Hundreds of millions of people across the globe suffer from chronic diseases such as psoriasis, Crohn’s disease, rheumatoid arthritis, diabetes and hemophilia to name a few. Many of these conditions are treated primarily with biologic drugs, which have proven to be highly effective. Yet, as of today, those drugs can only be injected. Sales growth for biologics has steadily increased; this holds particularly true for AbbVie’s blockbuster drug Humira.
Despite the explosive growth of the biologics sector, there are other factors that could further transform the market. In particular, the growing number of biosimilars combined with the potential for oral delivery of biologics could completely change the landscape for biologics. For patients, these changes mean more affordable access to the drugs they need, and at long last, an alternative to painful injections.
To give more perspective, the global biologics market exceeds US$200 billion (£154 billion) and is expected to reach a staggering US$399 billion (£308 billion) by 2025.
The backdrop of this growth is a highly competitive market, fueled by a relentless rise in healthcare costs and an aging population. As a result, pharma companies are looking for new ways to maintain and expand market share, and biosimilars along with new technology approaches are offering some hope.
While pharma companies are vying for their share of the market, patients, physicians and payers alike are also looking for alternatives. Biosimilars, for example, offer a new, much more cost-effective option for treatment versus current biologics. Beyond cost, patients are also driven by convenience and comfort as biologic injections can be quite painful. The world’s best-selling drug, Humira, is currently only available in injectable form, as is insulin therapy for diabetes, which entails a painful and inconvenient daily injection. The biologic Sandostatin, used to treat acromegaly, requires self-injection up to three times daily at the start of treatment.
There is clear demand from the patient and physician community for an alternative to injections. According to a recent Frost & Sullivan survey, patients and physicians alike would select an oral biologic over an injection. In fact, the survey found that 88% of patients would likely shift to a pill if given the choice over an injection and 86% of gastroenterologists and rheumatologists believe their patients would switch to a pill. In addition to the fact that painless pills would contribute to a better quality of life, survey respondents claimed that compliance could also expected to improve with an oral alternative.
Given the market demand and potential, it is no wonder that there have been more than 100 attempts and billions of dollars spent by companies in the past to convert painful injections into painless pills. Experts have often called this quest for oral biologics “the holy grail.” Why have these various attempts at oral delivery of biologics ended in failure? The reason is that these protein molecules are efficiently broken down via digestion. As a result of the breakdown of molecules in the GI tract, existing approaches have very low bioavailability. However, new technological innovations are breaking new ground to give hope that oral biologics are finally within reach.
Rather than try to change the drug to make it viable orally, which many others have tried before and failed, new approaches are now focusing instead on how the drug is delivered. Given the advances in electronics, nanomedicine and FDA-approved ingestible materials, it is likely that device-mediated oral biologics delivery, such as microneedles, will soon provide an alternative approach.
This could be a bonanza for pharma companies, but what is more important is the impact it could have on millions of patients. With an effective oral option, these patients would have an alternative choice to painful injections to treat their disease. The data shows that patients are much more likely to take a painless pill instead of a painful injection, which would improve compliance to a treatment regimen. This in turn could improve disease management and slow disease progression.
And for the pharma market, convenient, cost-effective and pain-free administration could mean big changes in the market landscape. Changes that threaten the market position of dominant drugs, not just by reducing the cost, but by significantly improving the quality of life for those millions of patients suffering from chronic diseases and the treatment of these diseases.
Mir Imran is chairman & CEO of Rani Therapeutics