European Medicines Agency Recommends Slew of Drugs for Various Indications

An array of new drugs is in line for approval from the Committee for Medicinal Products, which works under the aegis of the European Medicines Agency. The Committee has recommended for approval about 15 new products that will now have to receive the final nod from regulators shortly.

Among the drugs listed for approval are: Harvoni from Gilead, Ketoconazole HRA (ketoconazole) from Laboratoire HRA Pharma, and cancer drugs Vargatef (nintedanib) by Boehringer Ingelheim and Cyramza (ramucirumab) from Eli Lilly.

Harvoni—which belongs to a new antiviral products’ generation—has been recommended for clearance for treating hepatitis C among adults. On similar lines, Ketoconazole is being pushed as a treatment option for patients suffering Cushing’s syndrome – a rare disorder related to the hormones.

The cancer drugs that have been given the green signal – and now await a final approval – are Vargatef (nintedanib) for lung cancer (non-small cell) and cyramza for gastric cancer. These drugs have been pushed for the final round of approvals on the basis of their previous records and ability to tap into unmet needs.

Among the other drugs that have been recommended for approval are Teva’s Egranli and two drugs from Almirall (Duaklir Genuair and Brimica Genuair). A slew of drugs for other indications such as COPD and asthma, opioid-induced constipation, and erectile dysfunction from other pharma companies are also in line for being approved.

Interestingly, a number of hybrid applications have been also given the green signal, and will now have to receive final approval from regulators.

Regenerative Medicine (Bone and Joint) Market Expected to Reach USD 6.5 Billion Globally in 2019

According to a new market research report published by Transparency Market Research “Regenerative Medicine (Bone and Joint) Market (By Technology - Stem Cell Therapy, Biomaterial and Tissue Engineering; By Applications - Bone Graft Substitutes, Osteoarticular Diseases, Allogeneic Products, Autogenic Products and Others) - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 - 2019” the global regenerative medicine (bone and joint) market was valued at USD 2.6 billion in 2012 and is estimated to reach a market worth of USD 6.5 billion in 2019 growing at a CAGR of 12.8% from 2013 to 2019.

Regenerative medicine is considered as an emerging field of medical science that aims to regenerate, repair or replace damaged tissue and organs. U.S. National Institute of Health stated that regenerative medicine is the process of creating functional tissue to repair and replace tissue or organ which has lost their function due to damage, congenital defects, disease and age. Technological advancement in tissue engineering and stem cell therapy is expected to drive the global market for regenerative medicine (bone and joint). Moreover, growing prevalence of bone and joint disorder has also accounted for the market growth of the global regenerative medicine (bone and joint) market. However, ethical issues pertaining to stem cell therapy and fear of disease transmission due to allogeneic bone implantation are considered as market hindering factors during the study period. Companies operating in this market focus on investing in emerging economies of Asia-Pacific such as India, China, Japan and South Korea. These economies represent huge potential for various bone and joint reconstructive products due to rising healthcare expenditure and presence of large patient pool suffering from arthritis disorder (rheumatoid arthritis).

The global market for regenerative medicine is segmented based on technology as stem cell therapy, biomaterials and tissue engineering. In 2012, biomaterials segment accounted for the largest market share in the global regenerative medicine (bone and joint) market owing to favorable reimbursement policies and strong demand of biomaterials in the global market. However, high cost associated with biomaterials is a factor that would restrict the global market demand to some extent during the study period.

Browse the Regenerative Medicine (Bone and Joint) Market Report:    

In addition, based on applications the global market for regenerative medicine (bone and joint) is segmented as bone graft substitute, osteoarticular diseases, allogeneic bones, autogenic bones and others. In 2012, bone graft substitute segment accounted for the largest market share in the global regenerative medicine bone and joint application market owing to growing demand of bone graft substitute in orthopaedic surgeries. However, post implantation rejection associated with bone graft substitute is considered as a crucial factor that would restrict the global market demand of bone graft substitute.

On the basis of geography, the regenerative medicine (bone and joint) market is segmented as North America, Europe, Asia-Pacific and Rest of the World (RoW). North America accounted for the largest market share for regenerative medicine (bone and joint) globally in 2012 owing to increase in orthopedic reconstructive surgeries and introduction of technologically advanced medical devices and products. According to the American Academy of Orthopedic Surgeons (AAOS), prevalence of Lumbar Spinal Stenosis (LSS) is increasing with rise in elderly population and is estimated that approximately 2.4 million Americans would be affected by LSS by 2021. It has also stated that in 1990 approximately 129,000 Total Knee Arthroplasty (TKA) surgeries were performed in the U.S.

