Success Rate of New Drug Development Expected to Leap from 10% to Nearly 30% By 2008
NEW YORK, March 9, 2000 - Leading pharmaceutical companies have set aggressive goals to meet shareholder expectations by planning to quadruple the number of new medicines launched annually, according to new Accenture research.
The improved success rates for new medicines, shorter development cycles and increasing the drug development pipeline will all contribute to making more new medicines available to the marketplace. The research found:
The success rate of newly approved medicines among leading pharmaceutical companies is expected to improve dramatically -- from the historical rate of one in ten (10:1) to nearly three in ten (10:2.8) by 2008
Although the industry has achieved a more than 30 percent improvement in drug development and approval cycles, continued investments in "time-to-market" initiatives by industry-leading pharmaceutical companies are projected to yield an additional 33 percent improvement over the next ten years
These leading companies will see a 65 percent increase in the number of potential medicines entering the clinical development process
"Leading pharmaceutical companies’ growth will be fueled by both the increased volume as well as the selection of new drug candidates with higher revenue potential." said Mary Jo Veverka, the Accenture partner who led this research. "Ultimately, the improved development success rate - made possible by scientific advances -- will make a significant contribution to stemming escalation in drug development costs."
Experts Provide Vision of the Industry in 2008
The Accenture research, Speed to Value: Delivering on the Quest for Better Medicines, ¹ is based on interviews with more than 100 pharmaceutical company executives and regulatory officials. Research participants shared many of their changing tactics and strategies to increase the volume and revenue potential of new medicines over the next decade.
"These research findings point to a future in which the companies who succeed in achieving the improved success rates will be well positioned to meet shareholders’ earning targets, while simultaneously making medicine more affordable, " Veverka said.
"With all the improvements that the new drug discovery sciences have brought us and those we anticipate, it is imperative that we continue to improve our development organizations to meet these new challenges. The healthcare community, patients and shareholders rightly expect us to keep launching better medicines, with as few delays as possible," said Eduard E. Holdener, Head of Global Drug Development, Hoffman-La Roche, Ltd.
The New eParadigm
The speed of the Web will soon transform clinical trials from laborious exercises in paperwork and patient recruitment into an efficient exchange of electronic communication, data analysis and expedited regulatory agency review of new drug applications, according to the Accenture report.
Consistent with these findings, Accenture believes the future of successful drug development will be driven by five key components, all of which depend on effective use of the Internet:
Informed and involved consumers exerting influence on drug developers, regulators and payers
Pharmaceutical company "ownership" of disease categories (e.g., diabetes, hypertension, etc.) through therapeutic knowledge, a deep understanding of patient needs and direct dialogue with consumers and caregivers
Science-based knowledge capital used to improve product selection, clinical trial design and regulatory decision processes
eEnabled clinical trial models that use netsourcing partners to streamline and speed trial administration and data management
Global regulatory alignment to expedite cost-effective product development and delivery worldwide.
The new Accenture research, Speed to Value: Delivering on the Quest for Better Medicines, is based on interviews with more than 100 pharmaceutical company executives and regulatory officials. Research participants shared many of their emerging tactics and strategies to expedite drug development of new medicines over the next decade.
During the course of this research, Accenture developed five key recommendations for how pharmaceutical companies will succeed:
1) Shift from a product-driven to a patient-driven strategy. Companies must capitalize on knowledge and customer relationships in their development programs to manage the full product life-cycle as well as develop follow-on products well in advance of patent expiration. This is necessary to shift the definition of success from maximizing peak sales to maximizing franchise value, and will allow more active patient involvement in shaping the drug development agenda. As the science enables more customized products, companies will "fast follow" their pioneer investments to achieve more rapid market penetration with better medicines for defined patient sub-populations.
2) Focus on improving success rates. Sharply reducing the resources expended on the development of new chemical entities (NCEs) that fail to meet regulatory or market acceptance - and doing so as early as possible - presents the greatest opportunity for offsetting rising development costs. As the science matures, customized products present an added opportunity to significantly improve success rates, time to market and development costs.
3) Create a learning organization. Successful drug development organizations will invest in the capability to translate their emerging scientific knowledge into demonstrated medical outcomes. Development projects should be prioritized by a deeper understanding of patient needs. As a result, The pre-clinical and clinical phases of drug development will be seamlessly integrated, allowing better and earlier selection of winning compounds. Global, cross-functional development teams will tap into a growing, global information base to provide insight into the unique requirements of diverse populations and widely varying healthcare delivery systems.
4) Redesign the clinical trials process. eEnabled technologies will force a complete redesign of the existing clinical trial models. The Internet will affect every phase of trial planning and execution, from recruiting participants to delivering trial data to regulators. Emerging Web-based offerings and netsourcing partners create an opportunity to enhance data quality and integration, reach patients and further reduce costs and time to market.
5) Support a common global regulatory framework. Real progress in achieving global regulatory alignment is essential to realizing more timely and cost-effective approaches to commercializing promising innovations. The Food & Drug Administration (FDA), the European Medicines Evaluation Agency (EMEA) and the Japanese Ministry of Health and Welfare (MHW) must define a common global regulatory framework to provide the platform for each authority’s next round of modernization initiatives. Additionally, industry leaders and regulators must collaborate to build the knowledge, global standards and integrated regulatory databases required to achieve these common goals.
¹ Seven leading pharmaceutical companies participated in this research : Bristol-Myers Squibb, Glaxo Wellcome, Hoffman-La Roche, Merck, Novartis, Pfizer and SmithKline Beecham-as well as the Food & Drug Administration, the Medicines Control Agency and the Committee for Proprietary Medicinal Products regulatory authorities.