Dr Sanjay Agrawal
Leading Pharmaceutical Consultant and Editor-in Chief of IJMToday
API- Active Pharmaceutical Ingredient, the active ingredient present in the drugs. It is believed that the synthetic API market will be one of the leading industry in the years to come. The demand for higher quality and lower cost ingredients combined with a tremendously growing demand for complex molecules and the generics throughout the supply chain is completely reforming the active pharmaceutical ingredient (API) industry.
The Indian market of APIs is taking a new turn and is expected to cross a revenue of USD nearly 6 billion by the end of 2020. Mainl the Indian active pharmaceutical ingredients market manufacturing segments is dependent on two sectors 1) branded and 2) generic or unbranded. Until recently the API 1market was dominated by US followed by China which is now considered as a leading producer of API. China is considered to be the largest producer of API, accounting for almost 50 per cent of the global market surpassing the North American market and the United States markets. India is the second largest supplier of generic APIs to the US market with around 30 per cent share.
At present, there are less than 2000 active pharmaceutical ingredient manufacturing companies in India and China. Of the suppliers the leading active pharmaceutical ingredient manufacturers in India are (GSK) GlaxoSmithKline, Aurobindo Pharma, Teva Active Pharmaceutical Ingredients (TAPI), Dr. Reddy’s Laboratories, Pfizer and so on.
RISE OF API MARKEN INDIA
The patent expiry of many blockbuster drugs that is an ongoing process and is believed to be one of the major cause to further contribute to the growth of the active pharmaceutical ingredient market in India. The major market for APIs in India is concentrated around the synthetic API market than for the biotechnology market for a long time till now. The increase of the biotechnology sector in India has caused an increase in biotech API market as well, but still this marke continues to lag behind the synthetic API market.
NEED FOR COMPLEX MOLECULES:
The demand for micronized APIs, drugs delivered using specialized delivery systems and polymers as well as painkillers formulated have all forced for the innovation and specialization in the sector. The most important trend today we see in the global API market is increase focusing on complex formulations in generics as a part of development. This is mainly because of among patient populations, all those with chronic diseases and those requiring the treatments in oncology, immunotherapies, and respiratory, for example. These are supposed to be one of the very complex conditions that are demanding a wide range of complex treatments using complex molecules.
GENERIC FOCUS The drugs that are mainly in the pipeline for the APIs are the once whose patent is off patent or soon-to-be off patent.
QUALITY CONCERNS According to the reports suggest that most of the APIs that are being used worldwide are manufactured in China, which is being widely acknowledged as the largest supplier globally. This is seen as a problem by observers and market analysts, who state that there are repeated and ongoing regulatory concerns and red flags about API manufacturing standards of China making it as a major concern. The recent issue with tainted valsartan that was produced in China is a case in point. This has enlightened the path for many manufacturing companies to start the API market instead of acquiring API from other companies have expanded their capabilities and start manufacturing their API.
ENVIRONMENT CONCERNS The other pivotal issue that has changed the dynamics of the API market sector in the very recent years is that the number of studies have linked improperly treated wastewater discharge from drug ingredient product facilities. Therefore various efforts to encourage manufacturers to source from API firms that process wastewater appropriately had to be introduced, only companies that are encouraging the green go were in favor for the regulatory Likewise, individual pharmaceutical companies in India have taken it as a point of importance and have also taken steps like in case of GSK, J&J, Merck, AZ, Pfizer and others have committed to reviewing their practices.
The Indian pharmaceutical industry ranks one among the top API markets in the world and China being its major competitor. The lower cost of the manpower and the growing technology and innovation are some of the main factors supporting its growth.
The API industries in India include domestic consumption as well as for the exports. API manufacturers of India are trying to strengthen their global marketing by different means mainly by focusing on the improvement of production of especially complex products as stated above, by through process modification, by increasing strategies to increase sales in international market etc. The Indian companies manufacturing API are being obliged to the standards and are compliant with many international regulations. Also the , improvements in the filed of technology in the country have enabled many manufacturers to venture into the highly regulated markets of the countries like United States and Europe. This has led that the Indian active pharmaceutical ingredient to get the approvals in various countries, increase the therapeutic applications and manufacturing facilities and henceforth aggressively strengthening their credibility in regulated markets. These API companies, are continuing to outpace the Chinese, Italian and other competitors in terms of DMFs, which are seen as a gradient of quality. Higher quality of the ingredient, coupled with cost-effectiveness has made India increasingly attractive for API outsourcing in the recent times. In fact, India has been recognized as one of the leading global players with the filing of large number of DMFs and dossier registrations for active pharmaceutical ingredients, with several manufacturing facilities approved by the regulatory authorities of developed countries.
CONCLUSION The important players being China and India are driving the market growth through their cost effectiveness and regulatory or quality issues and have emerged as manufacturing hubs for the APIs. But in the near future with the government support, improving IP systems and manufacturing standards in India it is expected that India will grow steadily in the coming years. In the near future India may beat China in global active pharmaceutical ingredients market.