The global breast cancer molecular diagnostics market was valued at $ 292.5 Million in 2017 and is forecast to grow at a modest 16.7 % CAGR between 2018 and 2025, culminating in 2025 global sales of $1050 Million.
Individualized and targeted treatments are reshaping oncology. Key to personalized medicine lies in molecular pathology. Use of high throughput sequencing technologies and identification of therapeutic targets has led to the development of many molecular diagnostic tests, which are far more superior to the conventional pathology tests. Despite recent development in novel targets and potential markers, the implementation of tests to identify in clinical and pathology practice is hard to achieve.
Global oncology molecular diagnostic market is expected to grow at a faster rate than expected due to rising demand from physicians, failure rate of conventional diagnosis, better and early detection, reducing cost of molecular diagnostic, improvement reimbursement coverage, technological, rising prevalence of chronic diseases and rapid increase in the geriatric population across the globe. Moreover, high unmet needs across the developing and emerging nations is also expected to boost the molecular diagnostics over the next few years.
Breast cancer is the most common cancer in women worldwide, with nearly 1.7 million new cases diagnosed in 2012 (second most common cancer overall). This represents about 12% of all new cancer cases and 25% of all cancers in women. It is the fifth most common cause of death from cancer in women. Survival rates for breast cancer vary worldwide, but in general rates have improved. This is because breast cancer is diagnosed at an earlier and localised stage in nations where populations have access to medical care, and progressive improvement in treatment strategies. In many countries with advanced medical care, the five-year survival rate of early stage breast cancers is 80–90 per cent, falling to 24 per cent for breast cancers diagnosed at a more advanced stage. According to The Susan G. Komen Breast Cancer Foundation statistics, it estimated that in 2018 in the United States there will be 266,120 new cases of invasive breast cancer, 63,960 new cases of in situ breast cancer and 40,920 breast cancer deaths will occur.
Aging factors significantly contribute to the onset of several oncological conditions. For instance, the average age for stomach cancer diagnosis is 69 and about every 6 in 10 patients diagnosed are aged above 65. The American Cancer Society estimates that nearly 28,000 stomach cancer cases will be diagnosed in 2017, with 17,750 cases in men and 10,250 cases in women. In the UK, as per 2014 Cancer Research estimates, each year nearly 6,682 new cases are detected, and the average survival rate is 15%.
“Optimal Price Point (OPP) for Endoscope Equipment”
Estimated Average Oncology Molecular Diagnostics product cost – $ xx globally. However, with improving access and availability of options, OPP and range of acceptable Prices (RAP) are going to change. We at Ameri Research continuously track these prices with our proprietary pricing model.
Due to the wide array of products available in the market, pricing, positioning, and sales channel optimization play a vital role in the success of a product. On an average, in the U.S., the molecular diagnostics products are available at USD 3600. However, the high-end products are available at much higher prices. The prices in emerging countries and developed countries vary significantly due to the difference in purchasing power and availability of latest products.
The oncology molecular diagnostics market is broadly segmented by product as Instruments, Reagents & Kits, Software & Services. Instruments like QIAsymphony SP/AS from QIAGEN and ELITe InGenius® from Elitech group are some of the instruments which integrate extraction, amplification and result interpretation with an unprecedented flexibility and assay menu possibility.
Reagents and kits are a large component of the overall market for Oncology Molecular Diagnostic. There are several options in the market for a wide range of usages from Thermo Fisher to Qiagen to Luminous Bioscience.
Today’s demanding business climate, rapid delivery of results from the lab directly to the patient has dramatically increased the informatics integration and workflow challenges in clinical testing and molecular diagnostic labs. Nautilus LIMS™ from Thermo Fisher is such a software solution.
Test Location Insights
Specialty clinics and laboratories constitute primary test locations for molecular diagnostic. Laboratories having high volume capacity are driving the market. However, to facilitate early diagnostic, POC (Pont of Care) diagnostic is increasing. Some of these POCs are retail clinics & pharmacies, student health clinics, neighborhood ambulatory care clinics, physician offices, CLIA waived labs, CLIA moderately complex labs, hospital floor (near-patient bedside), emergency rooms, intensive care units, rural health clinics, nursing homes, assisted living residence. CLIA waived labs are 5% of total POC and used primarily for respiratory testing.
The oncology molecular diagnostics market is broadly segmented by technology as PCR, In Situ Hybridization, Chips and microarrays, Isothermal Nucleic Acid Amplification Technology (INAAT), Mass spectrometry, Sequencing, Transcription Mediated Amplification. In 2017, PCR technology market share was little above 30% of market share. DNA and RNA sequencing expected to grow at a CAGR of 18% during the forecasted period and will provide high throughput analysis.
North America accounted for over 46% revenue share in 2016. The key reasons attributed for the high share include the high prevalence of stomach and GI cancers, strong reimbursement framework, highly skilled medical professionals, technological advancements and government support for R&D and innovation in medical devices sector. Moreover, the presence of high-end hospital and POC and high emphasis on preventive screening is expected to boost the usage rates over the forecast period.
Asia Pacific is expected to register the maximum CAGR of 7.5% through 2017 to 2025. The rapid increase in a number of cancer cases, growing healthcare expenditure and skill training, and improvement in reimbursement scenario are expected to favor the high market growth in the region.
Merger and Acquisition Insight
With the rising investor confidence and positive market trends, several players are actively engaging in merger and acquisition activities. Moreover, the disruption in the global healthcare market due to political factors such as repealing Obama Care Act, changes in the regulatory framework, and other trade barriers, are anticipated to trigger merger and acquisition activities to drive market consolidation and further intensify the market competition. We have identified 4 major deals from 2014 to 2017.
Top Players & Company Share
The Oncology Molecular Diagnostic market is highly competitive and some of the key success factors include technology, pricing, and distribution channel. As of 2017, major players in the market include Cepheid, Beckton Dickinson, Gen Probe (Hologic), Qiagen, Roche Diagnostics, Bayer Healthcare, Dako, Abbott Laboratories, Danaher Corporation, Siemens, Sysmex Corporation, Grifols, and Biomérieux Sa.
Breast Cancer Molecular Diagnostics Market by Products (Revenue, USD Million, 2014 – 2025)
- Reagents & Kits
- Software & Services
Breast Cancer Molecular Diagnostics Market by Test Location (Revenue, USD Million, 2014- 2025)
- Point of Care
Breast Cancer Molecular Diagnostics Market by Technology (Revenue, USD Million, 2014- 2025)
- In Situ Hybridization
- Chips and microarrays
- Isothermal Nucleic Acid Amplification Technology (INAAT)
- Mass spectrometry
- Transcription Mediated Amplification
Breast Cancer Molecular Diagnostics Systems Regional Outlook (Revenue, USD Million, 2014- 2025)
- North America
- Asia Pacific
- Latin America
- Middle East and Africa
- South Africa
- Saudi Arabia