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The trends and future Trajectory of biotech Clinical trials

 

 

In this report, data analyst and business intelligence firm GlobalData has partnered with Novotech, the Asia-Pacific CRO, to explore some of the trends seen in the past year using data analysis to share some perspectives on what’s next in the industry.

The paper looks at the trends in CRO activity including data showing that the Asia-Pacific is forecast to have 24% of the global CRO market by 2024.

It also explores the evolution of the clinical drug development market since 2018, including the ongoing shift in drug development from big pharma to biotechs, as well as the partnerships in clinical outsourcing.

Market changes in biotech clinical R&D

In recent years the industry has seen a significant shift in R&D towards biotechs. For example, of the 53 new drug approvals by the FDA in 2020, 39 of the 53 were from biotechs, with only 13 attributed to pharma firms. This is 10 more biotech drug approvals than in 2018. Therefore, biotechs accounted for 74 per cent of the drug development market in 2020 for biotechs compared to just 25 per cent for big pharma.

In further proof of biotechs' "takeover" of the drug development and medical devices industries is the finding from British pharma intelligence firm EvaluatePharma, that biotech-produced therapies are forecast to represent 35% of drug sales in 2026, compared to less than 30% in 2019. Plus emergent and established biotechs raised close to US $100 billion in equity capital in 2020, according to data from biopharma intelligence firm BCIQ (a 70 per cent rise from 2019). Based on current data we can expect large investments into clinical R&D from biotechs in the coming years.

New drug approvals by the FDA per sponsor type (2018 – 2020)1

Another trend in drug development is the shift towards orphan drug development. In fact, the total sales for orphan drugs is forecast to grow to US $255 billion in 2026 – up from US $127 billion in 2019 (+10% CAGR), while the overall prescription drug sales are forecast to grow by +7% CAGR over the same period.2

Increased need for outsourcing

With innovation shifting from big pharma to biotechs, the industry expects to see greater level of R&D outsourcing, especially for clinical drug development. This is further accelerated by an increased focus on cutting-edge drug therapies, an increase in orphan drug development and the use of more complicated protocols.

According to Frost & Sullivan, the percentage of R&D spend outsourced is expected to grow from 24% in 2017 to 32% in 2024, increasing at 4% per annum – only slightly lower than the increase in medicine sales. The only exception to this is the Asia-Pacific region, forecast to show a higher growth in R&D expenditure at 9% CAGR over that period.3

Furthermore, Asia-Pacific is forecast to record the fastest growth in contract research organisation (CRO) outsourcing services, at 16% annually, and is forecast to account for 24% of the global CRO market by 2024. 3

So, what happens when these smaller biotechs need to outsource? These companies have different clinical outsourcing needs than big pharma and look for agile, pragmatic, transparent, outsourcing partners. Those partners need to be able to recruit for clinical trials speedily, efficiently and, if trends are to be followed, with a focus on oncology studies.

BOXOUT – Market Research

As part of a market research endeavour, biopharma intelligence group PharmaIntelligence conducted a survey with management-level stakeholders from the biotech sector. The survey was aiming to understand key trends in clinical outsourcing in the global biotech sector.

From data collected (between October to January 2021):

  • 64% are likely or very likely to increase their clinical outsourcing activity in the next three years.
  • 42% of respondents believed Asia-Pacific will see its share of global clinical trial activity grow significantly over the next three years, versus only 10% for North America and 14% for Europe.
  • 67% of respondents stated "fewer competing trials" as the reasons sponsors would prefer APAC as a clinical trial destination.

Why the Asia-Pacific region is ideal for outsourcing clinical R&D

The Asia-Pacific region has become a prime spot for clinical trials – even for pharmaceutical or biotechnical companies located in North America or Europe.

As biopharma companies increasingly focus their R&D efforts on rare indications, study protocols and designs become increasingly complex, and so does patient recruitment. Biotech companies are increasingly turning to the Asia-Pacific for such trials given the size of patient pools in the region. We estimate over 45 million people may be suffering from a rare condition in Asia, with 10 million people in China alone.4,5

While Australia and New Zealand are preferred locations to run early-phase trials, sponsors often look to Asia for large, late-phase clinical studies.

