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Industry overview

  • The global pharmaceutical contract manufacturing market can primarily be categorized into injectables, solid and liquid dosage forms. Solid dosage is the largest segment by revenue, but the injectable segment is expected to show the greatest growth to 2015.
  • Asian CMOs started with large-scale manufacturing for generic and research driven companies but are now acquiring assets in the US and Europe to enter the discovery and development segments of the pharmaceutical value chain.
  • India has over 100 US FDA approved API formulation plants, the highest number outside the US, and over 150 current good manufacturing practice (cGMP)compliant manufacturing facilities.
  • India, riding on its cost-value proposition comprising low-cost skilled manpower and technical capabilities is strongly positioned to capture a significant portion of the growing CMO market. The Contract Research and Manufacturing Service (CRAMS) market will also continue to grow strongly.
  • India has emerged as one of the leading cost-competitive and quality manufacturing hubs for many multinationals including big pharma companies. Rising cost pressures have continued to drive pharmaceutical companies to seek the cost advantages offered by Indian CMOs.

Jubilant Organosys

  • Jubilant Organosys’s CMO business is well positioned to service full spectrum of life sciences companies, starting from large scale pharmaceutical players to virtual biotech organizations all over the world. Moreover, its acquisition in the CRAMS space such as Hollister-Stier in the US (June 2007) and Draxis in Canada (April 2008) have consolidated its position in the regulated markets.
  • The Washington Hollister-Stier facility is focused on the delivery of clinical and commercial fill and finish services for sterile parenteral pharmaceuticals, utilizing both liquid and lyophilisation capabilities, whereas the Draxis facility has multi-dosage potential ranging from sterile parenteral (vial and ampoule liquid and lyophilisation), to sterile and non-sterile semisolid manufacturing.
  • Jubilant Organosys’s business is divided into two broad categories: Pharma and Life Sciences Products and Services (PLSPS) and Agri & Performance Polymers. The PLSPS form the core business of Jubilant Organosys constituting 88.9% of the company’s overall business in FY 2010.
  • Custom Research and Manufacturing Services the largest business segment for the company, grew by 8.7% to reach $450m in FY 2010. Its Proprietary Products and Exclusive Synthesis segment posted the highest sales, reaching $198m in FY 2010. Furthermore, its CMO business of Sterile Injectables and Non-sterile Products remained the second best-selling segment under CRAMS, reaching $140m in FY 2010.
  • Jubilant Organosys offers a wide range of R&D and manufacturing services for intermediates, APIs, and in-market products from development to the post-launch stage. It assists in process development and process optimization for intermediates and APIs on a contract basis.

Dr. Reddy’s

  • Dr. Reddy’s is a leading globally generic manufacturer and a major Indian CMO. Its products are supplied and marketed all over the world, with major focus on India, US, Europe and Russia.
  • The company’s products and services are broadly categorized into: active pharmaceutical ingredients (API); Custom Pharma Services (CPS); Global Generics; Generic Biopharmaceuticals; and New Chemical Entities & Differentiated Formulations.
  • Dr. Reddy’s full-fledged R&D divisions are mainly concentrated on the development of chemical processes for API synthesis and intermediates used in Global Generics segment. It also support its custom pharmaceutical line of business through strong knowledge of process chemistry and finished dosage development expertise.
  • Although Dr. Reddy’s consolidated revenues increased marginally in local currency, it recorded a y-o-y decline of 2% in dollar terms to reach $1.5bn in FY 2010. Its Pharmaceutical Services and Active Ingredients (PSAI) business which is mainly composed of APIs and custom pharmaceutical services remained the second best selling division for the company recording FY 2010 sales of $431m at a y-o-y growth of 5.3%.

