The oncology field is witnessing rapid growth, owing to emergence of novel therapies with high efficacy, which in turn is boosting growth of the oncology drug pipeline market. For instance, in 2015, the U.S. Food and Drug Administration (U.S FDA) approved 45 New Molecular Entity (NME) and new Biologic License Applications (BLA), of which 16 were novel cancer therapies. Therefore, developments of novel drugs is a major factor propelling growth of the global oncology drug pipeline analysis market.
Furthermore, increasing initiatives for reducing cancer-related deaths is expected to boost growth of the market. For instance, in 2017, the World Health Assembly passed a resolution – 'Cancer Prevention and Control through an Integrated Approach', which urges governments and World Health Organization (WHO) to accelerate action for minimizing premature mortality in cancer. Such initiatives are expected to propel growth of the oncology drug pipeline market in the forecast period.
Oncology Drug Pipeline Analysis – Drivers
Innovative approaches in the cancer treatment is a major factor boosting growth of the oncology pipeline drugs market. For instance, the novel basket study includes patients with a certain genetic mutation in common, regardless of the site or origin of cancer in the body. Basket studies can be useful when a drug targets certain genetic mutation at a particular site and using that drug to treat same genetic mutation in cancer at another site. For instance, Larotrectinib, a drug of Loxo Oncology, Inc., is currently under review by the U.S. FDA for the treatment of tyrosine kinase mutation by using basket studies. This drug has been approved as Investigational New Drug in May 2018.
Combinational therapies are the latest development driving the growth of oncology pipeline drugs market. For instance, Pfizer Inc. is undergoing efficacy and safety study for Avelumab in combination with chemotherapy, followed by maintenance therapy of Avelumab with PARP inhibitor talazoparib in patients with history of untreated advanced ovarian cancer. This study is under clinical phase III trials and is expected to complete in May 2026.
Furthermore, increasing government investment to support oncology research is expected to propel the growth of market. For instance, in September 2018, U.S. FDA granted over US$ 18 million for new clinical trial research; out of which 33% is for rare forms of cancer, including advanced pancreatic cancer, head and neck squamous cell carcinoma, and acute myeloid leukemia. Key players are focused on mergers and collaborations to expand their share in the oncology drug pipeline market. For instance, in February 2018, Merck & Co., Inc. acquired Viralytics Ltd—an Australia-based oncolytic immunotherapies manufacturer— for US$ 394 million, to strengthen Merck & Co.’s presence in the immuno-oncology market.
Furthermore, in September 2018, Daiichi Sankyo Company, Limited, entered into a clinical trial collaboration agreement with a subsidiary of Merck & Co., Inc., to evaluate the combination of Daiichi Sankyo’s investigational Human Epidermal Growth Factor 2 (HER2) targeting antibody drug conjugate DS-8201 and Pembrolizumab. This combinational drug is intended to be used for metastatic breast and non-small cell lung cancers and is under clinical phase II development.
Table 1: Few Current oncology drugs Under Clinical Trials:
|Class||Drug||Indication||Sponsor||Current Status||Study Completion|
|Combination Chemotherapy||Gemcitabine, Cisplatin, and dendritic cytokine-induced killer cell (D-CIK)||Lung Cancer||Shenzhen Hornetcorn Bio-technology Company, LTD||Phase I,II||
|Combination Chemotherapy||Durvalumab, Tremelimumab||Ovarian Cancer||ARCAGY/ GINECO Group||Phase I,II||
|Immunotherapy||Anti-MUC1 CAR-T cells||Gastric, ColorectalCancer||PersonGen BioTherapeutics (Suzhou) Co., Ltd.||Phase I,II||
|Immunotherapy||Cervical cancer specific CAR-T cells||Cervical Cancer||Shenzhen Geno-Immune Medical Institute||Phase I,II||
|Monoclonal Antibody||Cetuximab||Colorectal Cancer||Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.||Phase I||
|Antibody-Drug Conjugate||Anetumab Ravtansine||Pancreatic Cancer||Stacey Stein||Phase II||
Sources: Clinicaltrial.gov, Annual Reports, Company Websites
Increasing prevalence of cancer also creates a need to develop new drugs for its treatment. Pharmaceutical companies are striving to bring new, safe and effective anticancer drugs in market which can drive growth of the oncology drug pipeline analysis market.
Oncology Drug Pipeline Analysis – Challenges
Increasing cost of therapies is expected to hinder growth of the oncology drug pipeline market. For instance, according to a report published in National Center for Biotechnology Information (NCBI), 2016, Pertuzumab-based therapy, used in treatment of HER2 positive breast cancer costs US$ 215,000 per patient.
Moreover, lack of patient’s participation in clinical studies, increase in clinical trial complexity, and resource constraints are some of the other factors hampering growth of the oncology drug pipeline market. For instance, according to a report published in Journal of Clinical oncology, June 2012, the rate of number of cancer patients enrolling in clinical trial worldwide is 3%-5% and the rate has not improved since 1980.
Oncology Drug Pipeline Analysis – Regional Analysis
On the basis of region, the global oncology drug pipeline analysis market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is expected to dominate in terms of growth in oncology drug pipeline market. According to the 2015 annual report of the American Cancer Society, although cancer-related death rate in the U.S. have reduced, cancer still remains the second most common cause of death in the country. Therefore, such high prevalence of cancer is expected to drive growth of the oncology drug pipeline market in North America.
Asia Pacific is expected to witness significant growth in the global oncology drug pipeline analysis market. This is owing to increasing prevalence of various kind of cancers in the region, especially in emerging economies such as China and India.
Furthermore, key players are focused on establishing manufacturing facility in Asia Pacific. For instance, in September 2018, BeiGene Co.Ltd. —a commercial-stage biotechnology company, selected GE Healthcare’s bio manufacturing facility— KUBio, for large-scale production of its cancer monoclonal antibodies in China.
Key players operating in the global oncology pipeline drugs market include, F. Hoffmann-La Roche Ltd., Bristol-Myers Squibb Company, Johnson & Johnson Services, Inc., AstraZeneca, Pfizer Inc., AbbVie Inc., Celgene Corporation, Novartis AG, Merck & Co., Inc., Sanofi, Eli Lilly & Co., GlaxoSmithKline, and Amgen Inc.
Oncology Drug Pipeline Analysis – Taxonomy
By Drug Class
By Cancer Type
By Route of Administration