The Harvard University, while addressing the risk associated with reactions of new drugs prescription, has stated some overwhelming facts. According to their findings, even properly prescribed drugs causes about 1.9 million hospitalizations a year and about 128,000 people die from drugs prescribed to them. Such epidemic condition is being tailgated by the need of safe and effective and specific use of the drug. Owing to such demands, companion diagnostic drug market is poised for exponential growth. Companion diagnostics is an in-vitro diagnostic tool that assists physicians in optimizing treatment decisions for their patients and is crucial for myriad of cancer and other therapies. Riding on the back of economic burden of global healthcare and with abundant potential to restrict the liability, companion diagnostic market size is estimated to be $2,950 million as of 2018.
Companion diagnostic (CDx) is a diagnostic test used as an associate to a therapeutic drug to regulate its applicability to an individual person. It involves multiple monitoring methods including immunohistochemistry (IHC), polymerase chain Reaction (PCR), in-situ hybridization (ISH), real-time PCR (RT-PCR), and gene sequencing. The companion diagnostics uses technologies such as molecular biology technique, drug and diagnostic technology, and oncology therapy for the treatment of colorectal cancer, breast cancer, and other chronic diseases.
An acute analysis of the region-wise companion diagnostic market share concluded with reckoning North America as the most lucrative market for CDx. This region with cutting-edge healthcare technology in the United States and Canada generates 41% of the global companion diagnostic market demand for alarming need for cancer diagnosis and treatment. According to the American Cancer Society, prostate cancer is the most common cancer among males (19%), followed by lung (14%) and colorectal (9%) cancers and among females, breast (30%), lung (12%), and colorectal (8%) cancers are the most common. Increasing instances of cancer along with neurological disorders, infectious diseases, Hepatitis A is augmenting the North American companion diagnostic market.
Companion diagnostic market with abundant potential as an effective tool for personalized medicine has found a tremendous scope of application in pharmaceuticals, laboratories, research institutes and hospitals. Hospital as an end-user industry is the leading segment progressing with an application CAGR of 12.5% going through 2025. Hospitalized patients account for a total of 2.74 million serious adverse drug reactions. Each CDx test is specifically designed to be corresponding with an exact drug. Such tests can also save significant hospital expenditure by targeting specific patients with the most effective therapy.
· The necessity for personalized therapeutics for the cumulative geriatrics population and the increasing figure of diagnostics centers in both the developed and developing economies is predominant to determine profits in the global companion diagnostics market.
· FDA had issued "Guidance for Industry: In Vitro Companion Diagnostic Devices," to assist syndicates recognize the necessity for companion diagnostics at an initial stage in the drug development procedure and to strategize for co-development of the drug and companion diagnostic test.
· On July 15, 2016, FDA introduced the draft regulation, "Principles for Co-development of an In Vitro Companion Diagnostic Device with a Therapeutic Product." This guidance text is envisioned to be a practical guide to support therapeutic product promoters and IVD sponsors in evolving a therapeutic product and an associated IVD companion diagnostic.
· The scientific progressions in the in-situ hybridization and automated silver-enhanced in-situ hybridization (SISH) for the monitoring of genes is trending in the global companion diagnostics market.
Some of the key players influencing the
global market are:-
In April 2017, Abbott acquired Alere for a new price of about $5.3 billion. Alere is the global leader in point of care diagnostics focused on the areas of infectious disease, molecular, cardiometabolic and toxicology. The collective business will offer the biggest point of care menu of infectious disease, molecular, cardiometabolic and toxicology testing. Abbott's platforms will be expanded to comprise benchtop and rapid strip tests.
The base year of the study is 2018, with forecast done up to 2025. The study presents a thorough analysis of the competitive landscape, taking into account the market shares of the leading companies. It also provides information on unit shipments. These provide the key market participants with the necessary business intelligence and help them understand the future of the companion diagnostic market. The assessment includes the forecast, an overview of the competitive structure, the market shares of the competitors, as well as the market trends, market demands, market drivers, market challenges, and product analysis. The market drivers and restraints have been assessed to fathom their impact over the forecast period. This report further identifies the key opportunities for growth while also detailing the key challenges and possible threats. The key areas of focus include the various diagnostics in companion diagnostic market, and their specific advantages.
The Companion Diagnostic Market report also analyzes the major geographic regions for the market as well as the major countries for the market in these regions. The regions and countries covered in the study include:
• North America: The U.S., Canada, Mexico
• South America: Brazil, Venezuela, Argentina, Ecuador, Peru, Colombia, Costa Rica
• Europe: The U.K., Germany, Italy, France, The Netherlands, Belgium, Spain, Denmark
• APAC: China, Japan, Australia, South Korea, India, Taiwan, Malaysia, Hong Kong
• Middle East and Africa: Israel, South Africa, Saudi Arabia
1. Is the market for the companion diagnostic growing? How long will it continue to grow and at what rate?
2. Which type of systems presents the major growth opportunities?
3. Is there a possibility for change in the market structure over time?
4. Are additional developments needed for the existing product or services offerings or do the existing products meet the customer demands?
5. Do the key vendors look for partnerships to expand their businesses with respect to geography or product?
6. What are the short-term, long-term, and medium-term growth drivers for the market?
7. What are the short-term, medium-term, and long-term challenges for the market?
8. What are the short-term, medium-term, and long-term opportunities for the market
9. Who are the top players/companies of the market?
10. What are the recent innovations in the market?
11. How many patents have been filed by the leading players?
12. What are the types of patents filed by the leading players?
13. What is our Vision 2030 for companion diagnostic market?
• Give a deep-dive analysis of the key operational strategies with focus on the corporate structure, R&D strategies, localization strategies, production capabilities, and sales performance of various companies
• Provide an overview of the product portfolio, including product planning, development, and positioning
• Discuss the role of technology companies in partnerships
• Explore the regional sales activities
• Analyze the market size and giving the forecast for current and future companion diagnostics during the forecast 2019–2025
• Analyze the competitive factors, competitors’ market shares, product capabilities, and supply chain structures.