AuroSource

  • AuroSource is the Contract research and Manufacturing Services (CRAMS) division of Aurobindo Pharma which offers outsourcing options to many biotech and pharmaceutical companies across the globe.
  • AuroSource’s portfolio includes several specialized R&D capabilities, with strong expertise in customized APIs, intermediates, pre-formulations, and formulations.
  • In the last few years, AuroSource has made a significant progress in CRAMS sector and established itselves as one of the Asia’s largest manufacturer of cephalosporins and penicillins.
  • In spite of global recessionary conditions and severe competitive pressure, Aurobindo Pharma strengthened its position in all geographies and improved its marketing reach. Although its formulation business has a share of revenues of over 50%, its generic pharmaceuticals and API segments remained the other major contributor to its consolidated sales of $770m in FY 2010.
  • AuroSource’s manufacturing services covers a wide range of techniques such as plant scale material for clinical trials, commercial scale chromatographic separation and lyophilisation. Moreover, the Company’s multi-product FDA inspected site for oral dosage formulation is one of the Asia’s largest solid oral facilities, equipped with a zero discharge system.

Divis Laboratories

  • Divis Laboratories, an Indian custom manufacturer of APIs and advanced intermediates operates through two subsidiaries: Divis Laboratories Inc (US), and Divis Laboratories Europe AG (Switzerland). The company also produces and markets of nutraceutical products in North American and European countries.
  • Divis Laboratories’ business model can be broadly categorized into two divisions – Generic APIs; and Custom Synthesis of APIs, intermediates and specialty ingredients for innovator pharma companies.
  • The company has four research centres with well defined functional focus on custom synthesis, contract research for foreign players involving processes like route design, route selection, process optimization, impurity profiling, pilot studies, pre-validation batches, validation of process and transfer of technology to plants.
  • With FY 2010 sales of $196m and a y-o-y decline of 24.6%, Divis Laboratories was a major company to feature among the leading contract manufacturers in India. Exports constituted over 90% of its gross sales during FY 2010.
  • Although the company was hugely impacted by recent global liquidity crunch and subsequent inventory rationalization, customers have almost finished the inventory de-stocking process which will lead to fresh orders in 2010/11.

Dishman

  • Dishman’s continued focus on strengthening its R&D expertise and strong reputation in intellectual property (IP) development and protection has enabled the company to emerge as one of the leading contract research and manufacturing services (CRAMS) player in the Indian CMO market.
  • Apart from Carbogen-Amcis’s acquisition in 2006, Dishman also ventured into a vitamin D and its analogue manufacturing, by acquiring the business from Solvay in 2008 which is expected to contribute around 8–10% of its total revenue in 2010/11.
  • Although Dishman initially started off its business operations with specialty chemical and Quats, CRAMS command a leading role in Dishman’s current business model with revenue contribution of over 70%.
  • In FY 2010 Dishman recorded revenues of $193m, a 16.6% drop in revenues on the year before. The decline in revenues was largely driven by a sharp fall in its Switzerland Subsidiary – Carbogen Amcis (which contributes a major portion to the total revenues) along with the global economic slowdown.
  • Dishman has also strengthened its contract manufacturing offerings by setting up a high potency API facility (targeted mainly for cancer) with an investment of around $17m, which is the only plant of its kind in the Asia-Pacific region.

Piramal Healthcare

  • Piramal Healthcare is one of the largest pharmaceutical manufacturers in India, and has a diverse portfolio of products spanning around 17 therapeutic categories. It is also recognized as a major contract manufacturing organizations with a global footprint of assets across North America, Asia, and Europe.
  • The company operates in two key divisions: Healthcare Solutions and Pharma Solutions, of which Pharma Solutions is considered as its contract manufacturing business. Its Pharma Solutions segment gained a significant scale of operations and recognition among its clients, following the acquisition of Pfizer’s Morpeth (UK) manufacturing facility in August 2008.
  • Piramal Healthcare’s business model is unique among its peers. In addition to its CRAMS operations, the company is also a major player in India’s pharmaceutical market.
  • The Healthcare Solutions is the flagship segment of the company with revenue contribution of around 54.5% followed by Pharma Solutions (24.1%), Critical care operation (8.9%), and Diagnostic services (5.6%).
  • Piramal’s Healthcare Solutions business recorded the highest sales for the company registering $422m at a y-o-y growth of 20.6% in FY 2010. However, its Pharma Solutions segment, which provides CRAM services such as clinical stage API synthesis, formulation development, and finished dosage supply, recorded $187m sales at a y-o-y decline of 19.2% in the same year.

