It is predicted that sales in the Chinese pharmaceutical market will reach 60 billion U.S. dollars by 2010, and will become the world's fifth largest pharmaceutical market; by 2020, it will reach US$120 billion, which may become one of the world's largest pharmaceutical markets. This article analyzes the status quo of the global pharmaceutical preparations and the development trend of the pharmaceutical market, and proposes pharmaceutical preparations, traditional Chinese medicine preparations, and pharmaceutical preparations for the treatment of major diseases and epidemics, medicines for improving quality of life, drug delivery systems, etc. The idea of ​​development hopes to enlighten the R&D personnel in the industry.
R&D is an important lifeline for the sustainable development of enterprises. It is the top priority for drug companies in pharmaceutical research and development to carry out research on new drug delivery systems and new preparations with high starting points and prospects. This requires pharmaceutical companies to look six ways and seize market opportunities. Below, the author gives some suggestions on the development of pharmaceutical preparations.
1. Excavate patent pending drug "gold mine"
The 13 NCE drugs with sales of nearly 30 billion U.S. dollars expired during the period 2008-2010 (see attached table), providing the industry with a large “gold mine†worth mining.
In the next few years, at least 60% of the countries in the world will target drugs that have expired patents one after another and want to seize the market through the improvement of dosage forms. For this “gold mineâ€, Chinese pharmaceutical companies should closely follow up and conduct in-depth research, and seize the opportunity to develop decisively according to their market prospects and their own capabilities.
2. The unique research and development of traditional Chinese medicine preparations
China's traditional Chinese medicine is rich in resources and its composition is less affected by foreign competition. In the research and development of traditional Chinese medicine preparations, the separation of its active ingredients can expand the broad path for the development of new drugs in China. In addition, with the increase in the number of Chinese herbal medicines developed, the research and development of dosage forms has become increasingly important.
Development of effective dosage forms with ease of use The author found that incomplete statistics on nearly 2,000 kinds of Chinese medicine literature revealed that there are more than 130,000 prescriptions with or without names in various Chinese medicine departments. In the course of improvement of dosage forms, a large number of secret recipes in the private sector should be tapped, and the comprehensive effects of Chinese herbal compound prescriptions and the characteristics of decoctions should be taken into account. The experience of Japanese preparations for Kampo preparations should be used for reference (optionally containing scattered, soup, fried, and Drinks, wine and pills, etc.)
The use of advanced preparation technology to improve the current market of traditional Chinese medicine preparations, small investment and quick results. At the same time, the market can also be seized by improving old dosage forms.
Development of new formulations using new technologies and new processes Supercritical fluid extraction technology, macroporous resin adsorption and separation technology, membrane extraction and separation technology, ultrasonic extraction technology, high-speed countercurrent chromatography extraction technology, microwave extraction technology, high-speed centrifugal technology, ultrafiltration ultrafine grinding Technology, nanotechnology, new adsorption technology, and new processes such as spray-drying, freeze-drying, and one-step granulation can develop new formulations and new dosage forms of high quality.
Preparations for new routes of administration such as capsules, soft capsules, granules, dripping pills and oral liquids are available.
Developing nutraceuticals Many active ingredients of traditional Chinese medicine can be developed into therapeutic drugs and pharmaceutical excipients, and can be developed into health drinks or food and cosmetics. For example, Ginkgo biloba leaf preparation has become the best-selling drug for geriatric drugs in Europe. Japan and other countries also marketed their functional foods and health drinks, and they are also very popular. In addition to granules, granules, capsules, dripping pills and tablets that have been and are being developed for Ginkgo biloba or its active ingredients, China has also developed nutritional health products.
3. Develop drugs for the treatment of major diseases and epidemics
Cancer Drug Delivery System Cancer is becoming the first killer of humans. The "Outline of China's Cancer Prevention and Control Program (2004-2010)" issued by the Ministry of Health pointed out that China's cancer harm has become increasingly serious.
Developing a drug delivery system for treating cancer is a challenge. The trend in the development of cancer administration is the targeting of lesions. The newer route of administration for the treatment of cancer is not only a supplement to conventional chemotherapy and radiotherapy, but also prevents damage to normal tissues and prevents drug resistance. Some new methods for cancer drug delivery are the use of microparticles as carriers for anticancer drugs. After injection into the blood circulation, a magnetic field is used to guide the drug to the target site. Other carriers include liposomes, microspheres, and monoclonal antibodies. Carmustine biodegradable implants have also been used to treat brain malignancies. Cancer vaccines have opened up a modern and safe way to treat cancers. It is predicted that by 2012, the market will reach 8 billion U.S. dollars.
