This article discusses about the current market status, growth and future of excipients and pharmaceutical intermediates in India. First of all, we should discuss briefly, ‘what are excipients?' In general, excipients are inactive and inert substances; play important roles in the formulation of drugs by providing the stability of the Active Pharmaceutical Ingredients (APIs) and pharmaceutical intermediates. Excipients preserve the efficiency and ensure the promised benefits of controlled drug delivery to a patient. Excipients change the behaviours and effectiveness of a drug. As the drug substances become more challenging to formulate, there is a need for new excipients to overcome these challenges and in this aspect excipient industry is a fast growing industry worldwide.
In earlier days excipients were considered inert substances but the advances in pharmaceutical science and technology have facilitated the availability of a wide range of excipients (which also includes colours, flavours and preservatives). It is now believed that excipients need not be inert substances, even these include some potential toxicants. Excipients can act by different mechanism such as capillary action, capillary absorption, swelling action. Excipients play an important role in the drug formulation and development. It has a significant amount of share in pharmaceutical industries. Some major ingredients used in the pharmaceutical excipients market are sugars, lactose, maltose, methyl cellulose acetate (MCC), starch, alcohols, sorbitol, maltitol, xylitol, minerals viz., calcium phosphates, calcium carbonates and magnesium stearates etc.
Most of the excipients are branded products. It would be advantageous to collaborate with a foreign company having established brands. Plant and machinery consist of primarily mixers and blenders, fluid bed dryers, spray dryers, classifiers, crushers, pulverisers, boiler etc. To follow the GMP, excipient manufacturing process needs quality control equipment as a major component of the plant. The raw materials include starch, micro-crystalline cellulose powder, ethylene oxide, Propylene oxide, chloroacetic acid etc. Power and steam are the utilities required.
Global and Indian excipient market
The pharmaceutical industry is one of the fast growing industries in India, like in China. To meet the requirements of Good Manufacturing Practices (GMP) and international standards the Indian pharmaceutical industries is fast modernizing and changing.
The overall sales in global excipient market were worth $4.1 billion in 2008, and increased to $4.3 billion in 2009, valued at approximately $ 5.3 billion (3.4 billion Euros) in 2010. Based on a recent market study data, the total global market for excipients was estimated at $4.5 billion in 2013), with an average annual growth of seven per cent to eight per cent in volume and four to five per cent in value. This means that, the global excipient market is approximately 0.4-0.5 per cent of the global pharmaceutical market, which is evaluated at $ 850 billion.
North America and Europe, as the main pharmaceutical producing areas, consume approximately 70 per cent of excipient output. Japan takes another estimated 15 per cent and India, Brazil and China have become major single markets in recent years and are expected to increase to $7.2 billion (4.9 billion Euros) by 2016. This represents a five-year Compound Annual Growth Rate (CAGR) of 6.5 per cent. It is reported that approximately 5 billion kg of excipients were used in 2011, globally.
The largest segment of the market, organic chemicals, was valued at $3.8 billion in 2008; this is expected to increase to $4 billion in 2009, and is projected to reach $5.5 billion in 2014, for a five-year CAGR of 6.4 per cent. Whereas, the estimated Indian pharmaceutical market in 2009 was Rs. 40,000 crore and the present value is about Rs.90,000 crore with a growth of 10 per cent per year.
The estimated share value for excipient in market in this is about 10 per cent of the total market of Indian pharmaceutical industries. Indian excipients are also widely used in cosmetic and other health care products, which contribute about another Rs. 10,000 crore market.
In India a lot of starch based excipients of different commercial grades are produced from starch plants after chemicals or physical processing. Commercial grade micro-crystalline cellulose is available from cellulose powder manufacturers, which by chemical and processing are converted to excipients. However, Indian excipient manufacturers need to depend on import components and the manufacturing of excipients, which must follow the good manufacturing practice requirements.
The present status and future trends
There are currently 1,200 or so excipients on the market and they fulfil the needs of the majority of finished pharmaceutical products. There is no unmet need in immediate-release dosage forms for new excipients, although the big exception here is for modified-release dosage forms. Europe and North America account for about 75 per cent of the global excipients market. Manufacturers from India and China are also contributing to market significantly and their market share increases every year, because both countries already have a strong presence in API and intermediates manufacturing. They built on brand image and increased their presence in the market. Some chemicals with new functional groups are also being introduced as excipients and have been approved in recent years. However, a few specialized drug manufacturers have formulated drug products containing novel excipients in recent years.
Indian’s leading names in pharmaceutical excipients have joined hands to set up its first ever excipient council. Leading pharmaceutical companies’ viz. ACG Worldwide (serving the pharmaceutical industry for five decades and is the second largest manufacturer of empty hard capsules in the world), Colorcon, Indchem International, Micro Labls, Dow Chemicals, Lubrizol India, BASF India, SPI Pharma and Merck Groups are the founder members of the International Excipient Council (IPEC). IPEC has launched its Indian chapter, IPCEA India in February this year. IPEC India is the fifth member of the IPEC Federation, the others being the Americas, Europe, Japan and China.
Internationally, the IPEC Federation is the leading federation of the pharmaceutical excipients industry and has over 250 members across all affiliates. The IPEC Federation provides a unified voice that promotes the proper use of excipients in medicines as a means of improving patient treatment.
IPEC India’s primary objectives are to promote the excipient industries in India which aims to be a knowledge base and resource centre for the Indian excipients industry. It conducts workshops and seminars, organize conferences where training are being given regarding best practices and provides other suitable forums in which knowledge and best practices can be institutionalised in member companies. Through EXCiPACT (a voluntary international scheme to provide independent third party certification of manufacturers, suppliers and distributors of pharmaceuticals) and other initiatives, IPEC India will set and maintain standards for Indian excipient manufacturers and suppliers. From best practices in manufacturing, to audit guides and templates that will ensure not just a level playing field, but a high reliability quotient for pharmaceutical manufacturers when they use these excipients.
IPEC India will work actively to promote excipients safety and harmonisation of regulatory standards and pharmacopoeial monographs. It will be a source of advice and expertise on excipients and excipients-related regulations.
The council will focus its attention on the law, regulations, science and business landscape of the Indian pharmaceutical industry for excipient manufacturers and suppliers. It aims to be a proactive colleague of the Indian pharmaceutical industry associations and federations.
(The author is a practicing chemical engineer based in Mumbai)