Stakeholders across the healthcare continuum are in a constant search for better and timelier information. This is particularly true in the pharmaceutical and device sectors where (i) pharmaceutical sponsors need data to determine where and how to deploy research and development capital;  (ii) physicians demand reliable, impartial data to be more clinically aware and educated about new and developing treatment options; (iii) patients are seeking information to learn about diseases and available clinical trials and treatment options; and (iv) payers are assessing comparative effectiveness and the economic benefit of new and developing therapies.

The Medical Affairs function is responsible for distilling and disseminating much of these data flows. Historically, the Medical Affairs function was solely performed by sponsors in-house. But over the past years outsourcing of some Medical Affairs tasks have increased. We expect this trend to continue, creating opportunities for third-party providers of these services.

The responsibilities of Medical Affairs groups vary among sponsors. Generally, the groups serve as a bridge between the scientific and commercial teams. A core task of many groups includes analyzing clinical trial data and communicating it to providers, patients and payers. In addition, some Medical Affairs groups are responsible for market access assessments, non-registration evaluation and health economics and outcomes research (HEOR) studies.

Individuals within Medical Affairs include a wide range of professionals, including health economists, market access professionals, medical researchers, medical writers, pharmacists, physicians, regulatory and compliance experts and scientists. Demand for Medical Affairs services is expanding, driven in part by increased global regulatory and compliance requirements and sponsors’ growing desire to use third-party experts to assist in a variety of Medical Affairs services.

An area of particular interest to sponsors is global market access assessments of compounds and devices in the discovery or development process. Gone are the days of beginning reimbursement conversations with payers shortly before or upon regulatory agency approval/clearance. Today, formulary and reimbursement discussions begin much earlier in the development process. This global market access information and payer feedback is critical and used by sponsors to determine if and to what extent development should continue. In addition, as the number of rare-disease and orphan therapies has expanded, sponsors are seeking assistance to properly position the therapeutic outcomes and economic benefits of these therapies. Lastly, outsourcing allows sponsors to access experienced third-parties’ Medical Affairs experts and achieve variability with associated costs. This trend is contributing to the growth in the number of providers of outsourced, global Medical Affairs services. 

The Medical Affairs market includes mostly outsourced providers of one or more point solutions, which is creating an opportunity for leading companies in the sector to add additional Medical Affairs solutions to their service offerings and consolidate. UDG Healthcare’s acquisition of KnowledgePoint360, Medical Communications Group, Drug Safety Alliance, Ashfield Healthcare, among others, is an example of such consolidation.

A few companies that provide Medical Affairs services that we expect to benefit from the ongoing global regulatory and compliance complexity, continued growth of personalized medicines and the desire of sponsors to utilize third-party Medical Affairs experts include:

Ashfield Healthcare Communications. An operating unit of UDG Healthcare plc, it services international healthcare services organization that redefines outsourcing.

Envision Pharma Group. A technology-led, innovative scientific communications company serving leading pharmaceutical, biotechnology and medical device sponsors. Providing strategic publication planning and related data dissemination and consultancy services, enhanced with industry-leading complementary technology solutions.

MediMedia Pharma Solutions. Acquired by ICON plc earlier this year, MediMedia is a leading provider of strategic payer-validated market access solutions to both biopharmaceutical and medical device sponsors.

Precision for Medicine. A specialized services company supporting next generation approaches to drug development and commercialization. It provides integrated services and infrastructure to support pharmaceutical and life sciences companies as they develop new products in the age of precision medicine.