You are here:     > Corporate Overview > Strategy for Global Formulations Business & API

Strategy for Global Formulations & API Business

The Global Formulations and Active Pharmaceutical Ingredients (API) business is the dynamo that powers our growth engine. Our clearly defined strategy for this segment is characterised by a sharp focus on important geographies and specific therapy areas; and backed by a prolific product pipeline of generic formulations and APIs for multiple markets. In future too, this strategy, coupled with our readiness to launch innovative products, build strong brands and strike partnerships for products and distribution where necessary, will help optimise our presence in key global markets.

Here’s a look at how our strategy is unfolding in these markets.

India

In the last 5 years, we have grown faster than the industry every single month, and are the only company among the Top 20 by market share to do so

In India, we are focussed on the fast growing therapy areas of dermatology, respiratory and cardio-metabolic. These focus therapies now contribute almost 75% of domestic sales. We have outpaced the Indian pharmaceutical market with the launch of innovative/ differentiated products and successful brand-building efforts. In the last five years, we have grown faster than the industry every single month; and are the only Company among the Top 20 by market share to do so.

The Indian Pharma market is expected to grow about 10% - 15% per annum between 2015 - 2020 and will outperform the global pharma industry. Factors such as greater urbanisation, increased life expectancy and improved access and affordability will drive the growth for the Indian pharma industry. Branded generics dominate the pharmaceuticals market, constituting nearly 80% of the market share in revenues.
(Source: IBEF.org)

Going forward, we will grow our share in the following core therapy areas with innovative product launches and leverage existing brands. We will use a combination of internal research and development and in-licensing to ensure a rich product pipeline for future launches.

Respiratory

While continuing to capitalise on the strong brand equity of our warhorses such as Alex and Ascoril, we are now moving up the value chain with innovative drug-device combinations. We launched Digihaler, India’s first digital dose inhaler designed to address the problems of pseudo-adherence and patient non-compliance to therapy. Airz, India’s first Dry Powder Inhaler (DPI) of the drug Glycopyrronium and Nebzmart, the first nebuliser with vibrating mesh technology that can nebulise both solutions and suspensions efficiently, are innovations to help patients better manage chronic respiratory conditions such as asthma and COPD.

Glenmark’s manufacturing facility at Baddi, India

Dermatology

Glenmark has always had a formidable presence in dermatology with several pioneering formulations launched in India for the first time. Customers recognise Glenmark as an innovation and quality-led organisation with strong brands like Candid, Candid B, Elovera, Scalpe, Onabet, Syntran and many more. The Candid franchise continues to be highly regarded among dermatologists across the country.

Glenmark has emerged as a leader in the dermatology space by focussing on three main aspects: therapy leadership, business leadership and knowledge leadership.

Therapy leadership was attained by introducing differentiated products and expanding our product range within the dermatology segment. Individual divisions were realigned to cater to the entire spectrum of dermatology and cosmetology, mass dermatology, clinical dermatology, pediatric dermatology, cosmetology and aesthetics.

Business leadership was attained by launching divisions, each catering to a specific aspect of dermatology and hence mapping the complete therapy range.

Knowledge leadership was built through a plethora of Glenmark Captive Scientific platforms that were instituted to share our expertise in dermatology to help doctors and patients alike.

We will continue to make the most of our capabilities built over the four decades to maintain leadership and bring first-in-India and differentiated products to the market.

Cardio-metabolic

Given the life-threatening and chronic nature of cardio-metabolic diseases, we endeavour to launch best-in-class treatments at affordable prices. We are the only Indian company to conduct a Phase III clinical trial in the country for Teneligliptin, a novel diabetes molecule from a class of drugs known as DPP-4 inhibitors; thus, making it available to the Indian population. The DPP-4 market, which was earlier restricted by high prices is now witnessing greater volumes. We have rapidly enhanced our share in the diabetes segment, and are now a leading player in the market. We have built strong marques such as Telma, our brand of hypertension drug Telmisartan and recently launched Asar, our brand of Azilsartan for hypertension. In a short span of time, we have built expertise and have a rich pipeline of products lined up for this segment.

Along with our Rx business, we continue to build a strong over-the-counter (OTC) franchise. Our strength has been in the product selection. Our female hygiene product Vwash has become a category creator in our OTC portfolio. Other major OTC products are Candid Dusting Powder (DP) and Scalpe+. CandidDP is a 30-year-old flagship and a prescription leader in the category of fungal skin infection. Scalpe+ is a 17-year old brand with a proven track record in dandruff treatment.

Leading Glenmark products in India
While continuing to capitalise on the strong brand equity of our warhorses such as Alex and Ascoril in the respiratory segment, Glenmark is now moving up the value chain with innovative drug-device combinations

USA

We are leveraging internal and external R&D capabilities for bringing more complex generics to the US market

Each year, close to 83 mn prescriptions are filled by our products in the US. Our business has grown at a CAGR of about 20% over the last five years in the US region. As an early entrant into the US generics market, we have established ourselves as a leading generics player. We are now looking to cement that position with a combination of niche and complex generics, significant first-to-file (FTF) opportunities, and innovative launches. The US generics market is valued at USD 115 bn as on March 2017 and is expected to grow by 5% in terms of prescription value over a period of five years.

