Tissue Diagnostics Market: Opportunities & Challenges

Posted on 2019-11-01 by MarketsandMarkets in Biotech, Healthcare, Marketing, Pharmaceuticals // 0 Comments

CITY, Country, 2019-Nov-01 — /EPR Network/ —

The global Tissue diagnostics market is expected to reach USD 5.14 billion by 2022 from USD 3.68 billion in 2017, at a CAGR of 6.9%. Factors such as the rising incidence of cancer, technological innovations, and increasing healthcare expenditure are the key drivers for the growth of the tissue diagnostics market. On the other hand, the high degree of consolidation, stringent regulatory requirements, lack of infrastructure, and low awareness in low- and middle-income countries are restraining the growth of this market. However, the high growth potential in emerging economies, increased use of personalized medicine, and rising number of clinical trials will present new growth opportunities to players in the tissue diagnostics market.

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What are the opportunities in emerging markets?

Emerging countries such as India, China, and Brazil are expected to offer significant growth opportunities to market players during the forecast period. The huge population base, especially in India and China, offers a sustainable market for tissue diagnostic products. In addition, changes related to lifestyle and nutrition are increasing the incidence of chronic diseases in these countries.

Growing healthcare expenditure is also a critical driver for these markets as it is increasing the accessibility of the patient population in these countries to advanced diagnostic and treatment approaches as well as improving the overall healthcare infrastructure in their respective healthcare systems.

What are the challenges posed by stringent regulatory requirements?

The current FDA approval process for tissue diagnostics instruments and consumables is very lengthy and complex. This is a major challenge faced by companies in terms of launching new and innovative products. Some products used for tissue diagnostics belong to Class III (under FDA classification) and require Premarket Approval (PMA) before they can be successfully marketed. PMA evaluates the safety and effectiveness of products and is considered as the most rigorous marketing application. Similarly, in April 2017, the European Parliament and the Council of the European Union issued the new Regulation (EU) 2017/746 for in vitro diagnostic medical devices. This resolution will replace the existing In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC, and companies will have five years to comply with the new regulations (which are more complex and stringent). Considering these stringent regulations, market players will find it challenging to align their processes with the stringent requirements, which could temporarily impact the time to market for new products, especially in the US and Europe.

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