Тo subscribe for regular updates on new articles, please subscribe here.Subscribe
It’s tempting, as another year comes to an end and we look back at the preceding 12 months, to fall back on clichés. We could reach for Dickens, for example, invoking his memorable opening lines from “A Tale of Two Cities.”
But they don’t really apply to biopharma in 2015. It was neither the best of times nor the worst of times.
Scanning a year’s worth of headlines from BioWorld Today, the Thomson Reuters daily biopharmaceutical news service, we were reminded of some dark moments, to be sure, or at least some challenges that arose in 2015. Top among them was no doubt the debate over drug pricing which put the industry in a harsh media spotlight and at least temporarily siphoned value from many of biopharma’s blue chip companies. The industry took a financial hit as a result of macroeconomic events, also, such as Greece’s debt crisis early in the summer, which roiled markets worldwide.
Despite the dips, however, it was a year of optimism overall. There were terrific advances in the clinic, celebrated drug approvals and complex and spectacular licensing and M&A deals. The business wins were inspiring enough to keep capital flowing into the industry, cancelling out some of the disappointing trial results. Investors seemed to acknowledge that – and here we’ll invoke perhaps the most time-honored of biopharma clichés – some shots will inevitably get blocked or miss the goal altogether.
Here are some thoughts on 2015:
The money continued to flow: Early last January, a slew of stories looked back at 2014 touting “a banner year” in venture money raised, IPOs and the value of deals made. Watch for stories with similar themes over the next few weeks as 2015 is ruminated upon. BioWorld’s Peter Winter highlighted the industry’s resilience as it rebounded from this year’s pricing crisis in a late November article headlined Biotech sector on track to close year in positive territory. “The sector’s fundamentals remain strong,” he wrote.
Pricing in the spotlight: This story will not go away, and nor should it. One hopes something positive emerges from the tale of Turing Pharmaceuticals. In the much-publicized scenario, Turing and its now-departed (and indicted) CEO, Martin Shkreli, rocketed up the price of a drug used for decades to treat parasitic infections by 5,000%, triggering a public outcry in late summer and scrutiny of the industry’s pricing policies from U.S. presidential candidates as well as its Congress (see Price hikes threaten to topple U.S. health care system). The episode is a solid reminder to the industry that in this age of rising healthcare costs and powerful payers, drugs must not just be safe and efficacious, but also cost-effective.
Hot sector to watch #1: immuno-oncology. Many of the biggest deals in 2015 involving some of the biggest industry players – Novartis, AstraZeneca, Merck, Sanofi, Bristol-Myers Squibb – focused on this technology that looks at harnessing the human immune system to block cancer. In advance of the American Association for Cancer Research meeting in April, BioWorld’s Senior Science Editor Anette Breindl captured the technology’s upbeat prospects in a preview titled Immuno-oncology continues quest for world domination.
Hot sector to watch #2: precision medicine. Linking biomarkers and genomic profiling to drug discovery and development to serve ever-more narrow groups of patients is by no means a new concept. But precision medicine came into its own in 2015, spurred in part by President Obama’s name-checking of it in his State of the Union address and the Precision Medicine Initiative in the U.S. that followed. Despite the clamor and high-profile attention, however, questions and challenges remain. See With targets aplenty, precision medicine seeks precise path forward and Precision medicine is evolving rapidly, yet few products approved.
More hot sectors to watch: We’re not being facetious here: Watch all of them. There is extraordinary work being done in big pharmas, small biotechs, universities and research labs across the globe targeting some of the most heart-breaking and tragic human diseases. The BioWorld team tracked innovation across all therapeutic areas in 2015, including these vexing targets: Mixed progress but no breakthroughs solving Alzheimer’s puzzle and Advance into complexity: Gene, cell therapy strides expose work still ahead.
Biosimilars: The FDA approved in March and Sandoz launched in September Zarxio, the long-awaited first biosimilar to become available in the U.S. Buoyed by the debut of biosimilars in the largest pharma market in the world (FDA is expecting a steady flow of biosimilar applications), this branch of the industry continued to attract both small biosimilars specialists and big pharma companies alike. Some of the initial optimism about biosimilars has been tempered as generics-like savings have not been achieved in many cases, suppressing adoption, as BioWorld Regulatory Editor Mari Serebrov reported in Great expectations of biosimilars being reined in by reality.
Global reach: While the biopharma industry remains a force in its traditional North American and European strongholds, the industry grew in many other regions worldwide in 2015. A BioWorld special report focused on the Middle East and North Africa, for example. India, Japan and Latin America sought to increase their presence on the world pharma stage. And down under, an investment company launched the largest ever life sciences fund in Australia.
More than any other nation or region, however, China has dramatically repositioned itself to be a drug development powerhouse, making sweeping regulatory changes that moved closer to international regulatory practices with a better system for getting quality drugs on the market. Chinese companies became much more active on the deal-making front in 2015 and a Chinese scientist won the nation’s first Nobel prize. For more, see China R&D innovation, investment catching up to global markets and China’s State Council promises to revolutionize drug development sector.
Patients in focus: At biopharma industry meetings and clinical conferences held throughout 2015, there was a common theme that kept emerging, regardless of whether your networking took place at the J.P. Morgan Healthcare Conference, the American Society of Clinical Oncology’s annual meeting, BIO International, the congress of the European College of Cardiology or the ChinaBio Partnering Forum.
Yes, this is an industry that must succeed in a business sense. It needs a healthy ROI to do its work. It is essential that capital keeps flowing and that the stocks do well.
But at the heart of the industry are the patients, as we were reminded time and time again in 2015: Patient engagement extends beyond drug, device development.
We look forward to seeing what 2016 brings.
Thomson Reuters hosted a free webinar offering insights into the 2015 Deals Landscape - View the webcast