Market Research Report
Metastatic Colorectal Cancer Market Insight, Epidemiology and Market Forecast -2030
|Metastatic Colorectal Cancer Market Insight, Epidemiology and Market Forecast -2030|
DelveInsight Business Research LLP
Content info: 337 Pages
Delivery time: 2-10 business days
DelveInsight's 'Metastatic Colorectal Cancer (mCRC) - Market Insights, Epidemiology and Market Forecast- 2030' report delivers an in-depth understanding of the mCRC, historical and forecasted epidemiology as well as the mCRC market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The mCRC market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM mCRC market size from 2017 to 2030. The report also covers current mCRC treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Colorectal cancer (CRC) is the third most common, with metastasis being the major cause of death in the majority of patients. CRC starts in the colon or the rectum. These cancers can also be called colon cancer or rectal cancer, depending on where they start. Colon cancer and rectal cancer are often grouped together because they have many features in common. CRC may develop when polyps, mushroom-like growths inside the colon, grow and become cancerous or cells along the lining of the colon or rectum mutate and grow out of control, forming a tumor.
CRC that spreads, or metastasizes, to the lungs, liver or any other organ is called metastatic colorectal cancer (mCRC). The most common site of metastases for colon or rectal cancer is the liver. CRC cells may also spread to the lungs, bones, brain, or spinal cord. If a person has been treated for CRC and cancer cells have been found in these areas, it may be a sign that the original CRC has spread. mCRC is different from recurrent CRC.
Generally, most CRCs (95%) are considered sporadic, meaning the genetic changes develop by chance after a person is born, so there is no risk of passing these genetic changes on to one's children. Inherited CRCs are less common (5%) and occur when gene mutations, or changes, are passed within a family from one generation to the next. Often, the cause of CRC is not known.
Most CRCs start as a growth on the inner lining of the colon or rectum. These growths are called polyps. Some types of polyps can change into cancer over time (usually many years), but not all polyps become cancer. The chance of a polyp turning into cancer depends on the type of polyp it is.
If cancer forms in a polyp, it can grow into the wall of the colon or rectum over time. The wall of the colon and rectum is made up of many layers. CRC starts in the innermost layer (the mucosa) and can grow outward through some or all of the other layers. When cancer cells are in the wall, they can then grow into blood vessels or lymph vessels (tiny channels that carry away waste and fluid). From there, they can travel to nearby lymph nodes or distant parts of the body. The stage (extent of spread) of a CRC depends on how deeply it grows into the wall and if it has spread outside the colon or rectum.
Approximately one-fifth of CRC cases are metastatic at the time of diagnosis. Patients can present with a wide range of signs and symptoms such as occult or overt rectal bleeding, change in bowel habits, anemia, or abdominal pain. However, CRC is largely an asymptomatic disease until it reaches an advanced stage. By contrast, rectal bleeding is a common symptom of both benign and malignant causes. Therefore additional risk factors might be needed to help identify those people who should undergo further investigation by colonoscopy. New-onset rectal bleeding should generally prompt colonoscopy in individuals aged 45 years or older. In younger patients, additional factors are used to identify those at highest risk for CRC (e.g., having a family history of CRC, change in bowel habits, unexplained weight loss, and blood mixed with the stool as opposed to blood on the surface of the stool).
Metastatic CRC is still an incurable disease for most of the patients, with most commonly liver, lung or lymph nodes and peritoneal metastases. In the past, 15 years ago, median overall survival (mOS) was approximately 12 months, and the 5-year survival rate was 13%. However, the survival rate of these patients has increased, mainly due to the combined treatment of metastases with surgery and systemic therapy. Long-term survival or even cure can be attained in 20-50% of the patients who undergo complete R0 resection of liver or lung metastases, and around 70% 5-year survival of these patients can be achieved.
