Pharma ProfessionalAugust 2011

Vol. 65 August 2011

With the growth rate of 14 percent per year, the Indian pharmaceutical industry is well established for rapid expansion. Indian Pharmaceutical Industry has made phenomenal progress over the years and made its impact in the global market. It has been recognized as a reliable source for drugs and drug intermediates and pharmaceutical formulations. With the strengthening of the IPR scenario in the country, the quarter ended December 31, 2005 witnessed major changes in the Indian pharmaceutical industry like the foreign MNCs increasing their presence in India through expansions and collaborations; Indian companies competing with them through new product launches and gaining more number of regulatory approvals. Many multinational companies have penetrated into India with an objective to marketing drugs and conducting clinical trials. Thus, Indian pharmaceutical research, manufacturing and outsourcing have received an impetus, thereby creating an image of a potential Pharma market and land of opportunities in the pharmaceutical division. Moreover the new Draft Drug Policy’ 2006 was released during this quarter.

Overview

Anesthesia equipment is used in medicine to induce a temporary loss of sensation in the patient. The most common type of anaesthetic machine in use in the developed world is the continuous-flow anaesthetic machine, which is designed to provide an accurate and continuous supply of medical gases (such as oxygen and nitrous oxide), mixed with an accurate concentration of anaesthetic vapour (such as isoflurane), and deliver this to the patient at a safe pressure and flow. The anaesthetic machine is usually mounted on anti-static wheels for convenient transportation.

Types of Anesthesia Equipments

The type of equipment used depends on the type of anesthesia being done and the medical procedure that the anesthetic is being used such as local and regional anesthesia.The anesthetic machines areModern versions, which combine numerous elements that are necessary to safely deliver anesthesia, as well as monitor a patient's condition. The combining of numerous medical tools into one piece of anesthesia equipment translates into better patient care and fewer deaths.

Continuous-Flow Anesthetic Machine: It is programmed to deliver an accurate, controlled and continuous level of medical gases, including oxygen, to the patient. It also delivers the gas/medication that causes the patient.

Airway equipment: TheAirway equipments include masks, endoscopes, tracheostomy tubes, endotracheal tubes, laryngoscopes and other items essential to the breathing function. Airway anesthesia equipment is critical, since the medication interrupts a person's normal breathing.

Market Growth

The anesthesia market is increasing rapidly with the growing safety awareness and technology enhancements in anesthesia machines. In china, the market potential of the anesthesia machines is huge, where the market is growing at an average rate of 8% to 10% per year. The major players in market are Draeger, GE health care, Philips health care, and Maxon medicals, whichencompass high precision driven systems. The market may see a growing acceptance of automated anesthesia workstations. The surgery centers,which have less overhead and greater interest in modernizing and automating the OR,are more eager to embrace the technology.

Emerging trends

There are few technological advances in endoscopy in India. At present we chiefly depend on imported products.New technologies in liquid handling systems from Eppendorf, Germany, would go towards improving and expanding the Indian market. Introduction of ultra light-weight, fully-autoclavable Research plus pipettes would provide comfort, precision, and accuracy that raise the user's expectations. Research plus pipettes with their ergonomics, flexibility, robustness, and the physiocare concept set the standards in the global liquid handling market.

Challenges Faced by End-Users

With the rapid advancements in the anesthesia industry, anesthesiologists sometimes find it difficult to keep up with anesthesia machine technology. The wide variety of designs available in the market leads to differences in how the ventilators work. The differences extend to the systems for generating pressure used by different manufacturers of each model, to the algorithms employed in the software, or the solutions proposed by each to compensate for certain deficiencies inherent to the design. Lack of uniformity prevents the anesthesiologist from meeting the ideal objective of working on a daily basis.

Global Scenario

The global anesthesia and respiratory devices market is forecasted to exceed US$14 billion by 2016 with a Compound Annual Growth Rate of10% from 2009-2016. The market is expected to be primarily driven by the huge patient population suffering from Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease and the availability of medical devices to treat OSA and COPD. Respiratory devices accounted for 55% of the overall anesthesia and respiratory devices market in 2009, making it the largest category. The Global market for anesthesia equipment market,including anesthesia delivery machines, anesthesia device accessories, anesthesia monitors, and anesthesia information systems, is projected to grow at a CAGR of 7%to reach US$8.3 billion by 2015.

Government Regulations

There is no significant role of the Indian Government in the endoscopy market.

However, though flexible and rigid endoscopes or cameras are not manufactured in India, the Government expects close to 10% customs duty for all the items imported in the segment.

This poses as a major challenge for the manufacturers and vendors.

Outlook

Anesthesia machines are a very useful piece of medical equipment used by physicians, who specializes in anesthesiology to support surgeons and doctors who operate on patients. Many modern anesthetic medical equipment machines are available with a ventilator, suction unit, and patient monitor. Medical Machines Online provide with a variety of new and refurbished anesthesia machines and other reliable medical equipment for practice, clinic or other hospital needs. Anesthesia machine is one of the necessary medical apparatuses in the hospital. Presently, China requiresabout 5,000 units of anesthesia machines annually, including about 3,000 lower-end ones, which aremainly provided by China’s domestic producers, and 2,000 middle-to-high end ones, 80% of which areimported. The high-end anethesia market is almost monopolized by foreign brands. About US$30m isinvested in importing middle-to-high end anesthesia machines annually.

