Indian Pharma Exports- Futuristic Opportunities & Challenges

• Indian pharma exports by the time the Pharmexcil (Pharmaceuticals Export promotion Council of India) was constituted in 2004-05 was merely USD 3.9 Bn. Pharmexcil was formed under Foreign Trade policy by the Department of Commerce, Govt of India in 2004 with an objective to promote the exports of pharmaceutical and allied products to the world
• Exports were outperformed in the last 20 years from
• USD 3.9 Bn (FY 2004-05) —-USD 14.9 Bn (FY 2014-15)—USD 27.85 Bn (FY 2023-24)
• Total CAGR from FY-2005 to FY-2024 was 11%
• In the last 6 years, exports were grown from 17.3Bn (2017-18) to 27.85Bn (2023-24) with CAGR of 8.25% and is projected to reach 55 Bn by 2030.
• India’s role in the Covid19 pandemic, who not only developed an indigenous vaccine, but shared the same with over 100 countries, making us a literal ‘Powerhouse of Vaccines’.
• According to a recent EY FICCI report, as there has been a growing consensus over providing new innovative therapies to patients, Indian pharmaceutical market is estimated to touch USD130 billion in value by the end of 2030.

The global pharmaceutical market, valued at USD 1,493 billion in 2023 & the generic market was 482 Bn in 2023.

Exports in FY- 2023-24:

• Exports valued $27.85 Bn with a Growth of 9.66% against the exports of 2022-23 ($25.4Bn)
• Formulations and biologicals holds major share accounting for 73.75% during this period with a value of $20.54 Bn. Our exports in this category have expanded by 11.33%.
• The second major category by value is Bulk drugs and drug intermediates. During Apr-Mar FY24 this segment grew marginally by 1.60%. The value of exports in this category was USD 4755.22 million.
• The value of exports in Vaccines was USD 1187.99 Million and it grew by 16.75%.

Region wise Exports:

• NAFTA accounted for a share of 34.40% of our exports. During Apr-Mar FY24, exports to this region reached USD 58 Billion and the region grew by 14.44%. One of the highest growth rates for this region in recent years and also one of the highest during this period.
• Followed by Europe with export value of USD 5.58 Billion having a share of 20.05% of our Region grew by 10.93%.
• Africa which was under negative trend in last FY has bounced back and recorded a growth of 18% with exports value of USD 3.95 Billion

• All regions except for CIS have registered a positive growth during the period of Apr-Mar CIS exports were USD 965.87 million with a degrowth of -3.85%
• Emerging regions are LAC & WANA . LAC is 4th largest region with exports of USD 82 Bn (5.88% Growth). WANA continuously outperforming with Growth rates of 11.13% this year (exports- USD 1.64 Billion) and 10.84% last FY .

Countries:

• India’s top 3 countries for pharma exports during FY23-24 were USA, UK and South
• Exports to USA, which account for 35% of our exports in pharma products, have expanded by 15.66%. Our exports to the USA were valued at USD 8728.60 million during FY24.
• UK emerged as second largest destination- valued at USD 784 million with growth of 21.12%

USA:

• The S., India’s largest export market for pharmaceuticals, relies heavily on Indian pharmaceutical companies. In 2022, Indian companies supplied four out of ten prescriptions filled in the U.S. They provided 47% of all generic prescriptions and 15% of the volume of biosimilars
• In 2022, medicines from Indian companies saved the U.S. healthcare system USD 219 billion, with total savings of USD 1.3 trillion from 2013 to 2022. Generics from Indian companies are expected to generate an additional USD 3 trillion in savings over the next five years

USA Approvals:

• India has the maximum no. of US FDA-approved manufacturing sites outside the USA. India is home to 10% of the finished dosage form (FDF) facilities and 19% of the API facilities
  that are supplied to the US.
• India’s industry has been continuously awarded with more than 30% of USFDA’s market authorizations during the last five years. During 2023 almost 44% of Market
  authorizations are granted to India companies (This is inclusive wholly owned India subsidiaries abroad).
• No.of USA approved sites- 748
• ANDA Market Authorisations granted to India based companies- 6440
• Total no.of DMFs- 5637

Imports:

• Though India’s imports during the period of Apr-Mar FY24 have increased marginally by 1.98% (from USD 8.10 Bn in FY-23 to USD 8.26 Bn in FY-24), it still lower than that of FY-22 (USD 9.07 Bn)

• India’s major categories of pharma products imported during Apr-Mar FY24 were Bulk Drugs and Drug Intermediates which comprised of over 55% of India’s total pharma imports. The value of imports in this category was USD 4.56 Billion & increased by 1.27%.
• Imports from China increased by 2.57% with a import value of USD 3.59 Billion

