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BioMarketing Insight
Newsletter
Pharma, Biotech & Medical Device |
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Greetings! |
Welcome to BioMarketing Insight's monthly newsletter. In order to fill the funding gap between Angels and VCs, more collaboration, partnerships and licensing deals are needed. To attract partnerships from larger companies, research should be concentrated in the areas where larger companies are focusing their R&D particularly since Big Companies are decreasing their R&D budget.
This month's newsletter is the second of three installments analyzing six (6) promising therapeutic growth areas for both pharma/biotech and medical devices and where they are today.
Please see News Link on the right for more industry information.
Feel free to email me if you have any questions, comments, or suggestions.
Sincerely,
Regina Au
Principal, Strategic Marketing Consultant
BioMarketing Insight
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R&D Overview | The six major R&D pharma/biotech therapeutic areas are: 1) Cardiovascular, 2) NeuroScience, 3) Metabolism, 4) Oncology, 5) Immunology and inflammation, and 6) Respiratory. This newsletter will look at six specific disease areas: 1) Alzheimer's Disease, 2) Obesity, 3) Diabetes, 4) COPD, 5) Arthritis and 6) Pain management. In addition to these six major diseases, rare or orphan diseases have recently been a major focus for most pharma/biotech companies. For more information on rare diseases please see my March newsletter.
For medical devices, the R&D focus is in two major areas; 1) tools for diagnosing and monitoring and 2) tools for minimally invasive procedures for treatment or repair. The six major therapeutic areas are: (1) cardiology including cardiac rhythm, (2) spine, (3) orthopedic, (4) general surgery, (5) gastroenterology, and (6) pulmonology. Recently, there has been a new focus on neurology in the treatment of brain aneurysms.
This month's newsletter will cover diabetes and chronic obstructive pulmonary disease (COPD) for pharma/biotech and market data and trends in orthopedic and general surgery for medical device. To read last month's topics on Alzheimer's disease, Obesity, Cardiology Devices, and Spine Devices please click on the newsletter archive link.
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BioMarketing Insight Services |
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Diabetes
| There is a need for new drugs to treat diabetes, particularly Type 1, since it is a chronic, long-term disease that has no cure. Compliance is the biggest obstacle in managing Type 1 because patients must test their blood sugar daily and self-administer insulin injections. There hasn't been any available alternative to daily injections of insulin since the 1920s but research continues to be conducted by many companies and institution.
90-95% of all diabetics are Type 2 diabetes. Type 2 and gestational diabetes however, can be prevented in many cases if we can prevent the incidence of obesity. Since the prevalence of obesity is rapidly growing, the incidence of Type 2 diabetes will grow in epidemic proportions making this an attractive market for many companies to pursue despite the difficulties in efficacy and safety. Trials and research for Type 1 and 2 are listed below.
Obesity is a precursor to many co-morbid diseases, which reinforces the biological network theory that when one system goes awry, or when you treat one system it affects all other systems as well. This maybe one of the reasons why it's so difficult to develop drugs that treats diabetes.
For more information on any of the drug trials, feel free to contact me.
Background and Market Data
In the United States, it is estimated that 25.8 million children and adults, or 8.3% of the population, have diabetes. Of the 25.8 million people with diabetes, 18.8 million were diagnosed with diabetes and about 7 million are undiagnosed. In 2010, there were 1.9 million new cases of diabetes are diagnosed in people aged 20 years and older.
There are three (3) major types of diabetes:
1) Type 1 diabetes, childhood, or juvenile diabetes is when a person's own immune system attacks insulin-producing cells in the pancreas. Daily insulin injections are required since the body makes little or no insulin.
2) Type 2 diabetes or adult acquired diabetes, accounts for 90 - 95% of all diabetes. The pancreas does not make enough insulin to keep blood glucose levels normal but daily insulin shots are not required. Many people with type 2 diabetes do not know they have diabetes and it's becoming more prevalent due to the increase in obesity and lack of exercise.
3) Gestational diabetes is high blood glucose that develops at any time during pregnancy in a woman who does not have diabetes. Women who have gestational diabetes are at high risk of type 2 diabetes and cardiovascular disease later in life.
United Health Group Inc., the largest U.S. health insurer by sales, predicts that in the next 10 years through 2020, the cost to treat diabetes will be $3.4 trillion with 60% of the cost covered by the government. Company officials claim that the number of Americans with high blood sugar will rise 44% to 135 million in 2020, from 93.8 million in 2010 said the company.
In 2010, it was reported that 285 million people, or 6.4% of the world's adult population, have diabetes in 2010. The number is expected to grow to 438 million by 2030, corresponding to 7.8% of the adult population.