Marketing

Americas

USA: Biotage introduces new microwave Peptide Synthesizer delivering higher reliability

The Biotage Initiator SP Wave is a versatile synthesis solution as it could be used as a standalone peptide synthesizer or easily converted to a high specification MAOS system. It is the ideal development tool for chemists synthesizing peptides, peptidomimetics and small molecules using single or multi-step procedures. The Initiator SP Wave is perfectly suited for the small scale synthesis of peptides and peptidomimetics including PNA using microwave irradiation, from a scale as low as 5 µmol. The semi-automated operation could reduce the consumption and waste of expensive reagents which occur in other systems due to priming or use of large dead volumes.

USA: High-Resolution imaging technology reveals cellular details of coronary arteries

GeneralHospital developed a one-micrometer-resolution version of the intravascular imaging technology optical coherence tomography, which could reveal cellular and subcellular features of coronary artery disease. In a Nature Medicine paper receiving advance online publication, the investigators describe how microOCT, which provides 10 times greater resolution than standard OCT, was able to show individual arterial and inflammatory cells, including features that may identify vulnerable plaques, within coronary artery samples. MicroOCT has the contrast and resolution required to investigate the cellular and subcellular components underlying coronary atherosclerosis, the disease that precipitates heart attack.

USA: Randox Life Sciences produce highly sensitive antibodies to a range of drugs

Randox Life Sciences developed and manufactured a wide range of products including high quality, cost effective recombinant proteins, polyclonal antibodies and conjugates targeting drugs of abuse, steroids, hormones and biochemical markers. These specific life science products are manufactured at ISO 13485 certified manufacturing plant in the United Kingdom using state of the art facilities.It is now accepted that drug misuse is a large and growing problem affecting not only the user but society as a whole. Drug testing could provide a tool for detecting users and monitoring the compliance of subjects in recovery programs. Randox Life Sciences developed an extensive range of drug targeted antibodies for research and development applications.

USA: Out Sourcing Manufacturing of Biopharmaceuticals

Outsourcing manufacturing, once used mainly as a cost-reduction or capacity supplement strategy, is now increasingly being viewed as a risk-mitigation for operational excellence and growth strategy. Ensuring consistent quality and reliable delivery require companies to understand their vendors' and contractors' areas of expertise, pose good control over their supply chain networks, and boast a solid risk-management strategy in place. The conference would bring these critical elements together and offer case studies on strategies that will lead towards a successful agent-sponsor relationship, thereby ensuring consistent high quality products from CMO partners.

USA: Verizon combines the power of 4G LTE tablet

The Cisco Cius would be available to Verizon enterprise and government customers around the world later this summer, and those located domestically would be able to combine the device with a Verizon Wireless 4G LTE mobile hot spot. Designed for the enterprise, the Android-based Cisco Cius combines voice, video, collaboration and virtualization capabilities on one device. When powered by Verizon’s 4G LTE network, mobile workers would be able to easily use bandwidth-intensive video applications between devices for more effective collaboration.Mobile applications over intelligent high-speed networks would continue to eliminate barriers in the workplace.

USA:Mayo Clinic launches its own social networking site

Touting it as the first of its kind, Mayo Clinic last week launched its own version of a free, open social networking community. According to a Minnesota Public Radio article,in 2010, Mayo launched Center for Social Media to boost engagement between medical professionals and health systems. The newest social networking site promises to be unlike other existing medical group or hospital online communities. The people are not aware of other online communities created by a medical provider group or hospital system.

USA: VA awards US$12 billion for Infotech work, including health IT

The Department of Veterans Affairs (VA) is hoping to upgrade and transform its information systems through a series of 14 recently awarded contracts worth US$12 billion. Under the Transformation Twenty-One Total Technology program, known as T4, the VA would modernize all of its systems. The upgrade would encompass program management and strategy planning; systems and software engineering; enterprise network, test and evaluation; independent verification and validation; cyber security; operations and maintenance; and training and IT facility support. The VA is also in the process of upgrading its decades-old VistA EHR by using open-source technology.

USA: JHP Pharma in pact to produce life saving drugs

JHP Pharmaceuticals, a contract manufacturing service provider of sterile injectables and ophthalmic/otic products, signed a deal with a pharma firm for the production of a life-saving drug.JHP's RochesterMichigan manufacturing plant covers over 80 acres of land and includes a 171,000sqft. production building and warehouse.JHP Pharma’s President and CEO said that their cGMP compliance record and experienced staff allow them to effectively serve the important customer. During the last six months, the company successfully completed FDA and EMA audits in addition to entering agreements with four new contract customers.

