipid nanoparticle or viral vector delivers the CAR gene directly to T cells inside the body. Large-cap interest has been emphatic: AstraZeneca acquired EsoBiotec and AbbVie acquired Capstan Therapeutics in 2025. Our in vivo CAR-T therapeutics market report assesses the technology platforms, early clinical data and the cost structure of an off-the-shelf model. That model could expand the treated population well beyond today's specialist centers and into autoimmune indications.

Analyst view: If in vivo CAR-T demonstrates durable responses comparable to ex vivo products, the economic center of cell therapy shifts from manufacturing capacity to vector and nanoparticle delivery platforms. That would be a structural change for CDMOs and cell-processing suppliers.

4. Precision and Targeted Oncology: Biomarkers, Degraders and the Undruggable

Precision oncology rests on a simple principle: match the drug to the molecular driver rather than the organ of origin. The precision oncology companion diagnostics (CDx) market study covers the gatekeeper to this model: next-generation sequencing panels, liquid biopsy and immunohistochemistry assays. These tests define eligibility for an expanding list of targeted therapies. Co-development of drug and diagnostic is now standard practice, and diagnostic access is often the limiting factor in uptake outside major cancer centers.

The logical end-point of that principle is tumor-agnostic approval. Our tumor-agnostic oncology drugs market report covers therapies approved on the basis of a biomarker regardless of cancer type, such as those targeting NTRK fusions, MSI-high or dMMR status and BRAF V600E. The category broadened in April 2024, when trastuzumab deruxtecan received a tumor-agnostic approval for HER2-positive (IHC 3+) solid tumors. The HER2-targeted cancer therapies market study places that development in the context of the whole HER2 franchise. That franchise faces trastuzumab biosimilar erosion on one side and the HER2-low and HER2-ultralow expansion on the other.

Three reports cover the small-molecule frontier:

  • The KRAS-targeted oncology drugs market report follows the class from the first KRAS G12C inhibitors, sotorasib (2021) and adagrasib (2022), to G12D-selective and pan-RAS inhibitors now in late-stage trials. Pan-RAS inhibitors could open a far larger pancreatic and colorectal opportunity.
  • The precision oncology small molecules market study covers next-generation kinase inhibitors and newer mechanisms such as menin inhibition. The first menin inhibitor, revumenib, was approved in November 2024 for KMT2A-rearranged acute leukemia.
  • The targeted protein degradation drugs market report examines PROTACs and molecular glues, which destroy disease-causing proteins rather than inhibiting them. The first oral PROTAC, the estrogen receptor degrader vepdegestrant, reached U.S. regulatory review in 2025.

Small molecules also face a policy headwind. Under the U.S. Inflation Reduction Act, they become eligible for Medicare price negotiation earlier than biologics (nine versus thirteen years after approval). That gap is shifting some investment toward large-molecule formats.

Four further reports give the portfolio view:

Nucleic-acid medicines are a smaller but fast-moving adjacency. Our RNA-based oncology drugs market report covers the field. Individualized mRNA cancer vaccines, such as intismeran autogene given with pembrolizumab in melanoma, are in Phase 3. The telomerase-inhibiting oligonucleotide imetelstat was approved in 2024 for lower-risk myelodysplastic syndromes.

5. Hematologic Malignancies and Multiple Myeloma: The Most Competitive Arena

Multiple myeloma is arguably the most crowded and fastest-changing indication in oncology. Four target classes now compete and combine:

  • CD38, led by daratumumab, most often given in its subcutaneous form.
  • BCMA, through CAR-T products, T-cell engagers and ADCs.
  • GPRC5D.
  • Newer targets such as FcRH5.

Treatment is moving earlier, with quadruplet regimens in the front line. In April 2024 an FDA advisory committee voted unanimously that minimal residual disease (MRD) could support accelerated approval in myeloma, which shortens development timelines for new entrants.

Four reports cover myeloma from complementary angles:

  • Our multiple myeloma therapeutics market report covers the full treatment landscape by line of therapy, from immunomodulators and proteasome inhibitors to cellular and bispecific therapy.
  • The multiple myeloma biologics market study isolates antibody-based and other biologic modalities, including the anti-CD38 franchise and its eventual biosimilar horizon.
  • The myeloma-targeted biologic therapies market report takes a target-antigen view (BCMA, GPRC5D, FcRH5, CD38) to show where competition is concentrated and where white space remains.
  • The GPRC5D-targeted therapeutics market analysis focuses on the target validated by talquetamab and now pursued through CAR-T and next-generation engagers, especially for patients who relapse after BCMA therapy.