However, in the field of systemic therapy, there has been significant progress with new drugs in recent years. There are more options of initial systemic chemotherapy, oxaliplatin, irinotecan, and fluoropyrimidines, in combination with targeted therapy with anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab, panitumumab) in case of KRAS wild type tumors or anti-vascular endothelial growth factor (VEGF) inhibitors (monoclonal antibodies bevacizumab, aflibercept, ramucirumab, regorafenib as per oral tyrosine kinase inhibitor). The combination of these novel chemotherapies and targeted therapy now extends the mOS up to 40 months.
The treatment plan may include a combination of surgery, radiation therapy, immunotherapy, and chemotherapy, which can be used to slow the spread of the disease and often temporarily shrink a cancerous tumor. Palliative care will also be important to help relieve symptoms and side effects. At this stage, surgery to remove the portion of the colon where cancer started usually cannot cure cancer, but it can help relieve the blockage of the colon or other problems related to cancer. Surgery may also be used to remove parts of other organs that contain cancer, called resection, and can cure some people if a limited amount of cancer spreads to a single organ, such as the liver or a lung. If the CRC has spread only to the liver and if surgery is possible-either before or after chemotherapy-there is a chance of complete cure. Even when curing the cancer is not possible, surgery may add months or even years to a person's life.
This section provides glimpse of the CRC epidemiology in the 7MM.
The epidemiology segment also provides the Metastatic Colorectal Cancer (mCRC)epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
The drug chapter segment of the Metastatic Colorectal Cancer (mCRC) report encloses the detailed analysis of Metastatic Colorectal Cancer (mCRC) marketed drugs and mid and late stage pipeline drugs. It also helps to understand the Metastatic Colorectal Cancer (mCRC) clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.
Braftovi (encorafenib) + Erbitux (cetuximab)/ Braftovi + Mektovi: Array BioPharma/ Pfizer
Braftovi is an oral small-molecule BRAF kinase inhibitor that targets a key enzyme in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, including melanoma, colorectal cancer, and others. While Erbitux is a recombinant, human/mouse chimeric monoclonal antibody. The antibody binds to epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) on both normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha. While Mektovi is an oral small molecule MEK inhibitor that targets key enzymes in the MAPK signaling pathway.
Keytruda (pembrolizumab) injection: Merck
Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. The drug is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1, and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. There are currently more than 1,200 trials studying Keytruda across a wide variety of cancers and treatment settings. In June 2020, the US FDA approved Keytruda for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) CRC.
Nivolumab (Opdivo) + Ipilimumab (Yervoy): Bristol-Myers Squibb
Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth. Combined nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) mediated inhibition results in an enhanced T-cell function that is greater than the effects of either antibody alone and results in improved anti-tumor responses in metastatic melanoma and advanced RCC.
Cyramza (ramucirumab) injection + FOLFIRI: Eli Lilly
Ramucirumab is a monoclonal antibody, VEGFR2 antagonist that specifically binds VEGFR2 and blocks binding of VEGFR ligands, VEGF-A, VEGF-C, and VEGF-D. As a result, ramucirumab inhibits ligand-stimulated activation of VEGFR2, thereby inhibiting ligand-induced proliferation and migration of human endothelial cells. The drug inhibited angiogenesis in an in vivo animal model. In April 2015 the drug was approved for use in combination with FOLFIRI (leucovorin, fluorouracil, irinotecan) for treatment of patients with mCRC with disease progression on a first-line line regimen including bevacizumab (Avastin), oxaliplatin, and a fluoropyrimidine. The drug was initially approved to treat patients with gastric cancer and, subsequently, to treat non-small cell lung cancer
Lonsurf: Taiho Oncology
Lonsurf (trifluridine/tipiracil), discovered and developed by Taiho Pharmaceutical., is an oral anticancer drug, which utilizes the combination of trifluridine (FTD) and tipiracil (TPI), whose dual mechanism of action is designed to maintain clinical activity and differs from conventional fluoropyrimidines. FTD is an antineoplastic nucleoside analogue, which is incorporated directly into the DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase.
