Biosurgery Market: Opportunities and Challenges
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How will the untapped emerging markets create opportunities for players in the biosurgery market?
The penetration of biosurgery products is very low in the Asia Pacific, Latin America, and the Middle East & Africa. In the coming years, countries such as China, India, and Brazil are expected to offer significant growth opportunities for players operating in the biosurgery market. This is because the markets in these countries are characterized by a large patient base for target indications (such as cardiovascular, orthopedic, general/abdominal, and gynecological disorders), rising health awareness, growing healthcare expenditure, rising medical tourism, and rapidly developing healthcare infrastructure.
Government agencies in several Asia Pacific countries are undertaking initiatives to support their respective healthcare systems. For instance, the government of China implemented its USD 124 billion (CNY 850 billion) healthcare reform plan in April 2009, which aimed at providing affordable healthcare to its entire population by 2020. This reform involves the upgrading of laws related to healthcare investments, pharmaceuticals, and the medical device industry. Such developments have further opened up the Chinese market for players operating in the global healthcare market. As a result, a number of players are focusing on expanding their presence in China to tap the available growth opportunities.
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Will stringent regulatory frameworks create challenges for market growth?
The development of new biosurgery products requires significant investments, and new products generally take more than 7–8 years to gain marketing approval. In the US, the FDA has made it mandatory for biosurgery product manufacturers to obtain Premarket Approval (PMA) for their products before they are introduced in the market. For this, the product has to demonstrate proper clinical trial data, which has to be submitted along with the application for PMA.
The cost and time required for a product to enter the clinical trial step and then clear clinical trials are very high, with minimum chances of the product gaining approval. Also, the possibility of obtaining clinically significant data showing clinical trial clearance has been low for biosurgery products such as adhesion barriers, semi-synthetic sealants, and hemostatic agents. Hence, despite huge investments in R&D, the risk of failure is very high in the case of biosurgery products. This is a major factor limiting the development of novel biosurgery products in the market.
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Mr. Shelly Singh
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