Marine Pollution Has Intensified and Fish Resources Are Decreasing, Protamine Sulfate Injection Industry Raw Material Supply Is Affected


Protamine sulfate injection is an isotonic solution of protamine sulfate in water for injection, which is used to reverse the action of heparin.  It is specifically used for the treatment of heparin excess, low molecular weight heparin excess, and for the reversal of heparin during labor and heart surgery.  Systemic anticoagulant neutralization of heparin during cardiopulmonary bypass heart surgery requires protamine administration, which, if given in sufficient doses, can neutralize heparin and reduce the risk of postoperative bleeding. 

Protamine sulfate injection is usually available in two sizes: 5mL and 25mL. In 2019, the market revenue of these two sizes was $44.93 million and $33.43 million, accounting for 57.33% and 42.66% of the market, respectively. In terms of downstream application fields, the global application of protamine sulfate injection is mainly concentrated in the field of cardiac surgery. In 2019, the market size of products used in cardiac surgery accounted for 93.92%, while that used in childbirth surgery was only 6.08%.



Market Analysis of Protamine Sulfate Injection in Different Regions

In terms of region, the United States is the largest revenue market of protamine sulfate injection industry in the world. In 2019, the market revenue of protamine sulfate injection in the United States was $27.70 million , accounting for 35.98% of the global market share. Europe was second with $21.07 million in revenue and a 27.37% share. China ranked third, with market revenue of $13.45 million in 2019, accounting for 17.47% of the global market. The market revenue of Japan is 3.01 million USD, and the market share is 3.91%, and the market share of other countries and regions is 15.77%. It can be seen that the regional concentration of the global industry is high, and the market is mainly concentrated in the United States and Europe. 

However, we predict that the share of the US and Europe will decline to 32.88% and 25.60% respectively by 2025.  On the contrary, the share of China and other regions is expected to increase over the forecast period, rising to 19.23% and 18.36% respectively by 2025.  Japan\'s market share will remain basically stable.


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Marine Pollution Has Intensified and Fish Resources are Decreasing, Protamine Sulfate Injection Industry Raw Material Supply Is Affected

Protamine is a kind of basic protein sulfate extracted from fresh mature sperm of fish. It is the full name of protamine sulfate injection. It is mainly used for bleeding caused by heparin overinjection and is necessary for heart surgery drugs.  Heart surgery patients receive cardiopulmonary bypass during surgery. To ensure normal blood circulation, doctors will use heparin anticoagulants to prevent blood from clotting outside the body.  After surgery, if the blood still does not clot, it will lead to internal bleeding, life-threatening.  Protamine is the "antidote" to remove anticoagulation to prevent massive bleeding. With the continuous development of medical technology, there are more and more cases of heart surgery, which brings many development opportunities to the protamine sulfate injection market. 

Three days before delivery, ordinary heparin can shorten the low level anticoagulation time by taking advantage of the advantages of protamine sulfate injection with short half-life and full anticoagulation effect.  Protamine sulfate injection can treat intraoperative bleeding and improve the efficacy and safety of antithrombotic therapy in childbirth operation.  As the global population grows and childbirth procedures increase, there are more and more emerging opportunities in the protamine sulfate injection market.  Research data show that the global protamine sulfate injection market revenue was 76.98 million US dollars in 2015 and increased to 78.37 million US dollars in 2019.  In the future, the market will continue to grow with the increase of cardiac surgery and childbirth surgery, as well as the broadening of the application range, and the global market revenue is expected to reach us $82.37 million by 2025. 

However, although protamine sulfate injection is a clinically necessary variety, its quantity is relatively small, which brings limited profit and growth space to enterprises.  From the perspective of cost, the production cost and transportation cost of protamine are relatively high. For example, the production process is complicated and the transportation process requires cold chain transportation, which are the burden of the company\'s cost.  As costs rise and profits fall, enthusiasm for production naturally declines.  If the market price is low, the business is producing at a loss.  In addition, protamine sulfate injection is a protein sulfate extracted from mature fish sperm, and production is limited by upstream raw material companies.  Marine pollution and the decline of fish resources will reduce the supply of protamine sulfate injection materials, which will also limit the market supply to a certain extent. 

On the other hand, problems with standards have resulted in protamine sulfate injections failing tests, so production has been discontinued in many locations over the past few years.  In addition, the pricing of protamine sulfate injection is also a concern.  The previous pricing mechanism largely limited the profit margin of enterprises.  The shortage of protamine sulfate injection still exists and the situation is not optimistic.  Many of the shortages involve older, unpatented or difficult-to-prepare products, as well as products with strict shelf lives and few or only manufacturers.  In order to improve the shortage of drugs, it is necessary to play the dual role of government and market, establish scientific and reasonable preventive measures, and establish a long-term mechanism to deal with the shortage of protamine sulfate injection.


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