It is predicted that the market for cancer drug release system will be 15.4 billion U.S. dollars in 2007, and is expected to be 23.5 billion U.S. dollars in 2012 and 25 billion U.S. dollars in 2015, which is worthy of attention.
Drug Delivery System for Diabetes Treatment Drugs According to the prediction of the World Health Organization, by 2025, the number of diabetic patients in the world will reach 300 million. According to Decision Resources, the global type II diabetes drug market will reach US$20.5 billion by 2012, with an annual growth rate of 8%. Strikingly, the impetus for the rapid expansion of this market is the launch of new mechanisms of action such as glucagon-like peptide-1 (GLP-1) homologues and the development of pharmaceutical preparations.
Cardiovascular drug delivery system According to forecasts, the global cardiovascular drug sales in 2010 could reach 104.4 billion U.S. dollars. The research and development of cardiovascular drug delivery system mainly focuses on oral sustained-release preparations and compound preparations, transdermal drug delivery systems, oral mucosa drug delivery systems, and stents (Stent).
Central Nervous System Drug Delivery System Global sales of therapeutic drugs for Alzheimer's disease (Alzheimer's disease) are expected to increase to US$7.8 billion in 2010, and sales of neuroprotective agents will reach US$11.5 billion. Various drug delivery systems with high efficacy and ease of use can be developed for the characteristics of the patient's disease. Such as oral rapid disintegration tablets, oral controlled-release preparations, oral compound preparations, long-acting injections.
4. Research and development of quality of life drugs have a market
Therapeutic drugs such as skin aging, obesity, hair loss, and sexual dysfunction constitute quality-of-life drugs. In recent years, the global sales of such drugs have been about 23 billion U.S. dollars, making it a big market for the pharmaceutical industry to make money. Although the diseases treated by these drugs are not life-threatening, they need to be used for a long time, which can bring profits to pharmaceutical companies for a long time. Take the United States alone as an example. By 2010, the market for anti-obesity drugs will reach 5 billion U.S. dollars. In addition, we should pay attention to the sexual dysfunction drug delivery system - It is estimated that there are 152 million cases of erectile dysfunction (ED) in the world and it is expected to reach 322 million cases by 2025. Currently, the market for ED therapeutic drugs is $3 billion. With the continuous development of the drug delivery system, this market will rapidly expand and reach 6 billion U.S. dollars by 2010. At present, relevant drug delivery systems that have been successfully developed include micro suppositories and testosterone transdermal patches for alprostadil. The overseas drug release company is improving the dosage form, making the drug into a gel, a nasal spray and a lotion, and developing a second generation drug delivery system that is safe, effective and effective for both men and women, such as Sildenafil Inner-speed disintegration tablets.
5. Biotechnology drugs have great potential for development
In 2010, the market size of recombinant protein drugs will increase to US$53 billion, of which recombinant interferon alpha will increase from US$1.8 billion in 2001 to US$5.5 billion. The development of biotech drugs has clearly promoted the development of its drug delivery system.
Although the market for biologic drug delivery system currently occupies a small share of the total drug release market, its formulation sales will grow at an average annual growth rate of more than 10% in the next few years. The sales of large molecular weight drug release system can be achieved by 2010. To reach 25 billion U.S. dollars should also be given enough attention.
6. Focus on the development of drug delivery systems for specific populations
Including the development of suitable dosage forms for children (oral rapid disintegrating tablets, chewing gum, nutritional preparations), women drug formulations and geriatric drug formulations.
7. The development of OTC varieties is vast
The average OTC drug market in China grows by more than 30% per year, and it has become a market with huge potential. This has provided tremendous business opportunities for pharmaceutical companies at home and abroad. It is predicted that in 2010 China's OTC drug sales can reach 9 billion US dollars, which also provides a vast world for the development of OTC varieties.
Develop products from the national OTC drug list, such as improving the quality of formulations and increasing the dissolution rate of solid drugs; developing OTC drug series for use in specific populations of the elderly, children or women; producing orally rapidly disintegrating tablets, dispersible tablets, shaped tablets or suitable for oral use Capsules, etc.
Concern over the shift from prescription drugs to over-the-counter drugs Statins dominate the profits of the pharmaceutical industry, and as many statin patents expire, they increase the chances of turning them into OTC.
