| Medical writing agencies in Europe and North America have experienced rapid growth over the past two decades. Nacho Mbaeliachi at Healthcare Project Management recognises that how they respond to new technologies and globalisation will determine their future
Art Gertel, a past president of the American Medical Writers Association (AMWA), once mused that nobody in medical writing had ever uttered the words “when I grow up, I want to be a medical writer”. That, of course, was an understatement. When he joined the profession more than 25 years ago, it was so obscure that even pharmaceutical experts were unfamiliar with it. Most people who had heard of it thought it had to do with writing doctors’ notes, and medical writers faced the arduous task of repeatedly explaining to family and friends what exactly they did for a living. Today, although explaining oneself may still be a difficult task, medical writing has grown into a multimillion dollar service industry with increasing recognition within the pharmaceutical industry. Thomson CenterWatch estimates that the market for medical writing today is over $600 million and has been growing at a rate of 15 per cent a year over the past few years.
The growth in medical writing has been fuelled by changes in regulations for drug development and a rise in the number of pharmaceutical-sponsored publications. Although growth is expected to remain strong in the near future, industry watchers predict that it will be accompanied by rapid changes due to new technologies and globalisation. How individual agencies respond to these changes will determine the shape of the industry in the years ahead.
CAPACITY VERSUS EXPERTISE
The debate as to whether medical writing agencies provide expertise to pharmaceutical clients or if they merely provide extra capacity to help them through large workloads used to be only of academic importance. Rapid growth of new business from companies who had recently downsized their work forces and the increased regulatory burden ensured that the distinction was unnecessary in the past.
Some agencies have managed to provide capacity not just for new products but for old products needing reformatting for new labels or doses and for submissions to new countries. Sometimes the business came unexpectedly from new regulations that affected old products. For instance, the EU’s Registration, Evaluation, Authorisation and Restriction of Chemical Substances regulations, which became law in June 2007, require the retrospective testing of thousands of substances that have already been in use, before tests on new chemicals are mandatory. According to The Economist, the result is likely to be around four million toxicology experiments that would not otherwise have happened (1), which will lead to a lot of extra documentation that companies (not just pharmaceutical ones) will need to outsource. But there is a concern that changes in regulations may not continue to spur growth in the future and that agencies may have to explore new growth areas by providing more expertise rather than capacity for their clients. |