April-May 2024-25 Exports:

• Pharma exports recorded 8.85% Gr during first two months of this FY (Apr-May 2024-25).
• Exports valued at 4730.66 mn USD as against 4346.03 mn USD (May – 10.45% (USD 2.30 Bn – up from 2.08 Bn) (April – 7.36% (USD 2.43 Bn – up from USD 2.26 Bn)

Priority Areas:

• With the advent of Quality concerns raised by Global agencies on Indian made products, Pharmexcil priority has been shifted to quality management and imbibing quality culture in the industry by way of organising Capacity Building Programmes(CBP) in states with pharmaceutical prevalence to uphold the image of Indian pharma on global platform.
• As the CDSCO revised Schedule-M & contemplating to implement soon, the efforts of Pharmexcil in educating the industry through CBP would be a great value addition to industry efforts in that direction.

iPHEX:

• The 10th edition of the International Pharma Exhibition (IPHEX), a flagship event of the Pharmaceuticals Export Promotion Council of India (PHARMEXCIL) is being organised with the support of the Ministry of Commerce & Industry, Government of India during 28th-30th August 2024 at IEML, Greater Noida.
• About 440 exporters from India are showcasing their products & services in the exhibition and over 500 overseas business delegates from 120+ countries are expected to attend the iPHEX. We are expecting more than 10,000 domestic visitors for the exhibition.
• This iPHEX certainly will help showcase the capabilities of Indian pharmaceutical industry and also build up confidence among the global stakeholders.

Challenges:

1. Increasing Geo-Political tensions
2. Supply chain issues
3. Self-reliance measures & Localisations of pharma manufacturing by developed countries as well as developing nations.
4. Pricing pressures
5. Increased Scrutiny by Global regulatory agencies
6. Strong acumen of neighbouring countries – Bangladesh, Indonesia & Vietnam in Generics manufacture

Strategy for export growth:

1. PLI Scheme for Pharma: Study on “Strategies to Reduce Import Dependence” by Pharmexcil gave inputs on key molecules which are largely imported from China based on which DoP announced PLI scheme. With the new facilities coming up by Aurobindo Pharma for Penicillin- G, heavy reliance on China is going to be seized in coming years.
2. Biosimilar/Similar Biologics:CAGR growth of 11-12 % is definitely possible with pursuing opportunities in newer product classes such as Biosimilars, gene therapy and specialty drugs. Spurring innovation in R & D, Biosimilars can usher-in the next phase of growth for Indian pharma industry. The Global Biosimilars market has the potential to exceed USD 60 billion by 2030.
3. Off Patented Drugs: During 2023-29, 15 blockbusters (including biological products) are going off patent worth USD 112 bn which would provide a tremendous growth opportunity for Indian pharmaceutical companies by another USD 10 bn.
4. Innovation, Research & Development: The schemes and initiatives in this direction such as ‘Promotion of Research and Innovation in Pharma MedTech Sector (PRIP)’ announced by D/o Pharmaceuticals in August 2023 geared for industry-academia linkage for R&D in priority areas will lead to sustained global competitive advantage and facilitate new drug discovery and new treatment solutions.
5. Trade Agreements: India’s strategic approach of fast-track product registration/market authorisation mechanism for facilities & products approved by SRA countries helps in achieving higher growth
6. Harmonising Regulatory Standards and MRAs: Harmonising regulatory standards and also isigning the MRAs with emerging markets and MoUs with Stringent Regulatory Authorities (SRA) resulting in the fast track approvals of the products and plant inspections and augmenting the exports of pharmaceuticals.
7. Contract Manufacturing and CRO Facilities: As the demand for affordable generic and biosimilar grows, India’s distinct demographic advantage and skilled workforce vis-à-vis the developed world with capabilities in manufacturing the entire therapeutic profile across the supply chain puts it in a position to capture larger share in contract manufacturing and CRO facilities.
8. Joint Ventures/Collaborations- Post-COVID, most of the countries have realised the need for indigenous manufacturing and African nations are actively pursuing the goal of achieving self-sufficiency. This presents a unique opportunity for India to extend its support in terms of technology transfer and investments

ANNEXURE
Category Wise Pharma Exports
Table 1: Product wise exports, ranked by share % for Apr-Mar, FY24 (Values in USD Million)

Region Wise Pharma Exports
Table 2: Region wise exports ranked by share % for Apr-Mar FY24 (Values in USD Million)

Country Wise Pharma Exports
Table 3: Country wise exports ranked by share % for Apr-Mar FY24 (Values in USD Million)