Beyond myeloma, three reports cover the wider hematology market:

6. The Tumor Microenvironment and Immune Escape: Solving Non-Response

The largest unmet need in immuno-oncology is the majority of patients whose tumors do not respond. Much of that resistance lies in the tumor microenvironment (TME): immunosuppressive regulatory T cells and myeloid cells, cancer-associated fibroblasts, TGF-beta signaling, hypoxia and adenosine. Together these turn tumors immunologically "cold".

The field has a sobering history. The IDO1 inhibitor epacadostat failed in Phase 3 in 2018, and development of the CD47 antibody magrolimab was halted in 2024. The consistent lesson is that TME drugs need biomarker-selected populations and rational partners.

Four reports map the TME opportunity:

A second cluster addresses the exhausted state that T cells enter after chronic antigen exposure:

The third cluster tackles the tumor's escape routes:

7. Formats, Maintenance, Biosimilars and Supportive Care

As molecular differentiation narrows, how a therapy is delivered and sequenced increasingly determines its commercial value. Subcutaneous administration is the clearest example. The FDA approved subcutaneous atezolizumab in September 2024 and subcutaneous nivolumab in December 2024, and subcutaneous pembrolizumab followed in 2025. Each cuts administration time from a 30-to-60-minute infusion to a few minutes, easing pressure on infusion chairs and supporting lifecycle management ahead of biosimilar entry.

Two reports cover the subcutaneous shift:

Treatment sequencing is the second lever:

Biosimilars and supportive care complete the picture:

  • The bevacizumab biosimilars market study covers one of the most mature oncology biosimilar categories; the first U.S. approval came in 2017. VEGF biology has also returned to strategic relevance through the PD-1/VEGF bispecific class.
  • The bone metastasis market report covers bone-targeted agents (denosumab, zoledronic acid and radium-223). Denosumab biosimilars, approved from 2024, are reshaping pricing in this segment.
  • Our oncology specialty drugs market study examines the specialty pharmacy and distribution channel through which a growing share of oral and injectable cancer drugs reaches patients.

Where Value Is Created: The Oncology Value Chain

The segments above are linked by a common value chain, and the bottlenecks within it often matter more to forecasts than clinical data alone. The table below summarizes where we see capacity, cost or access constraints through the forecast period.

Value-chain stageCurrent bottleneckMost exposed segments
Target and biomarker discoveryValidated tumor-selective antigens are scarce; antigen-density engineering widens the poolADCs, bispecifics, cell therapy
Modality engineeringLinker-payload IP, CD3 affinity tuning, vector and LNP designADCs, T-cell engagers, in vivo CAR-T
Clinical developmentCombination trial complexity; acceptance of MRD and surrogate endpointsCombinations, myeloma, hematology
Companion diagnosticsTest availability outside academic centers; reimbursement of NGS and liquid biopsyPrecision and tumor-agnostic therapy
ManufacturingHigh-potency conjugation capacity; isotope supply; viral vector and cell-processing slotsADCs, radioligands, cell therapy
Market accessIRA negotiation timelines; EU joint clinical assessments (from January 2025); combination pricingSmall molecules, multi-drug regimens
Site of careInfusion-chair capacity; CRS monitoring requirements; specialist-center concentrationCheckpoints, bispecifics, CAR-T

Deal flow reflects these constraints. Large pharmaceutical companies facing 2028–2032 exclusivity losses are paying premiums for de-risked Phase 2 and Phase 3 programs. China-origin assets now account for a rising share of in-licensed oncology molecules. Our late-stage oncology assets market report tracks that pipeline and the licensing and acquisition economics behind it. It is a useful reference for business-development teams and investors assessing which modalities will absorb the post-checkpoint revenue pool.

Regional perspective

  • United States. The largest oncology market by revenue and the primary launch market for new modalities. Inflation Reduction Act negotiation timelines are now a design input for portfolio strategy.
  • Europe. Access is shaped by health technology assessment. The EU's joint clinical assessments, applied to new oncology medicines since January 2025, are beginning to standardize evidence requirements across member states.
  • China. The fastest-growing source of oncology innovation. It is increasingly a first-in-human and proof-of-concept venue, particularly for bispecifics and ADCs, and domestic uptake depends on national reimbursement listing.
  • Japan and emerging Asia. Japan remains a priority for late-stage trials and launch sequencing. India and other emerging markets are important for biosimilar volume and cost-efficient trial recruitment.

