To encourage innovative drug development, China's State Council recently announced rules for a Marketing Authorization Holder pilot program: drug R&D institutions and individuals will now be able to apply for and hold CFDA approvals without having an in-house manufacturing capability. Previously this was not possible. Without incurring the expense of building a manufacturing operation, drug R&D companies and institutions can develop drugs, engage a contract manufacturer, apply for approval and market the drugs
Chronic Disease Rises Sharply in China
ChinaBio® Daily Update
Fully 25% of China's adult population suffer from hypertension and almost 10% have diabetes. The analysis was part of a ten-year study conducted by China's National Health and Family Planning Commission. Chronic diseases result from poor dietary habits, sedentary life styles and smoking, the report continued, though longer average lifespans also have an effect. The government plans an all-out education offensive to prevent the occurrence of chronic disease, and it pledged to develop best-practice use of western-style drugs and TCM products to treat chronic disease, once it occurs.
The CFDA has issued new policies to reduce the very long waiting times for approvals -- both for clinical trial and marketing approvals. According to a recent Ropes & Gray internet posting, the new rules: 1) expand the categories of new drugs that qualify for fast-track approval; 2) simplify the clinical trial approval procedure; 3) allow innovative companies to file for approval without owning their own drug manufacturing facility; and 4) classify drugs that are approved outside of China as generics for China approval
Over the next five years, China's spending on medicines will grow at a 6-9% CAGR, with a total drug spend of $150-$180 billion in 2020, according to a forecast released by healthcare consultancy IMS. Just one year ago, IMS predicted that China's drug market would grow at a 10-13% CAGR over the same time period. China's expected economic slowdown is part of the reason for the revision, but IMS also thinks that, as more of China's citizens gain access to medicines, there is a smaller driver for future growth.
By Tracy Staton
Margins, margins, margins. That's an inevitable mantra among top investors and analysts. Just ask Novartis ($NVS) CEO Joe Jimenez, who's pledged big improvements in the Swiss drugmaker's spread. Or Eli Lilly ($LLY) CFO Derica Rice, who's had to explain why his company can promise to maintain margins as its sales spiral downward.
But if you want to talk to CEOs whose drug companies top the ranks of profit-generators, you'll have to go much smaller. As Investor's Business Daily reports, Jazz Pharmaceuticals ($JAZZ) boasts one of the best margins out there--and not just among drug companies. Jazz rode its controversial narcolepsy drug Xyrem to a 54.4% annual margin, IBD says. Not to mention a 40% hike in Q2 sales to $291.2 million.
Celgene ($CELG), the blood cancer specialist that's been growing by the billions, has been kicking plenty of that top-line growth to the bottom line, too. The company boasts an annual profit margin of 47.4%, thanks to leaping sales of its multiple myeloma treatment Revlimid. And CEO Bob Hugin has promised to double sales to $12 billion by 2017, so he's clearly confident that Revlimid, plus its newly approved myeloma treatment Kyprolis, will keep delivering.
Meanwhile, the often-spotlit Regeneron Pharmaceuticals ($REGN) racked up a 44.4% margin, with more than $1 billion in 2013 revenue and a money-churning eye drug, Eylea. Its Q2 numbers were impressive, too, with a 45% increase in sales to $665.7 million.
Alexion Pharmaceuticals ($ALXN) comes in for a margin award, too. IBD calculates a 42.9% annual margin for the rare disease specialist, thanks to the continued strong growth of its ultra-pricey drug Soliris. For Q2, IBD points out, the company delivered more than a half-billion dollars in sales, a year-over-year increase of more than one-third.
Funny thing about delivering margins. It appears to deliver some hefty pay packages, too. Three of these four companies have CEOs that hit FiercePharma's highest-paid list this year--two at the very top: Regeneron's CEO, Len Schleifer; Celgene's Hugin; and Alexion chief Leonard Bell.
Capturing Pharma Opportunities in Emerging Markets till 2017 from GIA :
Pharmaceutical & healthcare companies will continue to focus on BRIC countries for 2012 - 2017
US pharmaceutical & healthcare companies have a wide range of definitions for Emerging markets including product penetration, penetration level of the company and stage of economic development
China is the easiest to do business in and Brazil is becoming more competitive in the global context
Russia has less widespread appeal
Top 5 deals in 1H14
If the Novartis-GSK transaction is not surprising the Bayer-Merck & Co is amazing...
