The pharmaceutical industry can isolate itself in a diminishing linear business model that is growing weaker as blockbuster patents expire, generic competition whittles away market share, and fewer new drugs prove innovative and economically viable. Or, the industry can channel a whirlwind of technological, scientific, social, and economic change into innovative business models that are more relevant to today's outcomes-focused healthcare delivery system.
Innovating research and development
In a more patient-centic business model, the pharmaceutical industry must direct its research and development (R&D) investment to products that the healthcare market defines as truly innovative. The industry must seek the involvement of public and private payers, providers, and patients by reaching out to these stakeholders earlier in the R&D process to ensure that products are viewed as innovative.
To develop new medicines, companies will need to continue to tap into academic research and biotechnology. Mergers and acquisitions can beef up product portfolios, but companies will need to rely more heavily on in-licensing and partnerships to accomplish the same goal at a faster rate and at lower cost. Megamergers may become less typical in the future because many have tended, in the past, to stifle creativity and failed to deliver sustainable cost reductions.
The most dramatic R&D changes will come in the way clinical trials are conducted. Clinical trials will become smaller, more targeted, and more iterative as regulators allow "live licensing" (in-life testing) to vet the safety and efficacy of therapies in selective patient groups before expanding to larger or different populations. In this environment, R&D will concentrate on complex, targeted products. Demand will shift to specialized medicines, primarily in the form of biologics. Although biologics are more complicated to develop, manufacture, and distribute, they hold industry's greatest hope for sustained profitability.
Focusing on outcomes
With advances in genomic research, lower-cost genetic mapping, and comparative effectiveness studies, industry will be better equipped by 2020 to determine which medicines have the most potential for delivering positive outcomes to specific patient subpopulations. This ability will be critical as health insurers and the federal government increasingly refuse to pay for therapies that fail to deliver cost-effective results. This "value-based purchasing" or "evidenced-based medicine" will further intertwine the value chains of payers, providers, and pharmaceutical companies, with each owning a stake in treatment effectiveness.
As the US Congress considers creation of a program for universal healthcare coverage, a strong likelihood exists for more government pressure on pharmaceutical companies to lower drug prices. An early indication of this move was illustrated last May when President Obama discussed a pledge by a consortium of executives from leading payers, providers, and pharmaceutical manufacturers committed to reduce the annual growth of healthcare spending by 1.5%—an expected savings of more than $2 trillion by 2018. In emerging markets, governments seeking to expand healthcare access for their surging populations also will demand price concessions. Broader access and rising incomes in emerging markets, however, may result in a higher number of prescriptions being written and may help offset some profit erosion.
Around the globe, technology-enabled outcomes measurement will drive product development, pricing, and reimbursement decisions, as well as risk-sharing arrangements. Electronic health records, ePrescribing, remote monitoring, pharmacovigilance systems, and other technologies will yield extensive, real-time outcomes data on the effectiveness of medicines. With appropriate privacy safeguards, monitoring this treasure trove of data will enable pharmaceutical companies and other organizations to more closely observe and encourage patient compliance. Better patient compliance will improve health, build broader product demand, and grow profits.