What to Watch Through 2032

  1. Pembrolizumab loss of exclusivity (from 2028): the speed of subcutaneous conversion and biosimilar uptake will set how much of the franchise is defended.
  2. Global PD-1/VEGF Phase 3 readouts: overall survival results outside China will decide whether the class becomes a new first-line backbone.
  3. ADC safety and earlier-line use: progress on interstitial lung disease mitigation will determine how far ADCs move into adjuvant and first-line settings.
  4. In vivo CAR-T durability: early clinical durability data will show whether off-the-shelf engineering can match ex vivo products.
  5. Radioisotope capacity: actinium-225 and lutetium-177 supply build-out will cap or unlock radioligand growth.
  6. MRD as an endpoint: extension beyond myeloma to other hematologic and solid tumors would accelerate approvals and change trial economics.
  7. Policy: IRA negotiation effects on small-molecule investment and EU HTA harmonization will shape where and how assets are launched.

Frequently Asked Questions

What is driving growth in the oncology therapeutics market?

Growth is driven by new modalities that address patients poorly served by checkpoint inhibitors: ADCs, radioligand therapies, bispecific antibodies and engineered cell therapies. It is reinforced by earlier-line use, longer treatment durations and expanding biomarker-defined populations. Each linked Mobility Foresights report provides segment-level sizing and forecasts.

What will replace Keytruda as the leading cancer therapy?

We do not expect a single successor. After pembrolizumab's U.S. exclusivity begins to lapse in 2028, value is likely to be split across subcutaneous pembrolizumab, PD-1/VEGF bispecifics, ADC-plus-immunotherapy combinations and novel classes that replace PD-1 monotherapy as the standard backbone.

Why are antibody-drug conjugates important in cancer treatment?

ADCs deliver highly potent chemotherapy selectively to cancer cells, improving efficacy while limiting systemic exposure. Enhertu, Padcev and Datroway have shown that ADCs can outperform standard chemotherapy and expand treatable populations, such as HER2-low breast cancer.

What is a PD-1/VEGF bispecific antibody?

It is a single molecule that blocks the PD-1 immune checkpoint and neutralizes VEGF, a driver of tumor blood-vessel growth and immunosuppression. Ivonescimab outperformed pembrolizumab on progression-free survival in a Phase 3 trial in China, prompting several multibillion-dollar licensing deals.

How do T-cell engagers differ from CAR-T therapy?

Both redirect T cells to tumors. CAR-T therapy genetically modifies the patient's T cells outside the body and reinfuses them as a one-time product. T-cell engagers are off-the-shelf antibodies given repeatedly that link unmodified T cells to cancer cells. Engagers are easier to access; CAR-T offers the potential for durable responses after a single treatment.

What is in vivo CAR-T and why does it matter?

In vivo CAR-T delivers the CAR gene directly into a patient's T cells using lipid nanoparticles or viral vectors, avoiding cell collection and individualized manufacturing. If clinical durability is confirmed, it could reduce cost, shorten time to treatment and extend CAR-T beyond specialist centers.

What limits the growth of radioligand therapy?

The main constraints are isotope supply (especially actinium-225), the logistics of short half-life products, nuclear-medicine infrastructure and specialist staffing. Companies with integrated isotope production and regional manufacturing are best positioned.

Which oncology segments are expected to grow fastest?

On current pipelines we expect the fastest growth in bispecific antibodies (including PD-1/VEGF and T-cell engagers), ADCs, radioligand therapies and next-generation cell therapies. Mature checkpoint monotherapy faces loss-of-exclusivity pressure from 2028.

Which region is the largest market for oncology drugs?

The United States is the largest oncology market by revenue and the usual first launch market. China is the fastest-growing source of oncology innovation and a rising share of global licensing activity, while Europe's growth is moderated by health technology assessment and pricing controls.

What is minimal residual disease (MRD) and why does it matter commercially?

MRD refers to cancer cells that remain after treatment at levels below conventional detection. Sensitive MRD testing allows treatment to be escalated or stopped based on response, and its acceptance as an accelerated-approval endpoint in myeloma can shorten development timelines.

What do Mobility Foresights oncology reports include?

Each report linked in this hub provides market size and multi-year forecasts, growth drivers and challenges, segmentation by product, indication and region, competitive landscape and company profiles, recent developments and pipeline analysis. Customization is available on request.

Work With Mobility Foresights

Mobility Foresights provides syndicated and custom market intelligence across oncology, hematology and the wider biopharmaceutical value chain. Each report linked above can be purchased individually or customized to a specific indication, region or competitive question. To discuss your requirements, request a sample or commission a bespoke study, contact our healthcare research team.