Vectibix (panitumumab) + Folfox: Amgen
Vectibix is the first fully human anti-EGFR antibody approved by the US Food and Drug Administration (FDA) for the treatment of mCRC.The drug was approved in the US in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy. In May 2014, the FDA approved Vectibix for use in combination with Folfox, as a first-line treatment in patients with wild-type KRAS (exon 2) mCRC.
Napabucasin (BBI-608): Sumitomo Dainippon Pharma
Napabucasin is an orally administered small molecule investigational first-in-class anti-cancer agent created by Boston Biomedical, a wholly-owned subsidiary of Sumitomo Dainippon Pharma. The drug is bio-activated by the enzyme NQO1 in cancer cells, which generates reactive oxygen species to inhibit cancer stemness and tumor progression-related pathways, including STAT3, which is expected to result in cancer cell death.
Fruquintinib: Hutchison Medipharma Limited
Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor (VEGFR) 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. The drug is designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability, and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib's low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.
Trilaciclib: G1 Therapeutics
Trilaciclib is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy and improve patient outcomes. Various randomized clinical trials have demonstrated that trilaciclib can provide myelopreservation benefits (i.e., reduction of chemotherapy-induced myelosuppression) and, in certain settings, trilaciclib has the potential to improve survival. It is a short-acting CDK4/6 inhibitor that is administered intravenously prior to chemotherapy.
Modufolin (arfolitixorin): Isofol Medical
Arfolitixorin is Isofol's proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced CRC. As the key active metabolite of the widely used folate-based drugs leucovorin and levoleucovorin, arfolitixorin can potentially benefit all patients with advanced CRC, as it does not require complicated metabolic activation to become effective. When treating CRC, arfolitixorin is administered in combination with 5-FU to increase cell mortality in circulating cancer cells and in cancerous tumors. Arfolitixorin is administered in conjunction with rescue therapy after high-dose treatment with the cytotoxic agent, methotrexate, to suppress the cytotoxic effect in surrounding healthy tissue.
Olaparib ± Bevacizumab: Merck
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks, and cancer cell death. Lynparza is being tested in a range of tumor types with defects and dependencies in the DDR.
Avelumab + Cetuximab: Merck
Bavencio (avelumab) is a human anti-programmed death ligand-1 (PD-L1) antibody. Bavencio has been shown in preclinical models to engage both the adaptive and innate immune functions. In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize Bavencio. Erbitux (cetuximab) is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard nonselective chemotherapy treatments in that it specifically targets and binds to the EGFR.
Lenvatinib + Pembrolizumab: Merck/Eisai
Lenvima (lenvatinib), discovered and developed by Eisai, is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). However, Keytruda (pembrolizumab) is an anti-PD-1 therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. The drug is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands.
Tucatinib + Trastuzumab: Merck/Seagen
Tucatinib (Tukysa) is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein, a protein that contributes to cancer cell growth. HER2 is overexpressed in multiple cancers, including colorectal cancers. The combination of Tukysa and trastuzumab have also been shown to increase anti-tumor activity in vitro and in vivo compared to either medicine alone. Trastuzumab (Herceptin) is a type of targeted cancer drug called a monoclonal antibody. It works by attaching to HER2, so it stops the cancer cells from growing and dividing
Tomivosertib + Avelumab: Effector Therapeutics
Tomivosertib (also known as eFT508) is a novel, potent, and highly selective oral small molecule inhibitor of mitogen-activated protein kinase interacting kinases 1 and 2, or collectively, MNK1/2. MNK1/2 plays a crucial role in the development of many tumors, like controlling in a coordinated manner, the expression of multiple factors that attenuate an immune response. The preclinical and clinical studies suggest combining tomivosertib with a checkpoint inhibitor that can overcome mechanisms of resistance to checkpoint inhibitors, resulting in enhanced sensitivity to checkpoint inhibitors and a higher response rate.
Colorectal cancer (CRC) is the second most frequent type of cancer that represents approximately 12-14% of all cancer cases in men and women. Out of these, approximately 25% of patients present with metastases at initial diagnosis and almost 50% may eventually develop metastases, contributing to the high mortality rates reported for CRC. In order to identify the optimal treatment strategy for patients with mCRC, tumor staging is essential and should include at least clinical examination, blood counts, liver and renal function tests, CEA, and CT scan of the abdomen and chest (or alternatively MRI).