Type 1 Diabetes Trials and Research
Many companies have tried developing alternative formulations of insulin such as oral and inhaled insulin and vaccines but so far none have been approved. However, there is still ongoing research in this area as indicated below.
1) Drug trial otelixizumab, a humanized anti-CD3 monoclonal antibody failed to meet primary end points for Type 1 diabetes for GSK and Tolerx.
2) A vaccine trial designed to halt the progression of type 1 diabetes failed to elicit a response. The trial was conducted by the Diabetes Research Institute at the University Of Miami Millar School Of Medicine in Florida.
3) Diamyd Medical and J&J discontinued a late-stage study of a vaccine designed to prevent people at risk of Type 1 diabetes from developing the disease.
4) Afrezza--a fast-acting inhaled insulin program, by Mankind Corporation, is waiting FDA approval after regulators asked for two new trials for Type 1 and Type 2 diabetes.
5) Generex Biotechnology Corporation announced positive preliminary results from two Phase 3 clinical trials testing the effectiveness of its potential treatment for diabetes, using their oral insulin called Oral-lyn.
6) Researchers at the Eliza Hall Institute in Melbourne, Australia are testing a nasal vaccine that could help prevent Type I diabetes. The vaccine works by desensitizing the immune system, where white blood cells are no longer prompted to attack insulin-producing pancreatic cells.
7) Results of a small, observational study conducted at the University at Buffalo suggest that liraglutide, an injectable medication used to treat Type 2 diabetes, also helps Type 1 diabetics on insulin to achieve optimal control of their blood glucose levels.
8) Engineering researchers at Rensselaer Polytechnic Institute are combining automation techniques from oil refining and other diverse areas to help create a closed-loop artificial pancreas. The device will automatically monitor blood sugar levels and administer insulin to patients with Type 1 diabetes, eliminating some of the compliance issues.
For more information on # 6, 7, 8, click on New Technology.
Type 2 Diabetes Trials and Research
Improving glycemic control for Type 2 diabetes has been a major focus for Big Pharma. It has not been an easy task to bring new products to market and numerous drug trials have failed.
1) Xoma Ltd.'s diabetes drug, XOMA- 052, did not hit its primary goal of reducing the blood sugar glycosylated hemoglobin as compared to placebo, after six monthly treatments in the Phase IIb trial, the company said. The drug was a potential once-a-month treatment for type 2 diabetes, targeting inflammation by inhibiting the protein interleukin-1, or IL-1.
2) Roche is returning its licensing rights to Ipsen after its diabetes drug taspoglutide, a GLP-1 analogue, raised unexpected safety issues in Phase III trials. This leaves Ipsen responsible for funding a €500 million late-stage trial that could kill the program.
3) Eli Lilly, Amylin, and Alkermes' drug Bydureon failed in a head-to-head study with Victoza, Novo Nordisk's new daily GLP-1 diabetes treatment that proved superior to the once-weekly Bydureon therapy in lowering blood sugar.
4) Bristol-Myers Squibb (BMS) and AstraZeneca (AZ) have submitted to the FDA advisory committee new two-year data on their drug dapagliflozin, an SGLT-2 inhibitor. It is designed for the body to purge excess blood sugar in urine. However, several reports covering the data noted that there were 18 cases of cancer with patients taking the drug.
5) BMS/AZ is the company to watch, since a number of companies, including Eli Lilly, J&J and Boehringer, are all developing drugs with a similar pathway to dapagliflozin for Type 2 diabetes.
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Chronic Obstructive Pulmonary Disease (COPD)
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Smoking is the leading cause of COPD and the easiest way to prevent this disease or exacerbating it is to stop smoking. About half of the people who have COPD go undiagnosed due to inadequate diagnostic tools. There is no cure for COPD so as long as people keep smoking there will be a need for more drugs to treat this disease. Worldwide, COPD is the 5th cause of death and it is predicted to be the 4th in 2030 particularly in areas where smoking is still prevalent such as Japan and China.
A possible way to control this disease and ease the burden of cost on the healthcare system is to diagnose patients early and plan an aggressive course of action. Don Sin, a Canadian research from St. Paul's Hospital, Providence Health Care is trying to discover and develop a biomarker blood test to diagnose patients with COPD and predict which patient is likely to experience life-threatening lung attacks. This will help guide physicians to the appropriate therapy.
For more information on the drug trials listed below, feel free to contact me.
Background and Market Data
Chronic obstructive pulmonary disease (COPD) is one of the most common lung diseases where it is very difficult to breathe. There are two main forms of COPD but most people have both:
Chronic bronchitis, defined by a long-term cough with mucus
Emphysema, defined by destruction of the lungs over time
Smoking is the leading cause of COPD. The more a person smokes, the higher the risk of developing COPD even though some people who smoked for years never get the disease.
