Biotechnology companies are focusing on the development of genotype- and phenotype-specific drugs for chronic diseases such as cancer in order to ensure that next-generation drugs are more efficacious. Multiplex and multi-analyte biomarkers play an important role in the development of translational medicine, which facilitates the translation of basic research into medical advances. In line with this, most pharmaceutical and biotechnology companies are committing to associate their drugs with diagnostic assays, as a number of multiplex biomarkers are directly associated with particular drugs. The growing research and development activities in cancer diagnostics are thus expected to bring revolutionary technologies in cancer diagnostics and in turn would drive the growth of the cancer diagnostics market. Future Market Insights, in its latest report on cancer diagnostics, estimates that the global market for cancer diagnostics is expected to expand 2.3x in terms of revenue by 2026 over 2016 and is estimated to reach US$ 76.8 Bn by 2026 end.
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Cancer Diagnostics Market: Overview & Global Market Scenario
Early detection of cancer requires suitable cancer diagnostics procedures to screen the asymptomatic population that is on average risk of cancer, particularly for breast cancer, cervical cancers, colon cancers and melanoma. Increasing awareness towards the early signs and symptoms of cancer among physicians and other healthcare professionals as well as the general population. The inclusion of cancer diagnostics and cancer screening tests to national cancer screening programs by various countries would flourish the global cancer diagnostics market. Regular mammography has been introduced in national cancer programs by major developed countries where the incidence of breast cancer is high. For instance, the U.S. government has included the National Mammography Program to its national cancer screening programs. The government of Australia conducts 3 cancer screening programs viz. BreastScreen Australia, National Cervical Screening Program and National Bowel Cancer Screening Program. Countries in Europe are increasingly adopting HPV DNA screening for cervical cancer as a part of National Cervical Cancer Programs.
Next generation sequencing (NGS) is the most cost-effective, time saving and successful technological advancement in cancer diagnostics in the last three decades. Revolutionary second-generation and third platforms for cancer diagnostics offered by Roche, Illumina and Life Technologies, Pacific Biosciences of California, Inc. are rapidly gaining adoption in the cancer diagnostics market. Many molecular pathology laboratories are transitioning from single molecular PCR protocols to NGS platforms and thus, the market for cancer diagnostics is expected to gain traction.
However, despite the high value propositions of molecular diagnostics for cancer diagnosis, insufficient coverage for costly test procedures discourages majority of patients from pursuing these tests. Moreover, according to the new pricing policy for 2017, CMS has increased rates for several new CPT codes including next-gen sequencing and multi analyte algorithm assays. For instance, CMS increased the cost of next-generation sequencing tests for hereditary breast cancer-related disorders (CPT code 81432) from US$ 623 to US$ 925. It is anticipated that state Medicaid programs will also adjust their prices to reflect Medicare rates.
Regulators of CMS as well as private payers are increasingly emphasizing on increasing value and single-source tests having strong evidence of clinical utility. In 2013, CMS discontinued the ‘code stacking’ method for molecular diagnostic reimbursement for cancer. The center has dissolved this policy due to the wrongful exploitation of payment scheme by some of the labs and has stopped paying bills for these tests until the new method of ‘market-based pricing’ comes into action by 2018.
The biopsy segment is likely to dominate the global cancer diagnostics market, primarily due to the introduction of new and advanced techniques such as liquid biopsy and fine needle aspiration for lung cancer. However, the imaging cancer diagnostics segment is expected to gain significant traction due to the high efficiency of imaging technologies such as PET/CT.
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Cancer Diagnostics Market: Competitive Analysis
The competition landscape in the global cancer diagnostics market is changing rapidly. Although molecular testing is a hotspot for investment in in vitro diagnostics, the market exhibits awfully delayed growth due to slow returns on investment. In spite of this, all big cancer diagnostics players in the global market are continuously investing in cancer diagnostics, including molecular biomarker testing, NGS, PET scanners, etc.
Companies are also investing in the automation of existing molecular assays for cancer diagnostics to foster future growth prospects in the cancer diagnostics market; however, due to the strong competition among companies in the cancer diagnostics market, they may confront price erosion. For instance, Roche, in spite of being a global leader in cancer diagnostics for many years, has lost some ground after huge investments by its global peers such as Thermo Fisher Scientific Inc. and Merck KGaA, among others.