Month: April 2015
VTE therapeutics & Atrial Fibrillation market was worth USD 4 billion in 2014 and USD 7.86 billion respectively. The VTE therapeutic market is expected to reach USD 5.5 billion by 2018 with a Compound Annual Growth Rate (CAGR) of 8.29% and Atrial Fibrillation market will reach on its peak value USD 13.28 billion by 2018 with compound annual growth rate (CAGR) of 14%, according to DelveInsight Analysis.
Anticoagulants reduce blood clotting in an artery, a vein or the heart. Clots can block the blood flow to heart muscle leading to heart attack. They can also block blood flow to brain, leading to stroke. Anticoagulants are given to prevent blood from clotting or prevent existing clots from getting larger.
Warfarin and Heparin were the only available anticoagulants since decades but now, the choice of anticoagulants is broadened by the approval of new oral anticoagulants bu U.S. Food and Drug Administration. The new oral anticoagulants include Dabigatran, Rivaroxaban, Edoxaban, and Apixaban. These novel oral anticoagulants are expected to replace older anticoagulants with their ease of use and favourable pharmacodynamic profiles.
Dabigatran and Rivaroxaban were the highest selling drugs in 2014 with the revenue generated ~1800 million and ~1700 million respectively. Dabigatran was the first oral direct thrombin inhibitor approved by U.S. FDA and Rivaroxaban was the first oral direct coagulation factor Xa inhibitor approved by U.S. FDA. The patent for Dabigatran is going to expire soon (in 2017) thus making way for generic drug in the market. Edoxaban is the newly approved (January 2015) factor Xa inhibitor for the prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and the treatment and recurrence prevention of venous thromboembolism (VTE).
Despite novel anticoagulants are seen as replacements for heparin and warfarin, there are some adverse hemorrhagic events reported. Absence of any approved antidotes for oral anticoagulants limit their use. Though there are 3 antidotes in clinical development which can reverse the effects in case of major bleeding. These antidotes are 1.5 years away from being clinically available.
Since the patient compliance increases with the orally available drugs, the companies are focusing on developing such anticoagulants. The drugs in pipeline are mostly thrombin inhibitors or Factor Xa inhibitors unlike traditionally used warfarin which was Vitamin K reductase inhibitor.
Anticoagulants are prescribed for number of diseases such as Heart attack, stroke, deep venous thromboembolism, pulmonary embolism, Atrial fibrillation, Unstable angina, or for the prevention of Venous thromboembolism (VTE) after major orthopedic surgery. With such a wide usage, one must be familiar with anticoagulants, their pharmacological properties, pharmacodynamics, dosing, monitoring and toxicity.
Written by Rashi Aggarwal, Associate Analyst at DelveInsight
Report: Anticoagulants-Competitive Landscape, Market & Pipeline Analysis, Forecasted Market Size 2015-2018
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Big Pharma Guiding the Stem Cells Future
Stem cells (SCs) have been an excitement area of medical research since 1800s. In the mid 1800s it was discovered that cells were basically the building blocks of life and that some cells had the ability to produce other cells and in 1900 scientists had discovered that some cells had the ability to generate blood cells. In 1968, first successful bone marrow transplantation was performed to successfully treat two siblings with severe combined immunodeficiency. Since 1968, stem cell research has progressed dramatically and every year, companies are increasing for stem cells research.
A human body is made of more than 200 different types of specialized cells like muscle cells, fat cells, skin cells all originating from stem cells. A stem is a un-specialized immortal cell which on differentiation performs a specific function but can no longer become another type of cell. Broadly stem cells are divided into adult stem cells/tissue specific stem cells and pleuripotent stem cells. Different types of stem cells have different levels of potential.
Big Pharmaceuticals Entering in Stem Cell Research through potential collaborations
In cellular therapeutics stem cell therapy has emerged out as key driver for the purpose of regenerative and restorative medicine globally across a number of diseases. There are presently more than 200 plus companies working in stem cell therapy products globally.
Adult stem cells are perhaps the most attractive source stem cells with more than 70% followed by embryonic stem cells, cord blood cells and fetal stem cells across all biopharmaceutical industry. Mesenchymal stem cells from bone marrow and hematopoietic stem cells have been widely used in four decades with lot of medical research done in neurodegenerative diseases using neural stem cells.