A new era in big pharmas strategies and profiles
To follow up
In-depth change in the pharmaceuticals arena : there is a definite room for innovation to promote drugs and deliver information :
Posted March 21, 2012
Survey of U.S. and E.U. Pharmaceutical Executives Reveals Widespread View That "the Business Model Is Broken"
Most companies plan to fix the problem by increasing marketing spending and redeploying resources in new ways
New York, NY; Philadelphia, PA – March 21, 2012: Confirming pessimism about the state of the pharmaceutical industry, a recent survey of U.S.- and E.U.-based pharmaceutical sales and marketing executives reveals that 68 percent believe "the current business model is broken." The survey, conducted jointly by Strategy & Brand formerly Booz & Company and National Analysts Worldwide, was designed to take the temperature of the industry on current challenges and help analysts understand how industry leaders plan to overcome those challenges in the next several years. It builds on surveys Booz & Company has conducted of E.U. pharma executives over the past several years.
"Those of us who work with pharma companies to develop and implement commercialization strategies know very well the challenges of maximizing asset value in this new environment, where both key customers and customer expectations are being redefined," observes Susan McDonald, CEO of National Analysts Worldwide and leader of the firm's healthcare practice. "We're not surprised to hear people acknowledge that they can't count on doing 'business as usual' and that they're looking for new ways to gain traction."
The greatest challenges identified by survey respondents are the growing healthcare system price/budget pressures and an increasing need to demonstrate cost-effectiveness and outcomes. In response to these challenges, more than half of the respondents expect to invest more heavily in marketing to key provider accounts and payors. Among the strategies seen as most important are new approaches to pricing, new service models, and new collaborations with payors.
Those convinced that the model is broken are reacting by making significant changes in how they spend marketing dollars and time. They are shifting their spending dramatically from community physicians to new stakeholders. In particular, they are disproportionately investing in key accounts, payors, and hospital stakeholders. By contrast, those who are not convinced the model is broken are making few adjustments to their spending.
"The pharmaceutical industry is the eye of a hurricane of change. The sales and marketing model is being forced to move to one that is much more complex. And this is happening in
an uncertain market with incredible pressure to reduce budgets. The only clear path out of the storm is for companies to identify and focus on building the few critical capabilities they will
need to succeed," says Danielle Rollmann, a partner in Booz & Company's global health practice.
The survey provides insights into the capabilities and strategies that will be most important moving forward, including:
• Organizing sales and marketing activities around diverse stakeholders, especially hospitals and insurers
• Taking a more creative approach to customer collaboration, including new pricing strategies, innovative service models, and novel partnerships
• Doing a more effective job of demonstrating value through outcomes
• Continuing to emphasize direct-to-consumer (DTC) marketing, in recognition that patients hold the other end of the purse strings
• More effectively using innovative digital media channels
"Virtually everything is changing in the model and the market. In response, most respondents say they plan to spend more on all their target marketing activities. Yet this is not aligned with what pharma is doing and needs to do at a company level. The companies that focus, prioritize, and follow a coherent strategy will be the winners," says Rolf Fricker, a Munich-based partner at Booz & Company.
As noted above, the survey also signals plans to do more direct-to-consumer marketing. "This is one of many areas where we are helping pharmaceutical companies think differently. The power base in the industry is fundamentally shifting toward insurance companies, integrated providers, and patients. Influencing a sale is getting increasingly complicated and requires more innovative approaches to reach multiple audiences, so expect to see more innovative digital and social media in this space," says David Levy, a partner at Booz & Company serving clients in the life sciences.
The survey, which was completed in late fall 2011, is based on a sample of 156 sales and marketing leaders, most with global responsibilities, at pharmaceutical companies in the U.S. and E.U. Survey participants were primarily vice presidents and directors. For a link to the key findings of the survey, visit: http://www.strategyand.pwc.com
Read more: Survey of U.S. and E.U. Pharmaceutical Executives Reveals Widespread View That "the Business Model Is Broken" - FiercePharma http://www.fiercepharma.com/press_releases/survey-us-and-eu-pharmaceutical-executives-reveals-widespread-view-business?utm_medium=nl&utm_source=internal#ixzz1pptMasqI