There is no cure for COPD, but the best way to relieve symptoms and retard the progression of this disease is to stop smoking. To retreat symptoms of COPD, inhalers to open airway and inhaled steroid to reduce lung inflammation are used.
An estimated 24 million U.S. adults have COPD: 12 million physician-diagnosed and 12 undiagnosed. Worldwide, COPD affects 210 million people. It was the fifth cause of death in 2002 and it is projected to be the fourth cause of mortality by 2030.
The annual cost to the nation for COPD in 2010 is projected to be $49.9 billion. This includes $29.5 billion in direct health care expenditures, $8.0 billion in indirect morbidity costs and $12.4 billion in indirect mortality costs.
COPD Trials and Updates
Two companies received FDA approval for their COPD drug and the status of several companies' drug programs are as follows:
1) Forest Labs and Switzerland's Nycomed have received a narrow approval of Daliresp (roflumilast) to prevent the exacerbation of COPD.
2) Novartis received FDA approval for their once-daily Arcapta(TM) Neohaler(TM) (indacaterol inhalation powder) 75 mcg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with COPD.
3) Novartis got impressive late-stage data on NVA237, an experimental COPD treatment. The data demonstrated the treatment was better than a placebo and just as good as Spiriva.
4) GlaxoSmithKline (GSK) and partner Theravance announced mixed results for two of their COPD studies with Relovair, but "support the continuation of the Relovair" program.
5) A meta-analysis found that the inhaled mist formulation of Boehringer Ingelheim's Spiriva, used to treat COPD is associated with a 52% higher risk of death among patients using Respimat than the placebo group in an overview of five trials using Spiriva Respimat inhaler.
6) Forest Laboratories and Almirall, S.A. submitted a New Drug Application (NDA) to the U.S. FDA for aclidinium bromide, a long-acting inhaled antimuscarinic agent developed for the treatment of COPD.
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Orthopedic Products - Medical Device
| The economy, Healthcare Reform and pricing pressure from the US and Europe have slowed the orthopedic market, since majority of procedures are elective. This market will however, remain one of the largest segments in medical devices due to three primary reasons: 1) advance biological technology products, 2) advanced procedures, and 3) demand for products as the result of our aging population living longer.
Until the economy turns around, it will be a long and slow road ahead. Companies will need to continue developing innovative products and expand into emerging markets, where there is more opportunity. (See January newsletter on emerging markets.) However, the challenges with the BRIC countries deem it a long-term goal, therefore companies should not only focused on Brazil, but evaluate all of Latin America and other developing countries such as Africa that are more western oriented.
When will the economy rebound? CEOs from Zimmer Inc. and Smith & Nephew give their perspective on the immediate future. "Sales of replacement hips and knees, once a high-growth business, has been one of the hardest hit areas of the medical device sector in the economic downturn as patients who lost their jobs and health insurance get fewer procedures."
While at the JP Morgan Healthcare Conference in San Francisco David Dvorak, CEO of Zimmer Holdings, Inc. commentedthat "There will continue to be an impact until unemployment rates are reduced and (insurance) enrollment rates go back up."
Dave Illingworth, CEO of Smith & Nephew who also spoke at the J.P. Morgan conference, said "Low consumer confidence is the primary issue. This lack of confidence is causing patients to defer procedures until the employment outlook is more certain."
For more information regarding the orthopedic market, feel free to contact me.
Background and Market Data
According to Global Industry Analysts, Inc. the global orthopedic instrumentation market is expected to exceed $47 billion by 2015.
Orthopedics is one of the largest segments in the medical device sector. There are a number of factors that contribute to the opportunity and growth of this segment.
1) Orthopedic tissue engineering, an emerging technology that is predicted to grow rapidly due to wide acceptance of the technology. It is hoped that this technology will eventually eliminate secondary surgical procedures, leading to quicker recovery time.
2) Incorporation of biologics such as bone growth factors, bone graft substitutes, meniscus and cartilage repair products, and synovial fluid replacements as minimally invasive procedures are expanded and adapted by physicians and patients in reducing recovery time.
3) An aging population living longer with increasing co-morbidity of diabetes and obesity will lead to an increase in knee and hip replacements. The development of longer-lasting and improved materials and implants is a key contributor to the industry's growth.
4) Age-related conditions such as osteoarthritis due to the aging population living longer increases the demand for reconstructive surgery worldwide.
5) High patient demand, as well as the shift to motion-preserving devices from fusion technologies, has made the spinal product segment the highest growth potential of more than 12% over the period of 2009- 2015 (see last month newsletter on spine market).
The US and Europe account for the majority share of the orthopedic instrumentation market. But the Asia-Pacific market is forecasted to have the fastest growth, expected to reach 9.6% CAGR through 2015.