Some of the major therapeutic areas addressed in this era mostly revolve in cardiovascular diseases, central nervous sytem (CNS) diseases, Hematopoietic diseases, orthopadic and diabetic diseases.
Many companies have started research using induced pleuripotent cells which may show pleuripotency and their proliferation may also vary. Two of the leading companies are iPierian, Inc. which is now acquired by Bristol Myers Squibb Company and Fate Therapeutics exploiting the iPS technology. In past two years, the global market for iPSCs have grown immensly crossing $ 1 billion.
Recently parthenogenesis emerged as new class of obtaining stem cells where embryo is created solely from female oocyte without genetic contribution from male. International Stem Cell Corporation is one such company which has poineered in new class. It avoids the ethical issues as well as show immune matching to patient which is most important in case of transplantation.
Moreover, stem cell therapy is getting huge attention from big pharmaceutical companies. The potentials of stem cells have clearly overcrossed the drawback and major pharmaceutical players like Novartis, Johnson & Johnson and Celgene Corporation have invested in stem cell reaserch. Novartis expanded its stem cell research by investing in Gamida Cell and Regenerex stem cell technology. Similarly J&J has invested in Capricor Therapeutics and Viacyte for cardiovascular and diabetic diseases. Recently Celgene entered into agreement and invested in Oncomed and Human Longevity Inc.
Let’s have a look at the Collaborations:
Written by Tarun Jain, Associate Analyst at DelveInsight
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PD-1and PDL-1 are the next targeted agents in Oncology. These therapies have the enormous potential to treat cancer and have an excellent response in the increasing number of patients. Many experts say that out of all of the therapies, PD-1/PD-L1 inhibitors look to be the most promising in treating cancer.
DelveInsight Report, “PD-1 and PD-L1 inhibitors – Competitive Landscape, Pipeline and Market Analysis, 2015” analyses that PD-1 and PD-L1 inhibitors are among the hottest and highly growing fields in biopharmaceutical industry. Most of these immunotherapeutic are being used in Oncology. According to the analysis, 34 drugs* are in pipeline. Focus of development is mainly on the antibody-based interventions targeting programmed cell death protein 1 (PD-1). Out of 34, 22* are in combination development with other therapeutics agents. Continuation of expansion of the combination regimens is likely to be one of the main themes surrounding immunotherapies as these partnerships are the key to developing competitively strong therapy regimens.
Future competitive landscape of PD-1 and PD-L1 inhibitors is estimated to be very strong. The market for PD-1 and PD-L1 drugs might be billions of dollars richer than many believe. These drugs which include Bristol-Myers’ Opdivo and Merck’s Keytruda, are going to be Blockbuster in upcoming years.
Scope of the Report
- Overview of PD-1 and PD-L1 inhibitors, role, significance, pathway, mechanism of action (MoA) and biomarkers of PD-1 and PD-L1 inhibitors Indication wise detailed epidemiology along with trends in epidemiology, incidence and prevalence segmented in to major geographies
- Report has covered the worldwide market of PD-1 and PD-L1 inhibitors, information of marketed molecules including along with patent expiry and impact on market after expiry and detail profiling of Pipeline assets
- Key topics covered include strategic competitor assessment, market characterization, opportunities, barriers and challenges in the market along with SWOT analysis of the PD-1 and PD-L1 inhibitors market
- Pipeline analysis: Comprehensive data split across different phases and emerging trends and comparative analysis of marketed and pipeline molecules, pipeline molecules with detailed clinical profiles, mechanism of action, route of administration and molecule type, along with latest updates
- Analysis of the current and future market competition in the global PD-1 and PD-L1 inhibitors drug market. Current scenario of market with upcoming blockbuster molecules and their impact on overall market.
Reason to Buy
- Identify emerging players with potentially strong product information and create effective counter-strategies to gain competitive advantage
- Identify and understand important and diverse types of therapeutics under development for PD-1 and PD-L1 inhibitors.
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- Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline
- Devise corrective measures for pipeline projects by understanding PD-a and PD-L1 inhibitors pipeline in-depth
- Develop and design in-licensing and out-licensing strategies by identifying prospective partners to enhance and expand business potential and scope
- Identifying the upcoming leaders in the PD-1 and PD-L1 inhibitors market in the coming years.
