Injectables makers from India are gaining prominence on the world stage as global pharma firms scramble for viable low cost assets. Here is a brief survey of recent happenings across India’s injectables landscape.

The most recent deal occurred between Nitin Lifesciences and Recipharm AB. Recipharm formally completed the process of acquiring 74% of Nitin for approximately $105 million in April. The privately owned Nitin specializes in manufacturing small volume parenterals. With three WHO-GMP facilities spread across the northern part of India, the CMO supplies liquid ampoules, dry powder of beta lactam and non-beta lactam, and lyophilized vials across various therapeutic areas. 

Recipharm’s chief executive officer, Thomas Eldered, said the addition of capacities would help the CMO expand not only in the fast-growing Indian market but would help it enter into other regions. The acquisition also bolstered Recipharm’s strengths in sterile injectables and lyophilization, according to Eldered.

Earlier media reports said the generic injectables business of Claris Lifesciences (CLL) was up for sale. Located in Ahmedabad, CLL’s manufacturing range includes blood products, anti-infectives, parenterals, plasma volume expanders and intravenous bags. The company runs three facilities and boasts product approvals from various regulated markets. CLL filed a total of 43 ANDAs with FDA and secured 13 approvals, according to the company’s most recent annual report.

CLL transferred its specialty injectables business into a separate entity called Claris Injectables Ltd. some time back. The spin-off of the business into a 100% subsidiary added grit to the mill. Rumors suggested the move was a precursor to a sale by the company, which spawned a rush of bidders. Interestingly, the long list of prospective buyers included many Indian players as well.

Premium buys
Big-ticket deals are not new to India’s generic injectables sector. Mylan acquired Agila from Strides Arcolab for $1.6 billion in 2013, adding 13 manufacturing facilities located across six countries and four R&D units. In 2009, Hospira bought out Orchid’s injectables business for $400 million. Both Mylan and Hospira deals stood out as these companies paid huge premiums for securing these Indian assets.

On the investment front, the U.S. buyout firm KKR & Co. paid $200 million for a minority stake in Gland Pharma, a generic injectables maker based in Hyderabad, late in 2013.

Unmistakably, injectables makers are the most sought-after because manufacturing sterile injectables involves complex know-how and is highly capital intensive. New entrants also find stricter regulations for manufacturing and supply of injectables another major barrier.

The global outsourcing of generic injectables is forecast to grow 10% annually over the next five years, according to CPHI’s 2015 annual report. Growth is being driven by a preference for high-potency products, demand from companies for using secondary manufacturing sites to de-risk supply chains, growth in emerging markets for generics, and the need for specialized technology from CMOs. Small molecule injectables are expected to grow at a faster rate while drug delivery systems like liposomes, pegylation and depot injections are also expected to grow.

Rising demand
Several Indian generic makers have already identified injectables as their targeted area for future growth. Aurobindo Pharma is looking at growing the sales of injectables by 50% year-on-year. To achieve this, the Hyderabad-based firm is banking on nearly four-dozen ANDAs pending with FDA for approval plus a robust pipeline of products. Aurobindo, which secured approvals for isosulfan blue single-dose vials and tranexamic acid injection from FDA this year, is working on penem products, non-SSP type antibiotics and anti-anxiety drugs. The company says it plans to enter oncology, hormonals and renal segments in the short-term.

The Mumbai-based Glenmark is reportedly building an injectables unit at its site in Monroe, NC, with an expected capacity of 20-25 million vials and pre-filled syringes per year.

Meanwhile, a few others with interest in injectables started adding capacities through mergers and acquisitions. Early last year, Mumbai-based Piramal Enterprises acquired the Kentucky firm Coldstream Laboratories to beef up the CMOs formulation offering. A year before Sun Pharma bought out Pharmalucence Inc., along with its new 70,000-sq.- ft. facility in Billerica, MA, for automated, isolated aseptic filling. Lupin also made an acquisition in the same year by bagging Naomi BV of The Netherlands, to firm up its foothold in the injectables market.

According to industry analysts, generic injectables will continue to see strong investment and growth in the years ahead.

“Outsourcing to India remains attractive,” said Sujay Shetty, partner and leader, pharmaceuticals and life sciences, PwC India. “But quality is paramount and companies will have to continue to be on top of quality issues to be in the game.”