Europe

France: Roche establishes R&D institute in France

Roche established a new research and development (R&D) institute in France under the lead of the company’s pharma research and early development (PRED) unit. The PRED French R&D Institute would be managed by a Roche academic team, which will be in charge of building new research networks with French academic partners, leveraging their expertise, technology platforms and scientific breakthroughs in areas of medical need. The Institute would serve for academic collaborations in France across multiple disease areas and scientific disciplines as oncology, neurosciences, metabolism, inflammation, virology, translational research and toxicology.

Asia-Pacific

India: Wipro launches cloud portal for clinical trials

Wipro Technologies launched Wipro Clinical Collaboration Portal, a secure based productized solution. The service is aimed at helping Drug Development Owners (DDOs), Clinical Research Organisations (CROs) and regulators to improve collaboration for multi-region clinical trials. Wipro stated the new launch would reduce the clinical trial cycle time by 20-30% by speeding communication and document exchanges between CROs, regulators and DDOs. The Wipro Clinical Collaboration based portal is supported by Wipro's Rapid Trial framework and integrated with leading market products for electronic data capture, interactive voice recording system and others.

India: AstraZeneca units delist move fails again

Sweden-based AstraZeneca Pharma AB once again failed in its bid to delist its Indian subsidiary AstraZeneca Pharma India Pvt. Ltd. The parent holds almost 90% in the Bangalore outfit, which is listed on the BSE and the NSE.AstraZeneca Pharma India stated the delisting plan would not take place as the parent did not get the mandated number of public shareholder votes to buy back the remaining shares. The buyback offered through postal ballots was launched a month back, with a floor price of Rs576.10 a share and not exceeding Rs1,152.The Swedish parent tried a buyback in mid-2004 but gave up the plan as it found the exit price of Rs3,000 a share the outcome of reverse book-building too high.

India: Focus on coir R&D to face competition

The collective efforts to introduce cost-effective technologies in the micro, small and medium enterprises sector, especially in the coir industry, which employs about 5.5 lakh persons, a majority of whom are women. The technology, marketing, credit and skill development should be the major areas of focus for a sustainable and stronger growth of the sector. The MSMEs, especially from the traditional sector, are not cost-effective, which made their products vulnerable to competition from other sectors.

India:JB Chem launches new biz division, shares rise

J.B. Chemicals & Pharmaceuticals launched a new business division catering to gynaecology and dental therapies with 15 products and exploit other therapeutic areas having good growth potential, sending its shares up over 7%.The gynecology and dental segments boast a combined market size of about Rs20 billion in India and are growing 16% every year. The new division encompasses a sales force of over 100 representatives and would triple the count over the next two years. The launch helps company to strengthen its position in the rural as well as urban markets in India, by adding necessary investments made for growth in the business.

India: Dow to sell polypropylene business to Braskem

Braskem SA, Latin America’s largest petrochemicals maker, agreed to buy Dow Chemical’s polypropylene assets (PP) for a total enterprise value to Dow of US$340m, comprised of US$323m cash price plus other cash and contingency assumptions of US$17m.The deal includes Dow’s two PP manufacturing facilities in USA and two in Germany, with a total capacity of 1.05-mtpa. The German plants are located in Schkopau and Wesseling, while the US plants are at Freeport and Seadrift. Also included in the deal are inventory, business know-how, certain product and process technology and customer contracts and lists.

India: Bayer rolls out novel technologies for gas phase phosgenation and ODC

Bayer Material Science successfully tested its innovative gas phase phosgenation technology at a new plant being commissioned for the manufacture of TDI, at its integrated production site at Caojing in Shanghai, China. The process technology, which was implemented together with Bayer Technology Services, reduces solvent consumption around 80%, and energy consumption up to 60%, and enables a significant reduction in operating costs, and cuts investment costs for this type of large-scale facility by about 20%. Compared with conventional production facilities of similar size, CO2 emissions could be cut by around 60,000-tpa.

India: Gevo setting up demo plant for processing biobased isobutanol

US-based biofuels company, Gevo Inc, joined hands with a US petrochemical manufacturer South Hampton Resources Inc to build a hydrocarbon processing demonstration plant outside Houston, USA. Gevo uses proprietary yeast to ferment corn sugars into isobutanol, which Gevo saidcould be used to produce cleaner fuel and products like synthetic rubber.Gevo and South Hampton Resources announced plans to build a demonstration plant at South Hampton’s facility in Texas, which would process up to 10,000 gallons of isobutanol into renewable hydrocarbon materials including jet fuel for engine testing and isooctane for gasoline. The demonstration plant is expected to be completed later this year.

India: Lanxess begins work on leather chemicals plant in China expands plastics plant

Lanxess announced project investments totalling more than €40m in China. The company recently broke ground for a new leather chemicals plant in Changzhou, Jiangsu province, representing a €30m investment. The new plant would boast acapacity of 50,000-tpa and would come on stream in the first half of 2013. The plant would produce leather chemicals used for leather tanning, dyeing and finishing applications. Lanxess also started up the third production line of its high-tech plastics plant in Wuxi, Jiangsu province. The €10m investment increases total capacities at the plant to 60,000-tpa.