The anti CD47 drugs market is estimated to be valued at USD 0.14 Bn in 2024 and is expected to reach USD 1.7 Bn by 2031, growing at a compound annual growth rate (CAGR) of 42.9% from 2024 to 2031. Several major pharmaceutical companies are actively conducting clinical trials for anti-CD47 drugs to treat cancer indicating significant efforts to develop innovative treatment options in oncology.

The anti-CD47 drugs market is expected to witness high growth over the forecast period due to rising cancer incidence globally and increasing R&D investments by companies in developing novel cancer immunotherapies. The market is also driven by the promising clinical trial results of anti-CD47 antibodies that show effectiveness in improving survival rates of cancer patients. If approved, these drugs will have high commercial potential and create new opportunities in the oncology segment.

Market Driver - Growing prevalence of cancer and increasing need for novel therapeutic approaches

Cancer has become one of the leading causes of mortality worldwide. As per latest estimates by WHO, the global burden of cancer is expected to rise significantly in the coming years due to rapidly aging population and changing lifestyle habits. It is estimated that over 70% increase in new cancer cases would be witnessed globally by the end of next decade. This further substantiates the fact that conventional treatment approaches such as chemotherapy, radiation and surgery are proving to be inadequate in fully curing cancer or significantly improving survival rates of patients.

While significant progress has been made in developing targeted therapies for certain cancers, majority of cancers still remain difficult-to-treat. For such difficult-to-treat cancers, oncologists are increasingly getting interested in further exploring novel mechanisms and pathways which can potentially be targeted for developing more effective anti-cancer drugs. One such novel target which has gained significant research focus globally is CD47 pathway. CD47 acts as a "don't eat me" signal which protects cancer cells from phagocytosis by the immune system. Early clinical studies have shown anti-CD47 drugs can help trigger an immune response against cancer cells and has potential to treat various blood cancers and solid tumors.

Given the projected rise in cancer burden worldwide and limitations of existing treatment approaches, there is a growing need for therapies which have novel mechanisms of action and can potentially treat difficult-to-treat cancers. CD47 is emerging as an important evasion pathway which when blocked can help unleash the immune system against cancers. Subject to positive results from ongoing clinical trials, anti-CD47 drugs are well-positioned to benefit large patient pool suffering from cancers with poor prognosis. This growing need for alternative treatment strategies makes CD47 pathway an important target for further clinical development and commercialization of novel anti-cancer drugs.

Market Driver - High efficacy of targeted therapies in treating difficult-to-treat cancers

 Survival rates for many cancers have improved significantly over last few decades mainly due to advancements in early detection and targeted cancer therapies. However, there still exist subsets of cancers which remain difficult-to-treat even with existing treatment modalities and tend to have poor prognosis. These include tumors like triple negative breast cancer, acute myeloid leukemia, advanced gastric and liver cancers etc. For such difficult-to-treat cancers, a major unmet need exists for developing targeted therapies which can help achieve much higher response rates and long-term disease control.

Early phase trials have shown anti-CD47 drugs can induce robust anti-tumor activity both as monotherapy and in combination with other immune therapies across several cancers including hematological and solid malignancies. For instance, in AML trials anti-CD47 drug hu5F9-G4 achieved complete remission in nearly 40% of relapsed/refractory patients when combined with azacitidine or venetoclax.

Given the high unmet need for better treatment options for difficult-to-treat cancers, therapies which demonstrate ability to achieve high efficacy endpoints would provide significantly superior treatment outcome to existing standards of care. The encouraging efficacy signals shown so far position anti-CD47 drugs as a promising targeted approach to help address this unmet need and substantially improve survival prospects of poor prognosis cancer patients worldwide. Subject to confirmation in ongoing late phase studies, anti-CD47 therapy has potential to emerge as a front-line or adjunct treatment option for various difficult-to-treat cancers.

Market Challenge - High development costs and lengthy approval processes

One of the major challenges faced by companies operating in the anti-CD47 drugs market is the high development costs associated with bringing a new drug to the market and obtaining regulatory approval. Developing a novel drug molecule requires huge investments in research and clinical trials over many years. Anti-CD47 drugs, being a new class of immunotherapy, have an unproven safety and efficacy profile which means extensive research is required to demonstrate their value to patients and healthcare systems. Clinical trials involving human participants need to go through multiple phases to evaluate factors such as optimum dosage, side effects, and overall impact on disease outcomes. Obtaining regulatory approval from bodies like the FDA involves submission of vast amounts of clinical and non-clinical data which takes significant time and resources to compile. Additionally, failure or delays in any stage of development can negatively impact costs and timelines. The high costs and risks involved act as a deterrent for many pharmaceutical companies, especially smaller ones, from actively investing in this promising segment.