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*Number of drugs are based on the different combinations of one drug
Analyze Anticoagulants Market with DelveInsight
Anticoagulants are drugs that are given to prevent blood from clotting or prevent existing clots from getting larger. They can keep harmful clots from forming in heart, veins or arteries. Clots can block blood flow and cause a heart attack or stroke. Until recently, the only available oral anticoagulants were the vitamin K antagonists, such as warfarin which is an Injectable solution. In the past few years, however, the landscape has changed with the introduction of new oral anticoagulants that specifically target either factor Xa or thrombin. Rivaroxaban, dabigatran and apixaban, the oral factor Xa inhibitors, are active compounds with an oral bioavailability of more than 50%. The new oral anticoagulants have several advantages over warfarin, including pharmacology, laboratory monitoring, class effects and differentiating effects.
Most drugs are recommended for Deep Vein thromboembolism (DVT) and pulmonary embolisms (PE) while the least being heparin-induced thrombocytopenia, thrombocytopenia, Peripheral vascular occlusion, Non-Q wave myocardial infarction, and disseminated intravascular coagulation. Currently there are 10 drugs and 9 drugs which are used for PE and DVT respectively.
DelveInsight- Anti-coagulant Report, “Anticoagulants-Competitive Landscape, Market & Pipeline Analysis, Forecasted Market Size 2015-2018”.
This DelveInsight report provides a thorough overview of these new oral anticoagulants, their approved indications, drug profiles, pharmacokinetic parameters and market growth, historical sales and forecasted sales of each molecule till 2018. The Report also provides the pipeline information and their drug profiles giving therapeutic analysis by route, mechanism of action and molecule type. The Report has also highlighted the two prevalent indications, Venous Thromboembolism and Atrial Fibrillation, its epidemiology segmented by geography and their current and future market. The Report has also given analysis on the basis of SWOT analysis.
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Antibody Drug Conjugate and Big Pharmaceutical Companies Boom
Antibody-drug conjugates is gaining popularity in the Biopharmaceutical industries. As Initial trials with these targeted treatments show success, more companies are looking to produce these drugs. Although antibody-drug conjugates show promise in the development of effective cancer therapies, there are still a variety of challenges involved in enabling the safe manufacture of these hazardous drugs. ADC’s continues to gain popularity but the market is in infant stage with only 3 drugs approved by U.S. FDA.
- Mylotarg from Wyeth (now Pfizer) was the 1st drug approved for the treatment of acute myeloid leukaemia back in 2000 but was withdrawn a decade later.
- Adcetris (brentuximab vedotin) from Seattle Genetics was approved by the FDA in 2011 for the treatment of Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma.
- Genentech’s Kadcyla (ado-trastuzumab emtansine) was given FDA approval in early 2013. ImmunoGen holds patents on Kadcyla and how it is manufactured, and receive royalties from Roche on its sales.
More than 264 Antibody-drug conjugates are under pipeline and as the large numbers of pharmaceutical companies are involved in antibody-drug conjugates market, therefore it is expected that this market will grow rapidly.
Although the market now has presence of many large pharmaceutical companies, but the technology lies with only few. Seattle Genetics and ImmunoGen are the pioneers in technology licensing, with most drugs using their technology.
The future of ADCs in the biopharmaceutical market will ultimately depend on their clinical success. Companies and researchers are seeking to meet that challenge by optimizing the selection of all the components in the ADC—the antibody, linker, and cytotoxin—and successfully combining manufacturing techniques for both high- potency APIs and biologics. Earlier unsuccessful attempts to generate ADCs with therapeutic value have emphasized the important role each component plays in determining the efficacy and safety of the final ADC.
Since ADC’s are highly complex to manufacture, it provides unique opportunities and challenges to Contract Manufacturers Organizations (CMOs) and biopharmaceutical companies seeking CMP partners for their ADC candidates.
In some cases, three separate CMOs are utilized- one for the chemical linker, one for the antibody and one for the highly potent drug. Then, everything is shipped to someone else for conjugation.
Some CMO’s which offer ADC Conjugation services include: Lonza, Laureate Biopharma, Piramal Healthcare Pharma Solutions, Abbott contracts manufacturing, Aquitaine Pharm International, etc.
ADCs are sometimes described as armed antibodies, and their cytotoxic components as warheads. Whether ADCs will prove to be an effective weapon against cancer or other diseases has yet to be seen as more are tested in the clinic.
By Shriya Sahni, Associate Analyst, DelveInsight
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