The global biotechnology industry achieved record levels in financing and deal making in 2007, Ernst & Young's annual report on the trends shaping the biotechnology industry.

The report,Beyond Borders: Global Biotechnology Report 2008, attributes the strong confidence shown by investors and strategic partners in the sector despite the tightening global financial conditions.

''In 2007, investors were drawn to the tremendous value of biotech's innovation, with impressive results, as venture financing and deal making reached unprecedented heights,'' said Glen Giovannetti, Ernst & Young's global biotechnology leader. ''To continue its multi-year track record of progress, the industry must meet the current challenges of cooling public equity markets, greater regulatory scrutiny and higher product approval and reimbursement hurdles with fiscal discipline and the creativity and innovation for which it is known.''

Highlights of the report include:
The global biotechnology industry had a very strong year on the financing front. Companies in the Americas and Europe raised more than $29.9 billion – a new high excluding the outlier genomics bubble year of 2000.

Venture financing reached an all-time high in 2007 with investment totaling about $7.5 billion, fuelled by a record total of $5.5 billion in the US and 72 per cent growth in Canada.

Global public biotechnology company revenue rose by 8 per cent in 2007, crossing the $80 billion threshold for the first time. Absent the acquisition of several leading biotech revenue producers by big pharma, revenue would have increased by about 17 per cent – in line with the industry's historical compound annual growth rate.

The global industry's net loss decreased from $7.4 billion in 2006 to $2.7 billion in 2007. In the US, the industry came closer to aggregate profitability than in any previous year.

Deal making reached new heights in 2007. In the US, the total potential value of deals announced during the year – including mergers, acquisitions and strategic alliances – was close to $60 billion, outdistancing all other years by a wide margin. In Europe, the total potential value of such deals skyrocketed to about $34 billion.

''Today's European biotech industry is vastly stronger than it was just a few short years ago, with firms able to draw strategic buyers in droves and achieving remarkable growth in deal values, thanks to their maturing pipelines and rise in product approvals," Jürg Zürcher, Ernst & Young's biotechnology leader for Switzerland and Central Europe, commented on the state of the European biotech sector. "As the industry faces a more difficult financing environment ahead, it will need to build on its enduring strength by translating its maturing pipeline into marketed products over the next couple of years.''

While industry performance was strong on several fronts in 2007, emerging challenges have made the road ahead more difficult for many biotech companies. In the US, product approvals slowed, as safety concerns related to new and already approved products increased, and the US Food and Drug Administration (FDA) faced resource constraints.

In the UK, growing pricing pressures brought the first-ever agreement by a company to refund a payor for the cost of treating patients that do not respond to its medication. In China, safety issues prompted a determined regulatory response. Meanwhile, the industry faces more stringent enforcement of numerous regulations – from sales and marketing rules to the US Foreign Corrupt Practices Act.

New rules for a changing game: sweeping industry changes ahead
The "Beyond Borders" report examines three key trends that are transforming business models and the nature of competition for biotechnology and pharmaceutical companies.

Reinventing big pharma:
As they face unprecedented patent expirations, pharma companies are trying to boost earnings by cutting costs and making deals. But the report points out that these approaches can only buy so much time – longer term, pharma companies need to fundamentally reinvent their structures and incentives to improve the productivity of their innovation efforts. For biotech firms, the opportunity is to work collaboratively with big pharma, using creative business models that give them increased flexibility and a larger share of the value they help create.

The rise of personalised medicine:
The adoption of personalized medicine is being hastened by business drivers such as pricing pressures and safety concerns. The Beyond Borders report predicts that personalized medicine will fundamentally alter the competitive landscape, changing the bargaining power of small and big drug companies and forcing firms to reassess traditional sources of competitive advantage.

Globalisation:
Similar to personalized medicine, globalization is radically altering the traditional competitive advantages of pharma and biotech companies. While the initial focus has been to lower drug development costs, these financial gains will be temporary, according to the report. The real opportunity is for western companies to work with partners in emerging markets to develop innovative products suited specifically for local market conditions.

Key regional findings:

United States
Revenues of public biotechnology companies in the US rose over 11% from $58.6 billion in 2006 to $65.2 billion in 2007.
The US industry's aggregate net loss was under $300 million – less than 0.5 per cent of revenues and the closest it has come to overall profitability in its history

The US industry raised an all-time high of $5.5 billion in venture capital, about $2 billion more than the previous record.

Approvals by the US Food and Drug Administration (FDA) for both pharmaceuticals and biologics slid precipitously in 2007, with the lowest number of new molecular entity (NME) approvals in over two decades.

Europe
The European industry's revenues declined in 2007 because of the loss of publicly listed biotech giant Serono, which was acquired by Merck KGaA. Without this acquisition, public companies revenue growth would have been 20 per cent. After years of lackluster growth, the European sector is sustaining robust financial performance.

The industry raised a total of €5.5 billion, an increase of 18 per cent from €4.6 billion in 2006.
The number of products in the clinical pipeline – including those in preclinical and clinical development – increased by 9 per cent, climbing to 1,712 in 2007 from 1,576 in 2006.

Asia-Pacific
Asia-Pacific biotechnology industry revenues grew by 21 per cent and net loss declined by 98 per cent, causing the industry to essentially break even. The strong performance was driven by the Australian sector, where the largest firm, CSL, had a very strong year.

There was a marked increase in IPOs, which brought in more than $750 million. Eight companies went public in Australia and five Chinese companies listed on US exchanges.