1 Global Crude Heparin Market Insight Analysis
The global crude heparin market revenue was valued at USD 4,134.71 million in 2024 and is expected to grow at a CAGR of 0.69% from 2024 to 2033.
Crude heparin is the raw material source of heparin APIs, which was originally obtained from the intestinal mucosa of both cows and pigs, but due to concerns about bovine spongiform encephalopathy (BSE), most countries now only use porcine-derived heparin. Because it contains a large number of impurities such as protein, nucleic acid, microorganism, etc., it is necessary to directionally obtain heparin with complete natural structural groups through physical and chemical extraction and separation processes, so as to prepare heparin APIs.
Figure Global Crude Heparin Market Size (M USD) and CAGR (2024-2033)
2 Crude Heparin Market Growth Drivers and Restraints
As the global population ages, the incidence of cardiovascular diseases and other diseases is increasing year by year. Heparin products, as important anticoagulants, play a key role in preventing postoperative thrombosis and other aspects, and their clinical use continues to increase. This has led to a continuous expansion of market demand for heparin products, and as the main raw material for heparin drugs, the market demand for crude heparin has also increased accordingly.
For example, in the treatment of cardiovascular diseases, heparin is widely used in anticoagulant therapy. As the number of patients increases, the demand for crude heparin also increases accordingly. From the perspective of industrial policy, China, as one of the world’s largest pig farming and slaughtering countries, has relevant policies to regulate and support the pig farming and slaughtering industries.
For example, the Outline of the National Pig Slaughtering Industry Development Plan (2010-2015) requires the elimination of backward slaughtering capacity, the increase of designated slaughtering ratios, the optimization of pork product structure, and the improvement of the comprehensive utilization rate of small intestine resources; the National Pig Production Development Plan (2016-2020) emphasizes centralized slaughtering and industrial integration.
These policies have promoted the supply and utilization of pig intestines, ensured the raw material source of crude heparin, and promoted the stable development of the crude heparin market. At the same time, the heparin API and preparation industry in China is an industry that encourages investment and is a key development industry.
Relevant companies enjoy policy dividends, such as the “12th Five-Year Plan” focuses on the development of the biopharmaceutical industry, and the “Guidelines for Industrial Structure Adjustment (2011)” includes new drug development, natural drug development and modern biotechnology drugs in encouraged investment projects. Heparin and low molecular weight heparin drugs are also included in the national basic medical insurance catalog, which are conducive to the development of the crude heparin market. FDA strengthens supervision of crude heparin. In the past, there have been incidents of sodium heparin adulteration, resulting in many deaths.
To avoid similar incidents, the FDA issued a draft guide for crude heparin quality supervision, requiring the testing of chondroitin sulfate content in each batch of crude heparin, clarifying the actual manufacturer, packager and distributor, and strictly implementing the ICH Q7 standard. Although this strict regulatory measure helps to ensure product quality, it also increases the production costs and compliance risks of enterprises. Some small and medium-sized enterprises may face operational difficulties or even exit the market due to their inability to meet strict regulatory requirements, which will impose certain restrictions on the overall development of the crude heparin market.
3 Technological Innovations in the Crude Heparin Market
Some companies continue to innovate in crude heparin production technology. For example, Changzhou Qianhong Biochemical Pharmaceutical Co., Ltd. has a number of technical advantages in the production process of sodium heparin. It has established a full supply chain traceability system, using PCR detection technology to strictly control the source of crude heparin raw materials, organically combining virus inactivation technology with low pH incubation, oxidation and membrane filtration, and using domestic leading molecular membrane ultrafiltration technology, alcohol graded precipitation technology and freeze-drying technology.
These technological innovations help improve product quality, ensure product safety and stability, and enhance the competitiveness of enterprises in the market. Technological innovation is also conducive to optimizing production processes, improving production efficiency, and reducing production costs, thereby occupying a more advantageous position in market competition. With the continuous advancement of science and technology, more advanced technologies may be applied to the field of crude heparin production in the future to promote the development of the entire industry.
Corporate mergers and acquisitions are one of the important dynamics of the crude heparin market. For example, Luohe Huisheng Biotechnology Co., Ltd. acquired Luohe Huisheng Pharmaceutical Co., Ltd. from Henan Shuanghui Investment Development Co., Ltd. for RMB 77.291 million on April 25, 2020. Through this merger and acquisition, Luohe Huisheng Biotechnology Co., Ltd. can integrate resources, expand the scale of the enterprise, and enhance its own strength.