Hikal

  • Hikal is a reliable outsourcing partner to many companies in the pharmaceuticals, crop protection and specialty chemicals industry. It has several long-term supply contracts with some of the leading life sciences companies such as Pfizer and Bayer Crop Science for the manufacture and supply of APIs and agricultural chemicals.
  • Hikal’s R&D group is mainly focused on developing efficient and sustainable processes for its existing and new products. Its discovery research, analytical method development, synthesis of impurities, scale-up and technology transfer enables it to develop new products for life sciences companies all over the world.
  • Acoris, Hikal’s contract research subsidiary in India, have already completed a number of projects with some of the leading global mid-size biotech and pharmaceutical companies, reflecting its established contacts in developed markets such as the US, Japan and Europe.
  • In spite of global economic slowdown, Hikal recorded a significant y-o-y growth of 8.5% to reach $113m in FY 2010. Its pharmaceutical division posted the highest sales for the company registering FY 2010 sales of $75m at a y-o-y growth of 25.2%.

Shasun Chemicals and Drugs Limited (SCDL)

  • Shasun Pharmaceuticals Limited is one of the leading contract manufacturers of APIs and drug products with a significant presence in anti-inflammatory and anti-ulcerative treatments.
  • Shasun has an active presence in the CRAMS market of both APIs and finished dose forms. Its investment in state-of-the-art cGMP facilities has enabled it to execute several projects for innovator big pharma companies such as GSK, Eli Lily, Wyeth (now part of Pfizer).
  • During FY 2010, Shasun’s CRAMS business posted the greatest share of sales at $62m, contributing 55.6% of the total revenues. Although this division recorded a significant y-o-y decline of 22.9% in FY 2010, increasing outsourcing and contract manufacturing opportunity in India will revive its sales in the near term.
  • Shasun targeted Japan as a key pharmaceutical market during FY 2010/11 and intends to establish long-lasting relationships with various Japanese pharma players.

Biocon

  • Biocon is one of the largest biopharmaceutical companies with specialization in biotechnology (Biocon), custom research (Syngene) and clinical research (Clinigene). Over the years, this company has systematically leveraged its technology platform to evolve from an enzyme manufacturer to a fully integrated biopharmaceutical enterprise.
  • Biocon has a distinctive business model of self-financed innovative R&D, bio-pharma products and contract research services. Its current business model spans the entire pharmaceutical value chain, from pre-clinical discovery through clinical development and post-launch services.
  • Biocon’s Syngene division is one of the India’s largest pre-clinical service providers with a portfolio of discovery services, including scaffold and library synthesis, medicinal chemistry, cGMP manufacturing of APIs, drug metabolism pharmacokinetics (DMPK) profiling, crystallography, efficacy studies in animals and oral dosage formulation for human studies.
  • Despite the recent slowdown in global custom manufacturing business, Biocon’s custom research division (which includes both contract research and manufacturing business) recorded y-o-y growth of 20.9% to reach $59m in FY 2010.
  • Biocon is also recognized as one of the Asia’s largest manufacturer of insulin and global scale mAbs. Additionally, in 2009, it acquired a synthetic chemistry facility in Hyderabad to boost capability in this segment.

Suven Life Sciences

  • Suven Life Sciences is a major Indian biopharmaceutical companies with key focus on drug discovery, custom manufacturing and commercialization of novel pharmaceutical products.
  • Suven’s capabilities include: process optimization and production of organic fine chemicals and pharmaceutical intermediates, APIs, chiral synthesis, generic APIs, orphan drugs, and racemic switches.
  • Suven is well known for its collaborative research partnerships with some of the leading global pharmaceutical companies. For instance, it has established two central nervous system (CNS) research collaborative partnerships with Eli Lilly in the year 2006 and 2008, where scientists from both companies work together to identify potential oral compounds that selectively modulate G protein-coupled receptors.
  • Due to the global economic slowdown in recent years, Suven’s revenues dropped 8.4% y-o-y to $28m in FY 2010. Its CRAMS business recorded the highest sales of $20m capturing a share of revenues of 71.9% in FY 2010.
  • Suven Nishtaa, a joint venture company of Suven Life Sciences, is a pharmaceutical formulations contract service provider for global pharma companies. With over 110,000 sq.ft of world class infrastructure, Suven Nishtaa is a dedicated provider of pharmaceutical product development, scale-up and manufacturing services to both pharma and chemical players.

Scope

Scope

CMOs are the Contract Manufacturing Organizations that offer manufacturing services, with production volume capabilities ranging from small amounts for preclinical studies to multiple ton quantities for commercial distribution. This report profiles the leading players in Indian contract manufacturing market.

This report analyzes the Indian contract manufacturing market in terms of market dynamics (market size and profitability), key deals activity, current industry trends, and the competitive positioning of the leading 10 players in the market. It also includes a brief overview of other major players in the industry. The leading 10 companies in the industry were assessed on the following parameters:

  • Financial performance in the Indian contract manufacturing market or Indian Contract Research and Manufacturing Services (CRAMS) sector;
  • Major contract research and manufacturing deals in India;
  • Business-related strengths and weaknesses, and insights into opportunities and threats.

Methodology

The leading 10 contract manufacturing companies in India were selected from a long list of companies that are active in the industry. In-house data, analyst reports and secondary research were the key source of data collection. The companies were ranked on the basis of their contract manufacturing or CRAMS business segments’ revenues in FY 2010. Interviews with executives at leading CMOs were also conducted as part of the exercise to gain additional insights.

Industry overview

Summary

  • The global pharmaceutical contract manufacturing market can primarily be categorized into injectables, solid and liquid dosage forms. Solid dosage is the largest segment by revenue, but the injectable segment is expected to show the greatest growth to 2015.
  • Asian CMOs started with large-scale manufacturing for generic and research driven companies but are now acquiring assets in the US and Europe to enter the discovery and development segments of the pharmaceutical value chain.
  • India has over 100 US FDA approved API formulation plants, the highest number outside the US, and over 150 current good manufacturing practice (cGMP)compliant manufacturing facilities.
  • India, riding on its cost-value proposition comprising low-cost skilled manpower and technical capabilities is strongly positioned to capture a significant portion of the growing CMO market. The Contract Research and Manufacturing Service (CRAMS) market will also continue to grow strongly.
  • India has emerged as one of the leading cost-competitive and quality manufacturing hubs for many multinationals including big pharma companies. Rising cost pressures have continued to drive pharmaceutical companies to seek the cost advantages offered by Indian CMOs.

What are CMOs?

CMOs are Contract Manufacturing Organizations that offer manufacturing services, with volume capabilities ranging from small amounts for preclinical studies to larger volumes for clinical trials and commercialization. Like Clinical Research Organizations (CROs), CMOs are focusing on re-alignment of their business models with prevailing industry trends. CMOs have traditionally dealt with primary development services and dosage form of manufacturing. But more recently, due to increasing demand for complex products such as cytotoxics, many CMOs have begun to look at high-end services including the manufacture of high potency APIs.

The global pharmaceutical contract manufacturing market primarily covers injectables, solid and liquid dosage forms. Solid dosage is the largest segment by revenue, but the injectable segment is expected to show the strongest growth. Moreover, the demand for specialized technologies and services such as biopharmaceuticals, sterile products, and lyophilization is likely to drive the market in coming years.

India, one of the most favored CMO destinations in Asia, is able to offer services across the contract manufacturing value chain – from custom chemical synthesis to APIs and finished dose forms with significant cost savings. In addition, large numbers of scientists and engineers with skills in the areas of process chemistry and biochemistry support India’s strength in contract manufacturing.

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