According to business data insights firm GlobalData, the median number of patients recruited in oncology clinical trials involving sites in the Asia-Pacific region was about 30% higher than the global median (2020 trials). 6

It was also found that about half of all oncology studies initiated worldwide in 2019 involved sites in Asia-Pacific and the number of oncology clinical trials in the region grew by +13% each year on average between 2017 and 2019.

Median number of patients recruited per oncology trial across regions (2020 trials) 6

Moreover, most Asian countries lack systematic reimbursement of standard of care which means clinical trials are often the only channel that patients can access novel treatments. This ultimately stimulates recruitment rates and encourages patient adherence to research therapies.

Pull quote: "I think the biggest difference between the APAC and, say US sites, again is really that strong engagement by the investigators and the sites in terms of enrolling the right patients for your drug based on the proposed mechanism of action"

- Executive Vice President and Chief Medical Officer at US West Coast Biopharma

Planning for drug development

As shown earlier in this white paper, biotechs are on the rise and will continue to capture more of the drug development market share. With smaller R&D budgets than big pharma, there is a need to optimise the resources they invest in R&D and one of the keys to making sure that R&D spend, effort and time are used to the fullest is to have a drug development plan (DDP). If these are not carefully thought through, it can lead to biotechs having to rerun clinical studies.

Pull quote: "I think the gold standard is go to the regulator early and as frequently as you possibly can. I think a lot of sponsors had traditionally shied away from the regulator, wanting to have sufficient data to go to them”. [For biotechs, it is critical] to make sure there is no wasted capital in having to repeat studies, or having to do the wrong studies and do them again".

- An R&D director at a biotech company

A DDP is a critical element to successfully establishing an intelligent clinical development program pathway and while biotechs may not have sufficient R&D budget, personnel or pre-clinical time, outside consultants such as CROs are often an important partner in drug development. Working with external regulatory affairs and product development partners is vital to avoiding unexpected regulatory hurdles and cost as well as positioning the company to attract and satisfy investors.

How can a DDP help biotechs?

A DDP describes the steps that are required to generate the evidence to support marketing authorisation and reimbursement. It includes CMC quality requirements, nonclinical requirements and the type and scope of clinical studies that are going to be needed to support the registration of the product.

Planning for drug development will often require looking at similar competitor products on the market or are currently in development. This forms not only an important part of commercial analysis, but also provides really useful information on the kinds of studies and information that will be needed to support the marketing authorisation of the product.

In addition to what might be the typical Phase I, II and III programme, a DDP highlights additional requirements or studies that might be needed to support the application, such as clinical studies in special populations, or drugdrug interaction studies. CROs are experienced in providing biotechs with clear outlines of studies required, and the evidence they will need to support existing studies.

Establishing a DDP also identifies ways to accelerate drug approval. It is important to make sure that the nonclinical package presented to a regulator is tailored to a specific product. There is a range of methods that companies should be aware of and a range of processes that the regulators offer in order to speed up drug approvals and drug development. They include orphan drug designation for a rare indication, and for products that are impacting lifethreatening disease there are options including breakthrough therapy and fast track designation programs.

    Worth Sharing?

    Citations:

  • 1. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2020
  • 2. EvaluatePharma white paper: World Preview 2020, Outlook to 2026
  • 3. a. b. Frost & Sullivan, Pharmaceutical and Contract Research Organization (CRO) Markets (October 2020)
  • 4. State of rare disease management in Southeast Asia. Shafie et al. Orphanet Journal of Rare Diseases (2016) 11:107. DOI 10.1186/s13023-016-0460
  • 5. Challenges in orphan drug development and regulatory policy in China. Cheng and Xie Orphanet Journal of Rare Diseases (2017) 12:13. DOI 10.1186/s13023-017-0568-6
  • 6. a. b. GlobalData. Novotech Analysis
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