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Ten predictions of global medical industry reform in the next five years

Release time: 2021-02-01

The report points out that the global medical industry will face a series of key turning points, and the changes in 2018 will be the key turning point driving the development of the global medical industry in the next five years. The types of drugs being developed, the contribution of medical technology to human health, and how to calculate the value of medical care will be significantly changed.

1. FDA will guide the adoption of RWE to support drug regulatory review

In 2018, FDA will release the framework to release the potential of real world evidence (RWE) to support regulatory submission and drug safety monitoring. As the big data collected in the real world medical environment becomes more common and powerful, it is increasingly being used as evidence in the entire health care system. It is expected that this transition trend of combining RWE with existing clinical trial data will promote more collaborative methods between life science companies and FDA around multiple fields (such as clinical trial design and post-marketing monitoring).

2. Niche biotherapy will go mainstream

The number of next-generation biotherapies under research and already on the market will continue to rise. From 2018 to 2022, it is expected that 5-8 next-generation biotherapies (including cell therapy, gene therapy and regenerative medicine products) will be approved for marketing each year, and these therapies will account for 20% of the 40-50 new active substances (NAS) expected to be launched each year.

On the other hand, these products will also subvert the consumption model. In most cases, the cost of the next generation of biotherapy will be close to or more than $100000 per patient. When there is no way to determine which patients are eligible for treatment, negotiate payment models based on treatment results, or have no ability to dilute the cost over time, how to make patients obtain these new therapies in a limited way will become a huge challenge for governments and insurance companies.

3. Mobile medical APP will be added to the treatment guide

In 2018, treatment guidelines from major clinical organizations will adopt and recommend the use of mobile medical APP. In fact, some clinical organizations have already done so. The trend of establishing and supporting digital tools and interventions for clinical application of hard evidence will continue in the next few years; In 2018, about 340 digital medical efficacy studies will be completed and released, while the number of digital medical studies expected to be completed in 2022 will reach 3500.

4. The application of telemedicine will be further expanded

In 2018, almost every patient with private insurance in the United States will receive some form of telemedicine, although it is rarely used. In 2017, the proportion of access to telemedicine was 2.6%, which will rise to 3.0-3.5% in 2018, and is expected to increase to 4.0% - 7.5% in the next five years.

5. Spending on branded drugs will decline

In the past five years, the net brand spending of developed market brand drugs has increased from 326 billion US dollars to 395 billion US dollars. Overall, 87% of the net increase of US $69 billion came from the US market. In 2018, the net expenditure of branded drugs in developed markets is expected to decline by 1-3%, which will reduce the net expenditure of branded drugs by about US $5 billion. The report predicts that the total net expenditure of branded drugs this year will be US $391 billion. In the next five years, although it is expected that several new branded drugs will be listed, the net expenditure of branded drugs in developed markets will remain the same as that in 2017.

6. Specialized brand drugs will promote the growth of developed markets

In 2018, the specialty brand drug market will grow from $172 billion in 2013 to $318 billion, accounting for 41% of the expenditures in developed markets. In fact, specialty drugs will drive all the growth of drug expenditure in 2018. However, these growth will be offset by the decrease of traditional drug expenditure. In 2022, specialty branded drugs are expected to account for 48% of total expenditures in developed markets.

7. The growth of the entire emerging pharmaceutical market slowed down

In 2018, the growth rate of the entire emerging pharmaceutical market will slow to 7-8% from the 9.7% CAGR of the previous five years, which indicates that the economic growth rate of this market in the third year is less than 10%. In the past 10 years, the share of emerging pharmaceutical markets in global pharmaceutical expenditure has increased from 13% in 2007 to 24% in 2017. Driven by changes in market capacity and the widespread use of generic drugs, the market in these emerging pharmaceutical countries is expected to grow by 6-9% to reach 345-375 billion US dollars by 2022.

In general, the process of promoting global health will continue, but due to the slowdown of economic growth in this group of key countries, the growth of drug availability in the past 10 years will not continue at the same rate.

8. US net per capita consumption expenditure will remain stable

In 2018, the net drug consumption per capita in the United States will decline and remain almost unchanged until 2022, about $800 per capita. After taking into account the strong new drug pipeline, the modest increase of 2-5% in net price (7-10% increase on the basis of pricing), and the impact of the loss of brand drug franchise (the impact in the next five years will be greater than that in the past five years), the per capita expenditure will remain stable.

9. Results-based contracts will play a limited role

The basic framework of the contract for payment based on the treatment results includes a payment schedule, which is based on the treatment effect of the drug or no payment in case of invalidity. The common method is that if the performance of a drug is worse than that used to support the clinical research approved by FDA, the insurance company can pay less, and if the drug performs better, it needs to pay more. According to these contracts, successful drugs will get full price coverage, or the payment price will be reduced proportionally for patients based on unsuccessful results. These contracts can provide real cost savings for taxpayers and suppliers, and can also provide more predictability for the overall cost.

With the greater friendliness of the medical system to electronic medical records and the wider use of RWE, the data collection required for these results will also become easier. However, unless the results are measurable, the administrative burden of all Parties will gradually escalate and become prohibitive.

10. A new round of biosimilars competition and opportunities appear

In 2018, the current total value of biotechnology expenditure in developed markets of US $19 billion will face the competition of biosimilars, which will be much higher than the US $3 billion biotechnology product expenditure that has already faced the competition of biosimilars in 2017.

It is worth noting that the new competition of biomimetic drugs exposed in 2018 is a single-year change so far, which also indicates the beginning of the next big wave of biomimetic drugs. The benefits of a functional biosimilars market are to expand access to drugs and save costs for public and private medical systems.