The U.S. orthopedic extremity market is projected to generate $4.6 billion by 2015, growing at a compound annual growth rate in excess of 10% according to the Millennium Group. The orthopedic extremities market was dominated by Arthrex, DePuy, Smith & Nephew, Stryker, Synthes and Zimmer Holdings in 2010.
The US bone graft substitute market is projected to generate nearly $2.3 billion through 2015. The introduction of new growth factor products such as Medtronic Spinal & Biologics'new bone morphogenetic protein, AMPLIFY or BioMimetic Therapeutics' Augment Bone Graft, a platelet-derived growth, is driving the market demand in this segment, according to Millennium.
In 2009, the total orthopedic trauma market was valued at over $3 billion, according to iData Research. This market will grow at a CAGR of 8.2% over the forecast period. In 2009, the fastest growing segments of the trauma market were intramedullary nails, plates and screws.
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General Surgery Products - Medical Device
| General or Endoscopic surgery will continue to expand more rapidly than other areas for two primary reasons: 1) the acceptance of endoscopic surgery, converting open surgery to endoscopic surgery and expanding into all specialty fields and 2) bariatric surgery and endoscopic procedures using Lap Band will grow rapidly, since the prevalence of obesity is increasing to epidemic proportions.
This is a positive trend for healthcare and it reduces healthcare costs. Endoscopic surgery has many benefits in reducing trauma, reducing scarring, decreasing hospitalization, and it is a less costly procedure, decreasing the cost of healthcare. In addition, the implementation of bariatric surgery or using the Lap Band device not only reduces the incidence of obesity, but patients are healthier. The weight loss may help reduce, prevent or eliminate other co- morbidity such as sleep apnea, psychological disorders, hypertension, osteoarthritis, diabetes, cardiovascular disease and cancer.
For more information regarding the general surgery market, feel free to contact me.
Background and Market Data
Endoscopic surgery, a minimally invasive procedure, continues to grow and it has a number of advantages, including reducing trauma, reducing scarring and shorter patient recovery which leads to reduced costs in the healthcare system. Endoscopic surgery has expanded to other specialty procedures in fields such as gastroenterology; obstetrics and gynecology, orthopedics, otolaryngology, thoracic surgery and urological surgery. General and pelvic endoscopic/laparoscopic surgeries, such as gastric bypass, endometrial ablation, laparoscopically assisted vaginal hysterectomy (LAVH), appendectomy, and prostatectomy totaled more than 2.8 million in 2008.
The U.S. market for products used in general and pelvic endoscopic surgery totaled more than $3.3 billion in 2008. It was projected that from 2009 -2013, this market is expected to grow at a healthy rate of 9.0% to nearly $5.2 billion in 2013. One of the reasons for this healthy growth despite the recession and pricing pressures is the demand for minimally invasive procedures that limit the cost of hospitalization and the endoscopy procedures are less costly.
Bariatric surgery, or gastric bypass, is a rapidly growing area, due to the prevalence of obesity. I mentioned in last month's newsletter that 33 states had a prevalence of obesity of 25% or greater and 13 states had a prevalence of 30% or greater in 2009.
The US Bariatric surgical devices market is forecasted to reach $1.9 billion by 2015, according to Global Industry Analysts, Inc. The primary growth drivers include the rising prevalence of obesity, improving success rate of surgeries, advanced surgical technologies, and the benefits of rapid and long-term weight loss in combating co-morbidities such as osteoarthritis, obstructive sleep apnea, and psychological disorders, as well as lowering hypertension and preventing diabetes and other cardiovascular diseases.
Gastric bypass was reserved for the severely obese who had a BMI of 40 or greater, or 35 and above if a person has at least one serious health problem, such as diabetes or high blood pressure, that is tied to obesity. Allergan developed the "Lap Band" device that is even less invasive than gastric bypass and widely accepted. The inflatable silicone ring is placed around the upper part of the stomach, limiting food consumption and makes one feel full faster.
Allergan requested that the FDA reconsider the criteria to qualify for surgery using the Lap Band device based on their new study that showed people in their proposed criteria of obesity that underwent the lap band procedure experienced "statistically significant decreases in all measures of weight loss." On February 16, 2011, the FDA approved the expanded use of their LAP-BANDŽ System. The revised criteria: Obese adults with a BMI of 30-40 with at least one obesity related co-morbid condition now qualify for LAP-BANDŽ system procedure when all other conservative weight-loss therapies have failed said the company.
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About BioMarketing Insight
We help companies de-risk their product development process by conducting the business due diligence to ensure that it is the right product for the right market and the market potential for the product meets the business goals of the company. We can then develop marketing strategies to drive adoption for the product.
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