Publications, thought leadership & studies

PwC’s Pharmaceutical & Life Sciences network is pleased to present you with our ninth issue of the Asia-Pacific Pharmaceutical & Life Sciences industry newsletter.

In this report, we look at how pharma companies can reach 2020 in a position to benefit from more favourable conditions thereafter - and the most important decisions senior managers will need to make.

Biopharmaceutical companies are expanding into emerging markets, sometimes without involving supply chain operations − which should play a strategic role in expansion planning.

In this edition we report on Australia’s upcoming disclosure regime in respect of the payments made to doctors and its pricing and reimbursement environment, China’s latest price cuts, Japan’s price reductions for generics and on India’s new drug pricing policy as well as changes in Taiwan’s taxation of shares and securities and some safe harbour provisions in Singapore.

Productivity’s still low, and money scarce, but a growing number of biotech and pharma companies are joining forces to tackle the challenges they face -- with alliances with new partners in new territories.

On July 9, 2012 President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) after overwhelming bipartisan approval by Congress. This renews a commitment to applicant funding of FDA drug and device reviews while requiring transparency, speed, and other process improvements. This paper discusses the implications of this congressional action.

Five major forces are dramatically altering the pharmaceutical industry's revenue models and creating new notions of value. These forces are hastening the arrival of an outcomes-based world in which the value of a drug tracks more closely with its impact on patient health. Significant barriers remain, particularly between drug manufacturers and health insurers. This report explores possible paths for pharmaceutical companies to unlock value, improve clinical and economic evidence, and continue to build transparency with other health organizations.

The Biotechnology and Medical Devices industries saw venture capitalists invest a total of $1.5 billion in the first quarter of 2012. While Medical Device venture funding accelerated, it could not offset the slowdown in Biotechnology and the first quarter of 2012 decreased 22% from the fourth quarter of 2011.

PwC recently surveyed executives from leading global and domestic Medtech companies with India operations representing $1.3 billion in revenues in India, or roughly 40% of the $3 billion Indian market. Their responses, combined with in-depth interviews and PwC’s research and experience in the industry, provide insight on how to succeed in India.

This PwC newsletter includes reports on the recent Indian and Singapore Budgets and the implications for multinationals and the local Pharma and Healthcare sectors.

Pharma and life sciences CEOs are gloomy about the state of the global economy but much more positive about their own prospects for growth.

This PwC document discusses the main implications that the latest IFRS-related proposals on revenue recognition have for the pharma and life sciences industry.

PwC’s Diagnostics 2011 provides an overview of M&A deal activity during the past two years and the factors driving it, the development of new prospects for early detection testing and a review of significant events for the development of personalised medicine. The report also includes an in-depth discussion about trends in companion diagnostics and business model considerations for pharmaceutical companies.

In our sixth release of the series, PwC discusses how pharma companies must develop different supply chain models, learn to use supply chains as a market differentiator and revenue generator, and recognise how information will drive the downstream flow of products and services.

Life sciences venture capital (VC) investment fell steeply during the fourth quarter of 2010, according to the PwC/NVCA MoneyTree Report with data from Thomson Reuters.

This paper evaluates the innovative capacity and capabilities of nine countries (Brazil, China, France, Germany, Israel, India, Japan, United Kingdom and the United States), all current or emerging leaders in medical technology in order to track global shifts in device innovation.

Poland remains the largest clinical trials market in CEE/CIS, however, both patient participation and site penetration rates indicate a potential for growth.

This series comprising five surveys is meant to provide insight to FDA and the industry on how to expand trust and build on their relationship.

This new publication highlighs the main trends dictating the need for a new way of conducting research and development, and two organisational concepts that would help biopharmaceutical companies become far more efficient.

The PwC MoneyTree report cites an exit poll by Thompson Reuters and the NVCA which concludes an active mergers and acquisitions (M&A) market and a level of initial public offerings (IPOs) consistent with a slow but steady economic recovery.