The treatment plan may include a combination of surgery, radiation therapy, immunotherapy, and chemotherapy, which can be used to slow the spread of the disease and often temporarily shrink a cancerous tumor. Palliative care is also important to help relieve symptoms and side effects.
The first, second, and third-line treatment regimen of mCRC involves the use of multi-agent chemotherapy (i.e. FOLFOX, FOLFIRI, CAPEOX), anti-angiogenesis therapy with or without chemotherapy, epidermal growth factor receptor (EGFR) inhibitors with or without chemotherapy, and others with or without chemotherapy. Along with these therapies, Opdivo, with or without Yervoy, and Braftovi, in combination with Erbitux, are approved for the treatment of mCRC patients as the only second and third-line therapies, while Keytruda is approved as the only first-line therapy of mCRC.
The backbone of first-line palliative chemotherapy alone, as well in combination with targeted agents, is comprised of a fluoropyrimidine (FP) (intravenous 5-fluorouracil [5-FU] or the oral FP capecitabine) in various combinations and schedules. Of these, the oral FP capecitabine is considered as an alternative to intravenous infusion 5-FU/LV. Anti-angiogenesis therapy is focused on stopping angiogenesis, which is the process of making new blood vessels. This class of therapy involves bevacizumab (Avastin), regorafenib (Stivarga), Ziv-aflibercept (Zaltrap), and ramucirumab (Cyramza). Either of these drugs can be combined with FOLFIRI chemotherapy as a second-line treatment for mCRC. On the other hand, drugs that block EGFR may also be effective for stopping or slowing the growth of CRC. Most commonly used EGFR inhibitors for treating mCRC patients include cetuximab (Erbitux) and Panitumumab (Vectibix). Besides these therapies, Keytruda, Opdivo with or without Yervoy, and Braftovi in combination with Erbitux comprise the most recent approvals seen by the mCRC market.
The pipeline of mCRC holds potential Phase III products by key players, such as Hutchison Medipharma (fruquintinib), Isofol Medical (arfolitixorin), Sumitomo Dainippon Pharma (napabucasin/BBI-608), G1 Therapeutics (trilaciclib + Chemotherapy), Merck (Olaparib ± Bevacizumab) and AB Science (masitinib + Chemotherapy).
Besides these therapies, several key players are investigating their products in mid and early phases of development (Phase II and I/II), namely, Pfizer (Braftovi [encorafinib] + Mektovi [binimetinib] + Erbitux [cetuximab]), Daiichi Sankyo/Astrazeneca (DS-8201a/ ENHERTU), Merck/ Eisai (Lenvima [MK-7902] + Keytruda), Merck/ Seagen (Trastuzumab + Tucatinib [TUKYSA]), Effector Therapeutics (Tomivosertib [eFT508] ± Avelumab), Exelixis (Cabozantinib), Mirati Therapeutics (Adagrasib ± Cetuximab), Merck (Avelumab + Cetuximab ± FOLFOX), Cardiff Oncology (Onvansertib), and NOXXON Pharma (NOX-A12 + pembrolizumab).
This section includes a glimpse of the mCRC 7MM market.
This section provides the total Metastatic Colorectal Cancer (mCRC) market size and market size by therapies in the United States.
The total Metastatic Colorectal Cancer (mCRC) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
The total Metastatic Colorectal Cancer (mCRC) market size and market size by therapies in Japan are provided.
This section focusses on the rate of uptake of the potential drugs recently launched in the Metastatic Colorectal Cancer (mCRC) market or expected to get launched in the market during the study period 2017-2030. The analysis covers Metastatic Colorectal Cancer (mCRC) market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.
The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for Metastatic Colorectal Cancer (mCRC) emerging therapies.
We perform competitive and market Intelligence analysis of the Metastatic Colorectal Cancer (mCRC) market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.