Europe accounted for the second largest share in the global regenerative medicine (bone and joint) market in 2012. Large geriatric population base is one of the important factors driving the growth of regenerative medicine bone and joint application market in this region. Asia-Pacific is expected to grow at the highest CAGR from 2013 to 2019, due to large pool of potential reconstructive surgery patients and strong support from federal government. Additionally, companies are expecting large revenue with sufficient market penetration from Asia-Pacific region and thereby focusing on increasing investments in this region. For instance, in May 2013, Smith & Nephew acquired Sushrut Surgical Pvt. Ltd. an Indian medical technology company. Sushrut Surgicals product portfolio includes trauma implants and instruments, spine and limb salvage products. This acquisition would expand and enhance the product offerings of Smith & Nephew and would also assist in capturing lucrative market share in Asia-Pacific region.

Major market players having presence in the global regenerative medicine (bone and joint) market include DePuy Synthes, Inc. (HEALOS Bone Graft), Medtronic, Inc. (INFUSE Bone Graft) and Zimmer Holdings, Inc. (CopiOs Bone Void Filler), Orthofix, Inc. (Trinity Evolution) and NuVasive, Inc. (Osteocel Plus).

The global regenerative medicine (bone and joint) market is segmented as follows:
Regenerative Medicine (Bone and Joint) Market, by Technology
  • Stem Cell Therapy
  • Biomaterial
  • Tissue Engineering

Regenerative Medicine (Bone and Joint) Market, by Application
  • Bone Graft Substitutes
  • Osteoarticular Diseases
  • Allogeneic Bones
  • Autogenic Bones
  • Others

Regenerative Medicine (Bone and Joint) Market, by Geography
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World

Federal Aviation Administration Allows Entertainment Companies to Use Drones Commercially

Last week, in an announcement that could have far-reaching implications, the Federal Aviation Administration allowed six leading filmmaking companies to make commercial use of drones fitted with cameras. Until now, drones could be used only over the wilderness of Alaska. However, with these flying machines now being allowed to operate over populated regions in the United States, the skies will likely never be the same again.

Film and entertainment companies such as Cirque du Soleil and Disney have already showed great interest in using drones in their productions. Disney, for instance, has made three patent applications for using drones in its outdoor shows. These drones will carry Disney characters’ marionette versions, or be lit-up as a substitute for actual fireworks.

On the other hand, Cirque du Soleil too recently released a video that that showed a man in a ‘flying dance’ performance with 10 ‘quadcopters’.

Computer-generated imagery is currently being felt in Hollywood and companies are vying to gain the first-mover advantage. The use of drones will help these companies generated awe-inspiring footage, ultimately potentially leading to better revenues at the box office.

The new decision by the FAA will boost the use of commercial drones, and unprecedented applications will now emerge from this new opportunity.

Last year, new reports about Amazon testing drones to offer 30-minute delivery on a purchase, created quite a buzz. The service is reportedly being called ‘Amazon Prime Air’. In addition to these big names, there are at least 40 other applications pending with the FAA for the commercial use of drones. Other companies that have been proactively pushing for this cause include Google and Facebook.

Boeing Joins Hands with Liquid Robotics for Unmanned Marine Drones

Boeing, in partnership with a liquid robotics manufacturer based in California, are working to develop technologically advanced ocean systems that can be deployed by defense organizations.

Liquid Robotics and Boeing will focus on conceptualizing and producing maritime defense

Boeing, on the other hand, will bring to the table its experience in working on surveillance, intelligence and reconnaissance solutions that it has gained over the years, largely through its Hazelwood-based facility – the Defense, Space and Security (DSS) unit.

According to CEO and president of DSS at Boeing, Chris Chadwick, the company views the partnership with Liquid Robotics as a great opportunity to create and deliver a unique defense services portfolio. This will benefit both existing and future customers of the company.

Boeing DSS operates under the aegis of Boeing Co. which is headquartered in Chicago and is listed on the New York Stock Exchange. In 2013, the revenues of the DSS unit notched US$33.2 billion – a 2% increase over fiscal year 2012. This unit is among the largest facilities in St. Louis, providing employment to over 15,000 workers.