The dynamics of the Global Supply Chain are driving the Life Science ecosystem to seek innovative approaches which improve product safety while at the same time reducing costs and risks. To attain the sustained benefits of globalization, the Life Science ecosystem must implement a new paradigm to manage Global Supply Chains. This was a key finding of a major study of Pharmaceutical Drug, Medical Device and Bio-Pharmaceutical Industry Executives released today by the analyst and strategic advisory firm Axendia, Inc.

This publication explains the changes and contains examples to illustrate the issues of the new standard that are relevant to pharmaceutical and life sciences companies.

The old economic order is shifting. As the global economy recovers some emerging markets are likely to grow faster than traditional economic powers.

Download Venture capital (VC) funding in the Life Sciences sector, which includes the biotechnology and medical device industries, captured the highest total of VC dollars invested during the second quarter of 2010.

First-quarter life sciences venture capital investment declines from previous period but rises year over year; sector still captures largest share of funding

Our report highlights that India now has a growing and increasingly sophisticated pharmaceutical industry of its own. It is likely to become a competitor of global pharma in some key areas, and a potential partner in others.

Tax policy, research collaborations, mergers and acquisitions, financial planning, systems requirements, and compensation structures are among areas that will bear the impact. In this paper, we address these and other accounting and business challenges stemming from the move to IFRS and outline how PLS companies can begin dealing with them today.

Companies in the Life Sciences sector, which includes the biotechnology and medical device industries, captured the largest share of overall venture capital during 2009, reflecting the relative strength of the sector during the economic downturn.This year in review summary includes where venture capital investments and funding were made, the nature of transactions that took place as well as the geographic distribution of funding for the biotechnology and medical device sectors during 2009.

The 2010 report on California's biomedical industry report is a collaborative effort between the California Healthcare Institute and PricewaterhouseCoopers. It offers a comprehensive overview of the impact of the biomedical sector on California's economy and includes data on employment, wages, education and investment, as well as a snapshot of the product development pipeline.

The fifth paper in the series, Pharma 2020: Taxing times ahead, focusses on the challenges ahead but also shows how companies can adapt their tax planning to support the provision of outcomes-based healthcare and remain competitive.

Accounting under US generally accepted accounting principles (GAAP) continues to evolve, and in today's world, where there is a growing demand for greater transparency and heightened regulatory scrutiny, the challenge of determining the proper accounting for transactions has never been greater.

The first edition of Pharmaceutical Deals analyses merger and acquisition activity in the pharmaceuticals industry in Turkey between 2006 -2009.

This publication is designed to assist pharmaceutical and life sciences companies understand the potential impacts of the upcoming US GAAP changes and the joint revenue recognition project to their businesses.

PricewaterhouseCoopers reviews deal activity in the in vitro diagnostics (IVD) sector and significant events for personalised medicine, a field which is fast rising to prominence in healthcare innovation.

Therapeutic and diagnostic biologics helped drive venture capital investment in the overall human biotech sector in 2008 and are the fastest growing subsectors within the life sciences industry. Read more on the impact biotech is having on pharma.

To get a clearer understanding of the great potential and opportunities offered by biotechnology-based drug discovery, PricewaterhouseCoopers carried out an investigation of the German landscape of drug discovery and biotechnology together with the Council of German BioRegions.

The pharmaceutical and life sciences industries face unprecedented compliance challenges, and the close regulatory scrutiny of the industry is likely to only increase. Globalisation, information protection requirements, business partnerships, heightened transparency expectations, external reporting obligations, and other drivers are forcing companies to re-examine their enterprise approach to information technology (IT) governance, risk, and compliance (GRC).

Fourth in the Pharma 2020 series, this report explains why Pharma's fully integrated business models may not be the best option for the pharma industry in 2020 and why more creative collaboration models may be more attractive. The paper also evaluates the advantages and disadvantages of the alternative business models and how each stands up against the challenges facing the industry.

The report covers various subjects that are considered to be of concern to the pharmaceutical industry and/or investors in the pharmaceutical (pharma) industry in China.