The development of health food products can be based on nutritional ingredients, use of people or formulations to develop nutrition and health products, such as vitamin products, sports nutrition products (bags, bottles and cans), etc.; development of enteral nutrition (dairy products, lactose-free products Etc.); special drinks.
R&D is an important lifeline for the sustainable development of enterprises. It is the top priority for drug companies in pharmaceutical research and development to carry out research on new drug delivery systems and new preparations with high starting points and prospects. This requires pharmaceutical companies to look six ways and seize market opportunities. Below, the author gives some suggestions on the development of pharmaceutical preparations.
1. Excavate patent pending drug "gold mine"
The 13 NCE drugs with sales of nearly 30 billion U.S. dollars expired during the period 2008-2010 (see attached table), providing the industry with a large “gold mine†worth mining.
In the next few years, at least 60% of the countries in the world will target drugs that have expired patents one after another and want to seize the market through the improvement of dosage forms. For this “gold mineâ€, Chinese pharmaceutical companies should closely follow up and conduct in-depth research, and seize the opportunity to develop decisively according to their market prospects and their own capabilities.
2. The unique research and development of traditional Chinese medicine preparations
China's traditional Chinese medicine is rich in resources and its composition is less affected by foreign competition. In the research and development of traditional Chinese medicine preparations, the separation of its active ingredients can expand the broad path for the development of new drugs in China. In addition, with the increase in the number of Chinese herbal medicines developed, the research and development of dosage forms has become increasingly important.
Development of effective dosage forms with ease of use The author found that incomplete statistics on nearly 2,000 kinds of Chinese medicine literature revealed that there are more than 130,000 prescriptions with or without names in various Chinese medicine departments. In the course of improvement of dosage forms, a large number of secret recipes in the private sector should be tapped, and the comprehensive effects of Chinese herbal compound prescriptions and the characteristics of decoctions should be taken into account. The experience of Japanese preparations for Kampo preparations should be used for reference (optionally containing scattered, soup, fried, and Drinks, wine and pills, etc.)
The use of advanced preparation technology to improve the current market of traditional Chinese medicine preparations, small investment and quick results. At the same time, the market can also be seized by improving old dosage forms.
Development of new formulations using new technologies and new processes Supercritical fluid extraction technology, macroporous resin adsorption and separation technology, membrane extraction and separation technology, ultrasonic extraction technology, high-speed countercurrent chromatography extraction technology, microwave extraction technology, high-speed centrifugal technology, ultrafiltration ultrafine grinding Technology, nanotechnology, new adsorption technology, and new processes such as spray-drying, freeze-drying, and one-step granulation can develop new formulations and new dosage forms of high quality.
Preparations for new routes of administration such as capsules, soft capsules, granules, dripping pills and oral liquids are available.
Developing nutraceuticals Many active ingredients of traditional Chinese medicine can be developed into therapeutic drugs and pharmaceutical excipients, and can be developed into health drinks or food and cosmetics. For example, Ginkgo biloba leaf preparation has become the best-selling drug for geriatric drugs in Europe. Japan and other countries also marketed their functional foods and health drinks, and they are also very popular. In addition to granules, granules, capsules, dripping pills and tablets that have been and are being developed for Ginkgo biloba or its active ingredients, China has also developed nutritional health products.
3. Develop drugs for the treatment of major diseases and epidemics
Cancer Drug Delivery System Cancer is becoming the first killer of humans. The "Outline of China's Cancer Prevention and Control Program (2004-2010)" issued by the Ministry of Health pointed out that China's cancer harm has become increasingly serious.
Developing a drug delivery system for treating cancer is a challenge. The trend in the development of cancer administration is the targeting of lesions. The newer route of administration for the treatment of cancer is not only a supplement to conventional chemotherapy and radiotherapy, but also prevents damage to normal tissues and prevents drug resistance. Some new methods for cancer drug delivery are the use of microparticles as carriers for anticancer drugs. After injection into the blood circulation, a magnetic field is used to guide the drug to the target site. Other carriers include liposomes, microspheres, and monoclonal antibodies. Carmustine biodegradable implants have also been used to treat brain malignancies. Cancer vaccines have opened up a modern and safe way to treat cancers. It is predicted that by 2012, the market will reach 8 billion U.S. dollars.
