By Jim Zhang, Ph.D., JZMed, Inc.
The pharmaceutical markets of China and India have been experiencing such rapid growth in the past decade that they are widely recognized as two of the world’s most dynamic emerging markets. Consequently, they have attracted many drug companies around the world.
Similarly, the pharmaceutical industry in these two countries has also experienced rapid advancements in recent years. The technical capabilities, production skills, and regulatory knowledge of the local companies have accordingly been greatly improved and reached acceptable levels for global companies. These features, coupled with the still-low costs of their services and/or products compared with those of the developed countries, have made these two countries the primary choices of global drug companiesfor sourcing raw materials and finished products or outsourcing of manufacturing work.
However, despite a number of similarities between China and India, there are still a larger number of differences between these two countries in the areas related to pharmaceutical manufacturing. The strengths and weaknesses of each country and their advantages and disadvantages to certain sourcing/outsourcing projects have become the key differentiators. Many sourcing/outsourcing companies are, however, still not clearly aware of these differences.
We recently conducted an indepth study and analysis on the pharmaceutical manufacturing industries in both China and India. Our study focused on the growth and development history of 200 major pharma companies in each country. The study revealed some interesting results, such as similarities and differences regarding their capabilities, capacities, market sizes, cost structures, strengths, and shortcomings. The research also indicated future development potentials, as well as the strategies of multinational companies in these two countries. This article summarizes our results.
General Comparison Of Pharmaceutical Industry Between China And India
In many aspects, China and India are very similar. Both countries are located in Asia with similar sized populations, and both belong to the group of emerging markets with fast-growing economies. Both countries also have low wages for most workers in many industries.
There are, however, also significant differences between these two countries. For example, generally speaking, China has a better general industrial infrastructure than India because the Chinese government has put enormous efforts and investments in this during the past two decades. The logistic service in China also is better developed and less expensive than in India. These advantages have made China attractive to foreign companies looking for a country where doing business is relatively easy.
However, India has its advantages, too. It has a better infrastructure in information technology (IT) than China, which is significant since IT skills play an important role in data management, bioinformatics, and clinical trials. The business philosophy and operating culture in most Indian companies are closer to Western traditions than their Chinese counterparts. This makes Indian companies easier to negotiate and reach business deals with their Western partners.
Analyzing further, to some extent, China has a better education system in biology, molecular biology, and other life science–related fields, resulting in, generally speaking, a better biotech industry in China than in India. However, India has paid attention to promoting its pharmaceutical industry a lot earlier than China. This has directly resulted in a stronger pharmaceutical industry in India than in China. For example, India currently has a substantial number of key players whose capabilities are strong enough to compete full-scale in the international market; whereas so far none of the Chinese drug companies has reached the same level or even come anywhere close.
At present, to global pharma companies, China and India possess the best ratio of cost to product/service quality among all emerging countries. However, the current labor and raw material costs in the Indian pharmaceutical industry are generally about 25% to 30% higher than in China. That fact makes China more attractive than India to pharma companies when they source bulk materials or outsource long-term, large-scale manufacturing projects.
Comparing China’s And India’s API Manufacturing
Unlike their Chinese counterparts, the majority of Indian pharma companies began with simple dosage forms and then gradually moved to novel and/or complex drug delivery systems, and later decided to expand their business scope to include APIs. This development model is commonly called reverse-engineering. To a large extent, this development pattern has resulted in the shortage of APIs in India. At present, only about 70% of the APIs the Indian pharma industry needs are made domestically. The rest are imported from other countries, mostly from China. Many Indian drug companies have thus been sourcing APIs from China for many years.
Compared with its Indian counterpart, in the global pharmaceutical manufacturing industry, China has been well recognized as the world largest API producer. For example, among the total of 2,000 or so APIs in the global market, China can make close to 1,600 of them. As a comparison, the Indian pharma industry is currently able to make about 400 APIs. However, at present, most Chinese API makers still do not have sufficiently good technical or R&D capabilities. They are mostly engaged in only low-tech manufacturing.
Currently, the most popular Chinese-made APIs are still those for the medications of bacterial infections. As a comparison, the APIs in the therapeutic areas of oncology, cardiology, diabetes, and tropical diseases are the main products of most Indian pharma companies.