This paper discusses how the industry is no longer being rewarded for incremental innovation, me-too products and selling the most pills.Companies need to add value to patients, and offer a package of products and health services that the market is willing to pay a premium for.

The 2009 report on California's biomedical industry report is a collaborative effort between the California Healthcare Institute and PricewaterhouseCoopers. It offers a comprehensive overview of the impact of the biomedical sector on California's economy and includes data on employment, wages, education and investment, as well as a snapshot of the product development pipeline.

Pay-For-Performance is a pricing concept under which the price paid for a given medicine is intended to reflect the economic benefits of a drug at an individual patient level. This paper discusses the issues and provides guidance as to when revenue may be recognised under these arrangements

Innovators in the health industry may be able to profit and grow their business in 2009, despite adverse economic realities and a prediction that the economy will continue to slow. However, to do this business leaders will also have to face additional external forces including new financial realities, regulations, technology and a new president and Congress. The PricewaterhouseCoopers' report from the Health Research Institute (HRI) identifies nine significant issues that will impact the health industry in 2009. The report also addresses the implications of these issues for businesses and the industry-at-large.

President-elect Obama has indicated that his administration will reform the American health system to expand access and make health care more affordable. However, his administration will need to address how these programs will be paid; the impact of expanding health insurance coverage; and the potential shortages or strains these reforms could pose for the existing health care system. This report examines the challenges the President-elect faces, explains how these reforms may be enacted, the potential impact for employers as well as those in the health industry and provides five ideas for making health care more affordable.

The dynamics of pharma outsourcing and location decisions in Asia are changing. Cost reduction is being augmented and companies need to set their strategic sights on a future world. This report highlights the dramatic change and development in pharmaceutical outsourcing in Asia.

To gauge readiness and reaction to the Registration, Evaluation and Authorisation of Chemicals legislation, or REACH, PwC's International Survey Unit interviewed 241 senior executives across 6 industries in 29 countries. Overall, we found that two in five companies have limited awareness of the regulation and one in four executives believes Europe's complex chemicals legislation will have no impact on operations.

The second paper in the PwC Pharma 2020 series, explores how pharma companies could dramatically improve the R&D productivity. It contends that by 2020 the R&D process may be shortened by two-thirds, success rates may dramatically increase, and clinical trial costs could be cut substantially. New computer based technologies will create a greater understanding of the biology of disease and the evolution of "Virtual man"; to enable researchers to predict the effects of new drug candidates before they enter human beings. Along with changes underway in the regulatory and socio-political environment, this will enable Pharma to overcome one of the most fundamental issues it needs to resolve over the next decade.

This report is an update of the 2004 and 2005 volumes 1 and 2 of IFRS Issues and Solutions for the Pharmaceutical Industry. The objective of this new edition is to give greater clarity on various grey areas of definition and interpretation that could have been raised following the implementation of the standards in 2005.

This third publication of IFRS Issues and solutions for the pharmaceutical and life sciences industries has been prepared to stimulate discussion and represents a first step in trying to establish a common platform or framework.

This review is based on an analysis of the 2006 financial statements of 12 major pharmaceutical entities reporting under IFRS. The aim is two-fold:

-to help pharmaceutical companies to compare their disclosure against their peers'
-to help users of financial statements to interpret and understand the methods and presentational options adopted in the financial statements

This report addresses particular accounting issues the pharmaceuticals and life sciences sector faces when using the US Generally Accepted Accounting Principles (US GAAP). The aim is to highlight the industry-specific factors which need to be considered, and to provide an opinion on the most pertinent accounting solutions for commercial situations under US GAAP.

Pharma 2020: The vision: Which path will you take? indicates that the current pharmaceutical industry business model is both economically unsustainable and operationally incapable of acting quickly enough to produce the types of innovative treatments demanded by global markets. In order to make the most of these future growth opportunities, the industry must fundamentally change the way it operates.

The report is based on in-depth interviews with 185 senior pharmaceutical executives across nine different territories in the region: China, India, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam.