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Enhanced R&D efforts and the growing manufacture of finished-dosage drugs in India will shape the country's future success, according to a new report from CPhI.
CPhI and Global Business Reports released Pharma Insights: India Market Report, an abridged version of the report CPhI India Pharmaceuticals 2015 – Industry Explorations, which will be released at CPhI India 2014 in Mumbai, India, December 2–4, 2014. The report highlights the growing trends in India’s pharmaceutical market and predictions for where the industry will be by 2020.
Over the past few years, India has seen changes in its domestic market because of shifts in manufacturing, exporting and importing, and government regulations. Traditionally, API manufacturing made up the majority of India’s manufacturing business. Recently, however, trends have led India to increase the manufacture of finished dosage drugs. API producers are increasingly moving toward “high-value low-volume work with complex chemistry and IP challenges,” according to the report. The industry in India was reliant upon supplying its own population of more than one billion people, until recently, when companies started to focus on global exports. The report notes that Indian pharmaceutical companies appear to be shifting from an industry dominated by foreign companies to one that is dominated by Indian multinational companies focused on global-scale manufacturing.
Subhanu Saxena, managing director and global CEO of Cipla, characterized India’s strategy as one that should be constantly evolving and must focus first on building a solid foundation in India, which boasts 45% of total income, and then work to expand globally.
Another change that is occurring regarding R&D in the Indian pharmaceutical industry has been met with praise, as well as some consternation. Many of India’s largest pharma companies are deciding to invest in R&D of drug delivery, technology, biosimilars, and generics. While there are Indian companies that are actively researching advanced healthcare innovations, some do not believe R&D is being cultivated to its full potential. Dr. Prasad Panzade, vice-president/head, corporate analytical services (R&D and quality), Aditya Birla Science & Technology, wrote in the report,“[In India, companies] are more focused on generic drugs and waiting to get the patents expired … R&D means just modifying what is available in the market. The industry needs to put in bigger efforts towards research and development.” Rao Vadlamudi, PhD, president of IPA, disagrees with this sentiment. He stated in the report, “I see the future for the Indian pharma industry in APIs and generic formulations rather than in R&D.” Regardless of the focus, spending on R&D in India was up 19.7% in the financial year leading up to March 2013, indicating that the industry is indeed beginning to move toward expanded R&D programs.
A recent analysis from IMS Institute for Healthcare Informatics reported that low-cost generics will continue to drive growth in India and Pakistan, as efforts to improve access to basic health insurance is occurring in these regions. Compared with all of the countries included in the IMS report, India had the lowest percentage of new molecular entities in 2013 across all medicine classes.
Governmental changes are also beginning to facilitate increased growth in India. Tight regulations are key to developing a strong market, pushing regulators to strive to bring India’s market close to other thriving markets, such as FDA. The Indian Drug Manufacturers’ Association (IDMA) is encouraging companies to invest in R&D, while the Government of India provides support and encourages education.
By 2020, it is expected that biosimilars will make up 15% of India’s market. Biocon introduced the world’s first biosimilar (trastuzumab) and has launched a number of monoclonal antibodies. Similarly, Ranbaxy introduced the first biosimilar for Remicade in India in December 2014.
India is a steadily growing market that will begin to see production costs rise. Considering that the US acquires over 40% of all of its drugs from India, the report predicts that India-based companies will replace the US “as the global centre of pharma manufacturing.”