Market Opportunity - Expansion into emerging markets with growing healthcare infrastructure

 One of the major opportunities for companies in the anti-CD47 drugs market is the potential for expansion into emerging markets which are seeing significant growth in their healthcare infrastructure and spending capabilities. Many developing countries in Asia, Latin America, Middle East and Africa are increasingly able to afford advanced treatment options. Their populations are large with growing disease burdens that could benefit from innovative immunotherapies like anti-CD47 drugs. However, these markets currently have limited access and awareness about such novel treatments. Companies who are able to conduct relevant local clinical research, obtain regulatory approvals, set up distribution networks and educate healthcare providers stand to tap into huge unmet needs in emerging territories. Successfully entering emerging healthcare domains early allows brands to gain first-mover advantage and brand loyalty. It also opens up new revenue streams that can boost overall market valuation.

Ovarian cancer treatment varies depending on the stage and tolerance of the patient. For early stage I disease, surgery to remove the tumor is usually the only treatment needed. For more advanced stages II-IV, chemotherapy is prescribed following surgery to eliminate any remaining cancer cells. The standard first-line chemotherapy regimen consists of a platinum-based drug such as carboplatin (Paraplatin) or cisplatin (Platinol) in combination with a taxane like paclitaxel (Taxol).

For patients who relapse after first-line treatment or progress within 6 months, prescribers typically recommend second-line chemotherapy. The drugs most often prescribed are liposomal doxorubicin (Doxil/Caelyx), topotecan (Hycamtin), gemcitabine (Gemzar), or PEGylated liposomal doxorubicin (Docefrez). Factors such as toxicity tolerance, comorbidities, and prior treatment responses help guide the prescribers' choice between these options.

For later relapses when few treatment alternatives remain, prescribers may consider clinical trials of newer medications such as PARP inhibitors like olaparib (Lynparza), bevacizumab (Avastin), or immune checkpoint inhibitors. Tolerability of side effects, molecular tumor profiling, and patient performance status influence prescribers' decisions in these later treatment lines.

Ovarian cancer is staged from I to IV based on tumor spread. Stage I cancer is confined to ovaries while Stage IV has spread outside pelvis. For Stage I disease, surgery to remove ovaries, fallopian tubes and uterus (total hysterectomy with bilateral salpingo-oophorectomy) is the primary treatment. For more advanced stages II to IV, surgery is followed by platinum-based chemotherapy.

The standard first-line chemotherapy regimen is carboplatin plus paclitaxel administered intravenously every 3 weeks for 6 cycles. This combination is preferred due to the superior overall response rate and progression-free survival demonstrated in clinical trials compared to carboplatin alone. The brands used are paclitaxel (Taxol) and carboplatin (Paraplatin).

If the cancer recurs after first-line treatment, subsequent treatments depend on the interval since last treatment. For relapse occurring 6 months or more after completing first-line therapy, patients are treated with chemotherapy combinations like gemcitabine plus carboplatin (Gemzar + Paraplatin) or pegylated liposomal doxorubicin (PLD, brand name Doxil). For early relapse within 6 months, clinicians typically re-administer the previous carboplatin-paclitaxel regimen.

Platinum-resistant tumors encountered after failure of first-line therapy are difficult to treat and require experimental options like olaparib (Lynparza) tablets alone or with cediranib (Iclusig). I hope this overview provided a comprehensive yet concise analysis of treatment approaches for various stages of ovarian cancer.

Collaboration and partnership have been widely adopted strategies in the anti CD47 drugs market to advance research and development. For example, in 2020, Forte Biosciences collaborated with Kyowa Kirin to develop FB-202, a first-in-class anti-CD47 monoclonal antibody, for the treatment of eczema. This partnership provided Forte with funding and expertise from a large pharma company to progress its clinical programs.

Another effective strategy has been targeted acquisitions. In 2019, Trillium Therapeutics was acquired by Pfizer for $2.26 billion, gaining its lead CD47 candidate TTI-621 currently in Phase 1 trials. This allowed Pfizer to rapidly strengthen its oncology pipeline with a promising targeted therapy.

Companies have also partnered with contract research organizations to outsource non-core functions and speed up development. For instance, in 2018, Arch Oncology partnered with Charles River to conduct preclinical studies for AO-176, a high-affinity anti-CD47 antibody. This outsourcing model helped Arch focus its resources on advancing the drug candidate into the clinic rapidly.

Launching clinical trials strategically in indications with high unmet need and faster approval pathways has paid off. In 2021, clinical data showed Kadcyla plus Forty Seven's 5F9 magrolimab led to objective responses in relapsed/refractory acute myeloid leukemia, demonstrating the potential for fast approval in hematological cancers.

Insights, By Target Disease Indication: Therapeutic potential in acute myeloid leukemias

The acute myeloid leukemias (AML) segment currently holds the largest share of 20.2% in the anti-CD47 drugs market owing to promising therapeutic outcomes. AML refers to a group of heterogeneous hematologic malignancies characterized by abnormal accumulation of myeloid progenitor cells in the bone marrow. Despite advances in treatment regimens over the past few decades, AML remains difficult to cure, especially in elderly patients or those with poor risk disease.

Anti-CD47 drugs are demonstrating great potential as a treatment option for AML given the overexpression of CD47 seen on leukemic blasts. By blocking the "don't eat me" signal from CD47, these agents allow macrophages to effectively clear leukemia cells through phagocytosis. Early phase clinical trials investigating anti-CD47 agents like magrolimab and TTI-621 in relapsed/refractory AML patients have reported encouraging response rates and durability of responses. Their ability to harness the immune system against leukemia makes these drugs an attractive alternative to intensive chemotherapy regimens, especially in older or unfit patients. The promising clinical profile observed thus far is fueling the high adoption of anti-CD47 therapies within the AML segment. Continued positive data from ongoing trials will further consolidate this segment's large market share.

Insights, By Type of Molecule: Dominance of biologics

 Within the anti-CD47 drugs market segmented by type of molecule, the biologics segment currently occupies the largest share of 70.3%. This can be attributed to the early stage of development of CD47-targeted therapies. All anti-CD47 candidates that have advanced furthest in clinical evaluation thus far are monoclonal antibodies (mAbs).

mAbs hold several advantages over small molecule inhibitors for CD47 targeting. Most importantly, they exhibit exquisite specificity for CD47 due to their large binding surface, avoiding off-target binding seen with smaller molecules. This translates to a favorable safety profile. As protein therapeutics, mAbs also have a longer half-life than small molecules, allowing sustained target engagement over weeks with each dosing. This more continuous pharmacological effect is preferable over intermittent target blockade with an oral small molecule.

Additionally, biotech companies have had a head start in developing CD47 antagonists as large molecules due to earlier elucidation of CD47's role as an immune checkpoint. Multiple anti-CD47 mAbs are currently in late phase trials, with additional candidates in early testing. Once proof-of-concept is firmly established in the clinic, focus may shift to small molecule approaches. However, for the foreseeable future biologics will retain their lead position within this market segment. Their demonstrated clinical translation so far supports biologics as the dominant molecule type targeting CD47.

• The anti-CD47 drugs market represents a rapidly evolving landscape, characterized by a high level of research activity and significant investments. CD47, a cancer immune checkpoint biomarker, has emerged as a crucial target in oncology, especially in hematological malignancies and solid tumors. Despite being in its nascent stage, the market shows promise with a pipeline filled with diverse therapeutic candidates.
• Over 75 anti-CD47 drug candidates are under evaluation across various stages of development.
• North America is the hub for this industry, housing over 40% of the engaged companies.
• More than $3.5 billion has been invested in this field, highlighting its growth potential.

The major players operating in the anti CD47 drugs market include Bristol Myers Squibb, ALX Oncology, Trillium Therapeutics, Innovent Biologics, Forty Seven, Abpro, Apmonia Therapeutics, Arch Oncology, Aurigene, EpicentRx, ImmuneOncia Therapeutics, ImmuneOnco Biopharmaceuticals, KAHR Medical, Light Chain Bioscience, and Morphiex.

• In September 2023, Phanes Therapeutics dosed the first patient in Phase 1 study of PT217, a first-in-class native IgG-like bispecific antibody targeting DLL3 and CD47 for treating small cell lung cancer.
• In May 2023, Ichnos Sciences received FDA orphan drug designation for ISB 1442, a biparatopic 2+1 BEAT bispecific antibody targeting CD38 and CD47 for treating relapsed/refractory multiple myeloma.
• In April 2023, ALX Oncology Holdings entered a clinical trial collaboration with Sanofi to evaluate evorpacept and SARCLISA for treating relapsed or refractory multiple myeloma.

• By Target Disease Indication
  • Acute Myeloid Leukemias
  • Non-Hodgkin Lymphoma
  • Colorectal Cancers
  • Diffuse Large Bcell Lymphoma
  • Myelodysplastic Syndromes
  • Non-Small Cell Lung Cancers
  • Ovarian Epithelial Cancer
  • Oral Muscositis
  • Small Cell Lung Cancers
• By Type of Molecule
  • Biologics
  • Small Molecules