APIs are also the largest class of products among all Chinesemade pharma-related products marketed overseas. China currently has about 1,000 API makers that market their products in the international market. The export value of the Chinese-made APIs reached $22 B in 2011, accounting for about 49% of the total export value of all Chinese-made pharma-related products. From 2005 to 2011 this Chinese pharma sector successfully maintained a CAGR of around 13%. As a comparison, the current export value of the Indian-made APIs marketed overseas is only about $6.7 B. From 2007 to 2011, this Indian pharma sector has successfully maintained a CAGR of about 15%.
Currently, there are about 150 Chinese API manufacturers that have various numbers of APIs registered with the international regulatory agencies; and about 30 of them have API production facilities that are cGMP-certified by the regulated countries. As a comparison, there are a total of more than 120 Indian pharma plants that have passed FDA’s cGMP inspection. More than 800 manufacturing units in India are also in compliance with WHO’s standard.
Comparing Drug Formulation And Manufacture Of Dosage Forms
For a number of years, China has been well-known for marketing APIs in the global market, but less recognized for any of its dosageform drugs. Although a large number of Chinese companies also produce dosage forms, only a handful of them are currently able to market a limited number of their finished products in the regulated markets. To a large extent, this has determined the low-end position of the Chinese-made pharma products in the international market and the long value chain of global pharmaceutical supply.
Collectively, the Chinese pharma industry is able to produce more than 60 dosage forms with a total of about 5,000 medicines. Among all dosage forms, the powder for injection is the largest group, followed by oral solids. As a comparison, India is currently able to make almost all types of dosage forms with a total of more than 60,000 medicines. A large number of Indian companies has even gained the formulation and manufacturing capabilities for difficult-to-make forms, including injectables and soft gels. Attracted by their capabilities in formulation, a number of major pharma companies have collaborated with Indian companies on codevelopment of generic drugs or licensed the sales rights to them.
Currently, an increasing number of Chinese pharma companies are aggressively improving their production facilities and aim to get them certified by the regulated countries. Compared with their Chinese counterparts, a larger number of Indian pharma companies possess large manufacturing facilities that have already been certified by the regulated countries.
Currently, China markets finished drugs in more than 170 countries and regions. But the largest markets are still the developing countries. The current total export value of dosage forms is only a little more than $2 B. Sales of the Chinese-made finished drugs in the developed countries account for about 40% and are mostly marketed by the Chinese divisions of major multinational pharma companies. In comparison, the current total export value of India’s finished drugs is about $11 B. About half of the Indianmade finished drugs are marketed in the well-regulated markets, mostly by the Indian companies themselves.
Where To Source Or What To Outsource
India has been playing increasingly important roles in the global pharmaceutical manufacturing industry. Its recognized capabilities in formulation development, finished drug manufacturing, and product marketing in the regulated markets have made it a trusted source for global pharma companies when seeking partners for codevelopment and/or comarketing of generics.
China’s current strengths reside in its better industrial infrastructure, large-scale manufacturing capabilities of raw materials, and relatively low labor and material costs. India’s current strengths include its stronger capability in process development, drug formulation, dosage form manufacturing, and marketing in well regulated markets.
Thus, it can be concluded that, at present, the Indian companies are the better choice for formulation development, manufacturing, and marketing of dosage form drugs. In contrast, Chinese companies are a better fit for upstream work, such as contract manufacturing (and sourcing) of advanced pharma intermediates and APIs. Also, Chinese companies charge less than Indian counterparts for the same type of services/products, thereby offering better cost-reduction benefits.
On the other hand, as our research results have revealed, even though China and India are presently the hotbeds for global pharmaceutical manufacturing, they still play much less significant roles than developed countries, in particular in the high-end areas such as the special formulation techniques and the manufacture of APIs and finished drugs that are still under patent protection. The situation is largely determined by the intrinsic weaknesses of these two countries in low R&D investment in pharmaceutical industry.
Jim Zhang, Ph.D., is president and managing director of JZMed, Inc., a market research company specializing in research on the Chinese pharmaceutical outsourcing industry. The company also provides consulting services for pharmaceutical outsourcing in China.