From the beginning, in addition to conventional oral solids, our focus has been on value-added niche generics in relatively high barrier-to-entry segments such as oral contraceptives and dermatology with less than five, sometimes even as few as two competitors. This has yielded results and today, we are one of the largest generics players in the dermatology market.

In parallel, we continue to target significant FTFs on blockbusters with either sole or shared exclusivity. In December 2016, we launched the first and only generic version of Merck’s cholesterol brand ZETIA® (Ezetimibe) in the US for which we are entitled to 180 days of generic market exclusivity along with our partner Endo.

To overcome pricing pressures caused by buyer consolidation and greater competition, we have successfully identified various newer therapy areas and dosage forms. Our endeavour is to enter one or two dosage forms with limited competition every year. In line with our therapy focus on oncology, we have already filed for nine cytotoxic injectables for approval, which are slated for launch in the next 12-18 months. In the respiratory segment, we are developing device based products such as inhalers and other complex generics. Once launched, these will help us combat emerging competition.

In addition, we are also leveraging internal and external R&D capabilities for bringing more complex generics to market. We have concluded multiple in-licensing deals and have others in advanced stages of discussion. In September 2016, we licensed the generic ABRAXANE®, which is a chemotherapy drug from Particle Science. Development has been initiated with a USFDA filing targeted for CY 19. As per MAT March 2017, ABRAXANE® registered sales of USD 657 mn in the US. In March 2017, generic NuvaRing®, which is a vaginal ring for birth control was licensed from Evestra Inc. We expect to file for marketing approval in FY19. Merck’s NuvaRing® registered sales of USD 783 mn as per MAT March 2017 in the US market. Our foray into specialty is expected to commence in CY 19 with the launch of GSP 301 for seasonal allergic rhinitis. This is our first branded specialty product to clear Phase III trials and we expect to file for USFDA approval in CY 18.

Glenmark’s manufacturing facility at Monroe, North Carolina, USA

Selected large and complex generic products in pipeline for the US market

Europe

The business model will morph into a hybrid of branded and generic as we prepare to launch innovative products from the Glenmark pipeline

Our European business is based on an optimal mix of internally developed and in-licensed products because of the unique nature of the European regulatory environment. We are primarily present in Germany, the UK and parts of Central and Eastern Europe (CEE). Over the last five years, our business in Europe has grown at a CAGR of 17.51%. In Germany, we are among the Top 15 generics firm and one of the fastest growing generics companies.

Going forward, we will deepen our presence in UK, Germany and select markets of CEE. Our selective forays into new markets will be based on the suitability of our product portfolio to those markets and the potential to build a profitable business. In countries where we don’t have a front-end presence, we will continue to out-license our products to partners. Like in the US, we will focus on differentiated generics from internal and external R&D sources in respiratory, dermatology and oncology. For instance, we expect to launch generic Seretide, a dry powder Inhaler, next year in the respiratory therapy, which has a relatively low competitive intensity. We have in-licensed the product from Celon Pharma for 15 European countries with a combined market size of USD 700 mn. We are also exploring tie-ups with channel partners to launch unique OTC products.

In addition, we continue to identify opportunities in our innovative and specialty portfolio, which can be leveraged for Europe. The business model will morph into a hybrid of branded and generic as we prepare to launch innovative products from our pipeline.

Other Emerging Markets

Russia, Brazil and Mexico will be major growth drivers in the next five years led by new launches in the respiratory and dermatology therapies

Our presence in the emerging markets i.e. Asia, Africa, Russia and CIS and Latin America is characterised by a strong track record of capturing share through durable brand-building. For instance, in Russia, Ascoril is the number three brand in the expectorants segment and we rank number four in the expectorants market. The Candid franchise is well-entrenched in dermatology and we continue to be one of the Top 10 players in this therapy area.

Over the past decade, we have continued to invest in building our presence in select therapy areas like oncology, respiratory and dermatology and the business is poised to grow continuously.

Our preferred growth strategy is to deepen our presence in existing markets.

We will focus on internally developing complex, high barrier-to-entry products while also exploring in-licensing opportunities. Products in our specialty pipeline which are being developed primarily for the US market will also be made available in emerging markets. Russia, Brazil and Mexico will be major growth drivers in the next five years led by new launches in the respiratory and dermatology therapies.

Another key strategy would be to drive profitable growth by focussing on operational excellence efforts and leveraging already established infrastructure.

API

We are sharpening our competitive advantage with intellectual property-protected innovation and a focus on first-to-file opportunities

Over the years, we have established and maintained leadership positions in multiple active pharmaceutical ingredients such Amiodarone, Lercanidipine, Adapalene and Perindopril. Glenmark’s API R&D business serves players targeting the regulated markets of the US, Europe and Japan.

We have forged strong relationships with a majority of large formulation players. Our USP is our intellectual property protected innovation and focus on first-to-file strategy. Moreover, our API business continues to support our internal requirements. This helps us to de-risk our supply chain and enhance our cost competitiveness. API business is largely focussed on the regulated markets and this has enabled us build a strong business both in terms of revenue and profitability.