Mergers and acquisitions may bring about synergies in production, sales, research and development, etc., which will help enterprises reduce costs, increase market share, and enhance risk resistance. For the acquired party, it can also achieve better development with the resources and advantages of the acquirer. Corporate mergers and acquisitions and reorganizations will also affect the market competition pattern, prompting market resources to concentrate on advantageous enterprises and promote the integration and optimization of the industry. In the future, as market competition intensifies, corporate mergers and acquisitions and reorganizations may become more frequent, further shaping the new pattern of the crude heparin market.
4 Global Crude Heparin Market Size by Type
Porcine crude heparin, derived from the intestinal mucosa of pigs, is the most widely used type in the market. This preference is largely due to the high yield and purity of heparin obtained from porcine sources, as well as the stringent regulations that limit the use of bovine sources due to BSE concerns.
In 2024, the market value for Porcine Crude Heparin is projected to reach approximately $4,073.16 million USD. This substantial figure reflects the growing demand for anticoagulant therapies, particularly in the treatment of cardiovascular diseases, where heparin plays a critical role. The increasing incidence of thromboembolic disorders, coupled with an aging population, drives the demand for porcine-derived heparin products. Furthermore, the production process for porcine crude heparin is well-established, ensuring a consistent supply to meet market needs.
Bovine crude heparin, while less commonly used due to safety concerns, is still a relevant segment in the market. It is sourced from the intestinal mucosa of cattle and is utilized in specific applications where porcine heparin may not be suitable. In 2024, the market value for Bovine Crude Heparin and Others is expected to be around $61.56 million USD.
The lower market value for bovine crude heparin can be attributed to the stringent regulations surrounding its use, as well as the public’s perception of safety associated with porcine-derived products. However, it is important to note that bovine heparin still finds applications in certain therapeutic areas, particularly in regions where porcine sources are limited or culturally restricted.
Table Global Crude Heparin Market Size by Type in 2024
Type | Market Size (M USD) 2024 |
|---|---|
Porcine Crude Heparin | 4073.16 |
Bovine Crude Heparin and Others | 61.56 |
5 Global Crude Heparin Market Size by Application
In 2024, the revenue of Low-Molecular-Weight Heparin (LMWH) is projected to reach 3,643.67 million USD. LMWH is a fragment of glucosamine sulfate after the cleavage of UFH. It is a mixture with a molecular weight range of 3000 – 5000KD and is a general term for a class of small molecular weight heparins prepared by the depolymerization of UFH.
This type of heparin has a wide range of applications in the medical field. For example, drugs like “enoxaparin sodium”, “nadribarin calcium”, and “dalteparin sodium” are all LMWH drugs. The market for LMWH has been growing steadily due to its effectiveness in preventing and treating various thrombotic diseases. Its relatively lower molecular weight provides certain advantages in terms of pharmacokinetics and safety, making it more popular among patients and healthcare providers.
In the same year, the revenue of Unfractionated Heparin (UFH) is expected to be 491.04 million USD. UFH is a glucosamine sulfate extracted from the intestinal mucosa of pigs or bovine lung, with a molecular weight range of 3000 – 30000KD. Although its market value is lower compared to LMWH in 2024, UFH still holds an important position in the market. It has been used in the medical field for a long time and is an essential anticoagulant drug. However, with the development of medical technology and the increasing demand for more targeted and safer drugs, the growth rate of the UFH market may be relatively slower than that of LMWH.
The difference in market values between LMWH and UFH in 2024 can be attributed to several factors. LMWH’s technological advancements and better clinical performance have led to its wider application and higher market acceptance. The continuous innovation in the production process of LMWH also improves its quality and reduces costs, further promoting its market expansion. In contrast, UFH faces more competition from new drugs and alternative treatments. However, UFH still has its unique advantages in some specific medical scenarios, ensuring its stable presence in the market.
Table Global Crude Heparin Market Size by Application in 2024
Application | Market Size (M USD) 2024 |
|---|---|
Low-Molecular-Weight Heparin (LMWH) | 3643.67 |
Unfractionated Heparin (UFH) | 491.04 |
6 Global Crude Heparin Market Size by Region
North America is one of the major markets for crude heparin. In 2024, its market value is expected to be 1,283.95 million USD. The United States, as the largest economy in North America, plays a dominant role in the region’s crude heparin market. The advanced healthcare system in the United States generates a high demand for heparin products, which in turn drives the market for crude heparin. The market in North America has been relatively stable, with a mature distribution and sales network. However, it also faces challenges such as intense competition among manufacturers and strict regulatory requirements, which may affect the market growth rate to some extent.
Europe is another important region for the crude heparin market. In 2024, its market value is projected to be 1,247.41 million USD. Germany, France, the UK, and Spain are the major contributors to the European market. Germany, with its strong pharmaceutical industry and high – level healthcare services, has a significant demand for crude heparin.
The European market benefits from its well – developed biotechnology and pharmaceutical research and development capabilities. At the same time, the aging population in Europe also increases the demand for heparin – based drugs, promoting the growth of the crude heparin market. However, factors like economic fluctuations and changes in healthcare policies in some European countries may bring uncertainties to the market.
The Asia – Pacific region has shown remarkable growth potential in the crude heparin market. In 2024, its market value is expected to reach 1,382.97 million USD, making it a crucial region in the global market. China, in particular, is a key player in the Asia – Pacific market. With the continuous development of the economy and the improvement of healthcare standards in China, the demand for crude heparin has been increasing steadily.
The Chinese government’s support for the biopharmaceutical industry also provides a favorable policy environment for the development of the crude heparin market. Other countries in the Asia – Pacific region, such as Japan, South Korea, and India, also contribute to the market growth with their growing pharmaceutical industries and increasing healthcare needs.
South America has a relatively smaller market for crude heparin compared to the above – mentioned regions. In 2024, its market value is estimated to be 134.33 million USD. Brazil is the largest market in South America. The development of the crude heparin market in South America is mainly driven by the growth of the local healthcare industry and the increasing investment in medical research. However, factors like economic instability and underdeveloped healthcare infrastructure in some areas may limit the market growth.
The Middle East & Africa region’s crude heparin market in 2024 has a projected market value of 86.05 million USD. The UAE, Saudi Arabia, and South Africa are the major markets in this region. The growth of the market in the Middle East & Africa is mainly due to the increasing investment in healthcare facilities and the growing awareness of healthcare. However, challenges such as political instability in some areas and differences in healthcare standards among countries may affect the market’s further development.
Figure Global Crude Heparin Market Size (M USD) by Region in 2024
7 Global Crude Heparin Market Analysis by Major Players
7.1 Fengrun Biological Technology
Company Introduction and Business Overview:
Fengrun Biological Technology, established in 2009, is a leading enterprise in the natural pork casing and crude heparin sodium processing industry. The company is listed on the National SME Stock Transfer System in China and operates manufacturing bases primarily in China.
Fengrun Biological Technology specializes in the extraction and processing of crude heparin sodium from pig intestines. The company has implemented a comprehensive and strict quality management system based on ICH Q7 standards, ensuring the effective, stable, reliable, and safe quality of its products. Its market distribution spans globally, catering to both domestic and international clients.
Products:
The company’s primary product is Crude Heparin Sodium, which is used as a raw material for the production of heparin APIs. Fengrun Biological Technology is known for its high-quality products and stringent quality control measures.
Market Performance in 2022:
In 2022, Fengrun Biological Technology reported a revenue of $157.86 million USD with a gross profit of $27.55 million USD. The company maintained a gross margin of 17.45%.
7.2 Shenzhen Hepalink
Company Introduction and Business Overview:
Shenzhen Hepalink, founded in 1998, is a multinational biopharmaceutical company with a core focus on the heparin industrial chain. The company is dual-listed in Hong Kong and mainland China, highlighting its significant presence in the global market.
Shenzhen Hepalink operates manufacturing bases in China and the USA, with its products mainly distributed in China, America, and Europe. The company is renowned for its high-quality heparin sodium products, which are used in the production of heparin sodium preparations and low-molecular-weight heparin.
Products:
Shenzhen Hepalink’s primary product is Heparin Sodium from Crude, which is extracted from porcine intestinal mucosa. The company’s products are widely used in the pharmaceutical industry for anticoagulant therapies.
Market Performance in 2022:
In 2022, Shenzhen Hepalink achieved a revenue of $165.27 million USD with a gross profit of $44.93 million USD. The company maintained a robust gross margin of 27.19%.
7.3 Hubei Wurui Bio-Engineering Co.,Ltd.
Company Introduction and Business Overview:
Hubei Wurui Bio-Engineering Co., Ltd., established in 1987, is a leading supplier in the casing and heparin sodium industry. The company is known for its high-quality products and extensive market reach.
Hubei Wurui Bio-Engineering operates primarily in China, with its products distributed across Europe, the United States, Japan, and Southeast Asia. The company’s core business involves the production and sales of crude heparin sodium, derived from animal organs. It adheres to strict quality control standards, ensuring the reliability and safety of its products.
Products:
The company’s primary product is Heparin Sodium, available in both crude and purified grades. Hubei Wurui Bio-Engineering is recognized for its high-capacity production and stringent quality assurance processes.
Market Performance in 2022:
In 2022, Hubei Wurui Bio-Engineering Co., Ltd. reported a revenue of $137.27 million USD with a gross profit of $27.76 million USD. The company achieved a gross margin of 20.22%.