Liquid Robotics’ headquarters are in Sunnyvale, California. The company, which was established in 2007, has managed to raise funds of over US$81 million in March last.

applications as well as anti-submarine warfare solutions. Liquid Robotics is among the many organizations that have forayed into developing unmanned drones and ocean vehicles.

Samsung’s Home Electronics will Soon Feature the Tizen OS

Samsung Electronics’ home appliances and electronics range will soon feature its state-of-the-art Tizen operating system. The electronics major said that starting 2015, a large number of its LCD televisions and home electronics will incorporate this OS.

The company is making this move with the intention of increasing the market penetration of its operating system, Tizen. Samsung is confident that it can leverage its global status in the electronics market to ensure that Tizen gains widespread acceptance and popularity among consumers. The Taiwan-based company will also soon set up a platform to develop a concept called ‘The Internet of Things’.

Taizen has already been used, with much success, in Samsung’s expanding range of wearable products. At the CES, which is slated to be held between January 6 and 9, 2015, Boo-Keun Yoon – the CEO of Samsung – is expected to present a keynote speech on the concept of ‘The Internet of Things’, as well as how it can promote interconnectivity between numerous electronic devices. He is expected to also discuss other topics such as applications and smart home appliances. The mobile devices industry has, in the recent past, witnessed dominance from operating systems such as Android and iOS. Thus, Taizen may not be able to break this dominance in the mobile phone industry just yet. Samsung is looking at the home electronics and wearable devices segment as a better alternative where it can push its Taizen OS.

Bolivia to Get New Pharma Production Facility, Courtesy Cuba

Bolivia will soon boast a new pharmaceutical manufacturing complex – its first such facility. The complex is being launched with help from Cuba. Labiofam, a Cuban state-owned chemicals and pharmaceuticals company said that it will set up the manufacturing plant in Bolivia, allowing the latter to meet 100% of its basic requirement for medicines. It was only last month that the country updated its list of basic and essential medicines.

While construction will begin immediately, the plant is expected to be fully operational by the end of 2020. It will produce pharma products that will be used by both countries, as well as others in Latin America.

This latest announcement is part of a larger co-operation agreement signed by the two countries in May 2013. The agreement was signed to provide incentives for increased pharmaceutical production in Latin American countries.

As things stand currently, Bolivia relies on imports to fulfill as much as 70% of its pharmaceutical demand. This costs the country approximately US$56 million per year.

Director General of Labiofam, Jose Antonio Fraga, told a leading news agency that the project will benefit both countries by reducing prices of pharmaceutical products and provide Latin American consumers improved access to certain medicines. He said that overall, this project could have a very positive outcome for the healthcare system in Bolivia. He said that the project aims at meeting the unmet needs of poor consumers as the prices set by large pharmaceutical companies are often beyond their reach.

The industries at the new manufacturing complex will be able to enjoy subsidies and provide drugs at a small profit margin.

Philippines Medical Devices and Healthcare Market Holds Massive Potential for U.S. Companies: ITA

The expanding medical devices and healthcare industry in Philippines is attracting the attention of global players eager to expand their international footprint and to cash in on the potential offered by emerging economies. A number of large healthcare corporations have shown an interest in investing in the Philippines. According to latest reports, the International Trade Administration (ITA), which works under the aegis of the U.S. Department of Commerce, is creating an investment and trade mission that will likely see nearly 20 U.S.-based companies enter the Philippines market. Most of these companies are leading participants in the medical devices and healthcare sector in the United States.

The ITA said that the Philippines has massive business opportunities to offer, considering that the demand for a number of healthcare devices and services is slated to grow. Industry officials said that the demand for healthcare services and medical devices will soar because of a higher per capita income of consumers, a growth in population, and consumers spending higher amounts of money on healthcare.

The ITA’s notice states that in 2013, consumers spent nearly US$9 billion on healthcare in the Philippines. In 2014, this figure is likely to witness a 10% increase. The notice issued by the ITA also mentions that approximately 64% of the entire workforce in Philippines is employed, and many of these employed persons depend on health insurance for their families and themselves. While the market may not be as large as other Asian economies, the ITA opines that the Philippines healthcare and medical devices market still holds strong potential for U.S. firms because it is entirely dependent n imported products, especially from the United States.

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