It is predicted that the market for cancer drug release system will be 15.4 billion U.S. dollars in 2007, and is expected to be 23.5 billion U.S. dollars in 2012 and 25 billion U.S. dollars in 2015, which is worthy of attention.
Drug Delivery System for Diabetes Treatment Drugs According to the prediction of the World Health Organization, by 2025, the number of diabetic patients in the world will reach 300 million. According to Decision Resources, the global type II diabetes drug market will reach US$20.5 billion by 2012, with an annual growth rate of 8%. Strikingly, the impetus for the rapid expansion of this market is the launch of new mechanisms of action such as glucagon-like peptide-1 (GLP-1) homologues and the development of pharmaceutical preparations.
Cardiovascular drug delivery system According to forecasts, the global cardiovascular drug sales in 2010 could reach 104.4 billion U.S. dollars. The research and development of cardiovascular drug delivery system mainly focuses on oral sustained-release preparations and compound preparations, transdermal drug delivery systems, oral mucosa drug delivery systems, and stents (Stent).
Central Nervous System Drug Delivery System Global sales of therapeutic drugs for Alzheimer's disease (Alzheimer's disease) are expected to increase to US$7.8 billion in 2010, and sales of neuroprotective agents will reach US$11.5 billion. Various drug delivery systems with high efficacy and ease of use can be developed for the characteristics of the patient's disease. Such as oral rapid disintegration tablets, oral controlled-release preparations, oral compound preparations, long-acting injections.
4. Research and development of quality of life drugs have a market
Therapeutic drugs such as skin aging, obesity, hair loss, and sexual dysfunction constitute quality-of-life drugs. In recent years, the global sales of such drugs have been about 23 billion U.S. dollars, making it a big market for the pharmaceutical industry to make money. Although the diseases treated by these drugs are not life-threatening, they need to be used for a long time, which can bring profits to pharmaceutical companies for a long time. Take the United States alone as an example. By 2010, the market for anti-obesity drugs will reach 5 billion U.S. dollars. In addition, we should pay attention to the sexual dysfunction drug delivery system - It is estimated that there are 152 million cases of erectile dysfunction (ED) in the world and it is expected to reach 322 million cases by 2025. Currently, the market for ED therapeutic drugs is $3 billion. With the continuous development of the drug delivery system, this market will rapidly expand and reach 6 billion U.S. dollars by 2010. At present, relevant drug delivery systems that have been successfully developed include micro suppositories and testosterone transdermal patches for alprostadil. The overseas drug release company is improving the dosage form, making the drug into a gel, a nasal spray and a lotion, and developing a second generation drug delivery system that is safe, effective and effective for both men and women, such as Sildenafil Inner-speed disintegration tablets.
5. Biotechnology drugs have great potential for development
In 2010, the market size of recombinant protein drugs will increase to US$53 billion, of which recombinant interferon alpha will increase from US$1.8 billion in 2001 to US$5.5 billion. The development of biotech drugs has clearly promoted the development of its drug delivery system.
Although the market for biologic drug delivery system currently occupies a small share of the total drug release market, its formulation sales will grow at an average annual growth rate of more than 10% in the next few years. The sales of large molecular weight drug release system can be achieved by 2010. To reach 25 billion U.S. dollars should also be given enough attention.
6. Focus on the development of drug delivery systems for specific populations
Including the development of suitable dosage forms for children (oral rapid disintegrating tablets, chewing gum, nutritional preparations), women drug formulations and geriatric drug formulations.
7. The development of OTC varieties is vast
The average OTC drug market in China grows by more than 30% per year, and it has become a market with huge potential. This has provided tremendous business opportunities for pharmaceutical companies at home and abroad. It is predicted that in 2010 China's OTC drug sales can reach 9 billion US dollars, which also provides a vast world for the development of OTC varieties.
Develop products from the national OTC drug list, such as improving the quality of formulations and increasing the dissolution rate of solid drugs; developing OTC drug series for use in specific populations of the elderly, children or women; producing orally rapidly disintegrating tablets, dispersible tablets, shaped tablets or suitable for oral use Capsules, etc.
Concern over the shift from prescription drugs to over-the-counter drugs Statins dominate the profits of the pharmaceutical industry, and as many statin patents expire, they increase the chances of turning them into OTC.
The development of health food products can be based on nutritional ingredients, use of people or formulations to develop nutrition and health products, such as vitamin products, sports nutrition products (bags, bottles and cans), etc.; development of enteral nutrition (dairy products, lactose-free products Etc.); special drinks.
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